Registered at the EFTA Court under N°E-9/23-1 on 26 day of July 2023
Brussels, 26 July 2023
Case No: 84708
Document No: 1111403
ORIGINAL
IN THE EFTA COURT
APPLICATION
submitted pursuant to Article 31(2) of the Agreement between the EFTA States
on the Establishment of a Surveillance Authority and a Court of Justice by
THE EFTA SURVEILLANCE AUTHORITY
represented by Claire Simpson, Erlend Møinichen Leonhardsen,
Marte Brathovde and Ewa Gromnicka
Department of Legal & Executive Affairs,
acting as Agents,
AGAINST
THE KINGDOM OF NORWAY
Seeking a declaration that Norway, in relation to certain national rules and practice
governing access to in-patient treatment in other EEA States, has breached Article
36 EEA, Article 20(2) of Regulation 883/2004 and/or Article 3 EEA, as well as the
principle of legal certainty.
Avenue des Arts 19H, B-1000 Brussels, tel: +32 2 286 18 11, www.eftasurv.int
Table of Contents
1 INTRODUCTION .................................................................................................... 1
2. SUMMARY OF PLEAS-IN-LAW ................................................................................. 3
3 PRE-LITIGATION PROCEEDINGS AND BACKGROUND ...................................... 4
4 RELEVANT LAW .................................................................................................... 7
4.1 EEA LAW ......................................................................................................... 7
4.1.1 The right to in-patient treatment abroad under Article 36 EEA ................... 7
4.1.2 The right to in-patient treatment abroad under Regulation 883/2004 ......... 8
4.1.3 Article 3 EEA ............................................................................................. 8
4.2 NATIONAL LAW ............................................................................................... 9
4.2.1 Introduction: Entitlement to In-patient Treatment under Norwegian law ..... 9
4.2.2 The National Insurance Act: Implementation of Regulation 883/2004 in
Norwegian law ...................................................................................................... 11
4.2.3 The Patients’ Rights Act and the Prioritisation Regulation ....................... 11
5 THE AUTHORITY’S SUBMISSIONS .................................................................... 13
5.1 IN-PATIENT TREATMENT ABROAD: EEA LAW REQUIREMENTS .............. 13
5.2 FIRST PLEA: BREACH OF ARTICLE 36 EEA AND/OR ARTICLE 20(2) OF
THE REGULATION BY MAINTAINING IN FORCE CONFLICTING NATIONAL
PROVISIONS AND/OR BY FAILING TO APPLY EEA LAW CORRECTLY IN
PRACTICE ............................................................................................................... 17
5.2.1 Breach by maintaining in force at the First Compliance Deadline provisions
such as Section 2-1b(4) PRA and Section 6 PR and/or by failing to apply EEA law
correctly in practice ............................................................................................... 18
5.2.2 Breach by maintaining in force at the Second Compliance Deadline
provisions such as Section 2-1b(4) PRA and Section 6 PR................................... 20
5.2.3 Breach by maintaining in force at the First Compliance Deadline provisions
such as Section 2-1b(5) PRA and Section 3 PR and/or by failing to apply EEA law
correctly in practice ............................................................................................... 21
5.2.4 Breach by maintaining in force at the Second Compliance Deadline
provisions such as Section 2-4a(2)(a) PRA and Section 3 PR and/or by failing to
apply EEA law correctly in practice ....................................................................... 25
5.3 SECOND PLEA: BREACH OF ARTICLE 36 EEA AND/OR ARTICLE 20(2) OF
THE REGULATION BY MAINTAINING IN FORCE A COMPLAINT/APPEALS
STRUCTURE WHICH DISCOURAGES THE RELEVANT BODIES FROM APPLYING
EEA LAW CORRECTLY, AND WHERE THOSE BODIES FAIL TO APPLY EEA LAW,
IN BREACH ALSO OF ARTICLE 3 EEA ................................................................... 28
5.4 THIRD PLEA: FAILURE TO COMPLY WITH THE PRINCIPLE OF LEGAL
CERTAINTY IN BREACH OF ARTICLE 36 EEA AND ARTICLE 20(2) OF THE
REGULATION, AND/OR OF ARTICLE 3 EEA .......................................................... 40
5.4.1 The Requirement of Legal Certainty ........................................................ 40
5.4.2 The Norwegian Rules in Relation to In-patient Treatment Abroad are Not
Sufficiently Clear and National Bodies have not been Conferred Competence to
apply Article 20(2) of the Regulation under Sufficiently Clear National Rules ........ 41
5.4.3 Maintaining Conflicting Rules in Force Leads to Uncertainty ................... 46
5.4.4 Conclusion on the Third Plea ................................................................... 48
6 CONCLUSION ...................................................................................................... 49
SCHEDULE OF ANNEXES
1
1 INTRODUCTION
1. Access to healthcare is important for everyone. Access to healthcare in time (within
a medically-justifiable deadline) is even more important. EEA law therefore
recognises and requires this of States in certain circumstances.
2. This means that, while EEA States have discretion over how to organise their
healthcare systems (which benefits to confer, whether public or private operators
are involved, funding, etc), they must ensure that patients are not denied their basic
EEA rights to healthcare in time.1
3. This Application concerns in-patient treatment. That is, hospital treatment involving
at least one overnight stay.
4. The Authority’s case is that Norway has failed to respect the rights of patients to in-
patient treatment in other EEA States (“abroad”2) when the same or equally-
effective treatment is not available in time in Norway. Thus, Norway has acted in
breach of Article 36 EEA and Article 20(2) of Regulation 883/2004.3
5. This situation has gone on for years, despite extensive discussions between the
Authority and Norway. Norway has made law changes, but these have failed to
address the problems. The Authority has received complaints from patients and
patient groups since 2009, and continues to do so.
6. Norway’s failure to comply with EEA law is serious and systemic in nature. The
failure relates to patient rights under the Norwegian Patients’ Rights Act4 (“PRA”)
1
See further Parts 4 and 5 below. Such rights are conferred under: (i) Article 36 EEA; (ii) Article 20(2) of
Regulation 883/2004 (the Act referred to in Annex VI to the EEA Agreement, Regulation (EC) No 883/2004
of the European Parliament and of the Council of 29 April 2004 on the coordination of social security systems;
OJ L 166, 30.4.2004, p. 1, as amended (“Regulation 883/2004” or just “the Regulation”). Regulation
883/2004 was incorporated into EEA Agreement by EEA Joint Committee Decision No 76/2011 of 1 July
2011, with entry into force on 1 June 2012); and (iii) the Patients’ Rights Directive (Act referred to in point 2
of Chapter I of Annex VI to the EEA Agreement (Directive 2011/24 of the European Parliament and the Council
of 9 March 2011 on the application of patients’ rights in cross-border healthcare; OJ L 88, 4.4.2011, p. 45
(“the Patients’ Rights Directive” or just “the Directive”). The Patients’ Rights Directive was incorporated
into the EEA Agreement by EEA Joint Committee Decision No 153/2014 of 9 July 2014, with entry into force
on 1 August 2015.)
2
For ease of reference, “abroad” is used in this Application as meaning in another EEA State, unless
expressly stated otherwise.
3
And also of Article 3 EEA: see further Part 5 below. The Authority’s concerns in relation to Norway’s
implementation of the Directive are being addressed in other cases, and do not form part of the present
Application. The Directive does not affect EEA States’ obligations under Regulation 883/2004 (see inter alia
Recital 28 and Article 2(m) of the Directive) nor under Article 36 EEA (see inter alia Recitals 10, 12, 21, 26
and 27 of the preamble to the Directive). Instead, the Directive draws on the principles established by case-
law and sets out certain minimum standards (see Recital 8 to the Directive).
4
Act of 2 July 1999 No 63 on the Rights of Patients (Lov 2. juli 1999 nr. 63 om pasient- og brukerrettigheter).
2
and Prioritisation Regulation5 (“PR”). These provisions grant rights to in-patient
treatment both in the EEA and third countries. However, the PRA/PR contain
substantive provisions which are in conflict with EEA law, or fail properly to reflect
EEA law rights. The problem is compounded by procedural/jurisdictional provisions
which prevent or discourage the relevant complaint/appeals bodies from correctly
applying EEA law. The Authority has examined hundreds of decisions from such
bodies which reveal that EEA law (whether Article 36 EEA or Article 20(2) of the
Regulation) is not correctly applied in practice – or that EEA law is not applied at
all. There is an overwhelming lack of legal certainty: it is confusing for patients that
conflicting sets of rules are in force, and that there are provisions which are unclear
or internally contradictory. Further, it is unclear to which bodies they may complain
and whether such bodies even have competence to apply Article 20(2) of the
Regulation in order to secure patient rights.6
7. Norway denies that there is a problem, insisting inter alia that the PRA/PR system
is intended as an ‘extra’ (better) system which is not specifically designed to
implement EEA law. It points to the fact that other ‘routes’ are available to patients
to seek treatment abroad – in particular, a route designed to secure patient rights
under Article 20 of Regulation 883/2004.7
8. This contention misses the point and reveals the fundamental misunderstanding at
the heart of Norway’s approach to EEA patient rights: all national healthcare routes
which lead to in-patient treatment abroad must comply with EEA law. Further,
statistics provided by Norway show that the PRA/PR system is not simply an
‘additional’ system, or one of little importance. In for example the period 2016-2021,
111 applications were received for treatment abroad under Norway’s ‘Regulation
883/2004’ system, while in the same period 1835 applications were received for
treatment abroad under just one part of the PRA/PR system.8
5
Regulation of 1 December 2000 No 1208 on Prioritisation of Health Services and the Right to Treatment
Abroad (Forskrift 1. desember 2000 nr. 1208 om prioritering av helsetjenester, rett til nødvendig helsehjelp
fra spesialisthelsetjenesten, rett til behandling i utlandet og om klagenemnd).
6
See further Part 5 below.
7
See further paragraphs 50 et seq. below.
8
Norway’s Reply to the Supplementary Reasoned Opinion (Annex A.1), pp. 5. 6 and 9. Further, it can be
seen from p.5 that the numbers of applications under the ‘Regulation 883/2004 system’ are diminishing year
on year: from 200 in 2014 to just 10 in 2021. For completeness, it should be noted that patients are entitled
to travel to third countries under the PRA/PR system, but from the Authority’s examination of relevant
decisions, it can be seen that very significant numbers of such applications relate to travel to other EEA States
(see Part 5.3 below).
3
9. In short, whether or not Norway intended it to be the case, the PRA/PR system
plays a major role in the lives of patients seeking access to in-patient treatment in
other EEA States. Through the breaches of EEA law set out in Part 5 below, Norway
has adversely affected patient rights. The Authority requests the Court to grant the
declaration sought, in order that the various breaches be remedied as soon as
possible, and patient EEA law rights be restored.
2. SUMMARY OF PLEAS-IN-LAW
10. FIRST PLEA: Article 36 EEA and Article 20(2) of Regulation 883/2004 confer on
patients the right to seek treatment abroad where the same or equally-effective
treatment cannot be provided in the home State within a time limit which is
medically justifiable, taking into account the patient’s current state of health and the
probable course of their illness (“the Right to EET in Time”). By maintaining in
force national provisions which are in conflict with, or do not correctly reflect this
right, and/or by failing correctly to apply Article 36 EEA and/or Article 20(2) of
Regulation 883/2004 in practice, Norway has acted in breach of Article 36 EEA
and/or Article 20(2) of Regulation 883/2004:
(i) At the First Compliance Deadline9: ss. 2-1b(4) PRA and 6 PR restricted the
ability of patients to seek treatment abroad when the medically-justifiable
deadline for treatment could not be met. Patients could not travel freely
abroad on expiry of the deadline but were required to contact the Norwegian
Health Economics Administration (“Helfo”).10
(ii) At the Second Compliance Deadline11: ss. 2-1b(4) PRA and 6 PR do not
provide any right for patients to seek treatment abroad when the deadline
cannot be met: any such right was removed by the Norwegian legislature with
effect from 1 March 2020. Prior to this date, the provisions were problematic
as set out at (i) above.
(iii) At the First Compliance Deadline: ss. 2-1b(5) and 3(4) PR were framed
and/or applied in such a way that the existence of waiting lists (lack of
capacity) was not taken into consideration and thus whether treatment could
9
20 January 2018.
10
In Norwegian: Helfo (The Authority understands that while this entity was previously named
Helseøkonomiforvaltningen, abbreviated to Helfo, it is now formally named Helfo and will be referred to as
such in this Application).
11
22 December 2022.
4
be given within a medically-justifiable deadline was not considered correctly
or at all.
(iv) At the Second Compliance Deadline: ss. 2-4a(2)a PRA and 3 PR (which
replaced the provisions mentioned immediately above) require the patient to
document that the treatment abroad is more effective than the national
treatment (a higher threshold than the same or equally-effective), and fail to
include any deadline within which treatment must be given.
11. SECOND PLEA: At the Second Compliance Deadline and at least since the
First Compliance Deadline, Norway has failed to secure patient rights to EET in
Time, in breach of Article 36 EEA and/or Article 20(2) of Regulation 883/2004, by:
(i) maintaining PRA/PR jurisdictional/procedural rules which prevent and/or
discourage the PRA/PR complaint/appeal bodies from correctly applying the
Right to EET in Time;
(ii) maintaining an administrative/decisional practice of the PRA/PR
complaint/appeal bodies which fails correctly to apply or secure the Right to
EET in Time, in breach also of Article 3 EEA.
12. THIRD PLEA: At the Second Compliance Deadline and at least since the First
Compliance Deadline, the unclear and/or conflicting national rules and practice,
and the national PRA/PR complaint/appeals procedure and practice breaches the
principle of legal certainty and undermines the effectiveness of Article 36 EEA and
Article 20(2) of the Regulation, in breach of those provisions and/or of Article 3 EEA.
13. The specifics of each breach are set out in Part 5 below.
3 PRE-LITIGATION PROCEEDINGS AND BACKGROUND
14. Having received complaints about the Norwegian system for in-patient treatment
and the ability to receive such treatment abroad, the Authority decided in 2009 to
conduct an own-initiative assessment of the relevant Norwegian rules. Between
2009 and 2013 the Authority and the Norwegian Government engaged in detailed
discussions about the issues raised in the complaints and the related rules.12
12
For details, see Section 1 of the Authority’s initial letter of formal notice of 14 May 2014 (Annex A.2). Since
2009 and until today, the Authority has received a number of letters and e-mails from patients and patient
groups in Norway with difficulties accessing in-patient treatment and other forms of healthcare in other EEA
States: see e.g. the letter from the Authority to Norway of 12 December 2013, referring to complaints received
(Annex A.3). The most recent examples include meetings with the Norwegian Cancer Association on 28 June
5
15. On 14 May 2014, the Authority issued a letter of formal notice to the Norwegian
Government13 concluding that, by maintaining in force certain provisions of national
law which affected the rights of patients to receive in-patient treatment abroad, or
to be reimbursed for such treatment, Norway had failed to meet its obligations under
Article 20 of Regulation 883/2004 and/or Article 36 EEA. The Government did not
accept that the Authority’s concerns were well-founded.14 Nevertheless, in its reply
of 15 August 2014 it explained that legislative amendments had been proposed
which would address some of the reimbursement-related issues raised by the
Authority.15 It indicated that it was also considering providing additional information
and clarifications in relation to rights to healthcare abroad, thus enhancing legal
certainty.16
16. Despite the adoption of legislation extending the Norwegian reimbursement
scheme to in-patient treatment abroad,17 the Authority considered that the rest of
its concerns had not been addressed and on 3 February 2016 issued a
supplementary letter of formal notice.18 Further to the incorporation of the Patients’
Rights Directive into the EEA Agreement, the Authority concluded that the relevant
Norwegian law was also or alternatively in breach of various articles of the Directive.
The Norwegian Government replied by letter of 3 May 2016.19
17. The Authority did not consider Norway’s reply wholly satisfactory, nor did it consider
that any legislative amendments made to the relevant provisions since the
supplementary letter of formal notice had addressed its concerns. On 20
September 2017 it therefore delivered a reasoned opinion to Norway.20 By letter
dated 19 January 2018, the Norwegian Government replied,21 maintaining that
and 22 November 2022 (where the Association explained difficulties they had faced in securing EEA law
rights for patients in the Norwegian administrative and judicial system), and a letter on behalf of 846 patients,
who complained that their rights to treatment in other EEA States were not secured: see Annex A.4 (the
Authority has not included the attached petition as it contains a large amount of personal data).
13
Annex A.2.
14
Reply of the Norwegian Government of 15 August 2014 (Annex A.5).
15
Annex A.5, p.5.
16
Annex A.5, pp. 17, 18.
17
See Regulation of 17 December 2014 No 1712, amending Regulation of 22 November 2010 No 1466 on
Benefits for Health Services Received in Another EEA Country (Forskrift av 22. November 2010 nr. 1466 om
stønad til helsetjenester mottatt i et annet EØS-land) (“the Reimbursement Regulation”). The amendments
entered into force on 1 March 2015. See also Norway’s Reply to the Letter of Formal Notice (Annex A.5),
pp.7, 8.
18
Annex A.6.
19
Annex A.7.
20
Annex A.8.
21
Annex A.9.
6
there was no breach of EEA law. It nevertheless explained how, with effect on 1
January 2018, a number of amendments had been made to the relevant provisions
to remove any doubt as to how they were intended to operate, or to clarify their
operation. By letter dated 11 April 2018, Norway also informed the Authority of
further assessments, planned changes in the legislative framework and practical
improvements planned in order to ensure an easily accessible system.22
18. The Authority considered the legislative amendments to be unsatisfactory, and
decided on 18 December 2019 to refer the matter to the EFTA Court.23 In the course
of preparing its application to the Court, the Authority, having received and
assessed additional information from a complainant, sent a request for information
to the Norwegian Government (“the RQI”) on 7 May 2021.24 In light of the reply to
the RQI,25 and having examined further legislative changes which the Norwegian
Government introduced after the expiry of the First Compliance Deadline,26 the
Authority decided to issue a second supplementary letter of formal notice on 18
May 2022.27
19. The Authority considered the Norwegian Government’s reply of 8 July 202228 to the
second supplementary letter of formal notice to be unsatisfactory. On 22 October
2022, the Authority issued a supplementary reasoned opinion (“the
Supplementary Reasoned Opinion”).29 One of the Authority’s concerns was that
the manner in which Regulation 883/2004 had been incorporated into Norwegian
law meant that the Regulation’s provisions would not prevail over conflicting
provisions of national law: in this case, the PRA. The Authority considered this to
be in breach of Articles 3 and 7 and Protocol 35 EEA (“the Protocol 35 issue”).
The Norwegian Government replied on 20 December 202230 (“the Second
Compliance Deadline”), maintaining its position that the relevant Norwegian law
was in compliance with EEA law. Nevertheless, Norway amended the manner in
which Regulation 883/2004 had been incorporated into Norwegian law, with entry
22
Annex A.10.
23
Annex A.11, Decision No 091/19/COL.
24
Annex A.12.
25
Annex A.13.
26
See Parts 5.2.2 and 5.2.4 below.
27
Annex A.14.
28
Annex A.15.
29
Annex A.16.
30
Annex A.1.
7
into force on 25 November 2022.31 The Authority considers that this sufficiently
resolved the Protocol 35 issue by the Second Compliance Deadline. Other issues
raised by the reasoned opinion and supplementary reasoned opinion however
remain, and Norway still fails to ensure patients’ rights to access in-patient
treatment in other EEA States, in breach of its EEA law obligations. The Authority
therefore submits the present Application to the Court.32
4 RELEVANT LAW
4.1 EEA LAW
4.1.1 The right to in-patient treatment abroad under Article 36 EEA
20. Article 36 EEA provides that there shall be no restrictions on the freedom to provide
services within the EEA in respect of EEA State nationals who are established in
an EEA State other than that of the person for whom the services are intended.
21. It is settled case-law that medical activities (including in-patient treatment) fall within
the scope of the freedom to provide services guaranteed by Article 36 EEA.33 EEA
States are therefore prohibited from introducing or maintaining unjustified
restrictions on the exercise of that freedom in the healthcare sector.34
22. National legislation must conform with both Article 36 EEA and Article 20 of the
Regulation. It is settled case-law that the application of Article 20 to a situation does
not mean that the freedom to provide services does not apply at the same time.35
31
Until 25 November 2022, Regulation 883/2004 was made part of Norwegian law by a national regulation
(‘forskrift’), which gave Regulation 883/2004 the status of a regulation in the national legal hierarchy. This
meant, inter alia, that Regulation 883/2004 would not prevail over conflicting provisions of earlier law, such
as the PRA (this is because s.2 of the Norwegian EEA Act provides that EEA law implemented via national
regulations will only prevail over later laws: in Norwegian: Lov 27. november 1992 nr. 109 om gjennomføring
i norsk rett av hoveddelen i avtale om Det europeiske økonomiske samarbeidsområde (EØS) m.v.). Further,
until 25 November 2022, the national regulation had a provision listing national acts over which it was intended
that the national regulation, and by virtue of that also Regulation 883/2004, would prevail. The PRA was not
on that list. As a consequence of these factors, the Authority considered that Regulation 883/2004 did not
prevail over conflicting provisions of the PRA, in breach inter alia of Protocol 35 EEA: see further the
Supplementary Reasoned Opinion (Annex A.16), Sections 3.1 and 4.2.
32
Annex A.17, Decision No 107/23/COL to refer the case to the EFTA Court.
33
Judgment of 19 December 2008, Case E-11/07 and E-1/08 Rindal and Slinning v Norway (“Rindal and
Slinning”), [2008] EFTA Ct. Rep, p.320, para. 42; judgment of 12 July 2001, Geraets-Smits and Peerbooms
v Stichting CZ Groep Zorgverzekeringen (“Smits and Peerbooms”), Case C-157/99, EU:C:2001:404, para.
53; Judgment of 13 May 2003, Müller-Fauré (“Müller-Fauré”), Case C-385/99, EU:C:2003:270, para. 38.
34
See e.g. judgment of 5 May 2021, Case E-8/20 Criminal Proceedings against N, para. 91; E-11/07 and E-
1/08 Rindal and Slinning, para. 43 and the case-law cited.
35
Judgment of 6 October 2021, TS, UT, VU v Casa Naţională de Asigurări de Sănătate (“TS”), C-538/19,
EU:C:2021:809, para. 32; judgment of 5 October 2010, Elchinov v Natsionalna zdravnoosiguritelna kasa
(“Elchinov”), Case C-173/09, EU:C:2010:581, para. 38; judgment of 16 May 2006, Watts v Bedford Primary
Care Trust and Secretary of State for Health (“Watts”), Case C-372/04, EU:2006:325, paras. 46-48. See also
8
4.1.2 The right to in-patient treatment abroad under Regulation 883/2004
23. Article 20 of Regulation 883/200436 provides:
“Travel with the purpose of receiving benefits in kind — authorisation to receive
appropriate treatment outside the [EEA] State of residence
1. Unless otherwise provided for by this Regulation, an insured person travelling to another
[EEA] State with the purpose of receiving benefits in kind37 during the stay shall seek
authorisation from the competent institution.38
2. An insured person who is authorised by the competent institution to go to another [EEA]
State with the purpose of receiving the treatment appropriate to his/her condition shall receive
the benefits in kind provided, on behalf of the competent institution, by the institution of the
place of stay, in accordance with the provisions of the legislation it applies, as though he/she
were insured under the said legislation. The authorisation shall be accorded where the
treatment in question is among the benefits provided for by the legislation in the [EEA]
State where the person concerned resides and where he/she cannot be given such
treatment within a time limit which is medically justifiable, taking into account his/her
current state of health and the probable course of his/her illness.
3. Paragraphs 1 and 2 shall apply mutatis mutandis to the members of the family of an
insured person.” (emphasis added)
4.1.3 Article 3 EEA
24. Article 3 EEA provides:
“The Contracting Parties shall take all appropriate measures, whether general or particular,
to ensure fulfilment of the obligations arising out of this Agreement.
They shall abstain from any measure which could jeopardize the attainment of the objectives
of this Agreement.
Moreover, they shall facilitate cooperation within the framework of this Agreement.”
E-11/07 and E-1/08 Rindal and Slinning, para. 41, where it was not clear whether authorisation had been
granted or applied for under Article 22 of Regulation 1408/71 (the predecessor to Article 20 of Regulation
883/2004) and the Court proceeded to consider the matter under Article 36 EEA; and judgment of 27 October
2011, Commission v Portugal (“Commission v Portugal”), Case C-255/09, EU:C:2011:695, para. 70.
36
Regulation 883/2004 largely replaced Council Regulation (EEC) 1408/71, see Article 90(1) of Regulation
883/2004. The main substantive content of these acts is, however, the same, especially as concerns Article
22 of Regulation 1408/71 and Article 20 of Regulation 883/2004. The case-law under Article 22 of Regulation
1408/71 is therefore relevant to the interpretation and application of Article 20 of Regulation 883/2004: see
e.g. judgment of 23 September 2020, WO v Vas Megyei Kormányhivatal, (“WO”) Case C-777/18,
EU:C:2020:745, paras. 41-42.
37
Article 1(va)(i) of the Regulation provides that “benefits in kind” means “for the purposes of Title III, Chapter
1 (sickness, maternity and equivalent paternity benefits) [thus including Article 20], benefits in kind provided
for under the legislation of a Member State which are intended to supply, make available, pay directly or
reimburse the cost of medical care and products and services ancillary to that care. This includes long-term
care benefits in kind.”
38
“Competent institution” is defined by Article 1(q) of the Regulation, and is generally the ‘home’ State
institution with which the patient is insured.
9
25. It follows from the principle of sincere cooperation that EEA States are under an
obligation to apply EEA law, including Regulation 883/2004, correctly,39 and to
disapply national provisions which conflict with provisions of EEA law which are
unconditional and sufficiently precise.40
4.2 NATIONAL LAW
26. For the convenience of the Court, all relevant provisions of national law (with
accompanying original Norwegian language versions) are set out in Annex A.18 to
this application (also referred to as “the Legislation Annex”).
4.2.1 Introduction: Entitlement to In-patient Treatment under Norwegian law
4.2.1.1 The basic entitlement to ‘necessary’ health care
27. Under Norwegian law, it is s. 2-1b(2) PRA which, in all cases, governs whether or
not a patient has the basic entitlement to the in-patient treatment sought. In other
words, this section acts as a ‘gatekeeper’ or ‘basic entry’ provision. The Norwegian
criteria for this basic entitlement to in-patient treatment are not in dispute. These
provisions are included to assist the Court by way of background.
28. Section 2-1b(2) PRA currently provides (the last sentence (in bold highlight) was
added at 1 January 2020):
“The patient is entitled to receive necessary health care from the specialist health service.
The specialist health service shall, within the assessment period pursuant to s. 2-2(1)
[PRA]41, set a time limit within which the patient shall at the latest receive the necessary
health care. The deadline shall be set in accordance with what professional responsibility
would require. […] The right to necessary health care applies to the services that the
specialist health service is responsible for providing and financing, cf. the Specialist
Health Services Act Sections 2-1 a and 4-4.”42
29. As such, at the expiry of the First Compliance Deadline, whether or not a patient
was entitled to a particular treatment under the Norwegian healthcare system was
39
Judgment of 14 December 2021, Case E-1/21 ISTM, para. 36; judgment of 14 December 2021, Norep v
Haugen Gruppen AS, para. 43 (principle of conform interpretation).
40
Judgment of 4 July 2023, Case E-11/22 RS v Fiscal Authority of the Principality of Liechtenstein (“RS”),
para. 41 (Article 3 and Protocol 35 EEA). This duty applies to all organs of State, including administrative
bodies: judgment of 4 December 2018, Minister for Justice and Equality, Case C-378/17, EU:C:2018:979,
para. 38.
41
Section 2-2(1) PRA provided, at both Compliance Deadlines, (and still provides today):
“The patient referred to the specialist health service shall, within 10 working days after the referral is received
by the specialist health service, receive information on whether he or she has the right to necessary health
care, cf. section 2-1 b second paragraph. The assessment shall be based on the reference. If a serious or
life-threatening illness is suspected, the patient is entitled to a faster assessment. If the patient is considered
to be entitled to the necessary health care, the patient must at the same time be informed of when the
investigation or treatment should be commenced.” See the Legislation Annex, (Annex A.18). p. 2.
42
Section 2 PR further clarifies when a patient will be considered entitled to necessary healthcare, within the
meaning of Section 2-1b(2) PRA. See Legislation Annex, (Annex A.18) pp. 2-3.
10
a need-based one: provided the in-patient (or other specialist) treatment was
considered ‘necessary,’ within the meaning of the relevant national law, the patient
was entitled to receive such in-patient treatment. As of 1 January 2020, thus
including at the expiry of the Second Compliance Deadline, the Norwegian
healthcare system moved closer to a nationwide ‘list’ based system of specialist
healthcare treatments to which patients are entitled, referred to in s. 4-4 of the
Specialist Health Services Act. The Authority does not take issue with this system
in this case and, importantly, the basic requirement (above) that the treatment must
be ‘necessary’ remains.
30. The Authority refers to the test as set out in s. 2-1b(2) PRA and s. 2 PR,
cumulatively, as “the Necessity Test.” Where the criteria in those sections are met,
the patient is entitled to receive the necessary healthcare from the specialist health
service within the time limit mentioned therein (“the National Time Limit”).
4.2.1.2 The three different Norwegian routes to in-patient treatment in the EEA
31. Once a patient has the basic entitlement to in-patient treatment (i.e. has met the
Necessity Test under the PRA), there are three different ways in Norwegian law to
seek publicly paid in-patient treatment abroad:
(i) the Patients’ Rights Act (and related Prioritisation Regulation).
(ii) Regulation 883/2004, as incorporated into Norwegian law,
(iii) the national provisions implementing the Patients’ Rights Directive (which
provisions are, as explained in footnote 3 above, not at issue in the present
case).
32. In its correspondence with the Authority, the Norwegian Government has
consistently distinguished between these three different routes. Regulation
883/2004 and the Patients’ Rights Directive are described by the Norwegian
Government as having been incorporated into Norwegian legislation “in order to
fulfil [Norway’s] obligations according to EEA law”.43 Norway describes the Patients’
Rights Act, with further implementing provisions in the Prioritisation Regulation, as
a “third set of rules (under the PRA and PR)” which “has a different function and
character”44 and gives “additional rights to access to health care abroad.”45
43
Reply to the RQI, (Annex A.13), p.3.
44
Reply to the RQI (Annex A.13), p.3.
45
Reply to the 2016 Supplementary Letter of Formal Notice (Annex A.7), p.2.
11
33. The focus of the present application is Regulation 883/2004 and the Patients’
Rights Act. Only the related Norwegian provisions are therefore set out below.
4.2.2 The National Insurance Act: Implementation of Regulation 883/2004 in
Norwegian law
34. With effect commencing 25 November 2022, Regulation 883/2004 was made part
of Norwegian law by Section 1-3a(1) of the National Insurance Act (“NIA”).46 The
provisions of Regulation 883/2004 therefore apply ‘as such’ in Norwegian law. The
incorporation through s. 1-3a(1) NIA gives the Regulation the status of an act in the
Norwegian legal hierarchy.47 As a consequence, Regulation 883/2004, as
incorporated, should prevail over conflicting provisions of national law.48
35. Further, Section 1-4(2) of the PRA, as it was adopted with effect commencing 25
November 2022, provides that provisions of the PRA or made pursuant to the PRA
(e.g. the PR) shall be deviated from to the extent necessary to comply with
obligations arising from, inter alia:
(i) the ‘main part’ of the EEA Agreement;49 and
(ii) regulations mentioned in s. 1-3a NIA, meaning Regulation 883/2004 and its
implementing regulation.50
36. Consequently, insofar as provisions of the PRA and/or the PR conflict with, inter
alia, Article 36 EEA and/or Regulation 883/2004, the EEA law provisions should
prevail.
4.2.3 The Patients’ Rights Act and the Prioritisation Regulation
4.2.3.1 Substantive provisions: entitlement to necessary healthcare abroad
37. Where patients are entitled to in-patient treatment nationally (i.e. the Necessity Test
under the PRA is met), the PRA and PR conferred and confer certain further rights
to such treatment abroad.
46
See the Legislation Annex (Annex A.18), p.4.
47
This means that the first issue explained at footnote 31 above should no longer arise: that is, Regulation
883/2004 is now incorporated as a national act, rather as a national regulation, which means under s.2 of the
Norwegian EEA Act that it should prevail in case of conflict over later and earlier laws.
48
Section 2 of the Norwegian EEA Act.
49
The Authority understands that Norway’s reference to the ‘main part’ of the EEA Agreement is intended to
refer to the 129 articles of the Agreement, but not its protocols and annexes, cf. Article 2(a) EEA, which clearly
distinguishes between the “main Agreement”, and the protocols and annexes to the Agreement (and the acts
referred to therein).
50
The Implementing Regulation (Regulation (EC No 987/2009) was incorporated into EEA Agreement by
EEA Joint Committee Decision No 76/2011 of 1 July 2011, with entry into force on 1 June 2012.
12
38. At the First Compliance Deadline, s. 2-1b(4) and (5) PRA51 provided that patients
were entitled to treatment abroad in two situations: when the National Time Limit
would be breached, and when there was a lack of adequate medical care in
Norway, respectively.
39. At the Second Compliance Deadline, s. 2-1b(4) PRA no longer confers any type of
right to in-patient treatment abroad when the National Time Limit will be
exceeded,52 while s. 2-1b(5) PRA has been repealed, and replaced by s. 2-4a(2)a
PRA. Section 2-4a(2)a PRA provides inter alia a right to treatment abroad if the
patient can establish that it is more effective than the national treatment.53
40. These provisions (and the related provisions of the PR) are set out in full in the
Legislation Annex (Annex A.18), and are also considered in Part 5 below.
4.2.3.2 Procedural provisions: patient rights of complaint/appeal
41. At the First Compliance Deadline, s. 7-2(1) and (2) PRA54 provided that complaints
about a breach of s. 2-1b(4) PRA (breach of the National Time Limit) must go to
the County Governor,55 while complaints about a breach of s. 2-1b(5) PRA (lack of
adequate medical care in Norway) must be made to the Appellate Body for
Treatment Abroad (“Appellate Body”).56
42. At the Second Compliance Deadline, s. 7-2(1) and (2) PRA had been amended to
refer to s. 2-4a(2)a PRA (rather than the repealed s. 2-1b(5)), but continue to
require patients:
(i) to complain about breaches of the s. 2-1b(4) PRA time-limit to the Country
Governor; and
(ii) to complain about breaches of s. 2-4a(2)a PRA to the Appellate Body.
51
Supplemented by ss. 6 and 3 PR, respectively, see the Legislation Annex, (Annex A.18) pp. 8-9.
52
The right in the related s. 6 PR has similarly been removed, see the Legislation Annex (Annex A.18) pp.
9-10 and related footnotes.
53
The preparatory works provide: "The right which until now has been regulated in § 2-1 b fifth subsection is
moved to new § 2-4 a second subsection letter a where the right is further specified and put in context with
other coverage schemes for health care abroad. Reference is made to chapter 5 for a more detailed
explanation" (Prop. 80 L (2018-2019) Endringer i pasient- og brukerrettighetsloven mv. (helsehjelp i utlandet),
p. 22). The related s. 3 PR has been amended accordingly.
54
And the related ss. 3, 7 and 8 PR, see the Legislation Annex (Annex A.18), pp. 8 and 11.
55
In Norwegian: Statsforvalteren.
56
In Norwegian: Klagenemnda for behandling i utlandet.
13
43. These provisions (and the related provisions of the PR) are again set out in full in
the Legislation Annex and, where relevant, in Part 5 below. For the convenience of
the Court, a diagram of the different complaint and appeals routes (and the relevant
bodies) can be found in Annex A.19.
5 THE AUTHORITY’S SUBMISSIONS
5.1 IN-PATIENT TREATMENT ABROAD: EEA LAW REQUIREMENTS
44. The Authority recognises that, in the absence of harmonisation at EEA level, States
remain free to organise their social security and healthcare systems and to
determine the conditions for the granting of in-patient treatment, provided that EEA
law is complied with.57 In the present case, this means, in accordance with settled
case-law, respecting the requirements of both Article 20 of Regulation 883/2004
and Article 36 EEA. The application of Article 20 to a situation does not mean that
the freedom to provide services does not apply at the same time.58 Further, Article
20 must be interpreted in the light of the case-law on the freedom to provide
services.59
45. States may provide for an authorisation system for seeking healthcare abroad,
provided it is suitably justified and proportionate.60 However, it is settled case-law
that Article 20(2) of Regulation 883/2004 and Article 36 EEA require that patients
must be permitted to travel abroad for in-patient treatment where two conditions
are satisfied:
(i) First Condition: the treatment in question must be among the benefits provided
for by the legislation in the State where the person concerned resides (i.e.
Norway);
(ii) Second Condition: cumulatively, the (i) same or equally effective treatment
compared with the treatment abroad cannot be provided in the home/residence
State (“the EET Element”); (ii) within a time limit which is medically-justifiable,
57
See e.g. E-11/07 and E-1/08 Rindal and Slinning, para. 43; C-173/09 Elchinov, para. 40; C-372/04 Watts,
para. 92; C-157/99 Smits and Peerbooms, paras. 44-46.
58
See e.g. C-173/09 Elchinov, para. 38; C-372/04 Watts, paras. 46-48. See also E-11/07 and E-1/08 Rindal
and Slinning, para. 41, where it was not clear whether authorisation had been granted or applied for under
Article 22 of Regulation 1408/71 (the predecessor to Article 20 of Regulation 883/2004) and the Court
proceeded to consider the matter under Article 36 EEA; and C-255/09 Commission v Portugal, para. 70.
59
C-538/19 TS, para. 32.
60
See e.g. C-385/99 Müller-Fauré, paras. 83-85; and E-11/07 and E-1/08 Rindal and Slinning, para. 48.
14
taking into account the person’s current state of health and the probable course
of their illness (“the Timing Element”).61
46. These two conditions therefore provide a type of ‘minimum guarantee’ for
patients:62 if healthcare to which they are entitled domestically is not available within
a reasonable time, they are entitled to go to another EEA State to receive the same
or equally-effective treatment. 63
47. Thus, when the two conditions are met:
(i) the patient must be authorised under Article 20(2) of Regulation 883/2004 (and
the national rules making that Regulation part of Norwegian law) to go abroad
for treatment.64 If such authorisation is unfairly refused, the patient has the right
to go abroad anyway, and to be reimbursed as if authorisation had properly
been given;65
(ii) independently of the patient’s rights under the Regulation,66 the patient must be
permitted under Article 36 EEA to go abroad for treatment, and to be reimbursed
accordingly.67
61
The case-law refers variously: (i) to a time-limit which is medically justifiable, taking into account the
person’s current state of health and the probable course of their illness (see e.g. Case C‑777/18 WO, para.
43, on Article 20 of Regulation 883/2004, and E-11/07 and E-1/08 Rindal and Slinning, para. 76, on Article
36 EEA); or (ii) to the treatment being provided “without undue delay” (see e.g. Case C-173/09 Elchinov, para.
65 (on the predecessor to Regulation 883/2004), and Case C-385/99 Müller-Fauré, para. 89 (on Article 56
TFEU)). The CJEU noted the use of these different terms in C-372/04 Watts, where it applied both Article 20
of the Regulation and the freedom to provide services. It held at paras. 59-61 that there was no reason to
justify interpreting these terms differently, depending on whether they appear in the context of Regulation
883/2004 or Article 56 TFEU, since in both cases the question is whether the treatment can be provided in
the State of residence within an acceptable time which ensures its usefulness and efficacy. For completeness,
the Authority notes that the term “in good time”, is sometimes also used (see e.g. judgment of 9 October 2014,
Elena Petru v Casa Județeană de Asigurări de Sănătate Sibiu (“Petru”), Case C-268/13, EU:C:2014:2271,
para. 31; judgment of 29 October 2020, A v Veselības ministrija, (“Veselības ministrija”), C-243/19,
EU:C:2020:872, para. 28), but submits, in line with Watts, that nothing turns on the precise formulation of the
time limit.
62
See e.g. the Opinion of Advocate General Geelhoed, Case C-372/04 Watts, EU:C:2005:784, para. 102,
where he describes Article 20 of the Regulation as granting a minimum guarantee or right from the perspective
of the patient.
63
These two conditions are also reflected in Article 26(2) paragraph 3 of the Implementing Regulation.
64
See e.g. C-243/19 Veselības Ministrija, para. 25: “The sole purpose of the second sentence of
Article 20(2) of Regulation No 883/2004 is to identify the circumstances in which the competent
institution is precluded from refusing the authorisation sought on the basis of Article 20(1) (see, to that
effect, judgment of 5 October 2010, Elchinov, C-173/09, EU:C:2010:581, paragraph 39 and the case-law
cited). That second sentence of Article 20(2) lays down two conditions which, if both are satisfied, render
mandatory the grant by the competent institution of the prior authorisation applied for on the basis of
Article 20(1). […] (emphasis added).”
65
Judgment of 12 July 2001, Vanbraekel and Others and Alliance nationale des mutualités chrétiennes
(ANMC) (“Vanbraekel”), Case C-368/98, EU:C:2001:400, para. 34; C-777/18 WO, para. 47.
66
See e.g. Case C‑777/18 WO, para. 33.
67
See e.g. C-372/04 Watts, paras. 46-47 (and the cases cited in footnote 58 above) and Case C-368/98
Vanbraekel, where the CJEU considered the rights of the patient under both Article 22 of Regulation 1408/71
and Article 49 EC.
15
48. The Authority’s concern in the present case relates to the Second Condition. It does
not take issue with the conditions for the basic entitlement to in-patient treatment in
Norwegian law (i.e. the Necessity Test and circumstances in which the First
Condition will be met).
49. The Authority’s concern is that, where the First Condition is met (the patient is
entitled to treatment in Norway), Norwegian law and practice, in particular in relation
to certain provisions of the PRA and PR, do not guarantee the patient’s EEA rights
to go abroad for treatment when the Second Condition is or will be met, in breach
also of Article 3 EEA.68
50. Norway’s position has consistently been that:
(i) there is no conflict between the PRA system and EEA law, because the PRA
system is a ‘parallel’ or “supplementary”/”additional”69 system to the two
national systems which were specifically designed to (and, in Norway’s view,
did) implement Regulation 883/2004 and the Patients’ Rights Directive (“the
Specific EEA Routes”);
(ii) the PRA system is in certain respects ‘better,’ in that, if it does apply, e.g. the
coverage of costs is broader than it would have been under the Specific EEA
Routes, because it fully covers costs for the healthcare, accommodation and
travel, including outside the EEA;70
(iii) and that, if a patient does not fulfil the conditions under the PRA system, the
patient may still apply for reimbursement under the Specific EEA Routes.71
51. The Authority agrees that the Regulation does not prohibit the existence of parallel
systems; indeed a number of EEA States provide for such systems both in national
legislation or in (bilateral) agreements.72 In the present case however (and as will
be shown in the three pleas below) such national PRA/PR ‘parallel’ system is
constructed and operated in a way that hinders the effective enforcement of
68
See paragraph 25 above.
69
Reply to the Supplementary Reasoned Opinion (Annex A.1) p.10.
70
Reply to the Supplementary Reasoned Opinion (Annex A.1) pp. 9, 11 (first paragraph).
71
See e.g. Reply to the Supplementary Reasoned Opinion (Annex A.1) p.4, final paragraph and p. 5, final
paragraph.
72
See the report prepared for the European Commission, “Cross-border healthcare in the EU under social
security coordination Reference year 2020”, (Annex A.20), p.68; also available at
https://lirias.kuleuven.be/retrieve/655835.
16
patients’ EEA law rights.73 The Authority recalls that all provisions of Norwegian law
impacting on free movement within the EEA must comply with and are subject to
EEA law. This means that the PRA system, in law and practice, must also comply
with relevant EEA law. The Authority recalls here that it is the Necessity Test under
the PRA system which determines whether patients have the basic entitlement to
in-patient treatment for all purposes: that is, whether they then seek access to
treatment abroad under the PRA/PR system or the Regulation 883/2004 ‘route.’74
It is not enough for Norway to have implemented the relevant EEA secondary law
in the field of in-patient treatment through specific national legislation: the
remainder of its national legislation in this field (the PRA system) must also be
consistent with and must not undermine EEA rights granted under the Regulation
and under Article 36 EEA more generally. Moreover, while Norway refers to the
PRA/PR scheme as a ‘supplement’ to the Specific EEA Routes, it nevertheless
appears to accept that a patient might first commence their attempted journey
abroad in the PRA/PR system.75 In such a case it is even more important that their
Right to EET in Time is secured at the outset.
52. Norway refers to Case C-777/18 WO, to claim that the co-existence under its
legislation of the Specific EEA Routes and the PRA system is just like the co-
existence of patient rights under the Regulation and Article 56 TFEU in the WO
case.76 This claim is fundamentally misconceived and reveals the
misunderstanding at the heart of Norway’s approach to patient rights. Different
rights or routes to treatment may co-exist, but they must all comply with EEA law.
By way of concrete example, the Authority refers to C-368/98 Vanbraekel.77 In that
case, Belgian law granted rights to additional reimbursement for treatment which
went beyond the State’s obligations under Article 22 of Regulation 1408/71. Having
concluded that Article 22 did not require Belgium to extend such additional
reimbursement to the patient who had travelled to France, the CJEU then went on
73
Further, as mentioned above at paragraph 8, the PRA/PR system receives easily more than ten times the
numbers of patient applications as Norway’s specific ‘Regulation 883/2004’ system: the PRA/PR system is
therefore in no way an unimportant route to accessing healthcare in other EEA States. For completeness and
by way of background for the Court, the Authority refers to the most recent report prepared for the European
Commission, “Cross-border healthcare in the EU under social security coordination Reference year 2020”,
which contains statistics reported by the EEA States (including Norway) on, amongst other things, prior
authorisation systems for in-patient treatment under Regulation 883/2004 (see Annex A.20, p.61).
74
Or indeed the Directive ‘route’, which is not relevant here.
75
See the Reply to the Supplementary Letter of Formal Notice (Annex A.15), p. 4, fifth and sixth paragraphs,
and the Reply to the Supplementary Reasoned Opinion (Annex A.1), p.4, final paragraph and p. 5, final
paragraph.
76
Reply to the Supplementary RDO (Annex A.1), p.5.
77
C-368/98, Vanbraekel.
17
to assess such additional rules in the light of the freedom to provide services. The
CJEU concluded that Article 56 TFEU required Belgium to grant such additional
reimbursement to the patient. Thus, even ‘extra’ rules going beyond what is
required by the Regulation (or Directive), will still be subject to assessment under
(and compliance with) Article 36 EEA.
53. In the Authority’s submission, the PRA system fails to ensure that, when the First
and Second Conditions are met, patients may go abroad for treatment, in breach
of Articles 3 and 36 EEA and Article 20(2) of the Regulation, as specified below.
54. The following pleas are made cumulatively and alternatively.
5.2 FIRST PLEA: BREACH OF ARTICLE 36 EEA AND/OR ARTICLE 20(2) OF
THE REGULATION BY MAINTAINING IN FORCE CONFLICTING NATIONAL
PROVISIONS AND/OR BY FAILING TO APPLY EEA LAW CORRECTLY IN
PRACTICE
55. As set out at paragraphs 45-47 above, both Article 36 EEA and Article 20 of
Regulation 883/2004 recognise that States may require patients to seek
authorisation before travelling abroad to receive medical care. However, the case-
law referenced above also confirms that, if two conditions are met, a State cannot
refuse such authorisation.78 If a patient is entitled to treatment domestically,
authorisation to travel abroad must be granted where the same or equally effective
treatment cannot be given without undue delay or within a time-limit which is
medically justifiable in the EEA State of residence (here, Norway).79
56. Once this deadline has expired, or if it is clear that the treatment cannot be granted
by the deadline (e.g. due to excessively long waiting lists compared to the needs
of the patient), authorisation to seek treatment abroad must be granted under
Article 20(2) of Regulation 883/2004 and/or Article 36 EEA.80 Norwegian law and/or
practice fails to secure such rights.
78
Put differently, where a patient is entitled nationally to the medical treatment in question (i.e. the First
Condition is met), States cannot prioritise home State treatment (that is, require the patient to be treated
domestically), unless, cumulatively: (i) the home State itself can provide treatment which is the same or
equally effective for the patient as the treatment abroad; and (ii) such home State treatment can be provided
within a medically justifiable time limit. See e.g. E-11/07 and E-1/08 Rindal and Slinning, para. 83; C-157/99
Smits and Peerbooms, paras. 103-104.
79
See e.g. C-372/04 Watts, para. 79.
80
See e.g. C-372/04 Watts, paras. 70, 72 and 79 (regarding Article 22(2) of Regulation 1408/71) and para.
120 (regarding Article 49 EC, the freedom to provide services); C-157199 Smits and Peerbooms, para. 107;
E-11/07 and E-1/08 Rindal and Slinning, paras. 102, 103.
18
57. In the first two Pleas, the Authority sets out the way in which Norwegian law and/or
practice results in a substantive breach of Article 20(2) of Regulation 883/2004
and/or Article 36 EEA, and also (in the Second Plea) of Article 3 EEA. Such
Norwegian law and/or practice also gives rise to problems of legal certainty, which
are addressed more specifically in the Third Plea. In this, the First Plea, the
Authority sets out how Norway has maintained in force, at the relevant compliance
deadlines, national provisions which conflicted with, or did not correctly reflect, the
Right to EET in Time, and/or has failed to secure patients the Right to EET in Time
in practice. Section 2-1b(4) PRA is considered at the First and Second Compliance
Deadlines before the Authority moves on to consider s.2-1b(5) PRA, in each of its
versions at the relevant compliance deadline.
5.2.1 Breach by maintaining in force at the First Compliance Deadline
provisions such as Section 2-1b(4) PRA and Section 6 PR and/or by failing
to apply EEA law correctly in practice
58. At the First Compliance Deadline (20 January 2018), s. 2-1b(4) PRA provided
certain rights for patients to seek treatment outside Norway if the National Time
Limit had been (or would be) exceeded:
“[4] If the regional health undertaking has not ensured that a patient who is entitled to
necessary healthcare from the specialist health service receives such care within the
time limit fixed pursuant to the second paragraph [i.e. within the National Time Limit],
the patient has the right to receive necessary healthcare without delay, if necessary from
a private service provider or a service provider outside the realm.”81
59. At that time, s.6(2)-(3) of the PR supplemented s.2-1b(4) PRA, by providing:
“[2] If the specialist health services cannot provide the patient with a commencement date
for the medical assessments or treatment which is before the deadline for when necessary
medical care at the latest should be provided, or the appointment time must be amended
so that the deadline cannot be met, or if the deadline is exceeded, the health specialist
shall immediately contact Helfo [The Norwegian Health Economics Administration], cf.
Section 2-1b(4) [PRA]. If the deadline is exceeded the patient can also contact Helfo.
[3] Helfo shall promptly provide the patient a service from a public service provider or, if
necessary, from a private service provider in the kingdom or, if necessary, abroad. The
patient cannot freely choose the service provider.”82
60. Therefore, first, until the deadline was exceeded, even if it was clear in advance
that it would be exceeded, the patient was required to wait for health services to
take action via Helfo. Second, while the patient could approach Helfo directly once
81
Emphasis added.
82
Emphasis added.
19
the deadline had been exceeded, the patient was prohibited (or at least
discouraged) under the legislation from directly going abroad: s.6(3) PR required
the patient to contact Helfo and provided that he/she could not freely choose the
service provider. This was confirmed by the Norwegian Government in its Reply to
the RQI83 and by an administrative circular.84 The Authority has further observed
this practice in certain decisions of the Appellate Body.85
61. Such a requirement restricted the ability of the patient to exercise his/her right to
go abroad for treatment in circumstances in which the case-law has clarified that
patients have a free-standing right to seek such treatment, because the medically-
justifiable time limit has expired or will expire without treatment. Norway has not
claimed that there was or is any objective justification for such a restriction. Instead,
the Norwegian Government has simply pointed to the ability of patients to rely on
other legal grounds for seeking treatment abroad.86 This ability was recorded in
Section 6(4) PR as follows:
“[4] Regardless of whether the deadline has been breached, the patient may apply for
reimbursement of costs for health services received in another EEA country in accordance
with the regulation on benefits for health services received in another EEA State [i.e. the
reimbursement regulation, which implements the Patients’ Rights Directive87]. The patient
may also be entitled to reimbursement for costs for health services in other EEA countries
in accordance with the terms of Council Regulation (EC) No 883/2004. Applications for
reimbursement under the [Reimbursement Regulation] or prior authorisation under
Council Regulation (EC) No 883/2004 is processed by Helfo.”
62. The existence of such a legislative cross-reference does not however cure the
above breach of Article 20(2) of the Regulation and/or Article 36 EEA. This is
83
Reply to the RQI (Annex A.13), p.14 (“Helfo shall in such cases find a provider … Patients could not choose
the provider abroad”).
84
Circular IS-8/2015, The Patient’s Rights Act with Comments, which described the deadline system in the
following manner (emphasis added): “The specialist health services shall set a deadline for when treatment
abroad at the latest is to be provided so that these patients have a similarly clear legal situation as patients
who receive healthcare in Norway, cf. Section 4 of the [PR]. If the regional health undertaking has not ensured
that a patient who is entitled to necessary specialist health care is given the necessary health care within the
prescribed period, the patient has the right to necessary medical care without delay, if necessary from a
private service provider or a service provider outside the realm, see [Section 2-1b(4) PRA]. It is Helfo which
in such cases finds a treatment offer for the patient.” Accessible at: https://lovdata.no/pro/static/ROO/is-
2015-0008.pdf., p.26 (In Norwegian: Rundskriv IS-8/2015 Pasient- og brukerrettighetsloven med
kommentarer.)
85
See e.g. Decision UKN-2012-108 (“When a reasonable deadline has been set and is broken, a patient can
turn to Helfo patient mediation, which will provide an offer either in Norway or abroad”) and similarly Decision
UKN-2010-111, both of which are available at Annex A.21, pp. 175 and 128 respectively. Original Norwegian
language versions of the decisions of the Appellate Body can be found in Annex A.21a.
86
See e.g. the complaint raised by the Authority in its Reasoned Opinion (Annex A.8, paras. 40, 96-97), and
Norway’s Reply to the Reasoned Opinion of 19 January 2018 (Annex A.9), p.2.
87
Regulation of 22 November 2010 No 1466 on reimbursement of health care received in another EEA State
(“the Reimbursement Regulation”). In Norwegian: Forskrift 22. November 2010 nr. 1466 om stønad til
helsetjenester mottatt i et annet EØS-land. See Reply to the RQI (Annex A.13), p.2, where Norway explains
how the Reimbursement Regulation was amended to implement the Patients’ Rights Directive.
20
because the route to treatment abroad provided for in ss. 2-1b(4) PRA and 6 PR
must itself be compliant with (or at least not undermine) EEA law.88 Moreover, s.
6(4) PR does not make it clear that in cases where the medically-justifiable deadline
will not be met, prior authorisation must be granted under Article 20(2) of the
Regulation (and under Article 36 EEA). Instead, s. 6(4) PR simply refers generally
to rights under the Reimbursement Regulation and Regulation 883/2004. Such a
general reference is not sufficiently precise to reflect the relevant EEA rights, and
leads to uncertainty about the relationship between those EEA rights and those
conferred under the PRA/PR.89
5.2.2 Breach by maintaining in force at the Second Compliance Deadline
provisions such as Section 2-1b(4) PRA and Section 6 PR
63. At the Second Compliance Deadline (20 December 2022), s.2-1b(4) PRA had been
amended to remove the right to treatment abroad when the deadline/time-limit was
or would be breached, as follows: 90
“[4] If the regional health undertaking has not ensured that a patient who is entitled to
necessary healthcare from the specialist health service receives such care within the
time limit fixed pursuant to the second paragraph [i.e. within the National Time
Limit], the patient has the right to receive necessary healthcare without delay, if necessary
from a private service provider or a service provider outside the realm.”
64. Similarly, s.6(3) PR was amended to remove the right to treatment abroad:
“[3] Helfo shall promptly provide the patient a service from public service provider or, if
necessary, from a private service provider in the kingdom or, if necessary, abroad. The
patient cannot freely choose the service provider.”91
65. Accordingly, s.2-1b(4) (and the related provisions of s.6 PR) no longer contain any
right for patients to seek in-patient treatment abroad when the National Time Limit
is exceeded. The patient is only entitled to receive treatment in Norway, if
necessary from a private provider.
66. The Authority submits that such provisions clearly conflict with the rights conferred
by Article 20(2) of Regulation 883/2004 and Article 36 EEA, as set out in
paragraphs 45-47 above, and undermine the effectiveness of those EEA rights.
88
See paragraph 52 above.
89
See further paragraph 147 in the Third Plea, below.
90
The text in strikethrough was repealed by Act 20 December 2019 No 104 concerning amendments to the
Patients’ Rights Act etc. (healthcare abroad), which entered into force on 1 March 2020. See the Legislation
Annex (Annex A.18), p. 5.
91
The text in strikethrough was repealed by Regulation 4 February 2020 No 119 concerning amendments to
the [PR], which entered into force on 1 March 2020. See the Legislation Annex (Annex A.18), p. 10.
21
5.2.3 Breach by maintaining in force at the First Compliance Deadline
provisions such as Section 2-1b(5) PRA and Section 3 PR and/or by failing
to apply EEA law correctly in practice
67. At the First Compliance Deadline, s. 2-1b(5) PRA provided:
“[5] If the regional health undertaking cannot provide healthcare for a patient who is entitled
to necessary healthcare, because there are no adequate medical services in the
realm, the patient has the right to receive necessary healthcare from a service provider
outside the realm within the time limit fixed pursuant to the second paragraph [i.e.
within the National Time-limit].” (emphasis added)
68. Section 3 PR supplemented s.2-1b(5) PRA, as follows:
“Healthcare abroad due to a lack of competence in Norway
[1] A patient who is entitled to necessary healthcare, but who cannot get healthcare
because the treatment cannot be performed properly in Norway according to accepted
methods, is entitled to medical care abroad, see Section 2-1b(5) [PRA]. It is a prerequisite
[for this provision to apply] that the healthcare can be performed properly by the service
provider abroad according to accepted methods and that the patient's condition and the
treatment in question satisfy the requirements of § 2 [PR]. The assessment of the patient's
benefit from the treatment shall be individual and be based on international medical
science.
[...]
[4] Insufficient capacity in specialist health services does not render patients eligible for
treatment abroad under this provision. Right to treatment does not include
shipment/sending of laboratory samples for analysis with a foreign service provider if it is
not part of treatment abroad.”
69. The preparatory works which accompanied the original introduction of s.2-1b(5) in
2003, provided:92
“By adding [Section 2-1b(5)], it is proposed to determine that the so-called “rights patients”,
i.e. patients who have a right to necessary health care under the second paragraph [i.e.
Section 2-1b(2) PRA], shall be entitled to necessary medical care abroad if there is no
adequate medical treatment in Norway. In practice this will particularly apply to those
patients who, under applicable law, may apply for a contribution to hospital treatment
abroad under the National Insurance Act § 5-22, second paragraph, when the necessary
competence in Norway is lacking. The patient will not be entitled to necessary medical
treatment abroad if there is a recognised treatment option in Norway, even if a
possibly more advanced treatment option might have been developed abroad. The
fact that there is a lack of capacity and long waiting time for medical treatment, will
not make the patient entitled to necessary medical care abroad under this
paragraph.”
70. Thus, long waiting times would not result in patients being entitled to medical care
abroad under these provisions.
92
Ot.prp.nr.63 (2002-2003) Om lov om endringer i lov 2. juli 1999 nr. 63 om pasientrettigheter
(pasientrettighetsloven) m.m., p. 61, emphasis added. See the Legislation Annex (Annex A.18), pp. 5-6.
22
71. This interpretation and application of the provisions was confirmed by the
Norwegian Government in its Reply to the RQI:
“In cases where the necessary health care can be performed properly in Norway due to
an accepted method, but there is a lack of capacity e.g. due to long waiting lists, patients
cannot use Section 3 PR as a legal ground for receiving medical treatment abroad.”93
72. Thus, s. 2-1b(5) PRA and s. 3 PR conferred a right to seek treatment abroad only
where the patient could show that the particular area of medicine/treatment was
completely lacking in Norway, or that the treatment was available, but could not be
performed properly in Norway (s. 3 PR requires the treatment abroad to be
performed according to “accepted methods”). The provisions do not permit patients
to travel abroad for treatment where long waiting lists mean that they cannot receive
treatment.
73. The Authority submits that s. 2-1b(5) PRA and s. 3 PR, and the related practice,
breached the Right to EET in Time, as follows.
74. First, s.2-1b(5) refers to a test which involves simply assessing whether there are
“adequate medical services in the realm.” This differs from the test applied by the
European Courts, which involves an assessment of whether national treatment
which is the same or equally-effective as that sought abroad can be provided in
time. There is thus a failure correctly to reflect the EET Element of the Right to EET
in Time (paragraph 45 above).
75. Second, it is settled case-law that, even if the same or equally effective treatment
is available nationally, a State may only prioritise its own treatment offer under
Article 20(2) of the Regulation and/or Article 36 EEA if that offer is available within
a time-limit which is medically justifiable.94 Section 2-1b(5) PRA and s. 3 PR were
however together framed and/or applied in such a way which failed to ensure that
this time-limit (the Timing Element of the Second Condition) was taken into account
and/or complied with, because long waiting times were considered irrelevant and/or
out of the scope of the provisions.
76. The Authority observes that, while s. 2-1b(5) PRA itself referred to the right to
receive necessary healthcare from a service provider abroad within the National
93
Reply to RQI (Annex A.13), p. 13 (original emphasis), and see pp. 14-15.
94
See e.g. C-157/99 Smits and Peerbooms, para. 107; and C-372/04 Watts, paras. 63-79.
23
Time Limit, s.3(4) PR (which implements s. 2-1b(5) PRA) was in contradiction with
this timing requirement. At the relevant time, s. 3(4) PR provided (as also reflected
in the relevant preparatory works to the corresponding PRA provision95):
“Insufficient capacity in specialist health services does not render patients eligible for
treatment abroad under this provision. […].”
77. As mentioned above, this interpretation and application of the provisions was
confirmed by the Norwegian Government in its Reply to the RQI.96
78. In short, in breach of Article 20(2) of the Regulation and Article 36 EEA and the
settled case-law, these provisions do not permit patients to travel abroad for
treatment where long waiting lists mean that they cannot receive treatment in good
time. As held by the CJEU in C-385/99 Müller-Fauré, a refusal to grant authorisation
based solely on the ground that there are waiting lists on the national territory,
without account being taken of the specific circumstances attaching to the patient’s
condition, cannot amount to a properly justified restriction on the freedom to provide
services.97 At the very least, s. 3(4) PR fails correctly to reflect patients’ EEA law
rights to travel abroad where equally-effective treatment cannot be provided without
undue delay.
79. The Norwegian Government has asserted that, in practice, patients in
circumstances such as the above (e.g. on a long waiting list) could have recourse
to the right to authorisation or reimbursement under Article 20(2) of Regulation
883/2004 or to reimbursement under the Reimbursement Regulation
(implementing the Directive and, in the view of the Norwegian Government, Article
36 EEA).98
80. This is however no defence to the problem.
81. First, as previously submitted, the PRA and PR must themselves comply with EEA
law. A breach of EEA law under the PRA//PR cannot be ‘justified’ by the fact that
another set of provisions is specifically intended to be EEA-compliant. If this were
correct, a State could immunise itself from scrutiny under EEA law in respect of a
95
See the preparatory works cited at paragraph 69 above, which works confirmed that “[t]he fact that there is
a lack of capacity and long waiting time for medical treatment, will not make the patient entitled to necessary
medical care abroad under this paragraph.” See the Legislation Annex (Annex A.18), p. 5.
96
See paragraph 71 and footnote 93 above.
97
See e.g. C-385/99 Müller-Fauré, para. 92; C-157/99 Smits and Peerbooms, para. 63.
98
Reply to the RQI (Annex A.13), pp.13 and 14.
24
large part of its legislation, simply by pointing to the fact that at least some of its law
correctly reflects the relevant EEA law rights. The fact that Norway refers to Article
20 of the Regulation as “other legal grounds for publicly paid treatment abroad”99
reveals the misunderstanding at the heart of Norway’s approach to EEA treatment
abroad: it fails to recognise that the provisions of the PRA and PR (here, s. 2-1b(5)
PRA and s. 3 PR) must also be in compliance with Article 20(2) of the Regulation,
and must not undermine the rights conferred therein.
82. Second, even if it were sufficient to have alternative ‘EEA-compliant’ routes (quod
non), there is nothing in s. 3 PR (or the related s.2-1b(5) PRA) which makes this
clear. There is no ‘link’ in the provisions to these other ‘routes’ abroad or even to s.
2-1b(4) PRA and s. 6 PR, which are in the same acts and contain a separate set of
‘time-limit’ provisions.100 This at the very least creates an issue of transparency and
legal certainty (see also paragraph 140 below). Further, as can be seen at
paragraph 112 below, patients who are refused authorisation to travel abroad under
this route are not redirected to Norway’s specific ‘Regulation 883/2004 route.’
83. Third and in any event, the problem goes beyond the text of the provisions, because
it is apparent from the practice of both the Offices for Medical Treatment Abroad,101
and the Appellate Body, that patients who find themselves in the s. 2-1b(5)
PRA/Section 3 PR ‘no adequate care route’ to treatment abroad, end up in a
position where their EEA rights to care within a medically-justifiable time-limit are
not respected or effectively secured.
84. This is evidenced, for example, by 26 decisions of the Offices for Medical Treatment
Abroad in 2019, all of which apply a test which considers long waiting times as
irrelevant to the right (or not) of the patient to go abroad, and further do not apply
any medically justifiable time-limit.102 The consistent practice of the Appellate Body
99
Reply to the RQI, (Annex A.13), p.13.
100
The Authority observes that administrative Circular IS-8/2015, The Patient’s Rights Act with Comments,
refers (https://lovdata.no/pro/static/ROO/is-2015-0008.pdf. p.26) to the ability of patients, where adequate
treatment is available in Norway, to travel abroad for treatment under the Patients’ Rights Directive (and
implementing national legislation), and to be reimbursed for such treatment. This does not however
adequately reflect the patient’s rights in the situation where the national waiting time exceeds a medically
justifiable time-limit, i.e. where there is a right to go abroad under Article 20(2) of the Regulation and/or Article
36 EEA.
101
In Norwegian: Utenlandskontorene.
102
See Annex A.22: OSLO-2019-1-R, p. 5, OSLO-2019-1-HN-R, p. 8, OSLO-2019-2-R, p. 10, OSLO-2019-
2-HN-R, p. OSLO-2019-3-R, p. 13, OSLO-2019-3-HN-R, p. 15, OSLO-2019-4-R, p. 17, OSLO-2019-4-HN-
R, p. 18-19, OSLO-2019-5-R, p. 22, OSLO-2019-5-HN-R, p. 24, OSLO-2019-6-R, p. 26, OSLO-2019-7-R, p.
29, OSLO-2019-8-R, p. 31, OSLO-2019-9-R, p. 33, OSLO-2019-10-R, p. 36, OSLO-2019-11-R, p. 38, OSLO-
25
also shows that, within the relevant time period: (i) it did not apply any medically
justifiable time-limit (whether under national law or under EEA law: see paragraph
105(ii),(iii),(vi)((vi)b) below) and (ii) it disregarded the relevance of long waiting
times for the right to go abroad.103 This is likely a consequence of the fact that the
jurisdiction of the Appellate Body is formally limited to reviewing ‘adequate
treatment’ cases under s. 2-1b(5) PRA and s. 3 PR: see ss. 7(2)(1)-(2) PRA and 7
PR. The Appellate Body has no jurisdiction to determine whether the National Time
Limit has been or will be respected under s. 2-1b(4) PRA and s. 6 PR: such a matter
rests with the County Governor. See further the Second Plea below.
85. Thus, ss. 2-1b(5) and 3(4) PR, as interpreted and applied by the Offices for Medical
Treatment Abroad and Appellate Body, restricted the ability of patients to go abroad
when the medically justified time-limit had expired or would expire due to long
waiting lists.
86. The Authority therefore considers that ss. 2-1b(5) PRA and 3 PR, as interpreted
and applied, are incompatible with the requirements of Article 20(2) of Regulation
883/2004 and/or Article 36 EEA.
5.2.4 Breach by maintaining in force at the Second Compliance Deadline
provisions such as Section 2-4a(2)(a) PRA and Section 3 PR and/or by
failing to apply EEA law correctly in practice
87. At the Second Compliance Deadline, s. 2-1b(5) PRA had been repealed and
replaced by s. 2-4a(2)a PRA. Section 2-4a(2)a is part of a new s. 2-4a PRA, which
entered into force on 1 March 2020. According to the Norwegian Government, s. 2-
4a provides an overview of the various schemes for covering expenses for
healthcare abroad and is mainly for informational purposes.104 Section 2-4a
provides, in relevant part:
2019-12-R, p. 40, OSLO-2019-13-R, p. 42, OSLO-2019-15-R, p. 44, OSLO-2019-16-R, p. 46, OSLO-2019-
17-R, p. 48, OSLO-2019-18-R, p. 50 OSLO-2019-21-R, p. 54, OSLO-2019-22-R, p. 56, OSLO-2019-23-R, p.
58, OSLO-2019-24-R, p. 60 and OSLO-2019-25-R, p. 62. See Annex A.22a for original Norwegian language
versions.
103
See Annex A.21: UKN-2005-26, p. 12, UKN-2007-18, p. 58, UKN-2008-2, pp. 70-71, UKN-2008-29, p. 74
(this particular applicant wanted treatment in Switzerland, but the statements of the Appellate Body in this
case (and those related to the USA, cited later in this footnote) also evidence their consistent practice of
disregarding long waiting-times), UKN-2009-53, p. 90, UKN-2009-95, p. 99-100, UKN-2010-21, pp. 110-111,
UKN-2010-103, pp. 126-127, UKN-2010-111, p. 130, UKN-2011-38, p. 139 (the US), UKN-2012-63, p. 170
(the US), UKN-2012-108, p. 176, UKN-2013-110, pp. 184-185, UKN-2014-53, pp. 190-191 (the US) and UKN-
2021-1194, pp. 248-249.
104
See Reply to the RQI (Annex A.13) p. 12, where Section 2-4a PRA is described in the following manner:
“The Ministry is of the opinion that the new provision Section 2-4 a gives patients a better overview over the
26
Ҥ 2-4 a. Health care abroad
Patient has the right to have expenses for health care received in another EEA State,
fully or partially covered
a) pursuant to the National Insurance Act § 5-24 a with regulations that implement the
Patients’ Rights Directive in Norwegian law. This applies when the health care in question
corresponds to health care that the patient would have been offered in the public health
and care service in Norway.
b) pursuant to Council Regulations (EC) Nos. 883/2004 and 987/2009, which, among
other things, gives the right to be reimbursed for necessary health care during temporary
stays and for planned health care in other EEA States if the health care is not provided
within a reasonable time in Norway.
Patient has the right to have expenses for health care received abroad fully or
partially covered
a) if the patient is entitled to necessary health care from the specialist health service
according to § 2-1 b and there is no offer in the country or the health care abroad is
documented to be more effective than the health care offered by the public sector in
Norway.
b) pursuant to the National Insurance Act § 5-24 and provisions issued pursuant to it,
which, among other things, gives the right to receive benefits for health services for
members of the National Insurance who stay abroad over time.
Expenditure on health care that has been decided not to be introduced in Norway is not
covered, cf. the Specialist Health Services Act § 4-4. However, this does not apply to
health care during temporary stays pursuant to the first paragraph, letter b.”
88. The first paragraph of s. 2-4a covers provisions which only apply to healthcare
received in the EEA, whereas the second paragraph contains provisions which
apply to healthcare in general: both within and outside the EEA.105 According to the
preparatory works, “[t]he first paragraph of the draft new Section 2-4a in the
Patients’ Rights Act discusses the schemes that only apply to health care received
in another EEA State. The provision continues the current legal situation and does
not involve any change beyond giving patients a better overview.”106
different legal grounds for publicly paid healthcare abroad and also gives more transparency to the conditions
for receiving publicly paid health care in those cases where the necessary health care is not available in
Norway or the health care abroad is documented to be more effective than the health care offered by the
public health services in Norway, cf. Section 2-4 a(2) subparagraph a. This will be helpful both for the patient
and for the administrators of these regulations. The new provision is mainly given for informational purposes.”
105
See the preparatory works, Prop. 80 L (2018-2019) p. 14-15:
“Health care abroad in general
The second paragraph of the draft covers the expenditure coverage schemes that apply to health care abroad
in general, also in countries outside the EEA area. […] Furthermore, the second paragraph will regulate the
right to treatment abroad in the event of a lack of services in Norway or when health care abroad has been
documented to be more effective.” See the Legislation Annex (Annex A.18), p. 7.
106
Prop. 80 L (2018-2019) p. 14. See the Legislation Annex (Annex A.18), p. 7.
27
89. Section 3 PR was amended to reflect the rights expressed in s. 2-4a(2)a PRA. It
provides (emphasis added):
“A patient who is entitled to necessary health care, but who cannot receive health
care because there is no service in the realm or health care abroad is documented
to be more effective than the health care offered by the public sector in Norway, is
entitled to health care abroad, cf. the Patients’ Rights Act § 2-4a second
paragraph a. It is a prerequisite that the health care can be performed properly by the
service provider abroad according to accepted method and that the patient's condition and
the relevant treatment satisfy the requirements in § 2. The assessment of the patient's
benefit shall be individual and based on international medical science.”
90. The Authority submits that the criteria provided in ss. 2-4a(2)a PRA and 3 PR are
not consistent with the Second Condition imposed by EEA law (paragraph 45
above): namely that the right to treatment abroad is engaged where the same or
equally-effective treatment domestically cannot be provided in time.107 For
example, EEA law does not require that the treatment abroad must be documented
to be more effective before EEA law rights are engaged. The Authority understands
that s. 2-4(2)a is intended to supplement rights available to individuals under EEA
law, but, by introducing a higher effectiveness threshold, which would also
presumably apply if the time-limit is exceeded, as well as failing to also refer to the
Timing Element of the Second Condition, this provision runs counter to EEA law
requirements and is at best confusing.
91. Further or alternatively, the Authority observes that decisions of the Offices for
Medical Treatment Abroad and of the Appellate Body demonstrate that, in practice:
(i) such bodies require patients to document that the treatment abroad is more
effective than the domestic treatment108 (rather than applying an equally-efficient
107
See E-11/07 and E-1/08 Rindal and Slinning, para. 83, reflecting the settled case-law that “prioritisation of
home State treatment, such as in the case at hand, cannot be justified unless the home State itself can
provide treatment which is the same or equally effective for the patient as the treatment abroad within a
medically justifiable time limit.” While the Court refers at para. 84 to “more effective treatment,” this was in
answer to a question of the national court which specifically related to more effective or advanced treatment.
108
From the Offices for Medical Treatment Abroad (Annex A.22) see e.g. decisions: OSLO-2022-2-R,
p. 63-64, OSLO-2022-2H-R, p. 65-66, OSLO-2022-3-R, p. 67, OSLO-2022-3-HN-R, p. 69, OSLO-2022-4-R,
p. 71-72, OSLO-2022-4H-R, p. 73-74, OSLO-2022-6-R, p. 77, OSLO-2022-6B-R, p. 78-79, OSLO-2022-7-R,
p. 80-81, OSLO-2022-8-R, p. 82-83, OSLO-2022-9-R, p. 84-85, OSLO-2022-10-R, p. 86-87, OSLO-2022-11-
R, p. 88-89, OSLO-2022-12-R, p. 90-91, OSLO-2022-13-R, p. 93-94, OSLO-2022-14-R, p. 96-97, OSLO-
2022-15-R, p. 98-99, OSLO-2022-16-R, p. 100-101, OSLO-2022-17-R, p. 102, OSLO-2022-18-R, p. 104-
105, OSLO-2022-19-R, p. 106-107, OSLO-2022-20-R, p. 108-109, OSLO-2022-22-R, p. 111-112 OSLO-
2022-23-R, p. 114-115, OSLO-2022-24-R, p. 117-118, OSLO-2023-25-R, p. 120-121, OSLO-2023-26-R, p.
123-124, OSLO-2023-27-R, p. 126-127, OSLO-2023-28-R, p. 128-129, OSLO-2023-29-R, p. 131-132,
OSLO-2023-30-R, p. 134-135, OSLO-2023-31-R, p. 137-138, BERGEN-2022-1-R, p. 157-158, BERGEN-
2022-2-R, p. 160, BERGEN-2022-3-R, p. 162-163, BERGEN-2022-4-R, p. 165-166, BERGEN-2022-5-R, p.
168-169, BERGEN-2022-7-R, p. 171-172,, BERGEN-2022-9-R, p. 176-177, BERGEN-2022-10-R, p. 179,
BERGEN-2022-11-R, p.182-183, BERGEN-2022-12-R, p. 184, BERGEN-2022-13-R, p. 187 and BERGEN-
2023-1-R, p. 190. From the Appellate Body (Annex A.21) see decisions: UKN-2020-4720, p. 232, UKN-
28
criterion); and that (ii) such bodies refuse to consider the timing element or consider
that long waiting times and/or lack of capacity is not relevant.109 Such a practice
constitutes a failure on the part of Norway correctly to apply the Second Condition.
5.3 SECOND PLEA: BREACH OF ARTICLE 36 EEA AND/OR ARTICLE 20(2) OF
THE REGULATION BY MAINTAINING IN FORCE A COMPLAINT/APPEALS
STRUCTURE WHICH DISCOURAGES THE RELEVANT BODIES FROM
APPLYING EEA LAW CORRECTLY, AND WHERE THOSE BODIES FAIL TO
APPLY EEA LAW, IN BREACH ALSO OF ARTICLE 3 EEA
92. As set out at paragraph 45 above, EEA law (the Second Condition) requires an
assessment of whether equally-effective treatment can be provided in time. This
assessment contains two components: the EET Element and the Timing Element.
Under the First Plea, the Authority has set out how the substantive provisions of
the PRA/PR fail correctly to reflect this two-pronged test, both in law and as applied
in the practice of the relevant complaint/appeals bodies.
93. This breach is compounded by the procedural rules governing the competence of
the PRA complaint/appeals bodies. As set out in this Second Plea, such rules
discourage or prevent these bodies from making, as they must under the Second
Condition, an overall assessment of whether treatment was both equally-effective
and could be provided in time.
94. Section 7-2(1) and (2) PRA (and the related provisions of the PR) split the
competence for handling complaints in relation to the PRA/PR between the County
Governor and the Appellate Body. In short, at the Second Compliance Deadline:
2020-9761, p. 244, UKN-2021-2248, pp. 252-253, UKN-2021-5490-1, p. 260, UKN-2021-6562, p. 263, UKN-
2021-6559, p. 267, UKN-2021-8834, p. 280, UKN-2021-10307, pp. 284-385, UKN-2022-542, p. 294, UKN-
2022-813, pp. 300-301, UKN-2022-543, pp. 297-298, UKN-2021-11716, pp. 284-285 and UKN-2021-11858,
p. 292.
109
From the Offices for Medical Treatment Abroad (Annex A.22), see decisions: OSLO-2022-10-R, p.86,
OSLO-2022-15-R, p. 98, OSLO, 2022-23-R, p. 115, BERGEN-2022-7-R, p. 172, BERGEN-2022-8-R, p. 174
(United Kingdom), and BERGEN-2022-9-R, p. 176. This seems to originate from the limited competence
which is granted to the Offices under the PRA system, see e.g., OSLO-2022-2-R, p. 63, OSLO-2022-3-R, p.
67 and OSLO-2022-4-R, p. 71 where the Office for Medical Treatment Abroad refers to s. 2-4a(2)a PRA as
the basis for its assessment. This, as explained in paragraph [90] above, fails to reflect the Timing Element
of the Second Condition. From the Appellate Body (Annex A.21), see decisions: UKN-2022-542, pp. 294-
295 and UKN-2022-1202, p. 305 (although it should be noted that these two examples relate to the United
Kingdom after Brexit). As in the decisions by the Offices for Medical Treatment Abroad, the Appellate Body’s
refusal to consider the Timing Element seems also to originate from its competence to apply only s.2-4a(2)a
PRA (and therefore not even the national law ‘timing provision’ of s.2-1b(4) PRA), see UKN-2021-8790, p.
276, UKN-2021-6713, pp. 271-272, UKN-2021-4648, p. 255, UKN-2021-1194, p. 248, UKN-2020-5914, p.
236, UKN-2020-6443, p. 240, UKN-2020-1625, p. 229 and UKN-2020-1615, p. 225.
29
(i) only the Appellate Body had competence to handle complaints about the
availability or effectiveness of treatment in Norway (thus under s. 2-4a(2)a
PRA, ex-s.2-1b(5) PRA), while
(ii) only the County Governor had competence to hear complaints about the
breach of the National Time-Limit under s. 2-1b(4) PRA.
95. As a consequence, neither complaint body was permitted under the PRA/PR to
consider both the adequacy/effectiveness of national in-patient services and
whether they could be provided in time. This was also the situation at the First
Compliance Deadline.110
96. For the avoidance of doubt, the Authority does not take issue with the fact that
Norway chooses to structure its complaints/appeals system or allocate competence
in a particular way: the issue is that the present system does not meet Norway’s
obligations to make Article 20(2) of Regulation 883/2004 and Article 36 EEA
effective.
97. At the Second Compliance Deadline, the relevant provisions of the PRA and PR
read as follows.
98. Section 7-2(1) PRA set out the general rule, that complaints concerning breaches
of the abovementioned provisions of the PRA, which form part of Chapter 2 PRA,
should go to the County Governor:
“(1) A patient or user or their representative who believes that the provisions in
Chapters 2, 3 and 4, as well as § 5-1, § 6-2 and § 6-3 have been breached, can
complain to the County Governor. The complaint is sent to the body which made the
decision.”111
99. Section 7-2(2) PRA provided an exception to this rule, which provides that
complaints about s. 2-4a(2)a must be made to the Appellate Body. It read:
“(2) A patient or a representative of the patient who believes that the provision in § 2-4a
second paragraph, subparagraph a, has not been complied with [i.e no treatment in
110
At that time, Section 7-2(1) and (2) PRA (and the related Sections 7 and 8 PR) contained the same split
of competence, but referred e.g. to Section 2-1b(5), the predecessor to Section 2-4a(2)a PRA. See the
Legislation Annex (Annex A.18), pp.11-12 for full details of the provisions in force at the time.
111
On 1 July 2023 this provision was amended by Norway, in order to address a drafting error in relation to a
different point: namely complaints made in relation to s.2-4a(1)(b) PRA. See paragraphs 137-139 below.
30
Norway or treatment abroad is more effective], may complain to an appellate body
appointed by the Ministry [i.e. the Appellate Body]. […].”112
100. The split competence to handle or review complaints is reflected in s. 7 PR,
which at the Second Compliance Deadline, and today, again provides the main rule
in the first sentence, and the exception in the second sentence:
“A patient who disagrees with the assessment made pursuant to § 2, § 2a, § 3, §
4 or § 4a [PR], or who believes that no such assessments have been made, may
complain to the County Governor, cf. the Patients’ Rights Act § 7-2. If the
assessment made by the specialist health service relates to whether the patient
has the right to treatment abroad, cf. § 3 [i.e. Section 3 PR, which provides for
healthcare abroad where there is no treatment in Norway or the treatment abroad
is more effective], he may appeal to the Appellate Body referred to in § 9.”
101. The Appellate Body’s competence is set out in s. 8(1) PR, which mirrors s. 7-
2(2) PRA and reads:
“The Appellate Body decides on appeals against decisions pursuant to § 3 [PR],
cf. the Patients’ Rights Act § 7-2 second paragraph.”113
102. Section 3(1) PR provides:
“A patient who is entitled to necessary health care, but who cannot receive health
care because there is no service in the realm or health care abroad is documented
to be more effective than the health care offered by the public sector in Norway, is
entitled to health care abroad, cf. the Patients’ Rights Act § 2-4a second paragraph
a. It is a prerequisite that the health care can be performed properly by the service
provider abroad according to accepted method and that the patient's condition and
the relevant treatment satisfy the requirements in § 2. The assessment of the
patient's benefit shall be individual and based on international medical science.” 114
103. Thus, at the Second Compliance Deadline, Sections 7-2(2) PRA and 3 and 8
PR confirm that the Appellate Body is competent only to decide on complaints
related to the availability or effectiveness of treatment in Norway (thus under s. 2-
4(a)(2)a PRA). Sections 7-2(1) PRA and 7 PR confirm that the County Governor
has competence over complaints related to the other provisions of s. 2-4a PRA and,
inter alia, to breach of the time-limit provided in s. 2-1b(4) PRA.
112
Whilst Section 2-4a PRA was introduced on 1 March 2020, amendments to reflect this in Section 7-2(2)
PRA were only introduced on 1 January 2021, as the Government originally omitted to propose the necessary
amendments to Section 7-2(2), see Prop. 59 L (2019-2020) p. 27, see the Legislation Annex (Annex A.18),
p. 12. During that period therefore, Section 7-2(2) PRA continued to refer to Section 2-1b(5) PRA, albeit that
that provision was no longer in force.
113
In Norwegian: “Klagenemnda avgjør klage over vedtak etter § 3, jf. pasient- og brukerrettighetsloven § 7-
2 annet ledd.”
114
See Legislation Annex (Annex A.18), pp. 8-9.
31
104. This formal division of competence between the appeals bodies can be seen in
practice. Its adverse impact on the incentive and ability of such bodies to correctly
apply both the EET and Timing Elements of the Second Condition can also be seen
in practice.
105. In respect of complaints/appeals related to s. 2-4a(2)a (and its predecessor s.
2-1b(5) PRA) the Authority has examined 245 decisions of the Offices for Medical
Treatment Abroad on applications at first instance (decided between 2019 and
2023),115 and 202 decisions of the Appellate Body on further appeal (decided
between the entry into force of the relevant provisions of the PRA, in 2003, and
2022).116 Unless otherwise stated, all of these decisions involved the EEA or are
presumed to concern the EEA:117
(i) in 35 decisions of the Offices for Medical Treatment Abroad, it is clear that
the Offices did not consider themselves competent to also apply the ‘timing
provision’ of s. 2-1b(4) PRA, and only considered themselves competent to
apply the PRA adequacy/effectiveness provisions (s. 2-1b(5)/2-4a(2)a);118
(ii) similarly, in 25 decisions of the Appellate Body it is clear that the Appellate
Body did not consider itself competent to also apply the ‘timing provision’ of
s. 2-1b(4) PRA, and confined itself to an adequacy/effectiveness assessment
under s. 2-1b(5)/2-4a(2)a PRA;119
(iii) in none of the other cases is there any indication that these bodies applied
the s.2-1b(4) PRA timing provision or otherwise considered themselves
competent to do so (it is simply that they do not expressly state that they are
not competent; whereas they make this lack of competence clear in the
cases mentioned at (i) and (ii) above);
115
The decisions of the Offices for Medical Treatment Abroad were provided by the Norwegian Government
upon the Authority’s request: see Annex A.23.
116
The decisions of the Appellate Body were retrieved from Lovdata on 9 May 2023. The Authority has
assessed all available Appellate Body decisions applying the relevant PRA provisions, from the time at which
the provisions concerning treatment abroad were moved from the NIA to the PRA, c.f. Act 12 December 2003
No 110 concerning amendments to the Patients’ Rights Act (in Norwegian: lov 12. desember 2003 nr 110 om
endringer i lov om pasientrettigheter).
117
Most decisions of the Offices for Medical Treatment Abroad provided by the Norwegian Government clearly
concern in-patient treatment in the EEA, whereas in a limited number of decisions, it is not possible to
ascertain which country they concern. Given the Authority’s mandate to monitor compliance with the EEA
Agreement, the Authority assumes that the Norwegian Government only provided decisions concerning
treatment in other EEA States.
118
See the 26 decisions referred to in footnote 102 above for s. 2-1b(5) PRA and the 9 decisions referred to
in footnote 109 for s. 2-4a(2)a PRA.
119
See the 15 decisions referred to in footnote 103 above for s. 2-1b(5) PRA and the 10 decisions referred to
in footnote 109 for s.2-4a(2)a PRA.
32
(iv) in at least one case (although there could be more), the patient therefore
resorted to running parallel complaints proceedings before the Appellate
Body and before Helfo (under the Patients’ Rights Directive) in an effort to
secure their EEA rights;120
(v) the split legal tests and split legal competence under the PRA (one set of
bodies for adequacy/effectiveness and another set of bodies for timing) thus
meant that the PRA provisions and practice were necessarily ineffective in
securing for patients the Right to EET in Time;
(vi) further, despite the fact that the Offices for Medical Treatment Abroad and
Appellate Body were empowered to apply Article 36 EEA,121 and could
therefore perform conform interpretation of national law or, in case of
conflict, disapply national law:
a. none of the decisions of the Offices for Medical Treatment Abroad
provided by the Norwegian Government applied EEA law at all,
whether Article 36 EEA or Article 20 of Regulation 883/2004;
b. none of the decisions of the Appellate Body mention or apply Article
20 of Regulation 883/2004, while only four decisions consider Article
36 EEA, but do not grant rights on that basis. 122
106. In the Authority’s submission, this split competence therefore prevented or at
least discouraged each such body from making the two-pronged assessment
required under the Second Condition, in breach of Article 36 EEA and Article 20(2)
120
See Appellate Body Decision UKN-2019-6144 (Annex A.21, pp. 217-220). Given however the number of
cases referred to below at paragraph 112, where the patient’s claim is rejected or the patient is redirected to
the County Governor, it is conceivable that other patients have similarly engaged in parallel proceedings.
121
See s.1 of the Norwegian EEA Act which, together with s.2 of that Act, provides that Article 36 EEA shall
prevail in case of conflict with provisions of national law. See the Legislation Annex (Annex A.18), p.3.
122
There are to the Authority’s knowledge only four decisions since the entry into force of the relevant PRA
provisions where the relevance of EEA law is at all discussed: see decisions UKN-2010-54, UKN-2011-97
and UKN-2017-8826, available at Annex A.21, pp. 116-121, 155-159 and 193-197. The latter case concerns
ESA’s complainant number 74770 and was a decision made twice under the same case number (the initial
decision on 16 February 2018 and its re-examination on 10 February 2020). The Authority notes that in all
four decisions (which concerned applications for treatment in other EEA States), EEA law seems to have
been considered because the applicant specifically raised it, not because the Appellate Body of its own accord
considered EEA law to be relevant. Without prejudice to the substantive reasons why these applications for
treatment abroad were denied, the Authority observes that none of these decisions applied the Second
Condition imposed by EEA law (paragraph 45 above): namely that the right to treatment abroad is engaged
where the same or equally-effective treatment domestically cannot be provided in time. See: (i) UKN-2010-
54, at p.120 of Annex A.21 (the particular patient was not entitled to the requested treatment but the summary
of EEA law is incorrect, referring in essence to a ‘competence in Norway’ test); and similarly (ii) UKN-2011-
97, Annex A.21, pp. 155-159; and (iii) UKN-2017-8826 Annex A.21, where in its initial decision (pp.193-195)
the Appellate Body found that it was required to apply the ‘problematic’ provisions of the PRA and PR, and
that, in order for it to apply EEA law, Parliament had to change the law. Thus, the Appellate Body disregarded
its duty to apply Article 36 and to set aside conflicting national law, if necessary, in breach also of Article 3
EEA (see e.g. Case E-11/22 RS, para. 41). In its re-examination of the same case (Annex A.21, pp.196-
197), the Appellate Body simply rejected the claim without going into the substance.
33
of the Regulation. It also made and makes it excessively difficult for patients to
enforce their rights under EEA law.
107. Thus, very significant numbers of patients each year find themselves in the PRA
system.123 Once there, the relevant PRA/PR provisions do not correctly reflect the
rights available to patients under the Second Condition, in whole or in part. For
example, s. 2(1)b-(4) PRA contains no right to go abroad if a medically justifiable
time-limit will be breached, while ss. 2-4a(2)a PRA and 3 PR confusingly require a
patient to show that the treatment abroad is more effective, while containing nothing
to reflect the Timing Element of the Second Condition. The effectiveness of the
patient’s right of complaint and appeal, in order to secure his/her EEA rights, is then
seriously undermined by the split competence structure, under which each body
(the Offices for Medical Treatment Abroad, the Appellate Body and County
Governor) is required to have ‘PRA tunnel vision’: examining only its allocated PRA
provisions, and where it is unclear whether the Norwegian Government intended
such bodies to have competence to apply Article 20 of Regulation 883/2004.124 All
this is reflected in a practice in which such bodies fail to consider overall the EET
and Timing Elements necessary to correctly assess whether the Second Condition
is met, in breach of Article 36 EEA and 20(2) of the Regulation.
108. Further, by systematically failing to take steps to, as appropriate, secure the
conform interpretation of national law or, in case of conflict, disapply national law,
such bodies and therefore Norway have failed to ensure the full effectiveness of
EEA law, in breach also of the principle of sincere cooperation in Article 3 EEA.125
109. Norway accepts that competence is split in this way between the two complaint
bodies,126 but appears to contend that this does not matter.
123
See e.g. paragraph 8 above and the Reply to the Supplementary Reasoned Opinion (Annex A.1), p.9.
124
See paragraphs 130-136 in the Third Plea, below: it is only Helfo and the Office for Health Service Appeals
to which Norway has purportedly (but ineffectively) given jurisdiction to apply Article 20 of the Regulation. The
Authority observes that the Norwegian Ministry of Health and Care Services recently (19 December 2022)
sent Helfo and the Office for Health Service Appeals a reminder about the need to correctly apply Article 20
of the Regulation and Article 36 EEA (see Annex A.24, originally attached to the Reply to the Supplementary
Reasoned Opinion). The fact that it appears not to have sent such a reminder (about the correct application
of Article 20 of the Regulation) to the Appellate Body or Country Governor would tend to confirm the
Authority’s understanding that such complaint bodies are not specifically empowered or encouraged to apply
Article 20. Again, see further paragraphs 130-136 below.
125
See e.g. E-11/22 RS, para. 41 and paragraph 25 above.
126
See e.g. p.11 of the Reply to the Supplementary Reasoned Opinion (Annex A.1).
34
110. The Norwegian Government makes the rather extraordinary statement that “the
fact that other bodies [the Appellate Body and County Governor] does not apply
these legal instruments [Regulation 883/2004, Article 36 EEA and the Patients’
Rights Directive] does not – in the Ministry’s view – in itself give basis for a claim
that the decisions of these bodies are contrary to EEA law. As explained above, the
rights provided in Article 2-4a(2)a PRA are supplementary to (not constrictive of)
the rights under Regulation 883/2004 and Directive 2011/24/EU and Article 36
EEA.”127 In other words, Norway appears to be of the view that, because patients
also have other rights under the Specific EEA Routes, which they can appeal to
other relevant complaints bodies, the failure of the PRA complaint/appeal bodies to
apply EEA law in part or at all is not concerning. The Authority makes six points in
response.
111. First, even if it were correct that patients can easily access the Specific EEA
Routes (which is not accepted), this does not remedy the fact that the PRA Routes
must also comply with EEA law: thus, the relevant PRA complaints/appeals bodies
must also apply the correct legal tests,128 and must be empowered in law and
practice, as organs of State, to apply the relevant provisions of EEA law. The
Authority recalls the EEA law requirement that “refusals to grant authorisation must
be capable of being challenged in judicial or quasi-judicial proceedings.”129
Requiring a patient to commence a new set of ‘EEA-Specific’
administrative/complaint proceedings, rather than being able to rely directly and
immediately on their EEA law rights before the current PRA complaint/appeal body,
fails to effectively meet this requirement.
112. Second, the Authority observes that patients who are denied authorisation130 (of
their original application or following a complaint) under the PRA system are not by
default directed to the Specific EEA Routes, even though they are seeking
authorisation or reimbursement for treatment in another EEA State. Many are
127
See p.10 of the Reply to the Supplementary Reasoned Opinion (Annex A.1), emphasis added.
128
i.e. assessments must be consistent with the Second Condition imposed by EEA law (paragraph 45
above): namely that the right to treatment abroad is engaged where the same or equally-effective treatment
domestically cannot be provided in time.
129
See e.g. E-11/07 and E-1/08 Rindal and Slinning, para. 48; C-157/99 Smits and Peerbooms, para. 90; C-
372/04 Watts, paras. 115–116.
130
The examples of denials/refusals to authorise given later in this paragraph are from a pool of cases where
the patient was not obviously denied treatment abroad for legitimate reasons, such as where the treatment in
question was experimental, or where the patient had no entitlement to the type of healthcare as a matter of
national law (failure to meet the First Condition). In other words, the Authority has made its best efforts to
select cases where patients denied treatment might have been entitled to such treatment, had EEA law been
applied correctly.
35
simply denied treatment abroad,131 whilst others are instead directed to the County
Governor and the ‘timing provision’ of s.2-1b(4) PRA.132 A third category of patients
is referred explicitly to Helfo and the ‘Directive route’, whilst there is no mention of
the ‘Regulation 883 route’.133
113. Third, the Authority disagrees with Norway’s claim that the PRA rights are “not
constrictive of”134 EEA rights, and that “the additional [PRA] route results in better
rights for patients compared to the situation where the patients would have to rely
only on the rights granted solely under EEA law.”135 This claim is, in the Authority’s
respectful submission, based on Norway’s fundamental misunderstanding of its
EEA law obligations and of how its own PRA system operates in law and practice.
As set out in the First Plea, a number of provisions of the PRA/PR conflict with EEA
law. It is simply not the case that things are ‘better’ for a patient under the typical
PRA scenarios. Thus, if, for example:
(i) the patient complains or is re-routed to the Country Governor (see paragraph
112 above and the related footnote 132), the County Governor will apply the
131
From the Offices for Medical Treatment Abroad (as first-instance decision-making body), see
decisions (Annex A.22): OSLO-2019-1-HN-R, OSLO-2019-2-R, OSLO-2019-5-R, OSLO-2019-7-R, OSLO-
2019-8-R, OSLO-2019-23-R, OSLO-2022-2-R, OSLO-2022-6B-R, TRONDHEIM-2019-9-R, BERGEN-2019-
1-R, BERGEN-2019-3-R, BERGEN-2019-4-R, BERGEN-2019-7-R, BERGEN-2019-8-R, BERGEN-2019-10-
R, BERGEN-2022-5-R, BERGEN-2022-11-R and BERGEN-2022-13-R, all concerning treatment in other
EEA States. From the Appellate Body, see decisions (Annex A.21): UKN-2005-24, UKN-2005-27, UKN-
2005-45, UKN-2005-37, UKN-2005-46, UKN-2005-73, UKN-2005-105, UKN-2006-50, UKN-2006-86, UKN-
2006-89, UKN-2006-111, UKN-2007-77, UKN-2007-86, UKN-2007-109, UKN-2008-77, UKN-2008-115,
UKN-2009-3, UKN-2009-33, UKN-2009-35, UKN-2009-67, UKN-2009-80, UKN-2009-112, UKN-2010-33,
UKN-2010-9, UKN-2010-85, UKN-2011-31, UKN-2011-63, UKN-2011-64, UKN-2011-90, UKN-2012-35,
UKN-2012-61, UKN-2012-89, UKN-2012-121, UKN-2018-7704, UKN-2018-7706, UKN-2018-7770, UKN-
2019-2771, UKN-2019-4619, UKN-2019-3151, UKN-2019-8665, UKN-2020-1625, UKN-2020-5914, UKN-
2021-10307 and UKN-2022-543, all concerning treatment in other EEA States. UKN-2012-61 is notable, as
the applicant in that case specifically argued before the Appellate Body that she needed treatment urgently
in order to prevent the condition becoming incurable, see p. 164 of Annex A.21, but the Appellate Body still
does not seem to have referred her to either the County Governor or Helfo.
132
From the Appellate Body, see e.g. decisions (Annex A.21): UKN-2012-108, p. 176 and UKN-2013-
110, p. 179 both concerning treatment in other EEA States. Before 1 January 2012, the competence to decide
on the ‘timing provision’ of s.2-1b(4) lay with the Norwegian Board of Health Supervision (in Norwegian:
Helsetilsynet), and breaches of the ‘timing provisions’ of the PRA and the PR were referred there, see
decisions UKN-2008-2, p.71; UKN-2009-53, p.91; UKN-2009-95, pp.99-100; UKN-2010-21, p.111; UKN-
2010-103, pp. 125-127; and UKN-2010-111, pp.128-131; all concerning treatment in other EEA States.
133
From the Offices for Medical Treatment Abroad (as first-instance decision-making body), see
decisions (Annex A.22): OSLO-2019-18-R (Switzerland), p. 50, OSLO-2019-19-R, p. 52, TRONDHEIM-
2019-2-R, p. 195, TRONDHEIM-2019-5-R, p. 199 and BERGEN-2019-2-R, p. 143-144, all referring to
treatment in other EEA States. From the Appellate Body, see decisions (Annex A.21) UKN-2011-58, pp.
140--143; UKN-2011-97, pp. 155-158; both concerning treatment in other EEA States. This practice (of
directing patients to the ‘Patients’ Rights Directive route’ rather than the ‘Regulation 883/2004 route’) may
itself give rise to concerns under Article 8(3) of the Patients’ Rights Directive. This provides that, in respect of
requests for prior authorisation, States must assess whether the conditions for authorisation under Regulation
883/2004 are met. If yes, States must grant authorisation under the Regulation rather than under the Directive,
unless the patient requests otherwise.
134
Reply to the Supplementary Reasoned Opinion (Annex A.1), p.10.
135
Reply to the Supplementary Reasoned Opinion (Annex A.1), p.13.
36
s.2-1b(4) PRA ‘national timing provision’, where there is no right to go abroad
at all, even when a medically-justifiable time-limit has expired (paragraphs 63
– 66 above);
(ii) if the patient instead relies on s.2-4a(2)a PRA (the ‘more effective treatment’
provision), waiting times and time-limits will be ignored (see paragraph 91
above), while they will have to establish that the treatment abroad is “more
effective” (a higher threshold than under the Second Condition). The
Authority’s findings show that the first-instance body to which patients must
apply (the Offices for Medical Treatment Abroad), has never applied EEA law,
and the situation is barely better on appeal (the Appellate Body has only
referenced EEA law four times in 20 years: see paragraph 105(vi)(b) above).
Further, as set out in the Third Plea, below, certain relevant provisions of the PRA
and PR are themselves confusing and lacking in legal certainty. Norway’s
perception of this system as ‘better’ is therefore misguided.
114. Fourth, in relation to rights of complaint/appeal under the Specific EEA Routes,
the Authority observes that, at the Second Compliance Deadline, Section 7-2(1)
PRA provided that complaints about the provisions of Section 2-4a(1) PRA (which
refer to rights under Regulation 883/2004 and the Patients’ Rights Directive) should
go to the County Governor. In practice however, such complaints were apparently
made neither to the County Governor nor even to the Appellate Body, but to the
Office for Health Service Appeals (Helseklage).136 The Norwegian Government
acknowledged that this was a drafting error and undertook to remedy the matter.
The error was corrected in part with effect from 1 July 2023.137 Nevertheless, this
example demonstrates the difficulties facing patients as they attempt to navigate
complex sets of legal provisions in order to find an EEA-compliant route abroad,
and to effectively enforce their rights on appeal if they consider that their rights are
being infringed.
136
In its Supplementary Reasoned Opinion (Annex A.16; paras. 53-56), the Authority observed that, while
s.7-2 PRA provided that complaints about Regulation 883/2004 should be made the County Governor, in
practice, applications and complaints about access to healthcare abroad under the Specific EEA Routes
appeared to be made to Helfo and to the National Insurance Court. In its Reply to the Supplementary RDO
(Annex A.1, p.11), the Norwegian Government confirmed this understanding and undertook to correct the
error. See also the letter of the Norwegian Government dated 14 April 2023 (Annex A.25, p.1), where the
Government expressed its hope to amend the legislation by the summer of 2023. Such legislation was indeed
adopted on 1 July 2023, but this law change was detected by the Authority. Norway has not (yet) notified the
Authority of this.
137
The PRA provision which conferred competence on the County Governor was removed. Such removal is
however ineffective to confer competence for Article 20 cases on Helfo and the Office for Health Service
Appeals, which must follow from other legislative provisions (but does not). See paragraph 139 below.
37
115. Fifth, even in respect of the Specific EEA Route which Norway has put in place
under Regulation 883/2004, the practice of the relevant complaint body (until 2019
Helfo (main office)), and appeals body (the National Insurance Court), is not
compliant with EEA law. The Authority has examined this practice over the time
period from 13 July 2012 to 7 June 2023.138
116. Firstly, the National Insurance Court, acting on appeal from Helfo (main office)
(and from 2019, the Office for Health Service Appeals),139 has not been consistent
on whether it has jurisdiction to apply EEA law at all. Until its judgment in TRR-
2014-2387 of 24 April 2015, there are examples of the National Insurance Court
considering itself competent to examine claims under Article 20 of Regulation
883/2004, and its predecessor, Article 22 of Regulation 1408/71,140 and two
examples of it applying Article 36 EEA.141 In its judgment TRR-2014-2387 however,
the National Insurance Court held that it did not have jurisdiction over Article 36
and/or Regulation 1408/71. In its judgment TRR-2016-301, this position was
reversed with respect to Regulation 1408/71, but that judgment did not mention
Article 36, nor did any subsequent judgment until at least the end of the Second
Compliance Date. Thus the National Insurance Court, in a period of almost eight
years, from its judgment TRR-2014-2387 dated 24 April 2015, and until its judgment
TRR-2020-2665 dated 2 March 2023 (and thus after the Second Compliance Date),
seems to have failed completely to apply Article 36 in any and all cases concerning
in-patient treatment in other EEA States.142
138
With respect to Helfo (as first decision-maker), the Authority has examined all decisions in the years 2019,
2020 and 2021; with respect to the National Insurance Court, the Authority has examined all of its 20 relevant
decisions concerning in-patient treatment and/or Article 20 and/or Article 36 from 13 July 2012 to 7 June
2023, available through searches in the database at Lovdata.no. In addition, the Authority contacted the
National Insurance Court by email of 1 June 2023 (Annex A.26) in order to ascertain whether there were
other relevant decisions. By emails of 7 June and 8 June (Annex A.27) the National Insurance Court provided
the Authority with a limited number of other decisions, which the Authority examined. To the extent that these
decisions concern in-patient treatment and/or Article 20 and/or Article 36, they are included in Annex A.28.
TRR-2019-1206, joined cases TRR-2021-1992 & TRR-2021-1993 and the following unpublished cases:
joined cases 19/1047, 19/1094 and 19/1097, 19/2505 and 20/406 do not concern in-patient treatment, Article
20, or Article 36 and are therefore not included in Annex 29. Original Norwegian language versions of the
decisions can be found in Annex A.28a.
139
Today, complaints on decisions made by Helfo (regional office) are handled by the Office for Health Service
Appeals, which decisions can be appealed to the National Insurance Court. In the National Insurance Court
decisions examined by the Authority, the first to concern a decision by the Office for Health Service Appeals
as complaints body is TRR-2019-1487, dated 8 October 2019 (see Annex A.28, p. 127).
140
See Annex A.28 for cases TRR-2012-268, TRR-2012-1439, TRR-2012-1883, TRR-2012-2553, TRR-
2013-514, TRR-2013-761, TRR-2013-2486 and TRR-2014-621. The Authority observes that no such Article
20/22 claims brought before the National Insurance Court in this period were successful.
141
See Annex A.28 for cases TRR-2012-1439 and TRR-2014-247.
142
In case TRR-2019-2736, the follow-up to Case E-13/20 O v Arbeids- og velferdsdirektoratet (judgment of
the EFTA Court of 30 June 2021) and which concerned unemployment benefits, the National Insurance Court
considered itself in principle competent to apply Article 36 EEA. This is included in Annex A.28 for the sake
of good order.
38
117. Secondly, without prejudice to whether the substantive conditions were or were
not met by the individual patient in any given case, both Helfo (main office) and the
National Insurance Court typically only assess whether a specific type of treatment
is available in Norway, and in that manner fail to apply the EET Element of the
Second Condition altogether. Thus, from at least 13 July 2012 (Case TRR-2012-
268) and until the end of the Second Compliance Deadline, such bodies rarely, if
ever, applied Regulation 883/2004 and Article 36 EEA in the manner prescribed by
the European Courts (as set out above at paragraph 45), thus including the EET
Element and the Timing Element of the Second Condition,143 to the apparent
detriment of patients.
118. In welcome contrast and for the purposes of illustration, after the Second
Compliance Deadline, the National Insurance Court in case TRR-2020-2665
described the relevant test as follows:
“Article 20 no. 2 sets out several conditions, all of which must be met in order for there
to be a right under the provision. Firstly, the treatment in question must be among the
benefits offered under the legislation of the state of residence. If this condition is met, it
must further be assessed (i) whether the same or equally effective treatment cannot be
provided in the state of residence (ii) within a period that is medically justifiable, taking
into account the concerned person’s current state of health and the likely development
of the disease, cf. for example C-173/09 paragraph 65.”144
119. Had the complaint/appeal bodies set out the relevant test in this manner in the
compliance period, the Authority would have considered this to be compliant with
EEA law. Instead, the test set out varies, but typically does not include the EET
Element.
120. For example, in TRR-2017-653, the National Insurance Court held:
“The question before the court is whether [the complainant] was entitled to have
expenses related to SIRT processing in Country C within the EEA covered according to
143
See e.g. TRR-2016-269 (Annex A.28), in which the National Insurance Court agreed with Helfo (main
office) that Article 20 is only relevant where adequate treatment cannot be given within reasonable time in
Norway. The approach of Helfo and the National Insurance Court is consistent with the various
(mis)characterisations of the Second Condition made by the Norwegian Government over the years. In for
example its Reply to the RQI (Annex A.13), pp. 3-4, the Norwegian Government describes the Second
Condition (thus together the EET Element and the Time-Limit Element) in the following manner: “the second
condition requires that the treatment cannot be given within a medically justifiable time limit, taking into
account the patient’s current state of health and the probable course of his disease.” For additional examples,
see footnote 114 in the Supplementary RDO (Annex A.16).
144
Judgment dated 2 March 2023 (Annex A.28, p. 165). As far as the Authority is aware, this was the first
time a competent body in Norway applied Article 20(2) in the manner prescribed by the European Courts (as
set out above at paragraph 45), with respect to the Second Condition, thus including the EET Element and
the Time Element. This observation on the methodology used by the court is without prejudice to any other
EEA related issues in the judgment, including the substance.
39
Council Regulation 883/04 article 20. The central question in the assessment under
Article 20 is whether the treatment in question is offered in Norway.”145
121. Similarly, among the 37 Helfo (main office) decisions examined by the Authority
from 2019-2021, 21 decisions formulated the test under Article 20(2) this way:
"That the waiting time cannot be considered justifiable is an objective medical
assessment based on your state of health and the likely development of the disease,
seen in relation to the predicted or actual waiting time. It is also a condition that you
have a medical need for a type of healthcare that is offered in Norway, and that the
institution you are planning treatment at is affiliated with the public healthcare system in
the country of treatment."146
Thus, unlike the test prescribed by the European Courts (as set out above at
paragraph 45), and as followed by the National Insurance Court in the recent case
TRR-2020-2665 (paragraph 118 above), the Helfo decisions from 2019-2021
systematically omit the EET Element and state that the relevant part of this test is
only whether the same type of health care is offered in Norway.
122. Sixth and finally, Norway has suggested that the allocation of powers between
the Appellate Body and County Governor did not prevent or discourage the
Appellate Body from applying EEA law.147 The analysis of the decisions just
described at paragraph 105 above reveals however that in practice the proper
application of EEA law does not happen.
123. In conclusion, the appeals and procedural structure under s. 7-2 PRA and ss. 7
and 8 PR prevents and/or discourages the relevant complaint/appeals bodies from
applying a legal test which complies with the requirements of Article 20(2) of
Regulation 883/2004 and/or Article 36 EEA. The Authority considers that this
makes it excessively difficult or impossible for patients to rely on and/or enforce
their rights before such bodies,148 and that Norway has therefore failed to ensure
the effectiveness of Article 20(2) of Regulation 883/2004 and/or Article 36 EEA, in
145
Annex A.28, p. 121.
146
This test can be found in identical terms in all the following decisions (Annex A.29): 20/105941-15
(HELFO-4) p. 7, 20/112229-3 (HELFO-5) p. 9, 20/127067-3 (HELFO-6) p. 11, 20/130989-3 (HELFO-7) p. 13,
20/217238-3 (HELFO-11) p. 20, 20/275805-3 (HELFO-12) p. 22, 20/352331-5 (HELFO-13) p. 24, 20/363635-
3 (HELFO-14) p. 26, 20/367805-5 (HELFO-15) p. 28, 20/501097-5 (HELFO-16) p. 30, 20/501102-3 (HELFO-
17) p. 32, 21/5454-5 (HELFO-18) p. 34, 21/47511-2 (HELFO-19) p. 36, 21/26659-7 (HELFO-20) p. 38,
21/108633-6 (HELFO-21) p. 40, 21/162098-4 (HELFO-23) p. 44, 21/206311-4 (HELFO-24) p. 46, 21/325101-
3 (HELFO-25) p. 48, 19/497549-22 (HELFO-33) p. 65, 20/105941-3 (HELFO-35) p. 70, 20/403353-3 (HELFO-
36) p. 72. None of the 37 examined cases applied EEA law in the manner prescribed by the European Courts
(as set out above at paragraph 45).
147
See e.g. Reply to the Supplementary Reasoned Opinion, Annex A.1, p.9.
148
The Authority recalls that the procedural system for authorisation must be “easily accessible” and that
patients must be able effectively to challenge refusals in judicial or quasi-judicial proceedings: see E-11/07
and E-1/08 Rindal and Slinning, para. 48 and the case-law cited; C-56/01 Inizian, paras. 48 and 49.
40
breach also of those provisions. In practice, as set out in paragraph 105 above,
such bodies fail or failed correctly to apply the Right to EET in Time, in breach of
Article 36 EEA and 20(2) of the Regulation. Further, in breach of Article 3 EEA,
such bodies fail or have failed to ensure the full effectiveness of Article 36 EEA and
20(2) of the Regulation, by e.g. performing conform interpretation of national law
or, in case of conflict, disapplying national law.149
5.4 THIRD PLEA: FAILURE TO COMPLY WITH THE PRINCIPLE OF LEGAL
CERTAINTY IN BREACH OF ARTICLE 36 EEA AND ARTICLE 20(2) OF THE
REGULATION, AND/OR OF ARTICLE 3 EEA
5.4.1 The Requirement of Legal Certainty
124. The principle of legal certainty is a general principle of EEA law.150 Ensuring
legal certainty is particularly important when people in vulnerable situations are
involved, such as those seeking access to necessary healthcare. Such people may
be in precarious situations due to their (often long-lasting and serious) health
issues, which cannot be effectively treated in the national system, and which may
involve very high costs.151
125. The principle of legal certainty imposes two requirements in particular on
Norway.
126. First, it is settled case-law that in order to be justified, national rules which
restrict or impact on the exercise of fundamental freedoms and EEA rights must,
inter alia, satisfy the principle of legal certainty.152 This means that the national rules
themselves must be “clear, precise and predictable as regards their effects,”153 and
the application of those national rules must “be foreseeable by those subject to
them.”154 More generally, this principle entails that “those concerned [must] […] know
precisely the extent of the obligations which are imposed on them, and those
persons must be able to ascertain unequivocally their rights and obligations and
149
See e.g. E-11/22 RS, para. 41 and paragraph 25 above, and also Judgment of 17 October 2014, Case E-
28/13 LBI hf v Merrill Lynch Int Ltd [2014] ETFA Ct. Rep. 970, paras. 41-42.
150
See e.g. Judgment of 16 July 2012, Case E-9/11 EFTA Surveillance Authority v The Kingdom of Norway
(“ESA v Norway”) [2012] EFTA Ct. Rep. 442, para. 99.
151
See e.g. Judgment of 29 April 2021 Banco de Portugal, Fundo de Resolução, Novo Banco SA, Sucursal
en España v VR (“Banco de Portugal”), C-504/19, EU:C:2021:335, at paras. 51-52, where the CJEU recalls
that the imperative of legal certainty must be observed all the more strictly in the case of rules liable to have
financial consequences. See also Judgment of 29 August 2014, Casino Admiral AG v Wolfgang Egger [2014]
EFTA Ct. Rep. 732, para. 56.
152
See e.g. E-9/11 ESA v Norway, paras. 99-100 and the case-law cited therein.
153
See e.g. Judgment of 25 January 2022, VYSOČINA WIND a.s., C-181/20, EU:C:2022:51, para. 47.
154
See e.g. Judgment of 11 September 2019, Călin, C-676/17, EU:C:2019:700, para. 50.
41
take steps accordingly”.155 Furthermore, criteria for prior administrative approval
must be objective, non-discriminatory and, more importantly here, known in
advance to concerned persons. Where national law does not meet the
requirements of clarity, precision and predictability, this in itself suggests that the
relevant measure restricts the rights conferred by EEA law to a disproportionate
extent,156 and that it is therefore in breach of EEA law.
127. Second, the principle of legal certainty means that States may not maintain in
force national legislation which is incompatible with EEA law, even if the State in
practice acts in accordance with EEA law (which is not accepted in the present
case).157 Maintaining in force such legislation gives rise to an ambiguous state of
affairs and makes it unclear for those subject to the legislation whether and in which
circumstances they may rely on EEA law.158 The Authority further recalls the settled
case-law that, under Article 3 EEA, national measures must, in general, facilitate
the application of EU/EEA regulations, and must not hinder their implementation or
effectiveness.159
128. The Authority submits that the PRA/PR provisions and practice considered
under the First and Second Pleas also breach the principle of legal certainty, in the
ways set out below (the Third Plea).
5.4.2 The Norwegian Rules in Relation to In-patient Treatment Abroad are Not
Sufficiently Clear and National Bodies have not been Conferred
Competence to apply Article 20(2) of the Regulation under Sufficiently
Clear National Rules
129. The Authority submits that the following provisions of the PRA/PR and the
related provisions of the NIA fail to meet the requirements of clarity, precision and
predictability set out at paragraph 126 above.
155
C-504/19, Banco de Portugal, para. 51; Judgment of 8 October 2021, Cases E-10/11 and E-11/11
Hurtigruten ASA, Norway v ESA [2012] EFTA Ct. Rep. 758, para. 281.
156
Judgment of 5 July 2012, Société d’investissement pour l’agriculture tropicale SA (SIAT) v État belge, Case
C-318/10, EU:C:2012:415, paras. 57-59 and the case-law cited therein. See also E-9/11 ESA v Norway,
paras. 99-101.
157
See e.g. Judgment of 7 September 2004, Commission v Belgium, C-469/02, EU:C:2004:489, para. 13. As
set out in all three Pleas, the practice of the Norwegian authorities is also deficient in a number of ways.
158
See e.g. Judgment of 11 June 1991, Commission v France, Case C-307/89, EU:C:1991:245, paras. 13-
14; Judgment of 9 July 2015, Radu Florin Salomie, Nicolae Vasile Oltean v Direcția Generală a Finanțelor
Publice Cluj, (“Radu Florin”) Case C‑183/14, EU:C:2015:454, para. 32; and Judgment of 7 October 2019,
Safeway Ltd v Andrew Richard Newton, Safeway Pension Trustees Ltd, Case C-171/18, EU:C:2019:839,
para. 25.
159
See e.g. Judgment of 14 October 1999, Adidas AG, Case C-223/98, EU:C:1999:500, para. 25; and
Judgment of 2 October 2015, Case E-3/15 Liechtensteinische Gesellchaft für Umweltschutz v Municipality of
Vaduz (“Municipality of Vaduz”) [2015] EFTA Ct. Rep. 512, para. 33, and the case-law cited.
42
130. First, despite Norway’s view to the contrary, at the Second Compliance
Deadline and still today, it is unclear which body or bodies have
jurisdiction/competence to hear complaints in cases relating to rights under
Article 20 of Regulation 883/2004. At the expiry of the Second Compliance
Deadline, this legal certainty problem was twofold:
(i) Section 7-2(1) PRA provided that the County Governor had competence over
complaints related to a breach of the provisions of s. 2-4a(1)b, and thus of
Article 20 of Regulation 883/2004;
(ii) Norway contended, despite the lack of a relevant legislative basis, that this
competence actually rested with the Office for Health Service Appeals.
131. Since the matter was first raised by the Authority in the second supplementary
letter of formal notice and Supplementary Reasoned Opinion, Norway has claimed
that benefits under Article 20 of Regulation 883/2004 are benefits covered by
Chapter 5 NIA, which concerns healthcare benefits. The bodies with competence
for Chapter 5 NIA benefits are set out in s.21-11a(2) NIA, being Helfo (delegated
from the Directorate of Health) and the Office for Health Service Appeals.
Accordingly, Norway claimed that the competence to decide on in-patient
applications under Article 20 is, by virtue of s.21-11a(2) NIA, conferred on Helfo at
first instance, with the Office for Health Service Appeals serving as the complaints
body. In its Reply to the Supplementary Reasoned Opinion, Norway maintained
this view.160 Despite however maintaining in the Reply that there was no issue in
relation to competence, Norway in fact introduced a new legal provision in relation
to this, s.5-1a NIA, with entry into force on 22 November 2022 (thus before the
Second Compliance Deadline). Norway failed to inform the Authority of the law
change in its Reply of 20 December 2022. The law change was detected by the
Authority in the course of its legal review while preparing its Application.
132. In the Authority’s view, the law change however failed to confer, under s.21-
11a(2) NIA, the desired competence on Helfo and the Office for Health Service
Appeals to apply Article 20 of Regulation 883/2004 in in-patient cases, as follows.
160
Annex A.1, p.10.
43
133. Chapter 5 NIA is entitled “Benefits for health services.” It sets out certain health
service benefits to which people are entitled, provided certain criteria are met. The
new s.5-1a, in Chapter 5 NIA, is entitled "The relationship with provisions on
international social security coordination” and reads:
“Benefits for health services [under Chapter 5] are sickness benefits within the meaning
of the Social Security Regulation. The provisions in this chapter shall be waived to the
extent necessary in view of relevant provisions in the main part of the EEA Agreement,
the Social Security Regulation, the implementing regulation and bilateral and multilateral
social security agreements, see s. 1-3 a and s,1-3 b.”
134. The first sentence of this provision explains (or confirms) that benefits covered
by Chapter 5 are sickness benefits under Regulation 883/2004 (and therefore
logically also under Article 20). The second sentence is a conflict of law provision
and is not relevant here. Section 5-1a does not however change the fact that in-
patient treatment is not among the benefits listed in Chapter 5 NIA.161 In-patient
benefits are conferred by virtue of the PRA (the Necessity Test), and not by virtue
of any provision of the NIA. Accordingly, any provision attributing competence to a
body to take decisions or hear complaints in relation to Chapter 5 NIA benefits
(even where they fall also within the scope of Article 20 of Regulation 883/2004) is
simply ineffective to confer such competence in relation to in-patient treatment.
Therefore, s.21-11a NIA cannot empower Helfo and the Office for Health Service
Appeals to apply Article 20 in relation to in-patient treatment.
135. For this reason also, the references to s.21-11a(2) NIA in the related provisions
of in ss.6(4) and 7(3) PR are ineffective to make Helfo and the Office for Health
Service Appeals the competent bodies for Article 20.162 In any event, in the
Authority’s understanding, even if provisions in a Norwegian Ministry regulation
(here, the PR) state that something follows from a legislative act, this in itself does
not make it so.
161
The preparatory works to the introduction of s.21-11a(2) NIA (Prop. 9 L (2015-2016) pp. 10-11) provide an
exhaustive list of benefits in relation to which Helfo (as delegated from the Directorate for Health) and the
Office for Health Service Appeals have competence. In-patient treatment is not on this list: see the Legislation
Annex (Annex A.18), pp. 14-15. Further, in the preparatory works to the changes enacted to inter alia NIA
and the PRA in November 2022, Prop. 71 L (2021-2022), (see the Legislation Annex (Annex A.18), p. 15-
16), it is recorded at p.16 that “to the extent that the public is given benefits pursuant to other [non-NIA]
legislation [such as the PRA], benefits are not given pursuant to Chapter 5 NIA, see s.5-1 third paragraph […]
nor do benefits provided under Chapter 5 of the National Insurance Act cover expenses for treatment in a
public outpatient clinic or for admission to a health institution in the specialist health service (hospitals, etc.)
[i.e. in-patient treatment]. These services are regulated in the Specialist Health Services Act and mainly
financed through framework grants to the regional health organisations, […].”
162
See the relevant provisions at pp.10-11 and 12-13 of the Legislation Annex (Annex A.18), and the
references in fns 13 and 14 of Norway’s Reply to the Supplementary Reasoned Opinion, Annex A.1, p.11.
44
136. This absence of a legislative basis (or a sufficiently clear legislative basis) for
the competence of bodies purportedly tasked with enforcing the rights of individuals
under EEA law, such as Article 20 in this case, is in itself not in conformity with the
requirement of legal certainty.163 164
137. Second, at the Second Compliance Deadline there was a difference
between national law and national administrative practice, and a conflict
between the relevant provisions of national primary and secondary law. As
described at paragraph 130 above, at the Second Compliance Deadline, s. 7-2(1)
PRA provided that it was the County Governor that had competence over
complaints related to a breach of the provisions of s. 2-4a(1)b, and thus of Article
20(2) of Regulation 883/2004. In practice however, patients were required to make
these complaints before the Office for Health Service Appeals, in direct conflict with
the wording of s.7-2(1) PRA at the time.165 This difference between the law and the
practice was confusing and made it difficult for patients to determine where they
should enforce their rights.166
138. Further, on the day before the Second Compliance Deadline, the Norwegian
Government amended s.7 PR, including a new s.7(3) PR, which provides that
complaints in relation to Article 20(2) of Regulation 883/2004 could be made before
163
See Case C‑183/14 Radu Florin, para. 32 (emphasis added): “the legal rules of the Member States must
be worded unequivocally so as to give the persons concerned a clear and precise understanding of their
rights and obligations and to enable national courts to ensure that those rights and obligations are
observed.” More generally, the Authority observes that the lack of competence may have important
consequences for the validity of decisions as a matter of national law.
164
For completeness, it is also unclear whether Norway considers the following other bodies to have
competence to apply Article 20: (i) in respect of the County Governor, Norway states (Annex A.1, p.12) that
Helfo and the National Office for Health Service Appeals have the competence and obligation to apply Article
20 of the Regulation and Article 36 EEA, “regardless of the competence of the County Governor”, which would
seem to imply that the County Governor has no such competence (but is not clear); (ii) in respect of the
Offices for Medical Treatment Abroad and the Appellate Body, Norway ambiguously states (Annex A.1,
p.12) that they have “also competence to consider relevant EEA law”, without specifying whether or not this
includes the Regulation. Finally, the Authority refers to the letter dated 19 December 2022, which the
Norwegian Government annexed to its Reply to the Supplementary RDO (attached in translation and original
in Annex A.24). This letter contains instructions from the Ministry to Helfo and the Offices for Health Service
Appeals to ensure that they apply Article 20 of the Regulation and Article 36 EEA in appropriate cases. No
such letter was provided (at least to the Authority) in relation to the County Governor or Appellate Body. This
suggests to the Authority that Norway does not view the application of Article 20 by the County Governor or
Appellate Body as relevant or as a priority.
165
The existence of this problem was accepted by Norway: see Reply to the Supplementary Reasoned
Opinion (Annex A.1), p.11 (“a drafting error”) and Norway’s letter to the Authority dated 14 April 2023 (Annex
A.25), p.1.
166
The Authority recalls that the procedural system for authorisation must be “easily accessible” and that
patients must be able effectively to challenge refusals in judicial or quasi-judicial proceedings: see E-11/07
and E-1/08 Rindal and Slinning, para. 48 and the case-law cited; C-56/01 Inizian, paras. 48 and 49.
45
the Office for Health Service Appeals.167 Thus, at the Second Compliance
Deadline, s.7 PR was in conflict with the corresponding provision of the PRA (s.7-
2(1) PRA), which continued to provide that such complaints should be made before
the County Governor.
139. The Authority notes that, with effect from 1 July 2023, and thus after the expiry
of the Second Compliance Deadline, s.7-2(1) PRA as amended now removes
complaints under s.2-4a(1)b PRA (and thus under Article 20 of the Regulation) from
the competence of the County Governor.168 Thus, the relevant provisions of the PR
and PRA are aligned. This removal of references to the County Governor as the
competent complaints body for Article 20 cases does not however confer
competence on Helfo and the Office for Health Service Appeals, which must follow
from other legislative provisions. The problem outlined at paragraphs 130-136
above therefore remains.
140. Third, at the First Compliance Deadline, the relevant criteria in s. 3(4) PR
and s. 2-1b(5) PRA were not sufficiently precise, as follows. Section 3(4) PR
provided that “lack of capacity in the specialist health service does not give the right
to treatment abroad according to this provision.” In other words, if there was a lack
of capacity and long waiting lists, this would not in itself result in the right to
treatment abroad. This wording (and the related practice of the
administrative/complaint bodies169) was however in conflict with the ‘mother
provision’ of s. 2-1b(5) PRA itself, which referred inter alia to “the right to receive
necessary healthcare from a service provider outside the realm within the time limit
fixed pursuant to the second paragraph” (i.e. it did appear to confer a right to
treatment within the (medically-justifiable) National Time Limit). The criteria and
wording of s. 3(4) PR and s. 2-1b(5) PRA therefore failed to meet the requirements
of sufficient clarity, precision and predictability (as described in paragraph 126).
167
As explained at paragraph 134 above, in the Authority’s view, such an amendment was ineffective to
actually confer competence on the Office for Health Service Appeals; in this paragraph 138 the Authority’s
point is rather that, at the Second Compliance Deadline, the relevant provisions of the PRA said one thing,
while those of the PR said another.
168
According to the preparatory works to the amendment, it “involves no change in which body is the appeal
body” and simply “clarifies that the County Governor is not a complaint body for complaints under [s.2-4a
PRA] regarding health care abroad”, see Prop. 91 L 2022-2023, p. 42 (Legislation Annex, Annex A.18, p.13).
While Norway indicated to the Authority that this law change would be made, it has not yet notified the
Authority that the change was actually made and entered into force. The Authority detected the law change
in the course of preparing this Application.
169
See paragraphs 71, 76, and in particular 83-84 above, which demonstrate that in practice the Offices for
Medical Treatment Abroad and Appellate Body do not apply any medically-justifiable deadline and/or consider
long waiting times to be irrelevant.
46
141. Fourth, at the First Compliance Deadline and until 19 December 2022 (thus
the day before the Second Compliance Deadline), s.7 PR was in itself unclear
about which body had competence to hear complaints under s.3 PR (i.e.
related to adequacy of treatment or whether the treatment abroad was more
effective). Section 7 PR read as follows (emphasis added):
“A patient who disagrees with the assessment made pursuant to s. 2, 2a, 3, 4, or 4a [PR]
or who considers that no such assessment has been made, may complain to the County
Governor, cf. the Patients’ Rights Act s. 7-2. If the assessment the specialist health
service makes concerns whether the patient has a right to treatment abroad, see s. 3 [i.e.
s. 3 PR, which provides for healthcare abroad where competence is lacking in Norway],
he may complain to the appellate body which is mentioned in § 9 [PR] [i.e. the Appellate
Body for Treatment Abroad].”
142. Thus, in one and the same legislative provision, two bodies were given
competence to hear complaints under s.3 PR. Further, s.7 PR was inconsistent with
the primary law provision of s.7(2) PRA, under which competence was clearly split
between the County Governor and the Appellate Body (with the Appellate Body
being given competence to apply s.2-1b(5) and s.2-4a(2)a PRA, at the relevant
times). This gave rise to an issue of legal certainty.
5.4.3 Maintaining Conflicting Rules in Force Leads to Uncertainty
143. Further to the above, the Authority submits that, by maintaining in force the
following provisions of the PRA/PR which conflict with EEA law, or render the use
or enforcement of EEA rights more unclear and therefore difficult, Norway has
breached the principle of legal certainty, contrary to the requirements set out at
paragraph 127 above.
144. First, at the Second Compliance Deadline and today, s. 2-4a(2) PRA provides
(emphasis added):
“Patient has the right to have expenses for health care received abroad fully or partially
covered
(a) if the patient is entitled to necessary health care from the specialist health service
according to s. 2-1 b [the Necessity Test] and there is no offer in the country or the health
care abroad is documented to be more effective than the health care offered by the
public sector in Norway. […]”
145. By conferring (or appearing to confer) a right to treatment abroad only where
there is no treatment offer in Norway or where the healthcare abroad is documented
to be more effective than the healthcare offered in Norway, this provision fails to
47
reflect the rights available to individuals under Article 36 EEA and Article 20(2) of
Regulation 883/2004 (namely the right to equally-effective treatment in time). The
Authority notes that the immediately preceding provision, s. 2-4a(1)b PRA, contains
a reference to rights available under Regulation 883/2004. This reference is
however generic in nature, referring only to “amongst other things” the right to be
reimbursed “for planned health care in other EEA States if the health care is not
provided within a reasonable time in Norway.” There is therefore nothing in s. 2-
4a(1)b or s. 2-4a(2)a PRA to indicate to patients how the rights are intended to
interact, and which test should be applied, when. Further, the description in s. 2-
4a(1)b PRA of the right available under Regulation 883/2004 refers only to the
Time-Limit Element and not also to the EET Element. This therefore incompletely
reflects the right available under Article 20(2) of Regulation 883/2004 (the Right to
EET in Time). It is also confusing for patients, particularly because the next part of
the provision, s.2-4a(2)a, specifically refers to the need for them to meet the higher
threshold of demonstrating that the treatment abroad is more effective.
146. Second, in their present form and at the Second Compliance Deadline, s. 2-
1b(4) PRA and s. 6(3) PR do not permit patients to seek in-patient treatment abroad
where national treatment is not available within a medically-justifiable time limit (in
such cases they may only receive treatment in Norway). This conflicts with and is
in clear breach of the rights granted under Article 36 EEA and Article 20(2) of
Regulation 883/2004.
147. Third, the need to consult Helfo under s. 6(2) and (3) PR on expiry of the
National Time Limit (or where it will expire) makes it unclear whether patients have
a right under Article 20(2) of the Regulation and/or Art 36 EEA to go abroad for
equally-effective treatment in such circumstances. While s. 6(4) PR explains that
patients may apply for reimbursement under Regulation 883/2004 or the Patients’
Rights Directive, this explanation begins “Irrespective of whether there is a breach
of the deadline,” in other words, nowhere in Section 6 PR is it made clear that
patients have a right to go abroad when the deadline will be exceeded and the
Second Condition is met.
148. Fourth, the twin-track/split-competence PRA/PR complaints and appeal system,
under which:
48
(i) each of the County Governor and the Appellate Body is required to have ‘PRA
tunnel vision’, examining only, in respect of the PRA/PR, its allocated provisions,
and
(ii) neither seems to have been empowered to apply Article 20 of Regulation
883/2004,170
appears to have left these bodies confused about the extent of their ability to apply
EEA law. As set out in the Second Plea (paragraphs 104-105 above), in practice,
such bodies almost never consider overall the EET and Timing Elements necessary
to correctly assess whether the Second Condition is met, despite being empowered
at the very least to apply Article 36 EEA and to disapply any conflicting rules of
national law.171 This suggests also that the complaints and appeals bodies are
themselves confused by what the rules are.172
5.4.4 Conclusion on the Third Plea
149. The above undermines the effectiveness of Article 36 EEA, and of Article 20(2)
of Regulation 883/2004.173 The Authority concludes that the Norwegian
Government, by maintaining in force provisions such as those mentioned above,
has created a system for seeking access to in-patient treatment in other EEA States
in which it is very difficult for the competent institutions and bodies to apply the
relevant provisions of EEA law correctly, and which makes it impossible or
excessively difficult for patients to identify, understand, and effectively enforce their
rights under EEA law. In so doing, Norway has created a state of ambiguity, in
breach of the principle of legal certainty, and has thereby undermined the
170
See paragraphs 130-136 above and the related footnotes (Norway’s intention appears to have been to
confer competence to apply Article 20 solely on Helfo and the Office for Health Service Appeals); and
paragraph 105(vi) above (which shows that none of the decisions of the Offices for Medical Treatment Abroad
or Appellate Body have ever applied Article 20, thus suggesting that they do not consider themselves
competent to do so).
171
See e.g. Case E-11/22 RS, para. 41.
172
The Authority recalls here also the case-law of the European Court of Human Rights, in which it held that
the principle of legal certainty was not complied with when a domestic statue was “shown to have been vague
enough to cause confusion even amongst the competent State authorities”: Jėčius v Lithuania, Application
no. 34578/97, para. 59.
173
The Authority recalls the case-law of the Court that “[I]t is essential that the legal situation resulting from
national implementing measures be sufficiently precise and clear and that individuals be made fully aware of
their rights so that, where appropriate, they may rely on them before the national courts:” Case E-15/12 Jan
Anfinn Wahl v the Icelandic State [2013] EFTA Ct. Rep. 534, para. 52. While the Court’s judgment in Wahl
concerned a directive, the Authority considers that the same applies a fortiori with respect to regulations. See
also, by analogy, Case E-3/15 Municipality of Vaduz, para: 33 (States must ensure the full application of
directives not only in fact but also in law; and must abstain from the application of rules which are liable to
jeopardise the achievement of the objectives pursued by a directive and, therefore, deprive it of its
effectiveness).
49
effectiveness of Article 36 EEA and Article 20(2) of the Regulation, in breach of
Article 3 EEA, and/or Articles 36 EEA and Article 20(2) of Regulation 883/2004.
6 CONCLUSION
150. In the first two Pleas, the Authority has set out the way in which Norwegian law
and/or practice results in a substantive breach of Article 20(2) of Regulation
883/2004 and/or Article 36 EEA (and in the case of the Second Plea, also of Article
3 EEA). Throughout these two Pleas, the Authority has highlighted individual issues
giving rise to legal certainty concerns. In the Third Plea, the Authority has shown
that these are not isolated shortcomings of national law and practice, but
demonstrate a serious systemic problem, in breach of the principle of legal certainty
and also of Articles 3 and 36 EEA and Article 20(2) of Regulation 883/2004.
Accordingly, the Authority requests the Court to declare that:
1. by maintaining in force legislation, such as ss. 2-1b(4) PRA and 6 PR, which
unjustifiably restricts or does not include the right to seek in-patient treatment in
another EEA State when a medically-justifiable deadline for providing treatment
cannot be met, the Kingdom of Norway has failed to fulfil its obligations under
Article 20(2) of Regulation 883/2004 and/or Article 36 EEA;
2. by maintaining in force legislation, such as ss. 2-1b(5) and 3(4) PR and ss.2-
4a(2)a PRA and 3 PR, which failed or fails correctly to reflect the rights of
patients to seek treatment in another EEA State where the same or equally-
effective treatment cannot be provided in the home State within a time limit
which is medically justifiable, the Kingdom of Norway has failed to fulfil its
obligations under Article 20(2) of Regulation 883/2004 and/or Article 36 EEA;
3. by maintaining in force an appeals and procedural structure under provisions
such as Section 7-2 PRA and Sections 7 and 8 PR which prevents and/or
discourages the PRA/PR complaint/appeal bodies from correctly applying and
securing the rights of patients to seek treatment in another EEA State where the
same or equally-effective treatment cannot be provided in the home State within
a time limit which is medically justifiable, and/or by maintaining an administrative
practice in which such rights are not secured, the Kingdom of Norway has failed
50
to fulfil its obligations under Article 20(2) of Regulation 883/2004 and/or Article
36 EEA, in breach also of Article 3 EEA;
4. by maintaining in force and applying the above unclear and/or conflicting
national rules and practice in relation to patients’ rights to seek treatment in
another EEA State, the Kingdom of Norway has breached the principle of legal
certainty and undermined the effectiveness of Article 36 EEA and Article 20(2)
of Regulation 883/2004, in breach of those provisions, and/or of Article 3 EEA.
Claire Simpson Erlend Møinichen Leonhardsen
Marte Brathovde Ewa Gromnicka
Agents of the EFTA Surveillance Authority
51
SCHEDULE OF ANNEXES
Description Referred to in this Number of
No Application at pages
paragraph(s)
Norway’s Reply to the 14
Paragraph 8
A.1 Supplementary Reasoned Opinion
(20 December 2022)
Letter of Formal Notice (14 May 25
A.2 Paragraphs 14, 15,
2014)
Letter from ESA to Norway describing 1
A.3 patient complaints (12 December Paragraph 14
2013)
Patient e-mail complaint on behalf of 1
A.4 Paragraph 14
846 signatories (2 March 2020)
Norway's Reply to the Letter of 125
A.5 Paragraphs 15, 16
Formal Notice (15 August 2014)
Supplementary Letter of Formal 25
A.6 Paragraph 16
Notice (3 February 2016)
Norway’s Reply to the
A.7 Supplementary Letter of Formal Paragraphs 16, 32 15
Notice (3 May 2016)
Reasoned Opinion (20 September 33
A.8 Paragraphs 17, 61
2017)
Norway’s Reply to the Reasoned 4
A.9 Paragraphs 17, 61
Opinion (19 January 2018)
Letter from Norway to ESA (11 April 2
A.10 Paragraph 17,
2018)
Decision No 091/19/COL to refer the 3
A.11 case to the EFTA Court (18 Paragraph 18
December 2019)
Request for Information from Norway 6
A.12 Paragraph 18
(7 May 2021)
Paragraphs 18, 32,
Norway’s Reply to the Request for
A.13 60, 61, 71, 79, 81, 21
Information (18 June 2021)
87, 117,
Second Supplementary Letter of
A.14 Paragraph 18
Formal Notice (18 May 2022) 36
Norway’s Reply to the Second
A.15 Supplementary Letter of Formal Paragraphs 19, 51 13
Notice (8 July 2022)
Supplementary Reasoned Opinion Paragraphs 19,
A.16
(20 October 2022) 114, 117 38
Decision No 107/23/COL to refer the
A.17 case to the EFTA Court (26 July Paragraph 19 4
2023)
Paragraphs 26, 28,
34, 38, 39, 40, 41, 16
A.18 Legislation Annex 63, 64, 69, 76, 88,
95, 99, 102, 105,
134, 135,139,
52
Diagram of different routes to
A.19 Paragraph 43
treatment abroad and related bodies 1
Cross-border healthcare in the EU
under social security coordination - 127
A.20 Paragraph 51
Reference year 2020 - European
Commission Report
Decisions of the Appellate Body for Paragraph 60, 84,
A.21
Treatment Abroad 91, 105, 112, 305
Decisions of the Appellate Body for
A.21a Treatment Abroad – Original Paragraph 60 277
Norwegian language versions
Decisions of the Offices for Medical Paragraphs 84, 91,
A.22
Treatment Abroad 112, 204
Decisions of the Offices for Medical
A.22a Treatment Abroad - Original Paragraph 84 196
Norwegian language versions
Correspondence between the
Authority and Norway to obtain 6
A.23 copies of the decisions of the Offices Paragraph 105
for Medical Treatment Abroad
(ending 24 May 2023)
Letter from the Norwegian Ministry
sent to Helfo and the Office for Health 5
Service Appeals (originally annexed Paragraphs 107,
A.24
to the Reply to the Supplementary 136
Reasoned Opinion) (19 December
2022)
Follow up letter regarding Norway's
alleged breach of Regulation Paragraphs 114, 2
A.25
883/2004 and Art. 36 EEA (14 April 137
2023)
Email to the National Insurance Court
A.26 on patients' right to treatment abroad Paragraph 115 2
according to the EEA (1 June 2023)
E-mails from the National Insurance
A.27 Court to the Authority (7 June and 8 Paragraph 115 6
June 2023)
Decisions of the National Insurance Paragraphs 115, 170
A.28
Court (downloaded from lovdata) 116, 117, 118, 120,
Decisions of the National Insurance
Court (downloaded from lovdata) - 156
A.28a Paragraph 115
Original Norwegian language
versions
Decisions of Helfo 2019-2021 (37 75
A.29 Paragraph 121
decisions provided by Norway)
Decisions of Helfo 2019-2021 (37
decisions provided by Norway) - 75
A.29a Paragraph 121
Original Norwegian language
versions
_______________________
Reg istered at the EFTA Court under N' E-9/23-7 on 9th day of October 2023
w
ATTORNEY GENERAL FOR CIVIL AFFAIRS
To the EFTA court oslo,09 october 2023
Statement of defence
by the Kingdom of Norway
represented by Ms Lotte Tvedt, Mr Simen Hammersvik, advocates, and Mr Andreas Runde,
associate, at the Office of the Attorney General for Civil Affairs, and Ms Marie Munthe-Kaas,
advisor at the Ministry of Foreign Affairs, acting as agents, in
Case E-9l23 - EFTA Surveillance Authority v The Kingdom of Norway
in which the EFTA Surveillance Authority ("ESA') is seeking a declaration that the Kingdom of
Norway has failed to fulfil its obligations under Article 20(2) of Regulation 883/2004 and/or
Articles 3 and 36 EEA.
aaa
1 INTRODUCTION
1.1 The essence of the case
(1) ESA holds in its application 26 )uly 2023, in essence, that Section 2-1 b(4) and (5) of the
Patient and Users' Rights Act ("PRA")l at 20 January 2018 (the "First Compliance Deadline")
and Section 2-4 a(2) at 22 December 2022 (the "second Compliance Deadline"), as well as
the procedural rules and administrative practice relating to these provisions, conflict with
Article 20(2) of Regulation 883/20042 and Articles 36 and 3 EEA.
t Act 2 July 1999 No 63 on Patient and Users' Rights.
2 Regulation (EC) No 883/2004 by the European Parliament and of the Council of 29 April 2004 on the
coordination of social security systems.
Universitetsgata 8, 0164 Oslo postmottak@ regjeringsadvokaten.no +47 2299O2O0
P.O. 8ox 8012 Dep. NO-0030 Oslo
[email protected] +47 22 99 02 54 1/49
(2) The Nonruegian Government (hereinafter "the Government") submits that ESA's application is
based on a fundamentally misconceived interpretation of both national law and EEA law and,
therefore, rejects the application in its entirety.
(3) The Government does not dispute that, pursuant to Article 20(2) of Regulation BB3/2004,
patients shall be authorised to receive treatment in another EEA State when two conditions
are fulfilled: (i) the treatment in question is among the benefits provided for by the
legislation in the Member State where the person concerned resides, and (ii) they cannot be
given such treatment within a time-limit which is medically justifiable, taking into account
their current state of health and the probable course of their illness.
(4) As the Government previously has explained to ESA, these requirements are in Nonlrregian
legislation ensured through the implementation and enforcement of Regulation 883/2004 in
the National lnsurance Act (NlA) Section 1-3a3. By virtue of this provision, Nonaregian
authorities are obliged to authorise insured persons to go to another Member States for the
purposes of receiving appropriate treatment or to provide reimbursement, subject to the
conditions in Article 20(2) of the Regulation. This means, in other words, that the situation
complained of in the application cannot arise, namely that national law denies an insured
person their rights under Article 20(2) of the Regulation. lt should thus already at this
juncture be apparent that the rights provided by PRA must necessarily come in addition to
the rights provided by Article 20(2) of Regulation 883/2004, which as mentioned are
implemented and thus guaranteed.
(s) However, Norway has in Sections 2-1 b(4),2-1 b(5) and 2-a aQ)@) PRA ("the
Supplementary Schemes") chosen to maintain odditionol rights to treatment abroad.a
Under Sections 2-1 b(4), patients may receive treatment abroad when the treatment in
question is available in the Nonruegian specialist healthcare service, but cannot, or is
expected not to, be provided within the relevant deadlines ("the Breach of Deadline
Scheme").s Under the previous Section 2-1 b (5), today 2-4 a(2Xa) PRA, the patient may
receive treatment abroad where the treatment in question does not exist in Nonruay, or the
treatment available abroad is more effective than the treatment available in Norway, and
hence not available as such ("the No Adequate Treatment Scheme").5
(6) These additional rights are beneficial for the patients in two respects: First, they provide
better financial conditions and support compared to Article 20 of Regulation 883/2004, and
3 This provision is set out in Annex A.18 to the Application.
4 ln addition to Regulation 883/2004 and the Supplementary Schemes, patients may receive cost
assumption for treatment abroad under Directive 2011/24/EU of the European Parliament and of the
Council of 9 March 201 1 on the application of patients' rights in cross-border healthcare (hereinafter
"Directive 2011/24/EU"), which is implemented into Nonruegian law by means of the Noruvegian Regulation
22 November 2010 No 1466 on reimbursement of healthcare services received in another EEA State ("the
Reimbursement Regulation"). That is why Norway, as will be elaborated upon in Section 3.3 below, in total
has three routes to in-patient treatment abroad.
s This scheme only covered treatment abroad at the First Compliance Deadline.
6 The scope of this scheme was somewhat broadened from
the First to the Second Compliance Deadline,
see Section 3.3.4(b) below.
2/49
second, they allow patients to go abroad for publicly funded in-patient treatment in
situations where EEA secondary law does not require this.7 At the same time, it must be
stressed that every patient who fulfils the criteria in Article 20(2) of the Regulation may
always choose to apply for prior authorisation or reimbursement in accordance with that
provision, even if they also fulfil the criteria for any of the other alternative schemes
providing coverage for treatment abroad.
(7) ESA nevertheless challenges the Supplementary Schemes, and holds that all national
schemes must reflect the conditions in Article 20 of Regulation 883/2004. However, ESA fails
to recognise that EEA healthcare law does not entail harmonisation of national legislation,
but merely sets out minimum requirements. The Government has previously attempted to
explain that the benefits provided in the Supplementary Schemes apply in addition to - and
goes beyond - the requirements of Article 20(2) of the Regulation. Thus, in the
Government's view, the Supplementary Schemes do not conflict with the obligations set
forth in Article 20 of Regulation 883/2004, Article 36 or Article 3 EEA.
(B) First, the No Adequate Treatment Scheme gives right to in-patient treatment abroad even
though the treatment in question is nof among the benefits provided for by the legislation
in the EEA State where the person concerned resides, i.e. benefits that actually is provided
for in the public social security system in that State. Such benefits thus fall outside the scope
of Article 2O(2), and the competent institution is consequently not required under that
provision to provide authorisation for in-patient treatment abroad in respect of such
benefits. For the same reason, this scheme does not constitute a restriction on Article 36
EEA.
(s) The Breach of Deadline Scheme, on the other hand, admittedly regulates treatment which is
provided for in Norway and which thus rs among the benefits provided for under the
Norwegian social security system. This means that Article 2O(2) of Regulation 883/2004
applies. National Authorities must, therefore, authorise patients to go to another EEA State
for the purposes of receiving appropriate treatment, if they cannot be given such treatment
within a time limit which is medically justifiable, taking into account their current state of
health and the probable course of their illness. ln this regard, it will be recalled that the
implementation of Article 20 of Regulation 883/2004 into Norwegian law guarantees this
right, and a patient can thus, in every case, request such authorisation or reimbursement.
What the Breach of Deadline Scheme does, however, is to provide that patient with an
additional choice, with better financial conditions and support.
(10) Drawing the lines together: the right to in-patient treatment in other EEA States, in
accordance with Article 20(2) of Regulation 883/20C/,, is guaranteed by the implementation
of that provision in NlA, while the Supplementary Schemes provide rights going beyond
those required by Article 20 (2).
7 The Government will return to this in Section 4.2.2 below.
3/49
(11) As to Article 36 EEA, it is recalled that Directive 2011/24, which codifies most of the caselaw
under Article 36 EEA and Article 56 TFEU8, is implemented in Nonrrregian law by the
Reimbursement Regulation. As long as patients' rights under EEA secondary law are ensured,
the Government holds that EEA States may introduce supplementary schemes. Additional
schemes cannot, however, constitute an unlawful restriction on primary EEA law. As will be
explained in Section 4.3 below, the Supplementary Schemes do not constitute a restriction
on Article 36, and any restriction may in any event be justified in overriding reasons of public
interest.
(12) ln addition, the Government holds that the procedural rules and administrative practice
related to the Supplementary Schemes, do not render the EEA Schemes ineffective, or make
the state of law uncertain for the patients. As will be explained in Section 5 and 6 below,
information on the different schemes is available for patients, and the bodies administering
the schemes provide guidance to patients as to what scheme they may apply for.
1.2 Overview of the obseruations
(1 3) ln the following, the Government will first give a brief overview of relevant EEA law (section
2). This is followed by a thorough description of Norwegian law in respect of the right to
healthcare in other EEA States (Section 3). The latter is necessary to provide the Court with
sufficient understanding of the contested legislation, including the criteria for being entitled
to such publicly funded healthcare. ln Sections 4-6, the Government will comment on ESA's
three pleas and demonstrate that all of these are unfounded.
(14) lt should also be noted thatthere are two separate compliance deadlines in the case.e Some
changes were made in the contested legislation between the two deadlines, partly with
specific reference to the ongoing dialogue with ESA. This makes it necessary to carry out
separate assessments for each deadline.
2 THE LEGAT FRAMEWORK UNDER EEA LAW
2.1 lntroduction
(1 s) The healthcare sector, and in particular hospital services, has special characteristics of a legal
and factual nature that must be appreciated when considering national regulations, and
when interpreting the relevant EEA law.
(16) Firstly, national autonomy as regards questions of public health is an important principle
underlying all EEA regulations of patients' access to healthcare. The EEA Agreement does
not, in principle, interfere with the competence of the EEA States to organise their social
security or healthcare system and to design legislation related to this. ln the absence of
harmonisation at EEA level, it is for the legislator of each EEA State to determine the
I Treaty on the Functioning of the European Union.
e 20 January 2018 and 22 December 2022 respectively.
4/49
conditions on which social security benefits, including in-patient treatment, is granted.l0 This
applies both to treatment at home and abroad, and irrespective of how the medical
treatment in question is financed.ll
(17) Secondly, there are relatively large differences between the health sectors, including the
hospital sectors, in the EEA States both as regards the organisation of the sector, the level of
public regulation, and the level of health seruices offered to the population. These
differences must, according to the case law of the ECJ,12 be respected, and it is irrelevant
whether other states have chosen a different - and potentially less restrictive - regulation.l3
(18) Thirdly, the healthcare sector is of the utmost importance for the States both from welfare
and economic perspectives. With the scientific and technological developments taking place
within this sector, public regulation and control is, as the Government sees it, increasingly
important, inter olia, to ensure that health resources, including health personnel, are used
where there is a genuine need from a health perspective.la Complex and often controversial
priority assessments have to be undertaken, probably increasingly often.
2.2 Three different schemes
(1e) Even though EEA law does not fully harmonise patients' rights to treatment in other EEA
States, the states' competence must be exercised in accordance with EEA law. EEA law does
neither systematically nor exhaustively regulate the right to receive cross-border in-patient
treatment in other EEA States, but several strands of EEA law are relevant.
(20) ln essence, the right to receive inpatient treatment in other EEA States are regulated by:
0 Regulation 883/2004, which concerns the coordination of the EEA States' social
security systems, including a right to an autorisation to receive healthcare in
other EEA States, see Article 20,1s
(iD Directive 2011124/EU, which seeks to codify the relevant case law under Article
36 EEA/Article 56 TFEU up until the adoption of the Directive,l6 and
(iiD the freedom to provide services under Article 36 EEA as developed through case
law.17
(21) These three schemes work in parallel with, and complement, each other. Although setting
out somewhat varying criteria for the right to publicly funded in-patient treatment in other
10
Joint cases E-1 1/07 and E-8l01, Rindal and Slinning, para. 43, case C-157/99, Smiffs ond Peerbooms, paras.
45 and 85, and case C-372/04, Wotts, para.92, and the case law cited, and C-385/99, Mtiller-Faur6 para 100
11
See, in particular, caseC-157/99, Smitts and Peerboms, para.87. See also recitals 7 and 13 and Article 1(1)
of Directive 2011 /24/EU.
12
Court of Justice of the European Union.
13
Case C-57/99,lmitts ond Peerbooms, para.87 in particular.
1a See, in this regard, recital 40 to Directive 2011/24/EU.
15 Presented in Section 3.3.2.
16 Presented in Section 3.3.3.
17 Presented in detail in Section 3.3.4.
s/49
EEA States, and to some extent providing different economic support, they mostly cover the
right to the same healthcare.
(22) The Government will elaborate on each of the schemes below.18 As regards the free
movement of services set out in Article 36 EEA, it is sufficient for now to recall that this
freedom also applies to patients' reception of healthcare services in other EEA States.le This
freedom may only be restricted by rules that are justified by overriding reasons in the public
interest, which are appropriate to securing the attainment of the legitimate objective
pursued, and proportionate having regard to that objective.2o
(23) Similar to Norwegian law, a person may under EEA law have rights under more than one
scheme at the same time. This holds true both for Article 20 of Regulation 883/2004 and
Article 36 EEA,21 and Regulation 983/2004 and Directive2011/24/ElJ.2z
3 NATIONAL LEGAT AND FACTUAT BACKGROUND
3.1 The Norwegian healthcare system - an overview
(24) To be able to judge whether the Norwegian legislation on in-patient treatment in other EEA
States conflicts with, or does not correctly reflect, EEA law, it is necessary to be familiar with
some of the main characteristics of the Norwegian healthcare system.
(25) ln short, Nonruay has a universal, public healthcare system, founded upon the principle of
solidarity, which is financed through general tax revenue. The system provides equal access
to healthcare services for all inhabitants, regardless of their social or economic status and
geog raph ical location.
(26) Patients residing in Norway are, as a main rule and irrespective of their nationality, entitled
to i.e. publicly funded necessary specialist and primary healthcare, adapted to the patient's
needs, cf. Sections 2-1a and 2-1b PRA. ln general patients who are resident in Norway are
entitled to receive these services for free, or subject to a very limited degree of cost-sharing.
(27) Healthcare is organised at three main levels: national/state level, Regional Health Authorities
(RHAs), and municipalities. The responsibility for specialist healthcare services, which
includes hospital services,z3 lies with the state, which is the owner of four RHAs,
18
See Section 3.2 (Regulation 88/2AAQ,3.3 (Directive 2011/24/EU) and 4 (Article 36 EEA).
1e
Joint cases E-1 1/07 and E-1l08, Rindal and Slinning, para.42 and the case law cited.
20 Case E-8/20, N, para. 91 and the case law
cited.
21 See case C-777/18, WO, para. 33 and
the case law cited.
22
Article 2(m) of the Directive.
23 Cf. Section 2-1a (1) of the Specialist Healthcare
Services Act
6/49
3.2 Right to necessary healthcare from the specialist healthcare service
3.2.1 Conditions for the rQht to necessary healthcare
(28) A fundamental requirement in order to be entitled to publicly funded specialist healthcare
seryices, including where these are delivered abroad, is that the patient must have the right
to necessary healthcare in accordance with Section 2-1 b (2) PRA and the Priority Regulation
("PR;".2+
(29) At the First Compliance Deadline, the relevant parts of Section 2-1 b PRA read:zs
" [...]
[2] The potient hos the right to necessory heolthcore from the speciolkt heolthcore
seruice. The speciolist healthcore service must during the course of the ossessment
period, cf. [section 2-2(l) PRA], set o deodline for when the patient must receive the
necessary healthcore at the lotest. The deadline must be set in occordance with what
p rof e ss io n a I re s p o n s ib ility w o u ld req u ire. [...]
Hl lf the IRHAI has not ensured that o potient entitled to necessary heolthcore from
the specialist healthcore service receives the necessary healthcore within the time set in
accordance with the second paragraph, the potient has the right to necessary
healthcare without delay, if necessary from o private service provider or service
provider outside the realm.
t\l lf the IRHA] connot provide heolthcare to a patient who is entitled to necessary
heolthcore because there is no adequate treotment offer in the realm, the patient has
the right to necessory heolthcare from a seruice provider outside the realm within the
deodline estoblished under the second paragroph.
L.l,
(30) At the Second Compliance Deadline, the following changes had entered into force:
- The following sentence were added at the end of the second paragraph: "The right
to necessary healthcare applies to the services that the specialist healthcare service
is responsible for providing and financing, cf. the Specialist Healthcare Services Act
Sections 2-1 a and 4-4"
- The wording emphasised above (i.e. the last part of (4), and the entire (5)) were
removed. The fifth paragraph was replaced by Section 2-4 a(2Xa) PRA26
2a
The Norwegian regulation 1 December 2000 no. 1208 on the prioritization of health services, the right to
necessary health care from the specialist healthcare service, the right to treatment abroad and on appeals
boards (the prioritization regulation.
2s See also annex A.18 to the Application.
7 /49
(31) ln essence, it follows from Section 2 PR27 that two conditions must be met in order for a
patient to be entitled to the necessary healthcare from the specialist healthcare service:
0 the patient must be expected to benefit from the healthcare, and
(iD the expected use of resources must be in a reasonable relationship with the
expected benefit of the healthcare.
(32) ln addition, it follows from Section 3 PR28 that the assessment of the patient's benefit from
the treatment must be individual and based on international medical science.
3.2.2 Deadlines
(33) Anyone who is referred to the specialist healthcare service must, within 10 working days
after the referral has been received by the specialist healthcare service, receive information
about whether they are entitled to necessary healthcare from that service, Cf. Sections 2-1
b(2) and 2-2()2s PRA.3o
(34) Patients who are assessed as having the right to necessary healthcare from the specialist
healthcare service, shall within the same 10 day period be given a deadline for when they at
the latest shall receive the healthcare, Cf. Section 2-2 PRA.31 lt follows from Section 2-1b(2)
second and third sentence PRA that this deadline must be set on the basis of a discretionary
individual and concrete health professional assessment of the individual patient. The setting
of the deadline must also be prioritised according to the criteria included in Section 2a PR.ln
the prioritisation between patients entitled to necessary healthcare, emphasis must be
placed on the benefit which the patient is expected to have from the healthcare, how serious
the condition of the patient is, and the resources needed to provide the healthcare.
(35) The deadline must be set so that the healthcare can be started and completed in a medically
justifiable time throughout the course. Furthermore, the deadline must be set so as to avoid
the patient's condition worsening or examination or treatment options are being lost along
the way. lt must be medically justifiable to postpone the healthcare untilthe deadline that is
set without the prognosis for the treatment being reduced. lf it later turns out that the
patient needs healthcare at an earlier time than the set deadline, e.g. because their state of
health has deteriorated, it follows from the duty to provide services in accordance with
professional responsibility and diligent care that the healthcare must be provided to the patient at
an earlier time.
(36) lt should be emphasised that a breach of the deadline set in accordance with Section 2-1
b(2) does not necessarily entail that the patient does not receive necessary healthcare within
26 See Section 3.3.4(b) below
27
Cited in annex A.18 to the Application
28
Cited in annex A.18 to the Application
2s Cited in annex A.18 to the Application
30 A faster
assessment shall be made if a serious or life-threatening illness is suspected, Cf. Section 2-2 first
paragraph third sentence PRA.
31 Cited in annex A.18 to the application
8/49
medically justifiable time limit. The deadline is to be set so that, if necessary, Helfo can find
an alternative provider who can provide the healthcare within a medically justifiable time
limit.32
(37) lt should be emphasised that a breach of the deadline does not necessarily entail that the
patient does not receive necessary healthcare within reasonable time. On the contrary,
whether that is the case depends on an overall assessment of the patient's condition, state
of health, when they actually receive necessary healthcare etc.33
(38) Furthermore, the specialist healthcare service must inform the patient of the time when the
examination or treatment is to be started within the ten days period mentioned above, cf.
Section 2-2(1) fourth sentence PRA. The time for starting an examination or treatment must
be set before the deadline for when healthcare must be provided at the latest.3a
3.2.3 Distribution of responsibilities
(3e) The specialist healthcare service is responsible for making the assessment of whether a
patient is entitled to specialist healthcare in accordance with Sections 2-1b PRA and 2 PR,
and, if so, for the assessment of which healthcare the patient needs, and which offer they
shall receive. lt is also for the specialist healthcare service to set the deadline mentioned in
Section 2-2 PRA. The RHA may, however, also delegate these competences to private
healthcare providers in accordance with Section 2-1 b(6) and (7) PRA.
(40) The patient has the right to choose to which public or private institution a referral to the
specialist healthcare service is to be assessed, but can only choose institutions that have the
right to assign patient and user rights according to Sections 2-1 b Cf .2-4 PRA. Patients who
have the right to necessary healthcare from the specialist healthcare service in accordance
with Section 2-1 b(2) PRA, can choose which healthcare provider shall be responsible for
providing the healthcare. This scheme - known as "free choice of treatment"3s - allows
patients the right to choose between treatment places throughout the country that are
owned by, or have a contract with, a RHA.
(41) The RHA remains responsible for ensuring that the patient received the services to which
they are entitled, irrespective of where the examination or treatment is carried out. This also
32 See Prop 118 L (2012-2013) p. 41, where the Ministry held that (office translation): ""Nor can the deadline
be set so marginally that it is not possible to provide the patient with a meaningful offer privately or abroad,
cf. Section 2-1b third paragraph tPMl. ln those cases where the patient needs health care over time, this
must be taken into account when the deadline is set, so that the entire patient care pathway is medically
justifiable."
33 See Prop 118L(2012-2013) p. 53. where the Ministry holds that (office translation): "The legal deadline is
set at an early stage in the patient care pathway, and is based on a "worst-case scenario". lt is therefore
conceivable that the situation has changed during the during the course of the patient care pathway so that
it is not necessarily medically unjustifiable to receive healthcare after the end of the deadline"
3a
Section 2-2 second paragraph first sentence PM
3s Changed to "right to choice of place of treatment" from 1 January 2023
9/49
applies if the examination or treatment is carried out abroad in accordance with
Sections 2-1b (4) and (5) (First Compliance Deadline) or 2-4 a(2Xa) (Second Compliance
Deadline) PRA.35
3.3 ln-patient treatment abroad
3.3.t Overuiew
(42) As set out in Section 1.1 above, there are three different legal grounds in Norway for publicly
funded in-patient treatment in other EEA States:
0 Regulation 883/2004, at the First Compliance Deadline incorporated by the
Nonrvegian Regulation 22 June 2012 No 585 and at the Second Compliance Deadline
incorporated by Section 1-3a of the National lnsurance Act (hereinafter "NlA")
(iD the Norwegian Regulation 22 November 2010 No 1466 on reimbursement of
healthcare services received in another EEA State ("the Reimbursement
Reg u lation"),37 wh ich im plements Di rective 201 1 /24 /EU,38 a nd
(iii) the Supplementary Schemes that covers two different situations:
(a) The Breach of Deadline Scheme: Where the healthcare in question is
available in Norway, but cannot be provided within the deadlines set for
when the treatment must be given at the latest, Cf. Sections 2-1 b(4) PRA
and 6 PR (First Compliance Deadline), and
(b) The No Adequate Treatment Scheme: Where there is no adequate
healthcare in Norway, Cf. Section 2-1 b(5) PRA (First Compliance
Deadline), or where the healthcare in question do not exist in Nonruay, or
the healthcare available abroad is more effective than what is available in
Nonaray, Cf. Section 2-4 a(2\(a) PRA (Second Compliance Deadline)
(43) Chapter 2 PRA and PR apply equally to all of these schemes as to the situation where the
healthcare is provided in Nonlrray. Hence, it is a fundamental requirement that the patient
has the right to necessary healthcare in accordance with Sections 2-1 b PRA and 2 PR, and
the deadlines set out in Sections 2-1 b and 2-2 PRA are also relevant in this regard.
(44) The EEA Schemes and the Breach of Deadline Schemes are supplementary in the sense that
a patient that meets the conditions under one scheme, is not precluded from choosing cost
assumption under one of the other schemes instead (provided that the conditions of the
alternative scheme are also met). Similarly, if a patient does not fulfil the conditions under
one scheme, this does not preclude cost assumption under one of the other schemes
(provided, again, that the relevant conditions under the alternative scheme are met). lf the
36 See Section 3.3.4(a) and (b) below
37
The Nor*egian Regulation has been adopted pursuant to, amongst others, Sections 5-3, 5-22, 5-24a and
21-12 NIA
38
Alternatives (i) and (ii) are referred to collectively as "the EEA Schemes" in the following
10/49
expenses are covered under one scheme, the patient is naturally not entitled to receive
reimbursement of the same costs under another scheme.
(45) Conversely, the No Adequate Treatment Scheme is the only scheme that allows for cost
assumption for healthcare that is not available in Nonaray, or where the treatment abroad is
more effective.
(46) lt is apparent from the number of applications and approvals under each of these schemes
that alternative (ii), namely reimbursement in accordance with Directive2011/24/EU, is by far
the most used scheme for in-patient treatment abroad. For example, in the years2017 -
2022there were in total 6808 totally and 33 partially approved claims for in-patient
treatment under alternative (ii), and only 6 approvals for authorisation in accordance with
Article 20 of Regulation 883/2004 (alternative D.3s The fact that the number of applications
under Article 20 is low compared to the other schemes, is in the Government's view mainly
due to the other schemes being more beneficial to patients.ao
(47) ln total 1336 application were approved under the No Adequate Treatment Scheme in the
same period,al whilst there have been no applications under the Breach of Deadline Scheme
since 2013.
(48) ln the following, the Government will present each scheme separately
3.3.2 Regulation 883/2004 (olternotive G))
(4e) Regulations 883112004 and 987/2009a2 are incorporated into Nonrvegian legislation os such.as
Article 20 of Regulation 883/2004 thus provides an independent legal basis in Norway for
publicly paid treatment abroad.
(50) Chapter 1 of Regulation 883/2004 sets out three different situations in which a person is
entitled to healthcare abroad, one of which is when a person travels to another EEA State
with the purpose of receiving medical treatment (Article 20). ln that case, they must seek
authorisation from the competent institution in order to be entitled to reimbursement of
costs under the provision.4 Under Article 20(2), the competent institution is obliged to grant
the authorisation when two cumulative conditions are satisfied: First, that the treatment in
question is among the benefits provided for by the legislation in the EEA State where the
person concerned resides, and second, when the treatment in question cannot be provided
3e
See annex 1 andZ where the numbers are set out in detail
a0
The Government will return to this in Section 5.3.2 below.
a1
See annex 3
a2 Regulation (EC) No 987/2009 of the European Parliament and of the Council of 16 September 2009 laying
down the procedure for implementing Regulation (EC) No 883/20U on the coordination of social security
systems
a3 Before 25 November 2022, Regulation 883/2004 and987/2009 was made part of Norwegian law by
Regulation (forskrift) 22 )une 2012 No 585 on the lncorporation of the Social Security Regulations of the
EEA Agreement.
44
Article zo(1)
'tl / 49
"within a time limit which is medically justifiable, taking into account his/her current state of
health and the probable course of his/her illness".
(511 ln the Government's view, the first condition entails that the patient must have the right to
necessary healthcare, and the healthcare in question must correspond to benefits provided
for by Nonruegian legislation.as
(52) The second condition reflects case law of the ECJ predating the Regulation. The ECJ has
ruled that authorisation cannot be refused when the first condition is met, and when the
"same or equally effective treatment" cannot be given "without undue delay" in the Member
State of residence of the insured person (referred to by ESA as "EET element" and "the
timing element").a6
(53) The effect of receiving authorisation under Article 20, is the right to treatment by the
institution of the place of stay, on behalf of the competent institution (here: Norway), i.e.
that the competent institution bears the cost of the treatment.aT However, a patient is
entitled to reimbursement even if they did not get prior authorisation before going abroad
for treatment, provided the conditions in Article 20 were in fact met.a8
(54) The Regulation only applies to public healthcare providers or providers within the social
security scheme of the EEA State providing the healthcare.as Thus, a person may not rely on
Article 20 of the Regulation if he or she seeks treatment abroad by private healthcare
providers which are not part of the social security system in the EEA State in question. As
shown beloq this is contrary to both Directive 2011/24/EU and the Supplementary Schemes.
(55) Further, the reimbursement of costs (for healthcare, accommodation, and travel) under this
scheme is based on the rates of the EEA State providing the healthcare, cf. Article 20 of
BB3/2004 and Article 26 of Regulation 987/2009. Once again, this is contrary to the cost
assumption provided for under the other schemes. A patient is never entitled to
reimbursement higher than the actual costs incurred.
(56) ln Norway, any application for prior approval, or subsequent reimbursement, are processed
by Helfo.so
as This is
elaborated on in Section 4.2.3 below
a6
Case C-56/01, lnizan, para. 45 and C-173/09, Elchinov para. 64-6
47
Article 26 (i) of Regulation 987/2009
Case a8 C-173/09, Elchinov, paras.4547
ae This
can be derived from the fact that the Regulation, pursuant to Article 3(1), only applies to "legislation"
on social security, a term which underArticle 1(l) excludes "controctuolprovisions", unless they "serveto
implement on insurqnce obligotion orising from the laws ond regulotions referred to in the precedi,ng
subporogroph or which hove been the subject of o decision by the public outhorities which mokes them
obligotory or extends their scope, provided that the Member State concerned makes a declarotion to that
effect, notified to the President of the European Parlioment ond the President of the Council of the Europeon
Union".
s0
The procedural system is elaborated on in Section 5
12/49
3.3.3 The Reimbursement Regulotion (olternative ii)
(s7) The Reimbursement Regulation, implementing Directive 2011124/EU, provides patients with
the right to reimbursement for expenses for healthcare services received in another EEA
State, Cf. Section 5-24 a NlA.
(sB) The Directive is mostly a codification of the ECJ's fairly comprehensive case law on the
freedom to receive cross-border healthcare financed, entirely or partially, by the public
purse.sl
(59) ln line with Article 7(1) of the Directive, costs incurred by an insured person who receives
cross-border healthcare are only reimbursed if the healthcare in question is among the
benefits for which the person would have received benefits or contribution for under NlA, or
which had been paid for in the public healthcare service if the healthcare in question was
received in Norway, cf. Section 2 of the Reimbursement Regulation. That entails, amongst
other things, that the right to reimbursement only covers situations where the patient has a
right to necessary healthcare pursuant to, and in accordance with, Section 2-1b PRA.
ln-patient treatment is among the benefits covered under this scheme, provided that the
patient has the right to such treatment in accordance with PRA/PR'52
(60) ln accordance with the Directive, the patient can freely choose a service provider, and
contrary to Regulatio n 883/2004 Article 20(2), the reimbursement scheme is not restricted to
healthcare provided by public healthcare services in other EEA States'
(61) Norway has decided not to require prior authorisation as a criteria for reimbursement of
costs of cross border healthcare, even though this is possible in accordance with Articles B
and 9 of the Directive. lt is, however, possible to apply for prior commitments from Helfo.
The commitment will clarifiT whether (i) the patient is entitled to reimbursement of expenses
for the healthcare in question, and (ii) the limitation of coverage for this healthcare, cf.
Section 9a of the Reimbursement Regulation. Such prior commitment entitles the patient to
reimbursement for their actual expenses for such healthcare up to, and including, the
amount specified in the prior commitment.
(62) As a consequence of Nonruay not requiring prior authorisation, the patient may apply for
reimbursement of expenses for healthcare received in another EEA State in accordance with
the Reimbursement Regulation regardless of whether the deadline for necessary healthcare
in Section 2-2 PRA is exceeded. For the sake of clarity, this is also specified in Section 6(4)
PR. Hence, contrary to Article 20(2) ol Regulation 883/2004, the reimbursement scheme
under the Reimbursement Regulation applies irrespective of whether the same or equally
sr See recital 8 to the Directive
sz lt follows from Section 3(d) of the Reimbursement Regulation that healthcare services that corresponds to
services provided fully or pafcially for free according to the Specialist Healthcare Service Act are covered-
Given that it is a requirement for having the right to necessary healthcare in accordance with the Specialist
Healthcare Services Act that the patient has the right to necessary healthcare in accordance with PRA/PR,
the coverage under the Reimbursement Regulation in this regard is limited to the situation where the
criteria in PM and PR are fulfilled.
13/49
effective treatment would have been provided in Nonrray within a medically justifiable time
limit or not,
(63) The reimbursement under the Reimbursement Regulation will in accordance with the
Directive be limited to the cost which the public healthcare providers would have assumed,
had the healthcare been received in Norway, see Section 7(2) of the Reimbursement
Regulation, yet without exceeding the actual costs of the healthcare received.s3 Hence,
contrary to Article 20(2) of Regulation 88312004, it is the level of cost assumption in Norway,
and not in the State of treatment, that is decisive.
3.3.4 The Supplementary Schemes (olternatives (iii)(a) and (b)
(64) As set out above, the Supplementary Schemes in Section 2-1 b(4) and (5) PRAsa at the First
Compliance Deadline covered two separate situations; (i) where the healthcare in question is
included in the basket of care that is covered by the Norwegian health system, but can, or is
expected to, not be provided to the patient within the time limit set in accordance with
Section 2-1b PRA, and (ii) where there is no adequate treatment in Nonruay to ensure the
patient necessary healthcare.
(65) The RHAs remain responsible for ensuring that patients who are entitled to it receive
necessary healthcare under both of these schemes. This also includes financial responsibility
It is Helfo (breach of deadline scheme) and the foreign offices (no adequate treatment
scheme) who find a service provider and to take responsibility for the practical aspects of
this, such as entering an agreement, paying for the healthcare and so on.
(66) lt is a fundamental principle that the patient in these situations shall not experience any
economic disadvantage from having to receive the necessary healthcare abroad. Hence, all
the necessary actual expenses are covered in such a way that the patient is financially
indemnified, Under both schemes, the RHAs cover expenses for treatment, catering, travel
and accommodation and travel and accommodation for a companion if this is necessary du
to the patient's age or state of health.
(a) The Breach of Deadline Scheme (alternative (iiiXa))
s3
For the sake of completion, the Government mentions that ESA delivered 5 July 2023 a
reasoned opinion to Norway regarding the national administrative practise to limit the
reimbursement of costs related to cross-border healthcare to 80 % of the relevant national
"diagnoses-related-group" (DRG). Norway has instructed the administration to raise the limit
for reimbursement of costs related to cross-border healthcare to 100 % DRG (in cases
handled from 2. October 2023)
s Cited in para. 29 above
14/49
(67) As regards the situation regulated by Section 2-1b (4) PRA at the First Compliance
Deadline,ss further provisions were set forth in Section 6 PR, which read:
5 6. Breach of deadline
The IRHA] in the patient's region of residence must ensure that patients who ore
entitled to the necessary heolthcore according to 5 2, or has the right to healthcare
obroad occording to 5 3, receives an offer of heolthcare from the speciolkt healthcare
seruice within the deodline set in accordonce with Sedion 4 or Section 4o.
lf the specialist heolthcare service cannot provide the potient with a commencement
date for the medicol exominotion or treotment which is before the deadline for when
necessary healthcare ot the latest should be provided, or the appointment is later
omended so that the deodlin cannot be met, or the deodline is exceeded, the speciolist
heolthcare seruice shall immediately contact HELFO, cf. Section 2-1b fourth paragraph
lPRAl. lf the deadline is exceeded the potient con olso contoct HELFO.
HELFO sholl promptly provide the patient with an offer from a public seruice provider
or, if necessary, from o privote service provider in the realm, or if necessary, abrood.
The patient cannot freely choose a service provider. Regardless of whether there is o
breach of the deodline, the patient moy apply for reimbursement of expenses for
heolthcare seruices received in another EEA country in occordonce with the
[Reimbursement regulotion]. The potient moy olso be entitled to hove expenses for
heolthcare services in other EEA countries covered according to the conditions in
[Regulation 883/20M] Application for reimbursement according to the
[Reimbursement Regulotion] or prior opprovol occording to [Regulation 883/2004] is
processed by HELFO.
(641 ln essence, Sections 2-1 b(4) PRA and 6 PR set out a system that shall ensure that the
patient's right to necessary healthcare is fulfilled within the deadline set in accordance with
Section 2-1 b(2) PRA. lf the institution responsible for delivering healthcare to a patient is
expected to breach, or actually breaches, this deadline, the patient has, in accordance with
Section 2-1 b(4) PRA the right to receive a service offer from another seruice provider.
(69) To ensure this, the specialist healthcare service is obliged to contact Helfo without delay in
case of a (expected) breach of deadline. ln practice, this is done as soon as the specialist
healthcare service has become aware that they will not be able to meet the set deadline. lf
there is a breach of the deadline, the patient may also contact Helfo directly and is entitled
to receive necessary healthcare without delay,
(70) lrrespective of whether it is the patient or the specialist healthcare service that contacts
Helfo, Helfo will search for an available service offer for the patient that will ensure that they
receive necessary healthcare within the deadline set in accordance with Section 2-2 PRA. ln
ss cited in para. 29 above
15/4s
practice, the RHAs are expected to try all possibilities to provide the patient with necessary
healthcare, including checking whether there are available capacity at other hospitals or
private service providers that have contracts with the RHA, before notifying Helfo.
(71) Helfo has, for its part, entered into framework agreements with private suppliers. When
Helfo is notified in accordance with Section 2-1 b(4) PRA, they will search for an available
treatment offer in accordance with these framework agreements. These agreements are
covered by, and handled in accordance with, the regulations for public procurements.s6
Economic operators established in other EEA States may participate in competitions relating
to these agreements.
(72) lt is still the RHA that remains responsible vis-6-vis the patient after Helfo has been notified;
Helfo merely gets the task of finding a service offer on behalf of the RHA.57
(73) lt is up to the patients to decide whether they wish to accept the alternative offer provided
by Helfo, or whether they wish to remain on the waiting list of the original service provider,
even if the latter leads to a breach of the deadline under Section 2-2 PRA.
(74) lt follows from this that it is Helfo who finds a service offer to the patient. Accordingly, the
patient cannot decide which service provider that is to deliver the healthcare. The reasoning
behind this is further commented on in Section 4.4.2below.
(75) As mentioned in Section 3.2.1, the reference to service providers outside the realm was
removed from Section 2-1 b (4) from 1 March 2020. By that time, no patient had received
healthcare abroad according to that provision since 2013, and the Ministry for Health and
Care considered the reference to "service providers outside the realm" in the provision to be
redundant, especially when also taking into account the possibility of coverage under
Regulation 883/2004 and/or the Reimbursement Regulation/Directive 2011/24/EU.sg
(76) lt should, however, be stressed that, irrespective of this change, the competitions related to
the framework agreements still are open to service providers from other EEA States.
(b) The No Adequate Treatment Scheme (alternative (iiixb))
(77) Sections 2-1 b(s)ss and2-4 a(2Xa) (First and Second Compliance Deadline respectively)
provided for healthcare abroad in situations where the treatment does not exist in Norway
The wording of the criteria to have a right under the provisions are somewhat changed,
whilst the system ensuring the right, and the consequences of fulfilling the requirements
have remained the same at both Compliance Deadlines.
56 The framework
agreements will normally be handled in accordance with the Nonivegian legislation
implementing Articles 74 following in Directive 2014/24/EU
s7 See Prop.1 1 I L (2012-2013) p. 53
s8 See Prop.80 L (2018-2019) p. 20
se
cited in para. 29
16/49
(78) At both Compliance Deadlines, it was a requirement that the patient had the right to
necessary healthcare pursuant to Section 2-1 b PRA and PR, see Section 3.2.1 above. lt was a
prerequisite that the healthcare can be properly carried out by a service provider abroad
according to an accepted method, cf. s. 3(1) second sentence PR. The patient's condition and
the healthcare in question must satisfu the requirements for benefit and resource use in
Section 2 PR.6o
(79) lt should be emphasised that neither lack of capacity nor long waiting times do not give the
right to treatment abroad under this alternative, cf. Section 3 last paragraph PR. This also
entails that this right arise immediately when the patient is considered to fulfil the
conditions, and they are not dependent on an (expected) breach of deadline.
(BO) Also at both Compliance Deadlines, given that the conditions in the provisions were met, the
RHAs has an obligation to provide necessary treatment abroad.61 ln most cases it is the
specialist health service (hospitals) that takes the initiative to send the patient out. As a rule,
the travel abroad is fully organised by the foreign offices. The offices make contact and enter
into agreements with relevant service providers, organise the travel and stay for the patient.
(81) The specialist health service must set a deadline for when treatment abroad in accordance
with Section 2-a aQ)@) must be provided at the latest, so that these the patients have an
equally clarified legal position as patients who can receive healthcare in Norway, Cf. Section
4 PR.
(BZ1 lt is recommended that patients apply for approval before accepting treatment from
providers abroad under this scheme.62 Otherwise they travel for own expense and risk.
However, in cases where the conditions are met and the patient has travelled out on their
own accord, the patient will be reimbursed for necessary expenses for treatment, travel and
accommodation.
(83) As regards Section 2-1 b(5) PRA (First Compliance Deadline), it was a basic requirement that
the patient is entitled to necessary healthcare, but that there is no adequate medical
treatment in Norway, Whether this was the case, depended on a concrete assessment of the
patient's condition and healthcare available in Norway and other States respectively. The
assessment of a patient's expected benefit from a treatment must be made individually and
based on international medical science.s3
(84) The scheme was moved to Section 2-aa Q)@) PRA at the Second Compliance Deadline,
which read:
60 Exceptions has been made in special cases, allowing patients with rare diseases or conditions to receive
experimental or trial treatment abroad even if the conditions in Section 2 PR are not met.
61 See Ot.Prp. 63 (2002-2003) p. 61
62 Cf. Circular with comments to PRA by the Norwegian Health Directorate, available on
https://www.helsedirektoratet.no/rundskriv/pasient-og-brukerrettighetsloven-med-kommentarer/rett-til-
helse-og-omsorgstjenester-og -transport
63 See Section 3 PR
17/49
The patient has the right to hove expenses for heolthcare received obroad fully or
partiolly covered
a. if the patient has the right to necessory heolthcore from the speciolist healthcore
service occording to 5 2-1 b ond there k no offer in the country or the healthcore
abroad is documented to be more effective than thot healthcare which is offered by the
public heolthcare service sector in Norwoy.
t...1
Expenses for healthcare thot have been decided not to be introduced in Norwoy are
not covered, cf. the Speciolist healthcare seruices Act 5 4-4. [...]
(85) As regards the alternative "there is no offer in the realm", the assessment is more or less the
same as under the previous scheme, namely a concrete review of the patient's condition and
the healthcare available.
(801 Turning to the alternative that the healthcare abroad is documented to be more effective
than healthcare offered in the realm, it is specified in the preparatory works that the
documentation must be clarified in line with requirements laid down in EEA law.il ln this
regard, the case law regarding "the EET element" is relevant as far as it concerns how the
treatments in questions are to be compared to each other.6s lt follows from this case law
that there must be made an individual assessment having regard to all circumstances of
each specific case, taking due account to the patient's medical condition at the time of the
assessment and their medical history.56 The assessment must be based on international
medicine.6T One factor that can indicate the healthcare being documented is that it has been
established and taken into use in a country within the EEA.
(87) Furthermore, it is clarified in the preparatory works that healthcare that is more effective can,
for example, be treatment that gives a better or safer result, or less lasting side effects or
discomfort for the patient. On the other hand, treatment methods where the difference is of
a minor nature cannot be considered healthcare "which is documented to be more
effective". For example, where a treatment method in Norway gives the patient temporary
problems such as moderate pain, nausea or other mild and harmless side effects, whilst a
treatment abroad is offered that has just as good an effect, but which can be carried out
without the patient experiencing such side effects, the latter treatment does not give better
results, but patients avoid temporary side effects. A treatment which enables the patient to
il See Prop.80 L (2018-2019) p. 16
6s lt must, however,
be stressed that the comparison is restricted to this specific guestion, given that the
existing case law concerns situations where the treatment in question is among the benefits provided for by
the State of residence, which the Government does not accept is the case under the No Adequate
Treatment Scheme
66
See case C-173109, Elchinov para. 66
67 See joint cases E-11107 and E-1l0&
Rindal and Slinning para.84 andC-157/99, Smitts and Peerbooms
para.108
18/49
avoid mild side effects which will in any case pass after a few days cannot justify the better
coverage for travel and accommodation in addition to the treatment expenses.
4 THE FIRST PLEA
4.1 lntroduction
(BB) ln its first plea, ESA claims, in essence, that Sections2-1b6) and (5) PRA (at the First
Compliance Deadline) and Sections 2-4 a(2)(a) and possibly the removal of Section 2-1 a (4)
PRA (at the Second Compliance Deadline) conflicts with, or do not correctly reflect, "the right
to EET in time"58.
(89) The Government disagrees, and respectfully submits that ESA's conclusion is based on a
misunderstanding of the Nonruegian provisions concerning in-patient treatment in other EEA
States. Accordingly, ESA applies the wrong legal test when assessing whether the contested
provisions are contrary to EEA law.
(90) ln summary, the Government maintains that the minimum requirements under Article 20(2)
of Regulation BB3/2004 and Article 36 EEA are ensured through the implementation of
Regulation 883|2004 in Norwegian law. lt is no breach of these requirements to provide
additional coverage through supplementary schemes (section 4.2). Further, these schemes
do not constitute unlawful restrictions on the free movement of services under Article 36
EEA (section 4.3).
4.2 No violation of Article 20(2) ol Regulation 88312004
4.2.1 lntroduction
(e1) The Government recalls that Regulation 883/2004 in its entirety is implemented as such into
Norwegian law, see Section 3.3.1 and 3.2.2 above. This is not disputed by ESA. Hence,
patients who fulfils the criteria set out in Article 20(2) of the Regulation, are entitled to
authorisation or reimbursement in accordance with the said provision, if they decide to
apply for this and provided that they have not received cost assumption for the same
healthcare under another scheme.
(92) There is nothing in the provisions setting out the Supplementary Schemes, nor in any legal
sources relating to them, that indicates that they in any way restrict this right. On the
contrary, the schemes serve as a supplement to the right under Article 20(2) of Regulation
condition under Article 20(2) of Regulation 88312004, that prior authorisation must be
68 Le. the second
granted when state of residence is unable to provide an "equally effective treatment within a medically
justifiable time limit".
19/49
883/2004 in the sense that they partly provide additional support6e and partly covers
different situationsTo than the said provision.
(93) Neither the Supplementary Schemes nor, for that matter, the Reimbursement Regulation
(implementing Directive 2011/24lEU) limit patients' right to apply for authorisation or
reimbursement under Article 20(2) of Regulation 883/2004. The only limitation in this regard
is that a patient cannot receive cost assumption under more than one scheme related to the
same healthcare.
(94) ln the Government's view, this does in itself exclude the possibility of conflict between the
Supplementary Schemes and Article 20(2) of the Regulation.
(95) ln the following, the Government finds it appropriate to discuss the contested legislation
(namely alternatives (iiiXa) and (b)) separately, given that these cover different situations and
hence raises somewhat different questions in relation to the Regulation.
4.2.2 The Breach of Deodline Scheme (alternotive (iii)(a))
(e6) The Government submits that there is no conflict between Article 20(2) of Regulation
BB3/2004 and Section 2-1 b(4) PRA.
(97) Firstly, the patient is entitled to necessary healthcare abroad from the moment the criteria
set out in the provisions in Section 2-1 b(2), Cf. Section 2 PR, are fulfilled. The specialist
healthcare seruice has a corresponding obligation to provide such healthcare within the
deadlines set in accordance with Section 2-2 PRA.71 Hence, provided that the necessary
healthcare abroad is carried out before the deadline set in accordance with Section 2-2 PRA,
the patient will not at any rate fulfil the second criteria in Article 20(2), namely that EET
cannot be given in Norway within a medically-justifiable time limit.
(98) Secondly, patients who fulfil the criteria in both Section 2-1 b(4) and Article 20(2) of the
Regulation, are free to choose under which of the said provisions they want coverage. The
Government cannot see that having supplementary schemes which patients who fulfil the
criteria may choose instead of Article 20 of Regulation 883/2004, conflicts with that
provision, as long as they are not precluded from choosing the scheme set out in Article 20
of Regulation 883/2004 (which they are not).
(99) ln this regard, it should also be recalled that Section 2-1 b(4) PRA are more favourable to
patients than Article 20(2) in three aspects:
0 Section 2-1 b(4) provides additional cost assumption compared to Article 20(2), even
compared to what the patient would have been entitled to if the healthcare was
delivered in Nonnray, and irrespective of the level of cost assumption in the State of
stay.
6s The Breach of Deadline Scheme.
70
The No Adequate Treatment Scheme and part of the Breach of Deadline Scheme.
71 See Section 3.3.4(a) above.
20/49
(ii) Under Article 20(2), patients are required to find a healthcare service provider abroad
themselves, Under Section 2-1 (bX4) patients are presented with an alternative by
Helfo.
(iii) Under Article 20(2) the service provider must be part of the public healthcare system
of another EEA State. This is not a requirement under Section 2'1 b(4). The service
provider can also be private.
(100) ESA's interpretation of Article 20(2) of the Regulation entails that EEA States cannot
introduce such alternative schemes unless they operate with the exact same conditions as
set out in Article 20(2) of the Regulation. ln the Government's view, there is no legal basis for
this interpretation, This would in practice entail that Article 20(2) fully harmonises EEA law on
this point.
(101) That is not the case. The purpose of RegulationSS3/2004 is to coordinate the EEA States'
social security systems, thereby ensuring the right to free movement of persons. The
Regulation only provides guidance on coordination, not harmonisation of the EEA States'
social security systems.T2
(102) Finally, the Government cannot see how the removal of the latter part of Section 2-1 b (4)
before the Second Compliance Deadline is contrary to the Regulation, given that the patient
still have their rights under Regulation 883/2004 (and, for that matter, Directive 2011/24/EU)
4.2.3 The No Adequate Treatment Scheme (alternotive (iii)(b))
(1 03) As regards the No Adequate Treatment Scheme, it is recalled that the basic requirement is
that the healthcare in question is not available in Norway. ln this regard, it is not relevant
whether there is no adequate treatment offer to the patient at all, or whether the treatment
offer abroad is more effective than the treatment in Norway; the decisive factor in this
regard is that the treatment abroad is not provided for in the Norwegian national healthcare
system.
(104) The Government submits that this scheme does not cover the same situations as Article
2O(2) of Regulation BB3/2004. ESA has not commented on this question at all, but merely
assumed that the situations covered by the national provisions fulfil the first criteria of
Article 20(2).73
(105) Article 20(2) covers the situation where the treatment abroad is "among the benefits
provided for by the legislation in the [EEA] State where the person concerned resides". lt is
not specified in the provision nor in any other part of the Regulation how the phrase
"provided for by the legislation" is to be interpreted. Nor is this clarified through case law.7a
72 See, in this regard. recital 4 of Regulation 883/2004 and case E-8/20, N, para.71-72
73 See para. 49 of the Application
7a ln case C-173/09, Elchinov, para.62, ECJ only pointed out that it is for the competent institution in the
State of residence to assess whether "the treatment method corresponds to benefits provided for by the
21/49
The wording, however, suggests that the provision only applies to treatment that is available
in the patient's state of residence.
(106) That Article 20(2) only applies to treatment that is actually available in the patient's state of
residence is also supported by its context. Pursuant to Article 20(2) second subparagraph,
the state of residence shall provide authorisation to treatment abroad where the treatment
cannot be given within a medically justifiable time limit. This makes little sense if the
provision also covers situations where the treatment is not available or offered in the public
health system in that state. ln these situations, the timing element in Article 20(2) second
paragraph would be without practical impact.
(107) It is also best in line with the purpose and object of the Regulation that the patients' right
under Article 20(2) is intrinsically linked to the healthcare services that are offered in the
national public healthcare system in their state of residence. This would ensure that it is for
each EEA State to decide what healthcare services that are to be covered under their social
security system, irrespective of whether the service is carried out domestically or abroad.
(108) It would unquestionably limit the EEA States' autonomy if Article 20(2) should be understood
as to also cover healthcare that is not covered by the State of residence's social security
system when that healthcare is carried out within that State.
(109) For the sake of completion, the Government adds that its interpretation of Article 20(2) is
also supported by recital 34 to Directive 2011/24/EU, which reads (emphasis added):
"[EEA] States of offiliation should gtve patients the right to receive at least the some
benefits in onother [EM] Stote as those provided for by the legislotion of the IEEA]
Stote of offiliotion. lf the list of benefits does not specify precisely the treotment method
applied but defines types of treatment, the IEEA] Stote of affiliotion should not refuse
prior authorisation or reimbursement on the grounds that the treatment method is not
avoilable in its territory, but should assess if the crossborder treatment sought or
received corresponds to benefits provided for in its legislotion. The fact thot the
obligotion to reimburse uoss-border healthcare under this Directive is limited to such
healthcare that is among the benefits to which the patient is entitled within its IEEAI
Stote of affiliotion does not preclude [EEA] Stotes from reimbursing the cost of cross-
border heolthcare beyond those limits."
(1 10) Alternatively, even if the treatment provided for in the No Adequate Treatment Scheme, fulfil
the first criteria of Article 20(2) of the Regulation, the Government maintains that the said
national provisions do not under any circumstances conflict with the Regulation.
(111) Once again, it must be stressed that neither the scheme in question nor any other part of
national legislation preclude patients from choosing to request and receive authorisation
under Article 20(2) where the criteria for this is fulfilled (see Sections 4.2.1 and 4.2.2 above).
legislation of that [EEA] State", applying the usual principles for interpretation and on the basis of
non-discriminatory criteria.
22/49
Sections 2-1b(5)/2-4 a(2Xa) PRA merely provides a supplementary scheme with additional
coverage of cost, based on somewhat different criteria than those set out in the Regulation.
4.? No restriction under Article 36 EEA
4.3.1 The restriction test
(112) ESA further holds that Sections 2-1 b(4) and (5) PM (at the First Compliance Deadline), and
Section 2- aQ)( ) PRA (at the Second Compliance Deadline), together with the underlying
provisions in PR also is contrary to Article 36 EEA.75
(113) ln the Government's vieq ESA's approach is positively incorrect, and leads to a wrong
assessment. lt is clear that the starting point when considering if the contested national
legislation constitutes a breach of Article 36 EEA, is to assess whether the legislation
constitutes a restriction,Ts and, if so, if that restriction may be justified.
(114) Surprisingly, ESA seems to jump right across this fundamental starting point and does
neither assess whether there is a restriction under Article 36 EEA, nor discuss or clarify what
that potential restriction actually consists of. On the contrary, ESA jumps right into
considering whether the contested legislation comply with the minimum requirements set
out in Article 20(2) and/or Article 36 EEA, namely whether the provisions allow for a
consideration of whether the patient will receive EET in time.77
(1 15) ln cases concerning patient mobility, the Court and the ECJ have constantly defined the
"restriction" of the freedom to provide services in a limited way, holding that there will only
be a restriction on the freedom to provide services if it is "more difficult" to provide services
between EEA States lhan within the State.zd Hence, the Court has held that:7e
"Article 36 EEA precludes the application of any national rules which hove the effect of
moking the provision of services between EEA Stotes more difficult thon the provision
of seruices purely within on EEA State [...]). This opplies not only to rules which regulate
the right to seek treatment abrood es such, but oko to rules on reimbursement from
notional social security systems of costs for treatment provided obroad [...]." (emphasis
odded)
(1 16) Hence, the right to reimbursement of costs of in-patient treatment abroad is dependent on
inter olia entitlement to treatment domestically. ln other words: The concept of restrictions
under Article 36 EEA, Cf. Article 33, is, in this instance, inextricably linked to the criteria for
right to healthcare set forth in the state in question. There is no restriction on the free
7s
See Section 3.3.4 above for further details on these provisions.
76
See, e.g. case C-562/1Q, Commission v. Germany para. 50.
77 See Section 3.3.2 and para. 2.
78 Case C-368/98, Vanbraekel, para.44 and the case law cited, and C-372/U, Watts, para. 94 and the case
law cited.
TsJointcases E-1 1/07 andE-1/08, Rindal and Slinning, para.44.
23/49
movement of health services provided that the conditions apply equally to domestic
treatment and to treatment abroad.
(117) This line of reasoning does de facto imply that the ECJ has concentrated its assessments on
discriminatory (direct and indirect) conditions for coverage of expenses for in-patient
treatment abroad is warranted due to the specifics of the health sector and of in-patient
treatment in particular. A stricter concept of restrictions in this particular field could - as a
matter of principle - have implied thal any national regulation would entail a restriction,
which would certainly have been contradictory to the national autonomy in the field of
healthcare services and to the characteristics of the health sectors outlined in Section 2.1
above,
(1 18) Thus, the question in the following is whether the Supplementary Schemes are designed in
such a way that they make it more difficult for patients to receive coverage for in-patient
treatment in other EEA States than it would have been in Noruvay in the same situation.
4.3.2 The Breach of Deadline Scheme (sections 5.2.1 and 5.2.2 of lhe opplication)
(119) ln its application Section 5.2.1, ESA holds that the requirements in Sections 2-1 b(4) PRA and
6 PR,80 restricted the ability of the patient to exercise his/her right to go abroad for
treatment in circumstances in which the case-law has clarified that patients have a
free-standing right to seek such treatment, due to the following:
"t...|fu!, until the deadline was exceeded, even if it was cleor in odvonce thot it would
be exceeded, the potient wos required to wait for health services to toke action vio
Helfo. Second. while the potient could opproach Helfo directly once the deadline hod
been exceeded, the potient wos prohibited (or ot least discouroged) under the
Iegislation from directly going abroad: s.6(3) PR required the patient to contact Helfo
and provided thot he/she could not freely choose the service provider.
(1 20) Contrary to ESA" the Government holds that the relevant factor in this regard is that the
conditions set forth in Section 2-1 b (4) PRA, at the First Compliance Deadline, apply equally
to domestic treatment and treatment abroad. lt should be kept in mind that, under this
scheme, the patient will already have been in contact with a public service provider who has
set a deadline in accordance with Section 2-2 PRA, lt is only when this deadline is, or is
expected to be, breached, that the right under Section 2-1 b(4) PRA enters into force.
(121) The fact that the patient cannot freely choose a service provider of their own choice when
the national time limit is breached, but need to consult with Helfo, applies regardless of
whether the treatment in question is to be performed by a national (private) service
provider, or a service provider abroad. This follows directly from the wording of the
provision.
80 See Section 3.3.4(a) above.
24/49
(122) Consequently, the Government submits that Section 2-1 b(4) PRA at the First Compliance
Deadline does not constitute any restriction on the freedom to provide services.
(123) Furthermore, it is difficult to see how the removal of the latter part of this provision before
the Second Compliance Deadline made it more difficult for patients to receive a service offer
under this scheme in another EEA State than Noruray. As set out in detail in Section 3.3.4(a)
above, the system under this scheme remained the same after this change; Helfo still
searches for service offers within the framework agreements they have entered into in
accordance with the regulations on public procurement, implying that tenderers from other
EEA States are able to participate in the competitions related to these agreements.
4.3.3 The No Adequate Treatment Scheme (sedions 5.2.3 and 5.2.4 of the opplicotion)
(124) The Government submits that Sections 2-1 b(5) (First Compliance Deadline) and 2-4 a(2)(a)
(Second Compliance Deadline) PRA and 6 PR do not make it more difficult for patients to
receive in-patient treatment in other EEA States compared to what the situation would be
for them to receive the same healthcare in Nonruay. The reasoning for this is very simple:The
basic requirement for Section 2-1 a(5), and the first alternative of Section 2-4 a(2)(a) lo
apply, is that the healthcare in question does not exist in Nonruay. Hence, there is no
sufficient basis for comparison, and consequently no restriction.
(1 2s) This holds true irrespective of the change in wording that was made between the first and
Second Compliance Deadline. ln this regard, the reasoning set out above applies equally to
the situation where there is no "adequate" or "effective" service offer in the realm.
(126) This reasoning also applies to the second alternative in Section 2-4 a(Z)(a) PRA, Cf. Section 6
PR, namely where the treatment abroad is "more effective". A patient is, under Norwegian
law, not entitled to cost assumption for a domestic treatment that is more effective than
what is offered and considered adequate by the specialist healthcare service in Norway.
(127) ln the Government's view, this conclusion is also supported by the Court's own assessment
in Rindal and Slinning,sl where it held that:
"lt is for the national courts to estoblish [...] whether the cases at hond concern
situotions in which no recognised treatment for the potients existed in Norway. lf thk is
found to be the cose, the Court cannot see any ertro burden resulting from the faa
that treatment took place obrood. ln thot situation, the Court con see no restriction on
the free movement of seruices when patients are refused reimbursement of costs for
treotment abrood. occording to rules which opply in the same way to treatment in
Norwoy in excluding experimental ond test treotment from coveroge."
(128) Although that case concerned a different matter from that in question here, it is striking that
the Court accepted that, in a situation where the same treatment was not offered or payed
for neither in Norway nor abroad, there was no restriction on Article 36 EEA. ln our case, the
81
Joint cases E-11l07 and E-1l08, Rindal and Slinning, paras.4647
zs/49
Norwegian legislator have gone even further and provided treatment abroad, which
certainly cannot be seen as a restriction on the free movement of services.
(12s) For the sake of good order, the Government finally remarks that a treatment abroad that is
"more effective" than a national treatment, is only the negation of a national treatment that
is not "equally effective" as a treatment abroad. Thus, the Government does not follow ESA
when it submits that Section 2-a(2)(a) does not properly reflect the "EET Element" of the
Second Condition,sz even though the Government holds that it is irrelevant whether the
provision reflects the condition.
4.4 Alternatively: The Supplementary Schemes are objectively justified in overriding
reasons relating to the public interest
4.4.t The legal test to be applied
(1 30) Should the Court find that the Supplementary Schemes constitute a restriction on Article 36
EEA, the Government maintains that it must be assessed whether such a restriction may be
justified in overriding reasons relating to public interests, and whether it is suitable and
necessary to obtain such objectives. Once again, this has not been done at all by ESA in the
application.
(131) According to ESA, the applicable test is whether the right to EET in time is fulfilled by the
provisions in question, without elaborating on why that is the case. lt is true that the ECJ has
held that prior authorisation schemes must ensure the patient's "right to EET in time" to be
considered a proportionate restriction under Article 20(2) of Regulation 883/2004 and Article
36 EEA.s3These are, however, no absolute requirements that every national scheme ensuring
cross-border in-patient treatment must fulfil, but must rather be seen as minimum
requirements that must be fulfilled through some means of national legislation. There are
several reasons for this:
(132) Firstly, ESA's understanding is not supported by neither EEA law nor practice. The
Government notes that EEA law itself contains different provisions allowing for different
levels of coverage of costs relating to cross-border healthcare under different conditions. ln
this regard, it is striking that not even Directive 201 1/24/EU contains any provisions relating
to "the right to EET in time", but rather leaves the conditions for reimbursement of costs
relating to cross-border healthcare with the national legislators.sa The fact that the Directive
applies without prejudice to Regulation BB3/2004,8s also underlines that EEA law certainly do
not preclude different approaches to coverage of costs relating to cross-border healthcare.
82 Para. 90 of the Application.
83 See the case law referred to in foonote
61 in the application.
s See in particularArticle 7(1) of the Directive.
8s cf. Article 2(m) of the Directive.
26/49
(133) This also follows from the ECJ's case law. The Government refers in particular to WO,85 where
the ECJ in para. 62 sets out what the Government believes to be the correct approach to
assessing whether additional national schemes comply with EEA law:
"[...] illt is necessory that the conditions establkhed for such authorisation to be
granted are justified in the light of req such as those mentioned in
parograph 59 of the present judgment, that they do not exceed whot is obiectively
necessary for that purpose ond thot the same result cannot be achieved by less
restrictive rules. Such o system must, in oddition, be bosed on obiective. non-
discriminatory criterio, which are known in advonce. in such a way as to circumscribe
the exerclse of the nationol authorities' discretion. so that it is not used orbitrarily (see,
to thot effect, Elchinov, porograph 44 and the cose-law cited)." [emphasis added]87
(134) The Government also refers to Vanbraekel,ss where the ECJ assessed whether Belgian rights
to additional reimbursement that went beyond the State's obligations under Article 22 of
Regulation 1408fl1e9 needed to be extended to a patient that had travelled to France to
receive treatment. The ECJ concluded that the Regulation did not require such additional
reimbursement to be extended to such a situation. However, as ESA also remarks in the
application,eo the ECJ went on to consider these additional rights under Article 59 of the
Treaty. What ESA does not mention, is that the ECJ in the subsequent paragraphs assesses
whether the Belgian state's refusal of this additional right to imbursement in cross-border
situations, was a restriction on the freedom of seruices, and whether this restriction could be
objectively justified by legitimate aims.el The ECJ did not assess whether these additional
rights properly reflected the "EET Element" or the "Timing Element" set out in the
Regulation.
(135) Secondly, the Government's interpretation of the provisions and case law in question is a
natural consequence of the fact that EEA law is far from being fully harmonised in this area.
ESA's interpretation would indeed entail that EEA States were, in practice, precluded from
providing additional schemes such as those in the contested Norwegian legislation. As
elaborated on in Section 3.3, these schemes provides financing and support that exceeds
what is required by Article 20(2) and/or Article 36 EEA, and the Norwegian legislator has
considered it necessary that these additional benefits are companied by additional
requirements adapted to the situations covered.
(136) lt would certainly both interfere with the State's wide autonomy and be contrary to patients'
interests if Article 36 EEA precluded the States from having such schemes without being able
to set out proportionate conditions.
86 Case C-777
/18.
87 See also case C-183/09, Elchinov,para.4 and the case law cited, where the same test is set out.
88 case C-368/98, Vanbraekel and Others.
8e Today replaced by Article 20 of Regulation 883/2004.
so Para.52.
e1 See paras.43-53 ofthejudgment.
27/49
(137) Consequently, the Government maintains that Article 36 EEA does not preclude legislation
which gives patients additional rights to receive healthcare abroad that goes beyond the
right to reimbursement set forth in secondary EEA law, given that the latter is already
ensured through other schemes, as they are in Nonruegian law.
(138) ln this case, this means that the relevant test to be applied to the Supplementary Schemes is
that set forth by the ECJ, last in WO.e2 Namely, whether the restriction(s) in question are
justified in light of overriding public interests, that they do not exceed what is objectively
necessary for that purpose and that the same result cannot be achieved by less restrictive
rules. Furthermore, the provisions in question must be based on objective,
non-discriminatory criteria that are known in advance, in such a way as to circumscribe the
exercise of the nationalauthorities'discretion, so that it is not used arbitrarily.
(139) As regards the justification of restrictions on healthcare services under Article 36 EEA, The
ECJ has especially recognised that the following objectives that may justify such restrictions:
(i) preventing the possible risk of seriously undermining the financial balance of a
social security system,
(ii) maintaining a balanced medical and hospital service open to all,
(iiD maintaining treatment capacity or medical competence on national territory, and
(iv) making it possible to create a plan seeking, first, to ensure that there is sufficient
and permanent access to a balanced range of high-quality hospital treatment in
the Member State concerned and, second, to ensure cost control and to prevent,
as far as possible, any wastage of financial, technical and human resources.e3
(140) As to the objective of preventing the risk of seriously undermining the financial balance of
the social security system (objective (i)), the ECJ has, in Rindal and Slinning,%para.55-56,
pointed out that this objective is capable of justifying a restriction so far as it could have
consequences for the overall level of health protection.
(141) Turning to objectives (iii) and (iv) above, which also have been presented together in
previous case law, the ECJ held in Watts paragraphs 105, 107 and 108 (emphasis added):es
"The Court has also held that Article 46 EC permits Member Stotes to restrict the
freedom to provide medical and hospital services in so far as the maintenance of
treotment capaciV or medicol competence on notional territory is essential for the
public health and even the survival. of the populotion (Kohll, paragroph 51; Smits and
Peerbooms, paragraph 74;and Miiller-Faurd and van Riet, paragroph 67).
t...1
s2 Cited in para. 135 above.
s3 See case C-777/18 para. 59, where the objectives recognised through previous case law is summarised.
s Joint cases E-11107 and E-1108.
ss Case C-37 2/04, W atls.
28/49
tt is well known thot the number of hospitals, their geographical distribution, the way
in which they ore organised ond the facilities with which they are provided, ond even
the noture of the medicol services which they are able to offer, are all malters for
which planning. generally designed to sotkfy vorious needs. must be possible.
For one thing, such planning seeks to ensure thot there is suflicient and permanent
occess to o balonced range of high-quoliY hospitol treotment in the Stote concerned. For
another thing, it ossists in meeting a desire to control costs and to prevent" os far os
possible. any wqstage oI Iinanciol technicol and humon resources. Such wastoge would
be oll the more damaging becouse it is generally recognised thot the hospital care sedor
generotes consideroble costs and must sotis[y increasing needs. while the finonciol
resources which may be mode avoiloble for healthcare are not unlimited. whotever the
mode of fundins ooplied."
(142) lf a national restriction is based on legitimate public objectives and suitable to achieve these
aims, the final test under EEA law is usually whether it is also "necessary" in the sense that
the same objectives cannot be achieved equally effective with less restrictive means (the
proportionality test).
(143) The criteria for this "necessity test", as laid down in the case law of the Court and the ECJ,
differ depending on the characteristics of the case and the sector concerned. The same goes
for the level and intensity of judicial review of the necessity of the restriction.
(144) The health sector, and in particular the hospital sector, has legal and factual characteristics
that imply that the EEA States must have a wide discretion when implementing the means
appropriate to ensure the objectives related to public health. This requires a cautious
approach from the Court as regard the review of the necessity of the regulations chosen
concerning coverage of costs of in-patient treatment in other EEA States, acknowledging the
national discretion within and the characteristics of the hospital sector.
(145) ln cases concerning prior authorisation schemes, the Court has held that the scheme must
not "exceed what is objectively necessary for that purpose and that the same result cannot
be achieved by less restrictive rules".e6
(146) As indicated above, it is not possible to find one standard approach to cases concerning
public health. As the Government sees it, a cautious approach is at least warranted in cases
as those before the Court now concerning the delicate matter of the extent of coverage of
in-patient treatment abroad. These are matters that - as stated by the ECJ -primarily are for
the states to determine. The legislation and priorities differ among the EU and EEA States,
and the issues involve national priority issues that will often be complex and controversial
due to, for instance, ethical and financial considerations.
s6 Case C-777/18, WO, para. 62.
29/49
4.4.2 The Breach of Deadline Scheme (sections 5.2.1 and 5.2.2 of the opplication)
(a) First Compliance Deadline
(147) For the further discussion the Government assumes that there is a restriction under Article
36 consisting of either 1) until the deadline was exceeded, even if it was clear in advance that
it would be exceeded, the patient was required to wait for health services to take action via
Helfo, and/or 2) while the patient could approach Helfo directly once the deadline had been
exceeded, the patient was prohibited or discouraged from directly going abroad, given that
Section 6(3) PR required the patient to contact Helfo and provided that they could not freely
choose the service provider.eT
(148) The Government submits that both these criteria can be justified by overriding reasons in
the public interest.
(14s) It is recalled that the Breach of Deadline Scheme only apply where the specialist healthcare
service does, or is expected to, not meet the deadline set in accordance with Section 2-2
PRA, and that the patient's right vis-5-vis the specialist healthcare service is extended to also
include the right to receive the necessary healthcare from another service provider, be it a
private provider or a provider abroad.ss ln such cases, it is still the RHA in the patient's
region of residence that is responsible for ensuring that the patient receives necessary
healthcare, and for financing it.
(1 s0) With this in mind, the Government maintains that the allocation of responsibilities under
Section 2-1 a(4) PRA is important first to ensure that the RHA fulfils its responsibilities via the
patient, and thus to ensure that the patient gets necessary healthcare within an acceptable
time.
(1 s1) The RHAs are, in principle, responsible for providing necessary healthcare to the patient
within the time limit set in accordance with Section 2-2 PRA. Given that the RHA is unable to
do this, it is only reasonable that the responsibility to contact Helfo who will be responsible
for providing the patient with an adequate service offer lies with the RHA, and not the
patient. lt is the RHA, and not the patient, who is closest to assess whether the deadline will
be breached, and consequently whether it is necessary to contact Helfo to ensure that the
treatment in question can be carried out by a private service provider or abroad.
(1 s2) Helfo, by and large, is better suited to find an appropriate service provider abroad than the
patient themselves. Leaving the responsibility for both contacting Helfo, finding a relevant
service provider that is capable of treating the patient within a time limit in accordance with
Section 2-2 PRA, organising this treatment and travels, and initially pay for the costs of that
treatment to the patient, is certainly not sufficient to ensure that the state's responsibility
vis-i-vis the patient is met.
e7 See para. 60 of the Application.
es
Cf. Ot.prp. nr.63 (2002-2003) Chapter 9.1
30/49
(153) The fact that these obligations are left with the patient under Article 20(2) of Regulation
883/2004 and Directive 2011/24/EU, is not in itself an argument in this regard. The allocation
of responsibilities is closely linked to both the control of costs and to prevent wastage of
financial, technical and human resources. ln this regard, it must be kept in mind that Section
2-1 b(4) PRA is not a reimbursement scheme, but provides full coverage of expenses for
healthcare delivered by completely private, as well as public, service providers abroad, as
well as travel and accommodation expenses.
(1 s4) ln the Government's view, it would present a risk of seriously undermining the financial
balance of the social security system if patients were allowed to seek treatment abroad
under this scheme without the involvement of Helfo.
(155) Furthermore, the Government maintains that the restriction(s) are suitable to ensure the
above-mentioned objectives. lt should be sufficient to point out that the involvement of
Helfo ensures that the public health authorities, and not the patient, are responsible for
providing the patient with necessary healthcare, and that it would not be sufficient to leave
the responsibility with the patient.
(156) Finally, the Government maintains that the restriction(s) in question is necessary in order to
secure overall health protection. Once again, the Government would like to stress that it is
an important part of the States' autonomy that they may freely decide what services are to
be covered under their national healthcare system, and under what conditions. Fufthermore,
as elaborated on in Section 2.1 above, the States must be allowed a wider margin of
appreciation than usual, due to the fundamental nature of restrictions set out to protect
public health.
(157) Furthermore, the Government maintains that it is for the States to decide the organisation of
their healthcare systems, including the structure of the administrative process required to
obtain the right to necessary inpatient treatment in other EEA countries.se
(158) Patients may seek healthcare in other EEA States in accordance with Regulation 883/2004 or
Directive 2011/Z |EU, and organise this themselves. But, if the patients wish to use private
service providers or get a higher level of coverage of cost than that provided for in the
Regulation, or indeed the Directive, the Government maintains that the State may require
that Helfo, due to the need for cost control and to ensure the financial balance of the
Norwegian health system, takes responsibility for organising the treatment abroad.
(159) For the sake of completeness, it should finally be added that the criteria in Section 2-1 a(4)
PRA are both objective and non-discriminatory, given that they apply without prejudice to
anyone who has the right to necessary healthcare, and who have not received this within the
time limit set in accordance with Section 2-1 a(4) PM. The criteria are certainly known in
advance in such a way as to circumscribe the exercise of the national authorities' discretion,
so that this is not used arbitrarily.
se See Section 5.2 below.
31/49
(b) The Second Compliance Deadline
(1 60) As regards the removal of the reference to service providers outside the realm in Section 2-1
b(4) PRA at the Second Compliance Deadline, it should be kept in mind that the potential
restriction is that patients who fulfil the criteria of the provision "only" will receive an
alternative service offer from Helfo within the realm. lf they wish to receive treatment
abroad, they may, irrespective of the change of Section 2-1 b(4) still receive healthcare in
other EEA States in accordance with either Article 20(2) of Regulation 883/2004 or the
Rei m bu rsement Reg u lation/Di rective 201 1 /24/EU.
(151) Hence, the potential restriction in question is of a relatively minor nature, especially taking
into account that service providers established in other EEA States still may take part in the
competitions for awarding the framework agreements with Helfo. lt should also be remarked
that it is unclear whether ESA actually submits that this constitutes an unlavyful restriction,
(162) Given that the healthcare in question actually is available in Nonruay, the Government holds
that the State is entitled to limit this particular scheme to that healthcare, and thus prioritise
healthca re delivered domestically.
(1 63) This is relevant both for maintaining treatment capacity and medical competence in Norway,
and for making it possible to make a plan seeking both sufficient and permanent to a
balanced range of high-quality in-patient treatment in Nonruay, and to ensure cost control
and prevent, as far as possible, any wastage of financial, technical and human resources.
(164) By restricting Helfo's search for alternative service offers to the patients to healthcare,
services available in Norway, it is ensured that available capacity in Norway is used as far as
possible and that patients are not unnecessarily sent abroad from treatment that could have
been carried out within the realm.
(165) ln the Government's view, the limitation of Helfo's search for available treatment capacity is
both suitable and necessary to ensure these interests, and does not go beyond what is
necessary to ensure them.
(1 66) ln any event, there has not been filed any applications under this particular scheme since
2013. Thus, no patients have been precluded from receiving a treatment offer abroad as a
consequence of the removal of the latter part of the provision.
4.4.3 The No Adequate Treotment Scheme (section 5.2.3 ond 5.2.4 of the applicotion)
(167) Given that the Sections 2-1 b(5) (First Compliance Deadline) and 2-4 a(2)(a) (Second
Compliance Deadline) PM constitute a restriction, the restriction would consist of the fact
that they were limited to provide access to in-patient treatment in other EEA States if there
were no adequate service offer/no service offer in the realm, or the service offer abroad were
more effective than the offer available in Nonrvay. lt should, in this regard, be emphasised
that there is no requirement for prior authorisation, which otherwise might have been seen
as a potential restriction.
32/49
(168) Concerning the objectives behind the potential restriction, it should be emphasised that the
situation where an adequate service offer do exist in Norway, or there is no more effectivel0o
service offer abroad, falls without the scheme in question. This falls exactly within the
situation commented on by the Court in Rindal and Slinning, where the Court held
(emphasis added):101
"However, where no such limitations opply and o patient, under the sociol security
system of his or her home State, fulftk the criteria for entitlement to treatment,
prioritisotion of home Stote treotment, such os in the cose ot hond, connot be iustified
unless the home Stote itself con provide treatment which is the same or equally
effective for the potient os the treatment abroad within a medically justifiable time
limit, compare Smits and Peerbooms, at paragrophs 103-104. Conversely, if the home
Stote offers the same or equally effective treatment. and provides it within a medically
justifiable time limit. the home State moyjustify prioritising its own offer of teotment."
(169) After this, it should be unnecessary to justify the potential restriction further, The
Government will, however, for the sake of completion, add that:
(170) The scheme includes highly specialised and resource-intensive healthcare. The right to
coverage under the scheme will trigger full coverage of expenses for necessary treatment
expenses also to private service providers in other countries and further full coverage of
necessary travel and accommodation expenses.
(171) lt would certainly constitute a risk of seriously undermining the financial balance of the
social security system if the EEA State were not allowed to limit its obligation to cover such
extensive costs to the situations defined in Sections 2-1 b(5) and 2-4 a(2Xa) PRA. lt would
have_major financial implications if the States who chose to offer additional offers to
patients who otherwise would have no (adequate) service offer, or who otherwise would
have a less effective service offer than available abroad was obliged to extend the level of
coverage of costs to the situation where the patient may get an adequate service offer
domestically. Should the Court rule in favour of the latter, Nonruay would have little choice
but to consider a repeal of the additional scheme in question.
(172) Furthermore, to remove the condition that there is no adequate service offer in the realm, or
the service offer abroad is more effective than the offer available in Norway, will very likely
affect the flow of patients that travel abroad. This would entail a right for patients who have
an adequate offer in the country to travel abroad on better financial terms than
domestically. This would again quickly have had an impact on the possibility to create a plan
seeking, first, to ensure that there is sufficient and permanent access to a balanced range of
high-quality in-patient treatment in Norway and, second, to ensure cost control and to
prevent, as far as possible, any wastage of financial, technical and human resources.
100
See Section 3.3.4(b) above about the content of this criteria.
101 Joint cases E-11107 and E-1l08, Rindal and Slinning, para.83
33/49
(173) There can be little doubt as to the suitability of the restriction of the right to the situations
mentioned in the provisions.
(174) As regards the necessity of the potential restriction, the Government will once again
underline that the State should enjoy a wide margin of appreciation when determining
which types of healthcare patients should have access to and on what terms, especially when
the healthcare in question does not exist, or exists only in a less effective manner, in the
Country.
(1 7s) It is difficult to see how less restrictive measures could achieve the same effects as the
requirements set out in the No Adequate Treatment Scheme. On the contrary, the provision
is limited to exactly that group that the State have found it appropriate to provide with an
additional scheme, and an extension to cover patients who would have an adequate offer in
the realm would undermined the entire purpose behind the scheme,
5 THE SECOND PLEA
5.1 Preliminary remarks
(176) ln Section 5.3 of the application, ESA holds that Norway breaches Article 36 EEA and/or
Article 20(2) of Regulation 883/2004, by
(i) maintaining PRA/PR jurisd ictional/procedu ra I ru les wh ich prevent and/ or
discourage the PRA/PR complaint/appeal bodies from correctly applying the
"Right to EET in Time";
(iD maintaining an administrative/decisional practice of the PRA/PR
complaint/appeal bodies which fails correctly to apply or secure the Right to EET
in Time, in breach also of Article 3 EEA.102
(177) The Government understands this to entail that ESA challenges both the procedural rules for
right to treatment abroad, and the odminktrative proctice from the bodies administering the
different schemes.
(178) ln this perspective, ESA's submissions under the Second Plea appear to be limited to the
procedural rules in PRA Section 7-2 and Section 7 and 8 P& and the administrative practice
of the bodies administering the schemes set out in the provisions in PRA Sections 2-1 (4)
and (5) and2-4a(2)(a) (the Supplementary Schemes).103
(179) lf the second plea is understood in this way, the Government's response may be done
shortly: As the Government is of the view that the Supplementary Schemes do not need to
reflect the "EET Element" and the "Timing Element" of the Second Condition,lu the
102
See summary of the second plea in the Application par. 11
103
See ESA's Application para.92 to 108.
1M Cf. Section 4 above.
34/49
Government submits that it is no breach of neither Article 20(2) of Regulation 883/2004 nor
Articles 36 and 3 EEA that the procedural rules in Section 7-2 PRA prevented the bodies
administering the Supplementary Schemes from applying these criteria,105 or that these
criteria were not applied in practice by the bodies administering these schemes.106
(180) As ESA to some extent also seems to challenge the procedural rules and administrative
practice related to the right to receive treatment abroad under Article 20(2) of Regulation
883/2004,t0t The Government will in any event submit that the procedural structure and
administrative practice under all "routes" to healthcare abroad, are compliant with relevant
EEA law. However, the Government will mainly focus on the procedural structure and
administrative practice under the EEA Schemes, even though this is only partly done by ESA.
5.2 Relevant EEA law
(181) EEA law does not detract from the EEA States the competence to organise their social
security system. This also include the EEA States' autonomy to organise its system for
coverage of costs relating to healthcare received in other EEA States as the state finds most
appropriate, provided that, the system and relevant bodies exercise their powers in
compliance with EEA law.
(182) The main part of the EEA Agreement does not set out general requirements for the
organisation of the national administration, nor for their case handling. This is, amongst
others, confirmed by the EFTA Court in Fokus Bank,where the Court held in para.41:
"The Court notes ot the outset thot the EEA Agreement does not, os o generol rule, Iay
down specific provisions governing the administrative proceedings in the Contracting
Parties' Iegol orders. However, such proceedings must be conducted in o monner that
does not impair the individuol rights flowing from the EEA Agreement. Such an
obligation on the Controcting Parties follows from Article 3 EEA, the provision
mirroring Article 10 EC.'4og
(183) This principle of procedural and organisational autonomy for the EEA States does not imply
that the EEA States are completely free to organise their administrative systems. Pursuant to
the duty of loyalty set out in Article 3 EEA, the principles of equivalence and effectiveness
have been developed through case law,
(184) ln essence, the ECJ has generally held that national procedural legislation must be lhe "some
as those to which tndividuak or undertakings in comparoble situations under notional law are
entitled" (principle of equivalence), and not make it"impossible in practice or excessively
10s
See ESA's submissions in para. 92lo 104 of the Application.
106
See ESA's submissions in para. 105 to 108 of the Application.
107
See Application par. 109 to 123 where these submissions are not set out independently, but as a
response to Norway's submissions in the response letter to ESA's Reasoned Opinion (Annex 1 to the
application).
108
Case E-1104, Fokus Bank.
35/49
difficult to exercise the rights [...] conferred by the Community legol order" (principle of
effectiveness).10s
(1Bs) To the Government' understanding, the essence of ESA's Second Plea relates to the principle
of effectiveness; ESA submits that the procedural rules in Section 7-2 PRA and the
administrative practice from the bodies administering the Supplementary Schemes, deprive
Article 20(2) of Regulation 883/2004 of its effectiveness.
(186) ln this context and as regards healthcare services in particular, the EFTA Court in Rindol and
Slinning held that "an administrative scheme must likewise be based on o procedural system
which is easily accessible and copable of ensuring that a request for authorisotion will be dealt
with objectively ond impartially within a reasonoble time. Further, refusals to grant
authorisotion must be copable of being chollenged in judicial or quasi-judicial proceedings."tto
(187) The latter part of the cited paragraph is an expression of the EEA States' obligation to ensure
compliance with the right to effective remedy in accordance with the principle of effective
judicial protection.lll This entails that private persons or undertakings must have the
opportunity to enforce the rights confirmed upon them by EEA law before the national
Courts.1lz However, EEA law does not give rise to a requirement of a right to appeal within
the national administrative system as such - the decisive factor is whether decisions may be
challenged in judicial (or quasi-judicial) proceedings.
(188) ln Section 5.3 below, the Government will explain why the procedural rules related to rights
to publicly funded healthcare abroad, fulfils these criteria.
5.3 The Norwegian complaint/appeal structure in relation to right to healthcare
abroad, is in accordance with EEA law
5.3.1 lntrodudory remarks
(189) ln Nonruay, the competence to deal with cases regarding reimbursement and or assumption
of costs in relation to healthcare in other EEA States is spread on different bodies:
- Helfo and National Office for Health Service Appeal ("Helseklage") decides on
applications and complaints, respectively, under both Article 20 of Regulation
883/2004113 and the Reimbursement Regulationlla lthe EEA Schemes)
- Helfo is responsible to ensure the patient a service offer in accordance with Section
2-1 b(4) PRA, and the County Governor handles complaints in relation to thislls (the
Breach of Deadline Scheme)
10e
See case C-349/07, Soprop6 para.38. See also case C-430l19 para.34.
110
Joint cases E-1 1/07 and E-1l0& Rindal and Slinning, para. 48
111
See, for example, case E-1 1/19 and E-12/19 para. 49-50.
112
See case 222/U, Johnston, paras. 17-18.
113
Cf. Section 21-11 a (2) NIA and PR Section 6 (4) and 7(3).
114
Cf. Section 10 (2) of the Reimbursement Regulation.
36/49
- The Foreign Office in the health region where the patient is resident (the "Foreign
Offices") and Norwegian Governmental Appeal Board Regarding MedicalTreatment
abroad (the "Appellate body") deals with applications and complaints, respectively,
relating to approval or reimbursement under Sections 2-1b(5)/2-4 a(zXa) PRA (First
and Second Compliance Deadlines respectively)116 (the No Adequate Treatment
Scheme)
(190) The EEA Schemes and the Supplementary Schemes have important differences which make
it reasonable and beneficial for the patients to divide the administering of the schemes on
different bodies.
(191) First and foremost While the schemes administered by Helfo117 safeguard patients' right to
reimbursement or cost-assumption in relation to healthcare abroad that is equivalent to
healthcare offered in Nonvay, the Foreign Offices handles cases which concerns treatment
that is not offered in the specialist healthcare service in Nonruay. These tasks necessitate
different competence. As regards the latter scheme, it is e.g. necessary that the
administrative body possess sufficient medical competence as to be able to assess whether
the treatments in question fulfil the criteria set out in Section 2-1 b PRA and, in particulal
Sections 2, 2a, and 3 PR.118
(192) Secondly, as the EEA Schemes are no more than "benefit" schemes, Helfo will, under these
schemes only assess whether the conditions are fulfilled and reimburse the patient or settle
the costs with the EEA state in question after the treatment is received. The patient is
themselves responsible for finding a place of treatment and to communicate with the
healthcare institution abroad. ln the Supplementary Schemes (mainly the No Adequate
Treatment Scheme), however, Helfo/the Foreign Offices usually also take responsibility for,
among other things, agreement with foreign hospitals on financial settlement, planning and
booking of travel and accommodation, follow-up during the treatment, invoice processing,
travel bills and medical coding.lre These major differences between the patients' rights and
the bodies' responsibilities under the different schemes, is another explanation of why these
schemes need different administrative bodies.
5.3.2 The EEA Schemes
(1e3) ln the Government's view, the procedural system linked to the right to treatment abroad
under Article 2O(2) of Regulation 883/2004 and the Reimbursement Regulation, fulfils the
criteria set out in Section 5.2 above.
1ls Cf. Section 7-2(1) PRA.
116
Cf. Section 7-2(2) PF./'.
117
This includes the EEA Schemes and Section 2-1 b (4) PRA.
118
See Ot. Prp. nr. 53 (2002-2003) p. 55 (office translation): "The ossessment of whether there is odequate
expertise in Norwoy requires in many cases medical expertise ot o high ond speciolized level, os well as a good
overview of the available expertise throughout the country."
11e
See Section 3.3.4 above.
37/49
(1e4) As to the accessibility and effectiveness of the system, patients may, pursuant to Section
21-11 a(2) NIA and Section 10 of the Reimbursement Regulation, respectively, apply directly
to Helfo for authorisation or reimbursement pursuant to Article 20(2) of Regulation
883/2004 and the Reimbursement Regulation.l20 Helfo will, in this regard, have both
competence and an obligation to assess applications under the criteria set out in these
provisions, as interpreted in case law.
(1es) The fact that the patient may alternatively choose to apply for authorisation or
reimbursement under the Supplementary Schemes, does not deprive the EEA Schemes of
their accessibility for the patients. Contrary to what ESA seems to suggest in the application,
there is no priority or hierarchy between the different schemes.121
(1e6) From the patients' perspective, the availability of the different schemes is evident from
Section 2-4 a PRA, which gives an overview of the different schemes. As this provision was
introduced after the First Compliance Deadline, the Government adds that the information
on different routes for getting healthcare abroad at both compliance deadlines were
thoroughly explained to patients and healthcare providers on helsenorge.no (the main
platform for information between the health authorities and patients/health personnel).122
(1e7) Further, in line with the general Norwegian administrative law requirement of guidance, the
bodies administering the Supplementary Schemes were, in the relevant period, encouraged
to redirect patients to the EEA Schemes upon rejection under the Supplementary Schemes,
and vice versa.123 ln most cases, it is evident from the negative decisions from the bodies
administering the Supplementary Schemes, that patients for a fact also were redirected to
the EEA Schemes.l2a ln any event, the Government does not agree with ESA that there is a
breach of EEA law that such redirection does not happen " by defaulT'.tzs
(1 e8) The fact that the numbers of applications received under Article 20(2) of Regulation
883/2004 are low compared to the other schemes,l25 is not an indication that this "route" to
treatment abroad is considered unavailable by the patients. The varying numbers of
applications on the different schemes may have many explanations. The most reasonable
variables are, in the Government's view which costs/the level of costs that are covered, the
possibility of travelling out immediately, the possibility of choosing private healthcare
120
The alleged unclear legal basis for this competence, is dealt with in Section 5.2 below.
121
Section 111 of the Application, last sentence.
122
See Annex 4.
123
This was also specifically addressed in a letter 7 October 2022from the Ministry (see Annex 5), and more
detailed in letter 19. December 2022 lo Helfo, the RHFs and Helseklage (see annex 24 in ESA's application).
12a
See the negative decisions from the Foreign Offices administering the No Adequate Treatment Scheme
attached in Annex A22 of the Application, that usually ends with the following phrase: "we drow attention
to the possibility of seeking reimbursement for received heolth core in onother EEA Stote. Those provisions ore
monoged by Helfo and there b more informotion obout the terms ot https://helsenorge.no/behondltng-i-
utlandet' (see e.g. p. 5 and 8). With regards the decisions from Helfo, the Government has attached an
overview of decisions where Helfo has redirected the patient to other schemes in Annex 6.
12s
Application par 112.
126
See para 42-43 above.
38/49
providers and assistance received from the authorities when seeking treatment abroad, i.e.
variables that should favour the schemes under the Reimbursement Regulation and the
Supplementary Schemes at the expense of Article 20(2) of Regulation 883/2004.
(199) Thus, the Government submits that the right to treatment abroad under the EEA Schemes
were, at both compliance deadlines, easily accessible for the patients, and that it was neither
impossible nor excessively difficult to exercise the rightl27 to treatment abroad under
Regulation 883/2004.
(200) ESA has not submitted that applications under the EEA Schemes are not dealt with
"objectively ond impoftially within a reasonable time", as required by the EFTA Court in Rindol
and Slinning, and the Government therefore does not consider it necessary to take issue
with these requirements.
(201) Turning to ESA's submission that the procedural structure makes it impossible or excessively
difficult to challenge refusals on authorisations in judiciol or quasi-judiciol proceedings, the
Government recalls that the patient may, after getting a rejection from Helfo, appeal to
Helseklage pursuant to Section 21-11 a (2) NlA. The right to appeal to Helseklage is not as
such required under EEA law, being only an appeal body within the administrative system.128
The way in which rejections under Article 2O(2) of Regulation 883/2004 may be challenged in
judicial proceedings, is by virtue of the fact that rejections from Helseklage may be brought
before the National lnsurance Court, which must be considered as providing a 'Judicial
proceeding" in relation to the requirement of effective legal remedy.l2e
(202) Contrary to ESA's assertions in para. 1 16 of the application, the Government submits that the
National lnsurance Court has and has always had competence to both (i) deal with appeals
in cases relating to Article 20(2) of Regulation 883/2004, and (ii) to apply Article 36 EEA in
general.
(203) The National lnsurance Court's competence to apply Article 36 EEA in general, follows from
the fact that Article 36 EEA is incorporated into Norwegian law as such, with priority over
conflicting national legislation (for instance NIA).130 The fact that the National lnsurance
Court, allegedly, has not in fact applied this provision in the judgements ESA has examined,
may have many explanations, and is no proof that the National lnsurance Court has not
considered itself competent to apply this provision.
(204) As for the National lnsurance Court's competence to deal with appeals under Article 20(2) of
Regulation 883/2004, the lnsurance Court has handled cases relating to this provision (and
to the former Article 22 of Regulation 1408/71) since the 1990s. The Government is aware
127
Cf. Joint cases E-1 1/07 and E-1/08, Rindal and Slinning para. 48.
128
See para. 187 above.
12e
The Government refers to the fact that the EFTA Court has accepted referrals from the National lnsurance
Court in several preliminary rulings, thereby accepting that this Court is to be regarded as a "court" under
Article 31 SCA, see e.g. E 13/20 Q v Arbeids- og velferdsdirektoratet.
130 EEA Act Section 1 and 2.
39/49
that, as ESA also points out in the application, the National lnsurance Court in one case from
2015 (TRR-2014-2387), with dissenting opinion from its leader, stated that it did not have
competence over such appeals. This judgement was however appealed to The Parliamentary
Ombud for Scrutiny of the Public Administration ("Sivilombudet"), who came to a different
conclusion. Shortly after, the National lnsurance Court (set with five members) held that
(office translation):
"Regarding the question of the National lnsurance Court's areo of jurisdiction, the
court ogrees with Sivilombudet's stotement. As stoted, Sivilombudet's position k in
accordonce with the position of the Ministry. The court [...] finds thot the Notional
lnsuronce Court hos competence to deal with issues of the right to benefits in
accordance with Article 20 of Regulotion 883/2004 (formerly Article 22 of Regulation
1408/71). The court will note that the position is in occordonce with the practice
established in the National lnsurance Court prior to the order in appeal 14/02387
[tRR-2074-2387]. ln this context, the Court refers to rulings in the Notionol lnsuronce
Court's appeols nr l2/02553 TfRR-2012-25531, 13/00514 [TRR-2013-514], 12/01883
st
IIRR- 201 2- BB3] ond 2/00268 [tRR-20 2- 2681."t
1 1 1
(20s) Although one judgement from the lnsurance Court said the opposite, there is no doubt that
the National lnsurance Court both at both Compliance Deadlines and historically has had
competence to handle appeals under Article 20 of Regulation 883/2004.
(206) ln conclusion, the Government maintains that decisions under the EEA routes may be
challenged in judicial proceedings.
5.3.3 The Supplementory Schemes
(207) As the Government holds that the right to receive healthcare in other EEA States under the
Supplementary Schemes constitutes an additional right to treatment abroad that is not
implementing EEA law, the Government holds that the EEA requirements of accessibility,
effectiveness and right to effective legal remedy referred to in Section 5.2 above, does not
apply to these schemes.
(208) The Government may still point out that decisions on approval or reimbursement under the
No Adequate Treatment Scheme are, as referred above, made by The Foreign Office in the
health region where the patient is resident, and may be appealed to Norwegian
GovernmentalAppeal Board Regarding Medical Treatment abroad. The latter's decisions
may be brought before the ordinary national coufts.
(209) Under the Breach of Deadline Scheme, Helfo has been appointed with the task of assisting
the RHAs in finding an alternative service provider to provide necessary healthcare in
accordance with Section 6(3) PR. lf the patient has not received an offer of necessary
healthcare within a medically justifiable time, the patient can complain to the County
131
TRR-2016-301, included in Annex A 28 of the Application (p. 76).
40/49
Governor, cf. Section 7-2(1) PM. The latter's decision may be brought before ordinary
courts.
(210) Thus, the Government is of the opinion that the EEA requirements of having an accessible
appeal structure where rejections may be brought before the national courts, are fulfilled
also as regards the Supplementary Schemes.
(211) The Government may also add that the Supplementary Schemes is not designed or applied
in a way that undermines the effectiveness of Article 20 of Regulation 883/2004, or make the
rights under this provision unavailable for the patients in practice. As held in Section 5.3.2
above, Section 2-4 a PRA provides an overview of the different schemes, and the patient is
always free to apply for authorisation or reimbursement under the EEA Schemes instead of
the Supplementary Schemes. ln addition, the bodies administering the Supplementary
Schemes, usually redirect the patient to the EEA Schemes when relevant.l32
(212) ln conclusion, the Government submits that the entire Norwegian appeal/complaint
structure in relation to right to healthcare abroad, is compliant with EEA law.
5.4 Administrative practice in relation to right to treatment abroad, is in accordance
with EEA law
5.4.1 The EEA Schemes
(213) ln the Government's opinion, ESA has not established sufficient proof of an administrative
practice of a consistent and general nature in breach of Article 20(2) of Regulation 883/2004
and or Article 36 EEA.
(214) lt is for ESA to substantiate their claim that Norwegian administrative practice is not
compliant with EEA law. The Government refers to case C-1 561g4ttz para. 50, where the ECJ
held that the failure to fulfil obligations can be established "only by means of sufficiently
documented ond detailed proof of the alleged proctice", and that administrative practice must
"to some degree [be] of a consistent ond generol noture".
(215) ln the application, ESA refers to a number of decisions and judgements from Helfo (main
office) and National lnsurance Court, respectively, which according to ESA does not apply
the EEA law in a correct way. ESA maintains that"both Helfo (moin office) and the Notionol
lnsurance Court typically only ossess whether o specific type of treotment is available in
Norway, and in thot manner fail to opply the EET Element of the Second Condition
oltogether."lsa
(216) However, ESA seems to overlook the fact that when the treatment in question is not
available in Norway, the First Condition under Article 2O(2) o't Regulation 883/2004 is not
132
See para. 197
133
Commission v Hellenic Republic.
134
See Application par. 117.
41/49
met.135 lf the first condition is not met, it is neither compulsory nor necessary to assess the
EET Element and the Timing Element of the Second Condition.135
(217) The decisions referred to by ESA generally relates to situations where the First Condition is
not fulfilled.l37 Although the Government cannot bombastically rule out the possibility that
there may be examples of decisions from Helfo and/or the lnsurance Court that applies the
criteria under Regulation 883/2004 in an incorrect way, the Government recalls that isolated
examples of EEA-breaches in practice, in any event are not sufficient to establish an
administrative practice in breach of EEA law.138
(218) ln conclusion, the Government submits that the administrative practice by Helfo and the
National lnsurance Court is compliant with EEA law. As it is ESA that has the burden of proof
in this respect, the Government does not consider it necessary to provide further evidence
for this submission.
5.4.2 The Supplementory Schemes
(21e) Regarding decisions on applications and complaints related to the Supplementary Schemes,
the Government holds that the bodies administering these schemes do not need to apply
the EET Element and the Timing Element under the Second Condition. Reference is made to
Section 4 above. Thus, ESA's submissions that the split competence between the appellate
body and County Governor under PRA Section 7-2(1) and (2) prevented these bodies from
applying both these criteria,l3s and that they also did not apply these criteria in practice,lao
constitute a breach of EEA law, must be rejected.
(220) The Government also recalls that, as held in para.197 above, the bodies administering the
Supplementary Schemes, usually redirect the patient to the EEA Schemes when relevant.
6 THE THIRD PLEA
6.1 lntroductory remarks
(221) ln the third plea, ESA holds that, at the Second Compliance Deadline, and at least since the
First Compliance Deadline, the Supplementary Schemes and the complaint/appeals
procedure and practice related to it, breaches the principle of legal certainty and
13s
See Section 4.2.3 above.
136
As ESA itself also points out in par. 49 and fn. 130 of the Application.
137
ln Annex A 29 to the Application, see e.g. Decision 25 May 2Q21 (ref:21l108633-6) (p. 40), Decision 28
January 2019 (ref: 19/50214-3) (p 52) and Decision 13 August 2019 (ref: 19/388959-4) (p.61). There are also
a number of examples where the first condition is not considered fulfilled due to a lack of documentation,
see Decision 4 November 2019 (ref: 191585086-4) (p. 5), Decision 6 May 2020 (ref: 2A/1059a1-15) (p.7),
Decision 7 October 2020 (ref: 201403353-3) (p.72).
138
See C-156104 Commission v Hellenic Republic par.51
13e
ESA Application para. 92to 104.
140
ESA Application para. 105 to 108.
42/49
undermines the effectiveness of Article 36 EEA and Article 20(2) of Regulation 883/2004, in
breach of those provisions and/or of Article 3 EEA.141
(2ZZ) More specifically, ESA submits in Section 5.4.2 ol the application that
a At the Second Compliance date it was unclear which body or bodies that have
jurisdiction/competence to hear complaints in cases relating to rights under Article 20 of
Regulation BB3/20O4, and in this respect also a difference between national law and
national administrative practice,la2
o At the First Compliance Deadline, the relevant criteria in s. 3(4) PR and Section 2-1b(5)
PRA were not sufficiently precise,la3and
a At the First Compliance Deadline, Section 7 PR was in itself unclear about which body
had competence to hear complaints under Section 3 PR.144
(223) ln addition, in Section 5.4.3, all the aspects of the Supplementary Schemes that ESA in the
, first plea submits constitutes a substontial breach on regulationBB3/2004 and Article 36 EEA,
are made into an independent breach of the principle of legal certainty.
(224) The Government once again points out that, in its opinion, patients' rights under both Article
20(2) of Regulation 883/2004 and Article 36 EEA are ensured in Norwegian legislation
through the implementation of Regulation 883/2004 in Section 1-3a NIA and the
Reimbursement Regulation respectively, and that EEA Law does not require every national
route to inpatient treatment in other EEA States to depend upon whether the same or
equally effective treatment cannot be provided in Nonvay within a time limit that is
med ically justifia ble.
(225) Should the Court be of the same opinion, the conditions for right to receive treatment
abroad under the Supplementary Schemes cannot at the same time constitute a breach of
the principle of legal certainty. This follows from the fact that such a conclusion is contingent
upon the Supplementary Schemes representing a substantial breach of Article 20(2) ot
Regulation 883/2004 and Article 36 EEA.145 On the other hand, should the Court agree with
ESA in that the conditions under the supplementary scheme do constitute a substantial
breach of the obligations under Article 20(2) and Article 36 EEA' the Government will not
submit that the maintaining in force of such legislation does not also constitute a breach of
the principle of legal certainty.
141
See para. 12 and Section 5.4 of the Application.
1a2
See para. 130-1 39 of the Application.
1a3
See para. 140 of the Application.
1a See para. 141-142 of the Application.
14s
Although not entirely clear from the Application, The Government assumes that ESA will not submit that
the supplementary national scheme represents a breach of the principle of legal certainty if the EFTA Court
should conclude that this route does not represent a material breach of Article 36 EEA or Article 20(2) of the
Regulation.
43/49
(226) Consequently, the Government does not consider it necessary to respond to ESA's
submissions under Section 5,4.3 of the application, which solely relates to the maintaining in
force of legislation that, according to ESA and contrary to the Government, are in breach of
Article 36 EEA and Regulation 883/2004. The same goes for the submissions under Section
5.4.2 which relates to the alleged imprecision of the provisions in Section 3(4) PR and
Section 2-1 b(5) PRA and Section 7 PR in relation to Section 3 PR, which all exclusively relate
to the Supplementary Schemes.
(227) The Government may however recall that, more generally, the Supplementary Schemes are
not designed in a way that undermines the effectiveness of Article 20 of Regulation
883/2004, or makes the patients' rights under this provision insecure in practice. As held in
Section 5.3.2 above, Section 2-4 a PM provides an overview of the different schemes, and
the patient is always free to apply for authorisation or reimbursement under the EEA
Schemes instead of the Supplementary Schemes. ln addition, the bodies administering the
Supplementary Schemes, usually redirect the patient to the EEA Schemes if relevant.
(228) Thus, the Government confine its submissions under the current Section to the part of ESA's
submissions under the third plea that relates to the alleged imprecision of which body that
has competence to handle complaints under Article 20 of Regulation 883/2004.
6.2 The competence to handle complaints in cases relating to rights under Article
20 of Regulation 88312004, is in a sufficiently clear and precise manner
conferred on Helseklage
(229) ESA's claim that it is unclear which body that has competence to handle complaints in cases
relating to rights under Article 20 of Regulation 883/2004, is based on two grounds:
First, that the provision in Section 21-11a (2) NIA does not provide a sufficient legal
basis for Helseklage's competence to handle complaints regarding in-patient
treatment abroad under Article 20(2) ol Regulation 883/2004, due to the fact that
Chapter 5 NIA allegedly does not cover in-patient treatment, and
that Section 7-2(1) PRA, according to ESA, on the Second Compliance Deadline
provided the County Governor with competence over complaints related to a breach
of the provisions of Section 2-4 a(1)(b), and thus of Article 20 of Regulation
883/2004.
(230) The Government disagrees with both of these submissions.
(231) The competence to handle applications for inpatient treatment in other EEA States under
Article 20 of Regulation 883/2004, has rested with Helfo at least since 2009, by delegation
from the Directorate of Health. After the establishment of Helseklage in 2016, it has
consistently been Helseklage that has handled complaints.l4s The Government refers in this
respect to the decisions from National lnsurance Court from the period July 2O12 to June
146 Until 2016, different bodies in Helfo acted as appeal body (Helfo klage, Helfo anke, Helfo regelverk)
44/49
2023 examined by ESA. All of these relate to appeals over decisions from either Helseklage
(after 2016) or the relevant appeal body within Helfo (before 2016).147 The decisions from
the lnsurance Court attached to the application, also demonstrates that it is Helfo that has
handled the applications in question in first instance.
(232) Consequently, in practice, there is, and has never been, any insecurity with regards Helfo and
Helseklage's competence to handle applications and complaints, respectively, under Article
20(2) ol Regulation 883/2004. This also holds true from the patients' perspective. The
Government will make three points in this regard:
a Sections 6(3) and 7(3) P& respectively, states lhat "decisions pursuant to Article 20 of
Regulation 883/2004 [...] is made by HELFO 1...1 cf. NIA Section 21 -1 'l o" , and " decisions
pursuant to Article 20 of Regulotion 883/2004 [...] can be oppeoled to the National
Offtce for Heolth Service Appeol, d. Section 27-71 o 6114."t44
a As held in Section 5.3.2 above, the different possibilities for getting healthcare abroad
are thoroughly explained to patients and healthcare providers on helsenorge.no.lae
This also includes which bodies to apply to.
a Upon receiving a rejection from helfo, it is explicitly stated in the decision that the
patient may appeal, and that Helseklage is the appeal body.1s0
(233) ESA's claims that it is uncertain which body that has competence to handle complaints over
decisions under Article 20 of Regulation 883/2004, is in the Government's view totally
unfounded and based on a narrow and incorrect interpretation of Secfion 21-11 a NlA.
(234) Before turning to that specific provision, the Government recalls that under Norwegian
administrative law, it is, at the outset, not necessary to establish a legislative basis for
subordinate bodies' competence to handle applications or complaints in relation to a
specific area of law. lt is usually sufficient with an internal order from the relevant Ministry.
As for the competence to handle complaints within the administration, this is, as referred in
para. 187 above, neither a requirement under EEA law.
(235) However, as regards healthcare benefits, the Ministry has chosen to establish a legislative
basis in Section 21-11 a (2) NlA, which reads as follows:
"Decisions on benefits under Chapter 5 ore made by the Directorate of Health. The
Directorate of Heatth may delegate decision-moking competence to subordinote
bodies or, after approval from the ministry, to the Directorate of Lobor and Welfore.
147
See annex A29 to the application.
1as
These provisions have been in effect from 19. december 2022,hhe day before the Second Compliance
Date. Howevel HELFO's competence to decide on applications under Article 20(2) of Regulation 883/2004
under PR Section 6 (4), has been in force since 1. January 2018.
1as
See annex 4.
1s0
The Government refers to the decisions from Helfo attached in Annex A29 in the Application, where this
is addressed in the end of each decision.
45/49
The National Office for Health Service Appeol ("Nasjonalt klogeorgan for
helsetjenesten") is oppeol body. "
(236) The competence conferred on the Directorate of Health in this provision, is delegated to
Helfo.
(237) As the wording suggests, both the Directorate of Health (at first instance, delegated to
Helfo) and Helseklage (appeals) are given competence to handle cases regarding "deckions
on benefits under chopter sil.1s1
(238) Contrary to ESA" the Government submits that this wording, in relation to this provision,
includes decisions on in-patient treatment abroad under Article 20 of Regulation 883/2004,
This can be derived from the fact that the provisions in Sections 5-24 and 5-24 a NIA (i.e.
provisions in Chapter 5 NIA) include benefits in relation to in-patient treatment abroad, and
in relation to in-patient treatment in other EEA States, respectively.ls2 1s3
(23e) The Government also adds that the Nonaregian legislator has in several preparatory works
assumed that Helfo has competence to handle decisions on Article 20 of Regulation
883/2004.1s4 As Helfo's competence, just like Helseklage's, is limited lo " benefits under
chopter 5", this illustrates that this wording is not understood as excluding benefits under
Article 20 of Regulation 883/2004. When ESA has found and referred to statements in
preparatory works that allegedly imply the opposite,lss they do not interpret these
statements in its correct context.lss
1s1 ln NIA Section 21-12(1) the exact same wording is restated with regards Helseklage's competence:
"Dec'sions pursuont to Chopter 5 con be oppealed to the Notional Appeals Body for the Health Seruice". For
the sake of ease, the Government will only refer to NIA Section 21-11 a (2) in the following.
1s2 Thus,
although benefits under Chapter 5 NIA generally does not include in-patient treatment the
provisions in Section 5-24 and 5-24 a show that this is not the case when it comes to inpatient treatment
obrood.
1s3 Because of ESA's submissions in para. 131 of the Application, the Government may in this respect clarify
that it does not consider the introduction of NIA Section 5-1 a as relevant for this interpretation. This is also
the reason for why the Government did not notify ESA of this amendment.
154
See Prop 118 L (2012-201 3) p. 65-65: lt is the authorities in the competent stote thot process the
"
opplication for prior authorisotion. [...] ln Norway, applicotions for such prior outhorisotion are processed by
Helfo. t..J lf the potient is granted prior authorisation, Helfo issues the 52 form and the patient con receive
heolth core in onother EEA state under the conditions that apply according to the legislotion of the country of
treotment.> and Prop. 80 L (2018-201 9) p, 10: <ln Nonuoy, opplicotions for such prior outhorisotion are
processed by Helfo.".
1ss Seefootnote 161 of ESAs complaint, wherethey referto statements inthe Prop.9 L(201 5-2016) pp. 10-
1 1 and Prop. 71 L (2021-2022) p. 15-16.
1s5
The statements referred to by ESA in Prop. 71 L (2021-2022) only relates to what benefits that generolly
falls under chapter 5 NlA, and which does not. As explained above, Section 5-24 and 5-24 a includes
benefits in relation to inpatient treatment abroad, which is the decisive factor in relation to Helseklage's
competence. Turning to the statements referred to in Prop.9 L (201 5-2016) p 10-11, the Government recalls
that it is not correct that this was the preparatory work to the introduction of article 21 11 (a) 2 NlA" but to
the establishment of Helseklage. The use of the wording "benefits under chapter 5" as the scope of Helfo
and the relevant appeal body's competence, was introduced long before this. Thus, the fact that the list of
benefits in Prop.9 L (2015-2016) pp. 10-11 does not mention inpatient treatment, is not decisive. ln any
46/49
(240) Turning to ESA's submission that Section 7-2(1) PRA at the Second Compliance Deadline
allegedly provided the County Governorwith competence over complaints related to Article
20(2) of Regulation 883/2004, the Government submits that this is based on an incorrect
understanding of Section 7-2(2) PRA.
(241) Section 7-2(1) PRA confers on patients a right to appeal to the County Governor on alleged
breaches of the provisions in Chapters 2, 3, 4 etc PRA, i.e. provisions regarding the extent
and content of the patients' right to necessary healthcare. Rights under Article 20 of
Regulation 883/2004 has, historically, never been a part of these provisions.
(242) However, when Section 2-4 a PRA was inserted into Chapter 2 PRA from 2 March 2020, the
refence to "chapter 2" in Section 7-2(1) could, read in isolation, be understood as also
including decisions under Article 20(2) of Regulation 883/2004, as Section 2-4 a(1)(b) refers
to patients' right to treatment in other EEA States under Article 20(2) of Regulation
883/2004.
(243) However, the Government holds that it was quite clear that the reference to the Regulation
in Section 2-4 a did not have the effect of extending the County Governor's competence
under Section 7-2(2) to cases under Regulation 883/2004.|n this regard, it must be kept in
mind that the reference to the Regulation in Section 2-4 a PRA was made for information
purposes only.
(244) ln this respect, account should also be taken of the provisions in Section 21-11 a (2) NlA,
Section 6 and 7 P& the information on helsenorge.no and the consistent practice from the
relevant bodies, that clearly shows that the competence is conferred on Helseklage.
(245) However, to avoid any misunderstandings, the Ministry on 1 July 2023 included an exception
in Section 7-2(2)for the provision in Section 2-4 a. But, the Government maintains that it
also before this amendment was sufficiently clear that it was Helseklage that decided on
cases related to rights under Article 20(2) of Regulation 883/2004.
(246) To summarize:The Government submits that NIA Section 21-11 a (2) conferred on Helfo and
Helseklage competence to handle decisions and appeals on Article 20(2) of Regulation
883/2004. This understanding can be established by the wording of the provision read in
context with the provisions of NIA Chapter 5, PR Section 7(3) and 6(4), and also consistent
practice from these bodies since at least 2009 and 2016, respectively.
(247) Any imprecision related to the fact that benefits under NIA chapter 5 generally excludes
in-patient treatment, or to the fact that Section 7-2(2) in a short period did not explicitly
make any exception for decisions under Article 20(2) of Regulation 88312004, is not of such
a character that it breaches the principle of legal certainty. The fact that one need to consult
event, the Ministry's list of benefits in this regard must in the Government's view be understood as a list of
benefits generally falling under chapter 5, but not necessarily exhaustive in relation to Helseklage's
competence.
47/49
with other sources of law to establish the correct interpretation of a provision, is in the
Government's view, not in itself a breach of the principle of legal certainty.lsT
7 CONCLUSION
(248) Based on the foregoing, the Norwegian Government respectfully request the EFTA Court to:
1. Dismiss the application of the EFTA Surveillance Authority as unfounded.
2. Order the EFTA Surveillance Authority to pay the costs of the proceedings.
aaa
Oslo,09/10/2023
Lotte Tvedt Marie Munthe-Kaas
Agent Agent
Attorney General- Civil Affairs Ministry of Foreign Affairs
Simen Hammersvik
Agent
Attorney General- Civil Affairs
Andreas Runde
Agent
Attorney General- Civil Affairs
1s7
The Government refers to C-1 10/03 Belgium v Commksion par.31, and C-206/16 Morco Tronchetti
Provera par.4O-42, where CJEU held that the principle of legal certainty does not preclude Member States
from having recourse to abstract legal concepts. ln the latter of thesejudgements, CJEU also acknowledges
that concepts used in national legislation, may need to be interpreted in accordance with national statutes
of interpretation in order to establish their true meaning, without this constituting a breach of the principle
of legal certainty. Thus, in the Government's view, the principle of legal certainty does not preclude a
fragmented national legislation where several provisions must be read in combination in order to establish
the actual state of law.
48/49
Schedule of Annexes
No. Description Referred to in this Numberof
Defence at pages
paragraph(s)
L Numbers of cases under Article 20(2) of Regulation 46 L
883-2004
2 Numbers of cases under the Reimbursement 46 L
Regulation
3 Numbers of cases under the No Adequate Treatment 47 1
Scheme
4 lnformation to patients on Helsenorge's wepages t96,232 5
5 Letter 7 October 2O22lrom the Ministry regarding L97 4
guidance on different routes to treatment abroad
6 Overview of decisions made by Helfo with references L97 2
to other schemes
49/49
Saatja: <
[email protected]>
Saadetud: 12.10.2023 11:43
Adressaat: <"SM Info">; <
[email protected]>
Teema: E-9/23
Adressaadid:
[email protected],
[email protected]
Välisministeeriumis registreeritud: 15.3-3/2023/398
Kohtuasja number: E-9/23
Vastuse kuupäev: 26.10.2023
Staadium: Uus menetlus
Märksõnad: patsiendiõiguste kohaldamine piiriüleses tervishoius;
raviteenuste osutamine; sotsiaalkindlustussüsteemide koordineerimine;
teenuste osutamise vabadus
Õiguslikud vormid: EMP lepingu artikkel 36; määrus (EÜ) nr 883/2004
Dokumentidega on võimalik tutvuda EELO keskkonnas aadressil
https://eelo.mfa.ee/eelotsus_vaata.php?id=7276
Palun teatage 7 päeva jooksul, kas kohtuasja temaatika kuulub teie
vastutusalasse.
Juhul, kui kohtuasja temaatika ei kuulu teie vastutusalasse, palun
viidake, milline teine ametiasutus sellega peaks tegelema.
Palun teatage, kas Eesti peaks selles eelotsusemenetluses seisukoha
esitama, ja põhjendage oma arvamust (ka eitavat seisukohta).
EL õiguse büroo
Välisministeerium