Kiri

JUDGMENT OF THE COURT

5 December 2024*

(Social security law – Free movement of patients – Article 36 EEA – Directive

2011/24/EU – Article 7 – Patients’ rights – Reimbursement of costs of cross-border

healthcare – Article 129 EEA)

In Case E-15/23,

REQUEST to the Court under Article 34 of the Agreement between the EFTA States on

the Establishment of a Surveillance Authority and a Court of Justice by the National

Insurance Court (Trygderetten), in the case between

K

and

Nasjonalt klageorgan for helsetjenesten (National Office for Health Service Appeals),

concerning the interpretation of Directive 2011/24/EU of the European Parliament and of

the Council of 9 March 2011 on the application of patients’ rights in cross-border

healthcare, and in particular Article 7 thereof and Article 36 of the Agreement on the

European Economic Area,

THE COURT,

composed of: Páll Hreinsson, President, Bernd Hammermann (Judge-Rapporteur) and

Michael Reiertsen, Judges,

Registrar: Ólafur Jóhannes Einarsson,

* Language of the request: Norwegian. Translations of national provisions are unofficial and based on those contained

in the documents of the case.

– 2 –

having considered the written observations submitted on behalf of:

− the National Office for Health Service Appeals, represented by Andreas Runde,

advocate;

− the Estonian Government, represented by Merili Kriisa, acting as Agent;

− the Polish Government, represented by Bogusław Majczyna, acting as Agent;

− the EFTA Surveillance Authority (“ESA”), represented by Marte Brathovde, Ewa

Gromnicka, and Melpo-Menie Joséphidès, acting as Agents; and

− the European Commission (“the Commission”), represented by Lorna Armati,

Sandrine Delaude and Esther Eva Schmidt, acting as Agents,

having regard to the Report for the Hearing,

having heard oral argument of K, represented by Lasse Nikolai Simonsen, counsel; the

National Office for Health Service Appeals, represented by Andreas Runde; ESA,

represented by Marte Brathovde; and the Commission, represented by Lorna Armati, at the

hearing on 14 May 2024,

gives the following

J U D G M E N T

I LEGAL BACKGROUND

EEA law

1 Article 36 of the Agreement on the European Economic Area (“the EEA Agreement” or

“EEA”) reads:

1. Within the framework of the provisions of this Agreement, there shall be no

restrictions on freedom to provide services within the territory of the Contracting

Parties in respect of nationals of EC Member States and EFTA States who are

established in an EC Member State or an EFTA State other than that of the person

for whom the services are intended.

2. Annexes IX to XI contain specific provisions on the freedom to provide services.

– 3 –

2 Article 129(1) EEA reads, in extract:

This Agreement is drawn up in a single original in the Danish, Dutch, English,

Finnish, French, German, Greek, Icelandic, Italian, Norwegian, Portuguese,

Spanish and Swedish languages, each of these texts being equally authentic.

...

The texts of the acts referred to in the Annexes are equally authentic in the

Bulgarian, Croatian, Czech, Danish, Dutch, English, Estonian, Finnish, French,

German, Greek, Hungarian, Italian, Latvian, Lithuanian, Maltese, Polish,

Portuguese, Romanian, Slovak, Slovenian, Spanish and Swedish languages as

published in the Official Journal of the European Union and shall for the

authentication thereof be drawn up in the Icelandic and Norwegian languages and

published in the EEA Supplement to the Official Journal of the European Union.

3 Directive 2011/24/EU of the European Parliament and of the Council of 9 March 2011 on

the application of patients’ rights in cross-border healthcare (OJ 2011 L 88, p. 45; and

Norwegian EEA Supplement 2018 No 27, p. 1) (“the Patients’ Rights Directive”) was

incorporated into the EEA Agreement by Decision of the EEA Joint Committee

No 153/2014 of 9 July 2014 (OJ 2015 L 15, p. 78; and Norwegian EEA Supplement 2015

No 5, p. 1) (“JCD 153/2014”). Patients’ Rights Directive is referred to at point 2 of Annex

X (Services in general) to the EEA Agreement. Constitutional requirements were indicated

by Iceland and Norway. The requirements were fulfilled by 9 June 2015, and the decision

entered into force on 1 August 2015.

4 Article 1 of JCD 153/2014 reads, in extract:

The following is added after point 1c (Commission Decision 2011/130/EU)

of Annex X to the EEA Agreement:

‘2. 32011 L 0024: Directive 2011/24/EU of the European Parliament and of

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 provisions of the Directive shall, for the purposes of this Agreement, be read

with the following adaptations:

Without prejudice to future development by the EEA Joint Committee, it should be

noted that the following acts are not incorporated into the EEA Agreement:

(a) Council Regulation (EC) No 859/2003 of 14 May 2003 extending the provisions

of Regulation (EEC) No 1408/71 and Regulation (EEC) No 574/72 to nationals of

– 4 –

third countries who are not already covered by those provisions solely on the

ground of their nationality,

(b) Regulation (EU) No 1231/2010 of the European Parliament and of the Council

of 24 November 2010 extending Regulation (EC) No 883/2004 and Regulation (EC)

No 987/2009 to nationals of third countries who are not already covered by these

Regulations solely on the ground of their nationality.

Therefore all references to these acts shall not apply to the EFTA States.

...’

5 Recitals 2 (in extract), 6, 8, 10, 11, 19, 20, 28, 29, 30, 31, 37 and 48 of the Patients’ Rights

Directive read as follows:

(2) Article 114 TFEU is the appropriate legal basis since the majority of the

provisions of this Directive aim to improve the functioning of the internal market

and the free movement of goods, persons and services. ...

(6) As confirmed by the Court of Justice of the European Union (hereinafter the

‘Court of Justice’) on several occasions, while recognising their specific nature, all

types of medical care fall within the scope of the TFEU.

(8) Some issues relating to cross-border healthcare, in particular reimbursement of

healthcare provided in a Member State other than that in which the recipient of the

care is resident, have already been addressed by the Court of Justice. This Directive

is intended to achieve a more general, and also effective, application of principles

developed by the Court of Justice on a case-by-case basis.

(10) This Directive aims to establish rules for facilitating access to safe and high-

quality cross-border healthcare in the Union and to ensure patient mobility in

accordance with the principles established by the Court of Justice and to promote

cooperation on healthcare between Member States, whilst fully respecting the

responsibilities of the Member States for the definition of social security benefits

relating to health and for the organisation and delivery of healthcare and medical

care and social security benefits, in particular for sickness.

(11) This Directive should apply to individual patients who decide to seek

healthcare in a Member State other than the Member State of affiliation. As

confirmed by the Court of Justice, neither its special nature nor the way in which it

is organised or financed removes healthcare from the ambit of the fundamental

principle of the freedom to provide services. However, the Member State of

affiliation may choose to limit the reimbursement of cross-border healthcare for

reasons relating to the quality and safety of the healthcare provided, where this can

– 5 –

be justified by overriding reasons of general interest relating to public health. The

Member State of affiliation may also take further measures on other grounds where

this can be justified by such overriding reasons of general interest. Indeed, the Court

of Justice has laid down that public health protection is among the overriding

reasons of general interest that can justify restrictions to the freedom of movement

envisaged in the Treaties.

(19) When a patient receives cross-border healthcare, it is essential for the patient

to know in advance which rules will be applicable. The rules applicable to cross-

border healthcare should be those set out in the legislation of the Member State of

treatment, given that, in accordance with Article 168(7) TFEU, the organisation

and delivery of health services and medical care is the responsibility of the Member

States. This should help the patient in making an informed choice, and should avoid

misapprehension and misunderstanding. It should also establish a high level of trust

between the patient and the healthcare provider.

(20) In order to help patients to make an informed choice when they seek to receive

healthcare in another Member State, Member States of treatment should ensure that

patients from other Member States receive on request the relevant information on

safety and quality standards enforced on its territory as well as on which healthcare

providers are subject to these standards. Furthermore, healthcare providers should

provide patients on request with information on specific aspects of the healthcare

services they offer and on the treatment options. To the extent that healthcare

providers already provide patients resident in the Member State of treatment with

relevant information on those specific aspects, this Directive should not oblige

healthcare providers to provide more extensive information to patients from other

Member States. Nothing should prevent the Member State of treatment from also

obliging other actors than the healthcare providers, such as insurance providers or

public authorities, to provide the information on specific aspects of the healthcare

services offered, if that would be more appropriate with regard to the organisation

of its healthcare system.

(28) This Directive should not affect an insured person’s rights in respect of the

assumption of costs of healthcare which becomes necessary on medical grounds

during a temporary stay in another Member State according to Regulation (EC) No

883/2004. In addition, this Directive should not affect an insured person’s right to

be granted an authorisation for treatment in another Member State where the

conditions provided for by Union regulations on the coordination of social security

systems are met, in particular by Regulation (EC) No 883/2004 or Council

Regulation (EEC) No 1408/71 of 14 June 1971 on the application of social security

schemes to employed persons, to self-employed persons and to members of their

families moving within the Community, which are applicable by virtue of Regulation

(EU) No 1231/2010 of the European Parliament and of the Council of 24 November

– 6 –

2010 extending Regulation (EC) No 883/2004 and Regulation (EC) No 987/2009 to

nationals of third countries who are not already covered by these Regulations solely

on the ground of their nationality and Council Regulation (EC) No 859/2003 of 14

May 2003 extending the provisions of Regulation (EEC) No 1408/71 and Regulation

(EEC) No 574/72 to nationals of third countries who are not already covered by

those provisions solely on the ground of their nationality.

(29) It is appropriate to require that also patients who seek healthcare in another

Member State in other circumstances than those provided for in Regulation (EC)

No 883/2004 should be able to benefit from the principles of free movement of

patients, services and goods in accordance with the TFEU and with this Directive.

Patients should enjoy a guarantee of assumption of the costs of that healthcare at

least at the level as would be provided for the same healthcare, had it been provided

in the Member State of affiliation. This should fully respect the responsibility of the

Member States to determine the extent of the sickness cover available to their

citizens and prevent any significant effect on the financing of the national healthcare

systems.

(30) For patients, therefore, the two systems should be coherent; either this

Directive applies or the Union regulations on the coordination of social security

systems apply.

(31) Patients should not be deprived of the more beneficial rights guaranteed by the

Union Regulations on the coordination of social security systems when the

conditions are met. Therefore, any patient who requests an authorisation to receive

treatment appropriate to his condition in another Member State should always be

granted this authorisation under the conditions provided for in the Unions

regulations when the treatment in question is among the benefits provided for by the

legislation in the Member State where the patient resides and when the patient

cannot be given such treatment within a time limit that is medically justifiable,

taking account of his current state of health and the probable course of the

condition. However, if a patient instead explicitly requests to seek treatment under

the terms of this Directive, the benefits which apply to reimbursement should be

limited to those which apply under this Directive. Where the patient is entitled to

cross-border healthcare under both this Directive and Regulation (EC) No

883/2004, and the application of that Regulation is more advantageous to the

patient, the patient’s attention should be drawn to this by the Member State of

affiliation.

(37) Member States may maintain general conditions, criteria for eligibility and

regulatory and administrative formalities for receipt of healthcare and

reimbursement of healthcare costs, such as the requirement to consult a general

practitioner before consulting a specialist or before receiving hospital care, also in

– 7 –

relation to patients seeking healthcare in another Member State, provided that such

conditions are necessary, proportionate to the aim, not discretionary or

discriminatory. This may include an assessment by a health professional or

healthcare administrator providing services for the statutory social security system

or national health system of the Member State of affiliation, such as the general

practitioner or primary care practitioner with whom the patient is registered, if this

is necessary for determining the individual patient’s entitlement to healthcare. It is

thus appropriate to require that these general conditions, criteria and formalities

should be applied in an objective, transparent and non-discriminatory way and

should be known in advance, based primarily on medical considerations, and that

they should not impose any additional burden on patients seeking healthcare in

another Member State in comparison with patients being treated in their Member

State of affiliation, and that decisions should be made as quickly as possible. This

should be without prejudice to the rights of the Member States to lay down criteria

or conditions for prior authorisation in the case of patients seeking healthcare in

their Member State of affiliation.

(48) Appropriate information on all essential aspects of cross-border healthcare is

necessary in order to enable patients to exercise their rights on cross-border

healthcare in practice. For cross-border healthcare, one of the mechanisms for

providing such information is to establish national contact points within each

Member State. Information that has to be provided compulsorily to patients should

be specified. However, the national contact points may provide more information

voluntarily and also with the support of the Commission. Information should be

provided by national contact points to patients in any of the official languages of

the Member State in which the contact points are situated. Information may be

provided in any other language.

6 Chapter I of the Patients’ Rights Directive entitled “General provisions” contains Articles

1 to 3. Article 1(1), (2) and (4) of the Patients’ Rights Directive, entitled “Subject matter

and scope”, reads:

1. This Directive provides rules for facilitating the access to safe and high-quality

cross-border healthcare and promotes cooperation on healthcare between Member

States, in full respect of national competencies in organising and delivering

healthcare. This Directive also aims at clarifying its relationship with the existing

framework on the coordination of social security systems, Regulation (EC) No

883/2004, with a view to application of patients’ rights.

2. This Directive shall apply to the provision of healthcare to patients, regardless

of how it is organised, delivered and financed.

– 8 –

4. This Directive shall not affect laws and regulations in Member States relating

to the organisation and financing of healthcare in situations not related to cross-

border healthcare. In particular, nothing in this Directive obliges a Member State

to reimburse costs of healthcare provided by healthcare providers established on

its own territory if those providers are not part of the social security system or public

health system of that Member State.

7 Article 2 of the Patients’ Rights Directive, entitled “Relationship with other Union

provisions”, reads, in extract:

This Directive shall apply without prejudice to:

...

(m) Regulation (EC) No 883/2004 and 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 883/2004 on the coordination of

social security systems;

(n) Directive 2005/36/EC;

...

8 Chapter II of the Patients’ Rights Directive entitled “Responsibilities of Member States

with regard to cross-border health care” contains Articles 4 to 6. Article 4(1) of the Patients’

Rights Directive, entitled “Responsibilities of the Member State of treatment”, reads:

Taking into account the principles of universality, access to good quality care,

equity and solidarity, cross-border healthcare shall be provided in accordance

with:

(a) the legislation of the Member State of treatment;

(b) standards and guidelines on quality and safety laid down by the Member State

of treatment; and

(c) Union legislation on safety standards.

9 Article 5 of the Patients’ Rights Directive, entitled “Responsibilities of the Member State

of affiliation”, reads, in extract:

The Member State of affiliation shall ensure that:

– 9 –

(a) the cost of cross-border healthcare is reimbursed in accordance with Chapter

III;

(b) there are mechanisms in place to provide patients on request with information

on their rights and entitlements in that Member State relating to receiving cross-

border healthcare, in particular as regards the terms and conditions for

reimbursement of costs in accordance with Article 7(6) and procedures for

accessing and determining those entitlements and for appeal and redress if patients

consider that their rights have not been respected, in accordance with Article 9. In

information about cross-border healthcare, a clear distinction shall be made

between the rights which patients have by virtue of this Directive and rights arising

from Regulation (EC) No 883/2004;

...

10 Chapter III of the Patients’ Rights Directive entitled “Reimbursement of costs of cross-

border healthcare” contains Articles 7 to 9. Article 7(1), (3), (4), (7) and (9) of the Patients’

Rights Directive, entitled “General principles for reimbursement of costs”, reads:

1. Without prejudice to Regulation (EC) No 883/2004 and subject to the provisions

of Articles 8 and 9, the Member State of affiliation shall ensure the costs incurred

by an insured person who receives cross-border healthcare are reimbursed, if the

healthcare in question is among the benefits to which the insured person is entitled

in the Member State of affiliation.

3. It is for the Member State of affiliation to determine, whether at a local, regional

or national level, the healthcare for which an insured person is entitled to

assumption of costs and the level of assumption of those costs, regardless of where

the healthcare is provided.

4.The costs of cross-border healthcare shall be reimbursed or paid directly by the

Member State of affiliation up to the level of costs that would have been assumed by

the Member State of affiliation, had this healthcare been provided in its territory

without exceeding the actual costs of healthcare received.

Where the full cost of cross-border healthcare exceeds the level of costs that would

have been assumed had the healthcare been provided in its territory the Member

State of affiliation may nevertheless decide to reimburse the full cost.

The Member State of affiliation may decide to reimburse other related costs, such

as accommodation and travel costs, or extra costs which persons with disabilities

might incur due to one or more disabilities when receiving cross-border healthcare,

– 10 –

in accordance with national legislation and on the condition that there be sufficient

documentation setting out these costs.

7. The Member State of affiliation may impose on an insured person seeking

reimbursement of the costs of cross-border healthcare, including healthcare

received through means of telemedicine, the same conditions, criteria of eligibility

and regulatory and administrative formalities, whether set at a local, regional or

national level, as it would impose if this healthcare were provided in its territory.

This may include an assessment by a health professional or healthcare

administrator providing services for the statutory social security system or national

health system of the Member State of affiliation, such as the general practitioner or

primary care practitioner with whom the patient is registered, if this is necessary

for determining the individual patient’s entitlement to healthcare. However, no

conditions, criteria of eligibility and regulatory and administrative formalities

imposed according to this paragraph may be discriminatory or constitute an

obstacle to the free movement of patients, services or goods, unless it is objectively

justified by planning requirements relating to the object of ensuring sufficient and

permanent access to a balanced range of high-quality treatment in the Member

State concerned or to the wish to control costs and avoid, as far as possible, any

waste of financial, technical and human resources.

9. The Member State of affiliation may limit the application of the rules on

reimbursement for cross-border healthcare based on overriding reasons of general

interest, such as planning requirements relating to the aim of ensuring sufficient

and permanent access to a balanced range of high-quality treatment in the Member

State concerned or to the wish to control costs and avoid, as far as possible, any

waste of financial, technical and human resources.

11 Article 9(1), (2), (3) and (4) of the Patients’ Rights Directive, entitled “Administrative

procedures regarding cross-border healthcare”, reads:

1. The Member State of affiliation shall ensure that administrative procedures

regarding the use of cross-border healthcare and reimbursement of costs of

healthcare incurred in another Member State are based on objective, non-

discriminatory criteria which are necessary and proportionate to the objective to

be achieved.

2. Any administrative procedure of the kind referred to in paragraph 1 shall be

easily accessible and information relating to such a procedure shall be made

publicly available at the appropriate level. Such a procedure shall be capable of

ensuring that requests are dealt with objectively and impartially.

– 11 –

3. Member States shall set out reasonable periods of time within which requests

for cross-border healthcare must be dealt with and make them public in advance.

When considering a request for cross-border healthcare, Member States shall take

into account:

(a) the specific medical condition;

(b) the urgency and individual circumstances.

4. Member States shall ensure that individual decisions regarding the use of cross-

border healthcare and reimbursement of costs of healthcare incurred in another

Member State are properly reasoned and subject, on a case-by-case basis, to review

and are capable of being challenged in judicial proceedings, which include

provision for interim measures.

12 Chapter IV of the Directive entitled “Cooperation in healthcare” contains Articles 10 to 15.

Article 10(1) and (4) of the Patients’ Rights Directive, entitled “Mutual assistance and

cooperation”, reads, in extract:

1. Member States shall render such mutual assistance as is necessary for the

implementation of this Directive, including cooperation on standards and

guidelines on quality and safety and the exchange of information, especially

between their national contact points in accordance with Article 6, including on

provisions on supervision and mutual assistance to clarify the content of invoices.

4. Member States of treatment shall ensure that information on the right to practise

of health professionals listed in national or local registers established on their

territory is, upon request, made available to the authorities of other Member States,

for the purpose of cross-border healthcare, in accordance with Chapters II and III

and with national measures implementing Union provisions on the protection of

personal data, in particular Directives 95/46/EC and 2002/58/EC, and the principle

of presumption of innocence. ...

13 Directive 2005/36/EC of the European Parliament and of the Council of 7 September 2005

on the recognition of professional qualifications (OJ 2005 L 255, p. 22; and Norwegian

EEA Supplement 2011 No 71, p. 1322) (“the Professional Qualifications Directive”) was

incorporated into the EEA Agreement by Decision of the EEA Joint Committee No

142/2007 of 26 October 2007 (OJ 2008 L 100, p. 70; and Norwegian EEA Supplement

2008 No 19, p. 70). The Professional Qualifications Directive is referred to at point 1 of

Annex VII (Recognition of professional qualifications) to the EEA Agreement.

Constitutional requirements were indicated by Iceland, Liechtenstein and Norway. The

– 12 –

requirements were fulfilled by 14 May 2009 and the decision entered into force on 1 July

2009.

14 Recital 3 of the Professional Qualifications Directive reads:

The guarantee conferred by this Directive on persons having acquired their

professional qualifications in a Member State to have access to the same profession

and pursue it in another Member State with the same rights as nationals is without

prejudice to compliance by the migrant professional with any non-discriminatory

conditions of pursuit which might be laid down by the latter Member State, provided

that these are objectively justified and proportionate.

15 Article 1 of the Professional Qualifications Directive, entitled “Purpose”, at the material

time, read:

This Directive establishes rules according to which a Member State which makes

access to or pursuit of a regulated profession in its territory contingent upon

possession of specific professional qualifications (referred to hereinafter as the host

Member State) shall recognise professional qualifications obtained in one or more

other Member States (referred to hereinafter as the home Member State) and which

allow the holder of the said qualifications to pursue the same profession there, for

access to and pursuit of that profession.

16 Article 2 of the Professional Qualifications Directive, entitled “Scope”, at the material time,

read:

1. This Directive shall apply to all nationals of a Member State wishing to pursue a

regulated profession in a Member State, including those belonging to the liberal

professions, other than that in which they obtained their professional qualifications,

on either a self-employed or employed basis.

2. Each Member State may permit Member State nationals in possession of evidence

of professional qualifications not obtained in a Member State to pursue a regulated

profession within the meaning of Article 3(1)(a) on its territory in accordance with

its rules. In the case of professions covered by Title III, Chapter III, this initial

recognition shall respect the minimum training conditions laid down in that

Chapter.

3. Where, for a given regulated profession, other specific arrangements directly

related to the recognition of professional qualifications are established in a

separate instrument of Community law, the corresponding provisions of this

Directive shall not apply.

17 Article 10 of the Professional Qualifications Directive, entitled “Scope”, reads, in extract:

– 13 –

This Chapter applies to all professions which are not covered by Chapters II and

III of this Title and in the following cases in which the applicant, for specific and

exceptional reasons, does not satisfy the conditions laid down in those Chapters:

...

18 Article 21(1) of the Professional Qualifications Directive, entitled “Principle of automatic

recognition”, reads:

Each Member State shall recognise evidence of formal qualifications as doctor

giving access to the professional activities of doctor with basic training and

specialised doctor, as nurse responsible for general care, as dental practitioner, as

specialised dental practitioner, as veterinary surgeon, as pharmacist and as

architect, listed in Annex V, points 5.1.1, 5.1.2, 5.2.2, 5.3.2, 5.3.3, 5.4.2, 5.6.2 and

5.7.1 respectively, which satisfy the minimum training conditions referred to in

Articles 24, 25, 31, 34, 35, 38, 44 and 46 respectively, and shall, for the purposes

of access to and pursuit of the professional activities, give such evidence the same

effect on its territory as the evidence of formal qualifications which it itself issues.

Such evidence of formal qualifications must be issued by the competent bodies in

the Member States and accompanied, where appropriate, by the certificates listed

in Annex V, points 5.1.1, 5.1.2, 5.2.2, 5.3.2, 5.3.3, 5.4.2, 5.6.2 and 5.7.1 respectively.

The provisions of the first and second subparagraphs do not affect the acquired

rights referred to in Articles 23, 27, 33, 37, 39 and 49.

19 Annex V to the Professional Qualifications Directive is entitled “Recognition on the basis

of coordination of the minimum training conditions”. Heading V.3 is entitled “DENTAL

PRACTITIONER”. At point 5.3.3 of Annex V entitled, “Evidence of formal qualifications

of specialised dentists”, the following is stated under “Orthodontics” as regards Poland:

Country Evidence of formal

qualifications

Body awarding the

evidence of

qualifications

Reference

date

Polska Dyplom uzyskania tytułu

specjalisty w dziedzinie

ortodoncji

Centrum Egzaminów

Medycznych

1 May 2004

20 Further at point 5.3.3 of Annex V, the following is stated under “Oral surgery” as regards

Poland:

– 14 –

Country Evidence of formal

qualifications

Body awarding the

evidence of

qualifications

Reference

date

Polska Dyplom uzyskania tytułu

specjalisty w dziedzinie

chirurgii stomatologicznej

Centrum Egzaminów

Medycznych

1 May 2004

National law

21 The National Insurance Act No 19 of 28 February 1997 (lov 28. februar 1997 nr. 19 om

folketrygd) (“National Insurance Act”) contains rules on reimbursement for treatment

abroad.

22 Section 5-1 of the National Insurance Act, entitled “Purpose, etc.”, read, at the material

time:

The purpose of benefits under the present chapter is to provide total or partial

compensation for insured persons’ necessary expenses for healthcare in the event

of sickness, injury, impairment, family planning, pregnancy, birth or termination of

pregnancy.

No benefits shall be provided for interventions which are essentially carried out on

cosmetic grounds, or for treatment of foreseeable consequences of such

intervention.

In so far as public benefits are provided pursuant to other legislation, no benefits

shall be provided under this chapter.

23 Section 5-1 a of the National Insurance Act, entitled “Relationship with provisions on

international coordination of national social security”, was enacted and entered into force

after the material time, on 25 November 2022. It reads:

Benefits for healthcare are sickness benefits under the social security regulation.

The provisions of this chapter shall be waived to the extent necessary to comply with

relevant provisions of the Main Part of the EEA Agreement, the social security

regulation, the implementation regulation and bilateral and multilateral social

security agreements: see sections 1-3 a and 1-3 b.

24 Section 5-6 of the National Insurance Act, entitled “Dental practitioner care”, reads:

The social security scheme shall provide benefits for coverage of expenses for

sickness-related examination and treatment by a dental practitioner.

– 15 –

The benefits shall be provided according to pre-established rates.

The Ministry issues regulations on benefits pursuant to the present section,

including on grants for common measures for dental practitioners.

25 Section 5-24 a of the National Insurance Act, entitled “Benefits for healthcare in another

EEA State”, reads:

Benefits shall be provided for coverage of expenses for healthcare incurred by the

insured person in another EEA country under rules laid down by the Ministry by

regulation.

The Regulation may contain more detailed provisions on inter alia:

a. which healthcare services and goods for which benefits are to be provided;

b. who is entitled to benefits;

c. conditions for benefits, including prior approval and requirements in respect of

the service provider;

d. calculation of the benefits;

e. coverage of travel and subsistence expenses;

f. requirements in respect of documentation and translation of documents;

g. relationship to other rules on benefits for healthcare received in other countries.

26 Section 1 of Regulation No 1702 of 16 December 2014 on benefits to cover expenses for

sickness-related examination and treatment by dental practitioners and dental hygienists

(forskrift 16. desember 2014 nr. 1702 om stønad til dekning av utgifter til undersøkelse og

behandling hos tannlege og tannpleier for sykdom) (“the National Dental Regulation”)

entitled “Benefits-eligible examination and treatment”, read, at the material time, in

extract:

Under Section 5-6 of the National Insurance Act, benefits shall be provided for

coverage of expenses for examination and treatment performed by a dental

practitioner in the event of the following conditions/cases:

…

– 16 –

6. Periodontitis;

…

Under Section 5-6a of the National Insurance Act, benefits shall be provided for

coverage of expenses for examination and treatment of periodontitis performed by

a dental hygienist pursuant to Nos 1, 4, 6 and 14 of the first paragraph.

The individual dental practitioner or dental hygienist shall be responsible for

determining whether an insured person is entitled to benefits pursuant to section 5-

6 or 5-6a of the National Insurance Act. The dental practitioner/dental hygienist

shall also determine whether the treatment is within the parameters of necessary

and appropriate dental treatment. The dental practitioner/dental hygienist must be

able to document their determinations, and the patient log shall contain all relevant

and necessary information: see the Healthcare Professionals Act with

accompanying regulations.

The Directorate of Health (Helsedirektoratet) shall lay down comprehensive

provisions and detailed guidelines for which treatments and conditions are covered

by the scheme under Section 1.

It is a condition for benefits under the present Regulation that the person in question

is an insured person under the national insurance scheme: see Section 5-2 of the

National Insurance Act.

27 Section 3 of the National Dental Regulation, entitled “The dental practitioner’s and the

dental hygienist’s competence”, reads:

Benefits shall be provided only if the examination or treatment is performed by a

dental practitioner or dental hygienist who is permitted to perform dental treatment

pursuant to Act No 64 of 2 July 1999 on healthcare professionals, etc. (the

Healthcare Professionals Act) (lov 2. juli 1999 nr. 64 om helsepersonell m.v.

(helsepersonelloven)), including dental practitioners or dental hygienists from

other EEA States providing temporary services in Norway: see Section 16 of

Regulation of 8 October 2008 No 1130 on authorisation, licensing and specialist

approval for healthcare professionals having professional qualifications from other

EEA countries and Switzerland (forskrift 8. oktober 2008 nr. 1130 om autorisasjon,

lisens og spesialistgodkjenning for helsepersonell med yrkeskvalifikasjoner fra

andre EØS-land og Sveits).

In the event of examination and possible start of orthodontics treatment, a referral

is required from another dental practitioner or dental hygienist before treatment

– 17 –

with the orthodontist may begin. A referral for insured persons covered by Section

1(8), group (b) or (c) shall be valid for 24 months from the date of the referral. The

treatment must be performed by an orthodontist or by a dental practitioner

undergoing specialist education in orthodontics. If the treatment is performed by a

dental practitioner undergoing specialist education in orthodontics, the treatment

must be performed as part of the training. If tasks are delegated to other

professionals: see Sections 4 and 5 of the Healthcare Professionals Act

(helsepersonelloven), it is assumed that delegated tasks are performed under the

responsibility, presence and full attention of the orthodontist.

Expenses for implant-anchored dental prosthetics treatment shall be covered only

if the surgical placement of dental implants is performed by a specialist in oral

surgery and oral medicine, specialist in maxillofacial surgery or specialist in

periodontics. In addition, the prosthetics-related part of the treatment must be

performed by a specialist in oral prosthetics or by a dental practitioner having the

necessary competence approved by the Directorate of Health. Treatment tasks

requiring specialist competence, or particular competence approved by the

Directorate of Health, may not be delegated to another healthcare professional

where reimbursement for treatment is claimed pursuant to the present provision.

Expenses for maxillofacial radiology examinations done using CT/MR shall be

covered only if the examinations are performed by a specialist in maxillofacial

radiology.

28 Section 1 of Regulation No 1466 of 22 November 2010 on benefits for healthcare received

in another EEA State (forskrift 22. november 2010 nr. 1466 om stønad til helsetjenester

mottatt i et annet EØS-land) (“the National Reimbursement Regulation”), entitled

“General scope”, read, at the material time:

The Regulation shall apply to benefits for coverage of expenses for healthcare

received in another country in the European Economic Area (EEA), hereinafter

called EEA countries.

Where telemedicine is used, the healthcare shall be deemed to be received in the

country where the service provider is established.

29 Section 2 of the National Reimbursement Regulation, entitled “Main conditions”, reads:

Benefits shall be provided only for healthcare for which the insured person would

have received benefits or a contribution under the National Insurance Act or had

covered by the public health and care service had the healthcare in question been

received in Norway.

– 18 –

Unless exceptions or adaptations are provided for in the present Regulation, the

same conditions shall apply as for equivalent healthcare at public expense in

Norway.

30 Section 3 of the National Reimbursement Regulation, entitled “Which types of healthcare

for which benefits are provided”, at the material time, read:

Benefits shall be paid to cover expenses for healthcare equivalent to healthcare:

a. for which benefits are provided under Sections 5-4 to 5-12, 5-14 and 5-25 of

the National Insurance Act;

b. for which contributions are made under Section 5-22 of the National

Insurance Act, limited to the contribution-related purposes hormonal

contraceptives and medicinal products in connection with fertility treatment;

c. which is given totally or partially free of charge under the first paragraph of

Section 1-3 of the Dental Health Services Act (tannhelsetjenesteloven), read in

conjunction with Section 2-2 thereof;

d. which is provided totally or partially free of charge under the Specialist

Healthcare Act (spesialisthelsetjenesteloven).

Benefits shall not be provided for substitution treatment for opioid dependency. This

applies even if the insured person is undergoing medicinal product-assisted

rehabilitation in Norway.

31 Section 6 of the National Reimbursement Regulation, entitled “Authorisation and other

requirements for the service provider”, read, at the material time:

The healthcare must be performed by a healthcare professional having official

authorisation in the profession in question which is valid in the country where the

healthcare is received.

When specialist approval is a condition for entitlement to benefits or healthcare at

public expense in Norway, the healthcare must be performed by a healthcare

professional having equivalent specialist approval that is valid in the country where

the healthcare is received. The same applies to other particular competence

requirements. Exceptions may be made to this condition if the speciality in question

or equivalent formal competence does not exist in the country where the healthcare

is received. It is a condition that, instead, it must be documented that the service

provider actually has equivalent substantive competence or other doctor

specialisation in medicine which it is natural to compare with the speciality

required in Norway.

– 19 –

The healthcare professional must have permission to practise lawfully in the country

where the healthcare is received.

It is not a condition that the healthcare must be performed by a healthcare

professional who is part of the public health service, although this is a condition for

equivalent healthcare at public expense in Norway.

32 There is an administrative circular which accompanies Section 5-24a of the National

Insurance Act (Rundskriv til folketrygdloven § 5-24 a – Stønad til helsetjenester mottatt i

et annet EØS-land) (the “Administrative Circular”). The following paragraphs reproduce

the Administrative Circular as it read at the material time.

33 In the part entitled “Introduction” of the Administrative Circular, the following is stated:

Section 5-24a confers entitlement to benefits for healthcare received in another EEA

country. Detailed provisions are laid down by regulation.

The reimbursement scheme provides an option to choose to receive treatment to

which a person is entitled in Norway also in other EEA countries. Thus, Section 5-

24a does not broaden which types of healthcare services a person is entitled to

receive but does entail greater freedom of choice in terms of place of treatment.

In order to assess a claim for reimbursement under Section 5-24a, regard is had to

the national conditions applicable to the healthcare in question (medicinal

products, dental health, medical care, etc.). The general rule is that treatment

should take place as if the healthcare was received in Norway. The patient may,

however, make use of private healthcare providers. Which conditions apply in

respect of the healthcare in question will not be discussed in the administrative

circular, unless there are particular matters which should be commented on.

34 In the part “Background to the scheme”, the following is stated:

The ECJ has held that the EU Treaty’s principle of freedom to provide services

encompasses healthcare services. Thus, the principle of freedom to provide services

entails that patients have rights as recipients of services.

The Patients’ Rights Directive was implemented in the EU in October 2013, and is

a codification of the ECJ’s case law. Section 5-24a implements the Patients’ Rights

Directive in Norwegian law.

35 Part 6 of the Administrative Circular, entitled “Authorisation and other requirements for

the service provider”, reads:

In order for the healthcare to be eligible for reimbursement, the service provider

must, as a main rule, have authorisation and, as the case may be, specialist

– 20 –

approval, etc., in an equivalent manner as if the treatment had been performed in

Norway.

36 Part 6.1 of the Administrative Circular, entitled “Requirement of official authorisation”,

reads:

An authorisation is a confirmation that a person fulfils the formal and professional

requirements for the applicable professional title in question.

It follows from the first paragraph of Section 6 that the healthcare must be provided

by a healthcare professional having official authorisation. The authorisation must

be valid in the country where the healthcare is received. Norwegian authorisation

is not required.

37 Part 6.2 of the Administrative Circular, entitled “Specialist approval and other particular

competence requirements”, reads:

Where specialist approval is a requirement for receiving benefits for healthcare in

Norway, the treatment abroad must be performed by a healthcare professional

having equivalent specialist approval. The specialist approval must be valid in the

country where the healthcare is received. Norwegian specialist approval is not

required.

For specialist doctors in medicine, approved specialities are largely harmonised

through the Professional Qualifications Directive, 2005/36/EC. Thus, the

requirement of medical speciality will generally be satisfied in most cases. For a

more detailed description of qualification requirements, see Annex V – approval of

harmonised courses of education.

Where particular competence requirements are imposed with respect to the service

provider for entitlement to benefits under Norwegian rules, they shall apply

accordingly. Examples include additional courses/education for certain rates for

care by a doctor in medicine, manual therapy and psychomotor physiotherapy, and

psychological care.

The Regulation allows for exceptions to be made from the condition on equivalent

specialist approval or particular competence. Two conditions must be satisfied in

order for an exception to be made. First, the speciality in question or equivalent

formal competence must not exist in the country where the healthcare is received.

Second, it must be documented that the service provider instead actually has

equivalent substantive competence or other doctor specialisation in medicine which

is clearly comparable to the speciality required in Norway.

– 21 –

Exceptions may not be made if the specialisation in question exists in the country

where the healthcare is received.

Specific remarks on specialist approval for implant-based prosthetics

In the regulation for benefits for dental treatment under Section 5-6 of the National

Insurance Act, for reimbursement for implant-based prosthetics and implant

surgery, particular competence requirements are set out for the dental practitioner

who performs the treatment. In order to receive benefits for implant-based

prosthetics in Norway, both the dental practitioner who places the implants (the

surgeon) and the dental practitioner who performs the prosthetics-related work

must have a specified specialist approval.

Dental/oral surgery is referred to in Annex V to the Professional Qualifications

Directive. Hence documentation may be required showing that the dental

practitioner who performed the surgical placement of implants in another EEA

country is in possession of the relevant specialities.

The speciality in oral prosthetics is not, however, referred to in the Professional

Qualifications Directive, and not all EEA countries have such specialist approval.

Nevertheless, allowance is made for reimbursement for the prosthetics-related part

of the treatment in countries where an oral prosthetics speciality does not exist. In

such cases, a specific assessment must be made of whether the service provider’s

competence can be deemed to be almost the same as the specialist competence

required in Norway.

Annex 2 accompanying the Regulation on authorisation, licensing and specialist

approval for healthcare professionals having professional qualifications from other

EEA countries can offer some guidance for the assessment of confirmation of

authorisation and the like from other EEA countries. The Annex contains a list of

names of diplomas, levels of education, etc., for different groups of healthcare

professionals.

38 Part 6.4 of the Administrative Circular, entitled “No requirement that treatment provider

must be part of the public health service”, reads:

It is not a requirement for benefits under this reimbursement scheme that the

treatment received is performed by a healthcare professional who is part of the

public health service.

– 22 –

II FACTS AND PROCEDURE

39 On 30 November 2017, K applied for benefits to cover dental treatment received in Poland

in the period 16 August to 24 October 2017. The application related to stage two of

treatment for severe marginal periodontitis that had been commenced in 2016. K had

previously applied for, and been refused, reimbursement for the first stage of the treatment,

also on the ground that the treating dental practitioner lacked the necessary specialisation.

The refusal of reimbursement for the first stage of the treatment was upheld by the National

Insurance Court’s ruling in Appeal Case No 20/00406 delivered on 9 April 2021.

40 By decision of 1 February 2018, the Norwegian Health Economics Administration

(Helseøkonomiforvaltningen (“Helfo”)) rejected K’s application for reimbursement for that

portion of the treatment at issue in the present case. The grounds given for the rejection

were the treating dental practitioner’s lack of specialisation.

41 Following a complaint by K, Helfo’s decision was upheld by decision of 25 February 2021

of the National Office for Health Service Appeals (“Helseklage”).

42 On 7 April 2021, K appealed against the decision of Helseklage to the National Insurance

Court. As part of the preparation of the appeals case, Helseklage re-examined the decision

under appeal in accordance with Section 13(1) of the National Insurance Court Act.

Following the re-examination, Helseklage arrived at the same conclusion as in the decision

appealed. In the cover letter dated 10 September 2021, the following was stated with regard

to the requirement of specialisation:

As mentioned, it follows from the third paragraph of Section 3 of the Dental

Regulation that expenses for implant-anchored dental prosthetics treatment are

covered only if the surgical placement of dental implants is performed by a

specialist in oral surgery and oral medicine, specialist in maxillofacial surgery

or a specialist in periodontics. In the present case, the surgical part of the

treatment was not performed by a specialist in oral surgery and oral medicine, a

specialist in maxillofacial surgery or a specialist in periodontics (see ruling

20/00406 of the National Insurance Court). Nor, accordingly, can the prosthetics

part of the treatment be covered.

The appellant submits that the requirement of specialisation in order to be able

to claim reimbursement is contrary to the EU rules on non-discrimination. In that

respect, reference is made, inter alia, to Case 205/84 Commission v Germany

and Case C-398/95 Symvoulio Epikrateias - Greece.

The National Office for Health Service Appeals wishes to point out that it is not

the right to place implants that is restricted under section 3 of the Regulation,

but rather the right to claim reimbursement for the placed implants. There is

nothing preventing a person from receiving treatment from a dental practitioner

– 23 –

not in possession of the necessary specialisation. The regulations concern only

the right to claim reimbursement for the treatment in question, and in no way

regulate who has a right to perform dental treatment. Since the judgments

referred to concern the requirements for providing services in another EEA

country, and not which national requirements that may be imposed for awarding

reimbursement, those judgments are not relevant in the present case.

In its ruling 20/00406, the National Insurance Court held that the regulation on

the requirement of specialisation in order to claim reimbursement was not

contrary to EEA law. The National Office for Health Service Appeals also refers

to Article 7 of the Patients’ Rights Directive, which regulates the right to receive

reimbursement for healthcare received in another EEA/EU country than the state

of affiliation.

Article 7(3) of the Directive provides that it is the Member State of affiliation

itself that to determine, whether at a local, regional or national level, the

healthcare for which an insured person is entitled to assumption of costs and the

level of assumption of those costs. […]

This means that it is the State itself that determines which healthcare services

can be covered and how much is to be covered. It further follows from Article

7(7) that the Member State of affiliation may impose on an insured person

seeking reimbursement of the costs of cross-border healthcare the same

conditions, criteria of eligibility and regulatory and administrative formalities,

whether set at a local, regional or national level, as it would impose if that

healthcare were provided in its territory.

This means that it is possible to impose the same conditions for reimbursement

in Norway as for treatment abroad. This is also in keeping with the EU principle

of non-discrimination, because if less stringent requirements were to be imposed

for reimbursement for dental treatment received in another EEA country, that

would amount to a discriminatory scheme towards those who receive dental

treatment in Norway.

The requirement that implant-anchored dental prosthetics treatment must be

performed by a dental practitioner with a given specialisation in order for

reimbursement to be granted applies irrespective of where you receive the

treatment. Accordingly, it makes no difference if you visit your dental

practitioner in Norway or if you travel to Poland. The requirement imposed for

reimbursement is the same.

In the light of the foregoing, the National Office for Health Service Appeals

finds that the conditions for benefits under Section 5-24a of the National

Insurance Act (folketrygdloven), read in conjunction with Section 5-6, are not

– 24 –

fulfilled, both because the time of and background to the loss of teeth is not

sufficiently documented and the requirement of specialisation is not satisfied.

43 According to the request, the parties disagree as to whether a requirement may be imposed

to the effect that the treating dental practitioner must have the same specialisation as what

is required for reimbursement under the third paragraph of Section 3 of the National Dental

Regulation.

44 Against this background, on 1 December 2023, the National Insurance Court decided to

request an advisory opinion, registered at the Court on the same day, referring the following

questions to the Court:

1. Is it compatible with Article 36 of the EEA Agreement and Article 7 of

Directive 2011/24/EU of the European Parliament and of the Council of 9

March 2011 on the application of patients’ rights in cross-border healthcare

to refuse reimbursement of costs for dental treatment in another EEA State

on the ground that the treating dental practitioner does not possess the

required specialisation in order to have equivalent treatment reimbursed in

the service recipient’s home State?

2. Does it affect the answer to Question 1 if the specialisation required in the

service recipient’s home State is included in Annex V to Directive

2005/36/EC of the European Parliament and of the Council of 7 September

2005 on the recognition of professional qualifications?

3. If the specialisation is not included in Annex V to Directive 2005/36/EC of

the European Parliament and of the Council of 7 September 2005 on the

recognition of professional qualifications, must the competent authorities in

the service recipient’s home State also conduct an assessment under Article

36 of the EEA Agreement in order to determine whether the treating dental

practitioner has equivalent competence to that required under national law?

45 Reference is made to the Report for the Hearing for a fuller account of the legal framework,

the facts, the procedure and the proposed answers submitted to the Court. Arguments of

the parties are mentioned or discussed hereinafter only insofar as is necessary for the

reasoning of the Court.

III ANSWER OF THE COURT

46 By its first question, the referring court asks, in essence, whether a national measure

imposing, for the purposes of reimbursement of national and cross-border healthcare, a

requirement of specialisation of the practitioner delivering the healthcare is compatible

with Article 36 EEA and Article 7 of the Patients’ Rights Directive. The second and third

– 25 –

questions, in essence, enquire whether it is of relevance if the required specialisation is

included in Annex V to the Professional Qualifications Directive, and whether the

competent authorities in the State of affiliation must also conduct an assessment under

Article 36 EEA in order to determine whether the treating healthcare practitioner has

equivalent competence to that required under national law. The Court finds it appropriate

to answer these questions together.

47 It should be observed from the outset that EEA law does not detract from the power of the

EEA States to organise their social security systems. In the absence of harmonisation at

EEA level, it is for the legislature of each EEA State to determine the conditions on which

social security benefits are granted. Nevertheless, when exercising that power, the EEA

States must comply with EEA law (see the judgment of 18 April 2024 in A v Arbeids- og

velferdsdirektoratet, E-3/23, paragraph 55 and case law cited).

48 The Court recalls that Article 36 EEA provides for the freedom to provide services, which

covers both providers and recipients of services within the framework of the EEA

Agreement. It follows from settled case law that medical services provided for

consideration fall within the scope of the provisions on the freedom to provide services.

Medical services are neither by their special nature nor the way in which they are organised

or financed removed from the ambit of the freedom to provide services (see the judgment

of 28 March 2023 in Stendi AS & Norlandia Care Norge AS v Oslo kommune, E-4/22,

paragraph 44 and case law cited). This is also reflected in recitals 6 and 11 of the Patients’

Rights Directive. As is apparent from recital 8 of the Patients’ Rights Directive, that

directive has codified case law relating to the freedom to provide services guaranteed by

Article 36 EEA in the field of healthcare, while intending to achieve a more general, and

also effective, application of principles developed on a case-by-case basis in that case law

(compare the judgment of 29 October 2020 in Veselības ministrija, C-243/19,

EU:C:2020:872, paragraph 66).

49 The Patients’ Rights Directive, as set out in Article 1(1) and recital 10 thereof, lays down

rules for the facilitation of access to safe and high-quality cross-border healthcare and

promotes cooperation on healthcare between EEA States, in full respect of national

competencies in organising and delivering healthcare. As noted in recital 2 of the Patients’

Rights Directive, it further aims to improve the functioning of the internal market and the

free movement of goods, persons and services. It follows from Article 1(2) and (4) that the

Patients’ Rights Directive applies, without prejudice to the provisions set out in Article 2,

for the reasons provided in recitals 28 to 31, to the provision of healthcare to patients in

situations related to cross-border healthcare, and therefore, as stated in recital 11, to

individual patients who decide to seek healthcare in an EEA State other than the State of

affiliation. Hence the Patients’ Rights Directive applies to situations such as those of the

main proceedings.

– 26 –

50 The responsibilities of the State of treatment and State of affiliation with regard to cross-

border healthcare, as defined in Article 3(c) and (d) of the Patients’ Rights Directive

respectively, are set out in Chapter II of the Patients’ Rights Directive. As noted by ESA,

Article 4(1)(a) and (b) thereof, sets out that cross-border healthcare must be provided in

accordance with the legislation of, and in accordance with standards and guidelines on

quality and safety laid down by, the State of treatment. Conversely, Article 5 sets out the

responsibilities of the State of affiliation. The State of affiliation must, inter alia, ensure

that the cost of cross-border healthcare is reimbursed in accordance with Chapter III and

must provide patients on request with information on their rights and entitlements relating

to receiving cross-border healthcare, in particular as regards the terms and conditions for

reimbursement of costs.

51 The general principles of reimbursement are laid down in Article 7 of the Patients’ Rights

Directive. According to Article 7(1), without prejudice to Regulation (EC) No 883/2004 of

the European Parliament and of the Council of 29 April 2004 on the coordination of social

security systems and subject to the provisions of Articles 8 and 9 of the Patients’ Rights

Directive, the State of affiliation shall ensure the costs incurred by an insured person, who

receives cross-border healthcare, are reimbursed, if the healthcare in question is among the

benefits to which the insured person is entitled in the State of affiliation. It is for the State

of affiliation, pursuant to Article 7(3), to determine, whether at a local, regional or national

level, the healthcare for which an insured person is entitled to assumption of costs and the

level of assumption of those costs, regardless of where the healthcare is provided. Article

7(7) further allows, subject to specified conditions, for the State of affiliation to impose the

same conditions, criteria of eligibility and regulatory and administrative formalities on an

insured person seeking reimbursement of the costs of cross-border healthcare as it would

impose if the healthcare in question were provided in its territory.

52 It appears from the request that K’s dental treatment is among the benefits to which he may

be entitled in Norway for the purpose of Article 7(1) of the Patients’ Rights Directive,

provided he meets the other eligibility conditions laid down in Norwegian law. According

to Helseklage’s submission, as set out in the request, the national measure at issue only

restricts the right to claim reimbursement for K’s dental implants and does not regulate

who may perform dental treatment. Therefore, the requirement that a specialised

practitioner delivers such healthcare appears to be a condition for reimbursement within

the meaning of Article 7(7).

53 In this respect, ESA’s argument that Article 7(7) of the Patients’ Rights Directive cannot

serve as a basis for the disputed specialisation requirement because that provision is said

to cover only administrative conditions and formalities, and not qualification requirements

imposed on the healthcare practitioner, must be rejected. It follows from the wording of

that provision that “criteria of eligibility” are also covered. This is further supported by a

contextual interpretation: while the responsibilities of the State of treatment are set out in

Article 4, the duty placed upon the State of affiliation to reimburse costs is governed by

– 27 –

Article 7. The compatibility of conditions for reimbursement provided for in the legislation

of the State of affiliation must thus be examined under the latter provision.

54 According to Article 7(7) of the Patients’ Rights Directive, it must be established that the

requirement of specialisation, and the conditions to prove that the requirement is fulfilled,

are neither discriminatory nor constitute an obstacle to the free movement of patients unless

objectively justified by planning requirements relating to the object of ensuring sufficient

and permanent access to a balanced range of high-quality treatment in the EEA State

concerned, or to the wish to control costs and avoid, as far as possible, any waste of

financial, technical and human resources.

55 It appears from the request that the national measure in question accepts the same

specialisation obtained in other EEA States. Furthermore, the national law permits

exceptions from the requirement of equivalent specialist approval or particular competence

to be made. Two conditions must be satisfied in order for an exception to be made. First,

the speciality in question or equivalent formal competence must not exist in the EEA State

in which the healthcare is received. Second, it must be documented that the service provider

has equivalent substantive competence or other specialisation in medicine which is clearly

comparable to the required speciality in Norway. Therefore, subject to verification by the

requesting court, the national measure does not appear to be discriminatory within the

meaning of Article 7(7) of the Patients’ Rights Directive. Nevertheless, the national

measure may constitute an obstacle to the free movement of patients.

56 With regard to the question as to whether the application of national legislation such as that

at issue in the main proceedings constitutes an obstacle to free movement under Article 36

EEA and the Patients’ Rights Directive, it should be observed, first of all, that all measures

which prohibit, impede or render less attractive the exercise of the free movement of

services must be regarded as restrictions (see the judgment of 5 May 2021 in Criminal

proceedings against N, E-8/20, paragraph 79 and case law cited).

57 Furthermore, it is of no relevance whether restrictions are imposed by the home State or by

the host State. Article 36 EEA also applies to any national rules that render the provision

of services between EEA States more difficult than the provision of services purely within

an EEA State (see the judgment in Criminal proceedings against N, E-8/20, cited above,

paragraph 80 and case law cited).

58 The Court notes that administrative procedures may in themselves constitute an obstacle if

they make the use of free movement less attractive for patients. This is so even if the

conditions for reimbursement are the same for treatment received within and outside of

Norway if, as a matter of practice, they make it more difficult for patients to seek treatment

abroad (see, to that effect, the judgment of 19 December 2008 in Rindal and Slinning,

Joined Cases E-11/07 and E-1/08, paragraphs 47 and 54). This may be the case, for

example, if the rules in question make it more difficult for patients to seek reimbursement

– 28 –

for treatment received abroad than would have been the case had the treatment been

administered in their home EEA State.

59 Notwithstanding the foregoing, the Court observes that in any system of reimbursement,

such as that regulated by the Patients’ Rights Directive, an administrative procedure and a

certain amount of paperwork will be required in order for the patient to successfully claim

reimbursement. The decisive factor is hence whether the effect of the specialisation

requirement represents an unjustified additional burden for individuals choosing to receive

treatment in another EEA State compared to patients seeking treatment in Norway (see, to

that effect, the judgment in Criminal proceedings against N, E-8/20, cited above, paragraph

86).

60 The existence of an obstacle under Article 7(7) of the Patients’ Rights Directive must thus

be subject to an overall assessment of both the substantive and procedural aspects of the

legislation at issue. As noted by the Commission, conditions, criteria and formalities for

reimbursement have significant potential to undermine the very purpose of the Patients’

Rights Directive, namely to facilitate the access to cross-border healthcare and to improve

the functioning of the internal market and the free movement of goods, persons and

services. Recital 37 states that such general conditions, criteria and formalities should be

applied in an objective, transparent and non-discriminatory way, and should not impose

any additional burden on patients seeking healthcare in another EEA State when compared

to the situation faced by patients receiving healthcare in their State of affiliation. Moreover,

decisions should be based primarily on medical considerations, and should be made as

quickly as possible. As such, if patients receiving treatment in another EEA State are

required to provide extensive documentation of the practitioner’s qualifications, and the

burden of proof for the acceptance of these qualifications falls on the patient, this could

discourage them from seeking cross-border healthcare to the extent that it will amount to

an obstacle under Article 7(7) of the Patients’ Rights Directive.

61 In assessing whether such an obstacle exists, it must also be considered whether other

national measures have been put in place to mitigate such restrictive effects. These may

include, but are not limited to, the availability of information to patients, assistance

provided by competent authorities, any agreements between authorities and healthcare

providers, and exchanges of information between competent authorities.

62 Hence, it is for the referring court to establish whether the conditions to prove the required

qualification of the practitioner delivering healthcare are more difficult and burdensome to

fulfil in cross-border situations than when the treatment is received in the State of

affiliation, considering also the information provided in accordance with Article 5(b) of the

Patients’ Rights Directive.

63 As set out in recitals 19 and 20 of the Patients’ Rights Directive, it is essential for patients

to know in advance which rules are applicable in order make an informed choice when they

– 29 –

seek to receive healthcare in another EEA State. In addition, as stated in recital 48,

appropriate information on all essential aspects of cross-border healthcare is necessary in

order to enable patients to exercise their rights in practice. Therefore, the Patients’ Rights

Directive establishes requirements for the administrative procedures regarding cross-

border healthcare in Article 9. That provision requires, inter alia, that such administrative

procedures are based on objective, non-discriminatory criteria which are necessary and

proportionate to the objective to be achieved and that they are easily accessible, and that

information relating to such a procedure is made publicly available at the appropriate level.

64 Since uncertainty for the patient as to whether the conditions for reimbursement will be

met is a strong disincentive to the use of cross-border healthcare, the referring court must

consider the possibilities for the patient to verify and prove whether the dentist providing

treatment meets the national qualification requirements.

65 The Court notes that Article 10 of the Patients’ Rights Directive establishes procedures for

mutual assistance and cooperation, inter alia, for the exchange of information. According

to Article 10(4), the State of treatment shall ensure that information on the right to practise

of health professionals established on their territory is, upon request, made available to the

authorities of other EEA States, for the purpose of cross-border healthcare, in accordance

with Chapters II and III. Hence, these possibilities for the State of affiliation must be taken

into account when assessing the burden of proof concerning the specific qualification

requirement in question.

66 The Court notes that further information in this regard, especially concerning the

reimbursement procedure, the requested documents and the assessment made by Helfo and

Helseklage as well as their assessment criteria, is not in the Court’s case file, but is to be

considered by the referring court in order to establish, whether the national measure

constitutes an obstacle to the free movement of patients.

67 In this context, and having regard to this additional information, it has to be assessed by

the referring court whether the fact that the required specialisation is included in Annex V

to the Professional Qualifications Directive may alleviate any additional burden and

whether there is a requirement under national law for the competent authorities to assess,

in addition, whether the treating healthcare practitioner has equivalent competence to that

required under Norwegian law.

68 Nevertheless, based on the information provided in the request, the Court can provide some

guidance for this assessment. It appears from the request that the rules in question in the

main proceedings require that the healthcare practitioner holds one of the following

qualifications: specialist in oral surgery and oral medicine, specialist in maxillofacial

surgery or specialist in periodontics. Of the three types of specialist referred to in the rule

in question, the first is listed in point 5.3.3 of Annex V to the Professional Qualifications

Directive concerning specialist dentists. The second is listed in point 5.1.3 of Annex V to

– 30 –

the Professional Qualifications Directive concerning specialist doctors. Point 1 in Annex

VII to the EEA Agreement refers to the corresponding Norwegian qualifications for both

these categories of specialists.

69 It appears from the request that the healthcare practitioner providing the dental treatment

was neither a specialist in oral surgery and oral medicine, nor a specialist in maxillofacial

surgery nor a specialist in periodontics. As submitted by ESA, it appears to follow from

the second paragraph of Section 6 of the National Reimbursement Regulation, as

interpreted in accordance with Part 6 of the Administrative Circular and subject to the

referring court’s verification, that the subsequent assessment of the treating healthcare

practitioner’s qualifications is not undertaken on a case-by-case basis with regard to

equivalent substantive competence or a comparable specialisation in medicine when the

required specialisation exists in the State of treatment. Rather it is decided on the basis of

whether the healthcare practitioner possesses evidence of the specialisation listed in Annex

V to the Professional Qualifications Directive.

70 The Court notes in this respect that the Professional Qualifications Directive, as is apparent

from its recital 3 and Articles 1 and 2 thereof, concerns the access to or pursuit of a

regulated profession in an EEA State other than where the professional qualification was

obtained and is therefore not directly applicable to the situation at issue in the main

proceedings. However, it is relevant to observe, as noted by ESA and the Commission, that

case law has explicitly taken into account the system of mutual recognition of professional

qualifications and the resulting trust that could be placed in the professional ability of

healthcare practitioners from another EEA State, in the context of the free movement of

healthcare services (compare the judgment of 19 April 2007, Stamatelaki, C-444/05,

EU:C:2007:231, paragraph 37).

71 Article 21 of the Professional Qualifications Directive provides for a system of automatic

recognition for evidence of professional qualifications for certain professions on the basis

of coordinated minimum conditions for training, including those for dental practitioners.

The system of automatic recognition is based on automatic and unconditional recognition

which does not involve any substantive examination by the host State of the evidence of

formal qualifications being recognised (see the judgment of 25 March 2021 in Lindberg,

E-3/20, paragraphs 40 and 45).

72 Those who cannot avail themselves of the system of automatic recognition must, under the

specific conditions of Article 10 of the Professional Qualifications Directive, be assessed

under the general system of recognition. This provision is intended to facilitate and

simplify the recognition of professional qualifications in the specific cases listed therein

(see the judgment in Lindberg, E-3/20, cited above, paragraph 60). Both Articles 10 and

21 refer to Annex V. However, Annex V does not contain an exhaustive list of all

qualifications that are available in each EEA State with regard to substantive competences.

– 31 –

73 The objective of the Professional Qualifications Directive is, as is apparent from Article 1

thereof and Article 30 EEA, to facilitate the mutual recognition of diplomas, certificates,

and other evidence of formal qualifications by laying down rules and common criteria

which result, as far as possible, in automatic recognition of those professional

qualifications and, thus, make the process of recognition more predictable and efficient for

the applicant. It is not the purpose of the Professional Qualifications Directive to make

recognition of professional qualifications more difficult in situations falling outside its

scope, nor may it have such an effect. The system of automatic recognition under this

directive thus complements the rights guaranteed under the main part of the EEA

Agreement but does not displace an assessment under those provisions (see the judgment

in Lindberg, E-3/20, cited above, paragraph 59 and case law cited).

74 In light of the above, in circumstances where the conditions for the recognition of

professional qualifications under the Professional Qualifications Directive are not met, the

right to recognition of professional qualifications may be derived from Articles 28 and 31

EEA. This also applies where a directive for the mutual recognition of diplomas has been

adopted for the profession in question, but the applicant does not satisfy the conditions for

recognition of qualifications (see the judgment in Lindberg, E-3/20, cited above, paragraph

61 and case law cited). The same applies with regard to Article 36 EEA.

75 It follows from established case law that the authorities of the host State must take into

account all of an applicant’s diplomas, certificates, other evidence of qualifications, and

relevant experience, when they compare the qualifications and experience held by an

applicant with the knowledge and qualifications required by the national legislation for

access to the relevant profession. The host State must therefore examine the qualification

and the specific content of the training. The assessment must enable the authorities of the

host State to assure themselves on an objective basis that a foreign diploma certifies that

the knowledge and qualifications are, if not identical, at least equivalent to those attested

by the national diploma. That assessment must be based exclusively on the level of

knowledge and qualifications which its holder can be assumed to possess, having regard to

the nature and duration of the studies and practical training to which the diploma relates

(see the judgment in Lindberg, E-3/20, cited above, paragraph 64 and 65 and case law

cited).

76 Accordingly, in order to establish whether the healthcare practitioner in another EEA State

has an equivalent specialisation or substantive competence, a specialisation listed in Annex

V to the Professional Qualifications Directive may be deemed sufficient proof of

substantive competence, since that person has a right to automatic recognition. However,

a specialisation listed in Annex V cannot be considered necessary to prove substantive

competence. Therefore, an assessment in order to determine whether the treating healthcare

practitioner has equivalent competence to that required for reimbursement purposes must

not be limited to cases in which the speciality in question or equivalent formal qualification

is not listed in Annex V.

– 32 –

77 It is important to emphasise, however, that even if the specialisation requirement allows

for an assessment in accordance with the interpretation of the Professional Qualifications

Directive provided for above, meaning that it does not in fact discriminate towards service

providers in other EEA States, the specialisation requirement may still amount to an

obstacle to the free movement of patients if it represents an unjustified additional burden

for individuals choosing to receive treatment in another EEA State compared to patients

seeking treatment in Norway. The Court recalls that requiring patients to provide sufficient

documentation relating to the healthcare practitioner’s qualifications and training to enable

an assessment of equivalence by the competent authorities, with the burden of proof resting

on the patient, could discourage patients from seeking cross-border healthcare, thus

constituting an obstacle to the freedom of movement of patients under Article 7(7) of the

Patients’ Rights Directive.

78 In addition, the formalities imposed will be discriminatory if, in a situation such as in the

case at hand in which the non-Norwegian qualification of the healthcare practitioner is

listed in Annex V to the Professional Qualifications Directive or Annex VII to the EEA

Agreement for a specialisation for which Norway also has an entry in the latter, the patient

is required to supply a greater volume of information pertaining to the healthcare

practitioner’s credentials than would be the case had the healthcare been supplied in

Norway. Conversely, however, if the procedure for such situations is identical in form and

in effect to that applicable in a purely internal situation, also taking into account the burden

placed on the patient in both scenarios, it will not constitute an obstacle to the freedom of

movement of patients, nor can it be viewed as discriminatory. It is for the referring court

to determine, in accordance with the interpretation set out above along with any additional

national measures aimed at reducing the administrative burden and legal uncertainty for

patients, whether the contested specialisation requirement, in practice, makes it more

difficult for patients to receive treatment in another EEA State than in Norway.

79 If the national measure is discriminatory or constitutes an obstacle to the free movement of

patients, it can only be objectively justified by planning requirements relating to the object

of ensuring sufficient and permanent access to a balanced range of high-quality treatment

in the EEA State concerned, or to the wish to control costs and avoid, as far as possible,

any waste of financial, technical and human resources within the meaning of Article 7(7)

of the Patients’ Rights Directive.

80 With regard to a justification of the specialisation requirement, Helseklage submitted that

by requiring the relevant specialisation, the risk of unsuccessful treatment is reduced to a

minimum, which will further reduce the risk of waste of financial and human resources. In

this regard, Helseklage submitted that unsuccessful treatment is likely to be very difficult

and expensive to rectify.

81 The Court observes that the justification of the wish to control costs and avoid, as far as

possible, any waste of financial, technical and human resources, cannot be interpreted so

– 33 –

as to allow a justification based on a need to control or ensure the quality or safety of the

provided healthcare in question. It is established case law that restrictions of the free

movement of patients cannot be justified on grounds of public health in order to protect the

quality of medical services provided in other EEA States (compare, inter alia, the judgment

of 28 April 1998 in Kohll, C-158/96, EU:C:1998:171, paragraphs 49 to 52, the judgment

of 28 April 1998 in Decker, C-120/95, EU:C:1998:167, paragraph 45, and the judgment in

Stamatelaki, C-444/05, cited above, paragraphs 36 and 37). Furthermore, it is apparent

from Article 4 of the Patients’ Rights Directive that it is the responsibility of the State of

treatment to ensure the quality and safety requirements of the cross-border healthcare

provided.

82 The Court notes that the justification of conditions, criteria of eligibility and regulatory and

administrative formalities of reimbursement, which are discriminatory or which constitute

an obstacle to the free movement of patients is limited to the grounds listed in Article 7(7)

of the Patients’ Rights Directive. According to the wording of this provision, restrictions

on patients’ right to free movement may only be justified by “planning requirements”.

83 The Court observes that the Norwegian translation of Article 7(7) of the Patients’ Rights

Directive, in contrast to other language versions such as the English, French, and Italian

versions, is ambiguous, as it seems to place the wish to control costs on an equal footing

with planning and rationalisation efforts.

84 The Court recalls that the purpose of Article 129(1) EEA, by providing for the translation

and publication of the acts referred to in the Annexes to the Agreement beyond the EU

official languages and into the Norwegian and Icelandic languages, is to ensure the uniform

interpretation of those rules across the EEA, in light of the versions existing in all EEA

languages (see the judgment of 28 September 2012 in Irish Bank, E-18/11, paragraph 87).

85 As such, the wording used in one language version of an EEA provision cannot serve as

the sole basis for the interpretation of that provision, or be made to override the other

language versions in that regard. Such an approach would be incompatible with the

principle of homogeneity and the requirement of the uniform application of EEA law (see

the judgment in Irish Bank, E-18/11, cited above, paragraph 88).

86 Further, it follows from settled case law that in the case of divergence between the language

versions of a legal act, a provision must be interpreted by reference to the purpose and

general scheme of the rules of which it forms a part (see the judgment of 25 January 2024

in A Ltd, E-2/23, paragraph 42 and case law cited).

87 Article 7(7) of the Patients’ Rights Directive must therefore be interpreted in the context

of the other provisions of that directive. The Court notes at the outset that Article 7(7)

constitutes an exception to the general principle of reimbursement as laid down in Article

7(1). Since the freedom of movement for patients is one of the foundations of that directive,

any limitations to that freedom must be interpreted strictly (see, by analogy, the judgment

– 34 –

of 21 March 2024 in Criminal proceedings against LDL, E-5/23, paragraph 51 and case

law cited).

88 In this context, it is relevant to note that Article 7(9) of the Patients’ Rights Directive refers

to “overriding reasons of general interest, such as planning requirements …”. This suggests

that other overriding reasons must be assessed separately from planning requirements. A

justification under Article 7(7) therefore cannot be based on other overriding reasons of

general interest as stated in Article 7(9), since that provision rather concerns a limitation

of the application of the rules on reimbursement for cross-border healthcare, which is not

applicable to a situation such as that at issue in the main proceedings. The language of the

latter suggests that planning requirements, the sole available ground of justification under

Article 7(7), form part of a larger set of potential justification grounds available under

Article 7(9), and applicable solely in the context to which the latter pertains. This mitigates

in favour of an interpretation whereby planning requirements represent the sole available

ground of justification under Article 7(7).

89 This interpretation is further reinforced by case law under Article 36 EEA, which the

Patients’ Rights Directive aims to codify. While reasons of a purely economic nature

cannot constitute overriding reasons in the public interest justifying a restriction on a

fundamental freedom guaranteed by the Agreement (see the judgment of 16 November

2018 in Kristoffersen, E-8/17, paragraph 115 and case law cited), the Court has recognised

that the aim of ensuring sufficient and permanent access to a balanced range of high-quality

hospital treatment in the EEA State concerned, and the desire to control costs and prevent

wastage of financial, technical and human resources, are aims which may justify

restrictions on the free movement of hospital services. The objective of maintaining a

balanced medical and hospital service open to all is inextricably linked to the way in which

the social security system is financed and to the control of expenditure. Thus, the risk of

seriously undermining the financial balance of the social security system may also

constitute an overriding general-interest reason capable of justifying a restriction on the

free movement of services and patients in so far as it could have consequences for the

overall level of public-health protection (see the judgment in Rindal and Slinning, Joined

Cases E-11/07 and E-1/08, cited above, paragraph 55 and case law cited).

90 However, since assuming the costs of one isolated case of treatment, carried out in another

EEA State, can never make any significant impact on the financing of the social security

system in the home State, an overall approach must be adopted in relation to the

consequences of freedom to provide health-related services (see the judgment in Rindal

and Slinning, Joined Cases E-11/07 and E-1/08, cited above, paragraph 56 and case law

cited).

91 The relevant test for the justification of such measures, which is for the referring court to

perform, will, as noted by the Commission, broadly reflect that related to any of the

fundamental freedoms of EEA law. As such, it is for the EEA State concerned to

– 35 –

demonstrate, firstly, that the measure is justified on the grounds listed exhaustively in

Article 7(7) of the Patients’ Rights Directive and, secondly, that it observes the principle

of proportionality, which entails that it is suitable for securing, in a consistent and

systematic manner, the attainment of the objective pursued and does not go beyond what

is necessary in order to attain it.

92 Therefore, the answer to the first question referred must be that a national measure

imposing, for purposes of reimbursement of national and cross-border healthcare, a

requirement of specialisation of the practitioner delivering the healthcare is compatible

with Article 36 EEA and Article 7 of the Patients’ Rights Directive only if the conditions

to prove the required qualification of the practitioner delivering the healthcare are neither

discriminatory nor constitute an obstacle to the free movement of patients, unless they are

objectively justified by planning requirements relating to the object of ensuring sufficient

and permanent access to a balanced range of high-quality treatment in the EEA State

concerned or to the wish to control costs and avoid, as far as possible, any waste of

financial, technical and human resources.

93 The answer to the second question must be that, in order to establish whether the healthcare

practitioner in another EEA State has an equivalent specialisation or substantive

competence, a specialisation listed in Annex V to the Professional Qualifications Directive

may be deemed sufficient proof of substantive competence, but cannot be considered

necessary to prove substantive competence. Any assessment undertaken by an EEA State’s

authorities under Article 7(7) of the Patients’ Rights Directive to determine whether the

treating healthcare practitioner has equivalent competence to that required for

reimbursement purposes must not be limited to cases in which the speciality in question or

equivalent formal competence is not listed in Annex V.

94 The answer to the third question must be that the competent authorities in the State of

affiliation must also conduct an assessment in order to determine whether the treating

healthcare practitioner has equivalent competence to that required under national law, even

if the specialisation is included by the State of treatment in Annex V to the Professional

Qualifications Directive but is not possessed by the healthcare practitioner. The

administrative procedures connected with the equivalence assessment must not, however,

represent an unjustified additional burden for patients choosing to receive treatment in

another EEA State compared to patients seeking treatment in Norway.

IV COSTS

95 Since these proceedings are a step in the proceedings pending before the national court,

any decision on costs for the parties to those proceedings is a matter for that court. Costs

incurred in submitting observations to the Court, other than the costs of those parties, are

not recoverable.

– 36 –

On those grounds,

THE COURT

in answer to the questions referred to it by the National Insurance Court hereby gives the

following Advisory Opinion:

1. A national measure imposing, for purposes of reimbursement of national

and cross-border healthcare, a requirement of specialisation of the

practitioner delivering the healthcare is compatible with Article 36 EEA

and Article 7 of Directive 2011/24/EU of the European Parliament and of

the Council of 9 March 2011 on the application of patients’ rights in cross-

border healthcare only if the conditions to prove the required qualification

of the practitioner delivering the healthcare are neither discriminatory

nor constitute an obstacle to the free movement of patients, unless they are

objectively justified by planning requirements relating to the object of

ensuring sufficient and permanent access to a balanced range of high-

quality treatment in the EEA State concerned, or to the wish to control

costs and avoid, as far as possible, any waste of financial, technical and

human resources.

2. In order to establish whether the healthcare practitioner in another EEA

State has an equivalent specialisation or substantive competence, a

specialisation listed in Annex V to Directive 2005/36/EC of the European

Parliament and of the Council of 7 September 2005 on the recognition of

professional qualifications may be deemed sufficient proof of substantive

competence but cannot be considered necessary to prove substantive

competence. Any assessment undertaken by an EEA State’s authorities

under Article 7(7) of Directive 2011/24/EU to determine whether the

treating dental practitioner has equivalent competence to that required for

reimbursement purposes must not be limited to cases in which the

speciality in question or equivalent formal competence is not listed in

Annex V.

3. The competent authorities in the State of affiliation must also conduct an

assessment in order to determine whether the treating healthcare

practitioner has equivalent competence to that required under national

law, even if the specialisation is included by the State of treatment in

Annex V to Directive 2005/36/EC but is not possessed by the healthcare

practitioner. The administrative procedures connected with the

equivalence assessment must not, however, represent an unjustified

additional burden for patients choosing to receive treatment in another

EEA State compared to patients seeking treatment in Norway.

– 37 –

Páll Hreinsson Bernd Hammermann Michael Reiertsen

Delivered in open court in Luxembourg on 5 December2024.

Ólafur Jóhannes Einarsson Páll Hreinsson

Registrar President