Case C-496/01

Commission of the European Communities

v

French Republic

(Failure of a Member State to fulfil obligations – France – Freedom to provide services – Right of establishment – Rules governing bio-medical analysis laboratories – Conditions for the grant of an administrative operating authorisation – Place of business in France)

Summary of the Judgment

1. Freedom of movement for persons – Freedom of establishment – Bio-medical analysis laboratories – Obligation to have a place of business on national territory – Whether permissible – Conditions

(Art. 43 EC)

2. Freedom to provide services – Restrictions – Bio-medical analysis laboratories – Obligation to have a place of business on national territory – Not permissible –Justification – None

(Art. 49 EC)

3. Freedom to provide services – Restrictions – Bio-medical analysis laboratories – Refusal to reimburse the analysis carried out by the laboratories established in other Member States – Not permissible – Justification – None

(Art. 49 EC)

1. A Member State does not fail to fulfil its obligations under Article 43 EC by imposing on bio-medical analysis laboratories the requirement that they have a place of business on national territory in order to obtain the requisite operating authorisation, if it is not shown how freedom of establishment might be affected; that would be the case, for instance, if a national of another Member State or a company formed in conformity with the law of one Member State and having its registered office, central administration or principal place of business in another Member State could not manage a laboratory in the Member State concerned as a branch or subsidiary of a laboratory which he or it also manages in another Member State, or if the legislation in question required a laboratory established in another Member State to transfer all of its activities to the Member State concerned so that the place of business in that State would no longer be a secondary establishment but would become the only place of business of the company in question.

(see paras 59, 61-63, 77, operative part)

2. A Member State fails to fulfil its obligations under Article 49 EC by imposing on bio-medical analysis laboratories established in other Member States the requirement that they have a place of business on national territory in order to obtain the requisite operating authorisation.

The aim of maintaining the quality of medical services may indeed justify a restriction on the freedom to provide services in the sector of bio-medical analysis laboratories in so far as it contributes to the attainment of a high level of health protection.

However the requirement to have a place of business on national territory goes beyond what is necessary to achieve that aim. Instead of requiring that bio-medical analysis laboratories have a place of business on national territory and thus precluding any cross-border provision of services, the Member State concerned may require that, in order to provide services to persons residing in that Member State, should they wish to do so, laboratories which have their place of business in another Member State comply, in accordance with the national rules, with the requirement to obtain authorisation, provided, however, that the conditions to be satisfied in order to obtain such authorisation do not duplicate the equivalent statutory conditions which have already been satisfied in the State of establishment.

(see paras 66, 69-71, 77, operative part)

3. A Member State fails to fulfil its obligations under Article 49 EC by precluding any reimbursement of the costs of bio-medical analyses carried out by a bio-medical analysis laboratory established in another Member State.

A restriction of the freedom to provide services may, in principle, be justified in so far as they are designed to contribute to ensuring a high level of public health protection. However the refusal by sickness insurance funds to reimburse the costs of analyses carried out by laboratories with their place of business in another Member State goes beyond what is objectively necessary for that purpose.

In the absence of harmonisation measures, Community law does not preclude the Member State from imposing, in the context of an authorisation scheme, its level of public health protection on bio-medical analysis laboratories established in another Member State which wish to offer services to members of one of the national sickness insurance schemes.

(see paras 91-93, 95, operative part)

JUDGMENT OF THE COURT (Sixth Chamber) 11 March 2004 (1)

(Failure of a Member State to fulfil its obligations – France – Freedom to provide services – Right of establishment – Rules governing bio-medical analysis laboratories – Conditions for the grant of an administrative operating authorisation – Place of business in France)

In Case C-496/01,

applicant,

v

defendant,

APPLICATION for a declaration that,

the French Republic has failed to fulfil its obligations under Articles 43 EC and 49 EC,

THE COURT (Sixth Chamber),,

composed of: V. Skouris, acting for the President of the Sixth Chamber, C. Gulmann, J.-P. Puissochet, R. Schintgen and N. Colneric (Rapporteur), Judges,

Advocate General: J. Mischo,

after hearing the Opinion of the Advocate General at the sitting on 26 June 2003,

gives the following

the French Republic has failed to fulfil its obligations under Articles 43 EC and 49 EC.

‘No bio-medical analysis laboratory may operate without administrative authorisation.

Without prejudice to the provisions of Article L. 6122‑1 on heavy equipment, authorisation shall be granted where the conditions laid down in this Book and in the decree provided for in Article L. 6211‑9 and determining the number and qualifications of technical staff and the standards applicable to laboratory fittings and equipment are satisfied.

That decree may lay down specific conditions applicable to laboratories whose activities are confined to certain procedures specified in that decree. The authorisation granted to those laboratories shall state that the activities covered are limited.

…

Authorisation shall be withdrawn where the requirements laid down by law or regulation are no longer satisfied.’

‘The application for authorisation provided for in Article L. 757 [now Article L. 6211‑2] of the Code de la santé publique shall be sent by registered letter to the Prefect of the

The application shall state the operating conditions and the volume of activity envisaged during the first year and be accompanied by supporting documents, including, in particular:

a description and plan of the premises;

a complete list of equipment;

a list of the directors, deputy directors and technicians, including their qualifications and diplomas;

where appropriate, the company statutes.

…

The applicant shall, where appropriate, specify the category or categories of analysis in respect of which authorisation is sought.’

‘Without prejudice to the provisions of the final paragraph of Article L. 757 (now Article L. 6211‑2) of the Code de la santé publique and those of Article 9 of the abovementioned Decree of 15 February 1983, authorisation may be withdrawn by the Prefect where he has established, following an inspection by a public health inspector who is a doctor or pharmacist, that the laboratory is operating under conditions which represent a danger to public health.

A decision to withdraw authorisation may be adopted only after the person responsible for the laboratory has been given formal notice to submit, within one month, his observations on the facts apt to justify that decision.

In an emergency, the Prefect may suspend authorisation for a period of not more than one month without any preliminary procedure.

A decision to withdraw or suspend authorisation shall be notified by registered letter.’

‘Where the results of the quality control of a laboratory show repeated or significant anomalies as regards their medical use, the case of that laboratory shall be submitted anonymously to the Commission du contrôle de qualité (Quality Assurance Commission), which shall make a determination on the serious nature of those anomalies. Where they are deemed to be serious, the laboratory shall be reported by the Director‑General of the Agence du médicament (Medicinal Products Agency) to the Minister responsible for health, to whom the Director-General shall communicate the results for the purposes of a control pursuant to Article L. 761‑13 [now Article L. 6213‑1] of the Code de la santé publique designed, in particular, to ascertain the measures taken by the laboratory to improve the quality of its analyses.’

‘As regards laboratory analyses and examinations, insured persons may, for each category of analysis, choose freely between approved laboratories, irrespective of the status of the operator. The conditions for approval shall be laid down in an inter-ministerial decree.’

‘exceptionally, and subject to a favourable opinion from the medical supervisory body, sickness insurance funds may reimburse, at a flat rate, the cost of treatment provided outside France to an insured person or his dependants, where the person concerned establishes that he was unable to receive the treatment appropriate to his condition in France.’

(a)

(b)

Arguments of the parties

Findings of the Court

Arguments of the parties

Findings of the Court

On those grounds,

THE COURT (Sixth Chamber)

hereby:

Skouris

Gulmann

Puissochet

Schintgen

Colneric

Delivered in open court in Luxembourg on 11 March 2004.

R. Grass

V. Skouris

Registrar

President