Keywords

Summary



Keywords

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)

Summary

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)