Keywords

Summary



Keywords

Freedom of movement for persons – Freedom of establishment – Restrictions

(Arts 43 EC and 48 EC)

Summary

Articles 43 EC and 48 EC do not preclude national legislation which prevents persons not having the status of pharmacist from owning and operating pharmacies.

It is true that such a rule excluding non-pharmacists constitutes a restriction within the meaning of Article 43 EC because it allows only pharmacists to operate pharmacies, denying other economic operators access to this self-employed activity in the Member State concerned. However, that restriction may be justified by the protection of public health, more specifically by the objective of ensuring that the provision of medicinal products to the public is reliable and of good quality.

In that regard, the therapeutic effects of medicinal products, which distinguish them substantially from other goods, have the consequence that, if they are consumed unnecessarily or incorrectly, they may cause serious harm to health, without the patient being in a position to realise that when they are administered. Overconsumption or incorrect use of medicinal products leads, moreover, to a waste of financial resources which is all the more damaging because the pharmaceutical sector generates considerable costs and must satisfy increasing needs, while the financial resources which may be made available for healthcare are not unlimited, whatever the mode of funding applied. There is thus a direct link between those financial resources and the profits of businesses operating in the pharmaceutical sector because in most Member States the prescription of medicinal products is borne financially by the health insurance bodies concerned.

In the light of those risks to public health and to the financial balance of social security systems, the Member States may make persons entrusted with the retail supply of medicinal products subject to strict requirements, including as regards the way in which the products are marketed and the pursuit of profit. In particular, the Member States may restrict the retail sale of medicinal products, in principle, to pharmacists alone, because of the safeguards which pharmacists must provide and the information which they must be in a position to furnish to consumers.

In this connection, given the power accorded to the Member States to determine the level of protection of public health, Member States may require that medicinal products be supplied by pharmacists enjoying genuine professional independence. They may also take measures which are capable of eliminating or reducing a risk that that independence will be prejudiced because such prejudice would be liable to affect the degree to which the provision of medicinal products to the public is reliable and of good quality.

Since non-pharmacists by definition lack training, experience and responsibility equivalent to those of pharmacists and consequently do not provide the same safeguards as pharmacists, it follows that a Member State may take the view, in the exercise of its discretion, that, unlike the case of a pharmacy operated by a pharmacist, the operation of a pharmacy by a non-pharmacist may represent a risk to public health, in particular to the reliability and quality of the supply of medicinal products at retail level, because the pursuit of profit in the course of such operation does not involve moderating factors, such as training, professional experience and the responsibility that pharmacists owe, which characterise the activity of pharmacists.

As it has not been established that another measure that restricts the freedom guaranteed by Article 43 EC less than the rule excluding non-pharmacists would make it possible to ensure just as effectively the level of reliability and quality in the provision of medicinal products to the public that results from the application of that rule, the national legislation at issue in the main actions proves appropriate for securing attainment of the objective pursued by it and does not go beyond what is necessary for attaining that objective.

In particular, a Member State may take the view that there is a risk that legislative rules protecting the professional independence of pharmacists will not be observed or will be circumvented in practice. Nor can the risks to the reliability and quality of the provision of medicinal products to the public be excluded with the same effectiveness by an obligation to take out insurance, because such a means would not necessarily prevent the operator concerned from exerting influence over the employed pharmacists.

(see paras 24, 27-28, 31-35, 37-39, 54, 57-58, operative part)