Commission of the European Communities v Italian Republic.

• Jurisdiction: European Union
• Celex Number: 62006CJ0531
• ECLI: ECLI:EU:C:2009:315
• Court: Court of Justice (European Union)
• Date: 19 May 2009
• Procedure Type: Recours en constatation de manquement - non fondé
• Docket Number: C-531/06

Case C-531/06

Commission of the European Communities

v

Italian Republic

(Failure of a Member State to fulfil obligations – Freedom of establishment – Free movement of capital – Articles 43 EC and 56 EC – Public health – Pharmacies – Provisions restricting the right to operate a pharmacy to pharmacists alone – Justification – Reliability and quality of the provision of medicinal products to the public – Professional independence of pharmacists – Undertakings engaged in the distribution of pharmaceutical products – Municipal pharmacies)

Summary of the Judgment

1. Actions for failure to fulfil obligations – Right of the Commission to bring proceedings – Exercise of that right not dependent on a specific interest in bringing an action – Exercise at its discretion

(Art. 226 EC)

2. Freedom of movement for persons – Freedom of establishment – Free movement of capital – Restrictions

(Arts 43 EC and 56 EC)

3. Actions for failure to fulfil obligations – Examination of the merits by the Court – Situation to be taken into consideration – Situation on expiry of the period laid down in the reasoned opinion

(Art. 226 EC)

4. Freedom of movement for persons – Freedom of establishment – Free movement of capital – Restrictions

(Arts 43 EC and 56 EC)

1. It is for the Commission, in performing the task conferred upon it by Article 211 EC, to ensure that the provisions of the Treaty are applied and verify whether the Member States have acted in accordance with those provisions. If the Commission considers that a Member State has infringed provisions of the Treaty, it is for it to determine whether it is expedient to take action against that State and what provisions the State has infringed, and to choose the time at which it will initiate infringement proceedings; the considerations which determine its choice of time cannot affect the admissibility of its action. Given this discretion, the Commission is free to initiate infringement proceedings against only some of the Member States which are in a comparable position from the point of view of compliance with Community law. It may thus, in particular, decide to initiate infringement proceedings against other Member States subsequently, after becoming aware of the outcome of the earlier proceedings.

(see paras 23-24)

2. A Member State does not fail to fulfil its obligations under Articles 43 EC and 56 EC by keeping in force legislation which restricts the right to operate a private retail pharmacy to natural persons who have graduated in pharmacy and to operating companies and firms composed exclusively of members who are pharmacists.

It is true that such national legislation constitutes a restriction within the meaning of those articles because, so far as concerns Article 43 EC, it denies other economic operators access to this self-employed activity in the Member State concerned and, as regards Article 56 EC, it prevents investors from other Member States who are not pharmacists from acquiring stakes in companies and firms operating pharmacies.

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 freedoms guaranteed by Articles 43 EC and 56 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 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 44-48, 51-52, 55-59, 61-63, 87-88, 105)

3. The question whether a Member State has failed to fulfil its obligations must be determined by reference to the situation prevailing in the Member State at the end of the period laid down in the reasoned opinion and the Court cannot take account of any subsequent changes.

(see para. 98)

4. A Member State does not fail to fulfil its obligations under Articles 43 EC and 56 EC by keeping in force legislative provisions which make it impossible for undertakings engaged in the distribution of pharmaceutical products to acquire stakes in companies which operate municipal pharmacies.

It is true that such legislation results in restrictions within the meaning of Articles 43 EC and 56 EC since it prevents certain economic operators, namely those who are engaged in the distribution of pharmaceutical products, from concomitantly engaging in activity in municipal pharmacies. Also, such legislation prevents investors from other Member States which are undertakings engaged in the distribution of pharmaceutical products from acquiring stakes in certain companies, namely those entrusted with the operation of municipal pharmacies.

However, the 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.

That legislation is appropriate for securing attainment of that objective and, moreover, does not go beyond what is necessary for attaining it given that a Member State may take the view that undertakings engaged in the distribution of pharmaceutical products are capable of exerting a certain amount of pressure on employed pharmacists with the objective of favouring the interest of making a profit. Furthermore, the Member State concerned may take the view, in the exercise of its discretion, that the municipalities’ supervisory powers over companies entrusted with the management of municipal pharmacies are not sufficient to prevent the influence of distribution undertakings over employed pharmacists.

(see paras 100-103, 105)

JUDGMENT OF THE COURT (Grand Chamber)

19 May 2009 (*)

(Failure of a Member State to fulfil obligations – Freedom of establishment – Free movement of capital – Articles 43 EC and 56 EC – Public health – Pharmacies – Provisions restricting the right to operate a pharmacy to pharmacists alone – Justification – Reliability and quality of the provision of medicinal products to the public – Professional independence of pharmacists – Undertakings engaged in the distribution of pharmaceutical products – Municipal pharmacies)

In Case C‑531/06,

ACTION under Article 226 EC for failure to fulfil obligations, brought on 22 December 2006,

Commission of the European Communities, represented by E. Traversa and H...