Apothekerkammer des Saarlandes and Others (C-171/07) and Helga Neumann-Seiwert (C-172/07) v Saarland and Ministerium für Justiz, Gesundheit und Soziales.

• Jurisdiction: European Union
• Celex Number: 62007CJ0171
• ECLI: ECLI:EU:C:2009:316
• Date: 19 May 2009
• Court: Court of Justice (European Union)
• Procedure Type: Reference for a preliminary ruling
• Docket Number: C-171/07,C-172/07

Joined Cases C-171/07 and C-172/07

Apothekerkammer des Saarlandes and Others

v

Saarland and Ministerium für Justiz, Gesundheit und Soziales

(References for a preliminary ruling from the Verwaltungsgericht des Saarlandes)

(Freedom of establishment – Article 43 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)

Summary of the Judgment

Freedom of movement for persons – Freedom of establishment – Restrictions

(Arts 43 EC and 48 EC)

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)

JUDGMENT OF THE COURT (Grand Chamber)

19 May 2009 (*)

(Freedom of establishment – Article 43 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)

In Joined Cases C‑171/07 and C‑172/07,

REFERENCES for a preliminary ruling under Article 234 EC from the Verwaltungsgericht des Saarlandes (Germany), made by decisions of 20 March and 21 March 2007 respectively, received at the Court on 30 March 2007, in the proceedings

Apothekerkammer des Saarlandes,

Marion Schneider,

Michael Holzapfel,

Fritz Trennheuser,

Deutscher Apothekerverband eV (C-171/07),

Helga Neumann-Seiwert (C-172/07)

v

Saarland,

Ministerium für Justiz, Gesundheit und Soziales,

joined party:

DocMorris NV,

THE COURT (Grand Chamber),

composed of V. Skouris, President, P. Jann, C.W.A. Timmermans, K. Lenaerts, J.‑C. Bonichot and T. von Danwitz, Presidents of Chambers, J. Makarczyk, P. Kūris, E. Juhász, G. Arestis, J. Malenovský (Rapporteur), L. Bay Larsen and P. Lindh, Judges,

Advocate General: Y. Bot,

Registrar: M. Ferreira, Principal Administrator,

having regard to the written procedure and further to the hearing on 3 September 2008,

after considering the observations submitted on behalf of:

– the Apothekerkammer des Saarlandes, Ms Schneider, Mr Holzapfel, Mr Trennheuser and Deutscher Apothekerverband eV, by J. Schwarze, assisted by C. Dechamps, Rechtsanwalt,

– Ms Neumann-Seiwert, by H.-U. Dettling, Rechtsanwalt,

– Saarland and the Ministerium für Justiz, Gesundheit und Soziales, by W. Schild, acting as Agent, assisted by H. Kröninger, Rechtsanwalt,

– DocMorris NV, by C. König, assisted by F. Diekmann, Rechtsanwältin,

– the German Government, by M. Lumma and C. Schulze-Bar, acting as Agents,

– the Greek Government, by E. Skandalou, acting as Agent,

– the French Government, by G. de Bergues and B. Messmer, acting as Agents,

– Ireland, by D. O’Hagan, acting as Agent, assisted by A. Collins SC and N. Travers BL,

– the Italian Government, by I.M. Braguglia, acting as Agent, assisted by G. Fiengo, avvocato dello Stato,

– the Netherlands Government, by Y. de Vries, acting as Agent,

– the Austrian Government, by C. Pesendorfer and T. Kröll, acting as Agents,

– the Polish Government, by E. Ośniecka-Tamecka and M. Kapko, acting as Agents,

– the Finnish Government, by J. Himmanen and A. Guimaraes-Purokoski, acting as Agents,

– the Commission of the European Communities, by E. Traversa and H. Krämer, acting as Agents,

after hearing the Opinion of the Advocate General at the sitting on 16 December 2008,

gives the following

Judgment

1 These references for a preliminary ruling relate to the interpretation of Articles 43 EC and 48 EC and the principles of Community law.

2 The references were made in two actions, brought by the Apothekerkammer des Saarlandes (Saarland Pharmacists’ Association), Ms Schneider, Mr Holzapfel, Mr Trennheuser and Deutscher Apothekerverband eV (German Pharmacists’ Association) (C-171/07) and Ms Neumann-Seiwert (C-172/07) against Saarland and the Ministerium für Justiz, Gesundheit und Soziales (Ministry for Justice, Health and Social Affairs; ‘the Ministry’), concerning national legislation which allows only persons who have the status of pharmacist to own and operate pharmacies.

Legal context

Community legislation

3 Recital 26 in the preamble to 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) states:

‘This Directive does not coordinate all the conditions for access to activities in the field of pharmacy and the pursuit of these activities. In particular, the geographical distribution of pharmacies and the monopoly for dispensing medicines should remain a...