Keywords

Summary



Keywords

1. Freedom of establishment – Restrictions – National legislation requiring prior administrative authorisation for the opening of new pharmacies in a particular region

(Art. 49 TFEU)

2. Freedom of establishment – Restrictions – National legislation requiring prior administrative authorisation for the opening of new pharmacies in a particular region

(Art. 49 TFEU; Council Directive 85/432, Art. 1(1) and (2); European Parliament and Council Directive 2005/36, Art. 45(2)(e) and (g))

Summary

1. Article 49 TFEU must be interpreted as not precluding, in principle, national legislation that imposes restrictions on the issue of licences for the opening of new pharmacies, by providing that:

– in each pharmaceutical area, a single pharmacy may be opened, as a general rule, for every 2 800 inhabitants;

– a supplementary pharmacy may not be opened until that threshold has been exceeded, that pharmacy being established for the fraction above 2 000 inhabitants; and

– each pharmacy must be a minimum distance away from existing pharmacies, that distance being, as a general rule, 250 metres.

Nevertheless, Article 49 TFEU precludes such national legislation in so far as the strict application of the basic ‘2 800 inhabitants’ and ‘250 metres’ rules prevent, in any geographical area that has special demographic features, the establishment of a sufficient number of pharmacies to ensure adequate pharmaceutical services, that being a matter for the national court to ascertain.

A Member State might consider it likely that some parts of its territory will be left with too few pharmacies and that, as a consequence, the provision of medicinal products might well not be reliable and of good quality and, accordingly, in view of that likelihood, may adopt legislation under which only one pharmacy may be set up in relation to a certain number of inhabitants, so as to result in the even distribution of pharmacies throughout the national territory. In order to determine whether the national legislation in question pursues, consistently and systematically, the objective of ensuring the reliable, high-quality provision of medical products to the public, it is for the referring court to ascertain whether the competent authorities make use of the adjustment measures provided for by that legislation that make it possible (1) to mitigate the consequences of applying the basic rule of 2 800 inhabitants, (2) to authorise, depending on the concentration of the population, a shorter distance between pharmacies, and thereby increase the number of pharmacies available in areas with a very high population density, and (3) to interpret the general rule as meaning that a licence may be granted for opening a new pharmacy within a distance of less than 250 metres, not only in highly exceptional cases, but whenever the strict application of the general 250 metre rule would jeopardise adequate access to pharmaceutical services in certain geographical areas with a high population density.

Moreover, since, in the light of the discretion enjoyed by the Member States in relation to the protection of public health, a Member State may consider that the ‘minimum number’ system, setting a minimum number of pharmacies for specified geographical areas, does not, as efficiently as the current system, make it possible to attain the objective of securing a reliable, high-quality provision of medical products in unattractive areas, it cannot be held that the legislation at issue in the cases before the referring court goes beyond what is necessary to attain the objective pursued.

(see paras 75-76, 78, 84, 95, 98, 100-102, 105-106, 112-113, operative part 1)

2. Article 49 TFEU, read in conjunction with Article 1(1) and (2) of Directive 85/432 concerning the coordination of provisions laid down by law, regulation or administrative action in respect of certain activities in the field of pharmacy, and Article 45(2)(e) and (g) of Directive 2005/36 on the recognition of professional qualifications must be interpreted as precluding criteria provided for under national legislation, by which the licensees of new pharmacies are selected, that have the effect, first, of increasing by 20% in points for professional qualifications for experience within a particular area of national territory and, second, when several applicants score an equal number of points on the scale, of the grant of licences being made according to an order giving priority to pharmacists who have pursued their professional activity in that area of national territory.

It is of course easier for pharmacists who are nationals of that Member State, who most often pursue their economic activities in national territory, to satisfy those criteria, than it is for pharmacists who are nationals of other Member States, who more frequently pursue those activities in another Member State.

(see paras 21, 122-125, operative part 2)