LEGISLATION/REIMBURSEMENT

Berlin  -  EU member states are free to control the establishment of new pharmacies by demographic and geographic restrictions provided that those rules are not discriminatory and that they do not prevent, in areas with special demographic characteristics, the setting up of a sufficient number of pharmacies to ensure adequate pharmaceutical services. According to the European Court of Justice (ECJ), the limits set by Spanish legislation for the opening of new pharmacies are not compatible with EU law.

In Spain, national legislation makes the setting up of a new pharmacy conditional upon prior administrative authorisation. That legislation is implemented by the Autonomous Communities, which set specific criteria for the licensing of new pharmacies. In Asturia, pharmacies may only be opened if they serve more than 2,800 inhabitants and are not located within 250 metres of an existing pharmacy. Lastly, the decree also sets out criteria for making a selection from among pharmacists competing for a licence, with points awarded on the basis of their professional and teaching experience.

According to the ECJ, the Asturian decree is not only justifying and does not go beyond what is necessary, but also is appropriate: The Court considers that, if that field were wholly unregulated, it is not inconceivable that pharmacists would become concentrated in the areas considered to be attractive, so that certain other, less attractive areas would suffer from a shortfall in the number of pharmacists needed to ensure a pharmaceutical service which is reliable and of good quality.

Nevertheless, the EU judges observe that the uniform application of the rules might well be unsuccessful in ensuring adequate access to pharmaceutical services in areas which have certain special demographic features. However, according to the ECJ it is for the referring court to determine whether, in any geographical area with special demographic characteristics, the competent authorities make use of the power conferred by the national legislation.

Not compatible with EU law is only one part of the Spanish legislation: Since under the Asturian decree, pharmacists with professional experience obtained within the Autonomous Community of Asturias are preferred, pharmacists from outside Spain could be disadvantaged. The Court concludes, therefore, that those selection criteria are discriminatory and hence precluded by the freedom of establishment.

PHARMA ADHOC, Tue, June 01, 2010 12:30pm CET