Brussels, 05/12/2013 (Agence Europe) - In a ruling issued on Thursday 5 December in combined cases C-159/12 and C-161/12, the European Court of Justice says that the prohibition in Italian law on the sale in para-pharmacies of prescription-only medicinal products is compatible with EU law. It says the prohibition is justified by the objective of ensuring that the supply to the public is reliable and of good quality.
The Regional Administrative Court of Lombardy in Italy is dealing with a case in which three registered pharmacists who are members of the Italian Order of Pharmacists complain because local health agencies (ASL) and the Italian health ministry have refused to allow them to sell prescription-only medicine in their para-pharmacies on the grounds that, under Italian law, such medicine must be sold by pharmacies. The pharmacists say that the ban runs counter to EU law. The Italian court asked the Court of Justice to clarify whether the Italian rules are compatible with the treaty on the functioning of the EU. Under the Italian law, a pharmacist who is qualified and registered with the professional body but does not own a pharmacy in the Italian government's “grid” under which pharmacies are distributed throughout the country is not allowed to sell, in the para-pharmacy owned by that pharmacist, prescription-only medicinal products the cost of which is borne not by the national health service but wholly by the purchaser.
In the ruling, the Court of Justice says that the Italian legislation constitutes a restriction on the freedom of establishment, since it is liable to hinder or render less attractive the establishment on Italian territory of a pharmacist who is a national of another member state and has the intention of operating a para-pharmacy there. Nevertheless, it may be justified by overriding reasons in the public interest because “the Italian legislation pursues the objective, which falls within a more general objective of protecting public health, of ensuring that the supply to the public of medicinal products is reliable and of good quality”.
In this connection, the Court points out that planning rules may be indispensable for filling possible gaps in access to public health services and for avoiding the duplication of structures, so as to ensure the provision of public health care which is adapted to the needs of the population, covers the entire territory, and takes account of geographically isolated or otherwise disadvantaged regions. If the sale of some prescription-only medicinal products were to be allowed in para-pharmacies, that would amount to those medicines being sold without being subject to the requirements of territorial planning, with the risk of causing a concentration of para-pharmacies in areas deemed to be the most profitable and bringing about, in those areas, a reduction in the number of customers and a loss of income for pharmacies. This situation might then bring about a lower quality of service provided by pharmacies to the public and also result in the definitive closure of some of them: a shortage of pharmacies in some parts of Italy could cause the supply of medicinal products to be unreliable and not of good quality. The court adds that the geographical distribution of pharmacies and the monopoly for dispensing medicinal products remains a matter for the member states to decide. (FG/transl.fl)