For pharmacists only

The ownership and operation of pharmacies can be restricted to pharmacists only, the European Court of Justice has recently confirmed. National regulations which impede non-pharmacists from owning and operating pharmacies are not in breach of EU internal market principles.

This ruling was given by the European Court of Justice in the course of two different proceedings. The European Commission itself filed proceedings requesting the Court to declare that Italian legislation which permitted only pharmacists to own and operate private pharmacies was in breach of EU law and in particular of the fundamental freedom of establishment and of free movement of capital as entrenched in the EC Treaty.

Italian law strictly prohibited even undertakings engaged in the distribution of pharmaceutical products from having a stake in municipal pharmacies.

A German court also made a preliminary reference requesting guidance from the European Court of Justice as to whether German rules which similarly stipulate that only pharmacists may own and operate a pharmacy breach EU law. The European Court of Justice affirmed that, as a general rule, such national laws as the ones at issue do constitute a restriction of the freedom of establishment and the free movement of capital. However, such a restriction may be justified by the objective of ensuring that the provision of medicinal products to the public is reliable and of good quality. Indeed, such rules were seen by the court as a protective measure which member states are entitled to take in order reduce public-health risks. Medicines are to be distinguished from other products, the court insisted, because of the risks to health that are involved if they are consumed unnecessarily or incorrectly. It is up to the member states themselves to determine the level of protection of public health that is necessary. Member states are free to enact rules which ensure that medicinal products are solely supplied by pharmacists enjoying genuine professional independence.

The court acknowledged that a pharmacist, like other traders, pursues the objective of making a profit. However, a pharmacist is also presumed to operate the pharmacy not only with a purely economic objective but also from a professional viewpoint.

Indeed, the profit-making objective ought to be intimately intertwined with the full use of his training and professional experience and with the responsibility which he owes to the public. Any breach of the rules of law or professional conduct undermines not only the value of his investment but also his own professional existence.

The European Court of Justice also noted that national rules which impede non-pharmacists from operating and owning pharmacies were not unduly restrictive since pharmacists, when employees and not self-employed, could find it difficult to oppose instructions given by the non-pharmacist employer.

This ruling goes to prove that though the fundamental freedoms as entrenched in the EC Treaty are the cornerstones of the EU's internal market, the European Court of Justice is prepared, in exceptional cases, to take cognisance of justifications even though such justifications could serve as a limitation on EU citizens' rights as emanating from the Treaty.

Dr Vella Cardona is a practising lawyer and a freelance consultant in EU, intellectual property, consumer protection and competition law. She is also a visiting lecturer at the University of Malta.

mariosa@vellacardona.com