Pharmacies of your choice?

EU law does not stop national governments from allowing certain restrictions on the operation of pharmacies. According to a judgement of the European Court of Justice in May this year, member states may, for instance, prevent persons who are not qualified pharmacists from owning and operating pharmacies.

A Dutch company, DocMorris MV, which sells medicinal products by mail order, wanted to open a branch in Saarbrucken in Germany. The German authorities agreed to grant it a licence on condition that the pharmacy would be managed by a qualified pharmacist personally and on his own responsibility.

However, the Chamber of Pharmacists objected to this decision saying such condition was not sufficient since, according to German law, only pharmacists could own and operate a pharmacy. They argued that this law was not satisfied merely by recruiting a pharmacist because the pharmacist also had to own and operate the pharmacy.

They therefore took the matter to court in order to reverse the decision of the German authorities to grant the licence. The question before the court was whether national law could restrict the ownership and operation of pharmacies limitedly to pharmacists.

This is a very interesting question even for our purposes because in Malta the number of pharmacies is also restricted, albeit for different reasons (notably geographical delimitations).

The European Court found that the restriction to limit the ownership and operation of pharmacies to pharmacists was justified. The reasoning of the court was the following:

Firstly, the court noted that EU law does not touch the power of national governments to organise their national health care systems, including with respect to pharmacies. Indeed, in the case of recognition of professional qualifications, EU law makes it clear that the geographical distribution of pharmacies and the monopoly for dispensing medicines should remain a matter for the member states and that EU law leaves unchanged national rules forbidding companies from pursuing certain pharmacists' activities or subjecting them to certain conditions.

Secondly, the court established that limiting the ownership and operation of pharmacies to pharmacists, constitutes a restriction to the EU principle of freedom of establishment. Nevertheless, the court moved on to establish whether this restriction was justified or not on grounds of public interest. In the event, it found that the restriction was indeed justified.

Thirdly, in addressing whether this restriction was justified or not, the court noted that, when it comes to human health, EU countries should be allowed discretion to establish what risks they consider to be acceptable and what risks are not. Where there is uncertainty on the existence or extent of risks to human health, national governments should be able to take protective measures and have the last say on the matter.

Fourthly, the court considered that the very particular nature of medicinal products distinguished them from other products because of their therapeutic effects, which call for special consideration that would not normally be allowed in the case of other products. These therapeutic effects are such that, if medicinals are consumed unnecessarily or incorrectly, then they may cause serious harm to health, without the patient being in a position to realise as much when they are administered.

Fifthly, the court also noted that, unlike pharmacists, non-pharmacists do not have the same training, experience and responsibility that balance the pursuit of profit with the need to safeguard consumers. Accordingly, they cannot provide the same safeguards to consumers and therefore, the operation of a pharmacy by a non-pharmacist may represent a risk to public health.

In the light of these risks, member states may make persons entrusted with the retail supply of medicinal products subject to strict requirements, such as by restricting the retail sale of such products to pharmacists alone because of the safeguards that pharmacists must provide and the information that they must be in a position to furnish to consumers. For these reasons, the court held that restricting the ownership and operation of pharmacies to pharmacists is a justified restriction for the purposes of securing that the provision of medicinal products to the public is reliable and of good quality and that, therefore, public health is protected.

This is an important judgement because all types of restrictions to trade and business are usually frowned upon by EU law. In Malta too, very few types of businesses remain protected by restrictions, such as the numerus clausus. This judgement confirms that, in certain exceptional cases, as in the case of pharmacies, restrictions may indeed be justified.

(This article refers to joined cases C-171/07 and C-172/07 of the European Court of Justice decided on May 19, 2009.)

Readers who would like to ask questions to be answered in this column can send an e-mail, identifying themselves, to: contact@simonbusuttil.eu or through www.simonbusuttil.eu.

Dr Busuttil is a Nationalist member of the European Parliament.