NEVER PRESUME WHEN TREATING PATIENTS

A new ruling from the EU's highest court should remind ophthalmic surgeons to think twice before they presume they can legally operate every aspect of their clinics just because they are authorised to treat patients. In the case, the European Court of Justice found that an Italian pharmacist could not rely on his authorisation as a retail pharmacist to sell drugs to the public to carry on business as a wholesale pharmacist. Under the 2001 EU Directive on the Community Code Relating to Medicinal Products for Human Use, a pharmacist who already holds a license to sell pharmaceutical products to the public must also possess an additional special licence to operate as a wholesale distributor of medicinal products. Under the Directive, which was transposed into Italian domestic law in 2006, the wholesale distribution of medicinal products is subject to the requirement to hold an authorisation granted by the region or the autonomous province. Any person in breach of the national legislation is liable to punishment in the form of imprisonment for a term of six months to one year and a fine of up to €100,000. Against that background, certain pharmacists in Italy were reported for engaging in activity as wholesale distributors in medicinal products without proper authorisation.

In criminal proceedings brought against a Sicilian pharmacist, Fabio Caronna, the District Court in Palermo requested the Court of Justice to decide, as a preliminary matter: 1. Does the requirement laid down in the directive to obtain authorisation for the wholesale distribution of medicinal products apply to pharmacists who, as natural persons, are already authorised under national law to supply such products to the public? If the answer to question 1 was 'yes', then the Italian court asked the Court of Justice to consider a second question: 2. To qualify as a wholesale pharmacist, must a pharmacist who is already authorised as a retail pharmacists satisfy all the requirements imposed for wholesale distribution or is it sufficient for the retail pharmacist only to fulfil the conditions laid down by domestic law for retail supply?

In his defence, which interestingly was accepted by Italian prosecutors who recommended that charges against Mr Caronna be dropped, Mr Caronna argued that the wording of the EU Directive allowed him to presume that he, as a retail pharmacist, was not subject to the extra requirement for a special wholesale licence. Mr Caronna’s lawyers submitted that the directive requirement that “any person involved in the wholesale distribution of medicinal products should be in possession of a special authorisation†did not apply to him as a pharmacist who was already in possession of a retail authorisation. The Court of Justice rejected that argument, saying that a retail pharmacist was clearly “any person†and that if Mr Caronna’s lawyers arguments were accepted, there would be no legal distinction between wholesale pharmacists and retail pharmacists. And that distinction was central to the provisions of the Directive. In fact, the court noted that on its reading of the Directive, the only pharmacists who did not require a separate authorisation for wholesale distribution were those pharmacists who confined their practice to retail pharmacy. The Court of Justice added that there was also an economic issue to consider, finding that “to allow pharmacists to engage in activity as wholesale distributors in medicinal products without special authorisation would confer on them an unjustified competitive advantageâ€.

On that basis, “the Directive must be interpreted as meaning that the requirement to obtain authorisation for the wholesale distribution of medicinal products is applicable to a pharmacist who, as a natural person, is also authorised under domestic law to operate as a wholesaler in medicinal products,†the court concluded in answer to Question 1.

Satisfy requirements

In considering Question 2 about the need for the retail pharmacist to satisfy all of the requirements imposed on wholesale pharmacists, the court noted that the EU Directive includes special provisions for the authorisation of wholesalers of medicinal products, which include requirements for suitable premises, installations and equipment, documentation and qualified staff to ensure that drugs are properly stored and distributed. “Given that the retail of medicinal products has different characteristics from the wholesale distribution of such products, it cannot be presumed from the simple fact that pharmacists satisfy the conditions governing retail supply in their respective Member States that they also satisfy the conditions laid down by harmonised rules at European Union level for wholesale distribution,†the court held. “Accordingly, in order to ensure that the Directive’s objectives are achieved, in particular those relating to the protection of public health, the removal of barriers to trade in medicinal products within the European Union and the need to exercise control over the entire chain of distribution of medicinal products, referred to in recitals 2 to 5 and 35 in the preamble to the Directive, the minimum requirements for the wholesale distribution of medicinal products must be fulfilled in a uniform and effective manner by all persons who engage in that activity in all Member States.†“Consequently, the answer to Question 2 is that a pharmacist who is also authorised under domestic law to operate as a wholesaler in medicinal products must satisfy all the requirements imposed on applicants for and holders of authorisation for the wholesale distribution of medicinal products.â€Â