Directives - Interpretation - Medicinal products
Fabio Caronna C-7/11: Court of Justice of the European Communities (Second Chamber): Judges Cunha Rodrigues (president of the chamber), Lõhmus (rapporteur), Rosas, Ó Caoimh, Arabadjiev: 28 June 2012
C, a pharmacist, was engaged in the wholesale distribution of medicinal products without obtaining the authorisation required under Italian law. Criminal proceedings were taken against him. Questions were referred by the court to the Court of Justice of the EU.
The questions were essentially: (i) whether article 77(2) of Council Directive (EC) 2001/83 (the directive) was to be construed as meaning that pharmacists were included among the class of persons who had to obtain authorisation for the wholesale distribution of medicinal products, or whether it was the legislature’s intention instead to exempt pharmacists from the requirement to apply for such authorisation; and (ii) what the correct interpretation to be given to the rules governing authorisation to distribute medicinal products laid down by articles 76 to 84 of the directive, with particular reference to the requirements to be met in order for a pharmacist (a natural person, not a company) who was already authorised to retail medicinal products under national law, also to be able to distribute such products by wholesale was. C submitted, inter alia, that the directive drew a distinction between pharmacists and persons authorised to supply medicinal products to the public.
The court ruled: (1) Article 77(2) of the directive meant that the requirement to obtain authorisation for the wholesale distribution of medicinal products was applicable to a pharmacist who, as a natural person, was also authorised under domestic law to operate as a wholesaler in medicinal products (see , ,  of the judgment).
To allow pharmacists to engage in activity as wholesale distributors in medicinal products without special authorisation would confer on them an unjustified competitive advantage vis-a-vis other persons authorised or entitled to supply medicinal products to the public, who were required, under article 77(2) of the directive, to apply for such authorisation (see  of the judgment).
(2) A pharmacist who was also authorised under domestic law to operate as a wholesaler in medicinal products had to satisfy all of the requirements imposed on applicants for and holders of authorisation for the wholesale distribution of medicinal products in articles 79 to 82 of the directive. That interpretation could not, of itself and independently of a law adopted by a member state, give rise to or aggravate liability in criminal law on the part of a pharmacist who had engaged in activity as a wholesale distributor in medicinal products without the requisite authorisation (see , ,  of the judgment).