On 28 June 2012 the European Court of Justice (ECJ) released an opinion, in response to a referral from the Court of Palermo, in relation to the requirements for pharmacists to hold specific authorisations for wholesale dealing of medicinal products under European Community Directive 2001/83/EC (Case C-7/11).
Under Italian law, pharmacists are not allowed to act as wholesalers unless they obtain a specific licence from the Italian authorities. After investigation by the Italian national police, several pharmacists were charged with breaking the law by acting as wholesalers without having first obtained the necessary licences.
While most of the cases were discontinued at the request of the prosecutors, the Criminal Court of Palermo sought the opinion of the Italian authorities as to whether the Italian implementation of the Directive required pharmacists to obtain a specific authorisation (above and beyond their pharmacy licenses) to engage in wholesale trade. When the authorities replied in the affirmative, the Court issued a referral to the ECJ, which sought the ECJ's guidance as to (1) whether the requirements of the Directive concerning wholesalers are intended to be applied to pharmacists; and (2) if pharmacists are permitted by national law to act as wholesalers without obtaining further specific authorisation, whether they are nonetheless required to satisfy all the requirements of the Directive that apply with respect to wholesalers.
With regards to question (1), the ECJ replied that, despite some inconsistencies in its wording (and particularly the use in some instances to "persons authorised or entitled to supply medicinal products to the public" and in others "pharmacists"), the Directive clearly applied to pharmacists acting as wholesalers, even though the retail supply of medicine is not harmonised at the Community level.
With regard to question (2), the ECJ replied that the Directive has harmonised the wholesale supply of medicines at the Community level and so requires that, even where national legislation would automatically grant permission to pharmacists to operate as wholesalers, the pharmacist-wholesaler must nevertheless comply with the all of the obligations placed on wholesalers under the Directive, including those concerning (for example) premises, equipment and staff.
The ECJ went on to note that its interpretation of the Directive could not be an independent basis for criminal liability in the Palermo proceedings because such liability can only flow from domestic laws, whether or not those laws comply with the requirements of European Union law.