ECJ rules on authorisation for wholesale distribution
By Sophie Petitjean | Thursday 28 June 2012
A pharmacist who is also authorised under national law to operate as a wholesaler in medicinal products must obtain authorisation for wholesale distribution under EU law. In a 28 June ruling, the Court of Justice of the EU considers, however, that this interpretation of EU law cannot have the effect of determining or aggravating the liability in criminal law of a pharmacist who does not have said authorisation.
In this case (C-7/11), the Tribunale di Palermo (District Court, Palermo) asks the Court of Justice how to interpret Directive 2001/83/EC on the Community code relating to medicinal products for human use as amended by Directive 2002/98/EC of the European Parliament and of the Council of 27 January 2003 setting standards of quality and safety for the collection, testing, processing, storage and distribution of human blood and blood components and amending Directive 2009/120/EC. This legal text provides that the member states should make the wholesale distribution of medicinal products subject to possession of a special authorisation, even when national law authorises the persons authorised or entitled to supply medicinal products to the public to also engage in wholesale business. The court’s answer should help the Italian jurisdiction on how to treat several pharmacists in Italy who were reported for engaging in activity as wholesale distributors in medicinal products without authorisation.
In its ruling, the court says, firstly, that the obligation to hold a specific authorisation also applies to said pharmacists. The court adds that since the retail of medicinal products has different characteristics from wholesale distribution, it cannot be presumed from the simple fact that pharmacists satisfy the conditions laid down by the member states for retail supply that they also comply with the conditions laid down by harmonised rules at EU level for wholesale distribution. However, the court goes on to say that that conclusion does not mean that a national authority cannot take into account any equivalent conditions laid down by national rules for the purposes of retail distribution.
Secondly, the court examines the consequences of this interpretation on the criminal liability of the pharmacists in question. In Italy, 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 between €10,000 and €100,000. The judges recall that a directive cannot have the effect of determining or aggravating the liability in criminal law of persons who act in contravention of the provisions of the directive. If the referring court were to reach the conclusion that national law, in the version applicable at the material time, did not require pharmacists to obtain special authorisation for the wholesale distribution of medicinal products and did not provide that pharmacists were subject to criminal liability, the principle that criminal penalties must have a proper legal basis would prohibit the imposition of criminal penalties for such conduct, “even if the national rule were contrary to EU law,” the court concludes.