French farmers have been nipping over the Spanish border to go shopping for their veterinary medicinal products. This is not allowed under French law, only French-authorised wholesalers can import veterinary drugs. The French farmers wonder if the internal market exists.
Background
Seven years ago, some French farms near to the Spanish border were raided by a French regulatory inspectorate. During the raids, Spanish veterinary medicinal products were uncovered.
Under French law, only state-licensed French wholesalers can engage in the parallel importation of veterinary medicinal products from other Member States. Therefore, the French farmers, plus a Spanish French-registered vet, were prosecuted in the French courts.
The legal issue is whether the French scheme, which restricts the parallel import of these products, is contrary to EU treaty law and two pieces of EU legislation. The first is Directive 2001/82/EC on the Community code relating to veterinary medicinal products (OJ [2001] L311/1). The second is Directive 2006/123/EC on services in the internal market (OJ [2006] L376/36).
Question Referred
According to the EUR-Lex website, the Pau Court of Appeal has asked:
1. Does national legislation comply with Articles 34 to 36 TFEU in so far as it reserves access to parallel imports of veterinary medicinal products exclusively to wholesale distributors in possession of the authorisation provided for under Article 65 of Directive 2001/82/EC […], thus excluding those with retail distribution rights and livestock farmers?
2. On a proper construction of Article 65 of Directive 2001/82/EC and Article 16 of Directive 2006/123/EC […] (the ‘services’ Directive), is a Member State entitled not to recognise authorisations for the wholesale distribution of veterinary medicinal products that are issued by the competent authorities of other Member States to their own nationals and to require that those nationals additionally hold wholesale distribution authorisations issued by its own competent authorities in order to be entitled to apply for and to use authorisations for the parallel importation of veterinary medicinal products within that Member State?
3. Does national legislation comply with Articles 34, 36 and 56 TFEU and Article 16 of Directive 2006/123 in so far as it assimilates parallel importers of veterinary medicinal products to holders of an operating licence which is not required under Directive 2001/82/EC, as amended, establishing a Community Code for veterinary medicinal products, and which consequently requires such importers to have available to them an establishment in the territory of the Member State concerned and to have successfully completed all the pharmacovigilance operations provided for under Articles 72 to 79 of Directive 2001/82/EC?
Comment
In separate but similar litigation, the parallel import of Spanish-authorised veterinary medicines into France has recently been considered by the criminal law division of the French Court of Cassation. One of the issues in cassation was how the appellate court had dealt with the defendants’ request that a preliminary reference be made to the CJEU, a request which the appellate court had turned down. When the French Court of Cassation handed down its judgment in December 2014, it castigated the appellate court for not having properly reasoned the refusal – the Court of Cassation pointed out that the duty to give reasons was enshrined in Article 6(1) ECHR.
The timing of the French farmers’ reference is most propitious. It coincides with a reference from the German Supreme Court about the internal market in medicines for humans. The German court queries whether the German system of pricing medicines is akin to an import restriction. See further, Case C-148/15, Deutsche Parkinson Vereinigung – bonuses for buying Dutch mail order medicines.
Update – 15 November 2015
The Fourth Chamber is due to hear the ‘Audace’ case on 17 December 2015.
Update – 27 December 2015
According to the Curia website, the Fourth Chamber is now due to hear this case on 28 January 2016.
Update – 8 February 2016
The Opinion of Advocate General Mengozzi is now due to be handed to the Fourth Chamber on 10 March 2016.
Update – 1 September 2016
There is a reference from the Bucarest Court of Appeal in Romania about vets and the sales of veterinary medicines. According to the Official Journal ([2016] C314/15), these are the questions in Case C-297/16, Colegiul Medicilor Veterinari din România:
1. Does EU law preclude national legislation which provides that veterinary surgeons are to have an exclusive right in relation to the retailing and use of organic products, special purpose anti-parasitic products and veterinary medicinal products?
2. If such an exclusive right is compatible with EU law, does the latter preclude such a right from additionally concerning the structures through which the sale of such products takes place, in the sense that such structures must be mainly or exclusively owned by one or more veterinary surgeons?
Update – 25 September 2016
The judgment of the Fourth Chamber is due on 27 October 2016.