In the context of criminal proceedings concerning the potential violation of the legal requirements applicable to the importation of veterinary medicines from Spain into France (so-called ‘parallel trade’), the Court of Justice (CJ) ruled that Articles 34 and 36 TFEU prohibit national legislation which requires livestock farmers to hold a wholesale distribution license to import veterinary medicines for the use for their livestock (Case C-114/15).
Although the CJ’s ruling would appear to pave the way, at least in principal, for livestock farmers to import veterinary medicines for their own livestock; the financial implications to comply with certain regulatory obligations incumbent upon them, such as the pharmacovigilance obligations, are likely to be too burdensome and therefore dissuasive.
Whist the CJ’s ruling is based on a very specific set of facts, the case addresses a number of interesting issues of wider application. It is particularly interesting to note the CJ’s comments on the jurisprudence established in the parallel trade of medicinal products for human use and the notion of ‘common origin’ developed by the CJ in Rhône-Poulec Rorer (C-94/98).
Criminal charges were brought, inter alia, against a group of French farmers following the discovery of Spanish veterinary medicines (and accompanying Spanish prescriptions and invoices) on a French farm during an official inspection. Some of the veterinary medicines were not authorised in France. Such illegal practices were reported by the French authorities to have become widespread.
At first instance, the livestock farmers were found to be criminally liable for importing veterinary medicines without authorisation. At appeal, the appellate court referred a number of questions to the CJ for preliminary ruling.
The CJ held, pursuant to Article 34 TFEU, that French national legislation that required livestock farmers to obtain wholesale distribution authorisation (pursuant to Article 65 Directive 2001/82) in order to obtain parallel importation authorisation was likely to hinder access to the market. The normal obligations required to be imposed on wholesale dealers (consistent with the requirement to protect public health pursuant to Article 36 TFEU) were found to go beyond those that were necessary for livestock farmers.
Such national legislation was accordingly held to be precluded under Articles 34 and 36 TFEU. The CJ also confirmed, in principal, that parallel importation authorisation must be granted to livestock farmers where these veterinary medicines are dispensed against the necessary prescriptions for use on their own farms where these products are authorised in the Member State of origin and the Member State of importation.
Importantly, the CJ also held that, as marketing authorisation holders, such livestock farmers would become responsible for the marketing of the veterinary medicinal products under Directive 2001/82. In particular, the farmers would have to comply with labelling and pharmacovigilance requirements and would have to have an establishment in the Member State.
Whilst the CJ considered that the livestock farmers would not be obliged to have the same staff, premises and equipment as would be necessary for wholesale distributers, the farmers would still have to comply with the pharmacovigilance requirements of Articles 72–79 of Directive 2001/82. This would require the farmer to permanently and continuously have at his disposal an appropriately qualified person responsible for pharmacovigilance. The livestock farmers must also meet specific obligations concerning the monitoring, recording and reporting of suspected adverse reactions. Furthermore, the CJ also placed the burden on the farmers to ensure that product leaflets were made available in the official language or languages of that Member State in question in accordance with Article 61(1) Directive 2001/82.
In relation to the requirement in the French legislation to have an establishment in France, the CJ ruled that livestock farmers are bound to have a farm for their livestock and therefore an ‘establishment’ in the Member State of import. Such legislation was accordingly not held to be precluded by Articles 34 and 36 TFEU. By this finding, the CJ appears to have applied a surprisingly wide definition of ‘establishment’ in the EU.
In conclusion, whilst the CJ has confirmed in principal that there should be a lower threshold for the parallel importation of veterinary medicines by livestock farmers for use on their own farms (if not for further distribution), in practice, the onerous pharmacovigilance requirements and labelling requirements may well dissuade farmers from importing veterinary medicines from other Member States.
It is worth noting that the UK national legislation does not require parallel traders of veterinary medicines to hold a wholesaler authorisation provided that the necessary contractual provisions are in place with an authorised wholesaler. It is possible that similar arrangements would be required to make the CJ’s ruling practicable in France and other Member States with similar national provisions.