The European Court of Justice delivers a new judgement on wholesale distribution of medicines
The European Court of Justice has ruled on (i) the extent to which a wholesale distributor can acquire medicinal products from persons who are only authorised to supply medicinal products to consumers, (ii) the qualifications that the wholesalers staff must have, and (iii) the circumstances that must be taken into consideration when revoking a wholesalers distribution authorisation.
On 21 September 2023, the Court of Justice of the European Union (CJEU) ruled in a case concerning the wholesale distribution of medicinal products. In the case, the national authorities found during an inspection that a pharmacy did not fulfil the requirements laid down in the Medicinal Products Directive as implemented into Austrian law. The pharmacy subsequently had its wholesale distribution authorisation withdrawn. The case led the Austrian court to stay the proceedings and refer a number of question to the CJEU for a preliminary ruling.
Firstly, the national court asked whether it was in accordance with the Medicinal Products Directive when a wholesale distributor acquires medicinal products from persons who only have an authorisation to supply medicinal products to consumers, but do not themselves have a wholesale distribution authorisation, when acquisition only involves a small quantity of medicinal products. The CJEU ruled that the directive must be interpreted as forbidding such an acquisition. In relation to this, the CJEU emphasised that it is irrelevant whether the medicinal products acquired are then resold by the wholesale distributor to other persons who are only entitled to supply medicinal products to consumers or whether they are resold to other holders of a wholesale distribution authorisation.
The second question concerned the qualifications that the wholesalers staff must meet. Here, the Court of Justice of the European Union was given the possibility to rule on the extent to which the designated responsible person can delegate tasks. The CJEU stated that it is not a requirement that the responsible person must always be present on the wholesalers premises, but that he or she must be contactable by telephone and that the employees present in the establishment must be able to provide an inspection service with information on the procedures falling within their area of competence when the inspection service requests such information. In addition, the Court stated that staff to whom the wholesaler may have outsourced activities must be taken into account when assessing whether the wholesaler has "sufficiently competent staff" within the meaning of the relevant provision of the Directive.
The third and final question referred to the CJEU concerned the circumstances that must be taken into consideration when revoking a wholesale distributers authorisation, when a distributor is found to have failed to comply with the requirements of the Directive. The CJEU stated that the authorities cannot necessarily withdraw the authorisation if, after the requirements have been found to have been neglected but before the decision has been taken, the distributor has remedied the deficiencies. In this case, due to the principle of proportionality, a concrete assessment must be made, including the nature and seriousness of the offence, how quickly the deficiencies have been remedied, and whether the deficiencies are repeated or systematic.
The Court's opinions should be taken into account when organising the wholesale distributor's staff, as well as when defining the wholesale distributor's purchasing strategy.
If you have questions about wholesale distribution of pharmaceuticals or life science regulation in general, please contact Plesner's Life Science team.