Parallel import of medicinal products

Parallel import of medicinal products consists in acquiring, in a Member State where its price is lower, a medicinal product authorised under a national procedure, then marketing it in another Member State outside the holder’s distribution network. It is based on the free movement of goods guaranteed by Articles 34 to 36 of the Treaty on the Functioning of the European Union. In France, it requires a parallel import authorisation issued by the ANSM. For medicinal products authorised through the centralised procedure, the term used is parallel distribution.

Regulatory conditions

The importer does not have to submit a full dossier. The Court of Justice of the European Union holds that the authority of the State of import must allow a simplified procedure where the imported medicinal product is authorised in the State of origin and is essentially similar to a product already authorised in the State of import. The French Public Health Code sets out the conditions for this similarity, which relate to composition, pharmaceutical form and therapeutic effects. The importer must also operate from an authorised establishment and provide labelling and a package leaflet in French.

Exhaustion of intellectual property rights

Under the doctrine of exhaustion of rights, the holder of a patent or trade mark cannot oppose the resale of a medicinal product that it has placed on the market in the European Economic Area, or that has been placed on the market there with its consent. Exhaustion applies even where the product was marketed in a State where it was not patentable, unless there was a legal obligation to market it. The Acts of Accession of the States that have joined the Union since 2004 have, however, established a specific mechanism allowing the holder of a patent or supplementary protection certificate to oppose the import of products from those States where such protection was not available there at the time of filing, the importer being required to notify the holder one month before applying for authorisation.

Limits under competition law and trade mark law

Pharmaceutical companies sometimes seek to restrict these flows through supply quotas or prices differentiated by destination. These practices are examined under Articles 101 and 102 TFEU. The Court of Justice accepts that a dominant undertaking may take reasonable steps to protect its commercial interests, but in principle regards the refusal to meet wholesalers’ ordinary orders as an abuse of a dominant position. Repackaging of the imported product is, for its part, governed by the conditions of trade mark law.

Key points

Parallel import of medicinal products is lawful provided the product has been placed on the market in the European Economic Area by the holder or with its consent. The holder should check the State of origin, since the specific mechanism applicable to the new Member States may provide grounds for opposition, as well as the compliance of the repackaging. For the importer, prior notice and justification of the method of repackaging are the two decisive precautions.

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This glossary entry is general in scope and does not constitute legal advice.

Dhenne Avocats acts in pharmaceutical patent disputes and on the medicines regulatory questions that accompany them, from the marketing authorisation to the supplementary protection certificate.

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