Falsified medicines and unique identifier

Under Directive 2011/62/EU, which amended Directive 2001/83/EC, a falsified medicinal product is any medicinal product with a false representation of its identity, its source or its history, including its packaging, labelling, composition or the documents relating to the distribution channels used. The definition excludes unintentional quality defects and leaves aside infringements of intellectual property rights, which fall under a different regime. The Public Health Code adopts this concept and penalises the manufacture and marketing of falsified medicines.

Safety features

Delegated Regulation (EU) 2016/161, applicable since 9 February 2019, requires two safety features to be placed on the packaging of most prescription medicinal products. The first is a unique identifier, carried by a two-dimensional barcode, which individualises each pack. The second is an anti-tampering device, which makes it possible to verify that the packaging has not been opened. Non-prescription medicinal products are in principle exempt, except those on a list drawn up on account of the risk of falsification.

The verification system

The identifiers are uploaded by the manufacturer to a repositories system managed by stakeholders at European and national level. The pharmacist verifies the authenticity of each pack and decommissions it at the time of supply, and wholesalers carry out verifications in the cases laid down by the Regulation. Repackaging by a parallel import operator requires the identifier and the anti-tampering device to be replaced by equivalent features, an operation that raises fresh questions under trade mark law. The online sale of medicines is, for its part, conditional on the display of a common EU logo identifying authorised websites.

Falsification and infringement

Falsification in the public health sense and infringement in the intellectual property sense often overlap but do not coincide. A falsified medicinal product frequently bears a trade mark reproduced without authorisation, whereas a duly authorised generic marketed in breach of a patent is not a falsified medicinal product. The right holder therefore has two complementary routes, the infringement action and reporting to the health and customs authorities. The Council of Europe Medicrime Convention also allows falsification to be criminalised irrespective of any infringement of an intellectual property right.

Key points

Falsification penalises misrepresentation of the identity, origin or history of a medicinal product, irrespective of any intellectual property right. Safety features make it possible to verify each pack up to the point of supply. Where a product is suspected, a report to the health authorities, an application for customs action and, where a trade mark or patent is affected, an infringement action should be combined.

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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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