European Parliament adopts position on revision of pharmaceutical legislation


On 10 April, the European Parliament adopted its position on the proposed reforms of EU pharmaceutical legislation. The legislative package, covering medicinal products for human use, consists of a new directive (adopted with 495 votes in favour, 57 against and 45 abstentions) and regulation (adopted with 488 votes in favour, 67 against and 34 abstentions). The Parliament has proposed a minimum regulatory data protection period (during which other companies cannot access product data) of seven and a half years, in addition to two years of market protection (during which generic, hybrid or biosimilar products cannot be sold), following marketing authorisation. 

Furthermore, pharmaceutical companies would be eligible for additional periods of data protection if their particular product addresses an unmet medical need (+12 months), if comparative clinical trials are being conducted on the product (+6 months), and if a significant share of the product’s research and development takes place in the EU and at least partly in collaboration with EU research entities (+6 months). However, MEPs also want a cap on the combined data protection period of eight and half years. 

A one-time extension (+12 months) of the two-year market protection period could be granted if the company obtains marketing authorisation for an additional therapeutic indication which provides significant clinical benefits in comparison with existing therapies. Orphan drugs (medicines developed to treat rare diseases) would benefit from up to 11 years of market exclusivity if they address a “high unmet medical need”. The file will be followed up by the new Parliament after the 6 - 9 June European elections. Further information on the Parliament’s position is available at:…