In brief

On 10 April 2024, the European Parliament, in a plenary session, approved the new proposals for a directive and regulation on medicinal products for human use. The two texts will now have to be approved by the European Council.

Key takeaways

These proposals aim at ensuring safer, more efficient, and high-quality medicines for European citizens, at promoting innovation and development of medicines to address unmet medical needs, and at strengthening the research on new medicines to tackle antimicrobial resistance.

Among the changes introduced by the European Parliament with respect to the texts proposed by the Commission, should be highlighted: (i) the extension to seven and a half years of the minimum period of patent protection, to which may be added 12 months of protection if the authorized medicinal products address an unmet medical need, or six months if comparative clinical trials are conducted, and an additional six months if a significant part of the research and development of the product takes place within the European Union, up to a total maximum of eight and a half years; and (ii) the provision of a maximum period of market exclusivity of 11 years for orphan drugs used in the treatment of rare diseases, if they meet a high unmet medical need.