On 10 April 2024 , the European Parliament has adopted its position on the EU pharmaceutical reform.
The new pieces of EU law come from the "pharmaceutical package" proposed by the European Commission in April 2023 to amend EU pharmaceutical laws. This package aimed to enhance availability, accessibility, and affordability of human medicines, while also fostering the competitiveness of the EU pharmaceutical sector with higher environmental standards.
Following compromise amendments released by the Environment, Public Health and Food Safety (ENVI) Committee, the Parliament voted at first reading, passing the new directive with 495 votes in favour, 57 against and 45 abstentions, and the new regulation with 488 votes in favour, 67 against and 34 abstentions.
The main novelties deal with incentives to boost research and the development of innovative medicines, like novel antimicrobials, and of medicines addressing unmet medical needs. To this aim, a granular regulatory data protection and incentives have been proposed according to the type of medicine and the type of development. All orphan medicines developed for rare diseases have been recognised as “unmet medical needs” and will benefit from more incentives if addressing ‘high’ unmet medical needs.
Insights on paediatric provisions according to the new directive and regulation have been shared by EPTRI (European Paediatric Translational Research Infrastructure) and are available here.
The EMA would be restructured in its committees and expert groups and regulatory procedures, e.g. those related to orphan and paediatric medicines are expected to be streamiled.
More details on the changes included in this legislative package can be found here and also here.
However, there are still various steps to be completed before the law package enters into force. The Council may accept Parliament’s position, thus adopting the legislative act, or adopt a different position, thus asking the Parliament for a second reading. A new Parliament will be established after the 6 - 9 June European elections, and it will follow the procedure. Thus, further updates about the implementation of the new pharmaceutical legislation will be provided after June.