EU: Parliament Adopts Position on EU Pharmaceutical Reform
On 10 April, the EU Parliament approved a legislative package to reform the EU‘s pharmaceutical legislation, with the aim of boosting innovation and improving the accessibility and affordability of medicines. The package, which includes a new directive and a regulation, recieved strong support from Members of the European Parliament (MEPs).
Key Points:
- The directive and regulation received overwhelming support from MEPs.
- MEPs want to introduce a minimum seven-and-a-half-year regulatory data protection period, in addition to two years of market protection, following a marketing authorisation.
- Additional periods of data protection are proposed, for example, for products undergoing comparative clinical trials.
- Orphan drugs could benefit from up to 11 years of market exclusivity.
- MEPs proposed measures to combat antimicrobial resistance (AMR), including market access rewards for novel antimicrobials, a subscription model scheme and additional months of data protection (up to 12 months).
The file will be taken up by the new Parliament and discussed with the European Council after the European elections in June.
We reported on the planned changes last year.
Source:
European Parliament: Press room
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