On 25 November 2020, the European Commission announced in its Communication for a Pharmaceutical Strategy for Europe a thorough review of the EU pharmaceutical legislation, which was originally planned for 2022.

The new proposal has been experiencing some delays, but in her EPSCO speech on 9 December 2022, Commissioner Kyriakides indicated that the impact assessment had been finalised and the proposal should be presented by the end of Q1 2023 at the latest. Interestingly, the European Commission seems to present its legislative proposal as a single package combining a proposal for the general pharmaceutical legislation, the Orphan Regulation and the Paediatric Regulation.

The other topics mentioned in the Commissioner’s speech, i.e. access to medicine, support of innovation and competitiveness, antimicrobial resistance, an environmental friendly ecosystem and a reduction of the regulatory burden, all follow the objectives highlighted in the Pharmaceutical Strategy.

We are closely monitoring further developments and will keep you informed.