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EC consults on revision to pharmaceutical legislation

The European Commission has moved to the next phase in its evaluation of the current EU pharmaceutical legislation and the potential for its reform by opening a 12 week online public consultation.

In November 2020 the EC published a Communication on the Pharmaceutical Strategy outlining the reforms to the EU pharmaceutical legislation that it intends to promote during its tenure to 2024. The Commission’s stated objectives are to:

  • ensure access to affordable medicines;
  • enable innovation for the development of high quality, safe and effective medicines, harnessing the benefits of digital and emerging science and technology while reducing the environmental footprint;
  • enhance the security of supply of medicines and address shortages;
  • reduce the regulatory burden and provide a flexible regulatory network.

The strategy roadmap anticipates that a new Regulation replacing Directive 2001/83 and Regulation 726/2004 will be adopted in Q4 2022. It seems likely that there may also be some revisions to the Orphan Regulation, the Paediatric Regulation and the Supplementary Protection Certificate Regulation to target incentives on areas of unmet medical need.

Now that a consultation on the roadmap for the reforms has been completed, this new consultation aims at capturing the evidence and views from a broad range of interested stakeholders, in the pharmaceutical industry and the general public, “allowing them to provide relevant information on the problems presented and on potential ways forward.”  Among the topics on which consultees are invited to provide their views are:

  • the definition of unmet medical need;
  • mechanisms to allow earlier generic and biosimilar entry, by reducing  the length of regulatory data protection and market exclusivity  and/or by amending the scope of the Bolar exemption;
  • how to encourage the re-purposing of off-patent medicines;
  • possible new incentives such as transferable priority review vouchers as is possible in the United States;
  • incentives for swift market launch across the EC, including smaller markets

The consultation will be open to the public until 21 December 2021. It will be complemented by a study, to be conducted by an external contractor and delivered in Q1 2022, evaluating how potential changes to the legislation might address the Commission’s objectives.


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