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EU Pharma legislation faces overhaul


The EU pharmaceutical strategy published this week is being seen as the first step in a “complete overhaul” of the medicines legislative framework in Europe.

The document contains a raft of changes to legislative and regulatory matters including the streamlining of drug approval procedures, better access to affordable medicines, and strengthened EU-level cooperation on pricing and reimbursement.

Other key areas mentioned are measures to boost competition from cheaper generic and biosimilar drugs, align clinical trials to patient needs, and strengthen supply chains to avoid drug shortages.
The strategy, part of the proposed “EU Health Union”, will also endeavour to support R&D into new treatments and vaccines and increase the competitiveness of the European pharmaceutical industry.

The strategy will be discussed by EU ministers on 2 December, and its implementation is due to begin immediately after adoption. The various actions and projects will be rolled out gradually, starting with the first proposals in the coming months, including the ongoing revision of the European Medicines Agency fees regulation and the EU orphan and pediatric legislation.

A complete overview can be found here

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