Open consultation response on the revision of the general pharmaceutical legislation

Position Paper

20 Dec 2021

Healthcare

HomePolicy and newsLibraryOpen consultation response on the revision of the general pharmaceutical legislation

The European Commission’s revision of the EU general pharmaceutical legislation Pharmaceutical Strategy aims at supporting the evaluation of the existing general pharmaceutical legislation on medicines for human use, with the purpose of ensuring a future-proof and crisis-resistant medicines regulatory system. The revision of the pharmaceutical legislation should enable an environment for the biopharmaceutical sector to flourish and help the EU remain competitive on the global stage. As making healthcare systems more resilient and sustainable continues to be a priority, it is critical to maintain frameworks that reward innovation and attract investment.

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Healthcare, competitiveness, innovation and simplification

Europe’s life sciences sector sits at the heart of the EU’s competitiveness agenda. It supports advanced manufacturing and helps bring new treatments and technologies to patients. Yet companies deciding where to invest need a regulatory environment that is predictable and open to global cooperation.

The European Commission’s work on the Biotech Act and the targeted revision of the Medical Devices and In Vitro Diagnostics Regulations (MDR/IVDR) offers an opportunity to improve that environment. Both files can help make Europe a stronger location for life sciences investment.

The EU should use this moment to build a framework that keeps pace with scientific progress. That means faster and clearer procedures. It also means better use of data and intellectual property rules that recognise the realities of global supply chains.

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