News about GMP/cGMP

04.12.2020

EU unveils the Pharmaceutical Strategy for Europe

What should a crisis-proof drug supply in Europe resemble? In this regard, the European Commission presented a 25-page pharmaceutical strategy on November 25, 2020. It was awaited with great interest. One thing is for certain: the implementation of the strategy will not leave the EU pharmaceutical legislation unaffected.

Patients shall be guaranteed access to innovative and affordable medicines and the competitiveness, innovation and sustainability of the EU pharmaceutical industry shall be supported. The developed strategy should enable Europe to meet the demand for medicines through sound supply chains, even in times of crisis such as the current corona pandemic.

Four main objectives are being pursued:

  • Ensuring access to affordable medicines for patients, and addressing unmet medical needs (e.g. in the areas of antimicrobial resistance, cancer, rare diseases);
  • Supporting competitiveness, innovation and sustainability of the EU's pharmaceutical industry and the development of high quality, safe, effective and greener medicines;
  • Enhancing crisis preparedness and response mechanisms, and addressing security of supply;
  • Ensuring a strong EU voice in the world, by promoting a high level of quality, efficacy and safety standards.

To implement the strategy, the Commission will progressively launch legislative and non-legislative actions covering the whole pharmaceutical ecosystem.

What actions are envisaged?

  • A revision of the basic pharmaceutical legislation* (target date for a proposal: 2022) with a view to making this framework future-proof and innovation friendly;
  • A proposal for a EU Health Emergency Response Authority (proposal: second half of 2021);
  • A revision of the regulations on medicines for children and rare diseases;
  • Initiating a structured dialogue with and between all actors in the pharmaceutical manufacturing and public authorities to identify vulnerabilities in the global supply chain of critical medicines and shape policy options to strengthen the continuity and security of supply in the EU;
  • Cooperation between national authorities on pricing, payment and procurement policies, to improve the affordability, cost-effectiveness of medicines and health system's sustainability;
  • The creation of a robust digital infrastructure, including a proposal for a European Health Data Space (target date for a proposal is 2021);
  • Support to research and innovation, notably via Horizon 2020 and EU4Health;
  • Actions to promote innovative approaches to EU R&D and public procurement for antimicrobials and their alternatives and measures to restrict and optimise their use.


More details as well as an informativ overall Q&A document on the strategy can be found on the website of the European Union.


Source: 
EU: Press release



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