EU Unveils Ambitions To ‘Future-Proof’ Entire Drug Regulatory Framework
Targets Include Access, Pricing, Innovation & Manufacturing
Ambitious efforts to make the EU more resilient to future challenges, such as health threats, drug supply problems, scientific advances and growing medicine costs, have taken a step forward with the publication of a roadmap for a wide-ranging Pharmaceutical Strategy to be adopted by the European Commission later in the year.
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Delegates at this week’s TOPRA conference heard the European Commission’s “holistic” vision of what it would like to achieve through its pharmaceutical strategy, including incentives for innovation, security of the supply chain, product shortages, real world evidence and big data, and the availability and affordability of medicines.
The EU Orphan Regulation and the Paediatric Regulation have helped to increase the number of products developed for rare diseases and children, but they both have some shortcomings that need to be addressed, according to an evaluation of the legislation carried out by the EU authorities. The European pharmaceutical industry has warned against opening up the legislation, saying it is “critical to maintain a stable and predictable incentives framework."
Participants at a workshop on the EU’s proposed Pharmaceutical Strategy discussed affordability and drug shortages and called for more urgency on the draft HTA regulation.