Rapid Response: Pharma Strategy Proposal

What are the key elements of the proposal? What is changing? What does it mean for innovators?

The European Commission is due to publish its long-awaited proposal for major revisions to the EU pharmaceutical legislation on Wednesday April 26. If this proposal is published,* our team will provide a rapid first take, covering some of the following hot topics:

• Changes to the incentives for research and innovation, including for orphan and paediatrics medicinal products
• New concepts of unmet medical need, high unmet medical need and significant benefit
• Changes to the regulatory regime for generics and biosimilars
• New obligations in relation to continuity of supply and prevention of shortages
• Rules on repurposing

*The Proposal has been delayed a number of times, so if the documents are not published, we will postpone this webinar.