Sounds of Science Podcast #18 on the Revision of the General Pharmaceutical Legislation

EUCOPE’s Sounds of Science Podcast – Episode 18

The Revision of the General Pharmaceutical Legislation: European Parliament Reports

In this episode of Sounds of Science, we explore the ongoing Revision of the General Pharmaceutical Legislation (GPL). On 10 April,  the European Parliament adopted their reports (Directive and Regulation) on the Revision of the GPL, less than a year after the Commission’s proposal was released. In this episode, not only we discuss the proposals adopted by the Parliament, but we compare them with the Commission’s approach, focusing on the incentives framework and the regulatory provisions. We also share our thoughts on how the revised framework might impact small and mid-sized companies and their investments in innovative treatments in Europe.

The guests of this episode are:

• Victor Maertens, Government Affairs Director, EUCOPE.
• Dr Seán Byrne, Senior Manager Legal and Regulatory Affairs, EUCOPE.

This episode is hosted by EUCOPE’s Senior Government Affairs Manager, Stefano Romanelli.

You can listen to Episode 18 and all other Sounds of Science podcast episodes using the links below:

• Spotify

Episode Highlights

• Victor Maertens, EUCOPE

“When we compare with the Commission’s proposal, the European Parliament has raised certain exclusivity periods. They are still lower than what we have today, but I think these changes indicate the Parliament’s understanding of some of the unique challenges we see in developing innovative therapies. We must make sure we continue incentivising industry to invest and undertake research in these therapies. One of the key elements is to build a predictable, stable and understood incentive framework .”

“There are a few positive changes, for instance in the regulatory system for ATMPs, which can contribute to a more positive clinical trial environment, as well as regulatory flexibility for novel medicinal products, such as regulatory sandboxes or platform technologies.”

• Seán Byrne, EUCOPE

“From an international perspective, the EMA will be more agile and faster in terms of delivering assessments, and this is something EUCOPE has asked for consistently in the past few years, and this is now reflected in the proposed revision.”

“An expansion of shortage preventions plans or shortage mitigation plans to all medicines is not going to help developers, it is not going to the MSGG nor the Member States to track security of supply. It is simply too onerous, too burdensome.”

 

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For more information on EUCOPE’s initiatives on the revision of the GPL and how your company can contribute to it, or if your company would like to put forward a topic for us to discuss or to participate in a future podcast episode please contact us.