Webinar notes: Revision of EU pharmaceutical legislation

Today, I listened to a webinar, "Even spaceships need a launchpad" presented by Reuters that focused on the ongoing revision of EU pharmaceutical legislation. That legislation is currently 20 years old.

 

There were for 4 panelists:

Emer Cooke, EMA

Nathalie Molle, EFPIA

Florian Schmidt, European Commission

Cristian-Silviu Busoi, European Parliament

 

The background to the discussion was that the EU has been falling behind in several fronts related to bringing new therapies to patients compared to other countries, including:

• Regulations do not support well the newer therapies (e.g., cell and gene therapies)
• Newer therapies include device combinations (~25%) that require bridging communications with the agency responsible for devices (delivery and companion diagnostics) and the two different regulatory frameworks
• A question remains is EMA staffed adequately to deal with the current science and the volume of work
• Fewer expedited pathways
• Practices need to be harmonized more across the countries

 

Once therapies are approved by the EU (EMA), taking on average 466 days, each of the 27 member countries has to approve. Subsequent to the individual country approvals, is the actual process (i.e., access) for getting new therapies to patients that include the payer approvals.

 

Emer Cooke refocused the discussion getting new therapies to patients.  She noted that a focus on unmet medical need therapies could be a more impactful approach vs therapies that provide only minor improvements over existing therapies. Additionally, an ongoing approach for multi-national review teams is aimed improving the post-EU approvals with the country approvals.

 

Florian Schmidt wants to improve the communications between the pharmaceutical sponsors and regulators to ensure more guidance is provided during the therapy development.  In the end, making sure that right research is completed so that the final submission is can undergo a smooth review.  He also wants to change the regulations to bring the drug and device regulators together to meet with the pharmaceutical sponsors during development so that the sponsors understand the expectations and have guidance from the regulators.

 

Overall, it was an interesting and insightful discussion on the challenges for obtaining new therapy approvals in the EU. Collaboration amongst the pharmaceutical therapy ecosystem is central to the future success. Worthwhile hearing for those who are supporting new therapy approvals for the EU.