EUCOPE Resources / News - October 13, 2022

?️Sounds of Science Episode 9 on ATMPs

Sounds of Science Podcast – Episode 9

Advanced Therapy Medicinal Products (ATMPs): How they will be impacted by the General Pharmaceutical Legislation

On our latest episode, we explore the topic of Advanced Therapy Medical Products, or ATMPs. This covers a wide range of therapies, but we’ll be using it as shorthand for gene and cell therapies for today’s conversation.

ATMPs have been receiving significantly more attention in recent years as a growing number of them come to market. As a potentially one-off, transformative treatment, these therapies are different from many therapies currently available or in development. However, much like all other therapies, ATMPs will be impacted by the ongoing review of the General Pharmaceutical Legislation, and many cases, the review of the OMP regulation as well. Beyond the legislative and regulatory framework, interesting developments are also taking place with regard to HTA and P&R. This combination of commercial and legislative developments will have long-term implications on ATMPs and the competitiveness of the EU.

Suffice it to say, there is a lot happening when it comes to ATMPs, and with the help of today’s guests, we hope we can start to unpack a few of these discussions, and possibly look into the future as well.

Today’s guests are:

  • Dr Lutz Bonacker, Senior Vice President and General Manager, Commercial Operations Europe, CSL Behring
  • Dr Alexander Natz, Secretary General, EUCOPE

This episode is hosted by EUCOPE’s Government Affairs Manager, Victor Maertens. 

You can listen to Episode 9 and all other Sounds of Science episodes using the links below:

Episode Highlights

Dr Lutz Bonacker, CSL Behring

“It’s crucial to meaningfully involve industry and developers in the dialogue on the definition of unmet needs in order to build on the existing framework and to ensure that progress in this area does not result in either being too restrictive or having undesired effects.”

“The new HTA joint clinical assessment represents one opportunity to simplify, to accelerate, and to improve the HTA process for ATMPs in Europe so that patients can gain access to treatment in a timely manner.”

“A constructive dialogue between payers and governments is really key to improving the availability and the quick access for European patients.”

Alexander Natz, Secretary General, EUCOPE

“The generation of real world evidence is a critical tool to allow better access to cell and gene therapies.”

“Launch obligation is really something which could actually discourage companies to launch in Europe, especially for rare diseases.”

If your company would like to put forward a topic for us to discuss or to participate in a future episode, please reach out to our producer, Dante Di Iulio.

For more information about our work on ATMPs or how to join our Cell & Gene Therapy Working Group, simply visit our Resource pageor send an email to