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The EU JCA process: Opportunities and challenges in bringing innovative medicines to patients in Europe

The Joint Clinical Assessment (JCA) process is central to the European Union’s Regulation on Health Technology Assessment (HTAR), which seeks to improve patient access to innovative health technologies, including medicines and medical devices. Many factors contribute to access challenges, including the wide variation in how long each country takes to manage the HTA process on a national and sub-national level, lack of healthcare system resources in smaller EU countries, and a tendency by the industry to focus on larger markets in Europe. 

Given these access challenges, the goals of the JCA are to reduce patient inequality, eliminate redundancy and improve efficiency by centralizing the HTA process. A pilot phase was carried out on 11 pharmaceutical products and 24 other technology assessments, including medical devices. The results of this pilot phase highlighted that despite good intentions, there remains significant complexity to deliver on the expected outcomes. Presently, the EUNetHTA 21 consortium is developing a draft framework for the JCA process, which will be discussed and approved by the Member State Coordination Group on HTA with official implementation in January 2025 for oncology and advanced therapy medicinal products (ATMPs).

During this panel discussion, healthcare system experts will explore the JCA process and efforts to ensure timely access to innovative healthcare products within this new framework. The discussion will consider the challenges and opportunities presented by the JCA and the potential next steps to best prepare Pharma & Biotech companies to manage the new process.


Key webinar learnings:

  • The rationale behind the JCA and initial expectations of the framework
  • Experience with products that have gone through the pilot phase, providing insight into the workings of the JCA process
  • Potential impact anticipated for patient access to innovative health products 
  • The opportunities and challenges presented by the JCA


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Moderator

Tommy Bramley, Ph.D.
Senior Vice President, Global Consulting at AmerisourceBergen

Speaker

Herbert Altmann, Ph.D.
Head Commercialization and Access Solutions Europe with PharmaLex, part of AmerisourceBergen

Speaker

Casper Paardekooper
Partner at strategy consultancy Vintura
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Speaker

Mihai Rotaru
Senior Manager Market Access at EFPIA
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Speaker

Jurgen Huismans
Global Director Access & HTA Strategy at MSD