EU policy to secure safe and timely access to advanced therapies for patients 

Hosted by MEP Billy Kelleher (Renew Europe, Ireland), Co-chair of the MEP Interest Group

With the recent European Commission communication on boosting the biomanufacturing and biotechnology sector, and Mario Draghi’s report on the EU’s competitiveness, innovative health technologies are set to become one of the EU’s key tools for driving Europe’s competitive edge forward. This ambition can only be achieved through a cohesive and comprehensive approach to the proposed Pharmaceutical Package, Biotech Act and other legislative tools set to influence the development of, and patient access to, Advanced Therapy Medicinal Products (ATMPs) in the years to come.

On 21 November, the TRANSFORM Alliance met with Members of the European Parliament (MEPs), representatives of the European Commission and national-level regulators to take stock of the current European ATMP landscape and regulatory environment, with an outlook on how present and future legislative initiatives could support a thriving research and innovation health ecosystem that supports timely access to advanced therapies. Our panelists took a close look at the hurdles faced by both developers and patients from a holistic, drug-lifecycle approach, from early discovery through to development, authorisation, pricing and reimbursement and, finally, patient delivery.

Read below our event report to find out more about the TRANSFORM vision for healthcare policy under the new European mandate.