Alliance for Regenerative Medicine Supports the Council Position on EU Joint Clinical Assessments

European Patients Stand To Benefit From Early Focus On Life-Changing ATMPs

BRUSSELS, BELGIUM – March 24, 2021

The Alliance for Regenerative Medicine (ARM) -- the global voice of the regenerative medicine and advanced therapies sector – welcomes the Council of the European Union’s support for EU-level joint clinical assessments. If adopted, joint clinical assessments can eliminate duplicative reviews of transformative Advanced Therapy Medicinal Products (ATMPs) across member states, reducing the time and cost required to bring durable, and potentially curative, cell, gene, and tissue-based therapies to patients anywhere in the EU.

ARM supports the Council’s position to apply joint clinical assessments to ATMPs before most other types of medicinal products, but asks negotiators to include ATMPs in the first class of medicinal products – along with new active substances for which the therapeutic indication is the treatment of cancer. ATMPs harness cutting-edge science and often target serious diseases with small patient populations, making them particularly well-suited for joint clinical reviews. Furthermore, ARM welcomes the inclusion of chimeric antigen receptor T cell (CAR-T) therapies for joint clinical assessments of oncology products, as they are ideal candidates for this review due to their complexity, smaller patient subsets, and curative potential.

Paige Bischoff, SVP of Global Public Affairs at ARM, commented: “Getting life-changing therapies to patients is a top priority. The Council rightly recognizes how critical joint clinical assessments are to expediting patient access to ATMPs. We recommend that negotiators from the European Parliament, Council, and the Commission go a step further and put ATMPs at the front of the line. Overall, though, if adopted this proposal would be a win for patients, innovative developers, and the European ATMP sector.”

ARM looks forward to further engagement with stakeholders on the joint clinical assessments file to ensure the specific benefits and characteristics of ATMPs are understood and reflected to deliver faster, more efficient access to treatment. ARM believes that a simple majority vote from member states must remain as the chosen voting mechanism throughout the trilogue negotiations to ensure that the joint clinical assessments function as intended.

Press enquiries

For more information or for media requests, please contact Stephen Majors from the Alliance for Regenerative Medicine at smajors@alliancerm.org or Consilium Strategic Communications at ARM@consilium-comms.com.

About the Alliance for Regenerative Medicine (Europe)

The Alliance for Regenerative Medicine (ARM) is the leading international advocacy organisation dedicated to realizing the promise of advanced therapy medicinal products (ATMPs). ARM promotes legislative, regulatory and reimbursement initiatives in Europe and internationally to advance this innovative and transformative sector, which includes cell therapies, gene therapies and tissue-based therapies. Early products to market have demonstrated profound, durable and potentially curative benefits that are already helping thousands of patients worldwide, many of whom have no other viable treatment options. Hundreds of additional product candidates contribute to a robust pipeline of potentially life-changing ATMPs. In its 11-year history, ARM has become the global voice of the sector, representing the interests of 380+ members worldwide and 85+ members across 15 European countries, including small and large companies, academic research institutions, major medical centres and patient groups. To learn more about ARM or to become a member, visit http://www.alliancerm.org.