EBE and EFPIA both welcome sincerely the initiative taken by the European Medicines Agency to identify concrete solutions to foster the development of advanced therapy medicinal products, while simultaneously embarking on concerted efforts to expand patient access to them across Europe.

EBE members – and increasingly EFPIA members too – are taking a keen interest in bringing innovative cell, gene and tissue-based therapies to market, noting their potential to reshape the treatment of a wide range of conditions, particularly in disease areas where conventional approaches have hitherto proven inadequate.

The biopharmaceutical industries appreciate, and have benefitted to a certain extent from EU Regulation (EC) No 1394/2007 on Advanced Therapy Medicinal Products (ATMPs), which entered into force on 30 December 2008. Nevertheless, we note the limitations in its application, concurring with the EMA’s own acknowledgement that if ATMPs are to fulfil their promise of providing innovative treatments for patients, regulators and legislators in the EU and its Member States must nurture a harmonised regulatory environment that encourages innovation, safeguards public health and, ultimately, facilitates timely patient access to safe and effective new therapies.

EBE and EFPIA are therefore appreciative of this initiative, the intention of which must be to seek out and identify hidden obstacles to the development, approval and access of advanced therapies, noting that obstacle removal will facilitate better patient access to these life-saving therapies.

EBE Executive Director Barbara Freischem said: “The EMA has gathered the relevant stakeholders and enabled a frank debate about the challenges that exist for advanced therapies, focussing on solutions, both within and outside of the EMA mandate. The unique scientific expertise in the EMA's Committee for Advanced Therapies (CAT) is well placed to facilitate the necessary discussion. We look forward to supporting solution-oriented follow-on initiatives.”