The Alliance for Regenerative Medicine Publishes Position on Proposed Regulation on Health Technology Assessment and Amending Directive 2011/24/EU
BRUSSELS, Belgium and WASHINGTON, D.C. –
July 11, 2018
The Alliance for Regenerative Medicine (ARM), the international advocacy organization representing multiple stakeholder groups comprising the cell and gene therapy and broader regenerative medicine and ATMP sector, today published its position in response to the proposal for a Regulation of the European Parliament and of the Council on health technology assessment and amending Directive 2011/24/EU (COM(2018) 51 final).
ARM’s position statement, available here, recognizes the benefit of the proposed regulation, which would require joint clinical assessments to be carried out for many medicinal products undergoing the central marketing authorization. These benefits include increased international harmonization and reduced duplication of efforts when companies apply for HTA of their products; a positive impact on time to market; and the potential for better alignment from Member States on issues such as clinical evidence requirements, selection of comparator(s), and design of studies.
In the position statement, ARM also makes three recommendations intended to ensure the success of the regulation in attaining the full impact of the benefits listed above. These recommendations include:
- The Regulation should ensure that EU Member States participating in joint clinical assessment adopt the conclusion report and do not repeat any assessment of aspects dealt with in the joint clinical assessment at national, regional or local levels.
- The Regulation should provide for a set of guiding principles for the join clinical assessments. In particular, the methodology should build on the EUnetHTA methodological guidelines and evidence submission templates, should address some of the specificities of advanced therapies, and provide a sufficient level of flexibility, allowing HTA bodies to adequately manage uncertainties on clinical outcomes or costs that are inherent to innovative therapies at the time of their marketing authorization approval.
- The Regulation should ensure that there is an appropriate effective mechanism for applicants to appeal after a joint clinical assessment.
The proposed Regulation of the European Parliament and of the Council on health technology assessment and amending Directive 2011/24/EU is available here.
About the Alliance for Regenerative Medicine:
The Alliance for Regenerative Medicine (ARM) is a global, multi-stakeholder organization that promotes innovation, growth, and delivery of transformative treatments or cures for patients suffering from chronic, debilitating, and often life-threatening diseases, many of which are rare diseases. ARM convenes all stakeholders with an interest in regenerative and advanced therapies to provide a unified voice for our 290+ member organizations, including companies – especially small- to medium-sized enterprises (SMEs); academic/research institutions; non-profit organizations; patient advocacy organizations, and other members of the global advanced therapies community. The organization’s aim is to connect all parts of the innovation lifecycle to address current unmet medical needs of patients, particularly through supporting commercialization objectives via legislative and policy frameworks that enable next generation therapies to reach those who need them. To learn more about ARM, visit http://www.alliancerm.org.