Joint press release on ATMPs and GMOs in Europe
From EuropaBio, EFPIA, ARM and EBE
Brussels, BELGIUM, September 27, 2017 - The Alliance for Regenerative Medicine (ARM), the European Biopharmaceutical Enterprises (EBE), the European Federation of Pharmaceutical Industries and Associations (EFPIA) and EuropaBio announced today the release of their joint position paper, entitled “Possible Solutions to Improve European Regulatory Procedures for Clinical Trials with Advanced Therapy Medicinal Products Consisting of or Containing Genetically Modified Organisms.” The paper advances a series of proposals to streamline the application and review processes by the relevant authorities and shorten the time before clinical trials of Advanced Therapy Medicinal Products (ATMPs) that consist of or contain GMOs with such products can be initiated.
In drafting this position, the organisations’ aim is to support European competitiveness in the biomedical sector, including the development of ATMPs, and to avoid unnecessary delays for patient access to such innovative medicines whilst ensuring patient and environmental safety.
The organisations identify several areas of concern with current GMO regulations for EU-based clinical trials and propose a number of near-, medium- and long-term solutions. These are designed to streamline a number of currently disparate and fragmented processes. Recommendations include the centralization of information, a website designed to host the key EU-wide requirements, links to relevant authorities for GMO-containing ATMP clinical trials, guidance that would lay down the requirements and promotes harmonisation of classification and parallel (rather than sequential) reviews by the Health and GMO authorities.
A key proposal calls for the creation of a “GMO Facilitation Group”, comprising GMO authorities across Europe to facilitate dialogue and foster the adoption of more uniform and rapid decisions. The position paper highlights the benefit of implementing a number of these proposals in conjunction with the Clinical Trial Regulation, currently planned for 2019, to leverage the advantages of the improved legal framework.
Barbara Freischem, Executive Director, EBE, said “The ability to better co-ordinate the environmental risk assessment required under the GMO-regulations with the advantages of the new Clinical Trial Regulation would clearly help ATMP developers bring their innovative and often much needed products to patients.”
“Harmonized approaches to safety requirements of the GMO registration process for clinical trials would lead to better and faster patient-access to medical innovations. We welcome the dialogue among the different GMO authorities in the EU,” added Ronald Jager, Director of Healthcare Biotechnology at EuropaBio.
“For highly innovative medicinal products such as CAR-T cells, and many new gene therapies for the treatment of severe diseases, GMO regulations are in addition to the regulations for medicinal products and are implemented in different ways in each of the EU’s Member States. This often increases the complexity and duration when receiving authorization to carry out clinical trials” said Jacqueline Barry, Chief Clinical Officer at Cell & Gene Therapy Catapult and chair of ARM’s European Regulatory Committee. “We urge the relevant authorities in the different Member States to consider a harmonization and streamlining of the GMO and clinical trial approval processes for these products, particularly with the upcoming implementation of the Clinical Trial Regulation*” she concluded.
The paper is available for download below.