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Parliamentary questions
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3 June 2019
E-001550/2019(ASW)
Answer given by Mr Moedas on behalf of the European Commission
Question reference: E-001550/2019

Genome-editing technologies can cure or treat patients affected by life-threatening diseases. In order to support these technologies, the EU has already invested more than EUR 450 million in research projects, including more than EUR 166 million since the start of Horizon 2020(1).

Examples include the projects Cell-PID(2) and UPGRADE(3), always complying with our framework’s ethical principles and relevant national and international legislation. Remaining calls in Horizon 2020 further support genome editing approaches and support will continue in Horizon Europe through the ‘Health’ Cluster of Pillar II, paving the way for their swift uptake into health systems.

Regulation No 1394/2007(4) governs the use of genome editing techniques in medicinal products for human use. The regulation provides for strict controls of quality, safety and efficacy and a centralised assessment by the Committee for Advanced Therapies.

Recognising the potential of gene therapy medicinal products — including genome-editing approaches, the Commission is working with the Committee and Member States to support developers while ensuring a high level of public health protection.

Examples are the recent Guidelines on Good Manufacturing Practices (GMP) for Advanced Therapy Medicinal Products and the ongoing development of scientific guidelines for gene therapy medicinal products, including genome editing approaches.

The Commission is exploring different activities to stimulate and inform the scientific and social debate on the applications of genome editing technologies for healthcare. A public survey such as Eurobarometer could be considered.

(1)The EU Framework Programme for Research and Innovation (2014-2020)
(2)on advanced cell-based therapies for the treatment of primary immunodeficiency https://cordis.europa.eu/project/rcn/96787/reporting/en
(3)which aims to improve precision gene therapy — https://cordis.europa.eu/project/rcn/219838/factsheet/en
(4)OJ L324, 10/12/2007.

Last updated: 3 June 2019Legal notice