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Parliamentary questions
19 March 2018
P-000932/2018
Answer given by Mr Moedas on behalf of the Commission

Under Horizon 2020(1), research intended to modify the genetic heritage of human beings that could make such changes heritable, or intended to create human embryos solely for the purpose of research or for the purpose of stem cells procurement, is not eligible for funding. Furthermore, the modifications to the subject's germ line genetic identity are prohibited under the EU clinical trials legislation(2)(3).

In 2017, the US National Academy of Sciences, Engineering and Medicine reported that although heritable germline genome editing trials shall not be prohibited, they should only be done for compelling reasons and under stringent conditions. Notably, US federal funds cannot be used for research that destroys embryos nor can the Food and Drug Administration consider a trial on embryo editing.

In reported studies from China and the United States(4), genome editing in early-stage human development showed neither safety nor efficacy in correcting pathogenic mutations. The current approach to avoid the inheritance of genetic diseases such as Huntington’s disease is preimplantation genetic diagnosis. This approach, legal in 17 Member States and permitted in most of the remaining Member States for certain medical indications, remains the most robust method.

The field of genome editing of non-heritable cells to treat and/or cure diseases is funded in Horizon 2020. In order to support the translation of scientific progress in this area, a number of initiatives have been launched(5). In preparing the next Framework Programme for Research and Innovation, consideration will be given to ensure that all the research and innovation activities carried out comply with ethical principles and relevant national, EU and international legislation.

(1)The EU Framework Programme for Research and Innovation (20014-2020).
(2)Directive 2001/20/EC of the European Parliament and of the Council of 4 April 2001 on the approximation of the laws, regulations and administrative provisions of the Member States relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use (OJ L 121, 1.5.2001, p. 34).
(3)Regulation (EU) No 536/2014 of the European Parliament and of the Council of 16 April 2014 on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC (OJ L158, 27.5.2014, p.1).
(4)http://www.nature.com/articles/nature23305 , https://link.springer.com/article/10.1007%2Fs13238-015-0153-5
(5)http://www.ema.europa.eu/docs/en_GB/document_library/Other/2017/10/WC500237029.pdf

Last updated: 20 March 2018Legal notice