At their last plenary session, several members of the Parliamentary Assembly of the Council of Europe (PACE), have signed Written Declaration No. 557 criticising the United Kingdom’s proposal to allow scientists to genetically engineer human embryos using DNA from three parents. The controversial technique was recommended to United Kingdom’s Government by the Human Fertilisation and Embryology Authority earlier this year, even though the creation of a human embryo with more than two genetic parents constitutes a violation of human dignity, according to various international human rights documents. The declaration is an important signal from all over Europe to the UK to stop project that would result in the creation of a three-parent-embryo. PACE members are invited to sign the declaration until end of January 2014.

The Parliamentary Assembly of the Council of Europe, which is an international body charged with upholding human rights and ethical standards, brings together parliamentarians from the Council’s 47 Member States. A total of 34 of the Assembly’s parliamentarians, representing 13 States of Europe from Spain to Georgia, have signed the Declaration affirming “that the creation of children with genetic material from more than two progenitor persons, as is being proposed by the United Kingdom Human Fertilisation and Embryology Authority, is incompatible with human dignity and international law”. 

The Written Declaration cites various internationally accepted documents that support its position. These include the United Nations Education, Scientific and Cultural Organisation’s (UNESCO) Universal Declaration on the Human Genome and Human Rights which asserts in its Article 24 that practises such as “germ-line interventions” could be “contrary to human dignity”.  The Written Declaration is also backed up by the Council of Europe’s European Convention on Human Rights and Biomedicine, whose Article 13 states that “[a]n intervention seeking to modify the human genome may only be undertaken for preventive, diagnostic or therapeutic purposes and only if its aim is not to introduce any modification in the genome of any descendants”.

While these texts clearly prohibit a practice which would introduce inheritable changes into the human germ-line, the Charter of Fundamental Rights of the European Union should also not be forgotten. Its Article 3 clearly states that “[i]n the fields of medicine and biology... the prohibition of eugenic practices, in particular those aiming at the selection of persons” — or the cloning of human beings — “must be respected”. Whereas in the Written Declaration, the signatories clearly consider “that the modification of human eggs or of early embryos for procreation using heritable (germ-line) interventions through the use of genetic material external to the entirety of the two parents’ hereditary information (their genomes) is a eugenic practice”.

This Written Declaration successfully reflects a growing international concern expressed by scientists and bioethicists all over the world. The bioethical advocacy group CARE for Europe has expressed support for the Written Declaration, saying “there are safety concerns about the techniques used in the process of modifying the human germ-line”. Whereas proposals in favour of Three-Parent Embryo legalisation “are being considered as a way of reducing the chances of a child being born with human mitochondrial disease (genetic disorders)”, CARE says “the procedure would only reduce risk of transmission from mother to child, rather than cure it outright”. David Fieldsend, bioethicist and manager of CARE for Europe, has called on the British government “to review its position and not to introduce legislation permitting these highly controversial procedures”, which promise to breach the “key ethical threshold” as firmly established in above-mentioned international documents.

The public interest group, Comment on Reproductive Ethics (CORE), which focuses on ethical dilemmas surrounding human reproduction, also expressed its support for the PACE delegates who signed the Written Declaration, saying “CORE is absolutely delighted that this Declaration against germ-line modification of the human embryo has been successfully registered”. CORE also added that “[v]arious groups of U.S. opponents of germ-line engineering, not least the Center for Genetics and Society, represented by Dr. Marcy Darnovsky, are also hugely encouraged by this initiative”.

Dr. Darnovsky is Executive Director of the Center for Genetics and Society, a U.S. non-profit information and public affairs organization which works to encourage responsible uses and effective societal governance of human genetic and reproductive technologies. She had addressed a public letter in September to the President of PACE to convey the grave concern of the American scientific community on “possible approval in the United Kingdom of techniques known as ‘mitochondria replacement’, which would constitute human inheritable genetic modification”. On behalf of her organization, Dr. Darnovsky said they “believe[d] that approval by the U.K. Parliament of a legal ‘exception’ to permit experimentation with these techniques on human subjects would be clinically, ethically and socially dangerous, and would be a breach of international norms”.

An earlier commentary on the topic by Dr. Darnovsky was published in Nature on July 9 under the title, “A slippery slope to human germline modification”. In it, the scientist states that mitochondrial replacement “would involve a woman affected by mitochondrial disease, whose egg provides a nucleus, a second woman to provide a ‘healthy’ egg and a man to provide sperm”. Based on this, the media has accurately framed mitochondrial replacement as a ‘three-parent babies’ matter.

From Dr. Darnovsky’s point of view, if granted a new regulation, the U.K. “would unilaterally cross a legal and ethical line on this issue that has been observed by the entire international community” as “this consensus holds that genetic-engineering tools may be applied, with appropriate care and safeguards, to treat an individual’s medical condition, but should not be used to modify gametes or early embryos and so manipulate the characteristics of future children”.

Supporters of the idea of a three-parent embryo believe such treatment could reduce the risk of children having potentially fatal illnesses, as well as save lives due to the substitution of damaged DNA (from a mother at risk of passing on a mitochondrial disease such as muscular dystrophy) with some from a healthy female donor.

Dr. Darnovsky acknowledges that it is “easy to sympathize with” techniques that are aimed “at allowing a small number of women, those affected by a particular kind of mitochondrial disease, to have healthy children who are genetically related to them”. However, it is also important to note that “these women have much safer alternatives, including pre-implantation genetic diagnosis and the use of third-party eggs with conventional IVF”. Moreover, this substitution technique could be criticized for doing “nothing to help people who are living and suffering with mitochondrial disease”.

Moreover, the widely used statistics used in arguments in support of mitochondrial replacement seem quite uncertain. Dr. Darnovsky says that while “[t]he U.K. Human Fertilisation and Embryology Authority (HFEA) repeatedly claims that 1 in 200 children is born each year with a form of mitochondrial disease”, the consensus of the scientific community “is that the number is more like 1 in 5,000”. Furthermore, even “[a]mong that much smaller group, a significant majority of cases involve mutations in nuclear as well as in mitochondrial DNA, and so could not be helped by mitochondrial replacement”.

PACE members or their subsitutes can sign the declaration until 31st of january 2014 through the tabling office of the Council of Europe. Signatures can be sent by fax, scan of hard copy.