Modification of the human genome: Human rights challenges raised by scientific and technical developments Jonathan Montgomery, Professor of Health Care Law Jonathan.Montgomery@ucl.ac.uk

‘Deliberate germline editing in human beings would cross a line viewed as ethically inviolable.’ R2115 (2017) An 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. (Oviedo Art 13) ‘Echoes a wide international consensus’ Rogers & de Bousingen Bioethics in Europe (1995) p 93

The need for an ‘affirmative genealogy’ ‘opens our minds to the way in which historically embodied meaning calls upon us.‘ Hans Joas The Sacredness of the Person (2013) Living documents not originalist fundamentalism Human Rights conventions have specific histories Experts, politicians, publics ‘Value generalisation’ Premature harmonisation? Acceptable margins of appreciation (subsidiarity) Three concerns Pluralism, Relativism, Nihilism (mere ’fiat’)

A genealogy of Art 13: long-standing concerns over… Absolutism ‘exceptional cases (where there is no conceivable alternative) in order to correct recognised abnormalities provided that it is carried out for the purpose of ending of alleviating severe human suffering and that strict standards of reliability and safety are observed.’ (Dec 1992) With regulatory oversight from ‘an independent body, preferably a national ethics committee’ Rejected with unanimous agreement on need for periodic review (5 years discussed) Attempt to insert ‘given the current state of scientific knowledge’ rejected

... Unintended consequences Steering Committee considered risk that cancer treatments with side effects that interfered with germline (1993) Intentions rather than objective effects to address this (1994) Compare objective test offered in 1995 ‘without any intervention in the germ-line’ Assumed that this was assessable because there would be oversight from research ethics committees (1994) Assumed the article would be reviewed (1994)

Language and explanations are unstable ‘Genome’ not ’germ cell line’ ‘Intervention’, ’modification’ not ‘interference’ Now ‘editing’ Not ‘engineering’ R934 (1982) ‘Aim’ to ‘unforeseen side-effects’ and ‘intention’ (explanatory report) Art 13 proposed ‘owing to this uncertainty’ about effects ‘Right to inherit a genetic inheritance that has not been artificially changed’ but with exceptions ‘for example in the field of therapeutic applications’ R934 (1982) based on Arts 2 & 3 ECHR

Human Rights Challenges to denial of access to germ-line therapies Equitable access (Art 3), non-discrimination (Art 11) Private life (ECHR Art 8) engaged and legitimate competing interests must be balanced, fairly and not arbitrarily Blanket bans deny chance to balance Benefits of advances must be available to all (UNESCO Universal Declaration on the Human Genome and Human Rights 1997, Art 12) Progress should be available to ‘future generations’ and ‘all humanity’ (Oviedo preamble) Holding on to the ‘germ-line prohibition is an example of ‘the interest of society’ prevailing over the individual in breach of Art 2 of Oviedo

Time for ‘broad and informed public debate’… Need to clarify the principle behind Art 13 It is not obviously a germ-line rule Need to clarify interplay between individual rights to use therapies and public heath and morals in the light of current scientific understanding Find ways to integrate political, expert, and public opinions into a mature deliberation Consistent with the expectations of those who produced Oviedo and with Arts 28, 31 and possibly 32