Turkmendag I

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Page 1    LexisNexis  Heritable genome editing ‘morally permissible’ but will require ‘international consensus’ LNB News 17/07/2018 110 Nuffield Council on Bioethics has found that heritable genome editing could be ‘morally permissible’ but will require significant governance to ensure that genome editing proceeds in an ‘ethically acceptable’ manner. Lawyers from Allen & Overy, Fieldfisher and Mills & Reeve LLP, and academics from Newcastle Law School, discuss the importance of regulation in this ‘ethically difficult, but socially and commercially important field’, highlighting that it is ‘not a decision for the UK government to make unilaterally’. The Council recommends that two principles should guide the use of genome editing. These are: • they must be intended to secure and be consistent with the  welfare of the future person • they should not increase disadvantage, discrimination or  division in society Other findings include: • research should be carried out on the safety and  feasibility of genome editing interventions to establish  standards for clinical use • social research should also be carried out, to develop greater understanding of the implications of genome editing for the welfare of the future person • the UK government should work with international human  rights institutions, such as the Council of Europe, to promote  international dialogue and to develop a framework for  international governance of heritable genome editing  intervention The Council also recommends the establishment of an  independent body in the UK to promote societal debate on the  issue, and related scientific and medical developments. ‘Only a matter of time before human germline editing  becomes a reality’ Isabel Teare, lawyer at Mills & Reeve LLP, notes that the  question surrounding ‘designer babies’ has been around for a  long time, but the recent emergence of ‘highly accurate gene  editing techniques’ means that researchers are now able to  ‘manipulate genetic material much more easily’. Teare adds it is ‘only a matter of time before human  germline editing becomes a reality’, due to a ‘powerful  desire’ of parents to improve their children’s future lives,  as well as ‘economic incentives’ for those developing  techniques to tackle genetic diseases. Dr Ilke Turkmendag, acting director of Law, Innovation, and Society at Newcastle Law School, highlights that the UK’s scientific progress in this field would largely depend on both the ‘optimism of the public, and its reputation for “permissive-but-strict” regulations’. Turkmendag warns that it is ‘important to critically assess  whose voices, and which assumptions shape any future regulations,  the worldwide implications of the UK’s regulatory decisions,  and our responsibilities toward future generations.’ Laëtitia Bernard, partner at Allen & Overy, says that  ‘much of the position in the national law in many  countries—including the UK—will need to change before it is  legal to perform gene editing of germ line cells or embryos for  reproductive purposes’. Bernard adds: ‘The exclusion from patentability for such  processes will also need to be amended before they can be  patented. If the status quo of unpatentability remains, once  CRISPR-Cas9 research on animal genomes leads on to research into  commercial human interventional products or services, it is  likely that any applications for patents will either be refused  or opposed on the grounds of being unpatentable subject matter,  well before any issue of enforcement arises.’ Bernard also notes that inventors will likely ‘fully explore  other options to secure patent protection’ and ‘push the  boundaries of existing case law in this regard’. Page 2 ‘Likely to raise human rights claims’ Sarah Ellson, partner at Fieldfisher, says it is important  that although the Nuffield Council’s recommendation is that  genome editing could be ethically applicable does not mean it  should be ‘allowed to be done anytime soon in the UK’: ‘Any legislation will take time to develop and debate, the  Nuffield report is intended to help inform that debate. Were it  to be decided that this is something we want to allow to happen  in the UK, it is likely that the law will follow a pattern  similar to the tests which already exist, which means that  embryos can only be tested for pre-implementation genetic  diagnosis) for the most serious of diseases or  abnormalities.’ Turkmendag discusses the human rights claims that are likely  to stem from heritable genome editing, noting that groups such as  rare disease patients might push for the ‘right to have a  healthy child’: ‘If the regulations allow genome editing to avoid  transmission of heritable disease, this would potentially provoke  counter-claims from, say disability rights campaigners. These  rights claims should be taken into account and given an equal  weight in regulatory decisions. ‘International harmonisation through soft law could be a  possible solution, as such mechanisms can help establish a  universal common goal for genome editing in a domain where the  actions of a single country can have global impact.’ ‘Not a decision for the UK to make  unilaterally’ Professor Dave Archard, chair of the Nuffield Council on  Bioethics said: ‘Huge advances are happening in genomics  research, and whilst we have to acknowledge that genes alone do  not shape a person, the possibility of using genome editing in  reproduction to secure or avoid a characteristic in a child  offers a radically new approach that is likely to appeal to some  prospective parents. ‘There may be good reasons for allowing some parental  preferences to be met, but we need to be careful that the use of  genome editing to help parents to exercise these preferences  doesn’t increase social disadvantage, discrimination or  division and that close attention is paid to the welfare of those  involved, especially any child born as a result.’ Teare notes that law and regulation in this area ‘varies  widely between countries’, but the engagement by Nuffield  Council is a ‘welcome development’. Tear adds that that the  right approach is to ‘build an international consensus now’,  instead of waiting for human germline modification to become a  reality. Bernard adds: ‘While the fact that subject matter may be found unpatentable on the basis of being “contrary to ordre public or morality” (Article 6(1) of the Biotechnology Directive 98/44/EC) allows the law to flex and shift in line with changing societal attitudes, it also leads to inherent uncertainty in the legal position of patents in this ethically difficult, but socially and commercially very important field. ‘Should it eventuate that the germ line gene editing is  practically unpatentable, then in the absence of the commercial  incentive provided by patents, it may well be the case that  public funding will be required for the public interest to gain  the most from developments in this technology that are applicable  to humans.’ Turkmendag concludes that even if the research can be proven as safe and in the best interest of future children, the UK should not permit heritable genome editing by itself: ‘These techniques will affect the entire human genome pool, and therefore not a decision for the UK government to make unilaterally.’ Source: Report: Genome editing and human reproduction—social and ethical issues     RELX (UK) Limited, trading as LexisNexis®. Registered office 1-3 Strand London WC2N 5JR. Registered in England number 2746621. VAT Registered No. GB 730 8595 20. LexisNexis and the Knowledge Burst logo are registered trademarks of RELX Inc. © 2017 LexisNexis SA-0617-25. The information in this document is current as of June 2017 and is subject to change without notice.  

Heritable genome editing ‘morally permissible’ but will require ‘international consensus’

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