Editor’s note. Caroline Simons attended both the April 28th (see her report on that here) and 29th Paris meetings on human gene editing/genetic modification. Today, we have her in depth report on the April 29th meeting. I have posted her piece in full with only minor edits. If you are in a rush you can skip to the last page for Caroline’s top 10 takeaways from the meeting.
By Caroline Simons
The meeting of NAS and NAM which took place in Paris on 29 April was webcast live. A recording of the presentations will be posted in the coming weeks. This blog post is my record of the presentations and an attempt to give an overall impression of the discussions.
This meeting is one of a series which has been organized by the Committee to assist in its examination of the ‘scientific underpinnings as well as the clinical, ethical, legal and social implications of the use of human genome editing technologies in biomedical research and medicine.’ The Committee is examining both somatic and germline genome editing. It focuses on 7 areas in particular. These relate to the current state of the science, future directions and challenges, potential clinical applications, alternative approaches, and the efficacy and risks of gene editing in humans. The Committee asks if explicit scientific standards should be established to quantify off-target genome alterations, if current ethical and legal standards for human subjects research adequately address human gene editing technologies and what are the ethical, legal and social implications of the use of these technologies in humans. The Committee seeks to identify what principles or frameworks might provide appropriate oversight for these technologies and to assess the prospect of international harmonization of policies.
The Committee will prepare a report and make recommendations later this year. This report will ‘include a focus on advice for the United States’, and will ‘provide a framework based on fundamental, underlying principles that may be adapted and adopted by any nation’.
This 3rd Consensus Study Meeting was a larger gathering than the meeting of FEAM, the UK Academy of Medical Sciences and the Académie Nationale de Médecine France which was held the previous day. Attendees included European Commission representation, prominent scientists, philosophers, ethicists and lawyers from Europe, the US, Canada, China, Singapore and Malaysia. Three panels of speakers addressed the principles underlying governance, international governance perspectives and potential applications for germline editing. The meeting wrapped up with a moderated discussion among all of the attendees.
It was clear from the outset that there would be no consensus in favour of germline editing. Most of those who spoke objected to it for reasons of safety based on the current insufficiency of scientific understanding. This was not the only reason for opposition. In the first session, which considered the principles underlying governance of gene editing technologies, a presentation was made by a scientist who is also a member of the Roman Catholic Pontifical Academy of Life. Professor López Barahona began from a position that deemed the use of embryos for research unacceptable because it treats the embryo as mere ‘biological material’ and results in their destruction. She advocated a complete ban of embryo gene editing either for research or therapeutic purposes. She proposed a ban of any human germline gene editing either for research or for therapeutic purposes that ‘implies transmission to offspring.’ This would prohibit editing of gametes, primordial cells and creating artificial gametes for reproductive endeavour. Provided the risks were not excessive or disproportionate to the gravity of the condition for which a cure is sought, she advocated regulation of somatic gene editing for therapeutic purposes and regulation of clinical trials of somatic gene editing. She sought a complete ban on gene editing for enhancement of human beings. In the discussion which followed this presentation, it was suggested that if gene editing were used in a well understood genetic condition and could be shown to have changed only the defect, that it would be difficult to find any argument against it which was not related to the moral status of the embryo. This was considered an insufficient basis on which to reject the technology.
The concept of dignity was discussed and the manner in which it was suggested that gene editing technologies could adversely affect the dignity of the embryo was questioned. Dr. Bartha Knoppers described dignity as a source of human rights rather than a human right of itself. She advised that the greatest universality exists in the human rights domain and ‘not in loose usage of terms such as eugenics, dignity, moratoria etc.’ She questioned why this was even being discussed. She cautioned that in taking this approach, worrying about future generations etc., this ‘unethical trump card’ couldn’t be answered because ‘no further discussion is possible when facing those terms that in and of themselves you cannot define.’ Dr. Søren Holm also questioned the meaning of dignity in this context and asked how it would be affected by gene editing.
Professor Jackie Leach Scully said that the people most likely to be affected by gene editing were missing from the discussion. She considered the potential socio-ethical impact of gene editing technologies on the so-called ‘disability community’ and on the manner in which members of that group would be perceived and treated. She spoke of the wide variety of opinion and some ambiguity about disability among disabled and chronically ill people. Some consider their disabilities as variations which are part of the diversity of life and which require some accommodation rather than editing out. She spoke of the need to recognize the views of people with disability and observed that PGD has changed people’s opinion, often for the worse, about how disability is viewed. She said that governments could be doing a lot more to improve the wellbeing of disabled people before planning on editing their genes.
Professor Leach Scully also pointed out the likely disproportionate effect of this technology on women. Women tend to be the caregivers for disabled people and will have to deal with the fallout of these new treatments. Women are likely to be the first recipients of gene therapies to improve fertility. Research projects are underway in Sweden and in the UK that will use gene editing technology to study early embryonic development. This will increase scientific knowledge and may avoid miscarriage and improve fertility treatment. Professor Leach Scully observed that ‘ Both initial research and ultimately treatment involves early embryos or eggs.’
Gemma Ortiz Genovese of Médecins sans Frontières added that another group was left out of the discussion – people living in poor countries. She asked how the benefits of ‘an elitist treatment’ will be shared with people in the developing world. She said sickle cell disease, malaria and dengue kill hundreds of thousands each year in the developing world. She mentioned gene editing strategies that are being developed which may edit mosquitos, which spread dengue and malaria, such that they will be unable to reproduce. She said that governance structures should ensure that the needs of people in developing countries are met.
Dr. Søren Holm proposed that the best way to achieve this would be to provide incentives for companies to invest in the technology. He said that in the past this had been done by shaming them when they do not. Dr. Holm emphasized the need for strong focus on the risk being sufficiently controlled before first use of gene editing technology in embryos. If it were being used for serious medical reasons, the risk would be assessed in a balancing way. But he warned that unless there is control of its use for other things, it will inevitably be used for situations where this balancing doesn’t take place.
Bethan Wolfenden of Bento Bioworks said that any policy on human gene editing would also have to take account of the DIY biology community who conduct their own low-budget genetic research. They have shown a lot of interest in CRISPR technology and how they might be able to use it. Ms. Wolfenden suggested that any policy framework should anticipate the access of this community to this knowledge and should assist them in managing their projects.
During the discussion of this session, Dr. Knoppers was asked about the lack of a universal bioethics and the possibility that in certain parts of the world gene editing techniques could be offered as part of the bio-economy, without any protections of human rights law. The defeat of the international convention against human reproductive cloning was cited. Dr. Knoppers responded that the discussion should concentrate less on trying to find principles in common, but rather focus on harnessing approaches.
In the second session, presentations were given on the governance perspectives of China, Singapore, Malaysia, the UK, Belgium and Spain. As I was unfamiliar with their regulatory landscapes, I was very interested in the presentations from the countries of the East. Given the international criticism that followed the publication of two Chinese research papers (the first by Dr. Huang et al and the 2nd more recent one in April of this year) on the use of CRISPR technology in 3PN embryos, the audience was particularly interested in the presentation of Professor Xiaomei Zhai.
Professor Zhai is the Executive Director of the Center for Bioethics at the Chinese Academy of Medical Sciences (CBCAMS) (and I take it from her slides in the first person plural, ‘we’, that she represented the views of that institution). Professor Zhai explained that the Chinese ethical and regulatory guidelines on clinical trials and biomedical research comply with universally accepted international documents including the Nuremburg Code, Helsinki Declaration and CIOMS/WHO International Ethical Guidelines. Regulations clearly stipulate that gene manipulation on the human gamete, zygote and embryo for the purpose of reproduction is banned in China. Clinical trials of somatic gene modifications are legally permissible within the terms and conditions set out in regulations.
The CBCAMS holds that ‘the regulated research in germline gene therapy (GGT) must not “Play God”, violate the sanctity of life, open a Pandora Box leading to eugenics, and current generation does have a responsibility of preventing serious diseases in future generations.’ It considers therefore, that ‘if the risk-benefit ratio is acceptable, a total ban on GGT is not ethically justifiable.’ Mitochondrial replacement techniques (approved in the UK) have not been approved in China, a position Professor Zhai described as prudent. She noted the recommendation in the Policy Forum published in Science on 19 March 2015 that steps be taken to “strongly discourage….any attempts at germline genome modification (GGM) for clinical application in humans, while societal, environmental, and ethical implications of such activity are discussed among scientific and governmental organisations.” She said that this was compatible with the views of Chinese bioethicists and the current policy of the Chinese regulatory bodies on GGM. She strongly rejected any suggestion that Dr. Huang had overstepped Western ethical boundaries because his research was not directed to any reproductive endeavour and most definitely not directed to the production of ‘designer babies’. His research was not a clinical trial, but an ex vivo experiment using unviable embryos which was directed to the improvement of genome editing technology. Professor Zhai said that this research will not harm anybody and that it will help to treat and also to prevent genetic diseases or gene related diseases in humans.
The CBCAMS does not regard the human embryo as human being and considers that the moral status of embryos should be lower than that of a human life after birth. This is also the view of most Chinese people. The question of whether ex vivo experiments on human embryos should be discouraged by the Chinese authorities is not decided.
Human enhancement by gene editing is not ruled out absolutely. The CBCAMS considers that they have no professional responsibility to provide enhancement for non-medical purposes. They consider that the risks outweigh the benefits ‘to the extent that we may not accept.’ They believe that the pursuit of the ‘perfection’ of human traits cannot be ethically justified and take the position that future children should be given an open future and that we ‘should not limit them in the range of genome we select for them’. Enhancement ‘for medical purpose’ ‘should be very carefully considered’. This type of enhancement appears to relate to the removal of and substitution for defective genes. Professor Zhai pointed to the excessive or extraordinary risks that might be involved and to the fact that adding genes instead of repairing them might interfere with the normal expression of other genes.
Professor Zhai emphasized the necessity for discussion of the societal, environmental and ethical implications of gene editing technology among scientific and governmental organisations and the necessity to engage scholars from the humanities and the public in this discussion. Like many of the speakers in Paris, she spoke of the need for ‘broad informed consent from the public’ to the use of this technology in humans. She was asked what attitude China might take if the European Union were to decide that the embryo has special meaning and shouldn’t be used for research. Her response was that China was ‘harmonized but not identical on non hard core areas.’
Dr. Jacqueline Chin advised that there are no regulations which deal specifically with gene editing and CRISPR technology in Singapore at this time. Singapore’s National Medical Ethics Committee’s (NMEC) Ethical Guidelines for Gene Technology of 2001 prohibit germline modification or inheritable genetic modification and allow somatic gene therapy to be carried out under stipulated conditions. The NMEC guidelines advocate a moratorium on the clinical application of germline modification in the interest of the fetus and the mother, in view of the risk to future generations and observe that ‘The line between germ-line gene therapy and eugenics is a tenuous one.’ The Bioethics Advisory Committee (BAC) took the same position in 2005, but undertook to monitor progress in germline genetic modification and to reassess its clinical applicability ‘at an appropriate time in the future.’
The BAC’s 2015 Ethics Guidelines for Human Biomedical Research (the BAC Guidelines) provide that embryos may be created for research, but only ‘where there is strong scientific merit in and potential medical benefit from such research. The BAC Guidelines provide that human embryos created for research by IVF of human eggs by human sperm, or created through any form of cloning technology, should not be allowed to develop beyond 14 days in vitro and should not be implanted into the body of any human or animal. It appears that the 14 day limit may not apply to human-animal combination embryos. All research involving human oocytes and embryos, including human-animal combination gametes or embryos, require approval of the authorities.
Following the UK’s move to permit the licensing of mitochondrial replacement techniques for clinical use, a Germline Modification Working Group (WG) has been established by the BAC. This body will prepare a public consultation paper. Dr. Chin described the WG’s framework as neutral in its outlook regarding assumptions about inherited genetic modification and identity issues. She believes that the framework reflects an openness to the possibility of change and said that the welfare of the future child, reproductive autonomy and potential risks and expected benefits will be explored.
Dr. Chin observed that the bio-economy is an important driver of this technology in Singapore. She said that a balance has to be struck between the desire not to be left behind and what will benefit the population. She emphasized that Singapore cannot be left behind.
Professor Rahman Jamal explained that there are national guidelines regarding reproductive technology in Malaysia, but no legislation at present. There is a dual system of law in Malaysia. Fifty-five percent of the population is Muslim. The Malaysian Constitution provides that Islamic law is a state law matter. Muslim jurists or the National Fatwa Council must be consulted when considering regulation regarding assisted reproduction, the use of stem cells etc. The International Islamic Code for Medical and Health Ethics of 2005 provides that the introduction of foreign genetic material into genital cells will change their structure, and will initiate effects on future generations and produce mixing of lineages which is not permissible. This Code provides that using genetic engineering for human beings is permissible if it is for purposes of disease prevention or therapy, provided that controls are applied to seek benefit, avoid harm, and prevent any confusion of lineage. In 1998, the Council of Islamic Fiqh Academy – Muslim World League approved benefiting from the science of genetic engineering in disease prophylaxis, cure or minimizing harm, provided harm should not exceed benefits. Professor Rahman advised that germline editing would not be allowed, but that somatic applications will be permissible.
Regarding research on embryos – the National Fatwa Council ruled in 2005 that research is permissible on excess embryos left over from IVF provided the couple has given informed consent. This applies only to Muslim couples. Unlike the US, China, UK and other jurisdictions which prohibit research on embryos after day 14, Professor Rahman advised that that majority of Muslims believe that ensoulment of the embryo occurs at 120 days and research is allowed to that point. (Scientific advances have prompted recent calls for the re-evaluation of the 14 day rule. This is coming up increasingly at conferences and I note that in the UK, the Nuffield Council on Bioethics will address this in its work later this year).
Mr. Lawford-Davies reiterated his advice to the FEAM meeting that that the UK is the best place in the world to do gene editing research and for clinical application and that it has a model regulatory framework which should be adopted by other jurisdictions. A research proposal is made to the Human Fertilization and Embryology Authority (HFEA). This must demonstrate that the research is desirable, not necessary. This research may be desirable in order to increase knowledge of disease, develop treatments etc., as provided in the legislation. If human embryos are to be used in the research, this use must be shown to be necessary. No embryo used in research can ever be used in reproduction. This research may only be undertaken by licence from the HFEA.
Germline gene editing for treatment (i.e., reproduction) is potentially licensable, subject to the condition that no nuclear or mitochondrial DNA of a cell can be altered while it forms part of an embryo, except to try to avoid the transmission of serious mitochondrial disease. Germline modification for clinical application is not allowed for any other purpose. Any change in this position would require amendment of the primary legislation.
Mr. Lawford-Davies made particular note of the absence of morally loaded terminology in the UK legislation. It doesn’t use terms like ‘eugenic’ or ‘dignity’, but states a simple prohibition, with no reason given. He spoke of the tension around the possibility of characterization of an embryo which has been subject to gene editing as a medicinal product, thereby bringing the activity within the terms of the European Union (EU) Clinical Trials Directive. Alternatively, it is possible that gene editing would be regarded as the application of a process rather than the creation of a separate product. Issues might arise under the EU Charter of Fundamental Rights which prohibits eugenic practices. Mr. Lawford-Davies advised in conclusion that the UK regulatory position offers a ‘stable, flexible and potentially permissive framework.’
Dr. Guido Pennings proposed that Belgium, not the UK, is the best country in which to do gene editing research. The law relating to research on human embryos is governed by the subsidiarity principle. This requires that research is first carried out on somatic or embryonic stem cells. If this is not possible or not the appropriate way to proceed, then research may use unused existing embryos and if that does not work, embryos may be created for research. There are currently approximately 5000 embryos available for research. Belgium has not signed or ratified the Convention on Human Rights and Biomedicine (the Orviedo Convention) because it was perceived that this convention might impede scientific progress. Belgium is unlikely to follow international co-ordination on gene editing unless forced to do so. Embryos on which research has been performed may not be used for reproductive purposes unless the research has a therapeutic goal for that embryo. Gene editing of embryos is allowed if it has a therapeutic goal. Germline gene editing is also permitted subject to the same requirement. Enhancement and eugenics are not allowed (but it is not certain what enhancement comprises. For example, enhancement of immunological systems for therapeutic purposes might be allowed). Cloning, social sexing, and creation of chimeras and hybrids are prohibited. To date, no gene editing project has been submitted to the Federal authority for approval.
Dr. Anna Veiga explained that Spain has signed and ratified the Orviedo Convention. Article 13 of that convention concerns interventions on the human genome. It provides that ‘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.’ Article 18 deals with research on embryos in vitro. It provides that where research on embryos is permitted, that adequate protection of the embryo must be ensured. It prohibits the creation of embryos for research. The Spanish law on assisted reproduction enables the donation for research of cryopreserved human embryos which are no longer required for a parental project. This law also permits research with human gametes and embryos (up to 14 days) subject to the satisfaction of specified requirements, the approval of the competent authorities and that provision is made for a follow up study of the approved projects. In apparent contradiction of the Orviedo Convention, therapeutic techniques can be performed in the pre-embryo with the aim of treating a disease and preventing its transmission. This therapy should avoid modification of non pathologic traits. Dr. Veiga presented research which indicated that approximately 35% of couples who no longer required their embryos which had been cryopreserved for 5 years+ would be willing to donate them for research. In contrast, couples whose embryos had been cryopreserved for 2-4 years wished to keep them frozen. It appears that if embryos are produced with donated gametes, couples would prefer to donate them to other couples rather than to donate them for research.
Somatic cell nuclear transfer (SCNT) is permitted for the derivation of human embryonic stem cells. Human embryos may not be created for research. However, the definition of ‘embryo’ is one produced by way of fertilization and what is created by SCNT is not considered an embryo for the purposes of the legislation.
It appears therefore that germline gene editing might be possible under Spanish law, subject to approval by the competent authority. To date, no research projects involving germline genome editing have been submitted for review and authorization by the Spanish National Commission for Assisted Reproduction.
In the discussion which followed these presentations, the speakers responded to questions of Dr. Penning about the oversight, data gathering obligations and openness of ART and IVF in their countries and the prohibition on the creation of animal/human chimeras.
Session 3 – Potential applications
In the third session Dr. Fredrik Lanner, Dr. Thomas Voit, Dr. Hans Clevers, Dr. Elizabeth Vroom and Professor Joerg Oliver Semler spoke about developments in gene editing technology and potential applications for germline editing.
Dr. Lanner told the meeting that inheritable genetic modification of human embryos is not permitted in Sweden and that research on embryos can only be done in the first fourteen days. His research team will begin experiments this year to disrupt key genes in the 4-cell stage embryo using CRISPR/Cas9 in order to better understand human embryo development.
Dr. Voit discussed the recent research and clinical trials regarding Duchenne Muscular Dystrophy. He said that research has shown proof of concept of germline editing of dystrophin DNA mutations. Most of the gene corrections so far have been incomplete in that they create deletions. Efficacy is limited and there are some side effects, but no genetic off-target effects noted. The corrections create a semi-functional dystrophin, sufficient to make the disease mild. All of these improvements are transient; the transferred gene will eventually be diluted. Nonetheless, in principle full dystrophin correction may be possible for many partial gene duplications.
Dr. Voit gave his opinion that there is ‘no high unmet medical need’ for germline editing for the dystrophin gene, that preimplantation genetic diagnosis (PGD) is preferable and available in almost all cases or scenarios. He pointed out that germline editing today can only correct a fraction of dystrophin mutations. Nevertheless, proof of concept has been established. In time, endonuclease-linked DNA correction will evolve for genome and germline editing.
Professor Semler spoke about his research on the possibility that transplantation of fetal mesenchymal cells before and/or after birth will ameliorate severe Osteogenesis imperfecta. He described the variability of phenotype in three generations of his family. He believes that it will be possible to improve bone quality without changing the genome of the fetus by transplanting cells which produce ‘normal’ collagen in addition to the impaired collagen. He anticipates no cure, but more ‘causative treatment’ than is available today.
Dr. Clevers’ research team has applied CRISPR/Cas9 to disease correction in adult stem cells isolated from cystic fibrosis patients. His team has demonstrated functional correction of the gene in clonally expanded intestinal organoids. Dr. Clevers couldn’t conceive of any situation where using CRISPR/Cas9 on an embryo wouldbe feasible. He said that if it were applied to a single cell embryo, it would kill the embryo and if it were applied to an eight cell embryo that one might as well do embryo selection (PGD).
Dr. Vroom is President of the Dutch Duchenne Parent Project and has expertise on the subject of Duchenne Muscular Dystrophy. She said that she didn’t want a ban on germline research, but observed that PGD is safer than genome-editing in humans. (Dr. Lovell-Badge pointed out that PGD relies on the mother being sufficiently healthy for the cycles of treatment that would produce embryos for PGD). Dr. Vroom presented the findings of a recent University of Amsterdam opinion poll which were largely favourable to the idea of somatic gene editing in humans and which showed a majority in favour of germline editing in order to avoid the transmission of inherited disease. She noted that the poll was conducted after a television programme on gene editing which might suggest bias.
The final session was co-chaired by Professor Alta Charo and Professor Jeffrey Kahn. Professor Charo is co-chair of the Committee.
Professor Charo described the US regulatory framework in relation to gene editing. She said that somatic gene editing is likely to be treated as standard research, subject to the rules regarding clinical trials, risk:benefit analysis at local and federal level. The manipulated cell is a medical process, even though it has been edited. The FDA can decide if the evidence shows that it is sufficiently safe and effective for use in clinical care. Once approved for one use in one population for one indication, this technique cannot be advertised for another purpose. However, doctors can in their own judgment prescribe the technology for another use. This is ‘off label use’. There is therefore somewhat less effective control of medicinal products after single use approval has been given.
An additional layer of review operates in the area of gene therapy. This is sometimes triggered by funding, sometimes it is voluntary. It gives a chance to review new technologies and to provide a public forum. It is an advisory review, not a decision-making process.
Research involving the human embryo is subject to limitations at federal and at state level. This research is legal in most US states. It is legal to make embryos for research and to use embryos in research, but the federal government will not fund research that puts the embryo at risk. Thus, research is funded by individual state governments, by companies etc. Each funder stipulates its own requirements, for example in relation to the kind of embryo to be used and the form of consents required.
There is a temporary legislative obstacle for approval of the FDA for use for clinical treatment of heritably altered embryos. There is a new legislative prohibition on the FDA reviewing a request for clinical trial of a manipulated embryo with heritable changes. This means there is no path forward. This prohibition will technically end on 30 June, but will probably be renewed in the budget bill.
Doing therapy in utero on a fetus is legal. There are special controls around the degree of risk that can be caused to a fetus. The pregnant woman has to give consent. The consent of the intended social father or genetic father is also required.
In Canada, legislation to control ARTs includes a number of prohibitions which are subject to criminal law, including genetically altering an embryo or germ cells which would cause heritable alterations. The provinces went to the Supreme Court and said that this law (over)steps into the provincial jurisdiction. No regulations have been laid out. As it stands, everything else is open for business. Human embryo research is permitted, human embryo stem cell research has to go through an agency.
Professor Jennifer Merchant, Professor Charo and Professor Ellen Wright Clayton discussed briefly the impact of Roe v Wade which made abortion a civil rather than a criminal matter (as it is in some European jurisdictions). Professor Clayton said that ART is almost completely unregulated in the US, which leads to a situation where ‘My liberty means I can tell you what to do.’ She observed that this is inherently contradictory and that the inability to regulate means a lot of things go on without obstacles. She said that medical practice is not hugely regulated, but doctors have huge freedom.
A question was asked if patents and the current patent dispute would interfere with research involving CRISPR/Cas9. The response was that patents wouldn’t interfere with research. In the US, research includes phase 1 and 2 trials. There would only be a problem if somebody tried to monetize use of the technique. But the point was made that the patent dispute would have a certain inhibiting effect on investment, especially for small start-ups.
Professor Charo asked if there was any consensus on enhancement, even in the somatic area. She asked what kind of policy would make sense as a recommendation to a single government or to a collective government. She said that most presentations suggested enhancement should be prohibited, but didn’t explain what is meant by ‘enhancement’. She gave as an example cataract surgery that would replace impaired sight with perfect sight rather than mediocre eyesight and asked if that would be enhancement. There were two responses. Dr. Lovell-Badge proposed that a prohibition on enhancement means that one can’t do anything that doesn’t exist in normal human populations. Professor Ewa Bartnik referred to an article in the Economist on human enhancement, which, she said, was getting lost in things that are impossible (which someone said are hyped by certain elements of the press). She suggested that (scientists) should say what could be done before anyone starts making regulations.
Dr. Peter Mills of the UK’s Nuffield Council on Bioethics acknowledged the potential of genome editing as ‘disruptive’ technology. He said that the UK has PGD which will deal with most of the indicators (for genetic defects). He cautioned that if genome editing becomes the technology of choice that the UK could become the only country doing PGD while everyone else is doing genome editing.
Top takeaways from the meeting –
- Germline gene editing technologies are not ready for clinical application in humans.
- No country has regulated specifically for these technologies, but some consider that their regulations would encompass, or at least not prohibit, somatic gene editing.
- Most countries prohibit germline gene editing.
- There is no support for the clinical application of germline gene editing, but there is consensus that basic research should continue.
- There is consensus that research and, when safety and efficacy concerns are satisfied, that clinical trials of somatic gene editing should continue.
- There is no common understanding of ‘enhancement’ and no consensus that editing to achieve it should be permitted, even in somatic cells.
- The UK is the only country to permit mitochondrial replacement techniques (MRT), which will result in germline alteration. Neither the US nor China consider it prudent to approve MRT technology at this time.
- There is no consensus on the status of the human embryo (or even on what is an embryo), no consensus that embryos may be created for research or that they ought be available for research beyond the fourteenth day.
- The scientific evidence presented in the session which considered potential applications for germline editing did not demonstrate any ‘high unmet medical need’ for germline editing at this time. In fact, Dr. Clevers couldn’t think of any situation where using CRISPR/Cas9 on an embryo would be feasible.
- There is consensus that public discussion of gene editing technology is urgently needed and that ‘broad, informed consent’ from the public is necessary before any clinical application of gene editing in humans.
About the author. Caroline Simons is a BCL Dip Eur Law LLM (International and European Intellectual Property Law) Solicitor. She is currently a candidate for an MA in Bioethics and Medical Law at St Mary’s University, London. She did her dissertation for LLM at Trinity College Dublin in 2014, which was on subject of 3-Person IVF. Currently she is researching legal issues around germline editing techniques for MA dissertation. You can follow her on Twitter here.