People regularly ask what genomics has got to do with fertility (beyond genetic testing of embryos) and assisted reproduction law and policy. They are often puzzled about the link between genomic technology and fertility and why this is something they should think about or concern themselves with, instead equating gene editing technology with scientists in laboratories and pharmaceutical trials focused on curing cancer and conditions like sickle-cell and Huntington’s disease.
Over the last couple of years, I have written a number of articles about the rapid development of genomics and why we need enlightened fertility and wider law reform. You can read more in my previous blog “Human gene editing: from evolution to revolution? Why we need fertility and wider law reform part IV”. In doing so, it has become evident that rapidly developing genomic technology, particularly human genome editing technology, increasingly has the capability to change not just the health and futures of individual children, adults and families but the human condition as well. Over time it will increasingly have the capability to not just combat and prevent the onset of serious genetic diseases, but also to overcome infertility and influence and change our biological legacy so as to reduce ill-health in future generations or potentially make them more resistant to diseases or environmental factors or stronger and more athletic. As such, how human genome editing technology is marketed and deployed in fertility clinics and treatment around the world and how it is regulated really matters. It raises all sorts of legal challenges and issues about ethics, social justice, respect for human rights, prevention of discrimination, creation of designer babies and risks that this technology will be used in harmful ways that exploits those in vulnerable situations or deployed for economic gain, global ambition, power and influence.
The World Health Organization’s framework for governance of human genome editing
I therefore welcome the World Health Organization’s (‘the WHO’s) finalised recommendations for global governance and regulation of human genome editing technology which were published earlier this month (July 2021). I am pleased to see that it sets out a governance framework which encompasses not just mainstream genomic healthcare delivery and science but also human gene editing for reproductive purposes as well. In doing so, it provides a quantum shift in thinking and a more cohesive approach to the delivery and governance of human genome editing in science, medicine and fertility treatment settings. I am also pleased to note that its guidance will take into account a wider context and “… will be informed by developments at the frontier of new scientific disciplines such as genomics, epigenetics, gene editing, artificial intelligence and big data, all of which pose transformational opportunities but also risks to global health” because these factors will increasingly influence and shape the overall landscape.
The WHO’s finalised recommendations for global governance and regulation of human genome editing also reinforces my view that important differences between human genome editing have until now been poorly explained or even ignored. It succinctly explains that human genome editing can be used in a variety of ways, in both a non-reproductive and a reproductive context stating in its foreword that “Potential benefits of human genome editing include new strategies for diagnosis, treatment and prevention of genetic disorders; new avenues to treat infertility; new ways to promote disease resistance, contribution to vaccine development and enhanced knowledge of human biology”.
Whilst the WHO’s new governance framework does not provide a panacea, it does mark a step forward in the development of much-needed joined up infrastructure to safely and responsibly harness the transformational power of human gene editing technology and overcome ‘silo mentality’, current gaps and grey areas across international healthcare, scientific and fertility sectors. Its governance framework is designed so that it can be implemented in different contexts and help those tasked with developing or strengthening oversight measures, whether this is as at an institutional, national, regional or international level. That said, the WHO makes clear that it does not have a mandate to enforce governance or implement sanctions for misuse of human genome editing technology. As such, there remains an ongoing risk that some individuals, organizations and nation states will simply pay ‘lip service’ to responsible governance, engage in “ethics-dumping” and covertly undertake human genome editing technology away from public scrutiny or hide in plain sight on their own wider terms. These are risks that we must remain vigilant about because the irresponsible application of this increasingly powerful human gene editing technology has the potential to irreversibly alter the human genome for future generations with unknown outcomes, introduce human enhancements that could cause great inequality and injustice and disrupt and change societies around the world.
World Health Organization: A Framework for Governance of Human Genome Editing
The WHO’s recommendations for global governance and regulation of human genome editing technology was published on 12 July 2021, representing over two years work by an international multi-disciplinary panel of experts. It examines and starts to address the scientific, ethical, social and legal challenges associated with human genome editing (somatic, that is, non-heritable; germline, involving studies on early embryos, eggs, sperm or their precursors; and heritable, where embryos subject to genome editing are used to establish pregnancies and create people who could pass on the edit to their offspring).
The WHO’s governance framework issues a timely reminder that the development and usage of human genome editing technology, such as CRISPR-Cas9, must strike a balance between benefit and harm, safety and speed, innovation and access. It also sets out a succinct table which helps to distil and clarify various different non-reproductive and reproductive current, potential and speculative applications of this rapidly evolving technology including:
- Basic or preclinical research (to alter genes or their activity in cells and tissues including early embryos).
- To treat genetic disorders (e.g. Duchenne muscular dystrophy, sickle-cell disease, beta-thalassaemia, cancer, Huntington disease).
- To avoid inheritance of genetic disorders.
- To treat infertility (to alter genes so that germ cells can form functional sperm or eggs or to correct mutations in germ cells in the testes or ovaries).
- To promote disease resistance (to reduce infectious diseases and reduce cancers).
- To enhance human traits (e.g. alter appearance, abilities, provide resistance to pollutants or environmental agents such as radiation).
- To improve robustness or quality of life (e.g. increase tolerance for lactose or gluten or reduce blood cholesterol levels).
- To add non-human traits (e.g. synthetic genes to improve tolerance to drought, heat or cold or improve sensory systems to ultraviolet or infrared light).
We should not underestimate the immense power and potential of these human genome editing applications. The attraction of avoiding a biological lottery at birth of a much-wanted child or the opportunity to confer perceived advantages or adopt a more proactive approach to prevent or minimise the risks of serious genetic disease will become more evident over time as this technology develops and awareness grows. As we have already seen, individuals are increasingly willing to access fertility treatment and cross international borders in their quest to have a child and access new assisted reproductive technology. The WHO’s recommendations for global governance recognises this stating “…governance for this technology is needed at national levels (domestic policy including laws, regulations and guidelines) and transnational levels (including conventions and treaties, as well as coordination of cross-border movement of researchers, clinicians (including clinician or physician scientists) and research participants or patients”. Declining fertility levels in many parts of the world, increased pressure on female biological fertility windows and growth in later-life parenthood are also likely to drive increased interest in human genome editing over time. This is why we need to develop new global governance to ensure human genome editing technology is used in ways that are responsible and prevents malfeasance and harm now and for future generations.
The WHO’s recommendations for global governance and regulation also importantly identifies the values and principles that help to explain why governance is needed and how those tasked with introducing or strengthening it can achieve this. It explains that the values and principles used to inform how decisions are made are (i) openness, transparency, honesty and accountability, (ii) responsible regulatory stewardship, (iii) responsible stewardship of science, (iv) responsible stewardship of research resources. It also explains that the values and principles to inform what decisions are made are (i) inclusiveness, (ii) caution, (iii) fairness, (iv) social justice, (v) non-discrimination, (vi) equal moral worth, (vii) respect for persons, (viii) solidarity and (ix) global justice. It goes on to explain that careful attention is needed to these values and principles to create trust in governance mechanisms and policy.
The WHO’s recommendations for governance acknowledges the potential dual-use applications of human genome editing technology to confer resistance to chemicals or to radiation for space travel as well as military applications conferring resistance to chemical or nuclear weapons. These applications raise a whole host of further challenging issues which run parallel to and intersect with considerations about use of human gene editing technology in a fertility context. This raises additional questions about the control, regulation and delivery of assisted reproductive technology and the risks of rogue clinicians, scientists or organizations running irresponsible experiments and trials involving human gene editing techniques and the location of such activity in places where there is less or little in the way of responsible governance. This adds further layers of complexity to geopolitical and rapidly evolving biopolitical considerations at play within the overall debate about the appropriate use and regulation of human gene editing technology, be it in a non-reproductive or reproductive or heritable setting.
Many countries currently prohibit heritable human genome editing (‘HHGE’) in the creation of genetically modified individuals, as is the case in the UK and the US. There are, however, increasing numbers of trials involving somatic (i.e. non-heritable) human gene-editing to combat genetic diseases and cancer. Some counties have no laws prohibiting the use of HHGE and allied technologies and this remains a significant concern. In the absence of effective international consensus and governance jurisdictions could develop different paradigms, have a change of mind and adopt different approaches to use of this powerful technology. What one nation state considers to be irresponsible use of human gene editing technology (non-reproductive, reproductive and heritable) another state could see as a responsible way of protecting their national interest. Whilst the creation of gene edited humans with enhanced attributes who could be used for malfeasance is for many hard to conceive, it remains a possibility in reality. We run the risk that gene editing programmes could operate ‘under the radar’ or hide in plain sight in some jurisdictions. This risks nefarious activity and use of this powerful technology leading to the development and release of biohazards that are genetically engineered with the capability to kill and decimate populations and nations, incapacitate or render people infertile in the short as well as medium and longer term. It could also lead to the creation of genetically enhanced human cohorts (e.g. who have enhanced intelligence, strength or resistance to disease) who could be used against or to infiltrate nations across the world for advantage and gain. Some jurisdictions could even potentially want to use this technology to achieve a genetically enhanced human population to bolster their national defence capability, achieve a healthier population, develop a more productive workforce and gain greater global influence. This adds further layers of complexity to issues about the appropriate use and regulation of human gene editing technology.
Armed with the benefit of the WHO’s recommendations for global governance for human genome editing technology, it will be important to see what law and policy decisions, frameworks and sanctions for non-compliance are taken in countries across the world. Integrated multi-disciplinary success is within reach but only if we continue to widen and shift our paradigms and encompass all the evolving factors that form part of this multi-faceted picture. In doing so, this will require us to play close attention to how human gene editing technology is utilised in a fertility context and applied for reproductive as well as non-reproductive purposes.
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