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Why we need fertility law reform: the paradigm shift

Over the next ten to twenty years and beyond, the world will evolve rapidly to take account of powerful digital, artificial intelligence, genomic science, epigenetic and human reproductive revolutions. These will increasingly blur the lines between the physical, digital and biological spheres. As more people embrace the transformational impact of these technological revolutions and calculate the economic benefits, we will see new trends resulting in fewer natural conceptions, more genetically planned parenthood and increased demand for fertility treatment.

However, these technological advances also create immense responsibilities. We will need to adopt an enlightened and multi-disciplinary approach as genetic medicine and science increasingly cross-cuts fertility treatment delivery. This will require a paradigm shift in our thinking, leadership and approach to law, policy and regulation. We will increasingly need new national and international legal frameworks and safeguards. There will also be greater need for integrated legal services to protect patients at an individual level as they undertake ever more complex treatment processes.

Reproductive revolution

We will see increased deployment of genomic science, medicine and technology over the next ten to twenty years and beyond. Genomic medicine and gene editing are already a reality. We witnessed the controversial birth of gene edited twin girls, Lulu and Nana, in China in November 2018. They are believed to be resistant to HIV despite having an HIV positive father. This use of CRISPR-Cas9 technology might not have been entirely accurate, but it happened, and there are early reports that the twins might also have genetically enhanced intelligence.

Three-person IVF has been approved in the UK since 2015. In 2018, the Human Fertilisation and Embryology Authority (HFEA) gave permission for the Newcastle Fertility Centre to carry out three-person IVF to help two women conceive a healthy child. Both women suffer from a serious hereditary and degenerative condition called Merrf syndrome, which affects around one in 100,000 people and causes loss of muscle control, dementia and early death. In April 2019, there was also news that a baby had been born in Greece using the 3-person IVF technique.

Gene editing technology, like CRISPR-Cas9 or prime editing, is a genetically programmable system with immense potential. We must not underestimate the allure of using this powerful technology to achieve a healthy child or human genetic enhancement.

As genomic science and medicine increasingly becomes a reality, we are also likely to see a shift in perception towards an ethical obligation to have a healthy child through genetically planned parenthood. This technology will help alleviate a biological lottery at birth, avoid condemning children and adults to preventable disease, pain and suffering and has the potential to give a child a ‘head start’ and better opportunities in life. It could also help address fundamental societal issues of declining fertility levels, later-life conceptions and ageing populations.

How this technology is used and regulated will require sensible and informed public debate and decision-making. Its deployment is likely to start slowly to prevent serious and deadly diseases running in families. It will then gain traction, creating a very significant legacy for future generations. It will lead to a new evolutional balance as we increasingly have the capacity to take control of human reproduction. The ongoing digital, artificial, genomic and epigenetic advances will accelerate the human reproductive revolution intensely and rapidly in the absence of new law and policy frameworks.

Gene editing (using CRISPR-Cas9 and prime editing technology) raises particularly challenging issues because of its permanency. It has the ability to irreversibly change the human gene pool. It can be carried out in germ cells and embryos without the consent of the future born person. It has the potential to bring about traits and skills which the individual might not find valuable in life and risks unpredictable outcomes.

The paradigm shift

Law, policy and practice must take account of the potent and rapidly evolving technological advancements and the digital, genomic, epigenetic and reproductive revolutions they are generating; please see the following diagram.

This will require centralised state law, policy and regulation. We would benefit from a dedicated Ministry for Genomics and Fertility, with a Minister providing a unified voice, agenda and future direction for the fertility sector as a whole. This would help develop a robust genomic and fertility policy and political strategy encompassing pre-conception through to birth and future genetic legacy. This would result in integrated national genomic fertility policy, which combined with advances in genomic science and digital and AI technology, will increasingly influence all aspects of life.

Added to this, we will need informed and effective oversight of genomic science and medicine to protect standards and prevent abuse of this technology. We will also need to seek international consensus and build new international legal infrastructures to mitigate the risks and prevent rampant genomic and fertility tourism.

We will also see changes to the delivery of fertility treatment and patient care at ground level in the fertility sector.

Future genetic and fertility treatment model

A future vision of a fertility treatment model builds on existing practices and combines new genetic science and medicine technology with standard delivery of fertility treatment. It introduces three additional genomic steps at the start of the treatment process: genomic sequencing, genetic counselling and genetic medicine; please see the following diagram.

In practice, this would mean the typical fertility treatment process would extend from a three or four step to a seven step process. It also integrates specialist legal services for fertility patients for a delivery of a truly multi-disciplinary medico-legal process.

Genome sequencing

Affordable genome sequencing is here. Genetic sequencing now costs a few hundred pounds per genome, making it affordable and capable of integration into mainstream delivery. Costs of genetic analysis and interpretation are on top, but costs will fall in the coming years. If genomic sequencing and analysis costs say £5,000 – £10,000, it still makes economic sense. It is far cheaper than the cost of treating a sick child or adult and lost productivity in the workplace. It is likely to decrease the costs of institutionalised care and result in healthier people living better quality of lives. This in turn is likely to increase GDP and lead to greater innovation and development of society as a whole.

Whole genome sequencing can identify upwards of 4,000 – 6,000 diseases and this technology will improve over time. Gene editing technology is becoming more accurate, affordable and accessible for use in laboratories. It can switch genes on and off, target and study DNA sequences and work on every kind of cell. Genomic technology therefore has great value in preventing serious and deadly diseases running in families. Over time, it is likely to gain traction and we will inevitably see greater pressure to push the boundaries of human genetic enhancements.

Genomic technology therefore has great value in practice. Added to this, we will see increasing commercial value in genomic datasets. As such, there needs to be effective legal regulation and safeguards to ensure this technology is used wisely. This will require new law, policies and infrastructure at individual, national and international levels.

Genetic counselling and medicine

Specialist genetic counselling will increasingly be needed to help fertility patients navigate the options, issues, implications and outcomes of genetic science and medicine. It creates new issues and decisions for patients as they embark on journeys to build their families in new ways.

Genetic counselling will help address the implications of predictive genome sequencing (emotionally, economically and medically). It will help fertility patients navigate decisions about early-life disease risk in offspring (which affect 1-2 % of children). It will help them navigate decisions about later-life disease risk in themselves and future born children (for example Alzheimer’s and cancer). It will help patients decide whether to undertake tried and tested genetic screening or make braver decisions and undertake gene editing. In due course, we are also likely to see the creation of gametes from stem cells.

If fertility patients decide to pursue gene editing, it creates further issues about whether this technology should be deployed to prevent serious disease or look to achieve genetic enhancement. The latter could be used to adjust genes governing behaviour, mood and personality. Some could perceive this as a good thing if it could alleviate or minimise depression and low mood, particularly for populations living in Scandinavian countries where there are long periods of darkness in winter. It could also be perceived by some as helpful if it could be used to reduce drink and drug addiction and make people more emotionally resilient and happier. Others could perceive benefits in achieving greater skin resistance to the sun for those living in hot climates, or perhaps greater muscle strength and athleticism, a higher IQ or perfect eyesight.

This technology generates risks and issues for debate and law and policy makers at an individual, state and international level. There is a need to develop safeguards against the risk of development of superior casts of individuals, where future leaders’ capabilities far exceed those of manual workers. We need to guard against a reproductive elite, whereby this technology is only available to those that can afford it and developed nations. Safeguards are also needed to guard against rampant genetic and fertility tourism and prohibitions that risk driving this powerful technology to less regulated jurisdictions or underground away from public scrutiny.

In the longer term, we will have greater capability to create gametes, embryos, foetuses and babies from stem cells. US research in mice published in just the last few weeks show that artificial mice embryos have been created from stem cells, albeit they were found to have serious malformations. This technology could also, longer term, help address absolute and sub-infertility, age-related infertility and later-life conceptions; all very real challenges affecting particularly western societies as people grapple with socio-economic factors in life.

Following genetic counselling, specialists in genetic medicine will increasingly undertake genetic screening (already a mainstream option) or gene editing (for example using CRISPR-Cas9 or prime editing technologies) to cure or perhaps genetically enhance an embryo.

Psychological counselling

Psychological counselling is already an integrated part of the UK fertility treatment model. Genetically planned parenthood adds further layers of emotional complexity to an already demanding treatment and family building process. Psychological counselling will therefore assist patients deal, in the short term, with imminent treatment involving more steps and decisions, requiring greater emotional energy and resilience.

Psychological counselling will also help patients deal with the medium term outcomes of genomic and fertility treatment including their: expectations, concerns, feelings, relationship issues and parenting experience. It will also help patients address longer term outcomes, including overall experiences of personal and family life and genetic legacy.

Legal advice

There are significant benefits in making specialist legal advice a mandatory and integrated part of the genomic and fertility treatment journey, particularly given the increasingly complex medico-legal landscape. Specialist legal advice helps ensure patients make informed decisions. It helps protect the well-being of patients and the best interests of children. It also helps prevent legal and practical problems further down the line, reducing stress, worry and costs.

Integrated legal advice can address a wide range of issues beyond the short term fertility treatment position. It can advise on giving informed consent to treatment, including consent to predictive genomic test results and the impact on future rights and responsibilities (for example in dealing with insurance and employment markets). It can address legal parentage given complex law and the disconnect between genetics, legal parenthood and birth registration. It can advise on legal parental rights and responsibilities for a child. It can also address legal protection of individual fertility and biological legacy, as more and more people appreciate the value of this, and the legal and practical risks of treatment.

Integrated legal advice can advise on legal protection and use of eggs, sperm and embryos. It can help legally safeguard modern family structures formed through assisted conception. It can advise on acquisition of legal parentage and the legal rights and responsibilities of those who are named on a child’s birth certificate. It can also legally advise on the benefits and merits of a bespoke known donor or co-parenting agreement and prepare accompanying legal documentation.

Specialist legal advice can help provide greater legal recognition and protection for children and parents undergoing cross-border genomic and fertility treatment. It can help address and overcome the lack of international harmonisation of law and policy and protect the legal identity, status, rights and responsibilities of parents, children and families in an international context.

Integrated legal services can also explain to patients the risks and options for legally structuring their family and arrangements for the care of their children if their relationship breaks down or unexpected problems crop up (for example illness, redundancy or relocation). It can also help patients navigate complex posthumous conception law and provide advice on the issues and options if their fertility, or that of a loved one, is lost or impaired through accident, illness or injury.

Fertility treatment

Fertility treatment will evolve in light of the ongoing digital, artificial, genomic and human reproductive revolutions. Over time, we are likely to see less egg harvesting, which is uncomfortable and invasive and only generates a finite number of eggs, reducing storage costs. We are likely to see less surrogacy and reduced pressure on women in terms of their natural biological clock. We will also see fewer natural conceptions.

In contrast, we will see more focus on planned genetic parenthood. This will result in increased demand for fertility treatment and enhanced revenue for the fertility sector. We will see greater deployment of gene editing technology, first on a curative basis and then inevitably over time increasing pressure to push the boundaries of human genetic enhancement.

We may also see greater focus on ovarian tissue freezing. This technology has the capability to extend a women’s own ability to create viable eggs, delay menopause and slow the ageing process. Added to this, we are likely to see greater deployment of womb transplants and artificial wombs to treat pre-term babies. Current artificial womb technology looks to bridge the gap between the very early risk period for babies born between 23 – 27 weeks who struggle to function in an air environment, reducing morbidity and delivering better quality of life and economic outcomes.

Looking further ahead, we will also likely see greater focus on the creation of gametes from stem cells. This has the capacity to create many more eggs in particular, with potential to overcome absolute, sub and age-related infertility.

Law and policy reform

We therefore need new law and policy to address this transformational technology as we increasingly move towards genetically planned parenthood. We will require new laws for new kinds of family creation as people seek to avoid genetic roulette. This will involve root and branch law reform and centralised legal regulation as we move from healthcare to health design. It will also increase the need for integrated legal advice for patients accessing genetic and fertility treatment services.

Law and policy makers will need to address a range of economic issues around this technological revolution. This will require renewed debate about price regulation, whether genetic and fertility treatment should be free at the point of access, subsidised by the state or privately funded. There will also need to be debate about the costs of future investment in this rapidly evolving technology, revenue and profit generation, the commercial value of genomic datasets and changes in GDP.

It will also be important for future law and policy to tackle the dark side of genomic science and medicine. It will need to address concerns that gene editing is tantamount to meddling with the human genome and experimentation without the consent of the individual. It will need to take account of the permanent and irreversible nature of changes to the human gene pool and the unknown impact on future generations. It will need to address issues around the creation of traits and skills which the individual might not find valuable in life and the risk of unpredictable outcomes. It will also need to combat concerns about the creation of ‘designer babies’ and superior casts of society.

Law and policy will also need to address issues around the delivery of new and rapidly evolving infrastructure to support this technological revolution. This will require debate about the creation and management of genomic laboratory hubs, data storage and protection issues. It will also require debate about education, training and monitoring to increase understanding, counter skillset deficits and protect and improve standards and delivery of genomic science and medicine.

Summary

Genomic science, medicine and fertility treatment of the future has the potential to significantly reduce disease, pain and suffering and create healthier populations. As we increasingly move towards genetically planned parenthood, it is also likely to increase revenue for the fertility sector and state GDP.

This transformational technology will require new law, policy and regulation to ensure it is used appropriately and to protect us against the genomic dark side. Law and policy makers should adopt caution in deploying this powerful technology. There needs to be close oversight and accountability. We should also seek to strike a careful balance between respect for the individual and the interests of the state.

In the UK, the implantation of a genetically altered embryo into a woman is currently prohibited under statute other than under certain conditions to prevent the transmission of serious mitochondrial disease. UK research involving human embryos, up to 14 days’ old, is permitted subject to statutory conditions. The government stated last year that it has no plans to amend statute to permit germline modifications. As such, there are no imminent plans to review the 14-day rule, with the ethical debate around this expected to take another five to ten years.

It will be important to see what law and policy decisions are taken in countries across the globe. It will require engagement and commitment to help law and policy makers build effective legal and regulatory frameworks that will safely and successfully harness the enormous transformational power of genomic science and medicine in the fertility sector over the next 10 – 20 years and beyond. The success is there for the taking, but the stakes are very high and we overlook root and branch law and policy reform at our peril.

For further information and assistance contact Louisa Ghevaert by telephone 44 (0)20 7965 8399 or by email louisa@louisaghevaertassociates.co.uk.

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