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Why we need fertility and wider law reform part II

Overview

This article addresses the need for fertility and wider law reform with reference to the following issues:

  1. Personal genomic information.
  2. Political situation.
  3. Economy, business and wealth.
  4. IT, science and medicine.
  5. Fertility treatment and reproductive legacy.

To help bring about law reform, the UK should establish an expert advisory committee to look at rapidly evolving inter-connected digital, artificial intelligence, genomic, epigenetic and reproductive technological advances. This would help inform understanding, generate public debate and shape future fertility and wider law, policy and practice.

The UK 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, biotechnology and fertility policies, which combined with advances in genomic science and digital and AI technology will increasingly influence all aspects of life.

Issues around fertility treatment, assisted conception and family building are becoming ever more complex medically and legally. Fertility levels are declining in the West and there is growing uptake of fertility treatment and prevalence of later-life conceptions. As such, there is increasing need for fertility patients and prospective parents to obtain specialist fertility and family law advice. This will help effective navigation of the legal and wider implications of this complex and rapidly evolving national and international landscape and secure the best family building outcomes and legal protection for family life.

There is also critical need for new international governance to effectively regulate human genome editing and genomic technology around the world.

Introduction

Root and branch law reform is required to address powerful inter-connected digital, artificial intelligence, genomic, epigenetic and reproductive revolutions that will increasingly impact and change our lives and those of future generations. This will require a paradigm shift in thinking, leadership, law, policy and practice and an enlightened and multi-disciplinary approach. See previous article.

The impact of this rapidly evolving fourth technological era will affect the physical, digital, biological and reproductive spheres. Please see the following diagram. This complex, inter-linked and rapidly evolving matrix will increasingly mean we can no longer adopt traditional independent approaches, particularly across the fertility sector. Instead, centralised national law, policy and regulation, international consensus and new international legal frameworks will increasingly be required to successfully harness the benefits and ensure effective oversight, governance and protection against the dark side of these immensely potent, interrelated and transformational technologies.

Personal genomic information

Issues around personal genomic data extend far beyond personalised and preventative healthcare and human reproductive options. Careful attention needs to be given to the implications and risks of big business controlling individual genomic data given rapid developments in human genome sequencing, growth in popularity of direct-to-consumer genetic tests and digital and artificial intelligence.

The two largest direct-to-consumer genetic testing sites, Ancestry.com and 23andMe, have between them tested more than 25 million people. Most people upload their genetic information in the hope of finding relatives, learning about their ancestry and obtaining insights about their health. However, these direct-to-consumer genetic tests raise legal and wider issues and risks that many users are unaware of and do not fully understand, including questions about personal genomic data security, commercial value and benefit derived from personal gene data, civil and human rights and genetic identity. Concerns continue to be raised about the accuracy of their results, particularly from a healthcare and reproductive perspective, and the fact they spell the end of donor anonymity. Many unanswered questions also remain about the implications and risks of sharing genetic information in combination with increasing public activity disclosing personal data on social media platforms and the ongoing digital, artificial intelligence and genomic revolutions. As such, there needs to be greater public awareness, understanding and better law, policy and regulation about the use and disclosure of personal genetic information.

Last autumn, a Judge in Florida’s Ninth Judicial Circuit Court gave permission for a detective to search a genetic database with approximately 1 million users to try and solve a criminal case. This legal ruling raises important questions about whether larger genetic testing databases are at risk in future from similar legal rulings despite their privacy policies and the impact this has on individual civil rights.

Personal genetic tests also carry wider implications from a state perspective too. Last year, the Trump administration implemented a pilot scheme seeking DNA samples from asylum-seekers at the Mexican border to confirm family relationships. Using Rapid DNA technology, it processes DNA samples in 90 minutes to prevent individuals posing as families to avoid lengthy periods of detention. Earlier this month, this pilot scheme was expanded and it began collecting the DNA of immigrants detained by US Customs and Border Protection (CBP) and Immigration and Customs Enforcement (ICE) in other areas of the Unites States. These DNA samples will be processed and stored on the FBI’s genetic database, the Combined DNA Index System (CODIS), which stores millions of genetic profiles used by law enforcement. The scheme is expected to expand across all areas and borders of the United States over the next three years and it raises issues about whether over time this policy could apply to US citizens and US permanent residents in custody too. The administration says the policy falls under the DNA Fingerprint Act 2005, which requires anyone arrested for a federal crime to provide a genetic sample, and its aim is to solve more crimes committed by immigrants and discourage illegal immigration. However, critics argue this marks a move from criminal investigation towards population surveillance.

Last month, the Pentagon warned US Military service personnel against using direct-to-consumer genetic tests saying they create security risks, are unreliable and could negatively impact their careers in the service.

In France, there continues to be a ban on direct-to-consumer genetic testing as part of the country’s bioethics laws, despite a review by the National Assembly last year. The French criminal code penalizes users of these genetic tests. In doing so, the French state seeks to preserve French genomic information, viewed as an important national resource, from perceived potential exploitation by foreign companies.

In China, a state policy focusing on the collection of individual genetic profiles continues to add to its nationwide DNA database, the China National Genebank (CNGB) operated by Chinese genetic company BGI. Recognising the strategic value of this genetic information, millions of Chinese people have already undergone genetic tests, including those from the Uighur, Han and Tibetan ethnic communities. This is said by Chinese researchers to help state authorities identify the geographical origin of criminal suspects and fight terrorism, but it also carries far wider implications.

Political stability and security

Advent of powerful gene editing technology, including CRISPR-Cas9 and prime and base editing techniques, as well as rapidly evolving synthetic biology and genomic sequencing technology, also raise ongoing concerns about an international biological arms race and bioterrorism. The Pentagon classifies gene editing technology as a weapon of mass destruction.

Increasingly, state funded programs are being initiated to apply this technology to address and counter the threat of bioterrorism, genetic warfare and deal with nuclear radiation fallout in the event of nuclear attack. US state funded research programs operate at a number of institutions across the San Francisco Bay Area. In China, there are multiple programs, including at the PLA’s National Defense University and General Hospital.

Genomic technology increasingly raises questions about political control, security and exploitation of the human and microbial genome in conjunction with the rapidly evolving digital and artificial revolutions. Genetics represent the fundamental essence of life. DNA programmes the human body and with the continual development of powerful digital and artificial intelligence we will increasingly have the capacity to digitally programme, enhance and create DNA and life itself. This creates a whole host of new issues and concerns, including human genetic enhancement, designer babies, superior casts of society and super-humans, eugenics and ethnic security that need to be carefully addressed with new laws, policies and practices.

Genomic technology also raises issues and questions about the suitability and capacity of other national and international bio-defensive measures, including water and air filtration systems, decontamination facilities, and early detection equipment. It brings into focus the need for enlightened and effective law and policy, funding and infrastructure to ensure there are sufficient resources of genetic coders, legal and IT security experts, biological computer aided design (CAD) systems, 3-D chemical printers, experts in epigenetics and the human and microbial genome now and moving forward. It also highlights the importance of adequate healthcare funding, delivery and research to sustain and protect the public.

Economy, business and wealth

Biotechnology has immense economic value and influence. Gene editing technology is increasingly used in medical and agricultural sectors where its value is estimated to reach $10 billion by 2025. This rapidly developing technology can be further leveraged with intelligent use of advances in digital and artificial technology to gain strategic economic and wider benefits and diversify state economies for wealth generation.

Genomic data carries important value for businesses and individuals too, ranging from the commercial value of genomic datasets to potential impact on career and employment prospects, insurance, mortgages, personal relationships and reproductive choices.

Hand in hand with this, we will increasingly require enlightened law and policy reform to oversee these economic opportunities and risks and balance the interests of state, big business and individuals at regional, national and international levels.

IT, science, medicine and technology

Increasingly, genomic technology has important healthcare application. Scientists are looking at ways to harness this technology to tackle severe strains of flu, counter traditional aggressive radiation cancer treatment and radically cure cancer and blood disorders.

This technology will increasingly lead to a shift from healthcare to preventative and personal precision medicine and over time more genetically planned parenthood. In doing so, it has the potential to create healthier populations, leading longer and better quality lives, reduce healthcare spend and increase national GDP.

Last year we had news of the first gene-editing CRISPR-Cas9 human clinical trials. In November 2019, promising initial results were published that application of this technology had cured a rare blood disorder in one transfusion-dependent patient with beta thalassemia and that a further patient with sickle cell disease was free of painful condition induced crises (albeit participants will need to be followed over a longer period of time to be sure). More results from these clinical trials are expected this year with publication of primary results scheduled for 2021. This year, we will also see clinical trials of CRISPR-Cas9 in treating multiple myeloma (cancer) and congenital amaurosis type 10 (LCAA10), a genetic cause of blindness. Further clinical trial results are expected in 2021 in treating B-cell cancer malignancies. These gene editing clinical trials do not edit the human germline and so the DNA changes will not be inherited by future generations.

In December 2019 He Jiankui, the Chinese scientist who announced in November 2018 that he had created the world’s first gene edited humans (allegedly resistant to HIV) in twin girls Lulu and Nana, was sentenced by a Chinese court to three years in prison and fined $430,000 for violating regulations and forging ethics review documents allegedly in the pursuit of “fame and fortune”. Two other members of his team were sentenced to two years and 18 months in prison. This followed international condemnation about the ethics and safety of his work. It remains to be seen what the future holds for Lulu and Nana and one other child subsequently born from this trial and whether they will suffer any off-target effects as a result of having undergone germline gene editing. What is clear, however, is that there is growing international consensus that gene editing technology should be restricted to somatic and not germline human application until we amass greater knowledge and understanding about its effects. How this is achieved and associated legal frameworks still needs to be fully worked out (see below).

Fertility treatment and reproductive legacy

Gene editing technology, like CRISPR-Cas9, is a genetically programmable system with immense potential. We must not underestimate the attraction of using this powerful technology to achieve a healthy child or human genetic enhancement. However, approaches to pre and post conception genetic testing and gene editing technology currently vary internationally.

As genomic science and medicine increasingly becomes a reality, we are likely to see a shift in perception towards an ethical obligation to have a healthy child and more fertility treatment and genetically planned parenthood. Genetic testing and gene editing technology will over time 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. As such, this will require new laws and policies for new kinds of family creation as people seek to avoid genetic roulette.

How this technology is used and controlled will require worldwide 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. The ongoing digital, artificial, genomic and epigenetic advances will accelerate this human reproductive revolution intensely and rapidly in the absence of new and enlightened law and policy frameworks. This will add further layers of medical, legal and emotional complexity for fertility patients. Without proactive governance, it has the potential for rampant fertility tourism to meet individuals’ reproductive wishes and expectations across the global fertility sector.

In Australia, a landmark pilot trial is currently underway involving 700 Sydney couples who are undergoing free genetic tests for more than 700 severe and terminal diseases. This could pave the way for Australian population-wide preconception genetic carrier screening. This represents a $20 million federal government-funded project known as Mackenzie’s Mission after the death of baby Mackenzie Casella in October 2017 aged 7 months following a diagnosis of spinal muscular atrophy (SMA). This pilot trial is the cornerstone of the $500 million Australian Genomic Health Futures Mission. Its aim is to decide whether population-wide genetic screening is cost-effective and assess the psycho-social and ethical impact of genetic screening. It hopes to build a new pathway over the next 10 years for preconception genetic testing, to empower women and help prospective parents make informed decisions about family building. The Australian government also sought public engagement with a consultation ending on 29 November 2019 on whether to legalise 3-person IVF. This followed an Australian Senate Enquiry last year where research showed many Australians are likely to support the introduction of this.

In the US, genetic screening and testing is often recommended to fertility patients who have had multiple failed IVF transfers, reoccurring miscarriage and a known family history of genetic risks. It is also offered to couples who intend to use donated gametes, to help them make informed decisions about potential genetic risks prior to donor selection and pregnancy.

In December 2019, the UK Human Fertilisation and Embryology Authority (HFEA) changed its traffic light rating of pre-implantation genetic screening of embryos from amber to red. It stated that “..PGS will not increase your overall chances of having a baby. It appears possible that reduced availability of embryos for transfer following PGS may counter any benefit of embryo selection. When considering whether to have PGS, you should also think about the cost as it is usually very expensive against the lack of conclusive evidence of benefit and the potential for harm.” Law in the UK, does, however, permit three-person IVF on a case by case basis overseen by the HFEA and research involving human embryos, up to 14 days’ old.

In the UK, we would benefit from an expert advisory committee (an update to the Warnock Committee) to consider these powerful genomic and technological advances. This would help address their implications, inform understanding, generate public debate and shape future fertility and wider law and policy. We would also 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, biotechnology and fertility policies, which combined with advances in genomic science and digital and AI technology, will increasingly influence all aspects of life.

In Hungary, the Hungarian government has recently announced that six nationalised fertility clinics will offer free of charge treatment as from February 2020. It views fertility clinics as being of ‘national strategic importance’ and this forms part of a wider drive aimed at stemming population decline and encouraging Hungarian couples to create an additional 4,000 children by 2022. This move marks a significant shift towards centralised fertility law, policy and regulation.

International governance of human gene editing

It is clear that rapid developments in gene editing are challenging and outpacing existing law and policy and that international governance is insufficient. Currently, there is no international organization or legal framework that can effectively regulate human genome editing and genomic technology around the world. Law, policy and practice varies across the globe and this creates risks that this powerful technology could be deployed recklessly in less regulated jurisdictions or driven underground away from public scrutiny.

At present, there are two main groups tasked with developing an international regulatory infrastructure for human gene editing, namely the World Health Organisation (‘WHO’) and the US National Academy of Sciences and the UK National Academy of Medicine.

In December 2018, WHO announced it was establishing a global multi-disciplinary expert panel to examine the social and legal challenges associated with human genome editing. In March 2019, this expert advisory committee agreed to develop global standards for governance and oversight of human genome editing. It concluded that it would be irresponsible at this time for anyone to proceed with clinical applications of human germline editing. In August 2019, it launched a new global registry which seeks to oversee research on human genome editing, including both somatic and germline trials, and create an open and transparent database of ongoing work. Over the next two years it will consult with a wide range of stakeholders and provide recommendations for a comprehensive governance framework for use at an international, national, regional and local level.

The US National Academy of Sciences and the UK National Academy of Medicine has also set up an international human genome editing initiative which aims to provide researchers, clinicians, policymakers, and societies around the world with a comprehensive understanding of human gene editing to help inform decision-making about this research and its application. It hopes to develop a framework for scientists, clinicians, and regulatory authorities to consider when assessing potential clinical applications of human germline genome editing. The framework will identify a number of scientific, medical, and ethical requirements that should be considered, and could inform the development of a potential pathway from research to clinical use (should this technology be deemed acceptable for human germline genome editing).

In December 2019, following recommendations from an expert panel the Japanese health ministry recommended a ban on implanting genetically modified human embryos. It stated it posed serious risks to the health of children concerned, future generations and risked the development of a market for ‘designer babies’. The expert panel did not, however, oppose continued research into gene editing of human embryos.

Last year in Russia, a scientist announced a desire to carry out human germline editing trials to switch off a rare gene that causes deafness subject to state approval. Discussions about human gene editing have been ongoing in Russia over the last few years with an expert panel reported to have met last summer to discuss matters in what remains a grey area.

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. In 2018, the government stated 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.

In the US, there is no federal legislation governing human gene editing. Gene therapy research is governed by two federal agencies, the Food and Drug Administration (FDA) and the Office of Biotechnology Activities at the National Institutes of Health (OBA). The FDA considers the use of human gene editing technology to be gene therapy and any application of gene therapy products or clinical studies of gene therapy in humans requires FDA approval. There is federal control over the allocation of federal funding for research projects. Federal funds cannot be used for research for germline gene therapy in humans. Federal control also governs the grant of FDA approval for the marketing of gene therapy products. However, there are gaps where privately funded research takes place involving non-clinical human gene therapy research.

Summary

The fertility sector and human reproduction is intrinsically linked to ongoing powerful inter-connected digital, artificial intelligence, genomic and epigenetic revolutions that will increasingly challenge and transform the legal and regulatory landscape, options and outcomes for fertility patients, children and families.

Although there is UK-wide statute governing fertility practices overseen by the HFEA, there is still significant variation in attitude, approach and delivery across the UK. Intelligent fertility and wider law reform would help us move forward in a coherent and structured way to ensure we remain a world leader in this rapidly evolving landscape.

To help bring about enlightened fertility and wider law reform, the UK would benefit from the establishment of an expert advisory committee to address these rapidly evolving technological advances, including pre and post conception genetic screening and gene editing. Together with the establishment of a new Ministry for Genomics and Fertility, this would help the future creation of sophisticated, integrated and detailed policies bringing biotechnology and genomics, digital, artificial intelligence, epigenetics and assisted reproductive technology under one umbrella.

It is clear that issues around fertility treatment, assisted conception and family building are becoming ever more complex medically and legally. As such, fertility patients and prospective parents should obtain specialist fertility and family law advice to effectively navigate the legal and wider implications of this complex and rapidly evolving landscape.

There is also critical need for new international governance to effectively regulate human genome editing and genomic technology around the world. Law, policy and practice varies across the globe and this creates risks that this powerful technology could be deployed recklessly in less regulated jurisdictions or driven underground away from public scrutiny in the absence of new international regulation.

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

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