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Why we need fertility and wider law reform part III

There is increasingly a need to implement intelligent fertility and wider law reform and develop new policies and practices. The world around us is changing at pace and we must adapt to a range of powerful and inter-connected factors:

  • Declining fertility levels.
  • Fallout from the Covid-19 global pandemic.
  • Changing geopolitics.
  • Intensification of genomic, digital and AI technology revolutions.

We would benefit from a top level multi-disciplinary strategy group that operates on a continuous basis in the UK and not just during emergencies. It would comprise bright, forward-looking and strategic thinkers who sit outside the elected political elite and are unconstrained by party politics.  They would shift paradigms and deliver enlightened assessments to inform law and policy-makers and shape the future more quickly and effectively. This top level strategy group’s remit would extend beyond that of the government’s Scientific Advisory Group for Emergencies (Sage).  It would be tasked with driving innovation, identifying and mitigating risk with joined up thinking between the fertility, technology, science, healthcare, education, economic and other sectors in the UK. It would help us respond effectively to the rapidly evolving inter-connected digital, artificial intelligence, genomic, epigenetic and reproductive technological advances. It would also help address ‘silo mentality’ and short-term decisions and responses to the many challenges we face. In doing so,  it would help create new legal frameworks and infrastructure to keep pace with the massive changes that are happening around us.

A new Ministry for Genomics and Fertility, with a dedicated Minister providing unified future direction for the fertility sector, would also help develop new integrated national genomic and fertility policy and political strategy. This would help combat our growing fertility problem in the UK. It would bring greater cohesion and promote and prioritise the fertility space. It would help create an all-inclusive policy and strategy that encompasses fertility issues from pre-conception through to pregnancy and birth, as well as individual fertility and genetic legacy in the UK.

Fertility in decline

New research published this month (July 2020) by the University of Washington’s Institute for Health Metrics and Evaluation shows global falls in the number of children being born, with 23 nations’ populations expected to halve by 2100. 183 out of 195 countries are expected to have a fertility rate below the population replacement level by 2100. Global fertility rates halved to 2.4 children in 2017 compared with women having on average 4.7 children in 1950. This has come about as more women enter education and work and have greater access to contraception.

The UK population is predicted to peak at 75 million in 2063 and then fall to 71 million by 2100. On the face of it, this UK prediction does not look too bad. However, like the rest of the globe, we will continue to develop an ageing population and inverted age societal structure. This will result in numerous issues at a law and policy level. How do we replace our population and protect our families, family building and fertility? How do we as a nation structure tax payments, retirement and fund healthcare and social care for the elderly? How do we ensure our workforce and the necessary skills and knowledge to drive and sustain our economy and wealth? Brexit will also bring these issues into sharper focus as the UK looks to create a more autonomous future.

New data this month (July 2020) from the Malaysian National Population and Family Development Board (LPPKN) highlights declining male fertility levels. It reports male infertility has increased over the last 20 years by 40 to 50 per cent or seven per cent of the male population. It also reports that the fertility level among men below the age of 30 has decreased by 15 per cent. It says that factors causing this include psychosexual problems, abnormalities in sperm production and function due to genetic defects, diabetes, infections such as mumps, and varicoceles, sperm delivery problems, environmental factors such as excessive exposure to chemicals, radiation, heat, tobacco smoke, caffeine, recreational drugs as well as damage to the testicles due to cancer or its treatment. This paints a picture of declining male fertility that is increasingly prevalent across the world.

Earlier this year, the Hungarian government bought six of the country’s ten private fertility clinics and increased state funded treatment from 90 to 100 percent. This is part of a centralised fertility policy initiative to counter population decline in Hungary and increase government oversight. It is also said to be politically and economically motivated in attracting votes and enabling the government to sell off the clinics for profit in future.

The UAE is now offering to pay for three rounds of IVF treatment a year for Emirati women to halt its population decline. Over the last 50 years, Emirati birth rates have dropped rapidly from 6.9 births per mother in the 1960s to 1.4 in 2017 due to lifestyle factors, better contraception and more working women. The UAE government has also reversed laws introduced in 2012 on embryo and egg freezing for unmarried women and couples. This marks a growing trend in centralised state fertility law and policy to address demographic changes and its impact on the economy.

Russia now offers free IVF to try and reverse its declining birth rates. This forms part of a centralised strategy announced by President Vladimir Putin earlier this year in his state of the union address which directly links Russia’s future success to the size of its population. Russia’s current population of 146 million is predicted to fall by between 4 to 12 million by 2035.

A new Ministry for Genomics and Fertility, with a dedicated Minister providing a unified voice and future direction for the fertility sector, would help develop new integrated national genomic and fertility policy and political strategy for the UK. It would bring greater cohesion and promote and prioritise the fertility space. It would also help create an all-inclusive policy and strategy that encompasses fertility issues from pre-conception through to pregnancy and birth, as well as individual fertility and genetic legacy in the UK.  In doing so, it would require us to revisit and address our growing fertility problem, the increasing age of first-time mothers in the UK, our ageing population, the year-on-year increase in demand for fertility treatment, the inequality of the IVF postcode lottery on the NHS and increasing concerns about commercial pressures on the UK fertility sector and affordability of fertility treatment.

Covid-19

The scale of disruption, uncertainty, change and loss caused by this global pandemic is continuing to unfold. We remain on alert about local and national lockdowns. Furthermore, the potentially catastrophic impact of a second wave of Covid-19 over the autumn and winter hangs over us in the absence of an effective available vaccine and limited treatment options (although clinical trials at Oxford University are looking promising).

The Covid-19 pandemic is unquestionably driving transformation and change at pace. Whether we like it or not, the world is now in a very different place. Few of us now take our health, our lives, our families or our independence for granted.

Experts are increasingly concerned that up to two million routine breast, bowel and cervical cancer screenings may have been missed in the UK as a result of the Covid-19 pandemic. If medical delays continue, it is feared there could be up to 35,000 additional cancer deaths within a year. It also raises a number of wider medical and legal questions and issues about people’s health, wellbeing, future fertility and conception arrangements. Will I be able to preserve my fertility if it takes longer to identify and treat my cancer diagnosis? Will I still be able to get pregnant or have a baby? How can I maximise and protect my declining fertility? What will happen to my, or a loved-one’s, eggs, sperm or embryos if there is a terminal diagnosis?

The continued uncertainty brought about by Covid-19 is likely to change attitudes and approaches to fertility treatment and family building. We are likely to see increased focus on fertility preservation and maximisation. This is likely to manifest itself in more demand for egg, sperm and embryo freezing as people seek to address extended waiting times for treatment and create breathing space to see how this ‘new normal’ will impact their jobs and livelihoods, health, wellbeing and futures. As such, the disruption and loss caused by Covid-19 could cause more people to delay fertility treatment and assisted conception and lead to a further rise in the age of first-time parents in the UK. Increased demand and reliance upon storage and use of frozen eggs, sperm and embryos in turn creates a range of complex legal and practical issues that need to be considered and managed carefully.

For too long, we have seen a fragmented approach to the fertility space, a laissez faire attitude towards individual fertility and a slow uptake of precision and preventative healthcare measures in the UK. We need a different way forward.  As we navigate through this global pandemic, it presents an opportunity to bring about meaningful change and improvements to national healthcare delivery and fertility treatment services. To maximise this will require a step change in our thinking and a new centralised strategy that works in partnership with advances in artificial intelligence, digital technology, genomic science and medicine and our changing social, political and economic landscape.

Covid-19 also raises challenging questions about the dark side of global pandemics and the impact of rapidly evolving and interconnected genomic, scientific, digital and AI advances in our inter-connected world. How will future Covid pandemics come about and manifest themselves? Will they be a natural occurrence or genetically engineered and released by man? What if they somehow cause infertility or birth defects in pregnancy? What if they focus on certain ethnic groups, nationalities, genetic profiles or physical characteristics? What if they create a legacy of life-limiting health problems (e.g. damage to the brain, heart, lungs, liver or kidneys)? What will happen to our national economy and individual wealth if they happen more frequently? Will they destabilise and polarise our society and undermine national security?

Covid-19 researchers are currently constructing family trees (phylogenies) from genetic data to map the changing form and spread of the disease. Covid-19 evolves rapidly as the genetic instructions that create the proteins that make up the virus change over time. Vaccines will only work if they target the sequence of amino acids that are in the virus in its current form. If the virus mutates it can render a vaccine ineffective. The same applies to tests that measure the presence of antibodies in people who have had the disease. The tests will not work if the antigen, the piece of virus protein, changes form. This ongoing surveillance is of an unprecedented level and nature and it raises challenging issues from an individual, state and international perspective.

At the start of this pandemic, the UK had just 6.6 critical care beds per hundred thousand of population, ranking as one of the lowest across Europe, where the average is 12.5. Germany had around 30 critical care beds per hundred thousand of population. This prompted the government to call urgently on UK industry to switch to production of ventilators, acknowledging we needed many more than the existing stock of 5,000. Other countries took the same approach. Covid-19 has placed an intense spotlight on national critical care infrastructure, supplies of PPE, our reliance on overseas just-in-time supply chains, effective track, trace and containment protocols and the importance of adequate healthcare funding and delivery to sustain and protect the public. Lessons need to be learned from this, not just to cope with virus pandemics, but also to deal with the dark side of rapidly evolving genomic, digital and artificial intelligence technology and ensure we develop sophisticated national and international bio-defensive capability that can be deployed quickly and effectively.

Covid-19 shines a light on the rapid uptake and interconnection between genomics, science, digital and AI and domestic healthcare, economic and security issues. It is also intensifying the need for intelligent and integrated law, policy and infrastructure to help us manage the constantly shifting environment and the increasing reality that genomics, digital and AI technology are taking centre stage. Managing and responding quickly and effectively to this rapidly evolving reality would be greatly enhanced by a top level multi-disciplinary strategy group that operates on a continuous basis in the UK.

Geopolitics

The significance of population forecasts and declining fertility levels should not be underestimated. They are an important factor in geopolitics and a useful measure for planning and risk assessments for law and policy makers, long-term investment in infrastructure, the military and businesses.

That said, Covid-19 has brought about unprecedented change and has quickly lead to a change in the geopolitical balance. In seeking to combat Covid-19 we are seeing huge investment in virus and genetic testing capabilities and research. China is rapidly increasing its market share across the world, gaining global prominence and strategic position. BGI was one of the first responders to Covid-19 in China, making it very well placed to mount a global response to the pandemic. The BGI Group now produces millions of Covid-19 tests and distributes these to more than 80 countries. They are also helping set up and support population-scale genetic testing across the world with their equipment supplies and their “Fire Eye” fully automated mobile bio-safety P2 level laboratories. These are state-of-the-art offering rapid construction, fast deployment, ultra-cleanliness and have all of the equipment installed inside to detect and assess Covid-19. In addition, Illumina has technology, scientists and researchers in over 10,000 labs and 115 countries as it also continues to fight the battle against Covid-19. In doing so, Illumina provides technology to track transmission, conduct surveillance, develop therapies and vaccines.

This massive uptake in genetic testing capability is rapidly intensifying the convergence of digital, artificial and genomic technological revolutions. It has greatly increased the role and importance of genomics and biotechnology in our individual lives and at state level. In doing so, it raises serious questions from a health, economic and security perspective. Will our sensitive personal health and genetic data be protected? Who will process, have control of and access to it? What will it be used for? Will it be applied for our own good or oppression? Will it become a commodity to be bought and sold without our knowledge or consent? What about the wider implications of population-scale expansion of genomic, digital and AI technology to track and trace Covid-19 and our associated movements, independence, privacy and interactions?

Covid-19 has hit many countries hard with significant loss of life and jobs. The UK has seen 45,119 fatalities and 9.4 million jobs furloughed by the end of June. The US has seen 138,000 deaths and as of 11 June more than 44 million people filing for unemployment benefits for the first time since mid-March 2020. Other European countries like Italy and Spain have also seen massive losses. This has sent shock waves through our societies and lead to confinement and hardship for many. Whilst national governments struggle to tackle these domestic issues, the wider international geopolitical balance is shifting. Governments’ focus of attention is more inward looking rather than externally strategic. In addition, some nation states are becoming more protectionist and focused on producing more internal supply chains to reduce reliance on overseas manufacturing and distribution networks. Despite this, it just takes a further Covid or biohazard crisis to cause international mayhem. If we had the presence of an active and continuous top level strategy group in the UK we would be better placed to identify external and internal opportunities, risks and solutions and deliver and expedite these in a cohesive and comprehensive way that takes account of the increasing centrality of genomics and digital and AI technology.

Genomics

$100 genome sequencing is here with recent news earlier this year (2020) from Chinese genomics company the BGI Group of a machine that can decode the DNA of 100,000 people a year and rapidly expand personalised medicine. It also has the potential for widespread DNA sequencing raising medical, legal and ethical issues that require fertility and wider law reform.

A Californian study (2018) known as “Project Baby Bear” shows that rapid whole genome sequencing of babies saves time and money in diagnosing genetic conditions. It reduces time spent in hospital and medical bills, as well as years of inexact treatment making it efficient and cost-effective. The project provided $2 million for new born babies to go through rapid genetic sequencing. Half of those babies with unknown conditions were able to receive a diagnosis through the technology. And about one-third of those babies received updated treatment plans that helped their health outcomes.

As more people embrace the merits of genomics and calculate the economic benefits, it brings with it a need for intelligent law and policy reform and new infrastructure and processes. This is necessary to manage the increasing shift towards personalized and preventative healthcare and the application of this technology both pre-conception and post-birth. It has the potential to save both lives and money, as well as improve individual quality of life. Given declining fertility across the world, this technology (if used well) also has the potential to protect and ensure healthier populations.

In June 2020, there was news that scientists at Cambridge University have also for the first time created models from human stem cells to study early stages of human life. This allows close study of the previously unknown 14-21 day period, known as ‘black box development’. UK legal restrictions prevent embryos from being developed in the lab beyond 14 days. These models known as ‘gastruloids’ lack brain cells and are incapable of being implanted in the womb and developing into a baby. This research enables close study of the development of the human body plan including the nervous system, muscles and gut. It marks a move towards deeper understanding of human reproduction and life, genomics, infertility, disease and birth defects.

This research is allowed in the UK because gastruloid models do not have the potential to develop into a baby. Other countries like the US take a different approach and restrict federal research into these models using embryonic stem cell. Over the next 5 – 10 years experts predict that these gastruloid models could develop with beating hearts, cells that mimic the placenta and the ability for a rudimentary organ to grow.  As such, these experiments push ethical boundaries and raise questions about whether these structures could develop into viable human embryos and foetuses. It is a further step towards the eradication of serious and deadly hereditary diseases running in families and progression of the ongoing human reproductive revolution. As such it will require close scrutiny and governance and enlightened law, policy and reform to prevent misuse and ensure it is used for the common good.

In May 2020, news emerged of the creation of mouse embryos that are 4% human (known as mouse-human chimeras) before their destruction at 17 days old. This reaches a much higher human proportion than previous attempts that only reached around 0.1%. The scientific team injected human stem cells into 3.5-day-old mouse blastocysts. Human cells then developed into eye, liver and red blood cells. The scientists report that this is a step closer towards growing human organs for transplant purposes. They say it could also help with larger studies and production of human cells to better understand the human immune system and respiratory system to help combat COVID-19 and diseases like malaria which destroy human red blood cells. The development and up-scaling of this scientific carries all sorts of medical, legal and ethical issues. It also carries with it risk, responsibility and a high level of accountability given the positive and negative directions this could take as the world navigates new digital, AI and genomic technologies.

Advances in this technique also enables human cells to grow at a much faster rate in mouse-human embryos than in human embryos. It also highlights other research into mixed-species chimera embryos (hybrid human-pig embryos) in China in 2019, where more than 4,000 pig embryos were injected with human stem cells and two piglets survived gestation and were born although both died within a week. This news comes at a time when we are dealing with a catastrophic global coronavirus pandemic that shines a light on the risks of deadly viruses jumping from animals to humans and the many unknown genomic consequences that may follow. As we have seen from the current Covid-19 pandemic viruses do not recognise national borders and can have devastating effects on public health and significant national security and economic implications as well as loss of established personal freedoms.

The way ahead

Covid-19 has been a catalyst for change. It has had a profound impact on everyone’s way of life, changing previously well-established social norms, activities and behaviours. In the UK, this life-threatening virus has caused us to re-evaluate policy and prioritise personal health over short term economic well-being. In addition, the significance of recent changes in the geopolitical balance and the massive upswing in genomics and associated technology needs to be recognised.

Given the rapidly evolving national and international landscape, it has never been more important to implement intelligent fertility and wider law reform and develop new policies, infrastructure and practices. The increasingly complex and sophisticated rate of change is driven by powerful and inter-connected factors which cannot be addressed by traditional ways of thinking, governance and delivery. If we are to successfully manage declining fertility levels, fallout from the Covid-19 global pandemic, changing geopolitics and intensification of genomic, digital and AI technology revolutions it is imperative to implement a new approach. The UK would be well served by a continuous top level multi-disciplinary strategy group to drive innovation, identify and mitigate risk with joined up thinking between the technology, science, healthcare, fertility, education, economic and other sectors. It would help us respond effectively to the rapidly evolving inter-connected digital, artificial intelligence, genomic, epigenetic and reproductive technological advances.

A new Ministry for Genomics and Fertility, with a dedicated Minister providing unified future direction for the fertility sector, would also help develop new integrated national genomic and fertility policy and political strategy. This would help combat our growing fertility problem in the UK.

You can read parts I and II in this series of blogs here:

Why we need fertility law reform: the paradigm shift.

Why we need fertility and wider law reform part II.

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

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