Science and the law: gene editing in danger of outpacing regulation



Despite everything we've learned about pregnancy and biology, the question of why women miscarry is yet to be sufficiently answered. New advances in genomics may change that, but the legal and ethical considerations are complex, as science begins to outpace law.

In January this year, a group led by Dr Kathy Niakan at the Crick Institute in London gained consent from the UK Human Fertilisation and Embryology Authority (HFEA) to undertake germline gene editing using human embryos. If successful, the project could have profound implications. ‘I believe our research could ultimately lead to improvements in infertility treatment and provide a deeper understanding of the earliest stage of human life,’ says Dr Niakan.

 DNA strands

‘I would like to understand the role of genes that we think are likely to be very important for healthy development and for stem cells. If we could study the role of these genes, they could be used as a biomarker to identify those embryos that would go on to develop successfully into a healthy baby,’ adds Niakan.

Globally, the estimated rate of miscarriage is 15–20 per cent among women who know they’re pregnant.

‘‘Better that it's done openly, with proper academic and ethical discussion, than done in a back shop somewhere less regulated

Patricia Barclay, founder, Bonaccord; Chair, IBA Healthcare and Life Sciences Law Committee

The research makes use of CRISPR-Cas9, a relatively low-cost technology which came to prominence in 2012 and was cited in some 600 research papers by 2015.

‘It has revolutionised the way gene editing is carried out,’ says Dr Sahar Shepperd, associate in intellectual property and commercial transactions at Bristows. ‘Numerous gene editing companies using this technology have exploded onto the scene.’ 

The scope for swift progress is enormous, generating much excitement in the global academic community.

However, controversy inevitably accompanies any new development where genes and embryos are concerned. Dr David King, Director of Human Genetics Alert, called this ‘the first step in a well mapped-out process leading to genetically modified babies, and a future of consumer eugenics’.

US President Barack Obama’s science adviser, John Holdren, called germline editing ‘a line that should not be crossed at this time’.

Regulatory responsibility

Behind the somewhat alarmist public discourse, the reality is that the consent for the Crick Institute’s project is extremely narrow and tightly controlled. James Lawford-Davies, a partner at Hempsons, advised the Institute on the application for the gene editing licence.

‘The regulatory responsibility for clinics and research centres is significant, and the law and regulations are complex and voluminous,’ he explains.

‘‘There's a real difficulty in how the global research community addresses the possibility of therapeutic tourism

James Lawford-Davies, Hempsons

In this case, Dr Niakan’s team are working with donated embryos from in vitro fertilisation (IVF) treatment, which, under the UK’s Human Fertilisation and Embryology Act 1990, cannot be used after 14 days, and are prohibited from ever being implanted in a woman.

Combined with the strict HFEA Code of Practice, the Act sets out a framework for new technologies that is flexible but unambiguous.

Lawford-Davies explains: ‘The UK doesn’t often regulate specific technologies or procedures. Regulations tend to be drafted far more broadly, and relate to the purpose of the research and treatment, as well as the material used. This allows a broad degree of flexibility to the regulator in deciding whether or not to grant a licence.

‘It's very clear from the UK law that the Crick Institute's work on gene editing is permitted, but you'll never find the phrase “gene editing” in UK law. Conversely, the use of gene-edited embryos is very obviously prohibited, despite not being specifically mentioned in UK law.’

In fact, the HFEA has 18 currently licensed research projects involving human embryos, including the Crick Institute’s – indicating that this type of research isn’t as startling as headlines might suggest.

 Patricia Barclay

Patricia Barclay

Patricia Barclay, founder of Bonaccord and Chair of the IBA Healthcare and Life Sciences Law Committee, agrees that the UK regime is ‘regulated but permissive', with the UK authorities making decisions in a scientific, unemotional manner. Besides, she says, the rapid advancement of CRISPR-Cas9 means that ‘if we don't do it, another country will – better that it's done openly, with proper academic and ethical discussion, than done in a back shop somewhere less regulated.’ 

Dr Niakan feels that ‘the HFEA has been instrumental in establishing a culture of proper discourse and regulatory oversight. At the moment, I believe the UK is the best place in the world to do this work.’

Elsewhere, a team of Chinese scientists claimed in April 2015 to have modified a gene linked to blood disease in human embryos.

A team led by stem cell scientist Yong Fan has published a paper claiming to have used CRISPR-Cas9 technology to modify an immune cell with the aim of making a human embryo immune to HIV infection. Fan’s team were quick to reassure a public who may feel that science is moving too fast, writing: ‘Any attempt to generate genetically modified humans through the modification of early embryos needs to be strictly prohibited until we can resolve both ethical and scientific issues.’

Legal and ethical issues

That ethical debate will be vital to gene editing’s future liability, particularly in an international regulatory environment struggling to keep up.

Juliet Tizzard, Director of Strategy and Corporate Affairs at HFEA, stresses that as far as the UK is concerned, ‘what other countries are doing is irrelevant to our licensing decisions’.

However, she does agree that ‘technology does sometimes move faster than the law, though in the example of gene editing, the law already permits this in research’.

Balancing scientific progress with public approval is always a key aim: ‘We try to keep our policies balanced between the interests of patients and researchers/research – and we take time to talk to people working in laboratories, in clinics and to patients. These kinds of relationships create more public trust than a government department alone might be able to achieve,’ explains Tizzard.

Not every jurisdiction will approach gene editing with the same scrutiny.

‘There's no doubt that CRISPR will eventually be used in a way that we'd never imagine being permitted here,’ cautions Lawford-Davies. ‘That's been the experience with stem cell research, and it can dent the confidence of the public and the press.

'In the Caribbean, for example, you can have foetal stem cells injected into your forehead for cosmetic purposes in a way that would be criminal in the UK. There's a real difficulty in how the global research community addresses the possibility of therapeutic tourism. The risk is that it's only a matter of time before there's a jurisdiction where this is used irresponsibly, which will be damaging to its responsible use in other jurisdictions.’

Dr Niakan’s work begins imminently, pending a sufficient supply of embryos. Gene editing will continue to push forward, both here and abroad: ‘The next decade or so will demonstrate how the power of this technology is harnessed to eradicate genetic abnormalities on a permanent basis,’ says Shepperd. ‘There may be a need for regulations on a cross-border level, but this will take time and a significant amount of debate, reasoning and analysis.’