This is a pivotal time for the future of human genetic technologies. New gene editing techniques such as CRISPR/Cas9 suggest that any limits to the uses of genetic engineering will not be due to the technology itself, but to political decisions. Given that the application of such technologies is a matter of choice, public debate about the acceptability of these practices has to rise to the occasion.
Last year, in an attempt to build consensus for the regulation of these techniques, pioneers in the field of genetic engineering called for a moratorium on human germ-line editing. The scientists argued that genetic interventions on eggs, sperm, or early embryos posed substantial risks to future generations. It was noted that even just accepting the therapeutic use of genetic engineering to fix ‘faulty’ genes could pave the way for non-therapeutic genetic enhancement and designer babies.
Unfortunately, ethical and social concerns have not held much sway over recent biosciences policy in the UK. Despite a lack of consensus about its acceptability, the UK Human Fertilisation and Embryology Authority recently approved the use of CRISPR/Cas9 to genetically modify genes in healthy human embryos. This came shortly after regulatory approval for mitochondrial DNA transfer, the ‘three parent’ IVF technique, despite it being subject to much controversy.
A similar lack of public deliberation has characterised the revolutionary 100,000 Genome Project, due to complete in 2017. The collection and sequencing of the genetic information of 100,000 individuals has been trumpeted as a success, leading to several diagnoses. It remains to be seen what further developments this will spawn. In response to a Freedom of Information request by EthicsandGenetics, the Department of Health (DoH) confirmed that a “decision will be made by the Secretary of State for Health following discussions with a range of interested parties.”
So who are these parties, and how much weight will be accorded to them in deciding the nature of the initiative? So far, we know that the infrastructure is currently being laid out with private sector involvement for what looks to be an expansion of the Project, potentially on a national scale: a ‘50 million Genome Project’.
The possible expansion of the Project in partnership with the private sector in turn raises a number of questions. Who will be responsible for storing and sequencing the data? What level of access will third parties be granted? Last, but not least, what will the genomic blueprints of an entire nation be used for? Freedom of Information disclosures to EthicsandGenetics confirm that the DoH has held meetings with the personalised medicine company 23andMe, in which the 100,000 Genome Project was discussed. 23andMe “expressed an interest.” Meetings were also held with Google, which has an “interest in the data that Genomics England is collecting.” Unfortunately, the DoH refused to provide any further information on the grounds that this could compromise Google’s commercial interests.
However, a hint as to the nature of this involvement might lie in an exposé published by the Daily Mail. The Mail acquired a recording of George Freeman, Minister for Life Sciences, telling guests at a meeting of the Institute of Directors that private companies could have a role in storing genomic and other health data. Freeman said that the “presumption at the heart of this [data] debate at the moment is ‘well, only by the government doing it’. I’m not so sure about that.”
He continued: “in banking and finance we all merrily, all day long, use our swipe cards, share our most precious information in a system that we trust, and it basically works. And if there is ever an error or a fraud everyone knows that you will be reimbursed, you can trust the system.” Rather than genomic data being governed by “civil servants in Whitehall”, Freeman recommended “that we embrace the best people at using data.”
It is conceivable that Freeman’s remarks refer to the meetings conducted with Google and 23andMe. If companies like these are to play a part in a future expansion of the Genome Project, it has to be done with public knowledge and consent regarding their commercial interest in genomic data and degree of access to it. Unfortunately the DoH has set a bad precedent for open and transparent dialogue. It has already misled the public over the level of access granted to commercial entities in the development of the 100,000 Genome Project.
More broadly, the high level of private sector involvement and Freeman’s framing of genomic technologies in economic terms illustrate the thinking behind contemporary bioscience policy, whereby subtle concerns are often overlooked in the drive to marry the genetic and digital revolutions. Should it be developed, the significance of a national Genome Project reaches far beyond improving health, advancing science, and giving the UK economy a shot in the arm. There are social and ethical concerns too, which will only be given the attention they deserve if the public is made fully aware of the direction of travel and its implications.
The principles of transparency and consent have to be placed at the heart of the UK’s bioscience policy, not only for the governance of genomic data, but also because of the steps being taken towards editing the human germline. Government and policymakers responsible for the development of this new field in healthcare have to be clear about the risks and ethical issues. More importantly, there needs to be greater respect for public opinion. If public consent is not forthcoming, then full account needs to be taken of that decision. This indicates that we need to reassess our priorities. It may be that what is required are improvements to our institutions, rather than our genome.
Edward Hockings and Lewis Coyne