Notions of ‘citizen participation’, ‘citizen science’, ‘responsible innovation’ and a ‘public ethics’ are commonly invoked in contemporary literature on good governance and policymaking in science and technology. The Nuffield Council on Bioethics (UK) report, “Emerging Biotechnologies: Technology, Choice and the Public Good” is a case in point, with its focus on the social, economic and political environment in which new technologies emerge and policy and regulatory decisions are taken. The centrality accorded to public consultation is a key feature of the report. The consensus in the literature is that public participation in science and technology – and specifically genetic engineering, as in the case of Nuffield’s report – is a valuable social good. We agree.
Fostering public involvement in decision-making in relation to bioscience policy has both ethical and pragmatic advantages. By including the public at the earliest stage, scientific innovation can be steered toward socially beneficial ends. Affording centrality to the public can give us a plurality of perspectives and values, and thus potentially greater scope for critical reflection. This can in turn give rise to more robust policy decisions, which have the ‘right impacts’. Furthermore, citizen involvement in policy making for the areas likely to impact on their everyday lives is something that we ought to strive for in democratic societies. Last, given the significant public interest in bioscience policy, the ‘democratic imperative’ has even greater salience.
The challenges ahead: The ideal of ‘science for society, with society’ is compelling. However, considerable barriers stand in the way of realizing this aspiration. Overcoming these will take time, and many important decisions will already have been taken. There is also a strong possibility that the decisions made before a fully inclusive, open and genuinely participatory approach is adopted could ‘lock-in’. Moreover, since economic framing has come to increasingly dominate policy relevant to the biosciences in the UK, commercial interests are likely to drive future decisions.
Safeguarding the public interest: Earlier this year, the Human Fertilisation and Embryology Authority granted regulatory approval for mitochondrial DNA transfer, and was followed by the same body approving genetic modification for research purposes in healthy human embryos. These decisions open up a path for techniques such as CRISPR/Cas9 to be used in the near future for a wider range of purposes. Pioneers in the field of genetic engineering have raised concerns that accepting therapeutic uses of genetic engineering to fix ‘faulty’ genes could pave the way for nontherapeutic genetic enhancement and designer babies. Set against a backdrop of commercialization this becomes more likely. Fostering an appreciation of the way policy decisions are interconnected can engender awareness that some of the goals being pursued, such as economic ones, could have long-term consequences, which may be of greater significance than the goals themselves.
Making decisions collectively: The public is capable of showing sensitivity toward the moral nuances of the biosciences. By contrast, the forces of commercialization are blind to the morally relevant differences between, for instance, a commercial model of germline gene editing and therapeutic uses of gene editing to eliminate genetic diseases such as cystic fibrosis. Our concern is that the consensus of the International Gene Editing Summit (that risks, benefits and alternatives would have to be considered and broad societal approval about the acceptability of specific uses would have to be reached before going ahead) is having to compete with economic pressures. In this environment, public engagement exercises – instead of keeping the public informed about possible policy trajectories so that public deliberation can feed into policy decisions – merely serve to legitimize decisions that have already been taken. The 100,000 Genome Project (100k GP) has been trumpeted as a success, leading to several diagnoses. Accordingly, 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’.
A disclosure by the Department of Health to EthicsandGenetics regarding the expansion of the project confirmed that, a “decision will be made by the Secretary of State for Health following discussions with a range of interested parties.” Our concern is that equal weight is unlikely to be given to a range of interests, and that sectional interests – which have been a determining factor from the beginning – will continue to be prioritized. In a memorandum submitted to the House of Lords Select Committee on Science and Technology, Glaxo Wellcome urged that National Health Service electronic medical records should be used to “establish a valuable genetic research database”. Evidence submitted by the Association of the British Pharmaceutical Industry to the House of Commons Select Committee on Health called for urgency: “there is an international race for benefit and competitive advantage in research where the UK could have a significant unique selling point, if research interests are given priority…making use of the full electronic patient record will provide substantial benefits to patients, the NHS and the economy”. This serves to highlight the influence forces on the ground have had over the policy agenda, and provides an indication of the likely future direction of policy in this area. As well as establishing the conditions for improved and more cost-effective treatments, the 100k GP and related initiatives have had the aim of promoting and, ‘locking in’ the use of clinical and genomic data for economic benefits, and to secure a ‘unique selling point’ for the bioscience and health research sectors.
Fostering openness & transparency in the framing of policy decisions: Economic pressures and embedded power structures account for the narrowing down of the way bioscience policy has been framed, which has impeded taking the ‘broad view’ advocated by Nuffield. It has also meant that subtle, longer term and broader concerns about the social impact of these developments are being overlooked. Having misled the public over the level of access granted to commercial entities in the 100k GP, the government has already set a bad precedent for the openness and transparency of public debate about bioscience upon which policy depends. In the case of Care.data, they have spuriously maintained that only anonymous data is made available, when in fact the data made available is pseudonymized. One of the problems with this, particularly in the case of the 100k GP, is that public deliberation about the risks and implications is potentially circumscribed. The commercialization of pseudonymized or identifiable data raises ethical considerations that have not been subject to adequate levels of public consultation or debate. There is an important difference between the extraction of sensitive personal medical and genomic data in order to improve healthcare and advance science, and the use of such data to further the knowledge economy for commercial ends. Despite that, the 100k GP Ethics Advisory Group (UK) has stated that no restrictions will be placed on the “research undertaken on the data, for example by limiting it to ‘noncommercial research’’’.
An open model of consent & public consultation on the uses of genomic data: It is widely felt that realizing the potential of genomics requires discarding the principle of ‘informed consent’. This view is often qualified by the stipulation, explicit in UNESCOs 2003 International Declaration on Human Genetic Data, that any such change must be accompanied by public participation in policy and governance decisions. While there have been opportunities to consult the public, and to engage in open and transparent debate about the risks and possible implications in order to reach an understanding about the values that should hold sway in this area, these have tended to be disingenuous. In 2013, motivated by the conviction that the risk-averse attitude toward sensitive patient data needed to be revised, the Department of Health launched the Information Governance Review, ‘Information: To share or not to share?’. The review conducted by Dame Fiona Caldicott concluded that data collected during the course of care and treatment should be used to support research. However, prior to the publication of Caldicott’s recommendations in 2013, the government’s ‘Strategy for UK Life Sciences 2011’ had already made it clear that there would be a shift to “a more progressive regulatory environment”. Caldicott was therefore never going to be able to meet its aspirations to give the public a stake in deciding whether or not information would be shared. Furthermore, the assertion made in the Caldicott report that “genetic information should not be treated any differently from other forms of information” is not a true reflection of public opinion, as the public were not consulted on the matter.
The Government has opted to exclude the public rather than to foster an inclusive and open dialogue about initiatives such as Care.data and the 100k GP. New gene editing techniques such as CRISPR/Cas9 suggest that any limits to applications of genetic technologies will not be due to the technology itself, but to political decisions. Should it be developed, the significance of a national Genome Project reaches far beyond improving health, the economy and advancing science. The Department of Health confirmed to us that meetings have been held with Google and 23andMe, in which both expressed an interest in the 100k GP. A whole sequenced genome is a wealth of information that could potentially be used by private or government actors in malign ways.
Getting policy right: If we are going to get policy and governance right in the long term then we will have set a precedent immediately. The main focus of our work has centered on the 100k GP and campaigning for transparency in regard to uses of genomic data and the inclusion of the public in decisions about such uses. Existing guidance in the UK on the use of genomic data is indeterminate, and no real checks and balances are in place. We believe that the adoption of an open model of consent must be supplemented with a guiding framework that clearly states who can have access to the data and for what purposes. The establishment of a quasi-independent body with adequate regulatory powers could provide much needed oversight and ensure that uses of genomic data do not get out of balance with public opinion. In view of the prospective expansion of the 100k GP and the certainty that, as gene editing techniques become more advanced, significant decisions will have to be taken.
Public consultation and participation must be institutionalized so that public opinion regarding acceptable uses of genomic data and the wider trajectory of bioscience policy can be solicited. Embedding public consultation and participation will push the government toward transparency and ensure equality. That is, all interests will be accorded equal weight when substantive decisions are to be made. The government’s approach to bioscience policy has been consistent. It is comfortable with commercialization, neglects to afford equal weight to a range of interests and resists transparency. Engaging the public in a debate about the wider trajectory of UK bioscience policy and holding the government to account regarding public opinion, can disrupt this pattern. Independent, civil society organizations can play a crucial part in facilitating this. By producing reports and articles, which scrutinize current and prospective policy – and situating them in broader context – we have endeavored to widen the scope of discussion surrounding UK bioscience policy, and provide an alternative voice.
A final concern is genetic discrimination. While the USA has legislated against genetic discrimination and the use of genetic information by insurers, in the UK there is merely a concordat which prohibits the latter. This expires in 2019. EthicsandGenetics is campaigning for the enactment of legislation designed to prohibit the use of genetic information in health insurance and employment.
A longer version of this article, published by the Journal, Personalised Medicine, can be found here.
Edward Hockings, the founder of EthicsandGenetics, is a bioethicist who has campaigned against violations of civil liberties, and published work in this area on the BBC News, the Guardian, the Independent, and the Daily Mail.