Emerging science and established problems — governing biomedical innovation in the UK

The Department of Health (DH) has announced the formation of a new body to advise on emerging healthcare scientific developments and their ethical, legal, social and economic implications. The new body, the Emerging Science and Bioethics Advisory Committee (ESBAC), will rise phoenix-like from the ashes of the Human Genetics Commission (HGC), which was incinerated in the government's recent bonfire of the quangos. It is a telling illustration of the continued governance challenges arising from biomedical innovation that the adverts for members to join this new committee were being prepared even before the HGC had held its final meeting.

A number of questions arise about the new body and how it will build on the impressive work of the HGC in achieving a position of public trust. First, how independent will it be of the Department of Health (DH)? The HGC had a large number of DH ex-officio members but established a robust independence from the Government, which added credibility to its reports.

Second, how transparent will its activities be, and how will it interact with stakeholders and the general public? The HGC had a high level of transparency with its plenary meetings open to the public, its work informed by lengthy public consultations, and its activities (minutes, reports and so on) readily available on its website.

Third, how will it fit into the policymaking process? Although not without influence, it is noteworthy that the HGC was largely excluded from the writing of the White Paper 'Our Inheritance, Our Future: Realising the Potential of Genetics in the NHS'. Thus it would appear that at crucial times there has been a twin-track approach to genetic policy - the open, transparent mode of the HGC, and the more traditional closed mode which produced the White Paper.

Fourth, how will ESBAC's work be supported? It is a sign of our current age of austerity that the new committee will have a wider brief than the HGC but, so we understand, fewer resources. As a result, pursuit of its work is likely to require some adept networking and collaborations with external bodies in order to pool resources, a strategy which we are led to believe is already under consideration.

Finally, there are questions of scope. The first of these relates to the breadth of enquiry. ESBAC would appear to have a horizon-scanning function and a remit to look at the ethical, legal and social issues (ELSI) and implications of new technologies. The ELSI framework of enquiry is demanding in its breadth, and economics is often the Cinderella at the ELSI ball. Again this becomes a question of resources; interrogating economic issues may be rather more expensive than bioethical deliberation — where is the money to come from?

Also, if the committee is genuinely to interrogate the full ELSI agenda then why does only 'ethics' appear in ESBAC's title? Better perhaps to replace the 'B' with a 'P' - the Emerging Science Policy Advisory Committee - if the department is not to appear to privilege ethical enquiry over legal or social science enquiry.

The second scope issue relates to the focus on emerging technologies. As a consequence of the shift from industrial policy to innovation policy we are more concerned with issues relating to invention and early adoption of new technologies — and we now focus far less of our attention on the policy challenges relating to technology use.

Yet it is not only emerging technologies which present governance challenges. The recent controversy over the PIP (Poly Implant Prostheses) breast implants illustrates the point nicely — whilst the bioethics literature has been awash with papers on the consumer genetics industry, there has been a dearth of work on the aggressive marketing techniques used to sell breast implants and other forms of cosmetic surgery.

In many ways public interest concerns mean that established technologies deserve far greater attention - they use up a greater portion of healthcare resources, patients are far more likely to encounter them, and their ethical, safe and (cost-)effective use presents policy challenges every bit as demanding as those arising from novel technologies.

The PIP scandal arose from profound deficiencies in Europe's approach to the regulation of medical devices. The failures of that regulatory regime have implications for the governance of novel technologies (such as the new wave of genomic diagnostics) but impact equally on more established technologies. Given this regulatory gap, do we need an Established Science Policy Advisory Committee to complement ESBAC or should the scope of the new body be broadened? And if it isn't broadened then where do we draw the line in pursuit of the protection of the public interest? When does science cease to be emergent?