EGN Conference 2013 – Parallel Two: Governance of New Technologies

by Elisabeth Barlow, Innogen Communications and Policy Officer

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For new technologies, policy makers are facing demands to devise and adapt regulatory systems before there is evidence on the nature of future products and processes, potential markets, or the benefits and risks to different stakeholders. They are facing a major challenge in meeting these demands without unnecessarily inhibiting innovation. This session brought together some of the leading voices in this area to discuss methods for improving the success rate of delivering life science products and processes that are both societally useful and commercially viable.

Based on a perspective from patients and families with rare diseases, Alastair Kent (Genetic Alliance UK) kicked off the session with a clear account of what a new regulatory framework could look like. Traditional regulatory decisions have been based on the licensing of small molecules for the benefit of large populations, ultimately delivering blockbuster drugs to millions while not being overly beneficial to patients and families with rare diseases.

Therefore, a new framework for regulating is needed – one in which regulation follows biology, not one that tries to make biology obey the law. In order to bring about this framework, Alastair explained a series of steps are required, including: collapsing the phases; testing using real world data; using patients as a resource; and utilising social media to spread to word and gather data.

Innogen’s Scientific Advisor, Joyce Tait, followed with a discussion on upstream and downstream regulation, in particular the need to balance top-down regulation of products and processes with bottom-up engagement and dialogue with stakeholders while maintaining a democratically governable system.

As Joyce explained, there is a need for smart, adaptive governance of innovative technology with both upstream and downstream components, including: regulation that can be modified in line with changes in risk assessment; recognising regulation’s role in constraining and enabling innovation; balancing the risks and benefits to people and the environment; balancing the interests and values of ALL relevant stakeholders; and being explicit about political influences on policy decisions.

Moving on from Joyce’s discussion, Ed Godber (GlaxoSmithKline) took the session to a more economic level. As he explained, fundamental changes on the demand and supply side for life science innovation are leaving the current system of regulation and public sector investment exposed. Ultimately, the rules that applied well to the era of blockbuster drugs and now having a distortive effect, and we are paying a penalty for not having a more adaptive, localised and collaborative model of regulation.

As a result, cultural productivity is critical to the life science model, including: patient accountability beyond consumer health; personalised outcomes vs personalised medicine; rule transparency in regulation; and remission from flare-ups in industry ways.

Alessandro Rosiello (Innogen Edinburgh) continued in the economic vein and concluded with a consideration of the effect of various factors on drug development performance, including R&D funds allocation across therapeutic areas and the proportion of biological molecules in the drug development portfolio. Ultimately, the empirical data from these factors has shown that a correlation exists between performance variables and the per-capita growth of biopharmaceutical firms’ revenues – an analysis that will hopefully be widely applicable across sectors.

EGN Conference 2013 – Plenary One: What's special about scientific advice, governance and policy-making in the life sciences?

by Chris Berry, Genomics Forum Press and Communications Officer

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The first plenary session of the EGN 13 conference examined the nexus between scientific advice, governance and policy making, with specific reference the life sciences. As the chair - Innogen Director, Professor David Wield - indicated in his introduction to the session, The Genomics Network has been highley successful at working with policy makers, both across the UK and internationally, even though engaging the policy community in issues relating to social implications of genomics is not always straightforward.

The first of four speakers to offer their perspective on the session's topic was Professor Brian Collins - a former Chief Scientific Advisor (CSA) to BIS and the Department of Transport. Professor Collins used two case studies from his time as a CSA to illustrate how differing approaches to dealing with policy issues can be progressed.

The first example related to Biofuels, which are already economically important to countries such as Brazil, and potentially have increasing significance for the UK. Professor Collins illustrated a number of confliciting issues impinging on the development of UK biofuel policy at the beginging of the last decade, including: the drive for biofuel crops impacting food production; the fact that biomass is much more suited to producing heat/energy than vehicular fuel; responsibility for different policy areas for biofuels resting with different government departments; and the fact that international agreements framing biofuel policy were already in existence. Through a coordinated approach by scientific advisors from different sections of government, it was possible to address these conflicting demands and produce an approropriately framed policy.

Following his second example, relating to the policy on the use of non-human primates in medical research, Professor Collins teased out some of the factors important to the approach taken by CSAs, including:

• Whether emphasis was placed on preventing or curing an issue;
• The need to be a "critical friend" when offering scientific advice; 
• The ability to work cooperatively across government departments; and 
• Maintining an external view, through links with academia and other CSAs etc.

Andrew Miller MP - Chair of the House of Commons' Select Committee on Science and Technology, offered insightful overview of the importance of scientific advice from the perspective of a policy-maker.

He provided an overview and the structure and work of the Select Committee - how through undertaking enquiries it ensures that government policy is based on sound scientific advice, and how it can also ensure certain issues are pushed onto the policy agenda. He also pointed out that as the Committee is not necessarily composed of scientific experts, its members also rely on scientific advice.

Mr Miller then went on to speak specifically about policy relating to the life science sector, and how its increasing socio-econimic importance brings both opportunities and challenges for policy-makers. For example, the life sciences are unique insofar as they form a central componenet in a number of government areas, including health, enterprise, agriculture etc. Fortunatley, there is much expertise to draw upon to help formulate life sciene policy relating to different government departments, as each of these now has a team of dedicated scientific advisors.

Andrew Miller concluded his presentation by pointing out that to be truly effective scientific advice (including that relating to the life sciences) needs to be transparent. Currently, scientific advice is in a healthy state, and it is his Committee's objective that this should continue by ensuring goverment draws upon appropriate advice in its policy decision-making.

Jim Philp - Science and Technology Analyst with the OECD - brought an international insight to the relationship between scientific advice and policy development. Within his role this involved analysing the cost, risks and benefits of particular policy directions.

He indicated that there were a number of factors inherent in policy development that impacted upon how scientific advice influences this, such as governements working to five year, as oppossed to 50 year cycles. Conversely, exhisting - but overley complex - regulatory regimes can inhibit the timely delivery of beneficial biotechnology.

Focusing on the example of biofuels, Philp presented a case study on the parallels between the adoption of previous fuel sources - coal, oil etc. - and the policy challenges in relation to the acceptance and viability of new fuel sources produced through biotechnology.

He closed his presentation by concluding that in order for advances in biotechnology to gain societal acceptance, a policy roadmap informed by transparent scientific advice is required.

Innogen's Professor Joanna Chataway provided a social science perspective on UK public private partnerships in the field of stratified medicinie. Stratified (or personalised) medicine involves using biotechnology to tailor treatements to individuals or specific groups of people.

Professor Chataway identified that in the UK there was a growing number of public/private partnerships aimed at developing stratified medicine. The UK Life Science Strategy puts this kind of partnerships and coolaboration at heart of policy in relation to developing such treatments.

This has resulted in a lot of scientific research and experimentation, but this can often be fragmented, and there is a limited evidence base and lack of evaluation in relation to its efficacy. Professor Chataway concluded by identifying the role enhanced scientific and social scientific advice could play in contributing to policy responses to this area of bioscience.

Clear skies, cacti and collaborations

I’m back in blustery Edinburgh after a 3-week visit to the Center for Nanotechnology in Society (CNS) at Arizona State University -- and what an excellent sojourn it was. (Thanks everyone!) The idea for this trip first came about at the 4S conference dinner last year when Jane Calvert and I bumped into our old Edinburgh colleague Matt Harsh, who is now a researcher at CNS. In swapping news and research ideas, it seemed to us that there were several points of overlap between our respective centres. So we applied for a small ESRC–SSRC grant to support a visit to CNS, and fortunately received funding to cross the pond this October.