ESRC, USA and EU
The National and International Policy Environment for Genomics is a core project
in the research programme of the ESRC-funded Innogen Centre (Centre for Social and
Economic Research on Innovation in Genomics). The Innogen Centre has received over
£7 million to cover its research from 2002-2012 and it is part of the much larger
ESRC investment in the Genomics Network. The project contributes to the 'Policy
and Regulation of Genomics' theme and tries to understand some of the reasons behind
different national policy stances by exploring the effects of policy and regulatory
instruments on agriculture and food, health and pharmaceutical developments in genomics.
The project aims to monitor relevant policies and regulations and study their evolution.
The research
The project is attempting to build a model of policy interactions, classifying
policy and regulatory instruments, according to whether they are enabling or constraining,
discriminating or indiscriminate in order to explain their impact on industry strategies.
A network of researchers working in fields related to the governance of science
and innovation (within and beyond the ESRC Genomics Network) is being consolidated
as a result of workshops, conference sessions and collaborative publications that
have been organised and planned under the aegis of this project.
The project is currently exploring whether new technologies related to genomics
(such as stem cell therapies and synthetic biology) require new policy instruments.
It is also examining the links between governance and the creation of regulatory
frameworks (including the extent to which regulatory regimes are being updated to
take account of technological advances).
The project
By interacting with policy makers in the UK, EU and USA and international regulatory
bodies the project is exploring policy development processes and the assumptions
that underlie them. The project involves documentary analysis (academic journal
articles, policy documents and press articles). It also includes in-depth interviews
with relevant actors including policy makers in the UK, EU and USA, international
regulatory bodies, representative bodies, trade associations and other interest
groups engaged in influencing the policy process and industry stakeholders in pharmaceutical
and agricultural biotechnology firms.
In the context of US links, it builds on several aspects of Innogen's research
to date:
- An ongoing collaboration with the Tufts Centre for Drug Development, Boston,
on the outcomes of new regulatory initiatives as reflected in the characteristics
of approved drugs;
- Participation in the 'Transatlantic Dialogue' Workshop on Synthetic Genomics
held at Airlie House, Virginia, April 2006. (This was followed by an invited
presentation at the SynBio3 Conference in Zurich, June 2007);
- Funding from the International Risk Governance Council to study options
for the 'Appropriate Risk Governance of Synthetic Biology', involving European
and US participants (including representatives from MIT and the Venter Institute);
- A report to OECD International Futures Programme on The Bio-Economy to 2030
- Health Scenarios. This programme involves regulatory and industry representatives
from Europe and the USA.
Quotation: As Professor Joyce Tait noted in a recent Innogen Policy Brief,
"Regulation is the key, controlling influence on the long term resilience of the
'big pharma' innovation model. However, the balance of power is slowly shifting
and the regulatory system will also be the key to managed change in the health care
sector".
Contact:
Professor
David Wield, Director of Innogen.
Professor
Joyce Tait, Scientific Adviser, Innogen Centre.
Link:
More details of the project