Creating and implementing appropriate governance of the life sciences
Submitting InstitutionOpen University
Unit of AssessmentAnthropology and Development Studies
Summary Impact TypeSocietal
Research Subject Area(s)
Medical and Health Sciences: Public Health and Health Services
Studies In Human Society: Policy and Administration
Law and Legal Studies: Law
Summary of the impact
The ESRC Innogen Centre brought together a multiplicity of disciplines
for a large 12-year
research programme (2002-14) on the impact of regulation on innovation
dynamics in the life
sciences. Research design promoted interactions between stakeholders to
achieve policy impact.
Innogen developed a range of tooIs to disseminate research findings and
influence policy in
Europe, the African Union (AU), Kenya, Qatar and at the OECD. We used
temporary placements to achieve impact, as well as more traditional
activities and outputs,
resulting in major policy impacts in Europe, Africa and the Middle East.
The ESRC Innogen Centre
Innogen (ESRC Centre for Social and Economic Research on Innovation in
has crossed geographic and disciplinary boundaries to find solutions to
real-world challenges in
global health, food and energy security, the environment and the economy.
Appropriate Governance of the Life Sciences
In 2002, Professors Joanna Chataway and David Wield (OU
during the whole research period),
Professor Joyce Tait (Visiting Professor, OU since 1993), with Drs Julius
Anne Kingiri (2004-09) and Adele Langlois (2004-08), developed a research
`Appropriate Governance of the Life Sciences' (AGLS). The OU programme has
perspective with major empirical research results from Europe, North and
South America, Africa
and Asia (1-3).
AGLS focuses on the question: `Can the life sciences be better
regulated globally?' The research
programme investigates regulation and governance broadly — within a
framework of stakeholder
interaction, rather than as barriers to simple linear progression — as key
drivers of innovation.
Using a `triangle' model to structure our pathway to impact, our work
links three broad groups of
stakeholders: innovators (scientists, medics, farmers, firms); government
(multilaterals, OECD, EU); and public advocacy groups (patient
advocacy groups, NGOs). Our
research demonstrates that inappropriate and overly complex regulation can
development of innovative and potentially beneficial technologies in the
life sciences (4). Work in
more than 20 countries across four continents shows that regulation
strongly influences which
products are developed and which companies take the lead in their
development, and that poor
regulation decreases sectoral dynamism and plays into the dearth of
innovation in new medicines
and agricultural products (5-9).
Through analysing pharmaceutical sector changes, Innogen has investigated
new actors and
institutions that are changing regulation and governance structures (4,
10), finding that advances
have occurred in stratified medicine, rare and neglected disease
innovation, stem cells, and
synthetic biology, but regulatory systems are lagging behind. In
agriculture, Innogen's findings
show that US/European systems are driving biosafety, but differences
between the US and Europe
have stifled development and application of agro-biotechnologies in the
South (5, 6, 9). These
governance systems limit the opportunities for new entrant firms from
The significance of the research is evidenced by the successful review
and consequent four-fold
increase in funding from the ESRC to the OU Innogen Centre from 2007-14,
by further competitive
funds obtained (2-3), and by the independent evaluation that found
that Innogen had the strongest
density of UK interdisciplinary linkages between the social, health and
biosciences as measured
through Web of Science citations (see Rafols and Costa http://innogen.ac.uk/reports.php?id703).
bibliographic maps evidence the `remarkable breath of Innogen and its
exceptional degree of
cross-citation'. The reach of the OU research can be evidenced, for
example, by the 27 invited
international conference presentations given since 2003 in 11 countries
across 4 continents.
References to the research
3.1 Relevant Grants
1) ESRC Innogen grant, 2002-14 (£7.5m). (PI Wield, Chataway as
2) Julius Mugwagwa, `Cross-national technology regulation in
Africa' grant, Leverhulme, £80K,
2009-11 (PI Mugwagwa)
3) Chataway et al, `Institutional impacts of N-S partnerships in
Agro-biotechnology' and `Regulatory
practices and challenges of the African crop biotechnology sector', ESRC,
£90K, 2003-07 (PI
3.2 Relevant Publications
4) Chataway, J., Tait, J. and Wield, D. (2006) The governance of
agro — and pharmaceutical
biotechnology: public policy and industrial strategy, Technology
Analysis and Strategic
Management, 18, 169-185.
5) Chataway, J., Tait, J. and Wield, D. (2004) Company R&D
strategies in agrobiotechnology:
trajectories and blindspots, Research Policy, 33, 1041-1057.
6) Ayele, S., Chataway, J. and Wield, D. (2006) Partnerships in
African crop biotechnology and the
MDGs', Nature Biotechnology, 24, 619-621.
7) Mugwagwa, J. (2011) To harmonise or not to harmonise? The case
biotechnology governance in Africa, I.J. Technology Management and
Innovation, 6, 31-47.
8) Kingiri, A. (2011) Conflicting advocacy coalitions in an
evolving modern regulatory sub-system,
Science and Public Policy, 38, 199-211.
9) Wield, D., Chataway, J. and Bolo, M. (2010) Issues in the
political economy of agricultural
biotechnology, Journal of Agrarian Change, 10, 342-366.
Details of the impact
Innogen's AGLS research on life science regulation has had significant
impact on legislative and
policy formulation and implementation at national and international
levels, has contributed to the
formulation and strengthening of networks at national, international and
supra-national levels, and
has impacted public and policy discourse. Practical activities and outputs
policy-oriented outputs (10, 11); publications read by
practitioners, such as Nature Biotechnology
(12); and policy and press briefings. In the REF period, the named
researchers gave 39 talks in 11
countries to industry/government/international agency audiences; 21
workshops and public events;
3 select committee briefings. The Financial Times Pharmaceuticals
Correspondent confirmed that
the FT invited Chataway and Tait to prepare a session for their
high-level Global Pharma
conference (2009), because of the `significant policy relevance of their
research' (19). Chataway
maintained regular industry contact, leading to several research projects
with pharma companies
and the international Pharma Futures working group that began work in
Innogen supports the movement of researchers into policy environments as a
way of maximising
impact, and its staff are involved in numerous decision-making fora. Mugwagwa
placements at New Partnership for Africa's Development (NEPAD) and the AU
(2007 and 2012),
Langlois worked in the Parliamentary Office for Science and Technology
(POST) (2007) and
Chataway held a part-time placement at RAND Europe (2010-13) and is
currently vice-president of
Globelics where she promotes policy-relevant research.
Impact on European and global life science legislation, policy
Given the global nature of governance of life science products, such as
pharmaceuticals and GM
crops, European and global legislation and policy implementation has a
direct effect on policy and
legislation in developing countries. The OECD International Futures
Project invited us to develop
scenarios based on our research on the global healthcare sector
trajectory. This work investigated
possible trends in the development of health technologies and the
bioeconomy, focusing on the
period 2015-2030. Three scenarios were developed and published in an
influential report, which
concluded that wide-ranging governance reforms were necessary to ensuring
best outcomes from
biotechnology advances (10). 1985 copies were distributed, with
4851 downloads. The report
constituted the basis of the work of the OECD Working Party on
Biotechnology, comprising 33
member states, in formulating the influential new OECD policy on
harmonisation in biotechnology,
which subsequently led to its industrial biotechnology policy. The
Director of the OECD
International Futures Programme confirmed (14) the report was
discussed and presented in 60
OECD working groups, to member state governments (including Japan, US, UK
and to 14 large-scale stakeholder events. He also confirmed that the work
was `a crucial
contribution' to the OECD's involvement and influence in biotechnology.
The work of Adele Langlois has impacted public and policy discourse. As
part of her doctoral
studies, she secured a competitive scholarship from the Wellcome Trust to
undertake a fellowship
at POST (2008) to develop a policy briefing (13), widely
distributed among peers and MPs. POST's
Scientific Advisor for Biology and Health stressed the timeliness and
policy relevance of the work,
`which had been the reason for selecting Langlois's project for the
fellowship in the first place' (20).
The POSTnote received an average of 161 downloads a month during the
latest data period, and a
total of 1935 downloads by 2012.
Impact on African legislation and policy formulation and
AGLS research has been used to frame and establish new African policy and
regulation on drugs
and agro-biotechnology. Innogen's relationship with the AU began in 2006
with advice that led to
policy initiatives that improved and harmonised regulation of medicines
and biosafety. Chataway,
Mugwagwa et al wrote an invited report on building the case
for health systems innovation in
Africa, which the Science and Technology Advisor of NEPAD/AU confirmed
background document for the 8th Summit of the AU (2007). He
confirmed also that the work
informed ministerial-level discussions that led to the inter-ministerial
agreement on the science and
technology programme of NEPAD/AU, an example of international policy
impact (15). Later, it was
published as a book by the AU and made widely available in paper and
online (11). 15,000 copies
were distributed, and the book is now widely used by Ministries of Health
throughout Africa in
developing health policy.
While attached to the NEPAD Office of Science and Technology (2007), Mugwagwa
AGLS approach to develop a framework on medicine control harmonisation.
The Director of the
African Biosafety Network of Expertise (ABNE) and the Scientific Affairs
Officer of the Economic
Commission for Africa confirmed that this work constituted a core
dimension of the policy to
harmonise drug regulation within the AU (16). In particular, it
determined the agreed approach of
cluster-based harmonisation, as opposed to horizontal harmonisation across
In Kenya, Innogen research impacted agro-biotechnology legislation and
policy, as a result of
Kingiri's work with government agencies. During her OU doctorate
(2004-08), she worked on the
implementation of the Kenyan National Biosafety Act using Innogen
completion in 2009, she joined the African Centre for Technology Studies
in Kenya and was invited
to join the team drafting regulations later appended to the Biosafety Act.
She contributed to four
draft regulations (environmental release; import, export and transit;
contained use; labelling)
approved in 2011 and 2012. The Biosafety Director of the Kenyan Biosafety
confirmed the importance of her work and involvement from the initial
stages of the development of
the policy in 2008 (17). In addition, he stated that Kingiri and
her Innogen experience were
instrumental in the development of Kenya's first guidelines for inspection
and monitoring of
genetically modified (GM) field trials, a clear example of policy impact.
Kingiri is also a registered
member of the Kenyan Roster of Experts on Biosafety and the KBA confirmed
experience as important for her major role advising on new applications
for GMO field trials in
Impact on Qatar national research strategy
In Qatar, working with RAND researchers, Chataway used Innogen
research on research
governance and as PI, led a project that resulted in the Qatar National
Research Strategy 2012
with its strong focus on responsible and participative development of life
sciences, health and
environment. The Executive Director of the Research Division of the Qatar
Foundation stated that Chataway's expertise and leadership was fundamental
in formulating the
strategy, which has been formally adopted as national policy.
Implementation is underway (18).
In summary, Innogen's research question, `Can the life sciences be
better regulated globally?' has
led to significant influence and impact, which suggests not only that
regulation (and related
governance frameworks) can be improved, but also that Innogen has played a
significant role in its
Sources to corroborate the impact
5.1 Examples of publications produced with policy makers
10.) Tait, J. with Wield, D., Chataway, J. and Bruce. A. (2008) Health
Biotechnology to 2030.
Report to OECD International Futures Project. "The Bio-Economy to 2030:
Designing a Policy
Agenda', OECD, Paris; http://www.oecd.org/dataoecd/12/10/40922867.pdf.
11.) Chataway, J., Chaturvedi, K., Hanlin, R., Mugwagwa, J.,
Smith, J. and Wield, D. (2009)
Building the case for systems of health innovation in Africa, in Science,
technology and innovation
for public health in Africa, 7-94, African Union/NEPAD, Pretoria.
5.2 Examples of publications in outlets read by policy makers
12.) Chataway, J., Tait, J. and Wield, D. (2008) Off the rails or
on the mark? Nature Biotechnology,
13.) Langlois, A. (2008) Research governance in developing
countries, POSTnote 304.
5.3 Evidence from users
5.3.1 Available to be contacted by HEFCE
14.) Director, OECD International Futures Programme.
This contact will be able to speak to the impact of Wield and Chataway's
work on OECD policy on
biotech regulatory harmonization, especially in regard to bringing about
15.) Science and Technology Advisor, NEPAD/African Union.
This contact can corroborate the role of Chataway and Mugwagwa's research
on the shaping of an
inter-ministerial agreement on the science and technology programme of
16.) Director, African Biosafety Network of Excellence (ABNE) and
Scientific Affairs Officer, United
Nations Economic Commission for Africa.
This contact can discuss the role of Mugwagwa's research in the
development of the policy of drug
regulation harmonization within the African Union.
17.) Biosafety Director, Kenya Biosafety Authority.
This contact can speak to the importance of Kingiri's work in the
development of Kenya's biosafety
policy (2008), her role in drafting the Kenyan Biosafety Act, and Kenya's
first guidelines for
inspection and monitoring of GM field trials.
18.) Executive Director, Research Division, Qatar Foundation for
Education and Science.
This contact can discuss the role of Chataway's work in shaping the Qatar
Strategy 2012, and policies of the Qatar National Research Foundation.
5.3.2 Testimonials available upon request
19.) Financial Times Pharmaceutical Correspondent.
20.) Scientific Advisor (Biology and Health), Parliamentary Office
for Science and Technology.