Innogen’s research question, ‘Can the life sciences be better regulated globally?’ has had significant influence and impact globally, which suggests not only that regulation (and related governance frameworks) can be improved, but also that Innogen has played a significant role in its improvement.
Impact on European and global life science legislation, policy formulation and implementation
Given the global nature of governance of life science products, such as pharmaceuticals and genetically modified 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 Innogen to develop scenarios based on the Institute’s 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 ensure the best outcomes from biotechnology advances (Tait, J. et al. 2018). The report constituted the basis of the work of the OECD Working Party on Biotechnology, comprising 33 member states, in formulating the OECD policy on harmonisation in biotechnology, which subsequently led to its industrial biotechnology policy.
The Director of the OECD International Futures Programme confirmed that the report was discussed and presented in 60 OECD working groups, to member state governments (including Japan, US, UK and Germany), 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 Innogen Associate Adele Langlois has also 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 on research ethics in developing countries, which was widely distributed among peers and MPs (Langlois, A. 2008).
Impact on African legislation and policy formulation and implementation
Innogen research into the appropriate governance of the life sciences has been used to frame and establish new African policy and regulation on drugs and agro-biotechnology. Innogen’s relationship with the African Union (AU) began in 2006 with advice that led to policy initiatives that improved and harmonised regulation of medicines and biosafety. Innogen associate Joanna Chataway and colleagues wrote an invited report on building the case for health systems innovation in Africa, which the Science and Technology Advisor of NEPAD/AU confirmed formed the background document for the 8th Summit of the AU (2007). The work informed ministerial-level discussions that led to the inter-ministerial agreement on the science and technology programme of NEPAD/AU. Later, it was published as a book by the AU and made widely available in print and online (Chataway, J. et al. 2009). 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), former Innogen co-director, Julius Mugwagwa used the appropriate governance of the life sciences 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. In particular, it determined the agreed approach of cluster-based harmonisation, as opposed to horizontal harmonisation across all countries.
In Kenya, Innogen research impacted agro-biotechnology legislation and policy, as a result of work by Ann Njoki Kingiri with government agencies. During her doctorate (2004-08), she worked on the implementation of the Kenyan National Biosafety Act using Innogen approaches. Following 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 Authority confirmed the importance of her work and involvement from the initial stages of the development of the policy in 2008. 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 field trials.
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
Langlois, A. (2008) Research ethics in developing countries, POSTnote 304. http://www.parliament.uk/business/publications/research/briefing-papers/POST-PN-304
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.