BRIEFING SERIES: Appropriate Governance of the Life Sciences

Published: 2011
Author or Editor: Author

Appropriate Governance of the Life Sciences is a series of policy briefs describing Innogen's research on:

• Strategic innovation issues in life sciences
• The governance and regulation of innovation
• The resulting innovation trajectories determining which products are developed and which companies take the lead in developing them.

AGLS 1 - Multinational Company Innovation Strategies (Joyce Tait)

This paper examines this remarkable robustness in the pharmaceutical innovation model, but also recognises that disruptive change is becoming increasingly inevitable.

It focuses on the combinations of circumstances likely to lead to radical disruption and points to the need for such change to be carefully managed to ensure that life science research continues to deliver both public and commercial benefits.

To read the full brief, download AGLS1 - Multinational Company Innovation Strategies  (PDF 151kb)

AGLS 2 - The Case For Smart Regulation (Joyce Tait, Joanna Chataway, David Wield)

To say that regulation has an important impact on the kinds of product that are developed by an industry sector is a statement of the obvious '“ regulation is designed to ensure that products are safe, effective and of high quality.

However, the impacts of regulation are also more far-reaching, determining overall company strategies, which types of company succeed, and ultimately the structure and dynamism of the sector as a whole.

To read the full brief, download AGLS2 - The Case For Smart Regulation  (PDF 154kb)

AGLS 3 - Regulating GM Crops: lessons for next generation technologies (Joyce Tait, Ann Bruce, Joanna Chataway, David Wield)

Genetically Modified (GM) crops occupy a unique place among risk governance approaches for modern innovative technologies. They were the first such technology to be regulated on a precautionary basis from the earliest stages of a development process that began in the 1980s and is still evolving.

Today, there are distinctively different risk governance regimes in the European Union (EU) and the USA and the roots of these differences can also be traced back to the 1980s.

This policy brief builds on a series of research projects since the 1980s, exploring the complex antecedents of the European GM crops regulatory system and suggests a broader and more robust set of policy lessons to be drawn from the experience.

To read the full brief, download AGLS3 - Regulating GM Crops (PDF 156kb)

AGLS 4 - Pharmaceutical Futures: Health biotechnology to 2030 (Joyce Tait, Joanna Chataway and David Wield)

Innogen was asked to write a scenario report for the OECD International Futures Programme to consider the pathways that health biotechnologies could follow, the future trajectory of the bio-economy in the context of human health and the likely societal, economic and policy impacts of these projected outcomes, focusing on the period 2015 to 2030 .

To read the full brief, download AGLS4 - Pharmaceutical Futures  (PDF 155kb)

AGLS 5 - Health innovation for the world's poor: Who are the players and what is the game? (Joanna Chataway, Rebecca Hanlin, Joyce Tait and David Wield)

A variety of public private partnering arrangements and innovative financing mechanisms has begun to change the neglected disease landscape over the last decade.  How significant are these public-private partnership (PPP) arrangements?  Are these players likely to endure?  Do they deserve the continued support of development donors?  How do they relate to broader shifts in the pharmaceutical sector landscape and the changing '˜rules of the game'

To read the full brief, download AGLS5 - Health Innovation for the World's Poor  (PDF 39.4kb)

AGLS 6 - Where are Product Development Partnerships (PDPs) headed and how can Technologies for Health Systems Strengthening (THeSyS) help them get there? (Joanna Chataway, Rebecca Hanlin, Julius Mugwagwa and Lois Muraguri)

The last decade has witnessed a flourishing of new approaches to financing and addressing neglected diseases including Product Development Partnerships (PDPs).  Many PDPs have taken root with funding by the Rockefeller and Gates Foundations, some bi-lateral funding agencies and a range of other public and private donors. Most are not-for-profit.  They use public private partnerships arrangements to develop new drugs and vaccines for neglected diseases. 

To read the full brief, download AGLS6-Where are Product Development Partnerships (PDPs) headed  (PDF 155kb)

AGLS 7 - The feasibility of cross-national co-operation in technology governance: the case of biosafety in southern Africa (Julius Mugwagwa)

While southern African countries have found themselves in the throes of food emergencies before, the 2002/2003 crisis had the additional challenge that thousands of tonnes of food available to help cover the shortages were suspected to contain unspecified amounts of genetically modified (GM) maize. The dilemma laid bare the limited preparedness of countries, and the region to deal with these challenges. This gave new impetus to efforts towards development of regulatory regimes at both national and cross-national levels.

To read the full brief, download AGLS7-The Case of Biosafety in Southern Africa (PDF 161 kb)

AGLS 8 - Smarter Regulation of Drug Development: FDA Orphan Products and FastTrack Programmes (Joyce Tait & Christopher-Paul Milne)

Advances in biomedical sciences are predicted to have enormous impact on the prevention, diagnosis, treatment and cure of disease and disability, for example pharmacogenomics, proteomics, nanotechnologies, micro-arrays, biomarkers, bio-informatics, synthetic biology, and tissue engineering. On the other hand, the R&D process is increasingly costly, unpredictable and inefficient, so that these advances will not automatically translate into improvements in health care.

To read the full brief, download AGLS8 Smarter Regulation of Drug Development(PDF 152 kb)

AGLS 9 - Pros and Cons of the Precautionary Principle (PP): European Experience with the regulation of GM Crops (Joyce Tait & Joanna Chataway)

This policy brief reviews the development of the precautionary principle (PP) in Europe, mainly in the context of GM crops – the only area where it has been applied consistently to the development of an entire industry sector. We raise the question: Has the uncritical adoption of two key policy strands, the precautionary principle and ‘upstream engagement’ diminished the innovativeness and competitiveness of a major European industry sector and is it also challenging future innovation in life sciences?

To read the full brief, download AGLS9 Pros and Cons of the Precautionary Principle (PDF 126 KB)

AGLS 10 - Cross-national convergence of biosafety systems in Sub-Saharan Africa
(Julius Mugwagwa)

This policy brief presents some key observations from an analysis of the processes towards emergence of similar cross-national biosafety systems in Sub-Saharan Africa. The promises and challenges of modern biotechnology are as widely acknowledged as they are contested, raising the stakes for efforts to develop systems for governing the technology.

To read the full brief, download AGLS 10 Cross-national convergence of biosafety systems in Sub-Saharan Africa (PDF 1.73 MB)