VenueESRC Genomics Forum, Edinburgh
Theme 1: INNOVATION, REGULATION AND POLICY
Innovation policy and industry influence on genomics research
- Open science v. technology transfer in genomic knowledge-flows
- Do intellectual property rights restrict innovation?
- The role of international policy organisations in regulating genomics
By examining the driving forces in the development of genomic technologies and the role of major stakeholders who influence or control them, we can understand better the prospects for development and formulate strategies to monitor, regulate or intervene in technological development processes. This session looked at the impact of genomics innovation in the development of genomics research applications.
Participants discussed how global trends in life sciences research challenge research and development policies, with the view to assess the role of public research organisations, private sector and science and technology stakeholders. Issues debated were the role of intellectual property in forwarding research, the role of universities and scientists in driving and managing innovation, the fading tradition of open science and emerging conflicts of interest, difficulties that scientists have with gaining access to enabling technologies, shifts in academic collaborations with industry via university technology transfer agreements, their impact on the nature and levels of research investment and ways in which current regulation efficiently addresses (or does not) problems therein.
Participants discussed the ability of international organisations (WHO, UNESCO, WIPO, WTO, OECD) to inform, shape, influence or change regulatory agendas and policy drivers for research and development at global level.
Theme 2: GLOBALISATION AND GENOMIC KNOWLEDGE GOVERNANCE
Cultural, legal, social and ethical readings of technology
- New directions in the life sciences and their implications for IPRs
- On ‘biopiracy’ of genetic resources
- What is ‘common heritage’ and is the notion of ‘common heritage’ uneasy with IP?
- Expectations in commercialisation of genomics and 'sharing’ of ‘benefits’
- The expression of values in patent opposition proceedings
Intellectual property provides incentives and opportunities for economic co-operation in a variety of regulated areas, as in pharmaceutical and agricultural goods. Co-operation is regulated to large extent through agreements and laws on biodiversity and biosafety regulations. Current about managing genomic applications are closely linked to international concerns with biological and cultural diversity and the principles of the Convention on Biological Diversity.
The impact of IP standards and their harmonisation and the obligations upon developing and least developed countries to implement those standards are key issues for significant groups, including indigenous and traditional communities, policy advisors, intellectual property researchers and non-governmental organisations. This event provided a chance to discuss whether intellectual property protection is compatible with the facilitation of social, cultural and economic development of non-industrialised countries.
Participants discussed the impact of ‘bio-colonialism’, ‘bio-prospecting’ or ‘biopiracy’ and further examined the impact of globalisation, management of genomic knowledge on collaborative mechanisms and integrated innovation strategies for research. It proved vital to analyse the meaning and concept of ‘benefits’, whether framed in ‘development terms’ or ‘health terms’ or ‘profit terms’, as these emerge in current debates about participation in innovative research.
The Human Genome Organisation Ethics Committee provided a definition in their 2000 statement on benefit sharing, that ‘…a benefit is a good that contributes to the well being of an individual and/or a given community (e.g. by region, tribe, disease-group…); benefits transcend avoidance of harm (non-maleficence) in so far as they promote the welfare of an individual and/or a community... thus, a benefit is not identical with profit in the monetary or economic sense…; determining a benefit depends on needs, values, priorities and cultural expectations…’. Are health and wealth benefits mutually exclusive? To what extent are these concepts linked with how people view their contribution or participation to genomic-related research? And, how do people perceive benefits in relation to commercial profit, especially within different cultural settings, contexts and readings of new technologies?
The discussion focussed on how the potential for commercialisation shapes governance on human research participation. Examples were drawn from current international discussions on benefit sharing in human genetics, the implications for consent, intellectual property management and sharing of benefits in research biobanks.
Theme 3: COLLABORATIVE PARTNERSHIPS
Recent collaborative initiatives in genomics and intellectual property
- The role of interdisciplinary collaborations in intellectual property and genomics
- Intellectual property, genes and ethics in comparative perspective
The value and role of alternative and collaborative models in the regulation of research incentives and protections of participation in research were discussed. It was judged important to understand the role of current initiatives and protective mechanisms in genomics such as open source collaborations for open practices in the life sciences and initiatives in forming genomic patent pools. In discussing ways that could enhance swift availability of essential medicines for public health while keeping patent and licence costs low, it was discussed that it is necessary to assess whether collaborative mechanisms can create opportunities to change practices within intellectual property systems.