International Health Research and Commercialisation

Module summary

This module examines the changing nature of (international) health research, its key relationships and objectives, the interaction between health research and commerce, and the role of the law in regulating that interaction. The module explores three central problems relating to the use of law in the dynamic field that is modern health research:

  1. In an age of moral pluralism, it can be difficult for stakeholders to secure social consensus on how new models of research and their associated technologies should be controlled and exploited (so health research regulation has often been a site of sharp social disagreement);
  2. It is often difficult for regulators to keep pace with rapid advances in research practices and technologies (so existing legal concepts and regulatory frameworks can soon appear outmoded and inadequate);
  3. Health research is increasingly influenced by commercial interests and pressures (so how activities in this field are influenced by regulatory rules from the commercial field is important).

The module will examine how these fundamental tensions are mediated within the legal and regulatory structures governing (international) health research and (international) commerce.

Session titles

  1. Introduction
  2. Health and the Global Bioeconomy (health demands, right to health, tech trajectories, social implications)
  3. Old and New Models of Health Research (large molecules to cellular therapies; translational medicine; issue thrown up)
  4. International Regulation of Research (Nuremburg, Helsinki, CIOMS, CoE, UNESCO x 3, WHO)
  5. European and Domestic Regulation of Research (Directives and Legislation; complexity; categorisation issues)
  6. Commerce and International Law - GAT, GATTS, TRIPS, EPC, PCT (WTO, WIPO)
  7. IPRs in the New Health Biosciences I (IPRs and pharma; cases)
  8. IPRs in the New Health Biosciences II (IPRs and stem cells - WARF, Brustle cases; IPRs synth bio)
  9. Commercial Partnerships (private-public partnerships, role of academia)
  10. Financing Innovation in Health Research and Biotechnology (funding, public goods, enclosure)

Learning outcomes

By the end of the module students should be able to:

  • appreciate the range of competing interests and values at play in the regulation of international health research;
  • appreciate how international regulatory frameworks for health research and international regulatory frameworks for commercialisation co-evolve and shape research activities;
  • formulate well-reasoned and coherent arguments relating to health research and commercial practices and rules, and, where appropriate, suggest reforms thereto.

Assessment

5000-word essay (60%); assessed course work (20%); participation in online activity (20%).

Back to modules