Postgraduate Course: International Health Research & Commercialisation (LAWS11274)
Course Outline
| School | School of Law |
College | College of Humanities and Social Science |
| Course type | Standard |
Availability | Available to all students |
| Credit level (Normal year taken) | SCQF Level 11 (Postgraduate) |
Credits | 20 |
| Home subject area | Law |
Other subject area | None |
| Course website |
http://www.law.ed.ac.uk/ahrc/teaching/llm/information/moduleinformation/ |
Taught in Gaelic? | No |
| Course description | This module examines the changing nature of (international) health research and its key relationships and objectives, and the interaction between health research and commerce, and on 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); and (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.
Aims & objectives - the module aims to:
¿ consider the nature and diverse manifestations of modern health research in the international context;
¿ consider health research as a social, technological and economic endeavour;
¿ explore the role played by the law in resolving technical, ethical and commercial issues and conflicts;
¿ discuss the strengths and weaknesses of various legal interventions in international health research from both the health and commercial regulatory regimes.
List of sessions:
Week 1: Introduction
Week 2: Health & the Global Bioeconomy (health demands, right to health, tech trajectories, social implications)
Week 3: Old and New Models of Health Research (large molecules to cellular therapies; translational medicine; issue thrown up)
Week 4: International Regulation of Research (Nuremburg, Helsinki, CIOMS, CoE, UNESCO x 3, WHO)
Week 5: European & Domestic Regulation of Research (Directives & Legislation; complexity; categorisation issues)
Week 6: Commerce & International Law - GAT, GATTS, TRIPS, EPC, PCT (WTO, WIPO)
Week 7: IPRs in the New Health Biosciences I (IPRs and pharma; cases)
Week 8: IPRs in the New Health Biosciences II (IPRs and stem cells - WARF, Brustle cases; IPRs synth bio)
Week 9: Commercial Partnerships (private-public partnerships, role of academia)
Week 10: Financing Innovation in Health Research and Biotechnology (funding, public goods, enclosure)
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Entry Requirements (not applicable to Visiting Students)
| Pre-requisites |
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Co-requisites | |
| Prohibited Combinations | |
Other requirements | None |
| Additional Costs | Students should have regular and reliable access to the Internet. Print consumables are recommended to provide hard copy of some on materials. |
Information for Visiting Students
| Pre-requisites | None |
| Displayed in Visiting Students Prospectus? | No |
Course Delivery Information
| Not being delivered |
Summary of Intended Learning Outcomes
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.
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Assessment Information
| One essay of up to 4,000 words (60%); one piece of assessed work (20%); contribution to online discussions (20%). |
Special Arrangements
| None |
Additional Information
| Academic description |
Not entered |
| Syllabus |
Not entered |
| Transferable skills |
Not entered |
| Reading list |
Not entered |
| Study Abroad |
Not entered |
| Study Pattern |
Not entered |
| Keywords | Not entered |
Contacts
| Course organiser | Mr Shawn Harmon
Tel: (0131 6)51 4267
Email: |
Course secretary | Ms Clare Neilson
Tel:
Email: |
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