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DEGREE REGULATIONS & PROGRAMMES OF STUDY 2016/2017

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DRPS : Course Catalogue : School of Social and Political Science : Postgrad (School of Social and Political Studies)

Postgraduate Course: Regulation and Governance of the Life Sciences (PGSP11396)

Course Outline
SchoolSchool of Social and Political Science CollegeCollege of Humanities and Social Science
Credit level (Normal year taken)SCQF Level 11 (Postgraduate) AvailabilityAvailable to all students
SCQF Credits10 ECTS Credits5
SummaryIssues of risk, governance and regulation have had a particular resonance in a range of life science sectors. Indeed, processes of regulation and risk management are a core component of most life science industries and shape the very nature of innovation. It is essential for students wanting training in core competencies and broader knowledge and understanding of the bioeconomy to be acquainted with systemic issues around risk governance and regulation as they apply to different sectors within the life sciences. This Course is an essential component of the BIG Programme and provides in-depth knowledge and understanding, through rich case studies from the contributors┐ long-standing expertise and research findings in the field, of how regulation and risk-governance processes have impacted on life science-based innovations in the health, agriculture and environmental sectors.
Course description Issues of risk, governance and regulation have had a particular resonance in a range of life science sectors. Indeed, processes of regulation and risk management are a core component of most life science industries and shape the very nature of innovation. It is essential for students wanting training in core competencies and broader knowledge and understanding of the bioeconomy to be acquainted with systemic issues around risk governance and regulation as they apply to different sectors within the life sciences. This course provides in-depth knowledge and understanding, through rich case studies from the contributors' long-standing expertise and research findings in the field, of how regulation and risk-governance processes have impacted on life science-based innovations; particularly in health and agricultural sectors.

Outline Content

1. Health Regulation, Governance and the Challenge of Advanced Therapies

This session investigates some of the challenges of designing and conducting clinical trials for novel therapies, and explores the relationship between developers of new drugs and the regulatory institutions that govern them.

2. Managing Risk and Uncertainty for Genetically Modified Organisms (GMOs) and Impact on the Agro-Biotechnology Industry

This session explores the regulation of GMOs, particularly in Europe, and reveals the challenges of managing risk and uncertainty in the context of a highly divisive and political issue that reveals a growing risk-assessment policy gap.

3. Intellectual Property, Patenting and Governance

This session will cover the different forms of intellectual property (IP) with a special emphasis on patenting. Students will be introduced to what a patent looks like and its requirements. The institutions that make up the IP framework will be discussed, including national and regional patent offices and laws, the WTO and The Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS).

4. The Role of Stakeholders in the Governance of Life Science Innovation: Social and Ethical Issues

This session explores some of the current and emerging social, ethical and political issues that pose a challenge to those responsible for the regulation and governance of life science research. In particular, we will explore issues around informed consent, protection of confidentiality, access, and research participation/recruitment in the context of patient specific biological material and genomic data.

5. Student Led Workshop/Presentations

This session will involve student-led, group presentations and discussion. Small groups of 3-4 students will take a real or imagined agricultural or therapeutic technology or product and think through how to take it to market in the context of regulatory and governance challenges.

The course, which has no prerequisites, is delivered through a 5-week lecture and seminar discussion format. The two-hour sessions will typically consist of a short lecture (introducing the key themes of the week's topic and the core readings provided), followed by an hour and a quarter of classroom discussion and/or student-led presentations. Each week's class will typically cover conceptual, theoretical and empirical material related to the topic. Discussion with staff and with others on the course is a key element in learning.
Entry Requirements (not applicable to Visiting Students)
Pre-requisites Co-requisites
Prohibited Combinations Other requirements None
Information for Visiting Students
Pre-requisitesNone
High Demand Course? Yes
Course Delivery Information
Academic year 2016/17, Available to all students (SV1) Quota:  30
Course Start Block 2 (Sem 1)
Timetable Timetable
Learning and Teaching activities (Further Info) Total Hours: 100 ( Lecture Hours 10, Programme Level Learning and Teaching Hours 2, Directed Learning and Independent Learning Hours 88 )
Assessment (Further Info) Written Exam 0 %, Coursework 100 %, Practical Exam 0 %
Additional Information (Assessment) 80% (essay) and 20% (group presentation)

Assessment will be a group presentation (20%) and a final individual essay of no more than 3000 words (80%). A list of essay titles will be provided, but students may choose their own essay topic with approval from the course organiser. Full details about what is required for the group presentation will be provided at the beginning of the course.
Feedback Formative, non-assessed feedback will be provided on a 1-2 page essay plan submitted half way through the course.
No Exam Information
Learning Outcomes
On completion of this course, the student will be able to:
  1. Have a clear understanding, based in key theories and concepts, of how risk governance and regulatory regimes function in different sectors of the bioeconomy, and be able to critically evaluate the potential of different risk-benefit models for product and process innovations.
  2. Be able to analyse and appraise the systemic role of regulation in both early and late stage R&D, and be able to think critically about the broader governance of life science innovation and role different stakeholders can play in risk management.
  3. Have developed specific knowledge and understanding of the different methods for studying risk governance and regulation, as well as key skills in foresight/scenario planning to identify known and potential risks and develop strategies to mitigate them within different sectors of the bioeconomy.
  4. Appreciate the distinctiveness of regulatory and governance processes in the life sciences as opposed to those within other industries, such as Information and Communication Technologies (ICT).
Reading List
Brevignon-Dodin, L. (2010) Regulatory Enablers and Regulatory Challenges for the Development of Tissue-Engineered Products in the EU, Bio-Medical Materials and Engineering (in press) DOI 10.3233/BME-2010-0623
Eriksson, L. and A. Webster (2008) Standardising the Unknown: Practical Pluripotency as Doable Futures, Science as Culture, 17 (1), pp. 57-69
Kuiper HA, Davies HV (2010) The SAFE FOODS risk analysis framework suitable for GMOs? A case study. Food Control 21: 1662-1676
Lovell-Badge, R. (2008) The Regulation of Human Embryo and Stem-Cell Research in the United Kingdom, Nat Rev Moll Cell Biol 9 (12), pp. 998-1003
Lyall C, Tait J (2005) New Modes of Governance: Developing an Integrated Policy Approach to Science, Technology, Risk and the Environment. Aldershot, UK: Ashgate
May, C.R. and N.T. Ellis (2001) When Protocols Fail: Technical Evaluation, Biomedical Knowledge, and the Social Production of Facts about a Telemedicine Clinic, Social Science and Medicine, 53, pp. 989-1002
Mittra, J. (2006) Genetic Exceptionalism and Precautionary Politics: Regulating for Uncertainty in Britain's Genetics and Insurance Policy Process', Science and Public Policy, 33 (8) pp. 585-600
Mittra, J., & Tait, J. (2009) Stem Cells, chapter for RiskBridge Report , SAS6-CT-2006-036661, pp. 224-268
Mittra, J. (2009) Riskbridge Conference Proceedings, Brussels, 26-27 March 2009
Parthasarathy, S (2004), Regulating Risk: Defining Genetic Privacy in the United States and Britain, Science, Technology and Human Values, 29 (3), pages 332-352.
Tait, J. (2007) Systemic Interactions in Life Science Innovation┐, Technology Analysis and Strategic Management, 19 (2), pp. 257-277

Further reading material is provided in the course handbook uploaded to Learn.
Tait, J. And J. Chataway (2007) 'The Governance of Corporations, Technological Change and Risk: Examining Industrial Perspectives on the Development of Genetically Modified Crops' Environment and Planning C: Government and Policy, 25, pp. 21-37.
Tait, J. & R. Williams (1999) Policy Approaches to Research and Development: Foresight, Framework and Competitiveness, Science and Public Policy, 26 (2), pp. 101-112
Tait, J. & G. Barker (2011) Global Food Security and the Governance of Modern Biotechnologies, EMBO Reports 12, pp. 763-768
Additional Information
Graduate Attributes and Skills Not entered
KeywordsNot entered
Contacts
Course organiserDr James Mittra
Tel: (0131 6)50 2453
Email: james.mittra@ed.ac.uk
Course secretaryMs Carol Ramsay
Tel: (0131 6)51 5066
Email: cramsay2@exseed.ed.ac.uk
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