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DRPS : Course Catalogue : School of Law : Law

Postgraduate Course: Regulation of Health Research & Innovation (LAWS11382)

This course will be closed from 31 July 2018

Course Outline
SchoolSchool of Law CollegeCollege of Humanities and Social Science
Credit level (Normal year taken)SCQF Level 11 (Postgraduate)
Course typeOnline Distance Learning AvailabilityNot available to visiting students
SCQF Credits20 ECTS Credits10
SummaryThis course examines the features of innovative medicine, its key actors and objectives, the role of international and national law in its regulation, and new approaches to its governance. The course explores three challenges for governance in this dynamic field:

1. It may be difficult for policymakers, in the age of moral pluralism, to secure social consensus regarding how research methods, technologies and their outcomes should be controlled and exploited; as a result, innovations in the medical field are often a source of contentious debate;

2. Regulators may also have difficulty in keeping pace with rapid advances in research practices and technologies, and existing legal concepts and governance frameworks can therefore become outmoded and inadequate to address current realities;

3. In the environment in which the field is evolving, economic interests, policy, and commercial regulation play a significant part in the direction of health research and its innovations including big data and research tools, healthcare products and therapeutics.

A key theme of the course will be the creative tension that derives from the dialogue between the scientific, economic and public interests in this socially important arena. The course will enable students to evaluate how law, regulatory structures and new forms of governance mediate key issues and perpetual change at this complex interface to facilitate pursuit of the objectives of health.
Course description 1. Introduction. The global, multi-disciplinary context. Innovative medicine. Overview of the course. Themes. Scope. Expectations.

2. Biomedicine old and new. Science, technology and medicine. New knowledge and the aims and institutions of modern science. Sociology and economics of open science. Relationship of science to industrial technology: utility, exclusivity and productivity. Pasteur's quadrant: is medicine science?

3. Health research, innovative medicine and regulation. Research, innovation and privatisation; a new paradigm? Objectives (pursuit of public goods and health benefits for society); activities (at the interface of research, innovation, commerce and public policy-making); actors and stakeholders (public and private); examples. Regulation and ethics.

4. International Regulatory Structures. A. Regulation and governance: objectives and purposes; formal and non-formal; B. Regulation of research in international law (Nuremburg » WHO); C. Public international regulation of trade and intellectual property (WTO and WIPO): implications for modern medical research and product development.

5. European and Domestic Regulation. Economic policy and the direction of research. Directives (ATMP, MHRA) and UK legislation (HTA, HFEA).

6. Beyond Regulation: Facilitative Governance. New theories and models of governance. Biotechnology and the commons. Public-private collaborations eg stem cell banking. Example of EBiSC.

7. Challenges I. Persons & the Public Interest. Stem cells, genetic engineering and regenerative / precision medicine. The role of altruism, trust and transparency. The limits of consent and contract.

8. Challenges II. Property & Human Materials. Property in human tissue: problems and prospects. Biomaterials for research use; scalable production of research tools; manufacture of bio-therapeutics.

9. Challenges III. Intellectual Property Rights. A. Pharma. B. Stem cells (WARF, Brustle etc)

10. Challenges IV. Data & Privacy: data management, data sharing, and the protection of (genetic) privacy.
Entry Requirements (not applicable to Visiting Students)
Pre-requisites Co-requisites
Prohibited Combinations Other requirements None
Course Delivery Information
Academic year 2017/18, Not available to visiting students (SS1) Quota:  None
Course Start Semester 1
Timetable Timetable
Learning and Teaching activities (Further Info) Total Hours: 200 ( Seminar/Tutorial Hours 40, Programme Level Learning and Teaching Hours 4, Directed Learning and Independent Learning Hours 156 )
Assessment (Further Info) Written Exam 0 %, Coursework 100 %, Practical Exam 0 %
Additional Information (Assessment) online discussion participation (20%) «br /»
class exercise (20%) «br /»
essay (60%) «br /»
Feedback Feedback and grades will be provided within 15 working days of the date of assessment submission.
No Exam Information
Learning Outcomes
On completion of this course, the student will be able to:
  1. Appreciate the range of competing actors, interests and values at play, and the inherent tensions they create, in the governance of innovative medicine.
  2. Demonstrate knowledge that covers and integrates most of the main areas of the subject of regulation and governance in the changing field of medicine, including a critical awareness and understanding of current issues.
  3. Identify, and apply critical analysis and evaluation to, key issues in the subject area.
  4. Formulate well-reasoned and coherent arguments relating to key issues in the subject area.
Reading List
To be developed
Additional Information
Graduate Attributes and Skills Students will develop the following skills and abilities:

1. Cognitive skills. The course will enable the student to select and deploy appropriate research techniques; they will critically analyse and evaluate key issues in the subject area, and formulate coherent arguments relating to key issues in the subject area.

2. Communications. Students will be able to summarise and communicate information and ideas effectively in oral and written form. Students are also expected to interact with each other and with tutors online, and this forms part of the overall assessment.

3. Autonomy, accountability. Students will exercise personal autonomy and intellectual initiative in, and take responsibility for, the conduct of their own work.

4. Working with others. They will engage with others through participation in online discussion: articulating and supporting a line of argument and formulating critical analyses of arguments presented by others.
Special Arrangements This course is taught by distance learning.
Additional Class Delivery Information This course is taught by distance learning.
Keywordsmedicine,health research,innovation,regulation,governance,public/private,commercial,economic
Course organiserDr Murray Earle
Tel: (0131 6)50 8183
Course secretaryMs Clare Polson
Tel: (0131 6)51 9704
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