Postgraduate Course: Governance of Innovative Medicine (LAWS11381)
|School||School of Law
||College||College of Humanities and Social Science
|Credit level (Normal year taken)||SCQF Level 11 (Postgraduate)
||Availability||Not available to visiting students
|Summary||This is a course about facilitation of the development of innovative medicinal products and devices, and their release into the market and clinic, in order to fulfil the societal goal to deliver ┐public goods of health┐. It provides a framework for thinking about how governance mechanisms enable both the creation of novel research tools and therapeutic products, and their accessibility to the widest community of researchers and patients, in order to ensure their best use to generate the social benefits of health. This course draws the creative tension that derives from the dialogue between the scientific, economic and public interests in this socially important arena.
* Seminar 1: Biomedicine old and new.
This session provides an introduction to the course, as well as to the relationship between science, technology and medicine, and what this means for the governance of innovative medicine.
* Seminar 2. Global Architecture.
This session will look at public international regimes for the promotion of human welfare, human rights and economic markets, as they pertain to health and public goods of health. It will touch on some of the key organisations and instruments relating to health, economic development, international trade and IP. We will consider the relationship between these organisations┐ agendas, and the implications for the governance of innovative medicine.
* Seminar 3. The European Context.
Following on from the previous session, this week we will consider the main European organisations and instruments that are relevant to the governance of innovative medicine, and their roles in the development of policies for the promotion of health, health research and the production of innovative drugs and therapies in Europe.
* Seminar 4. Products, Devices and Therapies.
This week we will consider specific matters relating to European regulation of the development and authorisation of medicinal products, medical devices and ATMPs.
* Seminar 5. Trials & Tribulations.
This session focusses more specifically on the regulation of clinical trials, and the new Clinical Trials Regulation, as well as touching upon direct-to-consumer advertising, and pharmacovigilance.
* Seminar 6. From Regulation to Facilitation.
This week we return to a more conceptual approach, looking at ┐facilitative governance┐, as well as collective strategies of governance.
* Seminar 7. Persons & the Public Interest.
For the remainder of the course our focus will turn to potential challenges that confront actors involved in innovation and the production of health related products, in a bid to ensure that innovation is delivered to both market and clinic. In this seminar our focus is on the public interest and the role of transparency.
* Seminar 8. Property & Procurement.
This week┐s session will complement our learning in seminar 7, as we consider the tissue supply chain, including challenges associated with procurement of cells by donation and consent for industrial use.
* Seminar 9. Patents & Freedom to Operate.
This week we will consider the significance of the grant and exercise of patents for access to and use of biological tools of innovative medicine.
* Seminar 10. Data Access & Privacy.
The last challenge for governance initiatives associated with innovative medicine relates to the balance to be achieved between data access and data protection or privacy.
Entry Requirements (not applicable to Visiting Students)
||Other requirements|| None
Course Delivery Information
|Academic year 2018/19, Not available to visiting students (SS1)
|Learning and Teaching activities (Further Info)
Feedback/Feedforward Hours 2,
Formative Assessment Hours 2,
Summative Assessment Hours 4,
Programme Level Learning and Teaching Hours 4,
Directed Learning and Independent Learning Hours
|Assessment (Further Info)
|Additional Information (Assessment)
||* One essay of up to 4,000 words (60% of overall mark)
* One written exercise of up to 1,000 words (40% of overall mark).
The 40% assessment is intended to take the format of a piece of policy advice. The formative assessment opportunity will be in a format that is similar to the 40% summative assessment.
||Students can expect to receive timely feedback on their assessments.
A legal foresighting exercise will be used to help students think through the role of law in a new field of innovation and to offer law and policy recommendations. Feedback will be given on various elements of the exercise.
|No Exam Information
On completion of this course, the student will be able to:
- Appreciate the range of competing actors, interests and values at play, and the inherent tensions they create, in the governance of innovative medicine
- 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.
- Identify, and apply critical analysis and evaluation to, key issues in the subject area
- Formulate well-reasoned and coherent arguments relating to key issues in the subject area
|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.
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 seminar discussion: articulating and supporting a line of argument and formulating critical analyses of arguments presented by others.
|Course organiser||Ms Annie Sorbie
Tel: (0131 6)50 3633
|Course secretary||Mr David Morris
Tel: (0131 6)50 2010