Governance of Innovative Medicine

Course summary

This is a course about facilitation of the development of innovative medicinal products 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. To do this, the course draws on the notion that innovative medicines have led to innovative governance mechanisms, in a relationship based on dialogue.

The course will give students a fundamental understanding of:

  1. the range of actors and activities instrumental to the delivery of health benefits;
  2. the types of novel biotechnologies that are shaping research and new models of healthcare;
  3. international and EU institutions and instruments establishing human rights and economic regimes conducive to promotion of human welfare;
  4. the relationship between EU risk-based regulation of medicinal products, devices and ATMPs, and 'facilitative governance' through informal collective and public-private arrangements for promotion of innovation and its products;
  5. the interplay between public and private interests, and their influences on innovative medicine and its governance.

Learning outcomes

By the end of this course you should 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.

Assessment

One essay of up to 4,000 words (60%); one written policy development exercise of up to 1,000 words (40%). 

Terms and conditions

Please note the University reserves the right to make variations to the contents of programmes, including the range of courses offered, and the available choice of courses in any given year may change.

Find out more about the University's terms and conditions