This initiative builds on research previously conducted through the ESRC-funded Innogen Centre, as part of our core programme of work on regulation/innovation interactions. The topic is the development of novel bio-pharmaceutical drugs that are raising challenges for regulators, arising from new modes of manufacture, modes of action and delivery to the patient. This area of Innogen’s research focused on the ways in which regulatory systems are adapted to meet the needs of new technologies, that can inadvertently close off useful, potentially safe and effective, developments. This project will undertake discussions among a group of influential regulators with a view to achieving impact in the form of effective new regulatory systems that are more adaptive towards the needs of innovative products than current approaches.
Current regulatory frameworks have created a perverse incentive for people to navigate around them. Ensuring that the patient is receiving a good quality, safe and effective product, is still the primary function of regulation. However, a new approach is needed to cope with today’s advanced innovative medical technologies, particularly those related to biological products. A mechanism is needed to bring together the different parties involved and to devise a system which is sustainable in the context of modern healthcare systems that takes account of the issue of small populations.
|Effective start/end date||1/06/15 → 31/03/16|