Tomorrow the Nuffield Council on Bioethics will host a roundtable meeting ‘Novel medical treatments: innovation, hope, and headlines’, bringing together over 30 participants with a range of interests to discuss the ethical, social, and legal issues raised by novel medical treatments. The meeting will be chaired by Dave Archard, Chair of the Council and Emeritus Professor at Queen’s University Belfast.
Novel or innovative medical treatments are newly introduced or modified therapies that have not been fully tested in clinical trials. They include medicines, surgical procedures, stem cell therapies, and medical devices and implants.
Novel medical treatments might be sought because existing treatments are ineffective or unavailable. Patients, or families of patients, who seek novel treatments might be in a desperate situation. Various regulatory measures exist in the UK to enable patients to access medicines and devices before they are approved, such as the early access to medicines scheme. However, difficulties may arise in, for example, assessing the risks and benefits of unlicensed treatments, the resolution of disagreements between patients and healthcare professionals about treatment options, and the protection of patients from harm and exploitation.
The discussion will focus on establishing what kinds of activities might fall under the definition of novel medical treatments, how widespread these activities are in practice, what the key drivers are, and whether there are any ethical or regulatory gaps that need to be addressed. The discussion is likely to form the basis of a briefing note to be published later this year.