Professor Aisling McMahon, School of Law and Criminology, Maynooth University was recently awarded an Irish Research Council New Foundations Grant for the ACCESS project (‘Advanced Cancer Care: Enhancing Systems and Structures to Deliver In-House Personalised Therapies for Patients via the Hospital Exemption’). This project was awarded funding under the IRC New Foundations Civil Society Stream, and will be developed by Prof McMahon (PI) in conjunction with project partner Breakthrough Cancer Research and Dr Frances Drummond (Breakthrough Cancer Research).
The hospital exemption is a European pathway which allows hospitals, under certain conditions, to deliver personalised Advanced Therapy Medicinal Products (ATMPs), including CAR-T therapies, in cases of unmet need. However, there is uncertainty around to what extent, and in what circumstances, this avenue can be used in the European and in national contexts. There is a limited amount of academic research examining the hospital exemption scheme for ATMPs, including for advanced cancer therapies. This project aims to fill this gap. The project team will examine the scope of the hospital exemption scheme in Europe, its operation in the national Irish context, and the extent to which it could be used in Ireland to deliver access to advanced cancer therapies in cases of unmet need. As part of the project, we will examine the broader potential legal, regulatory and ethical issues that may arise around the use of hospital exemption pathway, and the challenges/opportunities presented by the hospital exemption scheme.
Professor Aisling McMahon is a Professor of Law at the School of Law and Criminology, Maynooth University where her research focuses primarily on health law and intellectual property law, and she has published widely in leading international peer-reviewed journals in such fields.
Breakthrough Cancer Research is an Irish medical research charity focused on cancer. Breakthrough works to significantly impact the number of children and adults who can survive this disease. It invests in world-class research in Ireland and beyond to impact the quality of life for people with cancer and save lives. Breakthrough are particularly focused on improving outcomes for those cancers, which are poorly served by current treatment options. For full details see Our Research Strategy - Breakthrough Cancer Research 'Make More Survivors'
For further details on the Irish Research Council New Foundations Scheme and recent awards, see here.