Advanced Cancer Care: Enhancing Systems and Structures to Deliver In-House Personalised Therapies for Patients via the Hospital Exemption

Prof. Aisling McMahon

Prof Aisling McMahon, Maynooth University was awarded and Irish Research council New Foundations with Breakthrough as partner.  She will investigate Advanced Cancer Care: Enhancing Systems and Structures to Deliver In-House Personalised Therapies for Patients via the Hospital Exemption

Access to personalised cancer therapies including CAR-T therapy is difficult to deliver in public health systems given the high costs (approx. €450,000/patient) under traditional innovation models. Sustainable pathways to deliver cost-effective access to such therapies are needed. The hospital exemption is one such pathway which allows hospitals, under certain conditions, to produce tailored personalised therapies for patients. Yet, there is uncertainty around how this avenue can be used. This
project fills this gap – examining the extent that it could be used in Ireland to deliver access to CAR-T, potential barriers and whether it could enhance patient access and clinical autonomy.

Events:

Prof McMahon hosts IRC funded workshop with Breakthrough Cancer Research on the hospital exemption pathway for the development of ATMPs for patients with ‘unmet need’

On 31^st October, Professor Aisling McMahon hosted a policy workshop in Maynooth University organised as part of the Irish Research Council New Foundations scheme funded “Advanced Cancer Care: Enhancing Systems and Structures to Deliver In-House Personalised Therapies for Patients via the Hospital Exemption” (ACCESS) project. This project is run in collaboration with Dr Frances Drummond and Breakthrough Cancer Research.

The ACCESS project focuses on the hospital exemption provision which is a pathway provided under Article 28(2) of Regulation 1394/2007/EC  that enables medical practitioners, under certain conditions, to deliver ‘Advanced Therapy Medicinal Products’ (ATMPs), such as CAR-T therapies, prepared on a non-routine basis for individual patients in cases of ‘unmet need’.  The ACCESS project examines the scope of the hospital exemption provision under EU law and its operation in national States. The project is led by Professor Aisling McMahon, together with the project team which includes Sinéad Masterson, Alanna Kells and Lauren Kane. The research is considering the potential legal, regulatory and ethical issues that arise around the use of the hospital exemption pathway in specific contexts. At a policy level, this research aims to understand the extent to which this pathway could be used to deliver access to advanced ATMPs in the cancer context on a non-routine basis to patients with ‘unmet need’.