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

    Short Title: ACCESS Project

    Civil Society Partner: Dr Frances Drummond, Breakthrough Cancer Research 

    Summary of project: The hospital exemption is a European regulatory pathway provided for under Article 28(2) of Regulation 1394/2007/EC  which 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'.  This project aims to examine the scope of the hospital exemption provision under EU law, its operation in the national Irish context, and the extent to which it could be used in Ireland to deliver access to advanced ATMPs in the cancer context on a non-routine basis to patients in cases of 'unmet need'. The project will consider the potential legal, regulatory and ethical issues that arise around the use of hospital exemption pathway in specific contexts.

    Project Objectives
    The project has three main objectives, namely:

    1. To develop a comprehensive understanding of how the legal/regulatory framework for the use of the hospital exemption mechanism operates under EU law, and to understand and compare how the hospital exemption route has been implemented at a national level with a focus on Ireland, Spain and Italy.
    2. To understand, specifically, in what contexts, the hospital exemption mechanism is or could be used in Europe to develop tailored ATMPs for patients with ‘unmet needs’, and how this may be impacted by proposed EU legal reforms to this area;
    3. To understand the potential challenges, opportunities and broader considerations around use of the hospital exemption route for the development and delivered of tailored ATMPs  for patients with unmet needs in the cancer context, including potential ethical, regulatory, legal, and resource considerations.

     
    Ultimately, the project aims to develop a more in-depth understanding of, and policy report on the hospital exemption route, considering the potential opportunities and challenges around using the hospital exemption route for the provision of ATMPs in cases of ‘unmet need’ in Ireland, with a particular focus on cancer therapies.
     
    ALL Institute members involved in the project
    Prof Aisling McMahon (PI)
    Sinéad Masterson

    Team Members:
    Alanna Kells
    Lauren Kane

    Funder: 

    Irish Research Council New Foundations