McMahon, Aisling and Kells, Alanna and Masterson, Sinéad (2023) Access and Provision of CAR-T Therapies in Ireland for Cancer Care: The Current & Future Landscape, Opportunities and Challenges: Legal, Ethical and Broader Policy Considerations. Project Report. Maynooth University.

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Abstract

This research was conducted as part of the Irish Research Council funded, ‘Patients’ Access to Advanced Cancer Therapies: Ethics and Equity of Access’ (PAACT) project. It aims to examine and map the current framework in Ireland for the provision of Chimeric Antigen Receptor T-cell therapy (hereafter ‘CAR-T therapy’) and to examine sustainable pathways to develop and provide access to such therapies in future. CART therapy is a type of immunotherapy which aims to use cells from a patient’s own immune system as part of the therapy. In simple terms, as part of the treatment, immune cells called T-cells are removed from the patient’s body, then outside the body these cells are modified so that they can target and kill cancer cells effectively. The modified T-cells are then reinfused or put back into the patient’s body to treat the cancer. When this therapy is successful, in some cases it has led to cancer going into remission – where such patients were previously terminally ill with no other viable potential treatment options. There are side effects associated with CAR-T therapies, including some which can prove fatal. However, clinical teams have developed strategies to try to minimise these risks, and to optimise management of such side effects. Nonetheless, ethical issues can arise in such contexts. CAR-T therapies were approved by the European Medicines Agency (EMA) for use in Europe in 2018. The provision of CAR-T therapies commenced in Ireland in 2021 for adult patients and in 2022 for paediatric patients in certain clinical contexts. Before this, patients based in Ireland (for whom such therapies were clinically indicated) needed to travel abroad to obtain CAR-T therapies. Currently several different CAR-T therapies have regulatory approval in Europe and are approved to treat certain types of haematological (blood) cancers such as lymphoma, leukaemia and myeloma, in specific contexts. Research in the field suggests they may have potential to treat other types of cancers, and other conditions in future. Accordingly, the numbers of patients who may benefit from such therapies may increase over time. However, there are remaining challenges for patients in accessing CAR-T therapies in Ireland. There are also challenges to providing CAR-T therapies within national public health systems, including the high costs of such therapies currently, and other legal, ethical, regulatory, resourcing, and infrastructural issues around increasing the development and provision of CAR-T therapies at a national level. This report examines the literature in the field and aims to provide an overview of the current landscape for the provision of CAR-T therapies for patients based in the Republic of Ireland (hereafter Ireland), it also outlines some of the main potential challenges for patients in accessing such therapies, and at a health systems level in providing CAR-T therapies. It concludes by offering ten main recommendations which aim to promote a deeper multi-disciplinary conversation around the provision of CART therapies in Ireland to address the main legal, ethical and broader policy challenges in this area, and to create further sustainable pathways to increase the development and provision of CAR-T therapies in Ireland in future.

Item Type:	Monograph (Project Report)
Additional Information:	This research was funded by the Irish Research Council's New Foundation Scheme and conducted in partnership with civil society partner Breakthrough Cancer Research. However, the research and recommendations in this report represent the views and opinions of the authors only, they do not represent the views or opinions of any other entities. Any errors or omissions remain the authors’ own.
Keywords:	Access; CAR-T Therapies; Ireland; Cancer Care; Current & Future Landscape; Opportunities; Challenges; Legal; Ethical; Broader Policy Considerations;
Academic Unit:	Faculty of Social Sciences > Law
Item ID:	18085
Depositing User:	Aisling McMahon
Date Deposited:	25 Jan 2024 15:54
Publisher:	Maynooth University
Funders:	: Irish Research Council, New Foundations Scheme
URI:
Use Licence:	This item is available under a Creative Commons Attribution Non Commercial Share Alike Licence (CC BY-NC-SA). Details of this licence are available here

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