McMahon, Aisling, 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) |
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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: | https://mu.eprints-hosting.org/id/eprint/18085 |
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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