Datta Burton, Saheli;
Kiladi, Maria;
Morrison, Michael;
Prainsack, Barbara;
(2022)
Responsible personalised medicine: Exploring the ethical, legal, social, political and economic issues of manufacturing, distribution, access and reimbursement. A Report of the Responsible Personalised Medicine Project, UCL Future Targeted Manufacturing in Healthcare Hub.
Future Targeted Healthcare Manufacturing Hub: London, UK.
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Abstract
This report provides an overview of the ethical, legal, social, political and economic (ELSPE) issues underpinning the “manufacturing, business and regulatory challenges” that confront the development and delivery of affordable and accessible new targeted biological medicines. We specifically focus on the evolving definitions and its implication for the public understanding of personalised medicine (section 1), issues of manufacturing and distribution of Personalised Therapies (section 2) and institutional readiness (section 3) specifically focusing on emerging regulatory and reimbursement pathways (section 3.2) and how these are shaping or being shaped by ‘real world evidence’ (section 3.3). This is followed by our reflection on the implications of and for the entangled, complex and contingent interrelationships between personalised medicine, society and responsibility (section 4). Finally we conclude with discussion of the gaps and priorities for future ELSPE research on manufacturing of advanced biotherapeutics in terms of access, reimbursement, skills and infrastructure, regulation, responsible research and innovation (RRI) and the international political economy of emerging personalised medicine markets (section 5). This is a necessarily narrower review of the spectrum of ELSPE issues that attend personalised medicine activities and reflects this report’s aims to focus on those aspects of personalised medicine addressed by the UCL’s Future Targeted Manufacturing in Healthcare Hub.
| Type: | Report |
|---|---|
| Title: | Responsible personalised medicine: Exploring the ethical, legal, social, political and economic issues of manufacturing, distribution, access and reimbursement. A Report of the Responsible Personalised Medicine Project, UCL Future Targeted Manufacturing in Healthcare Hub |
| Open access status: | An open access version is available from UCL Discovery |
| DOI: | 10.5522/04/21463050 |
| Publisher version: | https://doi.org/10.5522/04/21463050 |
| Language: | English |
| Additional information: | This version is the version of record. For information on re-use, please refer to the publisher’s terms and conditions. |
| Keywords: | Personalised Medicine, Data Driven Medicine, ELSI of Personalised Medicine |
| UCL classification: | UCL > Provost and Vice Provost Offices > UCL BEAMS > Faculty of Maths and Physical Sciences UCL > Provost and Vice Provost Offices > UCL BEAMS > Faculty of Maths and Physical Sciences > Dept of Science and Technology Studies UCL > Provost and Vice Provost Offices > UCL BEAMS UCL |
| URI: | https://discovery-pp.ucl.ac.uk/id/eprint/10158613 |
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