Nuffield Council on Bioethics issues consultation paper on personalised medicines
Tue, 19 November 2002
NCOB today isued a constulation paper on ethical issues raised by the development of personalised medicines (or pharmacogenetics)
The Nuffield Council on Bioethics today issued (19 November) a consultation paper on ethical issues raised by the development of personalised medicines (or pharmacogenetics).
People often respond differently to the same medicine. Some medicines are not effective for everyone; others may cause adverse side-effects, or even death. These different responses may be partly due to our different genetic make-up. Research in pharmacogenetics investigates how genetic variation between individuals affects their responses to medicine.
In the future, prescriptions could be tailored to an individual’s genetic profile. GPs may be able to take samples from patients, make a profile of their DNA, and predict which medicines will be most effective, or will have fewer side-effects.
Researchers in pharmacogenetics are already investigating current and future treatments for diseases such as HIV/AIDS, cancer and depression. The clinical applications of this research may not be widespread for some years, but it is important to consider ethical and legal issues which may arise. The Nuffield Council on Bioethics has established a Working Party which will consider these issues. The Working Party today invites members of the public and organisations to contribute their views.
The consultation paper poses 20 questions, including:
“We are looking forward to hearing a wide range of views on these issues,” said Professor Peter Lipton, Chairman of the Working Party and Head of the Department of History and Philosophy of Science at the University of Cambridge. “We would welcome comments from individuals and organisations on ethical, social and legal implications of this rapidly developing area.”
All responses will be considered by the Working Party, which includes philosophers, scientists and physicians. The period of consultation will last for three months. The Council will publish a Report in the autumn of 2003.
For further information:
The consultation paper can be downloaded from the Council’s website at:
www.nuffieldbioethics.org/pharmacogenetics
The closing date for the responses is 19 February 2003.
Notes for editors:
1. For further information please contact:
Nicola Perrin
28 Bedford Square, London WC1B 3JS
020 7681 9627
e-mail: bioethics@nuffieldbioethics.org
2. The Nuffield Council on Bioethics is an independent body which examines ethical issues raised by developments in medicine and biology. Established in 1991, it is funded by The Nuffield Foundation, the Medical Research Council and the Wellcome Trust.
www.nuffieldbioethics.org
3. Membership of the Working Party
Professor Peter Lipton (Chairman)
Head of Department of History and Philosophy of Science, University of Cambridge
Professor Haleh Afshar
Department of Politics, University of York
Professor Martin Bobrow
Head of Department of Medical Genetics, University of Cambridge
Deputy Chairman of the Nuffield Council on Bioethics
Professor John Caldwell
Dean, Faculty of Medicine, University of Liverpool
Professor Klaus Lindpaintner
Vice President, Research Director, Roche Genetics, Switzerland
Professor Sir Michael Rawlins
Chairman, National Institute for Clinical Excellence and Professor of Clinical Pharmacology at the University of Newcastle
Professor Nikolas Rose
Head of Department of Sociology, London School of Economics and Political Science
Dr Nigel Starey
Director, Centre for Primary Care, University of Derby
Professor Albert Weale
Professor of Government, University of Essex
Member of the Nuffield Council on Bioethics
4. Terms of Reference
1 To explore what pharmacogenetics offers now and is likely to offer in the near future;
In particular to examine the effect of pharmacogenetics on:
a) the design of medicines, the promotion of efficacy and safety in the administration of medicines to individuals;
b) the conduct of trials in the context of pharmaceutical research and development;
c) clinical practice.
2 To consider ethical issues specifically raised by pharmacogenetics;
In particular to examine the following areas:
a) consent, privacy and confidentiality;
b) the management of information about the likelihood of response to treatment;
c) the implications of differentiating individuals into groups based on the likelihood of response to treatment.
3 To consider the implications for the provision of healthcare.
5. Details of the progress of the Working Party will be posted on the Council’s website: www.nuffieldbioethics.org
6. Some of the issues raised by the use of pharmacogenetic tests in clinical trials and in general practice are familiar from recent discussions about the sale of genetic tests directly to the public. The Human Genetics Commission has recently completed a consultation exercise asking how such tests should be regulated and is expected to report before the end of the year. However, pharmacogenetics raises additional important issues, such as the effect on the development of new medicines and the provision of personalised treatment within the publicly-funded National Health Service.
Last Updated Thu, 10 June 2004