The Nuffield Council on Bioethics today issued a consultation paper on the 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:
  • Will the applications of pharmacogenetics increase inequalities in the provision of healthcare?

  • What are the implications of finding a genetic variant that influences the response to a medicine in a particular racial or ethnic group?

  • New tests will require the large-scale use and storage of genetic information. What regulations will be necessary to ensure that patients’ confidential information is respected and appropriate consent to its use is obtained?

  • Should a GP be responsible for providing a pharmacogenetic test or should tests be available directly to patients over the counter?

“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.