Ethics body reports on personalised medicines

The UK's Nuffield Council on Bioethics has published a report on the ethical and policy issues surrounding pharmacogenetics: the use of tests to match medicines to a person's genetic make-up. It concludes that although such tests may significantly improve the quality of patient care, it is still unclear how quickly and effectively the technology will be deployed. It also says that as well as potential benefits, the use of pharmacogenetic tests could cause 'unwanted negative consequences', such as the reduced availability of some medicines and possible genetic discrimination. The document, which can be downloaded from the Council's website, goes on to consider the ethical, legal and regulatory issues arising from pharmacogenetics, and makes several recommendations for the future development of this technology.

People often respond differently to the same medicine: it may be more effective in some people than others, or cause unwanted side effects in some. In some cases, these differences may be down to genetic variation. However, claims by companies that pharmacogenetics will lead to 'the right medicine, for the right patients, at the right dose' may be overstated, says Professor Peter Lipton, chairman of the working party set up to produce the new report. 'But it is important to encourage discussion of ethical and policy issues raised by the introduction of pharmacogenetics,' he added. The report includes the results of a public consultation carried out by the Nuffield Council between November 2002 and February 2003, which prompted 84 responses. Half of these were from organisations, representing a variety of pharmaceutical companies, medical practitioners, patient groups and insurers.

The report expresses concern that the use of pharmacogenetic tests in clinical trials might mean that some potentially valuable new medicines may not be developed, if the number of potential patients who might use a particular medicine is too small to be profitable. It recommends that medicine licensing agencies should pay attention to such 'pharmacogenetic stratification', possibly using existing 'orphan medicine' legislation. On the issue of confidentiality, the report says that genetic tests are no different to any other type of medical tests, such as blood tests, although it acknowledges that genetic tests can be rich in information. It also points out that pharmacogenetic test results would fall under the current moratorium on the use of genetic test results by insurance companies, which extends until 2006.