Pharmacogenetics and ethics: Nuffield Council reports 29/9/03. By the Public Health Genetics Unit The Nuffield Council on Bioethics, in its latest report 'Pharmacogenetics: ethical issues' recognises that it is too early to know exactly how the science of pharmacogenetics will be applied in practice, but stresses that it is not too soon to begin considering the potential ethical, legal, social and policy implications.

The report encourages continued research, including the incorporation of pharmacogenetic investigation into clinical drug trials, with the aim of enabling the development of new drugs that will be safe and effective in specific patient groups.

Patients asked to participate in such trials should be fully informed about the nature of the trial, how their samples will be used and how they will be stored. If the samples are anonymised, participants should be asked for broad consent covering possible future uses. For identifiable samples, consent should only be sought for the proposed current use, although broad consent for future use could be sought at a later stage.

Although the report states that it is unlikely that trials will produce useful information regarding any one individual's medical treatment, the opportunity for a patient to receive such information, if possible, should be discussed at the time of obtaining consent.

The report raises the concern that pharmacogenetics could lead to the stratification of populations into smaller groups based on genetic variants, with the risk that some of these groups might be too small to be of interest to the pharmaceutical industry; if this were to happen, remedies such as orphan drug legislation must be considered. Populations might also be stratified on the basis of race or ethnic group, as determined by genetic variants. While this may be useful for identifying populations to sample, researchers must be aware of the possibilities of negative stereotyping or causing prejudice.

Individuals should not be overly concerned about insurers having access to pharmacogenetic test information, as it is covered by the current moratorium on the use of genetic test results by insurers. Insurance companies have also stated that they believe such information would be of low value in setting premiums for policies. Nevertheless, the report recommends continuing the moratorium beyond its current expiry date of 2006.

The promise of 'personalised medicine' is likely to be still some way in the future, the report concludes, but the professionals who will eventually be involved in delivering the service - particularly GPs and pharmacists - need to begin acquiring an understanding of the science of pharmacogenetics and of how to communicate that information to patients.

Article courtesy of the Public Health Genetics Unit .

Further reading

Pharmacogenetics: Ethical Issues from the Nuffield Council on Bioethics