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6 A structure for the discussion of ethical and legal issues was proposed. A first chapter would address issues regarding research and development. A second chapter would consider the use of pharmacogenetic information, including questions of consent, storage and access to data. A final chapter would consider pharmacogenetics in clinical practice.

7 It was observed that the Report needed to reflect the uncertainties uncovered by the Working Party, regarding how pharmacogenetics will develop and how it will be applied. There was also uncertainty about the public reaction to pharmacogenetic testing. It was agreed that it would be sensible to consider particular outcomes or scenarios that could arise and to make conditional recommendations, rather than attempt to predict what would happen.

8 The Working Party considered the likelihood that pharmacogenetics would lead to an increase in orphan medicines, by stratifying patients. Conflicting opinions on whether this was likely had been received in responses to the consultation paper and from other sources. It was observed that pharmacogenetics could influence drug discovery in two opposing ways. On one hand, it could encourage stratification by distinguishing groups of patients with the same disease who were best treated in different ways. On the other, it could provide a way of ensuring that medicines were developed which benefited a greater proportion of patients by enabling companies to identify pharmacogenetic-related variation and then avoiding compounds that elicited selective response to such variation. It was not thought to be problematic that pharmacogenetics might lead to compounds being rejected early on, since the industry needed ways to target their selection.

9 In cases where medicines were nearing the end of their patent protection, there might still be an incentive for companies to develop pharmacogenetic tests, since patents could be extended if new indications for a medicine were found. In the case of established medicines such as warfarin, it could be argued that pharmacogenetic testing would be useful, and that there would be no incentive for either the public or private sector to conduct the necessary research and development. In these cases, it could be suggested that the public sector should be encouraged to pursue the research. However, it was noted that funders of research might take the view that this was not the role of academia. Partnerships between the public and private sectors could be fruitful in such cases. It would be interesting to know what the Government’s Green Paper on genetics would recommend in this area.

10 Currently, there was frustration that once medicines had been withdrawn, it was not possible to gain access to the data that would enable further work to be done on the compounds. However, in most cases, it was thought unlikely that medicines would have a realistic chance of resurrection. The question of the mandatory use of pharmacogenetic tests in clinical trials was discussed.

11 The Working Party discussed the requirements for anonymising samples in research and the types of consent that could be obtained. Individual feedback of individual results of tests on genetic samples was a difficult issue. An important question was the nature of the research and whether the findings in relation to particular participants would be of clinical relevance to them. Arguably, in pharmacogenetic research, it was more likely that results would be of clinical relevance since they would relate to medicines the participant was taking. The Working Party considered the implications of giving individual feedback and legal requirements such as the Data Protection Act.

12 The issues raised by the use of pharmacogenetic tests in clinical practice differed according to the content of the test. The forthcoming paper from the Department of Health on the storage of medical records would need to be considered. It was agreed that the quality of pharmacogenetic tests was of crucial importance.

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