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4 The structure of the report was discussed and agreed. The definitions of pharmacogenetics and pharmacogenomics were considered. Pharmacogenetics concerned differences between individuals in their response to medicines. These differences could be genetic characteristics of the person, whether related to their illness or not. Originally, these differences were only revealed when the medicines were administered, but with advances in genetics, it was now possible to identify them in advance. The ability to distinguish subgroups of a disease based on genetic information about the illness, was a new phenomenon. Thus, medicines such as Herceptin were an extension to the original concept of pharmacogenetics. Pharmacogenomics involved the use of genetic knowledge to design medicines and was a process of the development of medicines, and not concerned with testing individual patients.

5 Evidence for the burden of inefficacious medicines on the NHS would be researched. Good examples included medicines for depression and schizophrenia. There were two potential problems: patients who did not respond to any available medicines, and those who did respond to a particular medicine but only discovered which after a process of trial and error. Pharmacogenetics was likely to help in this second category. It was agreed that adverse reactions were a serious problem. Many were already preventable, but of those that were not, only some would be preventable through the application of pharmacogenetics.

6 It was noted that the Introduction to the Report should indicate that some pharmacogenetic tests were already used in clinical practice, and give an indication of the extent to which this would become more widespread in the future. It would be interesting to know more about pharmacogenetic medicines and tests currently at a late stage in the development process. The case of TPMT testing was interesting. The role of regulators in reviewing licence conditions for medicines in the light of pharmacogenetic research was considered.

7 The question of stratification was considered: would stratification increase?; and if it did, would that create problems? The definition of orphan medicines was considered. The question of whether differing national regulatory requirements meant that there could not be global markets for medicines was discussed.

8 The example of Glivec was discussed. Glivec had been rushed through the development process in order to treat a small group of seriously ill patients. Licensing was agreed for treating this group, and for the use of the medicine in further trials for other conditions. There was an annual review process to monitor developments. This example, and that of Lotronex, were good examples of flexibility on the part of regulators.

9 The relevance of racial differences was discussed.

10 The question of consent to treatment in clinical practice, anonymisation of samples, the breadth of consent, and the provision of individual feedback of research results were discussed. On the subject of insurance, the consultation response from the Association of British Insurers was considered in detail.

11 Consideration was also given to off-label use of pharmacogenetic medicines.

12 A clearer distinction needed to be made between the regulation of safety, efficacy and quality, which was the responsibility of the MCA and MDA, and the role of bodies such as NICE.

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