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3 A fact-finding meeting was held with Professor David Goldstein, Wolfson Professor of Genetics, University College London; Dr Rashmi Shah, Medicines Control Agency; and Mr Adrian Towse, Office of Health Economics. A record of the meeting is recorded separately. In advance of the meeting, the Working Party identified the issues to be discussed with the guests. One such issue concerned how regulators assess the balance between risks and benefits regarding particular medicines and whether it was right that such decisions should be made in private.

4 It was suggested that the ethical issues raised by pharmacogenetics could be seen as falling under two headings: stratification and handling of genetic information. In addition, there was a broader question about inequities in access to medicines. With regard to stratification, the implications of pharmacogenetics for different racial groups were important and needed to be discussed further. Another aspect of stratification was the economic framework in which the development of new medicines took place. The Working Party would have to confront questions about the duties and obligations of various groups with respect to promoting the development of medicines. It was observed that contrasting opinions had been expressed regarding the likely economic impact of pharmacogenetics on the pharmaceutical industry. The Working Party would need to solicit further views on this matter in order to reach a realistic conclusion.

5 There was some discussion of the way in which cost-benefit calculations were integrated into the process of developing new medicines. It was important to note that the more restrictions and regulatory hurdles were put in place, the higher would be the costs of conducting clinical trials and therefore of medicines. There was a serious danger that no medicines would be developed for diseases affecting small numbers of people if regulation was applied too stringently.

6 It was noted that the term orphan medicine had previously been used to refer to therapies for diseases that affected small numbers of people. In the light of pharmacogenetics however, it could also be used to refer to therapies that were effective only in a small proportion of people who had a disease that affected many people.

7 A further issue that should be explored was the possibility that pharmacogenetics would increase existing inequalities in healthcare both nationally and internationally. It could be argued that the development of a culture in which medicines were prescribed in conjunction with genetic tests would have serious implications for the treatment of those in developing countries as well as for poorer groups within developed countries.

8 Finally, the Working Party discussed issues concerning the divulging of genetic information to individuals and their families. There was evidence that comparatively few people with a family history of Huntington¡¦s disease opted to be tested presymptomatically. However, when treatment was available, people were more inclined to make use of genetic tests. It was possible that people would agree to pharmacogenetic tests to improve their medical treatment, but would not be able to avoid such tests also revealing information about susceptibility to other illnesses, which they may not have wished to know. Whether this would be a problem depended to some extent on the nature of the pharmacogenetic tests. It would be possible to restrict a test so that only the presence or absence of a single SNP, or a group of SNPs that affected response to a particular medicine, were identified. This would reduce the likelihood that other information would be revealed. However, the problem could still arise. One example of a gene that had more than one effect was the ApoE4 variant, which was involved in Alzheimer¡¦s disease and heart disease.

ADDITIONAL FACT-FINDING MEETINGS