Summary and recommendations - Nuffield Council on Bioethics
Summary and recommendations - Nuffield Council on Bioethics
Summary and recommendations - Nuffield Council on Bioethics
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Pharmacogenetics: ethical issues<br />
24 This stratificati<strong>on</strong> of groups of patients <strong>on</strong> the basis of genetic informati<strong>on</strong> has implicati<strong>on</strong>s<br />
both for patients <str<strong>on</strong>g>and</str<strong>on</strong>g> for those involved in developing new medicines. There may be both<br />
positive <str<strong>on</strong>g>and</str<strong>on</strong>g> negative effects. Some potentially valuable new medicines may not be developed<br />
if, as a result of genetic stratificati<strong>on</strong>, the number of patients who would benefit is too small<br />
to be profitable. However, stratificati<strong>on</strong> may also enable some medicines to be developed that<br />
would otherwise have failed because the subgroup in which the medicine is effective can now<br />
be distinguished. It is currently uncertain which of these trends is likely to prevail. We<br />
therefore recommend that agencies resp<strong>on</strong>sible for the licensing of new medicines pay<br />
attenti<strong>on</strong> to the possible negative effects of stratificati<strong>on</strong>. If pharmacogenetic stratificati<strong>on</strong><br />
does provide an ec<strong>on</strong>omic disincentive for those developing new medicines, c<strong>on</strong>siderati<strong>on</strong><br />
should be given to preparing guidance notes that encourage applicati<strong>on</strong>s to use existing<br />
orphan medicine legislati<strong>on</strong>, or any other policy instrument with equivalent effect, to provide<br />
incentives for development. We further recommend that if orphan medicine legislati<strong>on</strong> is to<br />
be applied, c<strong>on</strong>siderati<strong>on</strong> is given by the Internati<strong>on</strong>al C<strong>on</strong>ference <strong>on</strong> Harm<strong>on</strong>isati<strong>on</strong> to a<br />
global approach to orphan medicine legislati<strong>on</strong>. This should include rec<strong>on</strong>siderati<strong>on</strong> of the<br />
definiti<strong>on</strong> of an orphan medicine, with particular reference to the implicati<strong>on</strong>s of genetic<br />
stratificati<strong>on</strong> of both patients <str<strong>on</strong>g>and</str<strong>on</strong>g> diseases (paragraph 4.40).<br />
Pharmacogenetics <str<strong>on</strong>g>and</str<strong>on</strong>g> racial groups<br />
25 A particular case of the stratificati<strong>on</strong> of patient populati<strong>on</strong>s is stratificati<strong>on</strong> based <strong>on</strong> racial or<br />
ethnic groupings. Race <str<strong>on</strong>g>and</str<strong>on</strong>g> ethnicity cannot be given precise biological or genetic definiti<strong>on</strong>s.<br />
There is c<strong>on</strong>siderable genetic variati<strong>on</strong> within racial <str<strong>on</strong>g>and</str<strong>on</strong>g> ethnic groups, whether defined by<br />
place of birth, self-identificati<strong>on</strong> or other criteria, as well as between them. N<strong>on</strong>etheless, some<br />
genetic variants are more comm<strong>on</strong> in some racial or ethnic groups than in others. This has<br />
implicati<strong>on</strong>s for the design of clinical trials <str<strong>on</strong>g>and</str<strong>on</strong>g> for the development of medicines <str<strong>on</strong>g>and</str<strong>on</strong>g><br />
pharmacogenetic tests. Trials c<strong>on</strong>ducted in different countries, or statements about efficacy<br />
based <strong>on</strong> evidence in <strong>on</strong>e particular populati<strong>on</strong>, may not be valid in other, genetically different<br />
populati<strong>on</strong>s, or may <strong>on</strong>ly be valid if a different prevalence in relevant genetic variants has been<br />
taken into account. We recommend that bodies giving approval for the clinical use of<br />
pharmacogenetic tests require these to specify the populati<strong>on</strong> groups in which the tests have<br />
been validated, <str<strong>on</strong>g>and</str<strong>on</strong>g> to issue warnings where there is evidence that such tests may not be<br />
usefully predictive of resp<strong>on</strong>se to medicines in other populati<strong>on</strong> groups (paragraph 4.43).<br />
SUMMARY AND RECOMMENDATIONS<br />
26 Acknowledging that genetic variati<strong>on</strong> between populati<strong>on</strong> groups should be taken into<br />
account in the design of medical research should not be taken to imply that there are sharp<br />
lines that can be drawn between groups <strong>on</strong> the basis of genetic informati<strong>on</strong> which coincide<br />
directly with racial categories. Particularly in countries where medicines are advertised directly<br />
to c<strong>on</strong>sumers, there is a risk that medicines could be marketed to particular racial groups in a<br />
misleading manner, giving the impressi<strong>on</strong> that all members of that group would be likely to<br />
benefit, or that the medicine was more effective than other, n<strong>on</strong>-racially defined, medicines.<br />
More generally, such developments may reinforce tendencies to view race as a biologicallydefined<br />
phenomen<strong>on</strong>. We recommend that those involved in pharmacogenetic research <str<strong>on</strong>g>and</str<strong>on</strong>g><br />
the development of new medicines should be sensitive to the potential for misunderst<str<strong>on</strong>g>and</str<strong>on</strong>g>ing<br />
<str<strong>on</strong>g>and</str<strong>on</strong>g> prejudice arising from racial stereotyping. We recommend further that regulatory bodies<br />
exercise careful scrutiny over claims as to racial specificity in the marketing of<br />
pharmacogenetic tests <str<strong>on</strong>g>and</str<strong>on</strong>g> medicines (paragraph 4.45).<br />
27 Denying treatment to a particular racial group, using race as a proxy for a genetic profile,<br />
would be problematic, since not every member of the group could be expected to have the<br />
genetic variant in questi<strong>on</strong>. It is possible that health professi<strong>on</strong>als would be tempted to use<br />
race as a proxy in determining treatment, if the pharmacogenetic test that would discriminate<br />
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