Summary and recommendations - Nuffield Council on Bioethics
Summary and recommendations - Nuffield Council on Bioethics
Summary and recommendations - Nuffield Council on Bioethics
You also want an ePaper? Increase the reach of your titles
YUMPU automatically turns print PDFs into web optimized ePapers that Google loves.
Pharmacogenetics: ethical issues<br />
of c<strong>on</strong>sent for pharmacogenetic tests compared to n<strong>on</strong>-genetic tests that might have similar<br />
risks associated with them, for example, tests for high blood pressure, which not <strong>on</strong>ly direct<br />
treatment, but also reveal informati<strong>on</strong> about the likelihood of future ill health. However, we<br />
recognise that <strong>on</strong>e important feature of genetic data is that they may reveal informati<strong>on</strong> that<br />
is unrelated to the illness in questi<strong>on</strong>, or indeed to any disease, <str<strong>on</strong>g>and</str<strong>on</strong>g> that this additi<strong>on</strong>al<br />
informati<strong>on</strong> may not be known about at the time the genetic sample is taken. This makes<br />
obtaining informed c<strong>on</strong>sent to the test difficult. The ethically significant requirement of<br />
c<strong>on</strong>sent is not that it be complete, but that it be genuine, since achieving fully informed<br />
c<strong>on</strong>sent is not possible (paragraph 3.29). No c<strong>on</strong>sent form can inform a patient about<br />
eventualities that are not known about at the time. However, c<strong>on</strong>sent forms may be required<br />
in some cases. We give two examples: (i) if there is a significant chance that the sample or test<br />
results will be used for purposes that are substantially different from the original goal of aiding<br />
prescripti<strong>on</strong>, or will reveal informati<strong>on</strong> about the patient unrelated to the medicines in<br />
questi<strong>on</strong>; (ii) if the results of the test may have a particularly serious impact <strong>on</strong> the health or<br />
lifestyle of the patient. It should be noted that both examples could also arise when n<strong>on</strong>genetic<br />
tests are proposed (paragraph 5.16).<br />
32 We recommend that in assessing whether written c<strong>on</strong>sent forms are required for<br />
pharmacogenetic tests undertaken in clinical practice, each test should be judged according to<br />
the nature of the informati<strong>on</strong> it provides. If informati<strong>on</strong> about unrelated medicines or<br />
diseases is likely to be obtained, or if the results of the test will have a significant impact <strong>on</strong><br />
the health or lifestyle of the patient, written c<strong>on</strong>sent may be appropriate. We take the view<br />
that, in most cases, written forms will not be required. However, written informati<strong>on</strong> for<br />
patients should be supplied, particularly if tests will reveal complex <str<strong>on</strong>g>and</str<strong>on</strong>g> probabilistic<br />
informati<strong>on</strong>. In developing such informati<strong>on</strong> resources, relevant organisati<strong>on</strong>s should c<strong>on</strong>sider<br />
whether informati<strong>on</strong> about n<strong>on</strong>-genetic tests which are similarly complex should also be<br />
developed (paragraph 5.17).<br />
SUMMARY AND RECOMMENDATIONS<br />
Resp<strong>on</strong>sibility for test <str<strong>on</strong>g>and</str<strong>on</strong>g> treatment<br />
33 Some pharmacogenetic tests are likely to provide clear, readily interpretable informati<strong>on</strong><br />
about medicines that can be purchased over the counter or obtained <strong>on</strong> prescripti<strong>on</strong>. If these<br />
tests are approved by the MHRA, we c<strong>on</strong>sider that there is no reas<strong>on</strong> to prevent their provisi<strong>on</strong><br />
directly to c<strong>on</strong>sumers. However, the majority of pharmacogenetic tests will be more complex,<br />
providing less certain predicti<strong>on</strong>s. In these cases, professi<strong>on</strong>al advice is likely to be needed both<br />
before <str<strong>on</strong>g>and</str<strong>on</strong>g> after taking the test, which means that the direct commercial provisi<strong>on</strong> of tests will<br />
be inappropriate (paragraph 5.22). The MHRA will be resp<strong>on</strong>sible for assessing the clinical<br />
validity <str<strong>on</strong>g>and</str<strong>on</strong>g> quality of tests (paragraph 4.3). We recommend that the UK Genetic Testing<br />
Network should take resp<strong>on</strong>sibility for advising <strong>on</strong> the sale of pharmacogenetic tests directly<br />
to patients, <str<strong>on</strong>g>and</str<strong>on</strong>g> should take a case-by-case approach. We c<strong>on</strong>sider that pharmacogenetic<br />
tests which are not to be sold directly to patients should not be advertised to them (paragraph<br />
5.22).<br />
34 A questi<strong>on</strong> arises regarding whether patients will have the opti<strong>on</strong> to receive treatment<br />
without taking an associated test. It cannot be assumed that patients will be keen to take a<br />
pharmacogenetic test, even if it will improve the likelihood of their receiving a safe <str<strong>on</strong>g>and</str<strong>on</strong>g><br />
effective treatment. Such an aversi<strong>on</strong> may be irrati<strong>on</strong>al, but may be based <strong>on</strong> a legitimate fear<br />
that informati<strong>on</strong> produced by the test could make it difficult to obtain insurance (paragraphs<br />
5.36-5.41), or that it might indirectly reveal informati<strong>on</strong> about a medical c<strong>on</strong>diti<strong>on</strong> which<br />
cannot be effectively treated.<br />
xxi