Pharmacogenetics
Regulation of pharmacogenetic tests
15 In the UK, the safety and efficacy of medicines is assessed by the Medicines and Healthcare Products Regulatory Agency (MHRA).3 The MHRA licenses new medicines for use and oversees the provision of information and warnings about products. Regulation of the quality of genetic tests is also the responsibility of the MHRA. Depending on the evidence submitted to the MHRA by a pharmaceutical company that has developed a new medicine, the Agency may require the use of a pharmacogenetic test as part of the the conditions of issuing a licence for its use. Notification about the need to perform the test before prescribing the medicine would then be included in the information about the medicine used by prescribers. This approach is analagous to that taken with medicines that require non-genetic tests to be carried out in order to assess the suitability of a patient for treatment or to monitor their response to the medicine. It is likely that pharmaceutical companies which have identified genetic variation that affects response to a new medicine will include this information in their application and will support its inclusion in the licence.
16 It is most important that pharmacogenetic tests are developed which are of high quality and able to identify the genetic variations in question. We recommend that the European Medicines Evaluation Agency (EMEA) and the Food and Drug Administration (FDA) provide guidance for applicants as to the circumstances in which pharmacogenetic tests will be incorporated into the licence conditions of a medicine. Relevant factors will include the reliability of the test, the level of information it provides, and the frequency and magnitude of the effect it predicts, whether an adverse reaction or a poor likelihood of response (paragraph 4.6).
Footnotes3 The MHRA was formed in 2003 as a result of the merging of the Medicines Control Agency with the Medical Devices Agency.