Pharmacogenetics
Regulation and public policy
Introduction
4.1 All medicines are required to meet standards of safety and efficacy. In addition, in the UK and a number of other jurisdictions, requirements of cost-effectiveness are also applied, so that medicines offer reasonable value for money. We have already seen that the application of pharmacogenetics will have implications for the number and variety of patients who may benefit from a particular medicine. These implications raise important issues of public policy concerning equity and fairness, which we seek to address in this chapter.
4.2 We begin by considering the implications for regulators regarding the licensing of pharmacogenetic tests and medicines, both for new tests and medicines and for those medicines which have previously been withdrawn from the market. In particular, we consider the contribution that pharmacogenetics could make to improving cost-effectiveness through the reduction of wasteful prescribing, and questions of the just allocation of resources that arise as a result of the stratification of patient groups through pharmacogenetic testing.
Regulation
4.3 In the UK, the safety and efficacy of medicines is assessed by the Medicines and Healthcare Products Regulatory Agency (MHRA).1 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. A European directive on in vitro diagnostic medical devices (98/79/EC) was agreed in 1998 which sets out the requirements for licensing diagnostic tests.2 The MHRA is responsible for the implementation of this directive in the UK.
Footnotes1 The MHRA was formed in 2003 as a result of the merging of the Medicines Control Agency with the Medical Devices Agency.
2 Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic medical devices. Available: http://europa.eu.int/smartapi/cgi/sga_doc?smartapi!celexapi!prod!CELEXnumdoc&lg=EN&numdoc= 31998L0079&model=guichett. Accessed on: 20 Jun 2003. For further discussion of the regulation of tests, see Melzer D et al. (2003) My Very Own Drug: What Must I Know? (Cambridge: Department of Public Health and Primary Care, University of Cambridge).