Recent developments in regulation

So far, this chapter gives an overview of some regulatory frameworks for genetic tests and outlines some of the major regulatory gaps that are cause for concern. Policy discussions seem to be moving into a new phase of activity in regard to the regulation of genetic tests. In the USA, the past two years have seen an investigation of direct-to-consumer testing by the Government Accountability Office (US Government Accountability Office, 2006), the introduction of two bills on oversight of genetic testing into the US Senate (US Congress, 2007a, 2007b) and the Secretary's Advisory Committee on Genetics, Health and Society (SACGHS, 2008) has published a new report that analyses the regulatory framework and recommends a wide range of changes.

Meanwhile, in the UK, the Human Genetics Commission (HGC) has published a follow-up to its 2003 report on the regulation of direct-to-consumer (DTC) genetic tests, intended to prompt the government to act (Human Genetics Commission, 2007). The HGC's recommendations included preventing DTC provision of predictive tests, ensuring pre-market review of new tests and establishing a code of practice to govern DTC testing services. At the European level, consultation has begun on revising the medical device directives including the IVD Directive, with much expectation that the system will become more prescriptive and plug some of the current regulatory gaps, in part to address concerns about genetic tests (European Commission, 2007). The Dutch government has issued a report outlining a new model for risk classification in Europe that would see the reclassification of genetic tests as moderate risk (Hollestelle and de Bruin, 2006).

Another European body, the Council of Europe, is also driving policy in this area. Its 2008 Protocol on Genetic Testing establishes a general rule that a 'genetic test for health purposes may only be performed under individualised medical supervision' (Council of Europe, 2008). The impact of the protocol will depend on how many states choose formally to ratify it and thereby accept it as a legally binding protocol.

Finally, in Australia the Therapeutic Goods Administration (TGA), the body responsible for licensing IVD devices, has revised its regulations partly in a response to concerns expressed by successive Australian governments about the regulation of genetic tests. The TGA intends to implement regulatory mechanisms that will prohibit access to home use (self-testing) tests, including genetic tests, for serious disease markers. As part of this process the TGA has issued a guidance document about the regulation of nutrigenetic tests (Therapeutic Goods Administration, 2007).

In the EU, there have been considerable efforts to harmonize oversight of laboratory quality assurance systems through a number of national, regional and international schemes, culminating in the European Molecular Genetics Quality Network. Participants in the Network include 34 European countries and laboratories from Australia and the USA. These quality assurance initiatives have led to a new project—EuroGentest—an ambitious attempt to move beyond the previous focus on laboratory quality assurance to develop a series of discrete, but linked programs that deal with all aspects of quality in genetic testing services, from evaluation of the clinical validity and utility of tests to genetic counseling.

International activities are also significant, not least the new OECD guidelines on quality assurance for molecular genetics laboratories (OECD, 2007b). These examples all demonstrate that policy is already under development.

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