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Appendix B: Regulation of Direct-to-Consumer Genetic Testing Outside the United States
Pages 47-50

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From page 47...
... UK Regulatory Authority and Advisory Bodies The UK's chief medical regulatory agency is the Medicines and Healthcare Products Regulatory Agency. Among other responsibili 1 Unless otherwise noted, the section "Relevant Legislation and Regulatory and Advisory Bodies in the United Kingdom" is based on the remarks of Timothy Aitman, Professor of Clinical and Molecular Genetics, Division of Clinical Sciences, Imperial College, London.
From page 48...
... In addition, the National Institute for Health and Clinical Excellence advises on the clinical utility and effectiveness of new medical prod ucts, including genetic tests. The Genetic Testing Network evaluates tests for Mendelian diseases, according to the well-established gene dossier protocol.
From page 49...
... The report recommended establishing: • A voluntary code of practice, which encourages providers to be open about tests' limitations and enables consumers to make informed decisions; and • A Department of Health web site for consumers containing upto-date and comprehensive information about the DTC genetic testing companies and the tests they offer. Because DTC genetic testing is a rapidly expanding international market and therefore not easily regulated using strictly national guide lines, the UK's Human Genetics Commission is eager to liaise with regulators in other countries.
From page 50...
... A comprehensive listing and description of other legislative and legal documents related to genetic testing in the European Union, EU-member and other European countries, and non-European countries can be found in the report, Definitions of Genetic Testing in European and other Legal Documents,6 prepared for the European Commission in 2009. 6 Report available at: www.eurogentest.org/web/files/public/unit6/core_competences/Back groundDocDefinitionsLegislationV10-FinalDraft.pdf, Accessed: March 29, 2010.


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