Appendix B
Regulation of Direct-to-Consumer Genetic Testing Outside the United States

RELEVANT LEGISLATION AND REGULATORY AND ADVISORY BODIES IN THE UNITED KINGDOM1

The United Kingdom (UK) does not yet have a legal or regulatory structure in place for complex gene tests or the DTC genetic testing companies that offer them. However, a collection of UK laws, regulatory authorities and advisory bodies, as well as European Union (EU) directives, are concerned with genetic testing in general.

UK Legislation

Genetic testing in the UK—and throughout the EU—is subject to the EU’s 1998 In Vitro Diagnostic Devices Directive (IVDD).2 In the UK specifically, the 2003 report Genes Direct3 was the impetus for the UK’s Human Tissue Act of 2004, which makes DNA theft—the collection or analysis of individuals’ DNA without their consent—a crime, punishable with a fine or imprisonment up to three years.

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.

2

Report available from: www.mhra.gov.uk/Howweregulate/Devices/InVitroDiagnosticMedicalDevicesDirective/index.htm, Accessed: March 29, 2010.

3

Report available at: www.hgc.gov.uk/UploadDocs/DocPub/Document/genesdirect_full.pdf, Accessed: March 29, 2010.



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Appendix B Regulation of Direct-to-Consumer Genetic Testing Outside the United States RELEVANT LEGISLATION AND REGULATORy AND ADVISORy BODIES IN THE UNITED KINGDOM1 The United Kingdom (UK) does not yet have a legal or regulatory structure in place for complex gene tests or the DTC genetic testing companies that offer them. However, a collection of UK laws, regula- tory authorities and advisory bodies, as well as European Union (EU) directives, are concerned with genetic testing in general. UK Legislation Genetic testing in the UK—and throughout the EU—is subject to the EU’s 1998 In Vitro Diagnostic Devices Directive (IVDD).2 In the UK specifically, the 2003 report Genes Direct3 was the impetus for the UK’s Human Tissue Act of 2004, which makes DNA theft—the collection or analysis of individuals’ DNA without their consent—a crime, punishable with a fine or imprisonment up to three years. 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. 2 Report available from: www.mhra.gov.uk/Howweregulate/Devices/InVitroDiagnosticMedi - calDevicesDirective/index.htm, Accessed: March 29, 2010. 3 Report available at: www.hgc.gov.uk/UploadDocs/DocPub/Document/genesdirect_full.pdf, Accessed: March 29, 2010. 

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 APPENDIX B ties, the Agency is charged with implementing the European Union’s IVDD, which encompasses genetic testing. Advisory bodies include the Genetic Testing Network and the Human Genetics Commission, which is the UK government’s main advisory body on genetics. 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. There currently is no analogous formal body for common diseases. The Human Genetics Commission (HGC) began considering DTC genetic tests in the 2003 report Genes Direct. Among other recommen- dations, the report advised that genetic testing for Mendelian diseases should not be offered direct-to-consumer, but only in the traditional clinical setting and with adequate pre- and post-test counseling. The HGC produced an updated report More Genes Direct in 2007.4 The report determined that most genetic tests fall into the lowest of four risk categories and therefore do not require pre-market assessment of clinical validity or utility; self-certification is sufficient. The Commis - sion has recently revisited its assessment and has now recommended that genetic testing should be classified as medium-risk. The European Union’s IVDD still considers genetic testing to be low-risk, however, and the UK’s official position reflects the EU’s assessment. The HGC held a seminar in 2008 with a wide range of stakehold- ers, including some DTC genetic testing companies. One of the conclu - sions, strongly supported by the companies, was to develop a common international code of practice. In September 2009, the HGC released for comment a draft document, A Common Framework of Principles for Direct to Consumer Genetic Testing Serices.5 The framework, which could form the basis of an international code of practice, included the principles: 4 Report available at: www.hgc.gov.uk/UploadDocs/DocPub/Document/More%20Genes%20 Direct.pdf, Accessed: March 29, 2010. 5 Report available at: www.hgc.gov.uk/client/Content.asp?ContentId=816, Accessed: March 29, 2010. The HGC subsequently released its final report on August 4, 2010. The report, A Common Framework of Principles for direct-to-consumer genetic testing services, is available at: www.hgc. gov.uk/Client/document.asp?DocId=280&CAtegoryId=10, Accessed August 18, 2010.

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 APPENDIX B • Test providers need to provide a high-quality service that both meets client expectations and safeguards their interests; • Tests for inherited diseases should be provided only with indi- vidualized pre- and post-test counseling; • Providers should comply with local, national or international advertising guidelines, and promotional claims should describe tests accurately and without bias; • Providers should supply clients with easily understood informa- tion, including likely outcomes of the test; • Tests should be carried out only with clients’ free and informed consent; and • Unless there is a clinically important reason to do so, individuals should not be tested until they have reached the age of consent. Comments on the common framework were due back to the Com- mission in December 2009. The UK Parliament has also begun considering issues raised by genetics and genomics. In July 2009, the Science and Technology Com- mittee of the House of Lords published its Genomic Medicine report. 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 up- to-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. Beyond the United Kingdom In April 2009, the German parliament passed legislation banning DTC

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0 APPENDIX B genetic testing. Under this law, genetic tests can be administered in Ger- many only by licensed physicians and with patients’ informed consent. 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.