Genetic testing legislation in Western Europe - A fluctuating regulatory target

Journal of Community Genetics

Volumn 3, Issue 2, 2012, Pages 143-153

  Soini, Sirpa ^a  

^a UNIVERSITY OF HELSINKI   (Finland)

Author keywords

Direct to consumers (DTC) genetic testing; Genetic exceptionalism; Genetic testing; Legislation; Regulation

Indexed keywords

ANXIETY; AUSTRIA; BIOMEDICINE; BIOTECHNOLOGY; DIRECT TO CONSUMERS GENETIC TEST; DOCTOR PATIENT RELATION; EUROPEAN UNION; FRANCE; GENE SEQUENCE; GENETIC DATABASE; GENETIC DISORDER; GENETIC SCREENING; GENOME ANALYSIS; GENOMICS; GERMANY; GOVERNMENT REGULATION; HEALTH CARE FACILITY; HEALTH CARE POLICY; HEALTH INSURANCE; HUMAN; HUMAN GENOME; HUMAN GENOME PROJECT; HUMAN RIGHTS; INFORMED CONSENT; LAW; MEDICAL ETHICS; MEDICOLEGAL ASPECT; MORALITY; NORWAY; PERSONAL AUTONOMY; PORTUGAL; PRACTICE GUIDELINE; PRIORITY JOURNAL; QUALITY CONTROL; REVIEW; SPAIN; SWEDEN; SWITZERLAND;

EID: 84863106395     PISSN: 1868310X     EISSN: 18686001     Source Type: Journal    
DOI: 10.1007/s12687-012-0078-0     Document Type: Review

References (26)

1. Benoît-Rohmer and Klebes (2005) Council of Europe law. Towards a pan-European legal area, Council of Europe, Strasbourg
2. Cassiman J-J (2011) Some considerations about a report on 'Public health in an era of genomic-based and personalized medicine' from the Public Health Foundation, Cambridge. J Community Genet 2:107-109
3. EC Expert Group (2004) 25 recommendations on the ethical, legal and social implications of genetic testing. European Communities, Brussels
4. EGE - European Group on Ethics in Science and New Technologies (2003) Statement on advertising genetic tests via the internet
5. European Society of Human Genetics (ESHG) (2010) Statement of the ESHG on direct-to-consumer genetic testing for health-related purposes. Eur J Hum Genet 18(12):1271-1273
6. Feinberg AP (2008) Epigenetics at the epicenter of modern medicine. JAMA 299(11):1345-1350 (Pubitemid 351439080)
7. PHG Foundation (2010) Public health in an era of genome-based and personalised medicine. ISBN 978-1-907198-06-9. Available at www.phgfoundation. org. Accessed on 15 Sept 2011
8. Gostin LO, Hodge JG Jr (1999) Genetic privacy and the law: an end to genetic exceptionalism. Jurimetrics 40:21-58
9. Harper PS (2008) A short history of medical genetics. Oxford University Press, Inc
10. HGC Human Genetics Commission (2010) The Common Framework of Principles 2010. www.hgc.gov.uk
11. Hogarth, Stuart and Melzer, David. IVD-directive and genetic testing. Problems and proposals. A briefing presented to the 20th meeting of Competent Authorities Lisbon, July 2007. Available at www.eshg.org. Accessed 27 August 2010
12. Hudson KL (2011) Genomics, health care, and society. NEJM 365 (11):1033-1041
13. Knoppers BM, Saginur M (2005) The Babel of genetic data terminology. Nat Biotech 23(8):925-927
14. Kraft P, Hunter DJ (2009) Genetic risk prediction - are we there ye. NEJM 360(17):1701-1703
15. Krajewska A (2009) Conceptual quandaries about genetic data - a comparative perspective. Eur J Health Law 16:7-26. doi:10.1163/157180909X400204
16. Laurie, Graeme (2002) Genetic privacy: a challenge to medico-legal norms. Cambridge University Press
17. Lifton RP (2010) Individual genomes on the horizon. NEJM 362 (13):1235-1236
18. Morgan, and Young (2007) An introduction to law and regulation. Cambridge University Press. Cambridge, UK
19. Organisation for Economic Co-operation and Development (2007) Guidelines for quality assurance in molecular genetic testing. OECD: Paris, France
20. Patch C, Sequieros J, Cornel MC (2009) Genetic horoscopes: is it all in the genes? Points for regulatory control of direct-to-consumer genetic testing. Eur J Hum Genet 17:857-859
21. Pinto-Basto J, Guimarães B, Rantanen E et al (2010) Scope of definitions of genetic testing: evidence from a EuroGentest Survey. J Community Genet 1:29-35
22. Rothstein MA (2005) Genetic exceptionalism and legislative pragmatism. Hastings Center Report 35(4):27-33
23. Rynning Elisabeth (2011) Still no Patients' Act in Sweden - reasons and implications in Elisabeth Rynning & Mette Hartlev (Eds.) Nordic Health Law in a European Context - Welfare state perspectives on patients' rights and biomedicine. Liber AB, Sweden
24. Soini S, Matthijs G, Aymé S (2008) Patenting and licensing in genetic testing. ethical, legal and social issues. Eur J Hum Genet 16:S10-S50 (Pubitemid 351587082)
25. Vialla F (2006) La loi de 2004 au regard des évolutions en bioéthique in Dix and des lois de bioéthique en France. Revue générale de droit médical, Les Études Hospitalièrs Éditions, Bordeaux
26. WHO (2003) Review of Ethical Issues in Medical Genetics. Report of Consultants to WHO Professors D.C Wertz, J.C Fletcher and K. Berg. World Health Organisation