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Journal of IMAB - Annual Proceeding (Scientific Papers)
Publisher: Peytchinski, Gospodin Iliev
ISSN: 1312 773X (Online)
Issue: 2011, vol. 17, book 1
Subject Collection: Medicine
Page: 135-138
DOI: 10.5272/jimab.2011171.135
Online date: 30 June, 2011
J of IMAB 2011; 17(1):135-138
LEGAL ASPECTS OF DIRECT-TO-CONSUMER GENETIC TESTS.
Mariela Yaneva – Deliverska
Institute for legal sciences, Bulgarian academy of sciences
ABSTRACT:
Genetic testing is a type of medical test that identifies changes in chromosomes, genes, or proteins. Most of the time, testing is used to find changes that are associated with inherited disorders. The results of a genetic test can confirm or rule out a suspected genetic condition or help determine a person’s chance of developing or passing on a genetic disorder.
The main difference between direct-to-consumer genetic testing and the standard genetic testing is the way informational support is provided in internet offers of testing. Counselling may be offered as an additional special service at extra costs and at the customer's request. It may also be that a recommendation or at least an offer is given for the customer to contact a doctor or health practitioner from the company via phone for counselling.
In a liberal society the fundamental individual rights can be considered to include access to medical treatment and diagnostics that may be helpful for improving one's health condition or that can help an individual make decisions regarding life style and health.
At the European level, there are no binding legal regulations that specifically apply for genetic testing. In some European counties, national laws, require a responsible medical person to be involved before a genetic test is provided.
The Convention on Human Rights and Biomedicine was adopted by the Committee of Ministers on 19 November 1996, while an Additional Protocol to the Convention, concerning Genetic Testing for Health Purposes, was adopted by the Committee of Ministers on 7 May 2008.
Direct-to-consumer genetic testing is closely watched by the community of medical genetics and counsellors, and the EU funded Eurogentest Network of Excellence.
In 2010, the European Society of Human Genetics has releaseda statement on direct-to-consumer gene testing for health-related purposes. The European Society of Human Genetics is concerned about the way in which commercial companies are currently introducing genetic tests into the market outside of the scope of the traditional healthcare system.
Key words: genetic condition, genetic testing, preventive medicine, legal regulations.
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REFERENCES:
1. Magnus, D., Cho MK, Cook-Deegan R, Direct-to-consumer genetic tests: beyond medical regulation?, Genome Med. 2009 Feb 2;1(2):17. [ PubMed ] [CrossRef doi: 10.1186/gm17]
2.
Analysis of privacy policies and practices of direct-to-consumer genetic testing companies: Private sector databanks and privacy norms, Health Law Institute, University of Alberta, March 2010.
3.
Hogarth S, Javitt G, Melzer D. The current landscape for direct-to-consumer genetic testing: legal, ethic, and policy issues, Annu. Rev. Genom. Human Genet. 2008.9:161-182. [ PubMed ] [CrossRef doi: 10.1146/annurev.genom.9.081307.164319
4.
Kaye, J., The regulation of direct-to-consumer genetic tests, Human Molecular Genetics, 2008 Oct 15;17(R2):R180-R183. [ PubMed ] [CrossRef doi:10.1093/hmg/ddn253 ]
5.
European Parliament, Directorate General for internal policies, Direct to consumer genetic testion study, November 2008.
6.
European Society of Human Genetics, Statement of the ESHG on direct-to-consumer genetic testing for health-related purposes, Eur J Hum Genet. 2010 Dec;18(12):1271-1273; Epub 2010 Aug 25 [PubMed] [CrossRef doi:10.1038/ejhg.2010.129 ]
Please cite this article as: Yaneva-Deliverska M. LEGAL ASPECTS OF DIRECT-TO-CONSUMER GENETIC TESTS. J of IMAB 2011; 17(1):135-138. doi: 10.5272/jimab.2011171.135