Personal genetics: Regulatory framework in Europe from a service provider's perspective

Grimaldi, KA; Look, MP; Scioli, GA; Clavero, JC; Marinos, S; Tagaris, T

dc.contributor.author	Grimaldi, KA	en
dc.contributor.author	Look, MP	en
dc.contributor.author	Scioli, GA	en
dc.contributor.author	Clavero, JC	en
dc.contributor.author	Marinos, S	en
dc.contributor.author	Tagaris, T	en
dc.date.accessioned	2014-03-01T01:36:38Z
dc.date.available	2014-03-01T01:36:38Z
dc.date.issued	2011	en
dc.identifier.issn	1018-4813	en
dc.identifier.uri	https://dspace.lib.ntua.gr/xmlui/handle/123456789/21368
dc.subject	direct to consumer	en
dc.subject	genetic testing	en
dc.subject	genotyping	en
dc.subject	human genetics commission	en
dc.subject	personal genetics	en
dc.subject	regulations	en
dc.subject.classification	Biochemistry & Molecular Biology	en
dc.subject.classification	Genetics & Heredity	en
dc.subject.other	article	en
dc.subject.other	biomedicine	en
dc.subject.other	consumer	en
dc.subject.other	cost	en
dc.subject.other	Europe	en
dc.subject.other	European Union	en
dc.subject.other	genetic screening	en
dc.subject.other	genetic service	en
dc.subject.other	genetics	en
dc.subject.other	genotype	en
dc.subject.other	government regulation	en
dc.subject.other	health care personnel	en
dc.subject.other	health care practice	en
dc.subject.other	health service	en
dc.subject.other	human	en
dc.subject.other	human genetics	en
dc.subject.other	human rights	en
dc.subject.other	laboratory test	en
dc.subject.other	lifestyle	en
dc.subject.other	medical service	en
dc.subject.other	nutrition	en
dc.subject.other	personal genetics	en
dc.subject.other	priority journal	en
dc.subject.other	Europe	en
dc.subject.other	European Union	en
dc.subject.other	Genetic Services	en
dc.subject.other	Genetic Testing	en
dc.subject.other	Genotype	en
dc.subject.other	Government Regulation	en
dc.subject.other	Health Services	en
dc.subject.other	Humans	en
dc.subject.other	Individualized Medicine	en
dc.subject.other	Practice Guidelines as Topic	en
dc.title	Personal genetics: Regulatory framework in Europe from a service provider's perspective	en
heal.type	journalArticle	en
heal.identifier.primary	10.1038/ejhg.2010.189	en
heal.identifier.secondary	http://dx.doi.org/10.1038/ejhg.2010.189	en
heal.language	English	en
heal.publicationDate	2011	en
heal.abstract	The purpose of this article is to give an overview and discuss the relevant regulations in place, or under consideration, regarding healthcare-related personal genetics services in Europe - this is a rapidly evolving field and in most European Union (EU) countries the regulatory framework is not yet clear. The review will be framed from the perspective of potential service providers (companies, health services and practitioners, including medical, nutritional, complementary, etc), the growing number of which will need to be aware of potential regulatory hurdles existing now and that may arise in the future. The main conclusion from the survey is that strict regulations regarding practitioner-delivered personal genetic-testing services are unlikely to be enforced over the next 5 years in most EU countries, with the exception of Germany. There is broad-based, but by no means universal, support for a strong voluntary code of practice as an alternative to government regulations to protect consumers and to enable all stakeholders to recognise serious and reputable service providers. On the other hand, there are influential bodies calling for strict regulation. As genotyping costs rapidly fall, it is likely that it will become routine and a major challenge that does not seem to be addressed by current debate on regulations is the emergence of companies offering/selling personal genetic services based on a customer's pre-existing genetic results and therefore no actual laboratory testing involved. European Journal of Human Genetics (2011) 19, 382-388; doi:10.1038/ejhg.2010.189; published online 1 December 2010	en
heal.publisher	NATURE PUBLISHING GROUP	en
heal.journalName	European Journal of Human Genetics	en
dc.identifier.doi	10.1038/ejhg.2010.189	en
dc.identifier.isi	ISI:000288505000006	en
dc.identifier.volume	19	en
dc.identifier.issue	4	en
dc.identifier.spage	382	en
dc.identifier.epage	388	en