Personal genetics, the European regulations maze and the way out

Colaiacovo, M; Grimaldi, KA

dc.contributor.author	Colaiacovo, M	en
dc.contributor.author	Grimaldi, KA	en
dc.date.accessioned	2014-03-01T11:47:07Z
dc.date.available	2014-03-01T11:47:07Z
dc.date.issued	2012	en
dc.identifier.issn	17410541	en
dc.identifier.uri	https://dspace.lib.ntua.gr/xmlui/handle/123456789/38096
dc.subject	direct-to-consumer	en
dc.subject	European law	en
dc.subject	health genetics	en
dc.subject	personal genetics	en
dc.subject	regulations	en
dc.subject.other	apolipoprotein E	en
dc.subject.other	Europe	en
dc.subject.other	genetic counseling	en
dc.subject.other	genetics	en
dc.subject.other	genotype	en
dc.subject.other	health care access	en
dc.subject.other	health care policy	en
dc.subject.other	health care system	en
dc.subject.other	law	en
dc.subject.other	practice guideline	en
dc.subject.other	priority journal	en
dc.subject.other	review	en
dc.title	Personal genetics, the European regulations maze and the way out	en
heal.type	other	en
heal.identifier.primary	10.2217/pme.12.62	en
heal.identifier.secondary	http://dx.doi.org/10.2217/pme.12.62	en
heal.publicationDate	2012	en
heal.abstract	Personal genetics and regulations have been the subject of active debate for at least the last 10 years, since the first direct-to-consumer tests were sold in the UK by Sciona Inc. (CO, USA). Opinions range from prohibition to free-for-all and all the shades in between. However, there has been very little progress in formulating regulations and the situation in Europe is particularly confusing, making it difficult for the provider and the consumer alike. The regulations maze is likely to be one major reason why the growth and public uptake has been slow: it is hard for companies to know how to operate and equally hard for consumers to understand what tests are useful versus those of dubious quality. This article gives a brief overview of the current situation regarding what regulations exist and looks closely at the areas where more clarity is needed. These include, exactly what should be regulated? What is health-related data? Who can and who should be able to have access to personal genetics? We conclude with specific proposals for improving the protection for consumers and encouraging growth of useful services. © 2012 Future Medicine Ltd.	en
heal.journalName	Personalized Medicine	en
dc.identifier.doi	10.2217/pme.12.62	en
dc.identifier.volume	9	en
dc.identifier.issue	5	en
dc.identifier.spage	515	en
dc.identifier.epage	522	en