Personal genetics: regulatory framework in Europe from a service provider's perspective.
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.
Biomedical Engineering Laboratory, Institute of Communication and Computer Systems, National Technical University of Athens, Athens, Greece. Keith.grimaldi@gmail.com
Keith A
KA
Grimaldi
Markus P
MP
Look
G Antonio
GA
Scioli
Juan Coll
JC
Clavero
Stathis
S
Marinos
Tassos
T
Tagaris
D005060:Europe; D005062:European Union; D033142:Genetic Services / Q000331:legislation & jurisprudence / Q000592:standards; D005820:Genetic Testing / Q000331:legislation & jurisprudence* / Q000592:standards*; D005838:Genotype; D033161:Government Regulation; D006296:Health Services; D006801:Humans; D017410:Practice Guidelines as Topic; D057285:Precision Medicine / Q000191:economics* / Q000639:trends