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Hum. Reprod. Advance Access published online on September 23, 2004
Human Reproduction, doi:10.1093/humrep/deh505
© 2004 by European Society of Human Reproduction and Embryology
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Opinion

Regulatory approaches to reproductive genetic testing

Bartha M. Knoppers 1* and Rosario M. Isasi 1

1 Centre de Recherche en Droit Public (CRDP), Faculté de Droit, Université de Montréal, CP 6128 succ., Centre-ville, Montreal, Quebec, Canada H3C3J7

* To whom correspondence should be addressed. E-mail: knoppers{at}DROIT.UMontreal.CA.


  Abstract

This report analyses the ethical and legal aspects of reproductive genetic testing in 11 countries (Australia, Austria, Canada, France, Germany, India, Israel, Japan, The Netherlands, Switzerland and the UK). The legal status of reproductive genetic testing in the countries under analysis is difficult to generalize due to the different regulatory systems adopted. These approaches are a reflection of the legal traditions and cultural and socio-religious beliefs which inform and shape public policy on assisted reproductive technologies and genetic testing. We divide approaches into two groups: public ordering (legislative, top-down approach) and private ordering (non-legislative, bottom-up approach). Even limiting our analysis to a number of countries that span the range from restrictive to pragmatic approaches, there is remarkable symmetry in both the (i) substantive requirements (i.e. gravity, health indications generally) and (ii) procedural safeguards (i.e. informed consent, counselling, confidentiality, civil status, oversight and accreditation) surrounding reproductive genetic testing. Indeed, irrespective of whether a country adopts a prohibitive or a permissive approach through legislation or self-regulation or a mix of both, the ultimate decision is--and should continue to be--a medical one. Nowhere is this more evident than in the substantive requirements.

Keywords: genetic testing; legal and ethical aspects; policy; preimplantation genetic diagnosis; prenatal testing.
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