Preimplantation Genetic Diagnosis in Europe
In vitro fertilisation (IVF) and preimplantation genetic diagnosis (PGD) are now well-established treatments and are provided in many European countries. However, regulations, practices, professional standards and accreditation requirements are often markedly different between Member States (MS). Differences between MS seem to be becoming especially pronounced because of the interface between assisted reproduction and genetics. To assess the extent of these differences and try to obtain an initial picture of the overall situation in Europe, in March 2005 the Institute for Prospective Technological Studies (IPTS) of the European Commission's Joint Research Centre (JRC), the European Society of Human Genetics (ESHG) and the European Society for Human Reproduction and Embryology (ESHRE) organised a workshop on the abovementioned interface . The two-day event brought together 50 experts from different specialities to review current practices in Europe and discuss potential needs in this area. The first thing that became clear was that no full picture was available of PGD practice and provision in Europe. Secondly, the lack of quality assurance for these services in general was perceived as a potential problem. The participants in the workshop unanimously agreed that European clinics should be certified or accredited and that licensing systems should be developed by professional self-regulation. Minimum quality standards should be set. The lack of common European rules and regulations to guarantee minimum standards was said to be adding to the problem. However, quality assurance and accreditation have taken on new significance in the light of the recent EU Directive 2004/23/EC on setting standards of quality and safety for the donation, procurement, testing, processing, preservation, storage and distribution of human tissues and cells. Thirdly, as a result of the abovementioned differences between MS, patients are travelling abroad to gain access to treatment which is not available in their own country. This, in turn, sometimes requires movements of gametes (oocytes and sperm) and embryos within the EU. Whilst it is known that couples and reproductive tissue are moving around Europe, the extent is not known – especially in the new MS. Lastly, an overview of how the different regulatory frameworks are having an impact on the actual practices of PGD services was deemed necessary in order to gain a better understanding of the trans-border flows.
Having pinpointed some of the needs in this area, the IPTS launched this study in an effort to address them and to obtain the missing knowledge on provision of PGD services in Europe. The aims of this study are two-fold: 1)to obtain a clear picture of current PGD practice in Europe, including the quality of the services and cross-border activities (flows of couples or reproductive tissue); 2)to carry out a comparative review of the different regulatory frameworks at MS level and identify potential gaps at European level and the impact these might have.
ZIKA Eleni;
CORVELEYN Anniek;
MORRIS Michael;
DEQUEKER Elisabeth;
LAWFORD DAVIES James;
SCHMUTZLER Andreas;
ANTIÑOLO Guillermo;
PALAU Francesc;
2007-12-11
OPOCE
JRC36703
978-92-79-05654-3,
1018-5593,
EUR 22764 EN,
OP LF-NA-22764-EN-C,
http://www.jrc.es/publications/pub.cfm?id=1531,
https://publications.jrc.ec.europa.eu/repository/handle/JRC36703,
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