Lyon, France -- A new study has shown that increasing numbers of couples are travelling abroad for preimplantation genetic diagnosis (PGD), and that the main reason for this cross-border movement is the legal position in patients’ countries of origin.
Mr James Lawford Davies, a solicitor specialising in reproductive and genetic technologies, told the 23rd annual meeting of the European Society of Human Reproduction and Embryology today (Monday 2 July) that the main reason couples travelled to other countries was because PGD was banned in their own. However, this led to concerns over how referrals were made, whether or not the referral itself might be unlawful, and the quality (or even the existence) of counselling, medical advice, support, monitoring and follow-up for families and their children. Other reasons for travelling abroad included the quality of the treatment, test availability, expertise in certain diseases, cost and length of waiting lists in their home countries.
This is the first EU-wide study of provision and regulation of PGD, a technique for testing embryos fertilised in the laboratory for specific genetic or sex-linked disorders such as cystic fibrosis or Duchenne muscular dystrophy. Only unaffected embryos are transferred to the woman’s uterus, thus avoiding the possible need for a pregnancy termination when the defect is picked up at a later stage.
The study [1] was launched by the European Commission after a workshop organised jointly by the Institute for Prospective Technological Studies (IPTS) of the European Commission's Joint Research Centre (JRC), ESHRE and the European Society of Human Genetics (ESHG) revealed that little was know about the extent to which couples crossed national boundaries to gain access to treatment and what different regulatory frameworks for PGD existed in Member States. Mr Lawford Davies, who lectures in law and medicine at the Institute for Human Genetics at Newcastle University and is a visiting research fellow at Durham University Law School, UK, is a co-author of the report and he focused on the legal, ethical and regulatory aspects of the research in his presentation to the ESHRE conference.
“Reproductive and genetic technologies are regulated in a wide variety of ways across Europe,” he said. “The free movement of people and goods around the EU is a welcome development, but there are disadvantages to such cross-border flow in relation to PGD where such treatment is prohibited in the family’s country of origin.
“The evidence provided in this study suggests that doctors in Ireland, Switzerland and Germany – where PGD is prohibited – are concerned about providing information to patients about suitable PGD clinics in other countries. Formal referral is said to be prohibited in Germany and at least one Swiss clinic feared that even informing patients about PGD might be illegal. In Ireland, doctors’ fears about potential prosecution has led to a peculiar ‘inverted referral’ process whereby patients must contact PGD clinics in other countries themselves and these clinics then approach the Irish clinic for the relevant patient information. In situations where patients are left to identify clinics themselves, they are deprived of the benefit of medical advice, counselling and support at a vulnerable time.
“Secondly, the prohibition of PGD in their own country may complicate monitoring and follow-up. Self-referred patients, who may have identified clinics via the Internet or other means, may go unnoticed and clinics in their home countries could be reluctant to get involved in following up families and children born as a result of prohibited treatment. The evidence indicates some clinics are not deterred, whilst others do not see it as their responsibility.
“Our research also revealed an apparent inconsistency in countries such as Germany, Switzerland and Ireland where, on one hand PGD is prohibited, but on the other hand, prenatal testing and pregnancy termination for serious genetic disorders is permitted – although the latter is not allowed in Ireland.”
The report’s authors sent an on-line questionnaire to PGD and IVF clinics in Europe, and then conducted a more in-depth analysis of PGD practice and provision in 11 countries, which had been chosen to include countries with different approaches to regulation: Belgium, Czech Republic, France, Germany, Greece, Ireland, The Netherlands, Slovak Republic, Spain, Switzerland and the UK. The survey identified 53 centres offering PGD, most of them located in Spain, Belgium, The Czech Republic, Greece and the UK. Seventeen centres confirmed that they received tissue samples and 36 treated patients from abroad. The countries that received the most numbers of couples from elsewhere were Spain (332), Belgium (127), the Czech Republic (110), and Cyprus (150).
Mr Lawford Davies said that the survey highlighted other areas of concern:
- quality assurance for PGD testing was insufficient, with only a third of centres participating in external quality assessment schemes;
- few clinics appeared to meet the requirements of the EU Human Tissue and Cells Directive, though the Directive will provide a degree of reassurance for patients travelling abroad for PGD once it is implemented fully;
- monitoring and follow-up during pregnancy, at the neonatal stage and in the medium and long-term is important for providing information about safety and efficacy, but the survey shows that it is rare and inconsistent across Europe.
He said: “The rights and interests of patients seeking and receiving PGD in Europe are protected to a varied degree, but current policies by some Member States create a barrier to treatment which forces patients to travel abroad in circumstances which may compromise their interests. It is for individual Member States to decide how best to approach this problem, but options that they could consider could include harmonisation of regulation across Europe, or regulating rather than prohibiting PGD.”
Abstract no: O-086 Monday 17.00 hrs CET (Auditorium Pasteur)