April 20, 2011
ESHRE Sets Standards For Cross Border Reproductive Care
The European Society of Human Reproduction and Embryology (ESHRE) is setting the first ever standards in Cross Border Reproductive Care (CBRC). The safety of patients, gamete donors, surrogates and future children take centre stage in ESHRE's Good Practice Guide for Cross Border Reproductive Care, published today (Wednesday, 20 April 2011).
The Guide aims to ensure high-quality assisted reproduction treatment as defined by the European Union criteria for good quality medical treatment and the ESHRE position paper on Good clinical treatment in Assisted Reproduction. Although in principle foreign and local patients should be treated the same and with the best possible treatment, there is evidence that this is not always the case.
The Guide is based on the core principles in health care: "Ëequity', "Ësafety', "Ëefficiency', "Ëpatient centeredness', "Ëtimeliness' and "Ëeffectiveness'. The principle of equity means that any difference between local and foreign patients should be justified, for instance the extra cost for a translator. Foreign donors should receive similar care to patients and local donors. No distinctions are to be made based on their origin and/or motivation. ESHRE recommends that national and foreign donors receive comparable compensation and that the recruitment criteria are the same.
According to the ESHRE Task Force on CBRC, the ideal is fair access to fertility treatment at home for all patients. However, often faced with no realistic alternatives due to legal restrictions, long waiting lists, lack of donors or unavailable or expensive treatments, patients travel across borders and may not receive adequate treatment in the country of their choice.
"Doctors should consider the principles of beneficence and non-maleficence together and aim at producing minimal risks with a maximum chance of pregnancy," says Dr. FranÃ§oise Shenfield, coordinator of the ESHRE Task Force. Here the group refers to the ESHRE position paper on "ËGood Clinical Treatment in Assisted Reproduction'. Treatments should abide by these rules. One example would be a restrictive embryo transfer policy to eliminate high order multiple gestations.
Patients should receive clear information about necessary tests, their costs and realistic waiting times; donors should receive a stimulation cycle that minimizes their health risk. In order to obtain information on repeated donations and to be able to verify legal restrictions on donations, ESHRE recommends the establishment of national registers of donors and for centers to participate in data registries. "To prevent abuse of donors coming from abroad, intermediate agencies should be avoided, since this may lead to violations of the rules of good clinical practice and, in the worst case, to trafficking," says Dr. FranÃ§oise Shenfield.
Legal advice about local rules should be given to patients at home and abroad. Potential legal problems in their home country should be outlined to patients. The ESHRE Task Force recommends that clinics follow up on children conceived after treatment at home and abroad.
Collaboration between the home practitioner and the receiving clinic offers the best chance of optimal care for the patient. The principle of "Ëpatient centeredness' includes adapting practical management to foreign patients. Counselling and psychological support should be available in a language understood by the patient. If this cannot be guaranteed, ESHRE recommends not treating the patient. This is important since the patients have to give proper consent. Clinics should provide patients with the details of their ombudsman or complaints department in order to give them the possibility to redress their grievances.
"Our recent study showed that an estimated 14.000 cycles of treatment are performed for infertile patients crossing borders in six European countries alone. The total number in Europe is therefore much higher. Together with collaborators such as egg donors or surrogates that also cross borders to provide reproductive treatment outside their home country, cross border care is a wide spread phenomenon, " says Dr. FranÃ§oise Shenfield. "ESHRE's Good Practice Guide for Cross Border Reproductive Care will provide guidance for clinics treating foreign patients and it will help regulators and policy makers to create a framework to enable centers to abide by these rules."
In 2011, the ESHRE Task Force aims to enroll as many signatures as possible to the Good Practice Guide from regulatory bodies, fertility societies and clinics. The International Federation of Fertility Societies has already agreed to it in principle. Further activities planned are data collection on unknown aspects of gametes donation and specifically oocyte donation across borders.