New Turkish legislation on assisted reproductive techniques and centres: a step in the right direction?
Article Outline
- Abstract
- Introduction
- Funding and eligibility
- Opening of new assisted reproduction treatment centres
- Number of embryos allowed for transfer
- Cryopreservation
- Gamete and embryo donation and surrogacy
- Conclusion
- References
- Copyright
Abstract
The Ministry of Health of Turkey has just passed a new legislation on assisted reproduction techniques. The new legislation covers significant changes in the regulation of opening new assisted reproduction treatment centres, funding of the treatment, number of embryos to be transferred, cryopreservation and donation. It takes a brave step towards reducing the incidence of multiple pregnancies. However, it also makes Turkey one of the most strictly regulated countries in the world. The statements on gamete cryopreservation and donation may have social and clinical consequences.
Keywords: assisted reproduction, cryopreservation, donation, embryo transfer, legislation, Turkey
Introduction
Turkey has one of the most rapidly growing IVF markets in the developing world. Currently there are in excess of 110 IVF centres across the country most of them located in the densely populated cities such as Istanbul, Ankara, Bursa, Izmir and Adana. More recently IVF centres also have been established in other cities (www.tsrm.org.tr). Over two-thirds of the operating centres are privately owned and located in free-standing buildings or private hospitals. Most centres are equipped with up-to-date technology and qualified personnel. Logarithmic increase in the number of abstracts in international meetings and peer-reviewed papers that appear in renowned journals attest to the scientific foundation of assisted reproduction treatment among Turkish physicians and embryologists. During the last 10
years a steady increase has also been observed in the number of foreign couples seeking IVF treatment in Turkey. This is not unexpected given the fact that most centres utilize state-of-the-art modern technology with high success rates, which in part can be attributed until very recently to the number of embryos (up to three) that were allowed for transfer.
Unfortunately, no reliable data exists on the number and outcome of assisted reproduction cycles despite mandatory reporting to the Ministry of Health since 1996. The Ministry has not since announced figures regarding the number of couples undergoing assisted reproduction treatment in Turkey each year, clinical pregnancy rates, multiple pregnancy rates and delivery rates. The outcome of pregnancies generated through IVF is also not known. The number of treatment cycles undertaken each year can at best be estimated from the consumption of gonadotrophin ampoules in the country using data derived from the industry.
IVF applications in Turkey are regulated by a legislation that is periodically updated by the Ministry of Health. The first legislation was published in 1987 and has since been updated three times. The legislation was prepared with the aim of regulating the establishment and control of centres assisting conception through assisted reproductive techniques. The legislation is to be abided by every IVF centre in the country and regulates the opening, licencing and subsequent treatments that are provided. The initial legislation did not allow cryopreservation of gametes, sperm banks, surrogate motherhood or gamete or embryo donation and limited the use of assisted reproduction treatment to married couples only (Elcioglu and Yildirim, 2004, Pelin, 1997). Since 2004 the government has provided limited funding for IVF cycles in couples where all other treatment options have been exhausted. The couple is required to prove this with a written report that can be obtained from university or state hospitals that run an IVF programme. The couple can then undertake their treatment at either a state or a private IVF centre. Since its application several shortcomings of this legislation became evident, one major obstacle facing the infertile couples being obtaining the report of eligibility. The old legislation that has now been replaced by the new one did not allow gamete donation on Turkish soil. Cryopreservation and preimplantation genetic diagnosis and screening (not for gender selection) were allowed. The number of embryos that were allowed for transfer was three and only to be increased at the discretion of the physician in couples with poor embryo quality and other poor prognostic characteristics.
The Ministry of Health recently passed new legislation that caused uproar from practising IVF centres, infertility specialists and infertile couples alike (Official Gazette March 6, 2010). Unexpectedly broad media coverage on the subject attests to the importance of the new IVF regulation in this country. There are several aspects of the new regulation that deserve in-depth scrutiny to uncover potential adverse implications on assisted reproduction procedures in this country.
Funding and eligibility
Assisted reproduction treatments are funded by the state for a maximum of two cycles in women between the ages of 23 and 39years. For funding to be available, a report is required stating that all other treatment options have been exhausted and at least one partner has paid his or her social security bills for a consecutive period of 5years. Couples are free to undergo treatment in state, university-based or private IVF centres. It is estimated that only one-third of all couples eligible for government funding eventually make use of this facility.
Opening of new assisted reproduction treatment centres
Private centres outside of private hospitals are not permitted in the new legislation. A requirement is made that all private centres operationally meet the new guidelines for architectural design and proportions. If these requirements are not met within a period of 4years, the centre will be forced to shut down. Furthermore, new IVF centres will only be allowed after the Ministry grants permission according to yet unknown or at best ill-defined criteria.
Number of embryos allowed for transfer
The new regulation limits the number of transferable embryos to one in the first two cycles in women younger than 35years of age. A maximum of two embryos can be transferred in the third and subsequent cycles. In women 35 or older, a maximum of two embryos is allowed.
Cryopreservation
Cryopreservation of embryos is permitted. Gamete cryopreservation is only permitted for medical indications such as cancer. Egg freezing for social reasons is prohibited. If spermatozoa are frozen for longer than 3months, DNA testing is required before it can be put to use.
Gamete and embryo donation and surrogacy
All of these procedures are prohibited both in and outside the country. The previous legislation banned gamete and embryo donation in Turkey. The new regulation explicitly states that gamete donation cannot be performed in and outside of Turkey. Furthermore, the doctors are not allowed to speak about donation to their patients even if this is clinically indicated and the only option of reproducing for that couple. Physicians counselling and directing their patients to centres performing these treatments will lose their licence to practise assisted reproduction treatment and further will be faced with charges on the grounds of violating the law. If a woman conceives with gamete donation, she and her husband will also be charged, which may result in a severe penalty. Officials say the measure is based on a law that forbids concealing a child’s paternity. Protecting the racial purity of the nation is also another reason given by health officials defending the policy. They claim that the main criterion is the protection of the unity of family. If the subject is approached through the Islamic faith, adoption should be the solution for those families who cannot bear a child. Being a secular state, inception by religious laws and ethical principles of medical treatments should at best be debatable (Arda, 2007, Mori, 2008). It appears that such advice will be of little comfort for many of the estimated 4000–5000 Turkish couples who annually receive gamete donation abroad annually. Most of these cross the borders for egg donation.
The Ministry should be commended for taking a brave step towards reducing the incidence of multiple gestations. However, a more gradual and flexible decline in the number of embryos to be transferred would have been more sensible particularly in an environment where the government provides only a limited amount of reimbursement for only two treatment cycles. The UK Human Fertilisation and Embryology Authority limits the number of embryos for transfer to two in women under the age of 40 and to three for older women. Belgium introduced a reimbursement system in 2003 that links the funding of six IVF cycles to the compulsory transfer of a single embryo for the first cycle in women younger than 36years. The number of embryos transferred in the following cycles depends on the age of the women and the quality of the embryos that are available (Pennings, 2009). A more individualized approach has been adopted in the USA where the American Society of Reproductive Medicine advised on the number of embryos to be transferred according to the woman’s age and other prognostic criteria (Dickey, 2007).
The regulations regarding gamete and embryo donation violate basic human rights, such as freedom to reproduce, to seek medical care and to provide the patients information regarding established medical treatments.
Conclusion
Although the new IVF legislation may seem as a step forward in some areas it is undeniable that some of the steps are in the wrong direction. It should be rectified as soon as possible for the best interest of the infertile couples and the IVF centres in the country that are serving them.
References
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PII: S1472-6483(10)00439-6
doi:10.1016/j.rbmo.2010.06.030
© 2010 Reproductive Healthcare Ltd. Published by Elsevier Inc All rights reserved.
