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Implementing a good practice guide for CBRC: perspectives from the ESHRE Cross-Border Reproductive Care Taskforce
Reproductive BioMedicine Online, 5, 23, pages 657 - 664
This article sets out views about cross-border reproductive care (CBRC) from the point of view of a professional clinicians’ group. After publishing the first international European dataset measuring the phenomenon of CBRC in six European countries in June 2010, the European Society for Human Reproduction and Embryology (ESHRE) Taskforce on CBRC set out to write a good practice guide, which aims at advising clinicians and professionals dealing with patients interested in seeking fertility treatment outside their country of residence. The background, outline and possible means of implementation of this guide are discussed here. The aims of the guide are to ensure quality of care and safety for all concerned, from patients to their future offspring, via gamete donors and surrogates if involved. Patient centredness is also an important aspect, as well as fair treatment of all parties, based on appropriate and intelligible information.
This article sets out views about cross-border reproductive care (CBRC) from the point of view of a professional clinicians’ group. The author is a clinician and academic in a teaching hospital in London, and co-ordinates the European Society for Human Reproduction and Embryology (ESHRE) CBRC Taskforce. The taskforce published the first international European dataset measuring the phenomenon of CBRC in six European countries in June 2010, and then set out to write a good practice guide, which aims at advising clinicians and professionals dealing with patients interested in seeking fertility treatment outside their country of residence. This article discusses the guide’s background and genesis and explains the content. The aims of the guide are to ensure quality of care and safety for all concerned, from patients to their future offspring, via gamete donors and surrogates if involved. Patient centeredness is also an important aspect, as well as fair treatment of all parties, based on appropriate and intelligible information. Finally the guide also outlines how it is hoped the described principles may be disseminated and applied for all the stakeholders benefit.
Keywords: cross-border reproductive care, good practice guide, information, justice, safety, standards.
This article sets out the genesis of the good practice guide (GPG) for cross-border reproductive care (CBRC) for centres and practitioners. This guide is now published ( Shenfield, 2011 ) on behalf of the European professional society in assisted reproduction and infertility treatment, European Society for Human Reproduction and Embryology ( ESHRE , www.eshre.eu ), whose role for over 25 years has been to promote good practice as well as information for all concerned with this specialty. The author is the present co-ordinator of the ESHRE CBRC Taskforce, as well as a founding member of the ESHRE Ethics and Law Taskforce, a group of ethicists and clinicians that has published regular considerations on the numerous ethical and legal dilemmas in the field of assisted reproduction.
CBRC has been in the news for several years now. Health professionals prefer the term ‘cross-border reproductive care’ to the more derogatory ‘reproductive tourism’ often used by the press ( Pennings, 2006 ). CBRC emphasizes that most patients who cross borders in search of reproductive treatment do this because they must and not by choice or for leisure as one would for a holiday ( Ferraretti et al., 2010 ). This very point of semantic stigmatization of patients who feel the need to cross borders to seek reproductive care was also made in one of the considerations of the ESHRE Taskforce for Ethics and Law. About the same time, it was decided that it was time to gather some evidence about the numbers of patients crossing borders, their characteristics and reasons, in view of the lack of published evidence amongst a flurry of press articles. Thus ESHRE set up another taskforce specifically to explore CBRC.
This initial collaboration for qualitative research was the brainchild of the Ethics and Law Taskforce and the ESHRE European IVF Monitoring (EIM) group, which has been collecting European data on assisted reproduction treatment for 10 years now. ESHRE, with its membership of (not exclusively) clinicians, paramedics, embryologists, psychologists and counsellors, lawyers and patients, is particularly well placed to gather interested colleagues to perform studies which cross borders of another kind, between different professions and skills: for instance, clinical practice and law, or ethics and research. The CBRC Taskforce started by reflecting on how to collect data and information about patients seeking treatment abroad, and it became obvious that it could not measure how many women or couples exited any one country. Thus a data-collection task was undertaken about 2 years ago, with a questionnaire aimed at women crossing borders in six different recipient European countries ( Shenfield et al., 2010 ).
Many clinicians and other professionals involved in infertility treatments, such as counsellors, are aware of CBRC movements and, unlike some politicians or reporters in the lay press concerned by findings of potential exploitation of women gamete donors or surrogates ( Dawar, 2009 ), often have no a-priori prejudice against this common phenomenon. Indeed it can be said to ‘clearly enhance patients‘ autonomy’ ( ESHRE Ethics and Law Taskforce 15, 2008 ). Furthermore, it is known that the reasons for CBRC vary between countries ( Pennings, 2006 ), the most common reasons being: law evasion (when the technique is either forbiddenper seor for a particular population group); access limitations at home, including long waiting lists; the seeking of a better quality of care or cheaper treatment abroad; and previous failure. Indeed, the Ethics and Law Taskforce concluded that in some cases ‘there may be good reasons for people to violate national law’, which are not necessarily immoral ( ESHRE Ethics and Law Taskforce 15, 2008 ).
Thus, in practice as a clinician, when asked by my UK National Health patients to comment on their plans on going abroad for treatment, my response is not a principled but a practical one, and one that is usually double pronged: I tell them that the ESHRE EIM database ( de Mouzon et al., 2010 ) gives some idea of general national success rates and multiple pregnancy rates. As high-order multiple pregnancy (more than twin pregnancy) is definitively considered a complication of assisted reproduction treatment and not a success, I advise patients not to have more than two embryos transferred, bar exceptional circumstances linked to their age. Such restriction, one may add, is both an affirmation of the patient‘s personal autonomy and in the interest (welfare) of her future child(ren) ( HFE Act, 1990 ; modified 2008), as multiple pregnancy is still the most common complication of assisted reproduction treatment.
Indeed, whilst the chance of achieving a much-wanted pregnancy is one of the most powerful motivations of the patient, the taskforce felt that safety should be a salient feature of the GPG for CBRC, not only for patients but for all collaborators involved in the child project, including gamete donors and surrogates. Thus, in the conclusion of the European cross-border study, Shenfield et al. (2010) stated that ‘ESHRE wishe(d) to reflect on the means of increasing the safety of crossing borders for our patients, with either the establishment of a Code of Practice (COP), or certification of centres’. ESHRE’s GPG for CBRC is aimed at clinics and practitioners and is now published online ( Shenfield et al., 2011 ). The current paper presents an analysis of its conception and concepts and how the taskforce hopes to implement it. Furthermore, it must be stressed that it is not necessary to be a member of ESHRE to both advertise and abide by the guide’s standards. The guide has also been approved in its principled approach by the International Federation of Fertility Societies ( ESHRE/IFFS joint press release, 2010 ).
Background of the ESHRE good practice guide
The ESHRE Taskforce for Cross-border Reproductive Care met to start preparing a GPG for clinicians and clinics after discussing this plan with several stakeholders in Paris in May 2010 ( Shenfield, 2010 ). This multidisciplinary meeting, involving regulatory authorities, clinicians, psychologists and patient support groups, indicated that indeed there was a will to implement common quality standards in order to increase the safety of patients, gamete donors and surrogates, as well as future offspring, and to ensure good professional communication. Indeed some authorities, like the statutory British Human Fertilisation and Embryology Authority ( HFEA ), already have information on their website in order to guide patients wishing to go abroad, albeit in general terms ( www.hfea.gov.uk ), which advise patients to check standards and safety abroad, the way that success rates are calculated, how the patient information is stored and who has access to it. They also encourage potential patients to find out about possible complaints and what happens if treatment goes wrong. Finally, they mention donor and surrogacy issues, including their compensation and transparency of information, multiple birth rates and the availability of counselling and support.
The broad consensus of that meeting was similar to the conclusion of the Ethics and Law Taskforce, that ‘there is no per se objection to CBRC as it enhances patient‘s autonomy’ ( ESHRE Ethics and Law Taskforce 15, 2008 ). Indeed, this phenomenon fits with the principle of freedom of movement of patients within Europe ( EU Commission, 2008 ), whilst acknowledging that some aspects are more problematic than others. One of them is ‘crossing borders to low income countries ... [which] further adds the complex potential use of scarce local resources to the detriment of local citizens’ ( FIGO, 2009 and ESHRE Ethics and Law Taskforce 16, 2009 ), a concern which does not only apply to countries far away and considered somewhat developing like India, but also to lower-income European countries whether in the EU or not. Of utmost importance, however, is the fact that ‘the ideal is (still) fair and equitable access to fertility treatment at home, which should be promoted at all levels ( ESHRE Ethics and Law Taskforce 14, 2008 ), as justice and equity demand. Sadly, in the UK and during the recent economic crisis, a few primary care trusts are already revoking their agreement for National Health Service IVF access ( Bionews, 2010 ), even though the National Institute for Health and Clinical Excellence has long recommended three cycles for all patients as just and fair chance of obtaining a pregnancy ( NICE, 2004 ). This has led to a letter from the Department of Health ( Bionews, 2011 ) reminding the trusts of their duty of care, albeit not in a prescriptive fashion.
Another point worth making here is that, although in principle the care of foreign and local patients should be of the same quality and befit good standards, there is evidence that it is not always so, even in ‘protected’ Europe. For instance, in Belgium, the rules and conditions of single embryo transfer ( Pennings, 2007 ), which limit the number of embryos transferred per cycle according to both age of the patient and rank of the IVF trial, were only applied to foreign patients after audit and seeking legal advice (de Sutter, personal communication, 2010) as some local practitioners were seemingly not aware of the universality of the law and only initially applied to Belgian patients. When the Belgian health ministry further sought confirmation of this practice, it was made perfectly clear that the law, widely held to be an intelligent compromise dedicated to the decrease of multiple pregnancies in Belgium and the continuation of generous funding for Belgian citizens, applied to all treatments performed in the country, whether for citizens or foreign nationals. It is also interesting to note that a recently commissioned report found that the number of egg donation cycles for foreign women in Belgium had actually recently decreased rather than increased ( Conseil superieur de la santé, 2010 ), although there was no obvious explanation for this trend.
Encouraged by the general goodwill shown by many participants, it was also decided at the Paris meeting to promote the use of good clinical practice everywhere and for all (ESHRE Good Clinical Practice, 2009), to optimize the care of patients and ensure acceptable success rates (quality standards) as well as minimize complications. Such aims were indeed obviously common to many stakeholders, like national and international patient support groups ( International Consumer Support for Infertility, 2009 ) and the taskforce went to work by proposing to set out appropriate standards for clinical care and professionals and promote gamete donors‘ and surrogates’ safety and protection with such safety standards. In this respect, it was noted that the EU Tissues and Cells Directive covers only some rather specific safety aspects, such as laboratory conditions, gamete donor screening for viral illnesses and ‘compensation’, defined as making good expenses and ‘inconvenience’, a term not explained further. Neither is its implementation detailed, a matter of utmost relevance both ethically and in practice. Furthermore, the frequency of the screening imposed for partner’s insemination and IVF has itself been criticized by many ( Wingfield and Cottel, 2010 ) as totally disproportionate with the infinitesimal risk of finding a positive result of viral contamination in a couple (usually HIV or hepatitis B or C) if their screening for the first cycle of assisted reproduction treatment is negative. The taskforce felt it was also important to discuss the concerns shared for the welfare of donors (especially oocyte donors) and surrogates: for instance, the number of donations or pregnancies they may undertake, the prevention of ovarian hyperstimulation syndrome and the risk of multiple pregnancy for any woman undergoing assisted reproduction treatment ( Hvidtjørn et al., 2010 ).
Another aim discussed in Paris was the promotion of proper information for patients concerning the financial implications of their treatment (real cost including travel, staying abroad, possibility of reimbursement at home) and of possible legal conflicts, especially with surrogacy and the rights of intended parents. Indeed, other kinds of more personal conflicts may also occur regarding donor anonymity, which is statutory in some countries (like Denmark, France or Spain) or relinquished in favour of non-anonymity (such as Sweden or the UK), as some patients prefer one to the other and return after treatment to a country where the law is different.
Other specific aspects of gamete donation and surrogacy were also discussed, such as anonymity, legal rights and obligations of all parties and the prevention of exploitation of collaborating parties. The subject of exploitation is an emotive and complex issue ( Pande, 2011 ). In general there may be a danger of exploitation with disproportionate compensation for egg donors or surrogates. Such enticement may consequently first endanger appropriate consent and second may put pressure on vulnerable, low-income women. This very complex issue is worthy of more detailed research and will be part of the work in progress on oocyte donors for the ESHRE CBRC Taskforce, starting in 2011. Indeed, regarding gamete donors and surrogates participating in CBRC, there is little systematic evidence of their safety and conditions of recruitment. For instance, the EU Tissues and Cells Directive ( Commission directive, 2006 ) only contains ‘non commercialization’ as a ‘protective’ feature against exploitation. However, if hard research is still hard to come by, many press reports in different languages and countries, often of the outrageous and outraged kind, make this very point ( Dawar, 2009 ). As the taskforce was working with a multidisciplinary group, the important subject of counselling was not forgotten and it was agreed to promote access to counselling with the specific aim of covering particular aspects of CBRC (International Consumer Support for Infertility website; ESHRE Ethics and Law Taskforce 15). Indeed, patients crossing borders to obtain treatment abroad may feel vulnerable, being isolated from their usual professional support system and family, not be fluent in the local language or fearful of stigmatization on their return home ( Thorn, personal communication, 2010 ).
Finally, whilst aware that a code of practice (COP) or GPG does not have the strength of certification, it was decided that this was an important first step that had not been previously undertaken. Definitions at this stage may be helpful: COP or GPG encompass ‘written guidelines issued by an official body or a professional association to its members to help them comply with ethical standards which does not normally have the force of law’ ( business dictionary ). Another interesting dimension, essential to the taskforce and its members from the ESHRE Ethics and Law Taskforce and the EIM monitoring group, is found in the United Nations Educational, Scientific and Cultural Organization definition: a COP is ‘considered to reveal a practice worthy of consideration’ ( UNESCO website ). The ESHRE CBRC Taskforce took the liberty to interpret the term ‘worthy’ in its moral sense as well.
There are indeed several models for this kind of surveillance in medicine in general and in reproductive medicine in particular. For instance, the UK went from a voluntary licensing system under a self-appointed authority, abiding by professional guidelines, to a statutory system in 1990 when the first HFE Act was passed by Parliament ( HFE Act, 1990 ). The Voluntary Licensing Authority was held in high repute because it preceded the law and showed the goodwill of the profession, although a more pragmatic view might be that, knowing there was no choice but the incoming statutory framework about to be voted by Parliament, it was better to show goodwill in order to be more influential at the time of legal implementation. What is certain is that the steps and debates prior to enacting the HFE Act, 1990 were discussed at length both in the media and in Parliament through a democratic process.
For ESHRE, the choice between a code or a guide for good practice and certification was clear from the onset of the process. Certification means inspections, needs manpower and is expensive. This is not always feasible for professional societies and may even not be totally funded if statutory, like the inspections required regularly for UK assisted reproduction clinics. For instance, the financial input necessary for the UK HFEA inspectorate that has been described as a ‘tax on the infertile’ ( Brinsden, 1991 ) and ‘a double pronged iniquity’ ( Shenfield, 1997 ), adding to the injustice of patchy national access. Further, part of the running of the HFEA is paid by a levy on each treatment cycle nationally. The CBRC Taskforce thus decided to write a set of principles for the GPG without excluding the possibility of using a stronger means of implementation at a later stage. It was hoped that centres that publicly declare to abide by the GPG would become a majority, from which centres not rallying would feel impelled to do so in order to be seen to provide good practice by the public.
The principles of the ESHRE good practice guide on CBRC
The GPG ( Shenfield et al., 2011 ) articulates guidance for centres and practitioners around six important ethical, clinical and legal principles: equity, quality, safety, evidence-based care, patient involvement and redress. Furthermore, such principles all apply to patients, donors and surrogates, the future child and professionals. It must be pointed out again that this first document is specifically designed for clinicians and professionals and that further steps with other collaborators are planned to make it patient friendly. Furthermore, there is an inevitable conflation between quality and safety which represent a patient‘s desire for a healthy child with as little risk as possible (both physical and psychological), all based on current evidence, the essential factor which helps to achieve such aims.
Equity implies that similar protocols and fees should apply to cross-border and local patients and that the same information, counselling and psychological support should be provided for patients coming from abroad as for the national patients. Any difference between local and foreign patients should be justified, such as, for instance, the extra cost for interpreters needed with foreign patients.
To achieve quality and safety, the planned treatment should combine minimal risks with a maximum chance of pregnancy and follow evidence-based care. It is important that patients should receive clear information about necessary investigations and their cost, waiting lists and the expected time they will have to spend outside their country. Indeed, part of a quality treatment is the quality of the explanations provided before it is started. This is not only a legal requirement in order to obtain informed consent (the legal aspect of the ethical injunction to respect autonomy), it is also a matter of good communication.
Communication between the home team and the team abroad (recipient team) is another important feature of CBRC. Apart from providing the recipient team with essential past fertility history and/or previous treatment, some degree of collaboration is also required, in order to minimize the need for repeat tests which are both expensive and cumbersome for the patient.
Quality of care for the oocyte donors is also essential and will be the matter of further research but it is essential to propose a stimulation cycle that minimizes their health risk ( Shenfield, 2011 ). Furthermore, in order to prevent abuse of donors coming from abroad, the taskforce recommends the avoidance of intermediate agencies which may lead to violations of the rules of good clinical practice and, in the worst case, to trafficking ( Shaikh, 2010 ). Post-donation care should be provided to the best possible standards at home or abroad.
Surrogacy problems have also led to headlines, although mostly concerning the legal problems of some cases or the particular case of Indian women ( Pande, 2011 ). Again, this is worthy of separate research, but for the sake of safety of the surrogate the taskforce clearly states that single embryo transfer is the only acceptable option in surrogacy.
Finally, for the benefit of future children, the taskforce emphasizes that treatment should abide by the rules of ‘good clinical practice in assisted reproduction treatment’ (ESHRE website). These rules state that ‘the decline in the number of multiple births can be regulated only with a reduction of the number of embryos transferred. This restrictive embryo transfer policy could be accepted as the only means of eliminating high order multiple gestations’. Taking into account that foreign patients should have the same protocol as local patients, as is now the case in Belgium after confirmation by the Conseil Superieur de la Sante, with due respect to their age and previous stimulations, one must also alert patients to the well-known differences in multiple gestation rates, as evidenced by the EIM database. This concern is complicated by the fact that fetal reduction rates vary from one country to another and may also represent one of the black holes in current knowledge, as they refer to reductions performed nationally without details of the origin of the woman’s pregnancy. However, from a study performed at University College London Hospital fetal medicine unit and analysing 10 years of consecutive data, it can be inferred that women whose pregnancy had been assisted abroad were 30% less likely to reduce a multiple pregnancy of high order than women whose pregnancy was started in their country of residence ( McKelvey et al., 2009 ). The added risk of multiple pregnancy to the future child(ren) is well known, and the difference between two groups who went through the same hard path of infertility diagnosis and treatment shows the extra stress and value put onto the pregnancy for these women. Informed by the same team in exactly the same way, women treated abroad were less likely to consider the risk of triplets (and more) to their future offspring as worthy of a partial reduction of pregnancy, always an extremely difficult decision to make anyway.
Furthermore, quality and safety must be based on evidence, in the sense that evidence provides knowledge regarding the safety of the many techniques used: this very same extra risk of multiple pregnancy, both for offspring and gestating mother, is also why the taskforce states that, when donor oocytes are used, embryo transfer must be limited to two embryos, as in this case the chances of multiple pregnancy is higher because of the generally younger age of the donors (indeed this is a legal requirement in the UK, where the woman should be aged 35 or younger).
Other recommendations include that the follow up of assisted reproduction children, whether conceived after treatment at home or abroad, should be encouraged. Whilst studies are already published on assisted reproduction children in general ( Sutcliffe and Ludwig, 2007 ), a particular concern is the children of gamete donation, who may have more difficulties than others conceived naturally when trying to find more information about their conception history. However, whilst some (generally a majority) consider that all such children should have access at some stage to nominal information about the gamete donor at the origin of their conception, the ESHRE taskforce stands by the Ethics and Law Taskforce ( ESHRE Ethics and Law Taskforce 3, 2002 ) that considered the double-gate approach acceptable, where intended parents choose either an anonymous donor or one who would undertake to be identifiable to the offspring at his/her majority.
Furthermore, still in the domain of good practice, the taskforce recommends collaboration between doctors, stating that ‘good communication in both directions includes details of previous investigations and treatment (stimulation dose, response, etc.), and that patients should be given copies of their medical files both by the home practitioners when they go abroad and by the practitioners abroad when they return home’.
The taskforce also alludes to the notion of professional responsibility. If a home practitioner refers to a specific clinic, the practitioner shares a responsibility for the general standards used in that centre (such as the complication rate). Obviously, the specific treatment of an individual patient abroad remains the responsibility of the local professional team. Joint responsibility is, of course, a complex moral and legal problem ( Storrow, 2010 ) and is some way dealt with under contractual law, particularly in the USA.
There is the added dimension of European law, recently exemplified by the case in Austria which was taken to the European Court of Human Rights because the combined use of donor spermatozoa and IVF was legally forbidden. Pending appeal, the Austrian state has been deemed to be discriminatory against such IVF. If this judgment stands, it will mean that fewer Austrian patients might go abroad for such treatment, as well as reassuring Austrian practitioners that the combination is now within the law ( ECHR, 2010 ). The hard case of whether an Austrian practitioner might be taken to court for recommending a banned treatment by sending his patients abroad is less likely to happen, although it actually has not been seen in court. Nor has it in Germany, in spite of this being an actual legal offence in German law.
With regard to patient involvement, along with enabling them to carry their relevant information across borders, the taskforce advises that professionals should take the specific circumstances of foreign patients into consideration, by adapting their practical management and offering counselling and psychological support. Support should be available in a language understood by the patients, as also recommended by counsellors ( Blyth et al., 2011 ).
Finally, the taskforce states that the availability of redress for patients going abroad is essential: clinics should provide the name of their ombudsman or the person to whom complaints should be addressed. Furthermore, having stated that good practice should be followed and evidence-based care applied, it is also worth mentioning what practitioners should not do. Fee splitting is mentioned in the taskforce’s consideration on CBRC ( ESHRE Ethics and Law Taskforce 15, 2008 ) as totally unethical. What this means is the enticement by offering a fee for practitioners to send patients to a particular clinic when there is no shared care but just a preferential address. In France, l’Ordre des Medecins issued a warning about this practice ( www.conseil-national.medecin.fr ) when a Spanish clinic sent a letter making such an offer to French gynaecologists. This episode elicited an official statement of protest from the French ministry to the Spanish Ministry of Tourism.
Another concern is brokerage. When practitioners are allegedly brokers, or involved with brokers in order to attract oocyte donors, there is risk of putting the whole profession in disrepute. The example of Israeli patients sent to Romania for egg donation when there was much evidence that this was not a donation but a simple case of buying eggs, and little evidence of consent from the alleged ‘donors’, is currently under investigation ( Jones, 2010 ). Also, using brokers increases the risk of disproportionate enticement, which in some cases can go as far as completely disregarding women’s rights and interests by submitting them to superovulation without explanation of either the process or the outcome ( Jones, 2010 ).
The whole subject of professional responsibility is indeed complex, but there is a responsibility to the future child, not only morally but indeed legally, as under the HFE Act in the UK. It may be the clinician‘s duty to not necessarily accept all patients’ wishes, especially when they are obviously putting the future child at risk ( ESHRE Ethics and Law Taskforce 13, 2007 ). One specific example is of the creation of hearing-impaired children for parents with the same disability, which has been strictly deemed illegal by the updated HFE Act (2008) , after much public and parliamentary debate. The rationale is that a child is growing up to be a social being and his/her interest is to function in the optimal manner in this environment, which soon becomes larger than his/her own immediate family: thus his/her welfare certainly trumps the claimed parental autonomy to impose a similar impairment to their child.
The implementation of the ESHRE good practice guide for CBRC
Ever since regulation has framed medical practice, the discourse on the role and efficiency of GPG, COP or even guidelines have been material for ethical and legal analysis ( Hurwitz, 1995 ). At this stage, the principle of voluntary adhesion to the GPG for CBRC naturally depends first on goodwill. This certainly can work for several reasons, with good dissemination as the key to success. First, the taskforce wishes to publicize the guide with all stakeholders concerned, in order that being ‘in the club’ of those who adhere to the GPG is a better assurance (of safety for patients) than not. The plan is to enrol as many national regulatory bodies and fertility societies as possible to disseminate the guidance. The initial steps, already in place, will involve linking the GPG statement with more detailed explanations from the ESHRE website. The taskforce already has approval from the UK’s statutory authority, the HFEA, which has its own information on its website ( Davies, 2010 ), as well as from its Portuguese equivalent. The taskforce also has commitment from the Italian registry, the Danish Fertility Society and the Spanish Embryology Society and awaits decisions from other national societies from (not exclusively) Belgium, the Czech Republic and Slovenia, as well as the French College of Gynecology.
Second, one has to recognize that increasing safety and good practice for all concerned in CBRC is very much a work in progress. For instance, the ESHRE CBRC Taskforce is planning a study on the characteristics and motivation of egg donors in Europe, to inform further reflections on a GPG concerning the conditions for donating and care of gamete donors.
Finally, scientifically, proper data collection is the essential backbone to the regulatory discourse. The taskforce is also proposing to gather more specific CBRC data by adding specific questions to the EIM data collection ( de Mouzon et al., 2010 ). Indeed, transparency and accuracy are essential keys to proper surveillance and efficient improvement. Such criteria are not always easy to implement, as shown recently in the observed discrepancy between the national assisted reproduction Spanish register and its Catalan equivalent, with particular disparity for oocyte donation cycles, although there was a good match for IVF cycles ( Lucen et al., 2011 )
Other challenges are also looming, as oocyte banking is becoming much more efficient thanks to vitrification ( Cobo et al., 2008 ). This means that eggs have started to cross borders as well, perhaps enabling some patients to stay at home in their preferred environment, but making it more difficult to check the conditions of donation for all concerned.
Conclusion: the future of a worldwide approach?
There is no doubt that implementing the GPG further afield than Europe is ideal, as shown by movements between Singapore and Malaysia ( Heng, 2007 ). Indeed, at a joint press conference with International Federation of Fertility Societies ( ESHRE website, 2010 ), the principled intent of issuing a joint statement was decided. Whilst the taskforce awaits confirmation of their further approval of the GPG, it must be stressed that there are dangers of labelling a guide as ‘merely’ European. One negative consequence would be for patients to decide to go further afield, where standards are different for oocyte donors, surrogates and especially the number of embryos transferred back into the uterus after IVF. Indeed, in India ( ISAR annual report, 2010 ) the proportion of multiple pregnancy after assisted reproduction treatment is higher than for most European countries, a concern for all couples involved and especially women and their future child(ren). Another concern is the occurrence of surrogacy twin pregnancy, without even going into the ethically complex subject of their compensation. The social science papers published in this special issue highlight in an often poignant fashion the personal history and complex background of several surrogates in India, where many feel they are offering their family a chance of good education and lodging that they could not otherwise afford ( Pande, 2011 ).
Furthermore, an important international concern is the fact that, at the local level, there is also a danger of shifting scarce local resources to the care of CBRC patients (ESHRE Ethics and Law Taskforce 16, 2009, Serour, 2009, and Shetty, 2010). This, which especially applies to low-income areas or countries, is a macro-ethical consideration within the realm of international justice. In fact, patients already travel to and from all continents, even though vicinity is definitively a factor for choice ( Shenfield et al., 2010 ). In particular, British patients will go to India and French patients to Vietnam because of previous colonial links that have persisted, but South Africa has also become a popular destination for egg donation, as is the Ukraine for surrogacy. It is time that patients travelling further afield than their nearest border may also be reassured by the undertaking of colleagues to attain a certain standard.
It is only by looking further into the evidence and having a better understanding of the scale of this CBRC phenomenon worldwide, whether of patients, collaborators or gametes, that the taskforce will gain a stronger voice, which can be used to better advise vulnerable patients and third-party collaborators (gamete donors and surrogates), as well as clinicians and other professionals, and increase safety for all. Protection of the vulnerable, whether the future child, the patients or reproductive collaborators, is indeed an ethical imperative shared by most societies, whatever their cultural differences. The reproductive medicine profession must continue to aim for transparency in CBRC and share knowledge and findings with all concerned. Indeed, if GPG is not followed by us, it may be imposed by the strong arm of the law ( Hurwitz, 1995 ); meanwhile, international societies in reproductive medicine have an important role to play.
- Bionews, 2010 Bionews, 2010. West Sussex PCT suspends IVF funding. Available from: < www.bionews.org.uk />.
- Bionews, 2011 Bionews, 2011. UK Department of Health publishes letter on IVF funding (591). Available from: < www.bionews.org.uk />.
- Blyth et al., 2011 E. Blyth, P. Thorn, T. Wischmann. CBRC and psychosocial counselling: assessing needs and developing an ethical framework for practice. Reprod. Biomed. Online. 2011;23:642-651 Crossref
- Brinsden, 1991 P. Brinsden. A Tax on infertility?. BMJ. 1991;303:309 Crossref
- Business dictionary, 0000 Business dictionary. Available from: < www.businessdictionary.com />.
- Cobo et al., 2008 A. Cobo, M. Kuwayama, S. Perez, A. Ruiz, A. Pellicer, J. Remohi. Comparison of concomitant outcome achieved with fresh and cryopreserved donor oocytes vitrified with the Cryotop method. Fertil. Steril.. 2008;89:1657-1664 Crossref
- Commission directive, 2006 Commission directive 2006/86/EC, implementing Directive 2004/23/EC of the European Parliament and of the Council as regards traceability requirements, notification of serious adverse reactions and events and certain technical requirements for the coding, processing, preservation, storage and distribution of human tissues and cells. Available from: < http://eur-lex.europa.eu />.
- EU Commission, 2008 Commission of the European Communities. Proposal for a Directive of the European Parliament and of the Council on the application of patients’ rights in cross-border healthcare. Presented by the European Commission on 2 July 2008. Copyright: European Communities, 2008; Directorate-General for Health and Consumers, European Commission – B-1049 Brussels. Available from: < http://ec.europa.eu/dgs/health_consumer/index_en.h />.
- Conseil superieur de la santé, 2010 Conseil superieur de la santé, 2010. Publication No. 8632, Conseil Superieur de la santé belge. Available from: < www.css-hgr.be />.
- Davies, 2010 T. Davies. Cross-border reproductive care: quality and safety challenges for the regulators. Fertil. Steril.. 2010;94:e20-e23
- Dawar, 2009 Dawar, A., 2009. Pregnant woman, 66, set to be the oldest woman to give birth in England. Available from: < http://www.guardian.co.uk/uk/2009/may/16/66-year-old-mother />.
- De Mouzon et al., 2010 J. De Mouzon, V. Goossens, S. Bhattacharya, J.A. Castilla, A.P. Ferraretti, V. Korsak, M. Kupka, K.J. Nygren, A. Nyboe Andersen, The European IVF-monitoring (EIM) Consortium, for the European Society of Human Reproduction and Embryology (ESHRE). Assisted reproductive technology in Europe, 2006. Hum. Reprod.. 2010;25:1851-1862 Crossref
- ESHRE/IFFS joint press release, 2010 ESHRE/IFFS press release, September 2010. Available from: < www.eshre.eu />.
- ESHRE Ethics and Law Taskforce 3, 2002 ESHRE Task Force in Ethics and Law 3. Gamete and embryo donation. Hum. Reprod.. 2002;17:1407-1408
- ESHRE Ethics and Law Taskforce 13, 2007 ESHRE Task Force on Ethics and Law 13. The welfare of the child in medically assisted reproduction. Hum. Reprod.. 2007;22:2585-2588
- ESHRE Ethics and Law Taskforce 14, 2008 ESHRE Task Force in Ethics and Law 14. Equity of access to ART. Hum. Reprod.. 2008;23:772-774
- ESHRE Ethics and Law Taskforce 15, 2008 ESHRE Taskforce in Ethics and Law 15. Cross border reproductive care. Hum. Reprod.. 2008;23:2182-2184
- ESHRE Ethics and Law Taskforce 16, 2009 ESHRE Task Force on Ethics and Law 16. Providing infertility treatment in resource-poor countries. Hum. Reprod.. 2009;24:1008-1011
- ESHRE, 0000 ESHRE Good Clinical Treatment in assisted reproduction. Available from: < http://www.eshre.eu/ESHRE/English/Guidelines-Legal/ESHRE-Position-Papers/page.aspx/942 />.
- European Court of Human Rights, 2010 European Court of Human Rights (ECHR), 1st Sec., 1 April 2010, S.H. and others v. Austria (No. 57813/00).
- Ferraretti et al., 2010 A.P. Ferraretti, et al. Reproductive care: a phenomenon focusing the controversial aspects of reproductive technologies. Reprod. Biomed. Online. 2010;20:261-266 Crossref
- FIGO, 2009 FIGO Ethics Committee. Cross border reproductive services. Int. J. Obstet. Gynaecol.. 2009;111:190-191
- Heng, 2007 B.C. Heng. Should fertility specialists refer local patients abroad for shared or commercialized oocyte donation?. Fertil. Steril.. 2007;87:6-7 Crossref
- HFE Act, 1990 HFE Act, 1990. Available from: < http://www.dh.gov.uk/en/.../Legislation/Actsandbills/DH />.
- HFE Act, 2008 HFE Act, 2008. Available from: < http://www.dh.gov.uk/en/.../Legislation/Actsandbills/DH_080211 />.
- HFEA, 0000 HFEA website. Considering fertility treatment abroad: issues and risks, last updated 28/8/2009. Available from: < http://www.fhea.gov.uk />.
- Hurwitz, 1995 B. Hurwitz. Clinical guidelines and the law. BMJ. 1995;311:1517 Crossref
- Hvidtjørn et al., 2010 D. Hvidtjørn, et al. Multiplicity and early gestational age contribute to an increased risk of cerebral palsy from assisted conception: a population-based cohort study. Hum. Reprod.. 2010;25:2115-2123
- International Consumer Support for Infertility, 2009 International Consumer Support for Infertility information booklet ‘Travelling abroad for assisted reproductive technology’. Available from: < http://www.icsi.ws />.
- ISAR annual report, 2010 I.S.A.R. – Indian Society For Assisted Reproduction ‘National ART Registry of India’. Available from: < http://www.isarindia.net />.
- Jones, 2010 B. Jones. Human egg-trafficking scam uncovered in Romania. BioNews. 2010;519 Available from: < www.bionews.org.uk/>
- l’Ordre des Medecins, 0000 Ordre des medecins. www.conseil-national.medecin.fr/IVG hors délai, dons d‘ovocytes, GPA. Racolage et dichotomie: le Cnom met en garde, 17/06/2009.
- Lucen et al., 2011 F. Lucen, et al. Comparison of IVF cycles reported in a voluntary ART registry with a mandatory registry in Spain. Hum. Rep.. 2011;22:3066-3071
- McKelvey et al., 2009 A. McKelvey, A.L. David, F. Shenfield, E.R. Jauniaux. The impact of cross-border reproductive care or ‘fertility tourism’ on NHS maternity services. BJOG. 2009;116:1520-1523 Crossref
- NICE, 2004 National Collaborating Centre for Women‘s and Children’s Health for the National Institute of Clinical Excellence (NICE), 2004. Fertility: Assessment and Treatment for People with Fertility Problems. RCOG Press, London.
- Pande, 2011 A. Pande. Transnational Commercial Surrogacy in India: Gifts for Global Sisters. Reprod. Biomed. Online. 2011;23:618-625 Crossref
- Pennings, 2006 G. Pennings. International parenthood via procreative tourism. F. Shenfield, C. Sureau (Eds.) Contemporary Ethical Dilemmas in Assisted Reproduction (Informa Health Care, Abingdon, Oxon, 2006) 43-56
- Pennings, 2007 G. Pennings. Decision-making authority of patients and fertility specialists in Belgian law. Reprod. Biomed. Online. 2007;15:19-23 Crossref
- Serour, 2009 G. Serour. Healthcare workers and the brain drain. Int. J. Obstet. Gynaecol.. 2009;106:175-178 Crossref
- Shaikh, 2010 Shaikh, N., 2010, Cyprus clinic suspected of egg trafficking. Available from: < www.bionews.org.uk/page_70939.asp />.
- Shenfield, 1997 F. Shenfield. Justice and access to fertility treatments. F. Shenfield, C. Sureau (Eds.) Ethical Dilemmas in Assisted Reproduction (Parthenon/Carnworth, New York/USA, 1997) 7-14
- Shenfield, 2010 Shenfield, F., 2010, Cross-border reproductive care outside Europe raises new ethical Considerations, Focus in reproduction, May 2010. Available from: < www.eshre.eu />.
- Shenfield, 2011 Shenfield, F., 2011, ESHRE ‘guidance’ on cross-border reproductive care now approved by Executive Committee, Focus in reproduction, January 2011. Available from: < www.eshre.eu />.
- Shenfield et al., 2011 Shenfield, F., Pennings, G., de Mouzon, J., Ferraretti, A.P., Goossens, V., on behalf of the ESHRE Task Force ‘Cross Border Reproductive Care’, 2011. ESHRE’s good practice guide for cross-border reproductive care for centers and practitioners. Hum. Reprod. doi:10.1093/humrep/der090 . First published online: April 19, 2011.
- Shenfield et al., 2010 F. Shenfield, J. de Mouzon, G. Pennings, A.P. Ferraretti, A. Nyboe Andersen, G. de Wert, V. Goossens, the ESHRE Taskforce on Cross Border Reproductive Care. Cross border reproductive care in six European countries. Hum. Reprod.. 2010;25:1361-1368 Crossref
- Shetty, 2010 P. Shetty. Medical tourism in India, but at what cost?. Lancet. 2010;376:671 Crossref
- Storrow, 2010 R. Storrow. The pluralism problem in cross-border reproductive care. Hum. Reprod.. 2010;25:2939-2943 Crossref
- Sutcliffe and Ludwig, 2007 A. Sutcliffe, M. Ludwig. Outcome of assisted reproduction. Lancet. 2007;370:351-357
- Thorn, personal communication Thorn, P., personal communication. ESHRE CBRC multidisciplinary meeting, May 2010.
- UNESCO website, 0000 UNESCO Code of practice definition, 2009. Available from: < www.qualityresearchinternational.com/ >.
- Wingfield and Cottel, 2010 M. Wingfield, E. Cottel. Viral screening of couples undergoing partner donation in assisted reproduction with regard to EU Directives 2004/23/EC, 2006/17/EC and 2006/86/EC: what is the evidence for repeated screening?. Hum. Reprod.. 2010;25:3058-3065 Crossref
University College Hospitals/Elizabeth Garrett Anderson, London, United Kingdom
Françoise Shenfield is a clinician at University College London Hospital and has provided infertility treatments for over 25 years. She has been involved in the ethics and law of assisted reproduction since completing a Masters in Medical Law and Ethics at King’s College 20 years ago. Françoise is a founder member of ESHRE’s Special Interest Group for Ethics and Law and its Taskforce for Ethics and Law and currently co-chair of FIGO’s ethics committee. She is the co-ordinator of the Cross-border Taskforce for ESHRE, a collaboration of the Ethics and Law Special Interest Group and the European IVF Monitoring group.
© 2011 Published by Elsevier B.V.