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Polygeia Sexual and Reproductive Health 2014
1
European Union Regulation on
Infertility Treatment: Open to
Interpretation by Member States
A Case Study of Cyprus
Authors: Cassandra Fairhead, Robert Hart, Sarah Dew, Xue-En Chueng, Molli Shomali, Thomas
Weatherby, Finnoula Taylor
Polygeia Sexual and Reproductive Health 2014
2
Contents
EXECUTIVE SUMMARY............................................................................................................................. 3
DEFINING THE PROBLEM......................................................................................................................... 4
Egg donation procedure...................................................................................................................... 4
Cyprus as a case study............................................................................................................................. 6
Egg retrieval:........................................................................................................................................ 6
Donors and compensation .................................................................................................................. 7
Donor recruitment and coercion:........................................................................................................ 7
Psychological and legal counselling for donors:.................................................................................. 8
The profile of Cyprus’ egg recipients:.................................................................................................. 8
Social Inequality and Fertility Tourism.................................................................................................... 9
Privatisation of fertility clinics............................................................................................................. 9
Globalisation, consumerism, and medical treatment....................................................................... 10
European Union Legislation .................................................................................................................. 11
Recommendations and Implementation Plans..................................................................................... 13
Accessibility of information and Clinic Transparency........................................................................ 13
Care for donors and recipients in Cyprus.......................................................................................... 14
Harmonise legal standpoints on reproductive tourism .................................................................... 15
Minimize need for egg donation....................................................................................................... 16
Conclusion ............................................................................................................................................. 17
References............................................................................................................................................. 19
Polygeia Sexual and Reproductive Health 2014
3
EXECUTIVE SUMMARY
The World Health Organization defines infertility as the inability of a sexually active, non-
contracepting couple to achieve pregnancy, and for a woman, the inability to maintain a
pregnancy, or an inability to carry a pregnancy to live birth1
. Assistive reproductive
technologies, that is technologies meant to assist an individual or couple in achieving or
maintaining a pregnancy, are on the rise. Approximately 1.5 million ART cycles are
performed worldwide annually. ARTs have brought about growing demand for third party
reproduction - whereby a woman provides her uterus (as in surrogacy), and/or a person
provides sperm, eggs or embryos in order to enable a person or couple to have a child.
Increasingly, couples will participate in reproductive tourism, whereby they travel to countries
with laws more permissible and/or services more affordable to seek third party reproduction.
A number of countries have become prime destinations for third party reproduction. The use
of third party reproduction, and the ensuing market of fertility tourism, raises concerns for
those involved and has caused much debate in the international sphere.
Fertility tourism is taken as the focus of this report. In particular, egg donation in Cyprus - a
popular egg donation destination within the European Union - will be examined. Policy
recommendations to address the regulation of, and concerns arising from, this industry will be
made. Particular attention is paid to the vague EU regulations on egg donation and the
subsequent implications this has on the differential interpretation of this by member states. It
is suggested that clearer regulation at the EU level is an important factor influencing the
gender and health inequalities that the current legislation may create. These recommendations
are highlighted within the context of infertility clinics in Cyprus, a country which has become
a hub for fertility tourism and where multiple infertility clinics operate.
Suggestions are offered on how recommended policy changes can be implemented. The
proposed changes in regulation towards the offering and reporting of infertility treatments in
low cost countries such as Cyprus is also addressed.
Polygeia Sexual and Reproductive Health 2014
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DEFINING THE PROBLEM
Infertility is a global issue. The level of infertility in the last twenty years has remained
unchanged, and is currently reported to affect approximately one in four couples, although
this is likely an underestimate2
. This is an area of reproductive health which is a significant
contributor to achieving Millenium Development Goal 5B: "achieving, by 2015, universal
access to reproductive health". It is highly improbable that this goal will be met, emphasising
the need for better solutions for access to reproductive healthcare worldwide.
The WHO-ICMART glossary defines infertility as ‘a disease of the reproductive system
defined by the failure to achieve a clinical pregnancy after 12 months or more of regular
unprotected sexual intercourse’3
. Infertility affects 15% + of reproductive-aged couples
worldwide4
. According to WHO, it affects > 10% of women5
. These are women who have
tried to become pregnant unsuccessfully, and remained in a stable relationship for 5 years or
more. Infertility has a variety of causes, with the most prevalent cause varying on location;
typically age-related in developed nations and STIs in less developed nations.
There are several treatments available for couples or single individuals seeking assistance in
having children6
. This report will focus on the requirement of egg donation for in vitro
fertilisation. It will address the implications of this procedure on health and gender
inequalities and how these inequalities can be addressed by highlighting current gaps in
legislation and policy guidelines.
Egg donation procedure
Egg donation is a lengthy and intrusive process lasting up to 6 weeks. During the natural
fertility process it is usual for just one egg to ovulate. However, donors are stimulated,
through the use of hormones, to produce as many as 50. Side effects of the procedure include
psychological stress, bloating, cramps, headaches and even kidney disease, blood clots and
premature menopause. The process of egg donation can be summarized as follows7
:
1. Ovaries are shut down to disrupt the natural ovulation cycle using medication.
2. Daily, for up to 10 days, the donor must inject themselves with hormones .
3. Surgery is performed to remove the egg follicles from the ovaries.
Polygeia Sexual and Reproductive Health 2014
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Donation is not risk-free8
. There are many potential side effects of the procedure, including
psychological stress, bloating, cramps, headaches and even kidney disease, blood clots and
premature menopause. Egg retrieval is carried out under general anaesthesia, which carries its
own risks, such as the possibility of serious malignant hyperthermia (REF). In addition to the
possible side effects mentioned above, the hormones used can also be a danger to donors. On
rare occasions patients may suffer an adverse reaction to the hormone regimen9
, but a more
common complication is ovarian hyperstimulation syndrome (OHSS) which can, in extreme
cases, be fatal10
.
Aside from the immediate risks to the donor’s health, questions have also been raised about
the procedure’s unknown long term risks8
. Some studies have suggested the drugs regimens
for infertility, which are often the same as those administered to egg donors, may be linked to
the development of certain cancers, including those of the breast and ovaries8
. It is not yet
clear, however, whether it is the fertility drugs, as opposed to underlying infertility, that
predisposes these women to disease. One 2004 study found no statistically significant increase
in breast or ovarian cancer in egg donors, but did find that the women were around 1.8 times
more likely to develop uterine cancer11
.
Polygeia Sexual and Reproductive Health 2014
6
Cyprus as a case study
With more more fertility clinics per capita than any other country, Cyprus is somewhat of a
hub for fertility tourism and in particular egg donation9
. A number of factors have made the
country an attractive, and convenient, destination for those seeking this type of reproductive
technology.
Waiting lists for donor eggs are almost non-existent due to a steady supply of women willing
to donate eggs. Indeed, many clinics have a database of potential donors ready to undergo the
procedure should a suitable recipient appear. Moreover, Cyprus has an exceptionally large
number of eligible egg donors. The country has 76,000 eligible donors aged 18 to 309
, and
estimates suggest that each year about 1500 (about 1 in 50) donate their eggs12
. This contrasts
with the US, where the figure is 1 in 14,00012
.
A 2010 Human Reproduction study found that while reasons for recipients travelling abroad
for treatment varied by country of origin, “legal reasons were predominant for patients
travelling from Italy (70.6%), Germany (80.2%), France (64.5%), Norway (71.6%) and
Sweden (56.6%)”13
. Quality of treatment, and for UK recipients better access to reproductive
technologies, were also cited as important13
.
The cost of fertility treatment in Cyprus is also very attractive. EggDonorWorld, an online
directory of egg donation treatment providers, says “egg donation treatment costs are lower
[in Cyprus] than in Spain“14
. In the US a cycle of IVF with donor eggs can easily cost at least
$40,0009
, and for many this is simply unaffordable.
It is clear that Cyprus’s popularity is based on a combination of many factors. While all these
factors would have been important in establising Cyprus as an egg donation hub, the now
thriving industry and established reputation of Cyprus makes this industry stable.
Egg retrieval:
Official statistics on the number of eggs retrieved from donors seem to not exist. This absence
of data, along with lack of official information on the numbers of women donating, how often
they are doing so, where they originate, income, marital status and occupations, suggests a
Polygeia Sexual and Reproductive Health 2014
7
lack of regulation and monitoring. This could be putting the health of the women involved at
risk by making exploitation easy and allowing medical complications to go under the radar15
.
Donors and compensation
It is estimated that 1 in 50 women between the ages of 18 to 30 in Cyprus have sold their
eggs16
; among Cyprus’s eastern European immigrant populations, the statistic is 1 in 417
.
There are roughly 30,000 immigrants from the former Soviet Union living in Cyprus, often
under highly protectionist migration policies. It is hard for migrants to find work in Cyprus as
work permits are only given once the employer has proved that no Cypriot national is
available for the job; furthermore, jobs are often short-term and migrant workers may be
poorly treated18
. The opportunities in their home countries are often equally bleak; for
instance, income inequality in the Russian federation is higher than in any other OECD
country19
. This has created a system in which donating eggs is a viable employment option for
migrant women in Cyprus. Since the 2009 economic recession, Europe has seen a rise in the
number of women applying to become egg donors20
. Eastern European immigrant women are
particularly popular egg donors as their Caucasian appearance is favoured by recipients.
However, donor women in Cyprus are placed at high risk of the health complications which
can follow from unregulated egg donation. Donors are paid more money the more eggs they
produce, and have been reported to be injected with Follicle-stimulating hormone, which can
lead to ovarian hyper-stimulation syndrome21
. This reflects on how young women from lower
income groups in the developed world have been shown to be subject to higher health risks22
.
International legislative differences and structural inequalities create a situation in which egg
donation is the best economic opportunity for some women; it is this situation upon which
reproductive tourism depends.
Donor recruitment and coercion:
Fertility clinics, via their websites, encourage young, healthy women to contact the clinic and
become donors. Media reports suggest that direct, lower socioeconomic status and migrant-
targeted advertisement is the primary form of recruitment. An example of such targeted
advertising can be seen in advertisements seeking 'young healthy girls for egg donation'
placed in local Russian-language newspapers10
.
Polygeia Sexual and Reproductive Health 2014
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Informed consent is a legal requirement for egg donation. While clinic websites claim this is
given, and can be withdrawn at any stage without repercussion, by potential donors, reports
from donors on their experience of the donation procedure suggest otherwise10
.
A study of an Israeli clinic in Romania highlights the issue with consent in that during
interviews they found that the donors (for whom they used the term sellers) did not feel their
concerns were address, and that they weren't informed. In fact they found that irrespective of
the level of education of the women they felt they were putting themselves in a “compromised
position”. It is also interesting to consider whether a desire to sell ova could be view as a
backlash to the strict reproductive laws that were in place in Romania under Ceausescu23
.
Psychological and legal counselling for donors:
Although there are indications from individual clinics in Cyprus of offering counselling to
donors before the donation procedure and that fully-informed consent is a priority, reports
gained from donors’ experiences contest this12
, which is a further indication of the lack of
neutral reporting of procedures followed by fertility clinics in Cyprus, leaving only the
subjective information from clinics and donors as information sources on the exact
interpretation of this EU member state of the EU-wide regulation on egg donation.
The profile of Cyprus’ egg recipients:
The nationalities of donor egg recipients include, but are by no means limited to, British,
Italian, German, French, Norwegian and Swedish13
. Tough legislation also drives many Israeli
couples to seek treatment in Cyprus. The cost of treatment is such that recipients tend to be
wealthy in comparison to donors, raising many ethical questions about what this industry
could be doing to health inequality, but may be of low enough socioeconomic status in their
own country such that they choose to seek treatment in Cyprus because of its competitive
prices.
Polygeia Sexual and Reproductive Health 2014
9
Social Inequality and Fertility Tourism
Cyprus’ health profile suggests a relatively healthy population, particularly in comparison to
the regional average. In 2012, the average life expectancy at birth for both sexes was 82,
which is higher than both the regional and global averages24
. However, this statistic masks
disparities within the Cypriot population, specifically the migrant groups, often unable to
integrate fully into the country due to unfavourable policies who may consequently have
poorer health.
Travelling across national borders to use fertility clinics contributes to health inequalities by
forming part of the global context which determines the risk of illness and shapes access to
treatment. The high monetary cost associated with going abroad to receive fertility treatment
excludes lower SES groups of all nationalities. The women who offer their eggs to fertility
clinics in Cyprus are those who need the large sums of money which they receive in return.
They are of a lower socioeconomic group, and are often migrants, and may have no other
viable employment options, at least none which can compare to the payment they receive
through egg donation. Therefore, it is this particular group who are at risk of the health
complications which can arise from unregulated egg donation.
Privatisation of fertility clinics
Fertility clinics in Cyprus do not form part of the public healthcare landscape. Whereas in the
UK certain fertility treatments are available under the NHS, accessing infertility treatment in
Cyprus requires paying out of pocket. This creates an immediate inequity in treatment access
in that only those able to pay can utilise the treatment. The financial cost is one of the most
important factors affecting utilisation of infertility treatment25
. This bias is made even more
prominent when a woman or a couple must travel abroad for treatment. Only Israel and
Scandinavian countries come close to an equitable access to a complete range of infertility
services at an affordable level26
. This is problematic when one considers Bell’s (2014) point
that more lower SES than higher SES women are infertile27
. Bell’s article focuses on
infertility in America and looking to this example suggests some long-term effects of
inequities in access to infertility treatment, which Europe could face in the future. Women in
America on a lower income have less access to infertility treatment than higher earners due to
Polygeia Sexual and Reproductive Health 2014
10
their lack of insurance coverage. Many lower SES women can therefore not reproduce,
reinforcing class biases about who should and should not have children28
.
Globalisation, consumerism, and medical treatment
Private fertility clinics in Cyprus form part of a global context in which certain medical
treatments are becoming increasingly commercialised and privatised. Mackintosh (2003)
defines the commercialisation of medical care as:
 The increasing provision of healthcare, through market relationships, to those able to pay
 The investment in, and production of, these services for the purpose of cash income or
profit
 The increase in the extent to which healthcare finance is derived from payment systems
based in individual payment or private insurance29
.
The dominance of market incentives in healthcare systems has been experienced worldwide,
and is further encouraged by economic crises. This is in part a product of globalisation, which
has opened economies to more closely combine the markets for goods and services29
. Without
mechanisms to ensure economic growth which benefits all groups on the socioeconomic
scale, healthcare inequalities inevitably persist and widen. The increasing privatisation and
fragmentation of healthcare is leading to inequalities as the encouragement of user-fees
excludes lower SES groups in both rich and poor countries. In other words, there is no sense
of equitable access. Problematically, higher private spending is associated with lower life
expectancy30
.
Infertility, particularly secondary infertility caused by voluntarily waiting to have children,
may not in most cases be life-threatening. However, differentials in access to infertility
treatment are a symptom of a wider global move towards more commercialised healthcare,
focused on treatment rather than prevention. Primary healthcare systems (PHC), which aim to
ensure universal coverage, are eschewed in favour of an emphasis on individual management
of risk. In such situations, the less well off gain less from health services than the better off.
Excluding lower SES groups from universal healthcare only serves to reinforce their ill
health, further preventing them from participating fully in wider society.
Polygeia Sexual and Reproductive Health 2014
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European Union Legislation
Different countries have many different regulations surrounding egg donation, especially with
reference remuneration to the degree to which women can be remunerated for undergoing the
hormonal treatment required to harvest the eggs. In particular there are disparities within the
European Union, which, combined with the freedom of movement between member states
and the declining costs of air travel have led to the burgeoning phenomenon of reproductive
tourism.
The UK has two year waiting lists for eggs largely due to the combined effects of the
reduction of compensation and allowing the progeny to trace the donor. French law is also
very strict on reimbursement of costs, with strict stipulations to prevent it being used to
disguise payment. Germany and Italy are even stricter31
with a complete ban on egg donation,
meaning that any German or Italian needing a donor egg is forced to travel abroad32
.
Within the European Union the principles to govern tissue and egg donation are set out in
Article 12 of the Directive 2004/23/EC of the European Parliament and of the Council of 31
March 2004 on setting standards of quality and safety for the donation, procurement, testing,
processing, preservation, storage and distribution of human tissues and cells. This Article sets
out the principle clearly that donations must be voluntary and unpaid, however does make the
concession that donors are permitted to receive compensation so long as it is limited to
covering expenses and the inconvenience incurred. However the precise definition of the
conditions surrounding these payments are left to the individual countries, leading to
variation33
.
It is of course debatable about what constitutes expenses, for example factoring in
reimbursement of childcare, travel costs and lost wages34
. However the directive does
explicitly state that Member States must “endeavour” that donations are carried out on a “non-
profit basis”, although the verb means that this is hardly a binding demand.
The Declaration of Istanbul was created at the Istanbul Summit on Organ Trafficking and
Transplant Tourism, and one of its aims is to strengthen laws against the commercial organ
trade, in against a context of increased globalisation35
, which allows patients from wealthier
Polygeia Sexual and Reproductive Health 2014
12
countries to travel more easily to use organs donated by people in poorer countries. This can
be considered analogous to egg donation, which reveals an interesting contrast because the
World Health Assembly36
has clearly objected to transplant tourism “to protect the poorest
and vulnerable groups from transplant tourism”, while the EU law has not fully addressed the
issue of fertility tourism.
Laws restricting financial inducement for egg donation in Europe and the removal of
anonymity for donors which discourages egg-sharing (receiving discounted treatment in
return for donating eggs), combined with the increasing demand for eggs37
in reproductive
medicine have led to clinics seeking eggs from overseas38
. Due to differences in purchasing
power parity between countries, this magnifies the size of payments for poor women from less
well-off nations, turning a minor sum into a serious incentive.
This is not the only way in which circumvention tourism disadvantages the poor. It has been
argued that the fact that some people are able to leave encourages states to enact stricter
policies domestically, leaving a great disparity of access to fertility treatment based on the
ability to pay for overseas travel39
.
However it has been found that many reproductive travellers object to the term reproductive
tourism is inappropriate as it portrays the experience as pleasurable, which they say
diminishes the suffering involved in what some would prefer to call reproductive exile from
restrictive laws at home.
It is worth questioning to what extent foreign egg donors are informed of the risks of the
extraction, particularly Ovarian Hyperstimulation Syndrome which can be severe and
sometimes even fatal. It is in the clinics' interests to extract as many eggs as possible, and
given the almost 'bonus'-like system in which they pay more for people who produce more
eggs they also make it in the donors' interests to take risks which high doses of hormones.
There is at present no mechanism to protect donors if they were later to develop serious
medical complications. It has been suggested that health insurance coverage be mandatory for
foreign egg donors40
, however there is a risk this could be a greater incentive than even
monetary payment, leading people desperate for medical care to feel coerced.
Polygeia Sexual and Reproductive Health 2014
13
Recommendations and Implementation
Plans
In light of the evidence and discussion presented in this report, there are several areas of
infertility clinic procedures in Cyprus that could be suggested as changes in the regulation of
infertility treatments in Cyprus.
Accessibility of information and Clinic Transparency
Given the commonly migrant profiles of the egg donors in Cyprus’ fertility clinics, more
accessible and transparent reporting of donor and procedure statistics from individual clinics
is needed. As outlined in this report, many of the egg donors are returning to their home
countries with no guarantee of follow-up medical care and cannot be assumed to give full
voluntary consent to procedures which are insufficiently explained in an official capacity and
with no evaluation of the potential differences in between clinics in terms of the extent to
which donors are informed of the procedures.
A possible way of providing accessible and comprehensive information about the procedures
as well as clinic-specific information would be a government-endorsed web page that details
the procedure, potential risks and donor rights and routes to help. Individual clinics might be
obligated to ensure that this website address to appear on their clinic websites and donor
advertisements in order to ensure that the information filters through to each individual donor,
regardless of whether they are migrants into Cyprus or not.
Accessible information for donors and recipients and a transparency into procedures in
individual clinics should be prioritised at a legal and regulatory level and at the EU level in
order to harmonise the interpretation of the current law by member states. An EU-wide law,
or other binding regulation, which makes it compulsory for all donors to be told the full
effects of egg donation before donating is essential to ensure implementation at individual
clinic level.
There is also a clear need for more thorough followup on the implementation of EU and
national level regulations in Cyprus in terms of the day to day operations of infertility clinics.
Polygeia Sexual and Reproductive Health 2014
14
In order to improve the reporting of donor and procedure statistics, a local governing body
might be beneficial, with which individual clinics would cooperate with and be accountable
to.
This report has given a brief overview of the debate on the conflict between defining the
compensation donors receive for their donations. With arguments that the current
’compensation’ system is functionally the same as pay, acknowledging this as such would at
least allow a minimum price to be set. There is a fundamental question about whether an open
“market” with pay and heavy regulation, which would arguably encourage more donation,
would be best, or whether banning anything other than very tokenistic compensation in the
hopes of making egg donation purely altruistic would be better, even if it limited the number
of eggs donated. The EU might consider implementing a fixed fee of compensation, as is the
case in the USA, or follow the ASRM suggested guidelines of no more than $10,000, and
reimbursement of any expenses for the donor in order to harmonise the interpretation of the
current EU regulation on ’compensation’ for donors between member states and provide
equal and fair compensation for all donors, regardless of country of origin or country where
donation occurs.
Care for donors and recipients in Cyprus
It is imperative that both donors and recipients in infertility clinics are not only
comprehensively informed of the procedures and risks before attending the clinic, but that
their health and wellbeing is prioritised during and after the procedures they undergo as well,
with full commitment from each individual clinic to provide followup care to their patients,
regardless of immigration status. This is particularly relevant in the current context of
increasing fertility tourism and the migrant profiles of donors in Cyprus specifically.
The standard and continuity of care for each donor and recipient can be ensured through a
process of having a named accountable doctor in the clinic who is obligated to provide
followup care at regulated time points with a requirement to provide evidence of the
completion of these followups. For migrant donors, whose access to healthcare in their home
Polygeia Sexual and Reproductive Health 2014
15
countries might not be available, this is essential as is a guarantee of the clinic where they
donated covering the cost of any complications should they arise.
Given the evidence on the irregularity between clinics in terms of the number of donations per
donor, and therefore the lack of regulation on the prevention of the negative health effects of
multiple donations, better recordkeeping and reporting of individuals donors’ health and the
number of donations they have made is needed. Whilst it is important to not lose sight of the
significance of maintaining donor anonymity, clear protocols on the number of eggs to be
retrieved (hormone stimulation), number of times a donor can donate, and number of eggs to
be implanted in recipient couples) must be implemented and evaluated. This process might be
aided by a national health registry for donors, which would allow the record keeping of donor
health, the number of times they donate as well as evidence of followup care from their
assigned doctor.
In order to reinforce this system, a process of fines or withdrawing the approval to provide
treatment from the clinics who fail to update their records of donors or provide sufficient
followup care might be considered. Being sensitive to the possible power dynamic between
the donor and the clinic, an anonymous whistleblowing system could be beneficial to aid the
reporting of inconsistencies in clinic reporting or care provided compared to implemented
protocols.
Comprehensive care for donors and recipients seems to also lack the provision of counselling
services, which is essential for not only ensuring fully informed consent to any procedures
undertaken but also for the management of any complications or psychological distress after
post-procedure. National as well as EU protocols requiring mandatory counselling services,
training and clear guidelines for counselors should be implemented.
Harmonise legal standpoints on reproductive tourism
European Union regulation of egg donation is outlined in Article 12 of the Directive
2004/23/EC of the European Parliament and of the Council of 31 March 2004. This sets some
guidance on the voluntary and unpaid nature of egg donation, but allows member states to
individually decide how the guidance should be followed or applied locally. Whilst limiting
pluralism in society is not desired, a common approach and clear implementation of this
Polygeia Sexual and Reproductive Health 2014
16
approach to reproductive tourism would benefit the donors and recipients in all EU member
states.
Minimize need for egg donation
The last area of recommendation in egg donation this report would like to propose is that of
minimising the need to egg donation through ongoing commitment worldwide to bettering
working conditions and gender equality in the home as well as through avoiding preventable
causes of infertility, informing couples of the risks of leaving starting a family until too late,
and popularising alternatives to egg donation such as fostering and adoption. This would
require efforts in the wider social context of the role of infertility in gender equality through
education and awareness raising programmes.
Polygeia Sexual and Reproductive Health 2014
17
Conclusion
A significant number of people currently travel abroad to receive fertility treatment due to
legal constraints and the cost of treatment in their own country. The demand for human eggs
and the fertility treatments that implant them has seen an industry grow around donating and
receiving human eggs. Cyprus is one of the countries at the heart of this development in
Europe. Official statistics on the nature of the industry are hard to come by. Information on
who is donating and the donating practices they partake in are limited, reflecting a poorly
regulated system that may be exposing those participating in it to unnecessary and
uncalculated risk. Ovarian Hyperstimulation Syndrome is but one cause of concern, as is the
health of travelling donors on return to their home countries.
The standards that members of the industry profess to maintain are often found to not be met.
There are many troubling accounts of donors being subjected to coercive practices forcing
them to take hormones and then being left without counselling or support after they have
donated their eggs. Practice in Cyprus is a particular cause for concern. Reimbursement for
egg donation in the European Union is currently covered under Article 12 of the Directive
2004/23/EC of the European Parliament and of the Council of 31 March 2004. This states that
donations must be voluntary and unpaid, but donors can receive compensation for expenses
and inconvenience. Countries can decide how this policy is applied, and it creates an incentive
to source eggs from outside Europe.
It is proposed that to address the ambiguity of the current industry and to protect those that
participate in it, particularly those of a lower socioeconomic background who are incentivised
to donate eggs for financial reimbursement but are offered little medical protection, the
industry must be better regulated and more information recorded on the medical practice that
occurs within it. Clinics that participate in reproductive and fertility treatments should keep
better records of the activity occurring in their practices, including how many treatments are
being performed, the number of eggs being collected from donors and the number then being
implanted into other women. This information should be reviewed as part of an inspection
process carried out by a regulatory body to ensure good medical practice. It is suggested that
care for donors and recipients of eggs needs to be improved, including all participants having
Polygeia Sexual and Reproductive Health 2014
18
a named accountable doctor, creating a national health registry for donors, providing
mandatory pre and post treatment information along with counselling services, and clearer
protocols on hormone stimulation, egg collection and egg implantation. There should be
clearer standards of reimbursement than those currently laid out in Article 12. Instead of the
current ambiguous qualitative statement, this could take the form of a fixed fee of
compensation.
‘Fertility tourism’ is an industry that has grown with rapidity and at a faster pace than the
regulation that controls it. This should not be accepted an excuse for the present state of the
industry, which does not protect the safety and wellbeing of those that participate in it. Action
should be taken to better understand the industry, and this information should empower the
creation of legislation and protocol to ensure the rights and health of the large numbers of
people now involved in the business of donating and receiving human eggs.
Polygeia Sexual and Reproductive Health 2014
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[HarperCollins Publishers]
10. Barnett, A., Smith, H., Cruel cost of the human egg trade, The Observer (April 2006)
http://www.theguardian.com/uk/2006/apr/30/health.healthandwellbeing (accessed
24/08/14).
11. Althuis, M. D., Moghissi, K. S., Westhoff, C. L., Scoccia, B., Lamb, E. J., Lubin, J.
H., Brinton, L. A., Uterine Cancer after Use of Clomiphene Citrate to Induce
Ovulation, American Journal of Epidemiology (November 2004) 161(7):607-615
12. Pedieos in-vitro fertilisation centre, Egg Donation, Pedieos in-vitro fertilisation centre
website (date not specified) http://www.pedieosivf.com.cy/en (accesses 22/08/14).
13. F. Shenfield, F., de Mouzon, J., Pennings, G., Ferraretti, A.P., Nyboe Andersen, A.,
de Wert, G., Goosse, V., and the ESHRE Taskforce on Cross Border Reproductive
Care, Cross border reproductive care in six European countries, Human Reproduction
(February 2010) http://humrep.oxfordjournals.org/content/25/6/1361.abstract
(accessed 24/08/14).
14. EggDonorWorld, Clinics: Europe: Cyprus, EggDonorWorld website (2014)
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24/08/14).
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15. Nygren, K., Adamson, D., Zegers-Hochschild, F., de Mouzon, J., Cross-border
fertility care--International Committee Monitoring Assisted Reproductive
Technologies global survey: 2006 data and estimates, Fertility and Sterility (June
2010) 94(1): e4-e10
16. Carney, S., The Cyprus Scramble: An Investigation into Human Egg Markets, Pulitzer
Centre (August 2010) http://pulitzercenter.org/blog/untold-stories/cyprus-scramble-
investigation-human-egg-markets (accessed 24/08/14).
17. Dogus IVF Centre, Egg Donation Treatment in North Cyprus, Dogus IVF Centre
website (2012) http://www.cyprusivf.co.uk/egg-donation.html (accessed 22/08/14).
18. North Cyprus IVF Clinic, Egg Donation Cyprus, North Cyprus IVF Clinic website
(2013) http://www.northcyprusivf.co.uk/treatments/egg-donation (accessed 22/08/14).
19. Carney, S., The Cyprus Scramble: An Investigation into Human Egg Markets, Pulitzer
Centre (August 2010) http://pulitzercenter.org/blog/untold-stories/cyprus-scramble-
investigation-human-egg-markets (accessed 24/08/14).
20. Carney S. The Cyprus scramble: an investigation into human egg markets. Pulitzer
Centre on Crisis Reporting. http://pulitzercenter.org/blog/untold-stories/cyprus-
scramble-investigation-human-egg-markets (accessed on 01.11.2014).
21. Carney S. Unpacking the Global Human Egg Trade. Fast Company
http://www.fastcompany.com/1676895/unpacking-global-human-egg-trade (accessed
on 01.11.2014).
22. Thomson M. Migrants on the edge of Europe: perspectives from Malta, Cyprus and
Slovenia. University of Sussex. Sussex Migration Working Paper No. 35, 2006.
23. Nahman M. Nodes of desire: Romanian egg sellers, ’Dignity’ and feminist alliances in
transnational ova exchanges. European Journal of Women’s Studies 2008; 15(2): 65-
82.
24. World Health Organization. Cyprus: health profile.
http://www.who.int/gho/countries/cyp.pdf?ua=1 (accessed 04.11.2014).
25. The costs and consequences of assisted reproductive technology: an economic
perspective. Hum. Reprod. Update (2010) 16(6): 603-613.
26. International disparities in access to infertility services – Robert D. Nachtigall, MD.
(Fertility and Sterility Vol. 85, No. 4, April 2006)
27. Diagnostic diversity: the role of social class in diagnostic experiences of infertility –
Bell, AV. Sociology of Health and Illness, 2014 May;36(4):516-30.
28. The Politics of Reproductive Benefits: US coverage of contraceptive and infertility
treatments – King and Meyer (1997)
29. Mackintosh M. Health care commercialisation and the embedding of inequality.
Ruig/UNRISD Health project synthesis paper. United Nations Research Institute for
Social Development, 2003.
30. WHO Social Determinants final report
31. F. Merlet and B. Sénémaud, “Prise En Charge Du Don D’ovocytes : Réglementation
Du Don, La Face Cachée Du Tourisme Procréatif,” Gynécologie Obstétrique &
Fertilité 38, no. 1 (January 2010): 36–44, doi:10.1016/j.gyobfe.2009.11.008.
32. Sven Bergmann, “Fertility Tourism: Circumventive Routes That Enable Access to
Reproductive Technologies and Substances,” Signs 36, no. 2 (January 1, 2011): 280–
89, doi:10.1086/655978.
33. EUR-Lex Access to European Law. Directive 2004/23/EC of the European
Parliament and of the Council of 31 March 2004 on setting standards of quality and
safety for the donation, procurement, testing, processing, preservation, storage and
distribution of human tissues and cells. Official Journal L 102, 0048-0058. http://eur-
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lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32004L0023 (accessed on
04.11.2014).
34. Idiakez IA. Egg donation: a case of body shopping. Presented at the University of
Innsbruck in the context of the semester focus ’Bioethics’ of Wissenschaft und
Verantwortlichkeit. Innsbruck, 2010.
35. Shimazono, Y. "The State of the International Organ Trade: A Provisional Picture
Based on Integration of Available Information." Bulletin of the World Health
Organization 85 (2007): 955-62.
36. World Health Organization. "Human Organ and Tissue Transplantation. (WHA
57.18)" (2004)
37. Sauer M, Kavic SM. Oocyte and embryo donation 2006: reviewing two decades of
innovation and controversy. Reproductive Biomedicine Online, 12(2), 153-162.
38. Fishman RHB. Infertility doctors use egg donors worldwide. Lancet, 353(9154), 736-
736.
39. Wannes Van Hoof and Guido Pennings, “Extraterritoriality for Cross-Border
Reproductive Care: Should States Act against Citizens Travelling Abroad for Illegal
Infertility Treatment?,” Reproductive Biomedicine Online 23, no. 5 (November 2011):
546–54, doi:10.1016/j.rbmo.2011.07.015.
40. Heng BC. Regulatory safeguards needed for the travelling foreign egg donor. Human
Reproduction, 22(8), 2350-2352.

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Polygeia_SRH_2014

  • 1. Polygeia Sexual and Reproductive Health 2014 1 European Union Regulation on Infertility Treatment: Open to Interpretation by Member States A Case Study of Cyprus Authors: Cassandra Fairhead, Robert Hart, Sarah Dew, Xue-En Chueng, Molli Shomali, Thomas Weatherby, Finnoula Taylor
  • 2. Polygeia Sexual and Reproductive Health 2014 2 Contents EXECUTIVE SUMMARY............................................................................................................................. 3 DEFINING THE PROBLEM......................................................................................................................... 4 Egg donation procedure...................................................................................................................... 4 Cyprus as a case study............................................................................................................................. 6 Egg retrieval:........................................................................................................................................ 6 Donors and compensation .................................................................................................................. 7 Donor recruitment and coercion:........................................................................................................ 7 Psychological and legal counselling for donors:.................................................................................. 8 The profile of Cyprus’ egg recipients:.................................................................................................. 8 Social Inequality and Fertility Tourism.................................................................................................... 9 Privatisation of fertility clinics............................................................................................................. 9 Globalisation, consumerism, and medical treatment....................................................................... 10 European Union Legislation .................................................................................................................. 11 Recommendations and Implementation Plans..................................................................................... 13 Accessibility of information and Clinic Transparency........................................................................ 13 Care for donors and recipients in Cyprus.......................................................................................... 14 Harmonise legal standpoints on reproductive tourism .................................................................... 15 Minimize need for egg donation....................................................................................................... 16 Conclusion ............................................................................................................................................. 17 References............................................................................................................................................. 19
  • 3. Polygeia Sexual and Reproductive Health 2014 3 EXECUTIVE SUMMARY The World Health Organization defines infertility as the inability of a sexually active, non- contracepting couple to achieve pregnancy, and for a woman, the inability to maintain a pregnancy, or an inability to carry a pregnancy to live birth1 . Assistive reproductive technologies, that is technologies meant to assist an individual or couple in achieving or maintaining a pregnancy, are on the rise. Approximately 1.5 million ART cycles are performed worldwide annually. ARTs have brought about growing demand for third party reproduction - whereby a woman provides her uterus (as in surrogacy), and/or a person provides sperm, eggs or embryos in order to enable a person or couple to have a child. Increasingly, couples will participate in reproductive tourism, whereby they travel to countries with laws more permissible and/or services more affordable to seek third party reproduction. A number of countries have become prime destinations for third party reproduction. The use of third party reproduction, and the ensuing market of fertility tourism, raises concerns for those involved and has caused much debate in the international sphere. Fertility tourism is taken as the focus of this report. In particular, egg donation in Cyprus - a popular egg donation destination within the European Union - will be examined. Policy recommendations to address the regulation of, and concerns arising from, this industry will be made. Particular attention is paid to the vague EU regulations on egg donation and the subsequent implications this has on the differential interpretation of this by member states. It is suggested that clearer regulation at the EU level is an important factor influencing the gender and health inequalities that the current legislation may create. These recommendations are highlighted within the context of infertility clinics in Cyprus, a country which has become a hub for fertility tourism and where multiple infertility clinics operate. Suggestions are offered on how recommended policy changes can be implemented. The proposed changes in regulation towards the offering and reporting of infertility treatments in low cost countries such as Cyprus is also addressed.
  • 4. Polygeia Sexual and Reproductive Health 2014 4 DEFINING THE PROBLEM Infertility is a global issue. The level of infertility in the last twenty years has remained unchanged, and is currently reported to affect approximately one in four couples, although this is likely an underestimate2 . This is an area of reproductive health which is a significant contributor to achieving Millenium Development Goal 5B: "achieving, by 2015, universal access to reproductive health". It is highly improbable that this goal will be met, emphasising the need for better solutions for access to reproductive healthcare worldwide. The WHO-ICMART glossary defines infertility as ‘a disease of the reproductive system defined by the failure to achieve a clinical pregnancy after 12 months or more of regular unprotected sexual intercourse’3 . Infertility affects 15% + of reproductive-aged couples worldwide4 . According to WHO, it affects > 10% of women5 . These are women who have tried to become pregnant unsuccessfully, and remained in a stable relationship for 5 years or more. Infertility has a variety of causes, with the most prevalent cause varying on location; typically age-related in developed nations and STIs in less developed nations. There are several treatments available for couples or single individuals seeking assistance in having children6 . This report will focus on the requirement of egg donation for in vitro fertilisation. It will address the implications of this procedure on health and gender inequalities and how these inequalities can be addressed by highlighting current gaps in legislation and policy guidelines. Egg donation procedure Egg donation is a lengthy and intrusive process lasting up to 6 weeks. During the natural fertility process it is usual for just one egg to ovulate. However, donors are stimulated, through the use of hormones, to produce as many as 50. Side effects of the procedure include psychological stress, bloating, cramps, headaches and even kidney disease, blood clots and premature menopause. The process of egg donation can be summarized as follows7 : 1. Ovaries are shut down to disrupt the natural ovulation cycle using medication. 2. Daily, for up to 10 days, the donor must inject themselves with hormones . 3. Surgery is performed to remove the egg follicles from the ovaries.
  • 5. Polygeia Sexual and Reproductive Health 2014 5 Donation is not risk-free8 . There are many potential side effects of the procedure, including psychological stress, bloating, cramps, headaches and even kidney disease, blood clots and premature menopause. Egg retrieval is carried out under general anaesthesia, which carries its own risks, such as the possibility of serious malignant hyperthermia (REF). In addition to the possible side effects mentioned above, the hormones used can also be a danger to donors. On rare occasions patients may suffer an adverse reaction to the hormone regimen9 , but a more common complication is ovarian hyperstimulation syndrome (OHSS) which can, in extreme cases, be fatal10 . Aside from the immediate risks to the donor’s health, questions have also been raised about the procedure’s unknown long term risks8 . Some studies have suggested the drugs regimens for infertility, which are often the same as those administered to egg donors, may be linked to the development of certain cancers, including those of the breast and ovaries8 . It is not yet clear, however, whether it is the fertility drugs, as opposed to underlying infertility, that predisposes these women to disease. One 2004 study found no statistically significant increase in breast or ovarian cancer in egg donors, but did find that the women were around 1.8 times more likely to develop uterine cancer11 .
  • 6. Polygeia Sexual and Reproductive Health 2014 6 Cyprus as a case study With more more fertility clinics per capita than any other country, Cyprus is somewhat of a hub for fertility tourism and in particular egg donation9 . A number of factors have made the country an attractive, and convenient, destination for those seeking this type of reproductive technology. Waiting lists for donor eggs are almost non-existent due to a steady supply of women willing to donate eggs. Indeed, many clinics have a database of potential donors ready to undergo the procedure should a suitable recipient appear. Moreover, Cyprus has an exceptionally large number of eligible egg donors. The country has 76,000 eligible donors aged 18 to 309 , and estimates suggest that each year about 1500 (about 1 in 50) donate their eggs12 . This contrasts with the US, where the figure is 1 in 14,00012 . A 2010 Human Reproduction study found that while reasons for recipients travelling abroad for treatment varied by country of origin, “legal reasons were predominant for patients travelling from Italy (70.6%), Germany (80.2%), France (64.5%), Norway (71.6%) and Sweden (56.6%)”13 . Quality of treatment, and for UK recipients better access to reproductive technologies, were also cited as important13 . The cost of fertility treatment in Cyprus is also very attractive. EggDonorWorld, an online directory of egg donation treatment providers, says “egg donation treatment costs are lower [in Cyprus] than in Spain“14 . In the US a cycle of IVF with donor eggs can easily cost at least $40,0009 , and for many this is simply unaffordable. It is clear that Cyprus’s popularity is based on a combination of many factors. While all these factors would have been important in establising Cyprus as an egg donation hub, the now thriving industry and established reputation of Cyprus makes this industry stable. Egg retrieval: Official statistics on the number of eggs retrieved from donors seem to not exist. This absence of data, along with lack of official information on the numbers of women donating, how often they are doing so, where they originate, income, marital status and occupations, suggests a
  • 7. Polygeia Sexual and Reproductive Health 2014 7 lack of regulation and monitoring. This could be putting the health of the women involved at risk by making exploitation easy and allowing medical complications to go under the radar15 . Donors and compensation It is estimated that 1 in 50 women between the ages of 18 to 30 in Cyprus have sold their eggs16 ; among Cyprus’s eastern European immigrant populations, the statistic is 1 in 417 . There are roughly 30,000 immigrants from the former Soviet Union living in Cyprus, often under highly protectionist migration policies. It is hard for migrants to find work in Cyprus as work permits are only given once the employer has proved that no Cypriot national is available for the job; furthermore, jobs are often short-term and migrant workers may be poorly treated18 . The opportunities in their home countries are often equally bleak; for instance, income inequality in the Russian federation is higher than in any other OECD country19 . This has created a system in which donating eggs is a viable employment option for migrant women in Cyprus. Since the 2009 economic recession, Europe has seen a rise in the number of women applying to become egg donors20 . Eastern European immigrant women are particularly popular egg donors as their Caucasian appearance is favoured by recipients. However, donor women in Cyprus are placed at high risk of the health complications which can follow from unregulated egg donation. Donors are paid more money the more eggs they produce, and have been reported to be injected with Follicle-stimulating hormone, which can lead to ovarian hyper-stimulation syndrome21 . This reflects on how young women from lower income groups in the developed world have been shown to be subject to higher health risks22 . International legislative differences and structural inequalities create a situation in which egg donation is the best economic opportunity for some women; it is this situation upon which reproductive tourism depends. Donor recruitment and coercion: Fertility clinics, via their websites, encourage young, healthy women to contact the clinic and become donors. Media reports suggest that direct, lower socioeconomic status and migrant- targeted advertisement is the primary form of recruitment. An example of such targeted advertising can be seen in advertisements seeking 'young healthy girls for egg donation' placed in local Russian-language newspapers10 .
  • 8. Polygeia Sexual and Reproductive Health 2014 8 Informed consent is a legal requirement for egg donation. While clinic websites claim this is given, and can be withdrawn at any stage without repercussion, by potential donors, reports from donors on their experience of the donation procedure suggest otherwise10 . A study of an Israeli clinic in Romania highlights the issue with consent in that during interviews they found that the donors (for whom they used the term sellers) did not feel their concerns were address, and that they weren't informed. In fact they found that irrespective of the level of education of the women they felt they were putting themselves in a “compromised position”. It is also interesting to consider whether a desire to sell ova could be view as a backlash to the strict reproductive laws that were in place in Romania under Ceausescu23 . Psychological and legal counselling for donors: Although there are indications from individual clinics in Cyprus of offering counselling to donors before the donation procedure and that fully-informed consent is a priority, reports gained from donors’ experiences contest this12 , which is a further indication of the lack of neutral reporting of procedures followed by fertility clinics in Cyprus, leaving only the subjective information from clinics and donors as information sources on the exact interpretation of this EU member state of the EU-wide regulation on egg donation. The profile of Cyprus’ egg recipients: The nationalities of donor egg recipients include, but are by no means limited to, British, Italian, German, French, Norwegian and Swedish13 . Tough legislation also drives many Israeli couples to seek treatment in Cyprus. The cost of treatment is such that recipients tend to be wealthy in comparison to donors, raising many ethical questions about what this industry could be doing to health inequality, but may be of low enough socioeconomic status in their own country such that they choose to seek treatment in Cyprus because of its competitive prices.
  • 9. Polygeia Sexual and Reproductive Health 2014 9 Social Inequality and Fertility Tourism Cyprus’ health profile suggests a relatively healthy population, particularly in comparison to the regional average. In 2012, the average life expectancy at birth for both sexes was 82, which is higher than both the regional and global averages24 . However, this statistic masks disparities within the Cypriot population, specifically the migrant groups, often unable to integrate fully into the country due to unfavourable policies who may consequently have poorer health. Travelling across national borders to use fertility clinics contributes to health inequalities by forming part of the global context which determines the risk of illness and shapes access to treatment. The high monetary cost associated with going abroad to receive fertility treatment excludes lower SES groups of all nationalities. The women who offer their eggs to fertility clinics in Cyprus are those who need the large sums of money which they receive in return. They are of a lower socioeconomic group, and are often migrants, and may have no other viable employment options, at least none which can compare to the payment they receive through egg donation. Therefore, it is this particular group who are at risk of the health complications which can arise from unregulated egg donation. Privatisation of fertility clinics Fertility clinics in Cyprus do not form part of the public healthcare landscape. Whereas in the UK certain fertility treatments are available under the NHS, accessing infertility treatment in Cyprus requires paying out of pocket. This creates an immediate inequity in treatment access in that only those able to pay can utilise the treatment. The financial cost is one of the most important factors affecting utilisation of infertility treatment25 . This bias is made even more prominent when a woman or a couple must travel abroad for treatment. Only Israel and Scandinavian countries come close to an equitable access to a complete range of infertility services at an affordable level26 . This is problematic when one considers Bell’s (2014) point that more lower SES than higher SES women are infertile27 . Bell’s article focuses on infertility in America and looking to this example suggests some long-term effects of inequities in access to infertility treatment, which Europe could face in the future. Women in America on a lower income have less access to infertility treatment than higher earners due to
  • 10. Polygeia Sexual and Reproductive Health 2014 10 their lack of insurance coverage. Many lower SES women can therefore not reproduce, reinforcing class biases about who should and should not have children28 . Globalisation, consumerism, and medical treatment Private fertility clinics in Cyprus form part of a global context in which certain medical treatments are becoming increasingly commercialised and privatised. Mackintosh (2003) defines the commercialisation of medical care as:  The increasing provision of healthcare, through market relationships, to those able to pay  The investment in, and production of, these services for the purpose of cash income or profit  The increase in the extent to which healthcare finance is derived from payment systems based in individual payment or private insurance29 . The dominance of market incentives in healthcare systems has been experienced worldwide, and is further encouraged by economic crises. This is in part a product of globalisation, which has opened economies to more closely combine the markets for goods and services29 . Without mechanisms to ensure economic growth which benefits all groups on the socioeconomic scale, healthcare inequalities inevitably persist and widen. The increasing privatisation and fragmentation of healthcare is leading to inequalities as the encouragement of user-fees excludes lower SES groups in both rich and poor countries. In other words, there is no sense of equitable access. Problematically, higher private spending is associated with lower life expectancy30 . Infertility, particularly secondary infertility caused by voluntarily waiting to have children, may not in most cases be life-threatening. However, differentials in access to infertility treatment are a symptom of a wider global move towards more commercialised healthcare, focused on treatment rather than prevention. Primary healthcare systems (PHC), which aim to ensure universal coverage, are eschewed in favour of an emphasis on individual management of risk. In such situations, the less well off gain less from health services than the better off. Excluding lower SES groups from universal healthcare only serves to reinforce their ill health, further preventing them from participating fully in wider society.
  • 11. Polygeia Sexual and Reproductive Health 2014 11 European Union Legislation Different countries have many different regulations surrounding egg donation, especially with reference remuneration to the degree to which women can be remunerated for undergoing the hormonal treatment required to harvest the eggs. In particular there are disparities within the European Union, which, combined with the freedom of movement between member states and the declining costs of air travel have led to the burgeoning phenomenon of reproductive tourism. The UK has two year waiting lists for eggs largely due to the combined effects of the reduction of compensation and allowing the progeny to trace the donor. French law is also very strict on reimbursement of costs, with strict stipulations to prevent it being used to disguise payment. Germany and Italy are even stricter31 with a complete ban on egg donation, meaning that any German or Italian needing a donor egg is forced to travel abroad32 . Within the European Union the principles to govern tissue and egg donation are set out in Article 12 of the Directive 2004/23/EC of the European Parliament and of the Council of 31 March 2004 on setting standards of quality and safety for the donation, procurement, testing, processing, preservation, storage and distribution of human tissues and cells. This Article sets out the principle clearly that donations must be voluntary and unpaid, however does make the concession that donors are permitted to receive compensation so long as it is limited to covering expenses and the inconvenience incurred. However the precise definition of the conditions surrounding these payments are left to the individual countries, leading to variation33 . It is of course debatable about what constitutes expenses, for example factoring in reimbursement of childcare, travel costs and lost wages34 . However the directive does explicitly state that Member States must “endeavour” that donations are carried out on a “non- profit basis”, although the verb means that this is hardly a binding demand. The Declaration of Istanbul was created at the Istanbul Summit on Organ Trafficking and Transplant Tourism, and one of its aims is to strengthen laws against the commercial organ trade, in against a context of increased globalisation35 , which allows patients from wealthier
  • 12. Polygeia Sexual and Reproductive Health 2014 12 countries to travel more easily to use organs donated by people in poorer countries. This can be considered analogous to egg donation, which reveals an interesting contrast because the World Health Assembly36 has clearly objected to transplant tourism “to protect the poorest and vulnerable groups from transplant tourism”, while the EU law has not fully addressed the issue of fertility tourism. Laws restricting financial inducement for egg donation in Europe and the removal of anonymity for donors which discourages egg-sharing (receiving discounted treatment in return for donating eggs), combined with the increasing demand for eggs37 in reproductive medicine have led to clinics seeking eggs from overseas38 . Due to differences in purchasing power parity between countries, this magnifies the size of payments for poor women from less well-off nations, turning a minor sum into a serious incentive. This is not the only way in which circumvention tourism disadvantages the poor. It has been argued that the fact that some people are able to leave encourages states to enact stricter policies domestically, leaving a great disparity of access to fertility treatment based on the ability to pay for overseas travel39 . However it has been found that many reproductive travellers object to the term reproductive tourism is inappropriate as it portrays the experience as pleasurable, which they say diminishes the suffering involved in what some would prefer to call reproductive exile from restrictive laws at home. It is worth questioning to what extent foreign egg donors are informed of the risks of the extraction, particularly Ovarian Hyperstimulation Syndrome which can be severe and sometimes even fatal. It is in the clinics' interests to extract as many eggs as possible, and given the almost 'bonus'-like system in which they pay more for people who produce more eggs they also make it in the donors' interests to take risks which high doses of hormones. There is at present no mechanism to protect donors if they were later to develop serious medical complications. It has been suggested that health insurance coverage be mandatory for foreign egg donors40 , however there is a risk this could be a greater incentive than even monetary payment, leading people desperate for medical care to feel coerced.
  • 13. Polygeia Sexual and Reproductive Health 2014 13 Recommendations and Implementation Plans In light of the evidence and discussion presented in this report, there are several areas of infertility clinic procedures in Cyprus that could be suggested as changes in the regulation of infertility treatments in Cyprus. Accessibility of information and Clinic Transparency Given the commonly migrant profiles of the egg donors in Cyprus’ fertility clinics, more accessible and transparent reporting of donor and procedure statistics from individual clinics is needed. As outlined in this report, many of the egg donors are returning to their home countries with no guarantee of follow-up medical care and cannot be assumed to give full voluntary consent to procedures which are insufficiently explained in an official capacity and with no evaluation of the potential differences in between clinics in terms of the extent to which donors are informed of the procedures. A possible way of providing accessible and comprehensive information about the procedures as well as clinic-specific information would be a government-endorsed web page that details the procedure, potential risks and donor rights and routes to help. Individual clinics might be obligated to ensure that this website address to appear on their clinic websites and donor advertisements in order to ensure that the information filters through to each individual donor, regardless of whether they are migrants into Cyprus or not. Accessible information for donors and recipients and a transparency into procedures in individual clinics should be prioritised at a legal and regulatory level and at the EU level in order to harmonise the interpretation of the current law by member states. An EU-wide law, or other binding regulation, which makes it compulsory for all donors to be told the full effects of egg donation before donating is essential to ensure implementation at individual clinic level. There is also a clear need for more thorough followup on the implementation of EU and national level regulations in Cyprus in terms of the day to day operations of infertility clinics.
  • 14. Polygeia Sexual and Reproductive Health 2014 14 In order to improve the reporting of donor and procedure statistics, a local governing body might be beneficial, with which individual clinics would cooperate with and be accountable to. This report has given a brief overview of the debate on the conflict between defining the compensation donors receive for their donations. With arguments that the current ’compensation’ system is functionally the same as pay, acknowledging this as such would at least allow a minimum price to be set. There is a fundamental question about whether an open “market” with pay and heavy regulation, which would arguably encourage more donation, would be best, or whether banning anything other than very tokenistic compensation in the hopes of making egg donation purely altruistic would be better, even if it limited the number of eggs donated. The EU might consider implementing a fixed fee of compensation, as is the case in the USA, or follow the ASRM suggested guidelines of no more than $10,000, and reimbursement of any expenses for the donor in order to harmonise the interpretation of the current EU regulation on ’compensation’ for donors between member states and provide equal and fair compensation for all donors, regardless of country of origin or country where donation occurs. Care for donors and recipients in Cyprus It is imperative that both donors and recipients in infertility clinics are not only comprehensively informed of the procedures and risks before attending the clinic, but that their health and wellbeing is prioritised during and after the procedures they undergo as well, with full commitment from each individual clinic to provide followup care to their patients, regardless of immigration status. This is particularly relevant in the current context of increasing fertility tourism and the migrant profiles of donors in Cyprus specifically. The standard and continuity of care for each donor and recipient can be ensured through a process of having a named accountable doctor in the clinic who is obligated to provide followup care at regulated time points with a requirement to provide evidence of the completion of these followups. For migrant donors, whose access to healthcare in their home
  • 15. Polygeia Sexual and Reproductive Health 2014 15 countries might not be available, this is essential as is a guarantee of the clinic where they donated covering the cost of any complications should they arise. Given the evidence on the irregularity between clinics in terms of the number of donations per donor, and therefore the lack of regulation on the prevention of the negative health effects of multiple donations, better recordkeeping and reporting of individuals donors’ health and the number of donations they have made is needed. Whilst it is important to not lose sight of the significance of maintaining donor anonymity, clear protocols on the number of eggs to be retrieved (hormone stimulation), number of times a donor can donate, and number of eggs to be implanted in recipient couples) must be implemented and evaluated. This process might be aided by a national health registry for donors, which would allow the record keeping of donor health, the number of times they donate as well as evidence of followup care from their assigned doctor. In order to reinforce this system, a process of fines or withdrawing the approval to provide treatment from the clinics who fail to update their records of donors or provide sufficient followup care might be considered. Being sensitive to the possible power dynamic between the donor and the clinic, an anonymous whistleblowing system could be beneficial to aid the reporting of inconsistencies in clinic reporting or care provided compared to implemented protocols. Comprehensive care for donors and recipients seems to also lack the provision of counselling services, which is essential for not only ensuring fully informed consent to any procedures undertaken but also for the management of any complications or psychological distress after post-procedure. National as well as EU protocols requiring mandatory counselling services, training and clear guidelines for counselors should be implemented. Harmonise legal standpoints on reproductive tourism European Union regulation of egg donation is outlined in Article 12 of the Directive 2004/23/EC of the European Parliament and of the Council of 31 March 2004. This sets some guidance on the voluntary and unpaid nature of egg donation, but allows member states to individually decide how the guidance should be followed or applied locally. Whilst limiting pluralism in society is not desired, a common approach and clear implementation of this
  • 16. Polygeia Sexual and Reproductive Health 2014 16 approach to reproductive tourism would benefit the donors and recipients in all EU member states. Minimize need for egg donation The last area of recommendation in egg donation this report would like to propose is that of minimising the need to egg donation through ongoing commitment worldwide to bettering working conditions and gender equality in the home as well as through avoiding preventable causes of infertility, informing couples of the risks of leaving starting a family until too late, and popularising alternatives to egg donation such as fostering and adoption. This would require efforts in the wider social context of the role of infertility in gender equality through education and awareness raising programmes.
  • 17. Polygeia Sexual and Reproductive Health 2014 17 Conclusion A significant number of people currently travel abroad to receive fertility treatment due to legal constraints and the cost of treatment in their own country. The demand for human eggs and the fertility treatments that implant them has seen an industry grow around donating and receiving human eggs. Cyprus is one of the countries at the heart of this development in Europe. Official statistics on the nature of the industry are hard to come by. Information on who is donating and the donating practices they partake in are limited, reflecting a poorly regulated system that may be exposing those participating in it to unnecessary and uncalculated risk. Ovarian Hyperstimulation Syndrome is but one cause of concern, as is the health of travelling donors on return to their home countries. The standards that members of the industry profess to maintain are often found to not be met. There are many troubling accounts of donors being subjected to coercive practices forcing them to take hormones and then being left without counselling or support after they have donated their eggs. Practice in Cyprus is a particular cause for concern. Reimbursement for egg donation in the European Union is currently covered under Article 12 of the Directive 2004/23/EC of the European Parliament and of the Council of 31 March 2004. This states that donations must be voluntary and unpaid, but donors can receive compensation for expenses and inconvenience. Countries can decide how this policy is applied, and it creates an incentive to source eggs from outside Europe. It is proposed that to address the ambiguity of the current industry and to protect those that participate in it, particularly those of a lower socioeconomic background who are incentivised to donate eggs for financial reimbursement but are offered little medical protection, the industry must be better regulated and more information recorded on the medical practice that occurs within it. Clinics that participate in reproductive and fertility treatments should keep better records of the activity occurring in their practices, including how many treatments are being performed, the number of eggs being collected from donors and the number then being implanted into other women. This information should be reviewed as part of an inspection process carried out by a regulatory body to ensure good medical practice. It is suggested that care for donors and recipients of eggs needs to be improved, including all participants having
  • 18. Polygeia Sexual and Reproductive Health 2014 18 a named accountable doctor, creating a national health registry for donors, providing mandatory pre and post treatment information along with counselling services, and clearer protocols on hormone stimulation, egg collection and egg implantation. There should be clearer standards of reimbursement than those currently laid out in Article 12. Instead of the current ambiguous qualitative statement, this could take the form of a fixed fee of compensation. ‘Fertility tourism’ is an industry that has grown with rapidity and at a faster pace than the regulation that controls it. This should not be accepted an excuse for the present state of the industry, which does not protect the safety and wellbeing of those that participate in it. Action should be taken to better understand the industry, and this information should empower the creation of legislation and protocol to ensure the rights and health of the large numbers of people now involved in the business of donating and receiving human eggs.
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