Fertility Europe
Equality of Access to Medically Assisted Reproduction across Europe
Keywords: Investigations Treatments EqualAccess Ethical considerations
Reimbursement scheme Eligibility criteria Safety Quality
Fertility Europe’s position onEquality of Access to Medically Assisted Reproduction across Europe
May 2012
Correspondence address: Page 1
Introduction
[i]The first successful birth of a "test tube baby", Louise Brown, occurred in 1978.Approximately four million individuals have so far been born worldwide following in vitro fertilisation. Robert G. Edwards, the physiologist who developed the treatment, was awarded the Nobel Prize in Physiology or Medicine in 2010.
[ii]One in six people worldwide experience some form of fertility problem at least once during their reproductive lifespan. [iii]Europe leads the world in the number of cycles taking place, initiating approximately 54% of all reported MAR treatment cycles. In 2006 the number of MAR treatment cycles in the EU approached 0.5 Million compared to approximately 200,000 cycles ten years earlier. The largest number of treatments is undergone by women aged between the ages of 30 and 39.
Medically Assisted Reproduction treatment (MAR)*
MedicallyAssisted Reproduction treatments includefertilisation in vivo such as simple hormonal treatments andinsemination (IUI), as well as in vitro fertilisation(IVF) andintracytoplasmic sperm injection(ICSI).
[iv]IVF is a process by which an egg is fertilised by sperm outside the body: in vitro. IVF is a treatment for infertility when other methods of assisted reproductive technology have failed. IVF could be performed by collecting the contents from a woman's fallopian tubes or uterus after natural ovulation, mixing it with semen, and reinserting into the uterus. The process involves monitoring a woman's ovulatory process, removing egg or eggs from the woman's ovaries and letting sperm fertilise them in a fluid medium in a laboratory.
Additional techniques that are routinely used in IVF include ovarian hyperstimulation to retrieve multiple eggs, ultrasound-guided transvaginal oocyte retrieval directly from the ovaries, egg and sperm preparation, as well as culture and selection of resultant embryos before embryo transfer back into the uterus.
IVF may also assist in male infertility, where there is defect sperm quality, and in such cases intracytoplasmic sperm injection (ICSI) may be used, where a sperm cell is injected directly into the egg cell. This is used when sperm have difficulty penetrating the egg. ICSI is also used when sperm numbers are very low.
MAR may also be used with egg and sperm donation. This means that MAR can be used for women and men past the natural age of conceiving to become parents.
MAR across Europe
Addressing reproductive care is a challenge that European governments are tackling whilst addressing the maintenance of balanced populations with sustainable population growth rates. However, infertility may be erroneously side lined and is considered to be a low priority on the public health care stage in many European countries.
[v]The European Parliament notes that infertility is a medical condition which can cause severe side effects such as depression and is recognized by the World Health Organization as a disease. It points out that infertility is on the increase occurring in approximately 15 % of people, and therefore calls on the Member States to ensure the rights of those affected to universal access to infertility treatment.
[vi]A recent jurisprudence from the European Court of Justice has stated that Article 8 of the European Convention on Human Rights provides a right to respect for one’s “private and family life, home and his correspondence” and applied in case of MAR because of the special importance of the right to found a family and to procreation.
Conclusion
Fertility Europe is the umbrella organization of 22 patient associations and interest groups in 21 European countries and with a potential of 70 million people who have difficulties in conceiving across the European Union.
We produced recommendations to make Europe a better place to live for people with fertility problems. Our aim is to achieve equality of access to investigations and treatments across the EU by raising the issue towards the European Parliament, the Commission and the Members States.
Through campaigns, we will be keeping the issue on the policy agenda with the support of other associations concerned with reproductive health issues including health professionals.
Fertility Europe: Equality of Access to Medically Assisted Reproduction across Europe - May 2012 Page 1
Towards a European Pact to address Reproductive Health:
RECOMMENDATIONS BY FERTILITY EUROPE
ETHICAL CONSIDERATIONS
It is vital that ethical issues are considered before possibilities of technological progress.
People have the basic right to decide on the number of children they have, and when they have them. The responsibility of couples and individuals in the exercise of this right should take into account the needs of their living and future children, as well as their responsibilities towards the community.
There are different ways of resolving involuntary childlessness, a full range ofMAR treatments*, as well as adoption. Those affected should also have the option of deciding against these treatments and alternatives and decide to live a life without children. Both options can bring a happy and fulfilled life.
There are known risks in pregnancy in relation to age and therefore more information andnational community debate is required before decisions about assisting not only older women but also older men i.e. women and men past the natural age of conceiving to become parents.
In relation to welfare of the child, both society and the medical profession should take into account not only the life expectancy and current state of health of the person, but also their expected future state of health and the known physical and psychological demands of being a parent.
Donation of gametes on commercial basis is ethically inacceptable.
ELIGIBILITY CRITERIA AND REIMBURSEMENT SCHEME
Infertility is a medical condition and a health need andshould be covered as such by national social insurance systems.
The inclusion of a full range of MAR treatments* in the provision of basic health care at least partially depends on the general level of welfare in society.
Fertility investigations and treatment should be reimbursedacross Europe, and treatments of proven benefit to patientsshould be made available, irrespective of the patient's income and place of residence.
To avoid unjustified discrimination the principles of needs assessment, cost effectiveness and clinical effectiveness should be used to determine the level of reimbursement for all assisted reproduction possibilities *.
SAFE AND QUALITY TREATMENTS
People with difficulties in conceiving should be given accurate information in a range of formats and languages on all assisted reproduction possibilities*,as well as adoption anda life without child, as well as being allowed to accept or to reject the diagnosis or treatment without discrimination.
Those undergoing MAR as well as those donating gametesshould sign an informed consent document ensuring that the risks and benefits of treatment are described in a balanced, evidence-based framework, and that appropriate warnings are given when evidence is inadequate to assess the efficacy or safety of specific drugs, devices or procedures.
Access to psychological counselling should be offered in the framework of fertility investigations and treatments. People should be offered implications counseling, particularly if their treatment includes the use of donated gametes and embryos. They should be informed about any potential long term risks and psychological, social and medical ramifications.
Background Information
Definition of infertility
Infertility is a medical condition that prevents people in the reproductive age from realizing the life goal of becoming a parent after 6 months up to 2 years of trying with regular intercourse. However if there is something in their medical history which indicates a fertility problem e.g. amenorrhoea, or where the female is aged 36 or over (given the impact of the age of the female on the success of treatment), investigations and possible treatment should be considered.
This includes those diagnosed with secondary infertility which is defined as infertility in a couple who have already had at least one pregnancy between them, whether that be a pregnancy resulting in the birth of a baby or a pregnancy that has miscarried, resulted in an ectopic pregnancy or led to a decision to terminate the pregnancy for medical reasons.
[vii]20-30% of infertility cases are linked to physiological causes in men, 20-35% to physiological causes in women, and 25-40% of cases are due to a joint problem. In 10-20% no cause is found.
[viii]Relative frequency of the different causes of infertility
The total is greater than 100% because some couples have more than one cause.
Causes % Couples
Ovulatory failure21%
Tubal damage14%
Endometriosis6%
Mucus defect/dysfunction3%
Sperm defects/dysfunction24%
Other male infertility2%
Coital failure 6%
Unexplained28%
Others11%
Some psycho-social consequences of infertility
Most people affected by difficulties in conceiving find it difficult to deal with, both physically and emotionally. There is a widespread mistaken belief that life continues as before. The childlessness, the prolonged uncertainty, and the monthly attempts to become pregnant, sometimes over several years, can affect every aspect of a person’s life, as well as impacting
relationships with family members and friends. Most people experience emotional distress such as frustration, shame, stigma, vulnerability, fear and grief.
As the years go by, this is a burden for many people to bear. People experience an impaired ability to function normally in society for long periods of time. For some, events such as the announcement of pregnancies within close circles, children's birthdays, and religiouscelebrations related to nativity, Mothers Day and other similar occasions are extremely distressing, difficult to deal with and are a painful reminder of their fertility problems.
Medical treatments*have been developed that can help to resolve this problem significantly. However infertility canstill be a misunderstood and social taboo subject. People often have to face stereotypes, prejudices, misunderstandings and guilty feelings. Thus some people do not dare to address this issue with friends and family. Little by little they become socially isolated, even more so if children are present in their network and neighbourhood.
The impact of fertility problems on men and women may also impact on their professional life. They need to take time out from their career, for investigations and treatment.
Criteria to ensure equality of access to MAR
Access to MAR treatments* should be governed by the same principles as other health services, namely needs assessment, clinical effectiveness and cost effectiveness.
-Health needsassessment is a systematic and equal method for reviewing the health issues facing a population, leading to agreed priorities and resource allocation that will improve health and reduce inequalities.
-Clinical effectiveness is the ability of a procedure or treatment to achieve the desired result. Specifically, how well a particular test or treatment works when used in the 'real world', rather than in carefully controlled clinical trials. Clinical effectiveness is not the same as efficacy.
-Cost effectiveness is a type of economic evaluation used to determine the best use of money available for medical care. Value for money. A test or treatment is said to be 'cost-effective' if it leads to better health than would otherwise be achieved by using the resources in other ways.
A patchwork of legislation and reimbursement across Europe
[ix]19 Member States of the European Union have specific legislations in place for MAR. In the remaining 8 countries, MAR is covered by the general health legislation. Israel, Switzerland, Croatia and Norway have different legislation in place.
The Fertility Europe tables in Annex to this paper show that there is inequality of access to fertility treatment right across Europe. Some countries provide well – some do not. Inequalities consist of both, the treatments which are permitted in some countries (eligibility criteria) and not in others, plus some countries provide more reimbursement for treatment than others.
In general, the main eligibility criterion for access to MAR treatment is the age of the female, the couples’ marital status (married or legally living together), and the existence of previous children from the current or a previous relationship.
Fertility treatment is fully reimbursed in some countries but the number of cycles being funded varies. In others, it is only partially reimbursed and only treatments up to, but not including, MAR such as IVF, is reimbursed forcing those whose only chance of conceiving with such treatment into the private sector or abroad.
In some countries, the right of access to fertility treatment does not necessarily mean that there is also a right to public funding of that treatment.
Fertility Europe is the umbrella organization of 22 patient associationsandinterest groupsin 21 European countries and with a potential of70 million people who have difficulties in conceiving across the European Union.
The purpose of the organization is:
-to improve the rights of those affected by difficulties in conceiving;
-to promote societal changes regarding the perception of infertility;
-to promote ethical practices andregulatory changes in the field of access to safe and qualitytreatments, as well as education in the field of protection of reproductive health and proactive approach to family planning;
-to build a strong cross border network amongst European patients and professionals in order to achieve the sharing of best practise.
Fertility Europe: Equality of Access to Medically Assisted Reproduction across Europe – May 2012 Page 1
Fertility Europe Membership
De Verdwaalde Ooievaar Netwerk Fertiliteit - BELGIUM
The Lost Stork - Fertility Network
Iskambebe - BULGARIA
I want a baby foundation
Sdruzhenie Zachatie - BULGARIA
Association Conception
ADAM - CZECH REPUBLIC
Landsforeningen for ufrivilligt barnlose – DENMARK
Lapsettomien yhdistys Simpukka ry - FINLAND
Infertility Association Simpukka
Maia - FRANCE
Kiveli - GREECE
Országos Lombikbébi Támogató Alapitvány - HUNGARY
Tilvera – ICELAND
CHEN - Patient Fertility Association - ISRAEL
Amica Cicogna - ITALY
Freya - Vereniging voor vruchtbaarheidsproblemen - THE NETHERLANDS
Fertility problems association
ØNSKEBARN - NORWAY
WishChild
Nasz Bocian - POLAND
Our Stork
Associação Portuguesa de (in) Fertilidade - PORTUGAL
A.P.F
SOS Infertilitatea - ROMANIA
SOS Infertility
Občianske združenie BOCIAN - SLOVAK REPUBLIC
Civil Association Stork
Barnlängtan - SWEDEN
Child longing
Verein Kinderwunsch - SWITZERLAND
Association Childwish
Infertility Network UK - UNITED KINGDOM
Associate members
Association RODA (STORK) - CROATIA
Fertility Europe: Equality of Access to Medically Assisted Reproduction across Europe – May 2012 Page 1
Fertility Europe: Equality of Access to Medically Assisted Reproduction across Europe – May 2012 Page 1
[i]Press Release on the Official site of the Nobel Prize (2010)
[ii]ART fact sheetJune 2010 from the European Society for Human Reproduction and Embryology (ESHRE).
[iii]Comparative Analysis of Medically Assisted Reproduction in the EU: Regulation and TechnologiesEuropean Society for Human Reproduction and Embryology (ESHRE).
[iv]Wikipedia
[v]Resolution on the demographic future of Europe from the European Parliament (2008).
[vi]European Court of Justice: Case of S.H. and others v. Austria judgment 1 April 2010.
[vii]ART fact sheetJune 2010 from the European Society for Human Reproduction and Embryology (ESHRE).
[viii]Report from the University of Bristol, Department of Obstetrics & Gynaecology by Professor Michael Hull: brief summary taken from an extensive reviewpublished in Human Reproduction in 1992.
[ix]Comparative Analysis of Medically Assisted Reproduction in the EU: Regulation and Technologies European Society for Human Reproduction and Embryology (ESHRE).
ANNEXE 1: Number of cycles reimbursed across Europe
Data provided from the FE members associations date: April 2012
Countries / Number of cycles IUI / Number of cycles IVF/ICSI / Pro life time / Pro baby / Single Embryo Transfer / Decision makers to allow reimbursementBelgium / 6 / yes / no / yes / Automatic
by social insurance
Bulgaria / 0 / 3
2 first one are not reimbursed / yes / no / no / Public Council of State Fund
Croatia / no limitation / 6 / no / yes / no / Automatic
by social insurance
Czech Rep. / 6 / 4 if the first 2 with SET
or 3 without SET / yes / no / yes / Automatic
by social insurance
Denmark
Finland / no limitation / 3 / yes / no / yes
depend on physicians decisions / Automatic
by social insurance
France / 6 / 4 to 5 / no / yes / no / Automatic
by social insurance
Iceland
only one private clinic / 0 / 3
first one is not reimbursed / yes
for only 1 baby with the same partner / no / yes / Automatic
by social insurance
Israël / no limitation
until 2 babies are born / no limitation
until 2 babies are born / no / no / no / Automatic
by social insurance
Netherland / no limitation / 3 / no / yes / no / Automatic
by social insurance
Norway / no limitation / 3 / no / yes / yes / Automatic
by social insurance
Poland
Portugal / 3 / 3 / yes / no / yes
depend on physicians decisions / Automatic
by social insurance
Romania *
Slovakia / 0 / 0 to 2-3 / yes / no / no / According to decision of health insurance company
Sweden / 6 / 0 to 3
1-3 pc freeze transfer / yes / no / yes
depend on women age, number of previous failed cycles and embryos quality / Policymakers in each county
should be based on medical facts but is also limited financially
Switzerland / 3 / 0 / yes / no / no
United Kingdom / 0 to 6 / 0 to 3 / yes / no / yes
depend on women age, number of previous failed cycles and embryos quality / Treatment by postcode
* Romania: Since 2011 partially reimbursed for one IVF cycle for a limited number of couples.
Reimbursement of In Vitro Fertilisation / ICSI across Europe in PublicCenters Data provided from the FE members associations date: April 2012
Countries / Laboratory / Drugs / Consulta-tions / Blood / Ultra Sounds / Private CentersBelgium / 100 % / 95 % / 95 % / 95 % / 95 % / same reimbursement
Bulgaria
only private clinics / 100 % / 100 % / 100 % / 100 % / 100 % / _
Croatia
good public system / 100 % / 100 % / 100 % / 100 % / 100 % / basically no reimbursement except 2 clinics which are offering each 100 cycles / a year
Czech Rep.
ICSI is not reimb. / 100 % / 100 %
only basic medication (urinary, recombinant is additional free) / 100 % / 100 % / 100 % / same reimbursement
Denmark / 100 % / 100 % / 100 % / 100 % / 100 % / no reimbursement
Finland / 100 % / 100 %
franchise of 600 Euros yearly for any drugs including fertility treatments / 100 % / 100 % / 100 % / only 40 % of the total expenses are reimbursed
France / 100 % / 100 % / 100 % / 100 % / 100 % / reimbursement depends on tariffs applied by private centers and the quality of the complementary private insurance
Hungary / 100 % / 70 % / 100 % / 100 % / 100 % / ?
Iceland
only one private clinic / 60 % / 60 % / 60 % / _
Israël / 100 % / 100 % / 100 % / 100 % / 100 % / same reimbursement
Italy / 100 % / 100 % / 100 % / 100 % / 100 % / no reimbursement
Netherland / 100 % / 100 % / 100 % / 100 % / 100 % / same reimbursement
Norway / 100 % / Drug expenses exceeding 2000 Euros reimbursed / Deductible 400 Euros / 100 % / 100 % / Same reimbursement
Poland
Portugal / 100 % / 69 % / 100 % / 100 % / 100 % / partial reimbursement for drugs. 0 % for the rest of the treatment. Some private insurance may cover consultations.
Romania *
Slovakia / 75 % / 75 % / 100 % / 100 % / 100 % / ?
Sweden
when the county
funded health care is over, infertile people have to pay / 100 % / 100 % / 100 %
except 30 Euros/doctor’s visit. / 100 % / 100 % / same reimbursem. if county agrees on reimburs.If the county does not have a public clinic, people will be sent to the nearest clinic, private, or to the clinic with whom the county council has made a financial contract.
Switzerland
United Kingdom / 0 or 100 %
depend on postcode / 0 or 100 %
depend on postcode / 0 or 100 %
depend on postcode / 0 or 100 %
depend on postcode / 0 or 100
depend postcode / no reimbursem.
* Romania: Since 2011 a pilot fund from the Health Ministry funded partially for 800 couples the consultations and IVF procedures (no laboratory, no drugs, no blood reimbursed)