FERTILITY A POLICY AUDIT ON - Analysis of 9 EU Countries - eshre

 
FERTILITY A POLICY AUDIT ON - Analysis of 9 EU Countries - eshre
A POLICY AUDIT ON
FERTILITY
Analysis of 9 EU Countries
March 2017

                             Supported by:
FERTILITY A POLICY AUDIT ON - Analysis of 9 EU Countries - eshre
Although the greatest care has been taken in the preparation and compilation of the Policy Audit on Fertility, no liability or responsibility of any kind
(to the extent permitted by law), including responsibility for negligence is accepted by partners namely, the European Society for Human Reproduction
and Embryology, Fertility Europe, Merck KGaA, Darmstadt, Germany, their servants or agents.

                                                Sponsored by Merck KGaA,
                                                   Darmstadt, Germany,
                                          as contribution to public policy debate.
FERTILITY A POLICY AUDIT ON - Analysis of 9 EU Countries - eshre
A POLICY AUDIT ON FERTILITY
                                                                                                                                                                                                                                           ANALYSIS OF 9 EU COUNTRIES

TABLE OF CONTENTS
FOREWORD...................................... . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
INTRODUCTION........................... . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
KEY FINDINGS OF THE REPORT.. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
ABOUT THE PARTNERS ......... . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
METHODOLOGY........................... . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
COUNTRY CHAPTERS............... . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15
The Czech Republic.. .................. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16
France.. ................................................... . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20
Germany............................................. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24
Italy........................................................... . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 28
Poland.................................................... . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 32
Romania.. .............................................. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 36
Spain. . ...................................................... . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 40
Sweden.................................................. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 44
United Kingdom............................. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 48
ANNEXES............................................ . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 53
Annex I: Organisations and respective experts consulted.. . . . . . . . . . 54
Annex II: Glossary........................ . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 55
Annex III: Fertility Europe's Positions on Ethics,
Access to Treatment and Fertility Protection. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 56
Annex IV: References................ . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 59

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FERTILITY A POLICY AUDIT ON - Analysis of 9 EU Countries - eshre
A POLICY AUDIT ON FERTILITY
ANALYSIS OF 9 EU COUNTRIES
FERTILITY A POLICY AUDIT ON - Analysis of 9 EU Countries - eshre
A POLICY AUDIT ON FERTILITY
                                                                            ANALYSIS OF 9 EU COUNTRIES

FOREWORD

                           It was without a moment’s hesitation that I made the decision to
                           support the Policy Audit on Fertility. I urge my fellow members of
                           the European Parliament to join me in advocating for the freedom
                           of citizens; freedom that cannot exist when education and access
                           to treatment remain unequitable. The right to family is protected
                           under Article 12 of the European Convention on Human Rights1. It is
                           our duty to evolve our understanding of this right in light of today’s
                           realities. I invite you to read the main findings of this policy audit
                           so as to better understand infertility in the 21st century, recognising
                           that infertility, while more prevalent, comes with solutions.

                           More than 25 million EU citizens are affected by infertility. One in
six couples worldwide experience some form of infertility. A full range of Medically Assisted
Reproduction (MAR) techniques have been developed to help infertile couples. However, due
to combining factors, including a lack of awareness, access and availability of treatments and
social stigma, many Europeans continue to face insurmountable barriers.

The consequences of not addressing the problem today are not only of a personal nature
(potential depressions, emotional and societal effects) but also impact society as a whole
by contributing to demographic decline in the EU. It is time to spread information and
raise awareness about fertility preservation and protection and that infertility is a medical
condition, not a choice. The public has the right to be educated on infertility and its treatment
options, in addition to being supported and empowered on their journey to have a child. The
time has come for us to recognise the right to have a child as part of an individual’s universal
human rights. To this end, adequate policy responses to infertility are part of a larger and
much needed solution to address the ageing population and demographic decline.

We cannot remain silent in the face of problems when we are privileged to have solutions.
In the spirit of the foundations that we find ourselves here, participating in progressive
collaboration, we have an obligation to ensure equity in access to infertility services across
member states. While many actions will need to be taken in respective countries, much can
be done at EU level, including data collection, awareness raising, exchange of best practices
and formalised, constructive debates on this topic.

                                                       Norica Nicolai
                                                       ALDE, Romania
                                                       Member of the European Parliament

                                                                                                         5
FERTILITY A POLICY AUDIT ON - Analysis of 9 EU Countries - eshre
A POLICY AUDIT ON FERTILITY
ANALYSIS OF 9 EU COUNTRIES

      Sponsored by Merck KGaA,
      Darmstadt, Germany, as
      contribution to public policy
      debate and conducted on behalf
      of Fertility Europe (FE) and the
      European Society of Human
      Reproduction and Embryology
      (ESHRE) between March 2016
      and January 2017. The findings
      of the audit are the result of
      targeted desk research, one-
      to-one interviews, written
      questionnaire responses and
      written input from ESHRE and FE
      national member associations
      and respective experts.

      Apart from local experts who
      provided country-specific
      information and perspectives
      (see Annex I), special
      acknowledgments go to Monika
      Bulmańska-Wingett, Isabelle
      Chandler, Elín Einarsdóttir and
      Satu Rautakallio-Hokkanen from
      Fertility Europe as well as Dr Roy
      Farquharson, Helen Kendrew,
      Dr Tatjana Motrenko and Bruno
      Van den Eede from ESHRE, who
      provided extensive review and
      coordination to this project.
FERTILITY A POLICY AUDIT ON - Analysis of 9 EU Countries - eshre
A POLICY AUDIT ON FERTILITY
                                                                                           ANALYSIS OF 9 EU COUNTRIES

INTRODUCTION
    This report provides an overview of the situation and policies in place to
    tackle infertility across a sample of nine EU member states, namely: the
    Czech Republic, France, Germany, Italy, Poland, Romania, Spain, Sweden
    and the United Kingdom.

I
   nfertility is defined and recognised     country chapter to support the reader’s
   by the World Health Organisation as      understanding. The TFR of the nine EU
   a medical condition characterised        member states included in this report
by the failure to achieve pregnancy         score between 1.32 (Spain and Poland)
after 12 months2 and without                and 2.01 (France) TFR, as compared to
investigations or treatment, it prevents    the EU average of 1.58.
people from becoming parents3. It is
estimated that one out of six people        It is through this lens that the audit
worldwide experience some form of           brings together key facts about
infertility during their reproductive       important public health issues ranging
lifespan. In the EU alone, infertility      from: infertility policies, screening and
affects approximately 25 million            diagnosis, treatment availability and
citizens4. While Medically Assisted         awareness raising activities specific to
Reproduction (MAR) offers a full range      each country examined. Accordingly,
of techniques to assist infertile couples   each country chapters includes a brief
or individuals, vast differences in         overview of the situation followed
accessibility exist between the nine        by detailed examination in six areas
countries examined in the report.           of interest: 1) Key Facts and Figures;
Treatments range in complexity from:        2) Infertility Policies; 3) Screening
Intrauterine Insemination (IUI) and In      and Diagnosis; 4) Treatment and
Vitro Fertilisation to Preimplantation      Reimbursement / State Funding; 5)
Genetics Diagnosis and Screening,           Awareness Raising Activities and 6)
to gamete and embryo donation and           Future Outlook.
surrogacy.
                                            The report is intended to contribute to
From a demographic perspective,             a constructive discussion and support
the EU as a whole is in a phase             a much needed exchange between
of population decline, further              stakeholders and policy makers
underscoring the need for supporting        with the aim to facilitate meaningful
policies that address growth and            progress for EU citizens.
support families. To this aim, figures
on the Total Fertility Rate (TFR)5 have
been provided throughout Table 1.
EU9 Overview on Fertility, Age, Access,
Treatments and Funding, Table 2. EU28
Key Facts and Figures and in each

                                                                                                                        7
FERTILITY A POLICY AUDIT ON - Analysis of 9 EU Countries - eshre
A POLICY AUDIT ON FERTILITY
ANALYSIS OF 9 EU COUNTRIES

                                                               KEY FINDINGS OF
                                                               THE REPORT

                                                               HIGH PREVALENCE OF
                                                               INFERTILITY
                                                                           25                             1 in 6
                                                                           million                        couples
                                                                                     EU citizens          worldwide

                                                               HIGH REGULATORY VARIATION
                                                               WITH RESPECT TO TREATMENT
                                                               AVAILABILITY

INFERTILITY                                                    HEALTH LITERACY,
BY THE NUMBERS                                                 STIGMA AND TABOOS
„„One in six couples worldwide experience some form of         „„Limited information and education on infertility
  infertility. Estimates suggest, more than 25 million EU        are common to all countries examined in this
  citizens are affected by infertility6.                         study. Infertility and fertility protection remain
                                                                 underestimated and misunderstood. Awareness raising
„„There is a lack of updated comparative data on infertility     campaigns are mainly driven by patient groups and
  rates in the EU 28 and/or examined nine EU countries.          healthcare professional organisations, with some
  The calculation of data identified and reflected upon          government involvement, as seen in Germany, France,
  in specific country chapters is based on different             Italy and Sweden.
  methodologies and therefore does not allow for
  proper comparison.                                           „„Infertility stigma and taboos remains a considerable
                                                                 issue to be addressed. Many experience difficulty
„„Fertility rates differ significantly across the nine EU        discussing infertility with their partner and/or
  countries examined, from Spain and Poland with a               healthcare provider for cultural reasons or due to
  rate of 1.32 to the UK (1.81), Sweden (1.88) and France        prevailing perceptions that it is a social, rather than
  (2.01). Across the nine EU countries, the highest              medical, condition. Male infertility stigma was identified
  fertility rate remains below the stabilising rate (2.1         in a recent Swedish report8 and a focal point in
  live births per woman) necessary for maintaining               awareness campaigns in the Czech Republic, Poland,
  population size, according to Eurostat7. Please see            Spain and the UK.
  Table 2. EU28 Key Facts and Figures for an overview of
  all EU member states.
FERTILITY A POLICY AUDIT ON - Analysis of 9 EU Countries - eshre
A POLICY AUDIT ON FERTILITY
                                                                                                        ANALYSIS OF 9 EU COUNTRIES

INFERTILITY                                                      REIMBURSEMENT /
LEGISLATION                                                      STATE FUNDING
„„All nine EU countries examined have legislation                „„A variety of biological factors determine an individual’s
  governing Medically Assisted Reproduction (MAR),                 eligibility for treatment reimbursement / state funding,
  whether independently or part of broader legislative             with age as a common criterion across all countries
  frameworks. Amendments and revisions over the                    surveyed. With the exception of Poland ceasing its state
  past 30 years have sometimes been surrounded by                  funding for infertility treatment in June 2016, women
  dividing debates (as with Italy in 2004 or Poland in             up to age 40 in most other countries, 43 in France, are
  2016). Nearly all the countries examined supplement              eligible for treatment reimbursement / state funding.
  legislation with professional guidelines.                        In Italy and Spain, it is necessary to obtain a medical
                                                                   certificate confirming an infertility diagnosis in order to
„„Treatment eligibility criteria (e.g. sexual orientation,         qualify for state funded IUI and IVF treatment.
  marital status, age etc.), as outlined by country specific
  laws, also differ significantly across all nine EU countries   „„IVF remains the first line of treatment for providers,
  surveyed. Access to MAR by single women and same                 however reimbursed at various levels and under
  sex couples is currently available in the Czech Republic,        differing criteria by each country. Surrogacy,
  Germany, Spain, Sweden, UK (see Table 1. EU9 Overview            gamete and embryo donation, remain embroiled
  on Fertility, Age, Access, Treatments and Funding).              by public debate.

„„Regulatory variation can be seen with respect to               „„Significant intra-regional variation in state funded
  treatment availability, most notably in: embryo selection        MAR can be seen in the UK, Italy, Spain and to some
  via Preimplantation Genetic Diagnosis (PGD) and                  extent, Germany. In Sweden and the UK, intra-regional
  Preimplantation Genetic Screening (PGS), anonymity of            variation was observed most significantly in wait times
  donors (e.g. gametes and embryos) and surrogacy. While           and availability of psychological counselling.
  the UK is the only country where surrogacy is legalised,
  legal vacuums in the Czech Republic and Romania allow          „„Political priorities and public attitudes also determine
  for its practice (see Table 1. EU9 Overview on Fertility,        the scope and availability of publically funded
  Age, Access, Treatments and Funding).                            treatments in the countries surveyed. Reimbursement
                                                                   / State funding levels and the criteria for inclusion in
„„Due to flexible legal frameworks and the safe, clinically        reimbursement schemes (e.g. marital status or sexual
  efficient, patient focused and evidence-based medicine           orientation) also vary significantly among the nine
  care offered, the Czech Republic and Spain rank 		               EU countries examined.
  among the highest in Europe for infertility treatment
  to non-nationals.

TREATMENT:
ACCESS AND REIMBURSEMENT/
FUNDING
„„Available treatments options vary across the nine EU
  countries. The Czech Republic and the UK have the                       CONSIDERABLE
  largest number of options available, followed by Spain                  STIGMA AND TABOOS
  where, with the exception of surrogacy, all treatment
  options are possible. It is important to note that while                „„Perception that it is a social rather
  treatments are available, there are rules, conditions and                 than a medical condition
  structures in place that may make treatment availability
                                                                          „„Difficulty discussing with the
  more restrictive (e.g. embryo freezing in Germany).
                                                                            partner and healthcare provider
„„In all nine EU countries, psychological counselling is
                                                                          „„Limited information and education
  recommended. However, patient groups identify a
  common need for psychological counselling not only                      „„Infertility and fertility protection
  before treatment but also during and after treatment.                     underestimated and misunderstood

                                                                                                                                     9
FERTILITY A POLICY AUDIT ON - Analysis of 9 EU Countries - eshre
Table 1. EU9 Overview on Fertility, Age, Access, Treatments and Funding

 Country   Total Fertility     Mean Age of          Legal right to MAR    Treatment Options Available:                                                                                                                                 Reimbursement/
           Rate                Women at             for:                                                                                                                                                                               State funding
           (2014, Eurostat)9   Childbirth                                 less                                                         complexity                                                               more
                               (2014, Eurostat)10
                                                                                                                                                m                    n                   tic                   tic
                                                                                                                                            er                   ze )
                                                                                                                                                             Fro FET                e ne                  e ne
                                                                                                        I),                 ),           Sp                                                                                  n
                                                                                                                                                                                                                                                        ANALYSIS OF 9 EU COUNTRIES

                                                                                                                         F            ic                                          G ),                  G ),
                                                                                                   (IU                                                     g, er (              n                     n                   io
                                                                                         e       n                   (IV           s m SI),
                                                                                                                                                      e zin nsf             t io GD               t io PGS            nat
                                                                                             i o                   n             a                                        a       P             a      (
                                                                                                                                                                                                                                                                                     A POLICY AUDIT ON FERTILITY

                                                                                                                                l IC                e a                nt s (                nt g
                                                                                      rin at                   tio           op (                 Fr Tr                                                            Do             cy
                                                                                  u te in              r                                       yo yo              p la osi              p  la nin              te
                                                    HS    SS   M&   SW         ra     e m          i t  o lisa
                                                                                                            i          a c yt tion
                                                                                                                              c           b  r      r           m      g n            m        e             e               o ga
                                                                              t s                V r      t           r
                                                                                                                     t je                         b           i
                                                                                                                                                             e ia                    i
                                                                                                                                                                                    e r      e           a m               rr
                                                               NM           In In           In Fe                 In In                Em Em               Pr D                  Pr Sc                 G                Su
    CZ           1.53                29.9           l     l     l    l       l                   l                   l                   l                   l                   l                   l                    l            l
    DE           1.47                30.9           l     l     l    l       l                   l                   l                   l                   l                   l                  U**                   U            l
    FR           2.01                30.3           l     U     l    U       l                   l                   l                   l                   l                   U                  l**                   U            l
    IT           1.37                31.5           l     U     l    U       l                   l                   l                   l                   l                   l                  l**                   U            l
    PL           1.32                29.1           l*    U*   l*    U*      l                   l                   l                   l                   l                   l                  l**                   U            U

    RO           1.52                27.5           l*    l*   l*    l*      l                   l                   l                   l                   l                   l                  l**                   U            l
    SE           1.88                31.0           l     l     l    l       l                   l                   l                   l                   l                   U                  U**                   U            l
    SP           1.32                31.8           l     l     l    l       l                   l                   l                   l                   l                   l                  l**                   U            l
    UK           1.81                30.2           l     l     l    l       l                   l                   l                   l                   l                   l                  l**                   l            l
Legend:
l   Yes
U   No
MAR – Medically Assisted Reproduction; HS: Heterosexual, SS: Same sex, M & NM: Married and Non-married couples; SW:Single women
CZ – The Czech Republic; DE – Germany; FR – France; IT – Italy; PL – Poland; RO- Romania; SE – Sweden; SP- Spain; UK – United Kingdom

An executive summary outlining the key findings has been included in each country chapter.

* PL - Right of Same sex couples and Single women under legal vacuum. The “National Procreation Programme” specifically refers to
married couples or couples cohabiting in partnership.; RO - This is due in part to absence of legislation.

** DE - Egg donation is not possible; Sperm donation is non-anonymous; Embryo freezing is available only in emergency; FR - Donation
is anonymous; IT - Donation is anonymous; PL - Donation is anonymous; There is a legal vacuum concerning surrogacy; SP - Donation is
anonymous; SE - Embryo donation is not possible; Gamete donation is non-anonymous; UK - Donation is non-anonymous
Table 2. EU28 Key Facts and Figures

     EU 28             Total Fertility   Mean Age of   Fertility Treatment Regulation   Public Clinics     Private Clinics   Reimbursement /
                       Rate              Woman at      (2015, ESHRE13; 2016, ECPRD14;   (2015, ESHRE;      (2015, ESHRE;     State Funding
                       (2014,            Childbirth    ESHRE, FE input)                 2016, ECPRD;       2016, ECPRD;      Yes/No
                       Eurostat)11       (2014,                                         ESHRE,             ESHRE,            (2015, ESHRE;
                                         Eurostat)12                                    FE input)          FE input)         2016, ECPRD;
                                                                                                                             ESHRE, FE input)
     Austria                1.47            30.4       Legislation                      8                  23                Yes
     Belgium                1.74            30.3       Legislation                      34 in total                          Yes
     Bulgaria               1.53             27.3      Legislation                      3                  32                Yes
     Croatia                1.46             29.8      Legislation + guidelines15       8                  8                 Yes
     Cyprus                 1.31             31.0      Legislation + guidelines         0                  5                 Yes
                                                                     16                               17
     Czech Republic         1.53            29.9       Legislation + guidelines         40 in total                          Yes
     Denmark                1.69            30.9       N/A                              8                  13                Yes
     Estonia                1.54            29.6       Legislation                      3                  2                 Yes
     Finland                1.71            30.5       Legislation                      10                 14                Yes
     France                 2.01            30.3       Legislation + guidelines         50                 50                Yes
     Germany                1.47            30.9       Legislation + guidelines         30                 100               Yes
     Greece                 1.30             31.1      Legislation + guidelines         9                  43                Yes
     Hungary                1.44            29.5       Legislation + guidelines         3                  9                 Yes
     Ireland                1.94             31.6      Legislation                      0                  7                 No
     Italy                  1.37             31.5      Legislation + guidelines         63                 95                Yes
                                                                     18
     Latvia                 1.65             29.2      Legislation
     Lithuania              1.63            29.4       Legislation                      0                  5                 Yes
     Luxembourg             1.50             31.4      N/A                              N/A                N/A               N/A
     Malta                  1.42             30.1      N/A                              N/A                N/A               N/A
     Netherlands            1.71             31.1      Legislation + guidelines         13                 0                 Yes
                                                                     19
     Poland                 1.32             29.1      Legislation + guidelines         4                  37                No (expired June 2016)
     Portugal               1.23             30.7      Legislation                      10                 16                Yes20
                                                                                  21
     Romania                1.52             27.5      Legislation + guidelines         2                  20                Yes22
     Slovakia               1.37             28.8      Legislation                      1                  8                 Yes
     Slovenia               1.58            30.2       Legislation + guidelines         3                  0                 Yes
     Spain                  1.32             31.8      Legislation + guidelines         41                 197               Yes
     Sweden                 1.88             31.0      Legislation + guidelines         6                  10                Yes
     UK                     1.81            30.2       Legislation + guidelines         78 in total                          Yes
                                                                                                                                                      ANALYSIS OF 9 EU COUNTRIES
                                                                                                                                                                                   A POLICY AUDIT ON FERTILITY

11
A POLICY AUDIT ON FERTILITY
ANALYSIS OF 9 EU COUNTRIES

ABOUT THE PARTNERS

With member representation from           The European Society of Human             Merck KGaA, Darmstadt, Germany
over 20 European countries, Fertility     Reproduction and Embryology               is a leading science and technology
Europe (abbreviated “FE”) is the Pan-     (abbreviated “ESHRE”) is a scientific     company in healthcare, life science
European organisation representing        society incorporated as an                and performance materials. As
infertility focused associations. FE      international non-profit organisation.    the world market leader in fertility
national organisations work tirelessly    ESHRE’s main aim is to promote            treatments it offers a complete
to assist those with difficulties         interest in, and understanding of,        and clinically proven portfolio of
conceiving. Their goal is to improve      reproductive biology and medicine. It     fertility treatments at every stage
the rights of individuals affected by     does this through facilitating research   of the reproductive cycle, and
infertility by building stronger cross    and the subsequent dissemination          combines this drug portfolio with its
border networks amongst European          of research findings in human             continuously expanding offering of
patients. These synergies foster          reproduction and embryology to the        innovative technologies. Merck KGaA,
the sharing of best practices, social     general public, scientists, clinicians    Darmstadt, Germany has an enduring
change in perception of infertility and   and patient associations. It also         commitment to improve treatment
increase education in the protection      collaborates with politicians and         outcomes for patients, in partnership
of reproductive health. FE’s work aims    policy makers throughout Europe. It       with their providers’, in accessing
to promote: patient empowerment,          promotes improvements in clinical         treatment.
the fight against health inequalities     practice through organising teaching
and discrimination, the support           and training activities, developing       For more information about Merck
of quality care, patient safety and       and maintaining data registries and       KGaA, Darmstadt, Germany visit:
patient centred treatments, as well as    providing guidance to improve safety      http://biopharma.merckgroup.com/
the development of ethical guidelines     and quality assurance in clinical and     en/index.html.
and regulations within each European      laboratory procedures.
country.
                                          For more information about ESHRE,
For more information about FE, 		         visit: https://www.eshre.eu/.
visit: http://www.fertilityeurope.eu/.

               This project was funded by Merck KGaA, Darmstadt, Germany as contribution to public policy debate. To
               ensure editorial integrity, in a Memorandum of Understanding with Fertility Europe (FE) and the European
               Society of Human Reproduction and Embryology (ESHRE), Merck KGaA, Darmstadt, Germany signed
               complete editorial control over the report to FE and ESHRE.
A POLICY AUDIT ON FERTILITY
                                                                                                      ANALYSIS OF 9 EU COUNTRIES

METHODOLOGY
   The Policy Audit on Fertility includes an examination of nine EU member
   states: the Czech Republic, France, Germany, Italy, Poland, Romania,
   Spain, Sweden and the United Kingdom. The country selection meant
   to ensure a meaningful and balanced geographical scope of analysis.
   The methodology of the report was to carry out research in a structured
   approach that included: a pre-defined questionnaire, desk research,
   interviews/written input and upwards of three revision cycles with the
   lead partners, FE and ESHRE, their respective members and experts.

A
       pre-defined questionnaire         to lack of a local FE representative in     Disclaimer
       was developed in collaboration    Spain and Germany, feedback into
       with the partners to guide        their respective country chapters          The views and opinions expressed
desk research and interviews.            were provided by the Wunschkind            in this audit report are exclusively
Partners agreed to the following         association in Germany and Dr Diana        those of Fertility Europe (FE) and
headings, as representative of the       Guerra, Spanish Infertility Association    the European Society of Human
main areas of interest: Key Facts        - Genera (dissolved in 2016). ESHRE        Reproduction and Embryology
and Figures; Infertility Policies;       members from each of the nine EU           (ESHRE) and do not necessarily
Screening and Diagnosis; Treatment       countries provided feedback via            reflect the official policies or positions
and Reimbursement / State Funding;       written input or interviews. Interviews    of stakeholders involved. This is in
Awareness Raising Activities; and        were conducted according to the pre-       keeping with the terms of agreement
Future Outlook. For each heading,        defined questionnaire and written          for full editorial rights and control
a number of specific questions           input on specific information was          by FE and ESHRE, as outlined in the
were developed to facilitate the         coordinated by members in each             memorandum of understanding
harmonised collection of comparable      country. This process was used to          between FE, ESHRE and its sponsor,
information, thus providing a            discuss and fact-check information         Merck KGaA, Darmstadt, Germany.
comprehensive assessment of the          garnered through desk research,            Content presented in this report is
situation in each country.               as well as to asses and gather             not reflective of consultations with
                                         opinions on the implementation of          government entities. Assertions
Desk research was carried out using      a framework that optimally presents        and statements provided by FE and
a range of internet sites including      the situation of the countries in focus.   ESHRE are, as per the methodology,
national ministries, academic                                                       the product of consultations with
institutes, professional and patient     Revision by the parties involved –         their respective networks and
associations, media articles and         information collected through desk         therefore should not be extended
approved reference documents.            research, complementary one-to-one         beyond the intent for which this
Information was gathered from each       interviews and written input were          report was originally conceived, a
of the nine EU countries based on        analysed and reviewed to create a          current state assessment of infertility
the pre-defined questionnaire.           comprehensive overview, followed by        in the nine EU countries surveyed.
                                         a 4-5 page in-depth assessment of
Interviews/written input were used       the situation in each of the nine EU
to build on desk research. Information   countries. The report then underwent
gathered from one-to-one interviews      upwards of three review cycles by
and rounds of written input were         members of FE and ESHRE, with
carried out with patient groups and      feedback incorporated into the report
fertility specialists, representing      you read today.
each of the nine countries surveyed.
FE member organisations from             This report was produced by Burson-
the Czech Republic, France, Italy,       Marsteller Brussels, a public affairs
Poland, Romania, Sweden and the UK       and communication agency, on
participated in the interviews. Due      behalf of the audit partners.

                                                                                                                                   13
A POLICY AUDIT ON FERTILITY
ANALYSIS OF 9 EU COUNTRIES
A POLICY AUDIT ON FERTILITY
         ANALYSIS OF 9 EU COUNTRIES

  COUNTRY
CHAPTERS

                                      15
A POLICY AUDIT ON FERTILITY
ANALYSIS OF 9 EU COUNTRIES                                                             THE CZECH REPUBLIC

OVERVIEW
    The fertility rate in the Czech Republic is 1.53 (vs. 1.58 EU average) 23.
    Fertility policy is part of family policy, which falls under the portfolio of the Ministry of Labour and Social Affairs. Access
    to Medically Assisted Reproduction (MAR) is regulated by “Act No. 373/2011, Coll. – the Act on Specific Health Services,
    Title II – Health Services Provided Under Special Conditions, Part 1 Assisted Reproduction” 24.
    A wide range of treatment options are available in the Czech Republic from, Intrauterine Insemination (IUI) to surrogacy,
    the latter practiced but surrounded by a legal vacuum. The use of donor eggs, as well as sperm and embryos are explicitly
    protected under Czech law.
    Women who undergo IUI or In Vitro Fertilisation (IVF) must first obtain written consent from the husband or male
    partner, to be registered as the biological father of the child if treatment results in a successful pregnancy. This is a
    requirement regardless of the origin of the gamete used in the process.
    In the Czech Republic, three to four IVF attempts are 100% covered by mandatory health insurance, but some related
    procedures require co-financing by the patient. Mandatory health insurance covers IVF for women between 22-39 years
    of age. The age limit may be reduced to 18 years, if the patient is found to have a bilateral fallopian tube blockage.
    Public awareness is raised predominantly by MAR centres, the Adam Česká republika patient association and by
    endowment funds.
    A new family policy is under development, with MAR on the agenda, as part of reform discussions. This may lead to
    legislative changes such as, raising the maximum age a woman is eligible to receive covered MAR treatments, as well as
    allowing single women to undergo IVF.
    The Czech Republic is a destination country for infertility treatment. The number of IVF cycles undergone by non-
    nationals increased from 1795 in 2010 to 3030 in 2014 25.

Table 1.
KEY FACTS & FIGURES
TOTAL FERTILITY RATE (TFR)26                    1.5327
INFERTILITY RATE                                20% of couples28
MEAN AGE OF WOMAN AT THE                        29.9 years29
FIRST CHILDBIRTH
FERTILITY TREATMENT 			                         30.5% (number of pregnancies relative to the number of IVF cycles in women
SUCCESS RATE                                    up to 34 years of age)30
REIMBURSEMENT                                   100% coverage by mandatory health insurance for up to four cycles IVF and six IUI,
                                                for women aged 22-39 years of age. The age limit criteria may be reduced to 18
                                                years, if the patient is found to have a bilateral fallopian tube blockage 31
AWARENESS RAISING CAMPAIGNS/                    Patient association campaign:
INITIATIVES                                       Adam Česká republika (www.adamcr.cz) is a patient association that offers
                                                  information to support men during infertility treatment.
                                                Two endowment fund campaigns:
                                                 The endowment fund of Petr Koukal, www.stkprochlapy.cz and the “Krtek”
                                                 endowment fund, www.maskoule.cz both focus on testicular cancer.
                                                Infertility websites:
                                                  www.zenska-neplodnost.cz – is a website focused on infertility, operated by the
                                                  Meditorial+ company;
                                                  www.stopneplodnosti.cz – published via an unrestricted educational grant
                                                  from Merck spol. s r.o.
A POLICY AUDIT ON FERTILITY
                                                                                                                 ANALYSIS OF 9 EU COUNTRIES

INFERTILITY
POLICIES                                         Access to Medically Assisted Reproduction     The Institute of Health Information and
                                                 (MAR) is regulated by “Act No. 373/2011,      Statistics publishes an annual report
It is estimated that 20% of couples in the
                                                 Coll. – the Act on Specific Health            on assisted reproduction in the Czech
Czech Republic are affected by infertility 32.
                                                 Services, Title II – Health Services          Republic, which includes the number of
The fertility rate in the Czech Republic
                                                 Provided Under Special Conditions, Part       IVF procedures performed, prevalence by
is 1.53 (vs. 1.58 EU average)33.
                                                 1 Assisted Reproduction”37. Other acts        diagnostic type and success rates43.
The Czech Republic’s fertility policy            and subordinate acts relevant to this         The law does not require information
is part of the “National Family Policy”,         Act include: “Act No. 227/2006, Coll., on     on sexual orientation or marital status
which falls under the portfolio of the           Research on Human Embryonic Stem              in order to access MAR44. For a woman
Ministry of Labour and Social Affairs.           Cells and Related Activities”38, “Act No.     to undergo IUI or IVF, Czech law requires
Fertility and infertility are part of the        296/2008, Coll., on Safeguarding the          written consent from the husband or male
“National Program for the Restoration            Quality and Safety of Human Tissues           partner who has to agree to be registered
and Promotion of Health” under the               and Cells Intended for Use in Man”39, “Act    as a biological father of the child, if
section for “Improvement of Reproductive         No. 101/2000, Coll., on the Protection        treatment results in successful pregnancy.
Health” 34. The National Program came            of Personal Data”40, and “Decree No.          This is a requirement regardless of the
into effect in 1991 under the Czech              116/2012, Coll., on the Transfer of Data to   origin of the sperm or embryo used in the
Republic Government Resolution. The              the National Health Information System        process. In the Czech Republic there is a
“Health2020” program was approved by             (NHIS)”41, which outlines the binding         legal vacuum with respect to surrogacy,
the Government in 2012 and is currently          instructions of the NHIS.                     as the law does not explicitly encourage,
under way35. The state policy also includes
                                                 A National Registry of Assisted               or have legal provisions discouraging it.
the training of medical personnel (e.g.
                                                 Reproduction (NRAR)42 was established         Under this circumstance, surrogacy is
introduction of a certified course in
                                                 in 2007 to collect information for            practiced in the Czech Republic45.
accordance with “Decree No. 185/2009,
                                                 the evaluation, management and
Coll. on Specialisation Areas in the
                                                 improvement of care for infertile couples.
Education of Physicians and Pharmacists”
                                                 Data from the NRAR also supports MAR
entitled “Reproductive Medicine Further
                                                 policy development and treatment
Education Program”)36. Conferences,
                                                 options. The NRAR is part of the Institute
seminars and courses on assisted
                                                 of Health Information and Statistics
reproduction are also held both nationally
                                                 of the Czech Republic, which is under
and regionally.
                                                 the purview of the Ministry of Health.
                                                 Data submissions are prospective and
                                                 mandatory for all providers of MAR.

                                                                                                                                              17
A POLICY AUDIT ON FERTILITY
ANALYSIS OF 9 EU COUNTRIES

“
Screening and diagnosis
in the Czech Republic is
advancing hand in hand
with the achievements of
                                  SCREENING AND
                                  DIAGNOSIS
                                  There is an assortment of screening and
                                  diagnostic options for patients in the
                                  Czech Republic46.
                                  Common female infertility diagnostic
                                                                               TREATMENT AND
                                                                               REIMBURSEMENT /
                                                                               STATE FUNDING
                                                                               A wide variety of treatments are
                                                                               available in the Czech Republic. Patients
                                                                               undergo infertility treatments such
science. Gynaecological           techniques include: ultrasound               as: IVF, transcervical embryo transfer
                                  examination of the pelvis, testing of
screening and women’s             hormone levels, X-ray examination
                                                                               and cryopreservation of gametes and
                                                                               embryos52 to name a few. Embryos are
healthcare in the Czech           of the uterus and fallopian tubes            examined genetically and continuously
Republic are generally            (hysterosalpingography or HSG for            monitored using an embryoscope in an
                                  short), hysteroscopy, laparoscopy testing,
top-quality. Infertility          genetic testing and immunological
                                                                               incubator. Surveillance facilitates early
                                                                               detection of irregularities in embryo
diagnosis is to a great           examination47,48.                            development, as well as the selection
extent covered by                 Common male infertility diagnostic           of the embryos that will undergo
                                  techniques include: sperm cultivation,       gestation53.
mandatory health                  andrology testing, sperm acrosome            The law allows for the use of donor
insurance regardless              integrity testing, DNA fragmentation         eggs, sperm and embryos54. While not
of age, and is also of 		     “   of sperms, genetic testing,                  explicitly defined by law, surrogacy is
                                  immunological examination and
a very high quality.              hormonal examination49.
                                                                               practiced in the Czech Republic55.
                                                                               Mandatory health insurance entitles a
Adam Česká republika              However, the number of follow-up             patient to three to four cycles of IVF and
patient association,              examinations covered by mandatory
Czech Republic                                                                 six cycles of IUI at 100% coverage56.
August 2016
                                  health insurance is limited. They            However, some treatment related
                                  include, for example: seven ultrasound       procedures, such as: Intracytoplasmic
                                  examinations per year, four cervical         Sperm Injection (ICSI), Preimplantation
                                  mucus examinations per month, one            Genetic Diagnosis (PGD), Embryo
                                  spermiogram examination every three          Cryopreservation, thawing and
                                  months, etc.50.                              subsequent Frozen Embryo Transfer
                                  Gynaecologists, urologists or andrologists   (FET) are not covered by mandatory
                                  are usually the first point of contact for   health insurance.
                                  couples seeking infertility treatment,       MAR is available for women of
                                  but patients may also contact a MAR          childbearing age, provided their health
                                  centre directly.                             allows for treatment. Mandatory health
                                  Gynaecologists typically refer patients      insurance covers IVF for women between
                                  for specialised examinations and to MAR      22-39 years of age. The age limit may
                                  centres. Once infertility is diagnosed,      be reduced to 18 years, if the patient is
                                  receiving treatment is generally quick       found to have a bilateral fallopian tube
                                  and easily accessible51.                     blockage57. IVF is not currently covered
                                                                               for women of the age of 40 and above58.
                                                                               Mandatory health insurance coverage
                                                                               includes procedures related to
                                                                               IVF treatment, as well as certain
                                                                               examinations prior to starting IVF.
                                                                               However, in order to receive 100%
                                                                               IVF coverage, the patient must agree
                                                                               to take complementary drugs. If the
                                                                               patient chooses not to comply, he/she
                                                                               is required to co-finance the drugs used
                                                                               during IVF. Surcharges for these drugs
                                                                               range from approximately CZK 3,000
                                                                               – CZK 10,000 (approximately EUR 110 –
                                                                               EUR 370)59,60.
A POLICY AUDIT ON FERTILITY
                                                                                                                        ANALYSIS OF 9 EU COUNTRIES

                                                                                                     “
Women outside of the eligible age range           In 2014 there were 42 MAR clinics
must cover all costs independently. The           (both public and private) in the
price of one IVF cycle (including drugs)          Czech Republic69. Reimbursement
is around CZK 45,000 (approximately               / State funding remains dependent                  The MAR situation,
EUR 1,665)61.                                     on contractual agreements between                  accessibility, quality of
Access to certain MAR treatments                  individual clinics (public or private)
may be limited by a patient’s ability             and their insurer.                                 screening and treatment
to pay62. This is due in part to how             Table 2. Treatment Options Available
                                                                                                     is very good in the Czech
the financing was initially established          in the Czech Republic                               Republic. However, the
during the 1990’s. Since then, science
and medicine have evolved to offer              Intrauterine Insemination (IUI)                      social context of MAR is              “
innovative, and accordingly, more               In Vitro Fertilisation (IVF)                         generally underestimated.
expensive drugs and techniques, not             Intracytoplasmic Sperm Injection (ICSI)              Adam Česká republika
captured under the current financing                                                                 patient association,
                                                Embryo Freezing; Frozen Embryo Transfer
model. While these advances are not                                                                  Czech Republic
                                                (FET)                                                August 2016
medically necessary, according to the
Human Reproduction Journal, they still          Preimplantation Genetic Diagnosis (PGD)
present additional costs, that can be
limiting for many patients63.
                                                Preimplantation Genetic Screening (PGS)              FUTURE
A recipient of donated gametes
                                                Microsurgical Epididymal Sperm Aspiration
                                                (MESA); Testicular Sperm Extraction (TESE)           OUTLOOK
may be a woman with normally                    Gamete Donation                                       A new “Family Policy” is under
functioning ovaries who has repeatedly                                                                development, including the set-up
undergone IVF without success, has              Surrogacy
                                                                                                      of an Expert Commission on Family
had chemotherapy, is about to start                                                                   Policy75, which will operate under the
menopause, has just gone through                                                                      direction of the Ministry of Labour and
menopause, or has a genetic variation64.        AWARENESS 		                                          Social Affairs,76 whose responsibility
MAR centers collaborate with
psychologists to provide patients with          RAISING 		                                            includes the drafting of the “National
                                                                                                      Family Policy”77.
psychological care. The government,
in partnership with municipalities, also
                                                ACTIVITIES                                            Outcomes from the Expert
                                                                                                      Commission may result in specific
offers free marriage and pre-marriage             Public awareness is raised                          proposals for amendments to
counselling with psychologists.                   predominantly through civic                         the current law. With declining
NGOs and informal groups also play                associations such as www.adamcr.cz,                 demographics, the Expert Commission
an important role in the delivery of              by endowment funds such as www.                     for Family Policy will discuss several
psychological support through a variety           stkprochlapy.cz and www.maskoule.cz                 changes to the current legislation,
of social and informational networks65.           and by MAR centres and pharmaceutical               including: raising the maximum age a
Clinical pregnancy occurs in one-third            manufacturers via websites, such 		                 woman is eligible to receive covered
of cycles in women aged 22-35, one-               as www.stopneplodnosti.cz and                       MAR treatments, as well as explicitly
quarter of cycles in women aged 36-39             www.zenska-neplodnost.cz.                           allowing single women to undergo
and one-tenth in women aged 40 and                Articles in lifestyle magazines                     IVF with the state guarantee and
above. Eggs donated by younger women              increasingly discuss infertility and the            state responsibility78.
make up the majority of cycles for                rise in male infertility70,71,72,73. One article    The Expert Commission for Family
women aged 40 and above, increasing               mentioned that 3-4% of children in the              Policy requests that the state increase
success rates66.                                  Czech Republic are born through MAR                 its financial support of MAR and
Due to the variety and availability of            treatments and that this proportion will            broader accessibility79.
treatments, as well as the high quality           continue to rise74. Unbiased information
of services, relative to price, the Czech         from scientific research can be found in
Republic is a top destination for infertility     scientific journals, but are not intended
treatment67. The number of IVF cycles             for the general public.
undergone by non-nationals increased
from 1795 in 2010 to 3030 in 201468.

                                                                                                                                                     19
A POLICY AUDIT ON FERTILITY
ANALYSIS OF 9 EU COUNTRIES                                                                                       FRANCE

OVERVIEW
   The fertility rate in France is 2.01 (vs. 1.58 EU average)80.
   Fertility policy is the responsibility of the Ministry of Health. Access to Medically Assisted Reproduction (MAR) is
   regulated under the 1994 bioethics law, which includes the following three laws: “Law 94-654” from 29 July 1994 on
   the “Donation and Use of Elements and Products of the Human Body, Medically Assisted Procreation and Prenatal
   Diagnosis”, revised in 200481 and again in 201182 and two supporting laws concerning respect for the human body and
   the use of personal data for medical research83.
   Treatment options covered under the law range from Intrauterine Insemination (IUI) to Preimplantation Genetic
   Diagnosis (PGD), gamete and embryo donation. Surrogacy, double gamete donation and Preimplantation Genetic
   Screening (PGS) are not available. MAR is currently available for women under 43 years of age, in a heterosexual couple,
   either married or cohabitating. Access to MAR is not available for same sex couples or single women.
   In France, reimbursement / state funding includes four IVF treatments and up to six IUI’s (one IUI per menstruation
   cycle), for women under 43 years of age.
   Doctors, scientists and patients believe stigma, insufficient information, support, education and prevention, as well as
   research, remain key challenges. They advocate for a National Fertility Plan to be put in place84.
   More specifically, patient groups call for a national plan that addresses: diagnosis, medical care, holistic support and
   increased treatment availability, including specific examinations and techniques (i.e. double gametes donation), as well
   as more inclusive access to treatment for single women and same sex couples85.
   Despite the 100 MAR centres in France (nearly 1 per department)86, patients report that access to clinically efficient,
   patient focused and evidence-based care is not insured equally throughout France87. Regarding access to oocyte
   donation, lengthy wait lists cause patients to seek treatment abroad88.
   The National Consultative Ethics Committee89 is expected to deliver a ‘general’ opinion on MAR in spring 2017 90. The
   outcomes of the 2017 presidential elections and subsequent legislation will determine long-term policies on infertility,
   including the planned 2018 revision of the bioethics law.

 Table 1.
KEY FACTS & FIGURES
TOTAL FERTILITY RATE (TFR)91               2.0192
INFERTILITY RATE                           There are two reference studies on the infertility rate in France:
                                             According to a 2003 “Perinatal National Survey” infertility was diagnosed in 18% of
                                             couples tested after a 12-month period and 8% in couples tested after a 24-month
                                             period93. The study did not specify the ages of women surveyed.
                                             The Epidemiologic Observatory of Fertility in France, found that 24% of couples
                                             tested after 12 months and 11% of couples tested after 24 months were infertile94.
                                             Women surveyed in this study (2007-2010) were between 18-44 years of age.
MEAN AGE OF WOMAN AT THE FIRST             30.3 years95
CHILDBIRTH
FERTILITY TREATMENT 			                    Approximately 25.5% live births with In Vitro Fertilisation (IVF/ Intracytoplasmic
SUCCESS RATE                               Sperm Injection (ICSI))96
                                           Approximately 10% live births with Intrauterine Insemination (IUI)97
REIMBURSEMENT                              IUI and IVF/ICSI are fully reimbursed for women under 43 years of age:
                                             Up to six IUIs (one IUI per menstruation cycle)
                                             Four IVFs 98
                                           MAR is available to heterosexual couples, of childbearing age, in a stable
                                           relationship (either married or cohabitating)99. The couple must be in one or
                                           both of the following situations:
                                             The couple or at least one partner must be diagnosed with medical infertility
                                             A partner has a serious disease that can be transmitted to their partner or the child
A POLICY AUDIT ON FERTILITY
                                                                                                               ANALYSIS OF 9 EU COUNTRIES

AWARENESS RAISING CAMPAIGNS/                   Governmental campaign:
INITIATIVES                                     A radio campaign on gamete donation, coordinated by the French Agency for
                                                Biomedicine in November 2016100. The campaign featured healthcare providers
                                                (HCPs) providing information on MAR.
                                              Patient associations and NGO campaigns:
                                                National Infertility Day, organised annually by the MAIA101 patient association,
                                                facilitates infertility discussions between patients, doctors and association
                                                members. The latest conference was held on 4 November 2016 in Paris.
                                                Manif pour tous (March for all)102 was a protest movement launched in France
                                                during the introduction of the marriage equality bill103. It called for access to MAR
                                                treatments for same sex couples and surrogacy.
                                                Infertility Awareness Week, a campaign organised by the Association of Medically
                                                Assisted Reproduction Patients and Infertile People (BAMP)104, took place between
                                                25 and 30 April 2016.

INFERTILITY
POLICIES                                      birth lens, focusing primarily on financial   MAR is currently available to heterosexual
Between 18-24% of couples report              support for families and day-care             couples, either married or cohabiting,
having failed to conceive after 12 months     service availability108.                      where the woman is under 43 years of
without contraception. After 24 months,       Access to MAR is regulated under the          age113. Access to MAR is not available for
the proportion decreases to 8%-11%105,106.    1994 bioethics law, which includes the        same sex couples or single women114.
The fertility rate in France is 2.01 		       following three laws: “Law 94-654” from       Patient groups feel there has been
(vs. 1.58 EU average).                        29 July 1994 on the “Donation and Use         reluctance to re-open the debate on
                                              of Elements and Products of the Human         access to MAR for all couples, since the
Fertility policy in France is under the                                                     debates on access to MAR for same sex
purview of the Ministry of Health.            Body, Medically Assisted Procreation and
                                              Prenatal Diagnosis”, revised in 2004109       couples in 2013-2014115. Recent debates
Over the years, infertility has been                                                        on marriage equality have further
discussed in relation to other health         and again in 2011110 and two supporting
                                              laws concerning respect for the human         solidified the French government’s
policies such as cancer and the effect of                                                   opposition to surrogacy116.
endocrine disrupters on fertility107. These   body and the use of personal data for
discussions have not led to the adoption      medical research111.                          In March 2016, doctors published the
of a consistent approach in addressing        A 2009 report on women’s health               “130 doctors manifesto” calling for
such risk factors. France’s family policies   in France found that the use of MAR           changes to the French MAR legislative
are typically assessed through a post-        treatments has consistently increased         framework to include wider and
                                              over the last 30 years112.                    improved access to some treatments117
                                                                                             in addition to a National Fertility Plan.

                                                                                                                                            21
A POLICY AUDIT ON FERTILITY
ANALYSIS OF 9 EU COUNTRIES

“
In terms of infertility, the
approach in France is
geared towards symptoms
treatment instead of
                                  SCREENING AND
                                  DIAGNOSIS
                                  France’s existing infertility screening
                                  professional guidelines have been
                                  developed by the Biomedicine Agency
                                  and are mandatory118. Guidelines were
                                                                                 TREATMENT AND
                                                                                 REIMBURSEMENT /
                                                                                 STATE FUNDING
                                                                                 Many treatment options are available
                                                                                 under French law, such as: IUI, IVF, ICSI,
                                                                                 Preimplantation Genetic Diagnosis
                                  also developed by the National College of
education and prevention.         French Gynaecologists and Obstetricians        (PGD), gamete and embryo donation,
Patients in big cities have       but are not mandatory119.                      Embryo Freezing and vitrification
                                                                                 (as of 2011). While gamete donation
better access to treatment        The following screening and
                                                                                 is anonymous121, surrogacy, double
than patients in rural areas,     diagnostic tests are available for
                                                                                 donation122 and PGS are not available123.
                                  women: examination to assess vaginal
who are faced with a so-      “   abnormalities, blood analysis and
                                                                                 In cases where both patients are infertile,
                                                                                 couples are reliant on donated embryos,
called ‘medical desert’.          examination of reproductive organs via.
                                                                                 which can take between 12 to 18 months
Maia patient association,         echography or X-rays.
                                                                                 to receive124. Every MAR centre in France
France                            The following screening and
July 2016                                                                        must follow-up with couples that have
                                  diagnostic tests are available for men:        frozen embryos and report annually to
                                  spermogram, hormonal screening                 French authorities125.
                                  through blood sample analysis,
                                                                                 The following MAR treatments are
                                  echography of the reproductive system
                                                                                 fully reimbursed for women under
                                  and immunological testing120.
                                                                                 43 years of age:
                                  Gynaecologists are the main contact
                                                                                    Up to six IUIs (one IUI per
                                  for couples struggling to conceive. If the
                                                                                 menstruation cycle)
                                  causes of infertility are not discovered
                                  after an initial screening, gynaecologists        Four IVFs126
                                  can refer patients to other specialists        Health insurance will reimburse
                                  such as: andrologists, endocrinologists,       treatment received abroad under the
                                  urologists, geneticists, psychologists or to   following conditions: that the patient
                                  a MAR centre. Clinical embryologists are       meets eligibility criteria in France, that
                                  available in every MAR centre.                 treatment is not delivered in France with
                                                                                 the same level of success and that the
                                                                                 treatment is appropriate to the patient’s
                                                                                 condition127.
                                                                                 While each MAR centre has its
                                                                                 own assessment criteria, patient
                                                                                 representatives believe there is an
                                                                                 acceptance bias on the basis of: age,
                                                                                 weight and simplicity of infertility
                                                                                 condition128. Couples may go to
                                                                                 a gynaecologist to perform their
                                                                                 inseminations or to an MAR centre.
                                                                                 Gynaecologists are subjected to
                                                                                 the same legal framework as MAR
                                                                                 centres and reproductive biology
                                                                                 labs. Laboratory costs are fixed by the
                                                                                 healthcare system129.
A POLICY AUDIT ON FERTILITY
                                                                                                             ANALYSIS OF 9 EU COUNTRIES

                                              AWARENESS
                                                                                             “
  A consult with a psychologist is
  mandatory for couples receiving gamete
  and embryo donations. The couple
  needs to confirm their MAR request in
                                              RAISING 		                                     Reimbursement has helped
  writing within a month following the
  consult. The letter is then sent to an
                                              ACTIVITIES                                     many couples have access
  MAR centre that will decide if access to    Patient groups consider stigma to be           to treatment, but now
  treatment is granted.130                    a significant problem that remains             France is lagging behind in
                                              unaddressed141.
  French legislation and the Agency for
                                              Currently, there are no state funded
                                                                                             Europe in terms of public
  Biomedicine’s website131 are one source
  of information on infertility treatment.    awareness campaigns, apart from                debates and policies on
                                                                                                            “
  Information is also available on patient    information on MAR on the French               infertility.
  associations’ websites132 and other         Agency for Biomedicine’s website142,143.
                                              The agency did organise a radio                Maia patient association,
  health websites133. In an article by the                                                   France
  French National Institute for Health        campaign on gamete donation in June            July 2016
  Research, better gamete selection can       2015144, with a second radio campaign
  lead to improved success rates134.          in November 2016145.
                                              On 4 November 2016, MAIA in                      More specifically, patient groups call
  Patient groups believe that access to                                                        for a national plan that addresses:
  fertility experts and MAR centres are       partnership with Magic Maman Famili
                                              magazine organised the 3rd annual                information campaigns, research,
  not equally insured throughout France                                                        equitable access across MAR centres,
  and that lengthy wait times for oocyte      Infertility Awareness Day. The Awareness
                                              Day provided an open forum for infertile         improved diagnosis and medical
  donations (estimated between 2-5                                                             care, holistic support and increased
  years) causes patients to seek treatment    individuals to receive information on
                                              infertility issues146.                           treatment availability, including
  abroad135.                                                                                   specific examinations and medical
  Patient groups also call for improved                                                        techniques (i.e. double gamete
  treatment standards, in keeping with
  scientific developments and increased       FUTURE 			                                       donation and double donor status
                                                                                               regarding gamete donation, embryo
  success rates136,137.
  MAR success rates are approximately
                                              OUTLOOK                                          screening, compensation for women
                                                                                               donating oocytes and self-preservation
  25% with IVF and 10% with IUI138.           The scientific community shows                   of oocytes), as well as more inclusive
  There are 50 private and 50 public MAR      increasing interest in the causes of             access to treatment for single women
  clinics in France139.                       male infertility. The national institute for     and same sex couples150. Further,
                                              health monitoring published a study in           stakeholders call for a regulated
  It is estimated that 25,208 children were   2012 on the environmental causes of              framework that allows for ethical and
  born through MAR, representing 3.1% of      male infertility147 but this has yet to lead     non-commercial surrogacy and the
  new borns in 2014140.                       to a shift in infertility policies.              registration of children born through
                                              The Biomedicine Agency regularly                 surrogacy abroad in the civil register151.
 Table 2. Treatment Options
                                              assesses success rate data from                  The National Consultative Ethics
 Available in France
                                              MAR centres and is currently working             Committee152 is expected to deliver
Intrauterine Insemination (IUI)               to address disparities among MAR                 a ‘general’ opinion on MAR in spring
In Vitro Fertilisation (IVF)                  centres148.                                      2017153. Long-term changes (including
                                              Recent debates around access to                  the revision of the bioethics law) will
Intracytoplasmic Sperm Injection (ICSI)
                                              MAR for same sex couples called into             depend on the outcome of presidential
Embryo Freezing; Frozen Embryo Transfer                                                        and legislative elections in 2017. Both
                                              question the need to increase access in
(FET)                                                                                          patient and healthcare professional
                                              general.
Preimplantation Genetic Diagnosis (PGD)                                                        groups are keen to be a part of these
                                              Doctors, scientists and patients believe         discussions154.
Gamete and Embryo Donation                    stigma, insufficient information,
                                              support, education and prevention, as
                                              well as research, remain key challenges.
                                              They advocate for a National Fertility
                                              Plan to be put in place149.

                                                                                                                                            23
A POLICY AUDIT ON FERTILITY
ANALYSIS OF 9 EU COUNTRIES                                                                                   GERMANY

OVERVIEW
    The fertility rate in Germany is 1.47 (vs. 1.58 EU average)155.
    The 1990 “Embryo Protection Act”156 and the regional guidelines for reproductive treatment by the States’ Medical
    Associations, regulates access to Medically Assisted Reproduction (MAR) techniques.
    The 2012 Directive on the “Granting of Aid to Promote Activities of Assisted Reproduction”157, known as the MAR funding
    Directive, offers reimbursement in addition to the regular statutory health insurance reimbursement.
    As of 2015, sperm donation is no longer anonymous. Egg donation and surrogacy are not available.
    If the age criterion is met by married couples, statutory health insurance reimburses 50% of MAR treatments for the
    first 3-4 attempts, while the remaining 50% is paid by the couple. In some federal states 25% of the private cost is
    reimbursed by federal and state governments. As of 2016, non-married couples who meet the age criteria, are eligible to
    be reimbursed up to 12.5% of their private costs in 6 out of 16 federal states.
    The Ministry of Family Affairs (BMFSFJ) offers an online portal with information on infertility issues and treatment
    options 158. Patient organisations offer similar information portals, in addition to organising awareness campaigns159.
    According to patient organisations, couples discussing infertility and treatment options with their gynaecologist do not
    encounter many issues. However, infertility is surrounded by many taboos and is largely perceived as a social, rather
    than biological, condition160.
    Although ethical discussions remain ongoing, patients call for an amendment to the 1990 “Embryo Protection Act” to
    allow for greater access to treatments such as, egg donation and surrogacy and to improve access to existing treatments
    like: Embryo Freezing, Preimplantation Genetic Diagnosis (PGD) and Preimplantation Genetic Screening (PGS)161.

 Table 1.
KEY FACTS & FIGURES
TOTAL FERTILITY RATE (TFR)162                 1.47163
INFERTILITY RATE                              Primary infertility: 2%
                                              Secondary infertility: 8%164
MEAN AGE OF WOMAN AT THE FIRST                30.9 years165
CHILDBIRTH
FERTILITY TREATMENT 			                       20.5% live birth rate per treatment cycle for In Vitro Fertilisation (IVF) and
SUCCESS RATE                                  Intracytoplasmic Sperm Injection (ICSI)166
REIMBURSEMENT / STATE FUNDING                   Regarding available treatment options, health insurance reimburses 50% of the
                                                costs, while federal and state governments provide 25% respectively to cover the
                                                remaining private contributions - available only to married couples (women aged
                                                25-40 and men aged 25-50)
                                                As of 2016, non-married couples within the age criteria detailed above, are eligible
                                                to receive up to 12.5% reimbursement of their private costs, depending on available
                                                supplementary support at the federal level – currently only available in 6 out of 16
                                                federal states167
AWARENESS RAISING CAMPAIGNS/                    Ministry of Family Affairs (BMFSFJ) information portal “Kinderwunsch” 168
INITIATIVES                                     Patient organisation information campaign “Wunschkinder” 169
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