ART and politics

1. ART and politics Patrik Vankrunkelsven Senator

2. ART and politics: our concerns • Health of high standard: includes ART (as solution for infertility and prevention of heritable diseases) • Accessable for everyone: in security system • Budget under control • Care for secundary negative effects (babies!) • Ethical problems • Within normal procedure • New challenges eg high-tech surrogacy • Status of embryos • ….

3. ART and politics: legislation • Existing legislation I. Centres for ART: A and B (KB Febr 1999) II. Embryos & experiments in vitro (Law May 2003) III. Refunding ART (KB June 2003) KB = Royal Decree • Future legislation I. ART, general rules II. Surrogacy

4. Existing legislation

5. I. KB: Fixing centres for ART: A and B • A-centres: diagnose, treatment, prelevation of ovocytes, no « lab » (read IVF/ICSI) (max 1/700,000 inh) • B-centres: diagnose, treatment, prelevation of ovocytes, including « lab » (max 1 in each province) Goals: concentration of knowledge, quality control, budget control

6. II. Law on Embryos & Experiments • Research in vitro permitted first 14 d • No commercial acts • No eugenetic goals • Selection or treatment of non-pathological genetical features • No selection of sex (exception sex-related pathology) • No reproductive cloning • Approvement by local ethical committee and federal commission

7. III. KB: Refunding ART • Max 6 cycli per woman • Max number embryos to transplant in function of woman age, embryo quality,… • Max age 42y Goals: greater accessibility less MP, LBW> less costs for pediatric support > budget for refunding

8. Future legislation

9. I. Assisted ReproductiveTechnology general rules • First draft started from principles: • Infertility is problem of the couple • (triangulation >< single) • The situation where a couple does not succeed in achieving a spontaneous pregnancy in spite of « exposure to the risk of pregnancy » during a given periode of time (>< rigide) • Second … third draft: more technical and answer to concrete problems

10. (I.) Assisted ReproductiveTechnology general rules: Problems • To much IVF/ICSI • Age of the woman • What about redundant (supernumerary ?) embryos • Information / counseling • Anonymity • Decease of male partner

11. 1. To much IVF/ICSI • No conception after at least 12 months of unprotected intercourse (WHO 2000) • Increase of IVF • Medical « controled », « act » • Increased risk of major congenital malformations • Commercial advantage to the patient as well as to the unit • Budget out of control

12. (1)To much IVF/ICSI:Diagnosis/Treatment • Infertility: a multifactorial disease (man !) • Genetic abnormalities • Lifestyle (smoking (!), obesitas,..) • Environment (xeno-oestrogens, lead,..) • Diseases (varicocele, infections, …) • Management of oligozoospermia

13. (1)To much IVF/ICSI:Smoking • Clinical pregnancy rate

14. (1)To much IVF/ICSI:Cost per delivery • Per 1 million euro spended for infertillity treatment • Apply WHO guidelines: 300 babies • IVF 80 babies

15. (1)To much IVF/ICSI:Solutions In case of infertility and BEFORE IVF/ICSI • a good diagnosis is obligate • treatment necessary (if reasonable achievable) • alternatives to explore (eg IUI, stop smoking, …)

16. 2. Age of the woman • Prelevation of ovocytes max age = 45 • Majority; minors in case of medical reasons (eg radiation) • Implantation of embryos or insimination max age = 47

17. 3. What about redundant embryos • No other prelevation if cryoconserved embryos are available • If reproductive use isn’t necessary anymore • Donation • Destruction • Research

18. 4. Information / counseling • Condition and period (5 y, exceptions possible) of cryoconservation • Options of redundant embryos • What in case of decease, divorce, … • Informed consent

19. 5. Anonymity • Donation of gametes or embryos is ANONYMOUS • = status quo, wait and see solutions for huge problems abroad • Decrease of donors • Position of parents • Right of children to know parents isn’t absolute

20. (5) Anonymity/information • Information on caracteristiques available for other centres • Max 6 siblings

21. 6.Decease of male partner • Post mortem implantation • after delay of 6 months • no longer than 2 years later

22. II. Law on Surrogacy • Consequences of absence of legislation • No concentration of competence • Psycological • Juridical • Uncertainty • Surrogate mother (finance, baby, …) • Prospective parents (baby, health, adoption,…) • Abuse (baby Donna), commerce

23. Surrogacy = Ultimum remedium • Right for child isn’t absolute • Sacrifice of surrogate mother = huge • Emotional, psycological, physical health • Familial, social implications • Surrogacy is treatment, not way for not-natural needs

24. Surrogacy = Treatment • Treatment of woman • Uterus absent • Uterus a-functional • May include frequent abortion, failing IVF • Pregnancy threatens life of mother or child • Problem of uterus is central • not infertility; a normal uterus gives possibility to bear child (donor–embryo, donor gamete)

25. Surrogacy: Conditions • Very intensive consouling • Concentration of competences: one centre in Flanders, one in Wallonië • Follow up of child, parents and surrogate mother • Start in research setting

26. Surrogacy: Conditions for surrogate mother • at least one child (complications, emotional experience, here one procreation) • < 45 y • Took decision totally free

27. Surrogacy: Conditions for prospective parents • Strict medical indications • < 43 y (one ovocyte), other cases < 45y

28. Surrogacy: Other conditions • Number of embryo’s as in KB june 2003 • Contract • Child must be handed over in all situations • Child must always be accepted • Embedding of the way to make medical decisions • No commercial goals • Contract is pre-adoption declaration • Simplified adoption procedure

29. Thanks