ART and politics

Patrik Vankrunkelsven

Senator

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– ….

ART and politics: legislation

• Existing legislationI. 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 legislationI. ART, general rulesII. Surrogacy

Existing legislation

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

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

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 accessibilityless MP, LBW> less costs for

pediatric support > budget for refunding

Future legislation

I. Assisted Reproductive Technology 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

(I.) Assisted Reproductive Technology general rules: Problems

1. To much IVF/ICSI

2. Age of the woman

3. What about redundant (supernumerary ?) embryos

4. Information / counseling

5. Anonymity

6. Decease of male partner

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

(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

(1)To much IVF/ICSI: Smoking

• Clinical pregnancy rate

0

5

10

15

20

25

30

35

40

ICSI IVF

non smokerssmokers

(1)To much IVF/ICSI: Cost per delivery

• Per 1 million euro spended for infertillity treatment

– Apply WHO guidelines: 300 babies

– IVF 80 babies

(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, …)

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

3. What about redundant embryos

• No other prelevation if cryoconserved embryos are available

• If reproductive use isn’t necessary anymore– Donation– Destruction– Research

4. Information / counseling

• Condition and period (5 y, exceptions possible) of cryoconservation

• Options of redundant embryos

• What in case of decease, divorce, …

• Informed consent

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

(5) Anonymity/information

• Information on caracteristiques available for other centres

• Max 6 siblings

6. Decease of male partner

• Post mortem implantation– after delay of 6 months – no longer than 2 years later

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

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

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)

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

Surrogacy: Conditions for surrogate mother

• at least one child (complications, emotional experience, here one procreation)

• < 45 y

• Took decision totally free

Surrogacy: Conditions for prospective parents

• Strict medical indications

• < 43 y (one ovocyte), other cases < 45y

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

Thanks