RESTRICTIVE LAWS IN ITALY: IMPACT ON COUPLES

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RESTRICTIVE LAWS IN ITALY IMPACT ON COUPLES

• 9 International ICSI Conference
• Budapest 2008
• Rossella Bartolucci
• Sos Infertilità Onlus
• http//www.sosinfertilita.net
• Italy

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SOMETHING ABOUT US

• The 5 of us belonging to the Board of the
  Association, have been infertile patients, we
  have gone through ART.
• Some of us had children through ART, some through
  adoption, some naturally.
• After years of experience giving information in
  the website, we gave birth Sos Infertilità Onlus,
  to help patients overcome lonelyness, lack of
  correct information, limitations of Law n 40.
• How? Through a help-line, a news letter, monthly
  meetings with patients and professionals
  (doctors, biologists, psychologists), website
  with useful contents, discussion forum.
• We cooperate with Milano Provincial Government.

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LAW 40/2004 ON ART

• Law 40/2004 on ART, introduced in Italy, imposed
  various and important limitations to patients
• -Access to ART to infertile patients only,
  excluding couples with genetic and infectious
  troubles. (Art. 4)
• -Limits in the number of embryos to be created
  in vitro, no more than 3. (Art. 14)
• -Obligation to replace in the patients womb all
  the generated embryos. (Art. 14)
• -Prohibition of embryo freezing (except than in
  particular cases). (Art. 14)
• -Prohibition of any donor techniques (oocytes,
  sperm, embryos). (Art 4)
• -Prohibition of PGD. (Guide Lines of the Law)
• -Proibition of Stem Cells Research (Art. 13)
• -Surrogacy, clearly forbidden by this law (Art.
  12), was anyway not possible in Italy even before
  due to the principle The mother is that one who
  delivers

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EXAMPLES OF PUNISHMENTS

• Professionals (not patients) who practise ART
  with donor sperm or eggs, are punished with a
  fine from 300.000 euros up to 600.000 (Art. 12).
• Those ones who organize surrogacy are punished
  with jail from 3 months up to 2 years and with a
  fine from 600.000 to 1.000.000 euros (Art. 12).
• Professionals treated as criminals.

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AND, BEFORE THIS LAW?WHICH SITUATION?

• No Law on ART in Italy, before 2004.
• Circlular Letter Degan (Minister of Health) 55/75
  about Donor (egg and sperm) ART, permitted in
  Private Clinics, forbidden in Public Hospital,
  not reimbursed.
• From 1997 up to 2002, various Orders forbade
  advertisement, import, export, sell of gametes
  and embryos.
• Code of Medical Ethics contained a part regarding
  ART forbidding, for instance, post mortem
  insemination.
• Private Codes of Conduct as the CECOS Clinics
  one.

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DID WE NEED A LAW?

• What there is need of, is a clear regulation of
  Clinics standars and quality.
• Up to now, Italian ART Registry, the only
  positive creation of Law 40, didnt complete
  the Clinics census.

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WHY THIS LAW?

• To satisfy ethical and religious point of view of
  a part of italian citizens. To please the Church.
  Because, at the moment, italian main Political
  Parties power depends on catholic people votes.
• To protect embryo, considered the same as a
  full human being, even in the first 48 hours of
  its life. 8 cells Embryo is more protected than
  grown up woman and mans health.
• To protect the blood line, in the prohibition
  of Donor ART.

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WHAT HAPPENED AFTER THE LAW HAD BEEN APPROUVED?

• JUNE 13 2005 Referendum on ART, to abrogate key
  articles of the Law.
• 1- To abrogate the prohibition of stem cells
  research on 30.000 surplus embryos existing in
  Italy.
• 2- To abrogate the limit of 3 embryos to be
  created and the obligation to transfer all the
  obtained embryos.
• 3- To abrogate the article where the conceived
  one, the embryo, is given the same status and
  rights as the parents.
• 4- To abrogate the prohibition of Donor ART.

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RESULTS OF THE REFERENDUM

• Following a rich and strong campaign of
  ScienceLife, the Long hand of the Church, to
  invite italians to not vote, only a 25,9 voted
  (of this percentage, almost the totality voted
  yes for the abrogation).
• In Italy, a referendum is valid if 501 people
  vote.
• The referendum failed, the Law is still there.

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(No Transcript)
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WHAT IMPACT ON INFERTILE PEOPLE

• DECREASING OF QUALITY OF THE TREATMENTS, IN TERMS
  OF PREGNANCY RATES.
• INCREASING OF CROSS-BORDER REPRODUCTIVE
  CARE/PROCREATION TOURISM.
• LETS GO TO DATAS

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Italian ART registry pre and post Law results
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PREGNANCY RATE PER (fresh) TRANSFER Italy

IVF
ICSI
2003 2004
2005
Plt0.001
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PREGNANCY RATE PER (fresh) TRANSFER EUROPE

IVF
ICSI
Year 1997 1998 1999 2000
2001 2002 2003 2004
La distribuzione della età è simile a Italia
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Registry Datas 2005Oocytes

• Eggs pick up 29.380 ( 88 of started cycles)
• 209.236 picked up eggs ( 7.1 ovociti /pu)
• 76.914 inseminated eggs ( 2.7 per insem.)

25.489 cryopreserved 106.833 eliminated ( 51 )

For every picked up egg around 300-400 UI of FSH
are used. 42 milions of FSHs UI thrown away.
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Insemination ICSI vs FIVET

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Number of replaced embryos

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Eggs vs Embryos criopreserved cycles
2005 2003
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2005 Italian Register Impact on patients

• The efficacy of treatments is decreased
• and risks increased by some law restrictions

Cross-border Reproductive Care promoted
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Vitanova Copenhagen Insemination. Couples,
single women and lesbians. Acupuncture.
www.vitanova.dk
Riprod. Assistita ProCrea Centro Fertilità della
Svizzera Italiana - Lugano e Bellinzona
www.Procrea.ch
Iscare, a.s. Centro assistenza alla riproduzione
IUI, ICSI, PiGD www.iscare.it
Fecondazione Assistita Anche informazione in
italiano Institut Dexeus. Barcellona. Spagna
www.dexeus.com
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Couples cross the border for

• Sperm Donation
• Egg Donation
• Embryo Donation
• PGD
• Gold Standard FIVET and ICSI

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ovodonazione
Donazione di seme
PGD
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Increasing of italian couples in foreign
clinicsN of italian patients in 21 selected
foreign clinics
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Cross-Border reproductive care in selected
foreign clinics
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Cross the border is expensive
The majority of those ones crossing the borders
has not money problems, only a minority of the
poorer people go abroad the Law caused a
disparity of treatment butween rich and poorer
people.
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DATAS FROM OUR HELP-LINE

• Requested info
• ART in general 16
• Donor ART 6
• Italian clinics 21
• Foreign Clinics 12
• Medical Info 16
• Emotional Support 27
• Other 2

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MATILDA

• I went through 3 ICSI cycles in Italy, after
  the Law all failed.
• Last one, with the limitations of Law 40, with a
  low stimulation, I produced 18 eggs.
• All but three were thrown in the rubbish, because
  of the new Law limits.
• Three eggs inseminated, one bad quality embryo
  transfered, no pregancy, again.
• I felt without hope.
• We decided to go abroad, saving money for months
  to do that.
• We went to Belgium, we felt so lonely there, far
  from home, with a hiding feeling, with the
  simple, denied, desire to become parents.
• I produced 19 eggs this time (despite my age,
  38), they inseminated them all 5 good embryos
  created, 2 of them frozen, 3 replaced and
• My daughter is here with me now!

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GIANNA

• Im 29 years old. Because of some problems with
  my husbands sperm (they are too slow to catch
  the egg!!!) we had to undergo ICSI. We went to
  Milano, to a big Hospital, Doctors said that, due
  to my age, we had good possibilities to succeed
  the very first time. Somebody told me about a new
  law, about limits, risks. But I didnt know, I
  didnt mind, I just wanted a child.
• Three eggs were inseminated, three very good
  quality embryos replaced (because, they told me,
  law obliged them to do so, but I didnt mind, I
  didnt know the risks), three wonderful babies
  started growing inside me.
• We were so happy.
• Suddendly, ad 24 weeks pregnancy, the happiness
  ended.
• The babies were born.
• Francesca, the girl, died 2 days later. A part of
  me died with her.
• 2 boys survived, they are still in intensive
  care, dont know what will happen.
• Now I know, I mind, I know that this tragedy
  happened to me because of a Law that wants to
  protect the embryo.

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SANDRA AND DAVIDE

• We are a couple at genetic risk, we are not
  infertile, our risk is 1 in 4 to conceive a child
  sick with beta-thalassemia we can be pregnant
  naturally and then, if, at 20 weeks, we discover
  the baby is not healthy, we can abort it. This we
  can do in Italy. What, according to the law, we
  cannot do, what we had to go to Turkey to do is
  the much less painful thing, conceive through IVF
  and select not affected embryos through PGD.
• Well, thank to turkish law, we are 23 weeks
  pregnant with a healthy baby.

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HOW TO CHANGE THE SITUATION

• . In September and December 2007, in Cagliari and
  Firenze, 2 couples needing PGD filed a petition
  to Court and they won, they got the permit to
  undergo PGD in Italy.
• . In January 2008, following another lodged
  appeal, the Court of Lazio Region abrogated Law
  40 Guidelines, the ones forbidding de facto PGD
  and claimed Art 14 of the Law (the one related
  with limits to 3 embryos to be created and
  obligation to transfer them all) to go against
  Constitution because damaging womans health.
• . At the moment, we are waiting Health Minister
  of the former Government (recently falled down)
  to publish new Guidlines (she, according to the
  law, should have published them within 2007 June
  30).
• . As the best action we associations could do
  now, we are preparing to support more and more
  couples in filing petitions to obtain PGD,
  Golden Standards IVF and reimbursment of ART
  Cycles they had to undergo abroad.

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CONCLUSIONS

• Law n 40 had a negative impact on couples
  because
• Decreased pregnancy rate
• Decreased, de facto, born babies less 1041.
• Increased maternal and fetal risks.
• Increased costs.
• Increased cross-border reproductive care.
• Increased the donor business.
• Increased the suffering of all.

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THANK YOU

• I thank you for Your kind attention.
• Thank you to Dr.Ferraretti, Dr.Chelo, Dr.Borini
  for some datas I used.