CASE OF COSTA AND PAVAN v. ITALY
Remainder inadmissible;Violation of Article 8 - Right to respect for private and family life (Article 8-1 - Respect for family life;Respect for private life);Non-pecuniary damage - award
András Sajó;Françoise Tulkens;Guido Raimondi;Helen Keller;Isabelle Berro-Lefèvre;Paulo Pinto De Albuquerque
7. The applicants were born in 1977 and 1975 respectively and live in Rome. 8. Following the birth of their daughter in 2006, the applicants learned that they were healthy carriers of cystic fibrosis. The child had been born with the disease. 9. In February 2010, when the first applicant was pregnant again, the applicants, who wanted to have a healthy child unaffected by the genetic disease, had a prenatal test carried out. The results showed that the foetus was affected by cystic fibrosis. The applicants then decided to have the pregnancy terminated on medical grounds. 10. The applicants now want to take advantage of assisted reproduction technology (hereafter “ART”) and preimplantation genetic diagnosis (hereafter “PGD”) before the first applicant becomes pregnant again. However, under Law no. 40 of 19 February 2004, ART is available only to sterile or infertile couples. There is a blanket ban on the use of PGD. 11. By a decree of 11 April 2008, the Ministry of Health extended access to ART to couples in which the man suffers from a sexually transmissible viral disease (such as the HIV virus, or hepatitis B and C) to allow them to conceive children without the risk of contamination of the woman and/or the fœtus inherent in conception by natural means. 12. According to the information provided by the Government and the first third-party intervener, this operation is done by “sperm washing” prior to in vitro fertilisation. “Access to assisted reproduction technology shall be authorised only where proof is adduced that it is otherwise impossible to eliminate the causes of inability to procreate, and, in any event, [said access] shall be limited to medically certified inexplicable cases of sterility or infertility and to cases of sterility or infertility [deriving] from a medically certified and verified cause. ...” “... Adult couples, composed of two persons of opposite sex, who are married or living together as a couple, of potentially fertile age and alive may have access to assisted reproduction technology.” “Individuals satisfying the conditions provided for in section 5 shall be informed of the number and, at their request, the state of health of the embryos produced and destined to be transferred into the womb.” “... Any test regarding the state of health of an embryo created in vitro, within the meaning of section 14(5) [of Law no. 40 of 2004], must be for observation purposes alone (dovrà essere di tipo osservazionale). ...” 13. In this decree the reference to “observation” purposes mentioned in Ministry of Health decree no. 15165 of 21 July 2004 was deleted. 14. Furthermore, the part of this decree concerning certification of infertility or sterility provides that, for the purposes of access to assisted reproduction technology, this must be done “... having regard also to particular conditions in the presence of which – where the man is a carrier of a sexually transmissible viral disease by infection with HIV, or hepatitis B and C – the high risk of infection for the mother or for the fœtus constitutes de facto, in objective terms, an obstacle to procreation, requiring precautions that necessarily result in infertility of a kind comparable to acute male infertility deriving from a verified and medically certified cause such as that referred to in section 4(1) of Law no. 40 of 2004”. 15. In this judgment the court set aside on grounds of ultra vires the part of Ministry of Health decree no. 15165 of 21 July 2004 limiting any test relating to the state of health of embryos created in vitro to observation purposes alone. The court found that the power to establish the scope of application of such tests was a matter for the legislature alone and not the ministry, which had purely implementing powers. 16. In this order, following urgent proceedings, the delegated judge of the Salerno Court granted, for the first time, a couple who were neither sterile nor infertile, and both healthy carriers of muscular atrophy, access to PGD. 17. The judge referred, among other things, to the new provisions introduced by the Ministry of Health decree no. 31639 of 11 April 2008 no longer limiting tests on the state of health of embryos created in vitro to observation purposes alone and authorising access to assisted reproduction for couples in which the man carried a sexually transmissible viral disease. 18. He thus considered that PGD had to be regarded as one of the prenatal monitoring techniques for ascertaining an embryo’s state of health. Accordingly, prohibiting access to the technique, in the claimants’ case, engaged the medical liability of the Health Director of the Centre for Reproductive Medicine, who was the defendant in the proceedings, for failure to provide a health service. 19. The judge also found that since the mother had the right to abort an unhealthy fœtus, it would be unreasonable not to guarantee her the right to know the state of health of the embryo by means of PGD. 20. The judge accordingly ordered the health director to carry out a PGD on the claimants’ in vitro embryo in order to determine whether it was affected by muscular atrophy. 21. The relevant parts of this Convention read as follows: “Tests which are predictive of genetic diseases or which serve either to identify the subject as a carrier of a gene responsible for a disease or to detect a genetic predisposition or susceptibility to a disease may be performed only for health purposes or for scientific research linked to health purposes, and subject to appropriate genetic counselling”. 22. Paragraph 83 of the Explanatory Report to the Oviedo Convention provides: Article 12 as such does not imply any limitation of the right to carry out diagnostic interventions at the embryonic stage to find out whether an embryo carries hereditary traits that will lead to serious diseases in the future child. 23. The Oviedo Convention, signed on 4 April 1997, has not been ratified by the Italian Government. 24. This directive has established a minimum quality and safety standard for the donation, procurement, testing, processing, preservation, storage and distribution of human tissues and cells, thus providing for harmonisation of national regulations. It also covers embryos transferred following PGD. 25. The CDBI drew up this report with a view to providing information on preimplantation and prenatal diagnosis and the legal and ethical questions arising from their use in various European countries. The relevant extracts of this document are worded as follows: [a) Context] “In vitro fertilisation has been performed since the late ‘70s to help couples with fertility problems. Advances in reproductive medicine have opened new possibilities to avoid genetic disease by selective transfer of embryos. At the beginning of the’90s, preimplantation genetic diagnosis (PGD) was introduced as a possible alternative to prenatal genetic diagnosis (PND) for couples at risk of transmitting a particularly severe genetic defect, avoiding the difficult decision of whether or not to terminate a pregnancy.” [b) PGD cycle] “A “PGD cycle” comprises the following steps: ovarian stimulation, oocyte retrieval, in vitro fertilisation of several mature oocytes, by introcytoplasmic sperm injection (ICSI), removal of 1 or 2 embryonic cells, genetic analysis of nuclear material from those cells and lastly selection and transfer of embryos not carrying the abnormal genetic characteristics in question.” [c) PGD uses] “Use of PGD for medical indications has been offered to couples at high risk of transmitting a specific genetic disease of particular gravity ... and untreatable at the time of diagnosis. The risk was often identified on the basis of family history or the birth of affected children. Numerous monogenic indications currently meet these criteria justifying application of PGD, such as cystic fibrosis, Duchenne Muscular Dystrophy, myotonic dystrophy, Huntington’s disease, spinal muscular atrophy in infants and haemophilia.” “In those countries where preimplantation genetic diagnosis (PGD) is performed, it has become an established clinical method to analyse genetic characteristics of embryos created by in vitro fertilisation, and to obtain information which is used to select the embryos to be transferred. The use of PGD is mainly requested by couples carrying genetic conditions linked to severe disorder or premature death of their offspring who wish to avoid initiation of a pregnancy that may not come to term or that may entail the difficult question of terminating the pregnancy in case of a detected particularly severe genetic defect.” 26. This report shows that PGD patients from countries where the practice is prohibited go abroad for the diagnosis. Italian patients generally go to Spain, Belgium, the Czech Republic or Slovakia. 27. The study also points to the inconsistency of legislative provisions which prohibit access to PGD yet authorise access to prenatal diagnosis and medical termination of pregnancy in order to avoid serious genetic diseases in children. 28. The relevant parts of the press release on this report read as follows: “Concerted action at EU and national level is needed to tackle this problem, according to a report adopted by Parliament today. The current EU legislative framework is poorly suited to rare diseases and not well defined. Although rare diseases contribute greatly to morbidity and mortality, they are mostly invisible in health care information systems due to the lack of appropriate coding and classification systems. ... Parliament adopted an amendment today which recommends that Member States encourage efforts to avoid rare diseases which are hereditary, through genetic counselling of carrier parents and, where appropriate and “not contrary to existing national laws and always on a voluntary basis, through pre-implantation selection of healthy embryos”.” 29. The documents in the Court’s possession (namely, the reports of the Council of Europe and the European Commission, paragraphs 25 to 27 above) show that PGD is banned, at least for the prevention of transmission of genetic diseases, in the following countries: Austria, Italy and Switzerland. 30. With regard to Switzerland, the Court notes that on 26 May 2010 the Federal Council submitted for consultation a draft amendment to the current ban on PGD contained in the Assisted Reproduction Act, to provide for regulated access. An amendment to Article 119 of the Federal Constitution will be necessary in order to implement the change. 31. It also appears that PGD is authorised in the following countries: Germany, Belgium, Denmark, Spain, Finland, France, Georgia, Greece, Norway, the Netherlands, Portugal, the Czech Republic, the United Kingdom, the Russian Federation, Serbia, Slovenia and Sweden. 32. PGD is not the subject of specific regulations in the following countries: Bulgaria, Cyprus, Malta, Estonia, Ireland, Latvia, Luxembourg, Poland, Romania, Slovakia, Turkey and Ukraine. The Court notes that three of those countries (Cyprus, Turkey and Slovakia allow access to PGD in practice. 33. The Court also observes that in the case of Roche v. Roche and Others ([2009] IESC 82 (2009)), the Irish Supreme Court established that the concept of the unborn child did not apply to embryos created through in vitro insemination, which accordingly did not benefit from the protection provided for in Article 40.3.3. of the Irish Constitution recognizing the right to life of the unborn child. In that case the applicant, who had already had a child following in vitro fertilisation, had applied to the Supreme Court for leave to have implanted three other embryos created by the same fertilisation process, despite the lack of consent of her former partner from whom she had separated in the meantime. 34. This Bill seeks to extend the use of PGD to precluding the risk of giving birth to a child who is a healthy carrier of a serious genetic disease (access to this technique to avoid giving birth to children affected by genetic diseases being already provided for in Belgian law). The relevant passages of the Bill are set out below: “Requests for preimplantation testing have increased over time and this is now an option for couples who run a high risk of giving birth to a child with a serious hereditary disorder where mutation can be detected. ... Future parents generally prefer preimplantation genetic diagnosis (PGD) to prenatal diagnosis. Indeed ... “where the fœtus is affected this will involve terminating the pregnancy from three months onwards, which is generally a source of mental distress for parents who have invested emotionally in the fœtus as their future child ... Moreover, it is possible that several successive pregnancies have to be terminated before a healthy fœtus can be obtained [Source: Bioethics Advisory Committee, opinion no. 49 on the use of PGD] Accordingly, the main advantage of preimplantation testing is that termination of pregnancy can be avoided. It has been observed that this constitutes the main motivation of the majority of couples seeking the treatment, these couples having often already endured the distressing experience of terminating a pregnancy on medical grounds.”