CASE OF PARRILLO v. ITALY

1. The case originated in an application (no. 46470/11) against the Italian Republic lodged with the Court under Article 34 of the Convention for the Protection of Human Rights and Fundamental Freedoms (“the Convention”) by an Italian national, Ms Adelina Parrillo (“the applicant”), on 26 July 2011.
2. The applicant was represented by Mr N. Paoletti, Ms C. Sartori and Ms N. Paoletti, lawyers practising in Rome. The Italian Government (“the Government”) were represented by their co ‑ Agents, Ms P. Accardo and Mr G. Mauro Pellegrini.
3. The applicant alleged, in particular, that the ban (under section 13 of Law no. 40 of 19 February 2004) on donating to scientific research embryos conceived through medically assisted reproduction was incompatible with her right to respect for her private life and her right to the peaceful enjoyment of her possessions guaranteed under Article 8 of the Convention and Article 1 of Protocol No. 1. She also complained of a violation of freedom of expression guaranteed under Article 10 of the Convention, of which scientific research was, in her submission, a fundamental aspect.
4. The application was allocated to the Second Section of the Court (Rule 52 § 1 of the Rules of Court).
5. On 28 May 2013 notice of the complaints under Article 8 of the Convention and Article 1 of Protocol No. 1 was given to the Government and the remainder of the application was declared inadmissible.
6. On 28 January 2014 a Chamber of the Second Section composed of Işıl Karakaş, President, Guido Raimondi, Peer Lorenzen, Dragoljub Popović, András Sajó, Nebojša Vučinić and Paulo Pinto de Albuquerque, judges, and Stanley Naismith, Section Registrar, relinquished jurisdiction in favour of the Grand Chamber, neither of the parties having objected to relinquishment (Article 30 of the Convention and Rule 72).
7. The composition of the Grand Chamber was determined in accordance with Article 26 §§ 4 and 5 of the Convention and Rule 24.
8. The applicant and the Government each filed observations on the admissibility and merits of the application.
9. The European Center for Law and Justice, the associations Movimento per la vita, Scienza e vita, Forum delle associazioni familiari, Luca Coscioni, Amica Cicogna Onlus, L’Altra Cicogna Onlus, Cerco Un Bimbo, VOX – Osservatorio italiano sui Diritti, SIFES (Society of Fertility, Sterility and Reproductive Medicine) and Cittadinanzattiva and forty-six members of the Italian Parliament were given leave to intervene in the written procedure (Article 36 § 2 of the Convention and Rule 44 § 3).
10. A hearing took place in public in the Human Rights Building, Strasbourg, on 18 June 2014 (Rule 59 § 3).
There appeared before the Court:
(a) for the GovernmentMs P. Accardo, Mr G. Mauro Pellegrini, Co-Agents, Ms A. Morresi, member of the National Bioethics Committee and professor of physical chemistry at the Department of Chemistry, Biology and Biotechnology, Perugia University, Ms D. Fehily, inspector and technical adviser at the National Transplantation Centre, Rome Advisers;
(b) for the applicantMr N. Paoletti,
Mr M. De Luca, professor of biochemistry and Directorof the Centre for Regenerative Medicine “Stefano Ferrari”, University of Modenaand Reggio Emilia Adviser.
The Court heard addresses by Ms Accardo, Ms Morresi, Mr Paoletti, Mr De Luca and Ms Sartori, and answers to questions by judges from Ms Accardo, Mr Mauro Pellegrini, Mr De Luca, Ms Paoletti and Mr Paoletti.
I. THE CIRCUMSTANCES OF THE CASE
11. The applicant was born in 1954 and lives in Rome.
12. In 2002 she had recourse to assisted reproduction techniques, undergoing in vitro fertilisation (IVF) treatment with her partner at the Centre for reproductive medicine at the European Hospital (“the centre”) in Rome. The five embryos obtained from the IVF treatment were placed in cryopreservation.
13. Before the embryos could be implanted the applicant’s partner died, on 12 November 2003, in a bomb attack in Nasiriya (Iraq) while he was reporting on the war.
14. After deciding not to have the embryos implanted, the applicant sought to donate them to scientific research and thus contribute to promoting advances in treatment for diseases that are difficult to cure.
15. According to the information provided at the hearing before the Grand Chamber, the applicant made a number of unsuccessful verbal requests for release of the embryos at the centre where they were being stored.
16. In a letter of 14 December 2011, the applicant asked the Director of the centre to release the five cryopreserved embryos so that they could be used for stem-cell research. The Director refused to comply with her request on the ground that this type of research was banned and punishable as a criminal offence in Italy under section 13 of Law no. 40 of 19 February 2004 (“Law no. 40/2004”).
17. The embryos in question are currently stored in the cryogenic storage bank at the centre where the IVF treatment was carried out.
II. RELEVANT DOMESTIC LAW AND PRACTICE
A. Law no. 40 of 19 February 2004, in force since 10 March 2004 (“Rules governing medically assisted fertilisation”)
“(1) In order to remedy reproductive problems arising as a result of human sterility or infertility, recourse may be had to medically assisted reproduction in the conditions and in accordance with the procedures provided for by this Law, which guarantees the rights of all the persons concerned, including those of the subject thus conceived.”
Section 5 – Conditions of access
“... [only] couples [composed of persons] who have reached the age of majority, are of opposite sex, are married or cohabiting, are of reproductive age and living may have recourse to assisted reproduction techniques.”
Section 13 – Experiments on human embryos
“(1) It is forbidden to experiment on a human embryo.
(2) Clinical and experimental research on a human embryo shall be authorised only on condition that it is performed exclusively for therapeutic or diagnostic purposes with the aim of protecting the health and development of the embryo and that no alternative methods exist.
(4) Anyone who infringes the prohibition provided for in subsection 1 shall be liable to a term of imprisonment ranging from two to six years and to a fine of 50,000 to 150,000 euros. ...
(5) Any health professional convicted of an offence provided for in this section shall be debarred from practising medicine for one to three years.”
Section 14 – Limits on application of technology to embryos
“(1) The cryopreservation or destruction of embryos is forbidden, without prejudice to the provisions of Law no. 194 of 22 May 1978 [rules on social protection of maternity and voluntary termination of pregnancy].
(2) Embryo production techniques shall not result in the creation of a higher number of embryos than that strictly required for a single and simultaneous implantation and in no circumstances shall more than three embryos be created.
(3) Where the embryos cannot be implanted into the uterus for reasons of serious and proven force majeure affecting the state of health of the woman concerned which were unforeseeable at the time of fertilisation, cryopreservation of the embryos shall be authorised until the date of transfer, which shall be effected as soon as possible.”
18. By judgment no. 151 of 1 April 2009 (see paragraphs 29-31 below), the Constitutional Court declared unconstitutional the provision in section 14(2) of Law no. 40/2004 according to which embryo production techniques must not result in the creation of a higher number of embryos than that strictly required for “a single and simultaneous implantation and in no circumstances shall more than three embryos be created”. It also declared section 14(3) unconstitutional on the ground that it did not provide that the transfer of the embryos should be performed without jeopardising the woman’s health.
B. Opinion of the National Bioethics Committee on adoption for birth (“ADP”) (18 November 2005)
19. Following the enactment of Law no. 40/2004, the National Bioethics Committee examined the issue of the fate of abandoned cryopreserved embryos, the Law making no specific provision in this regard but implicitly banning the use of surplus embryos for scientific research.
20. In that connection the Committee issued an opinion in favour of “adoption for birth”, a practice enabling a couple or a woman to adopt surplus embryos for implantation and thus allowing the embryos in question to be used for the purposes of bringing them to life and starting a family.
C. Ministry of Health decree of 11 April 2008 (“Explanatory notes on assisted reproduction”)
“... Cryopreservation of embryos: ... There are two categories of embryos amenable to cryopreservation: the first is embryos that are awaiting implantation, including those that were cryopreserved prior to the entry into force of Law no. 40 of 2004; the second is embryos that have been certified as abandoned ...”
D. Final report of the “Study Commission on embryos” of 8 January 2010
21. By a decree of 25 June 2009, the Ministry of Health appointed a Study Commission on embryos stored in cryopreserved form in assisted reproduction centres. The following is a passage from the final report by that Commission, adopted by a majority on 8 January 2010.
“The legal ban on the destruction of embryos is to be understood as prohibiting the interruption of cryopreservation other than in two cases: where the thawed embryo can be implanted in the uterus of the mother or another woman willing to have it implanted; or where natural death or permanent loss of viability as an organism can be medically certified. In the light of current [scientific] knowledge, the viability of an embryo cannot be certified unless it has been thawed, thus creating the paradoxical situation in which, once thawed, an embryo cannot be frozen a second time and if it is not immediately implanted into the uterus death will inevitably ensue. Hence, a tutiorist prospect of frozen embryos being stored for an indeterminate period. However, it can be assumed that advances in scientific research will make it possible to determine the criteria and methods for diagnosing death, or in any event loss of viability, of cryopreserved embryos. It will thus be possible to overcome the present – and legally inevitable – paradox of potentially indefinite cryopreservation. Pending those results, [it should be reaffirmed that] the explicit ban under section 14 of Law no. 40 of 2004 on the destruction of embryos, including therefore frozen embryos, cannot be ignored. That is not all, for as regards the fate of surplus embryos, the authors of Law no. 40 opted for their storage and not their destruction, thus establishing as a principle that they should be kept alive even where their fate is uncertain.”
E. The Constitution of the Italian Republic
22. The relevant Articles of the Constitution provide as follows.
“The Republic promotes the development of culture and of scientific and technical research. ...”
“The Republic safeguards health as a fundamental right of the individual and as a collective interest. ...”
“Legislative power is exercised by the State and the Regions in compliance with the Constitution and the constraints deriving from the Community legal order and international obligations. ...”
F. Constitutional Court judgments nos. 348 and 349 of 24 October 2007
23. These judgments address questions raised by the Court of Cassation and an appellate court regarding the compatibility of Legislative Decree no. 333 of 11 July 1992 on the criteria for calculating expropriation compensation with the Constitution and with Article 6 § 1 of the Convention and Article 1 of Protocol No. 1. They take account of the Court’s Grand Chamber judgment in Scordino v. Italy (no. 1) [GC], no. 36813/97, ECHR 2006 ‑ V.
24. In these judgments, after reiterating the legislature’s obligation to comply with international obligations (Article 117 of the Constitution), the Constitutional Court defined the place assigned to the European Convention on Human Rights in the Italian legal system, stating that it was of intermediate rank between an ordinary law and the Constitution. The Constitutional Court also stated that the courts below had to interpret rules of domestic law in a manner compliant with the Convention and the Court’s case-law (judgment no. 349, point 6.2, see paragraph 26 below) and that, where such an interpretation was impossible or the courts below doubted the compatibility of the domestic law with the Convention, they had to raise a question of constitutionality before the Constitutional Court.
25. The relevant passages of judgment no. 348 of 24 October 2007 read as follows.
“4.2. ... It is necessary to define the rank and role of the provisions of the European Convention on Human Rights with a view to determining, in the light of [Article 117 of the Constitution], their impact on the Italian legal order. ...
4.3. While on the one hand [these provisions] complement the protection of fundamental rights, and therefore supplement the values and fundamental principles protected by the Italian Constitution itself, on the other hand they maintain their formal status as simple sources of ordinary legislation. ...
Today the Constitutional Court is called upon to clarify the normative and institutional question [referred to above], which has significant practical implications for the everyday work of legal practitioners. ...
The ordinary courts do not have the power to set aside ordinary legislation conflicting with the European Convention on Human Rights, since the alleged incompatibility between the two raises a question of constitutionality regarding a possible violation of Article 117 § 1 of the Constitution and [thus] falls within the exclusive jurisdiction of the Constitutional Court. ...
4.5. ... The principle enshrined in Article 117 § 1 of the Constitution will only become operative in practice if ‘the international law obligations’ binding on the legislative powers of the State and the Regions are duly specified. ...
4.6. Compared with other international law treaties, the European Convention on Human Rights has the particular feature of having instituted the jurisdiction of a court, the European Court of Human Rights, which is assigned the role of interpreting the provisions of the Convention. Article 32 § 1 [of the Convention] provides: ‘The jurisdiction of the Court shall extend to all matters concerning the interpretation and application of the Convention and the Protocols thereto which are referred to it as provided in Articles 33, 34, 46 and 47.’
Since legal provisions acquire meaning [ vivono ] through the interpretation which is given to them by legal practitioners, and in the first place the courts, the natural consequence of Article 32 § 1 of the Convention is that the international law obligations undertaken by Italy in signing and ratifying the European Convention on Human Rights include the duty to bring its own legislation into line with the provisions of the Convention in accordance with the meaning attributed to these by the [European] Court [of Human Rights], which was specifically set up to interpret and apply those provisions. It is therefore not correct to speak of a jurisdictional competence that operates in addition to that of the Italian courts, but rather of a pre-eminent interpretative role which the signatory States have recognised in the European Court, thus contributing to clarifying their international law obligations in that particular area.
4.7. It should not be inferred from the foregoing that the provisions of the European Convention on Human Rights, as interpreted by the Strasbourg Court, have the force of constitutional law and thus escape scrutiny by this court of their constitutional legitimacy. It is precisely because the provisions in question supplement constitutional principles, while remaining of lower rank, that it is necessary that they be in conformity with the Constitution. ...
Since, as stated above, the provisions of the European Convention on Human Rights acquire meaning through the interpretation given to them by the European Court, scrutiny of their constitutionality must give consideration to the norms that result from that interpretation, and not the provisions considered in themselves. Moreover, the judgments of the Strasbourg Court are not unconditionally binding for the purposes of reviewing the constitutionality of national laws. This review must always be a balancing exercise between the constraints arising from international law obligations, as imposed by Article 117 § 1 of the Constitution, and the constitutionally protected interests enshrined in other Articles of the Constitution. ...
5. In the light of the methodological principles set out above, the constitutional review requested by the referring court must be carried out in such a way as to ascertain: (a) whether there is actually a conflict that cannot be resolved through interpretation between the domestic provision in question and the provisions of the European Convention on Human Rights, as interpreted by the European Court and regarded as a source supplementing the constitutional principle contained in Article 117 § 1, and (b) whether the provisions of the European Convention on Human Rights integrating that principle, and understood according to their interpretation by the [European] Court, are compatible with the Italian constitutional order. ...”
26. The relevant parts of judgment no. 349 of 24 October 2007 read as follows.
“6.2. ... [The principle laid down] in Article 117 § 1 of the Constitution [does not mean] that the provisions laid down in international agreements and implemented by ordinary legislation, as is the case for the provisions of the European Convention on Human Rights, must be regarded as having constitutional status. As the constitutional principle in issue imposes a duty on the legislature to comply with those provisions, any national provision incompatible with the European Convention on Human Rights and thus with the ‘international law obligations’ referred to in Article 117 § 1 would ipso facto violate this constitutional principle. Article 117 § 1 ultimately creates a reference to Convention provisions which may be relevant in a particular case, giving life [ dà vita ] and substantive content to the international law obligations evoked generally and to the [underlying constitutional] principle, such as to be generally classified as ‘interposed provisions’, and which in turn are reviewed in terms of their compatibility with the Constitution, as will be discussed below.
It follows that it is a matter for the ordinary courts to interpret national law in conformity with the international legal provision in question ... Where this is not possible, or where the court doubts the compatibility of the national law with the ‘interposed’ Convention provision, it must raise a question of constitutionality before the Constitutional Court in the light of Article 117 § 1 of the Constitution ...
Regarding the European Convention on Human Rights, consideration must be given to its special nature compared with other international agreements since it goes further than simply listing reciprocal rights and duties of the signatory States. The latter have created a system for the uniform protection of fundamental rights. The application and interpretation of that system is naturally in the first instance a matter for the courts of the member States, which are the ordinary courts in relation to Convention law. Definitive uniformity in application is on the other hand guaranteed by the centralised interpretation of the European Convention on Human Rights – a task assigned to the European Court of Human Rights in Strasbourg, which has the last word and the jurisdiction of which ‘shall extend to all matters concerning the interpretation and application of the Convention and the Protocols thereto which are referred to it as provided [therein]’ (Article 32 § 1 of the Convention). ...
The Constitutional Court and the Strasbourg Court ultimately have different roles, even though both share the same objective of protecting as effectively as possible fundamental rights. The interpretation of the Rome Convention and of the Protocols is a matter for the Strasbourg Court, which guarantees the application of a uniform level of protection throughout the member States.
However, where a question is raised before the Constitutional Court regarding the constitutionality of a national provision in the light of Article 117 § 1 of the Constitution in respect of an incompatibility – insurmountable through interpretation – with one or more provisions of the European Convention on Human Rights, it is incumbent on this Court to determine whether there actually is an incompatibility and [where one is found to exist] to verify whether the actual provisions of the European Convention on Human Rights, as interpreted by the Strasbourg Court, guarantee a protection of fundamental rights that is at least equivalent to the level guaranteed by the Italian Constitution.
This does not require an assessment of the interpretation by the Strasbourg Court of a provision of the European Convention on Human Rights ... but verification as to whether that provision, as interpreted by the court expressly charged with that task by the member States, is compatible with the relevant constitutional provisions. Accordingly, a correct balance will be struck between the duty imposed by the Constitution to guarantee respect for international obligations and the need to prevent this resulting in a breach of the Constitution itself.”
G. The case-law of the Constitutional Court
1. Constitutional Court Order no. 369 of 24 October 2006
27. In this Order the Constitutional Court declared inadmissible a question of constitutionality raised by the Cagliari Court in respect of section 13 of Law no. 40/2004, which bans the use of pre-implantation diagnosis.
28. In ruling thus the Constitutional Court observed that the court referring the question for a preliminary ruling had confined itself to raising the question of the constitutionality of section 13 alone of Law no. 40/2004 whereas, according to the terms of the application for a preliminary ruling, other provisions of the same Law also had the effect of banning pre ‑ implantation diagnosis, particularly section 14(3).
2. Constitutional Court judgment no. 151 of 1 April 2009
29. This judgment concerns the constitutionality of the provisions of section 14(2) and section 14(3) of Law no. 40/2004, which provide for the creation of a limited number of embryos (maximum of three) and the obligation to implant them simultaneously and also prohibit the cryopreservation of surplus embryos.
30. The Constitutional Court held that the subsections in question were unconstitutional because they jeopardised women’s health by obliging them to undergo several cycles of ovarian stimulation and also to expose themselves to the risk of multiple pregnancies on account of the prohibition on selective abortion.
31. The judgment does not make any reference to the European Convention on Human Rights. Nor was the Convention cited by the referring courts (Lazio Regional Administrative Court and Florence Court).
3. Constitutional Court Order no. 97 of 8 March 2010
32. In this Order the Constitutional Court declared inadmissible the questions of constitutionality that the Milan Court had raised before it, as those questions had already been dealt with in its judgment no. 151/2009.
4. Constitutional Court Order no. 150 of 22 May 2012
33. In this Order, which referred to S.H. and Others v. Austria ([GC], no. 57813/00, ECHR 2011), the Constitutional Court remitted to the lower court the case brought before it concerning the ban on heterologous fertilisation laid down in Law no. 40/2004.
5. Constitutional Court judgment no. 162 of 10 June 2014
34. This judgment concerns the constitutionality of the blanket ban on access to heterologous fertilisation in the event of medically established sterility or infertility, as provided for in Law no. 40/2004.
35. Three courts of ordinary jurisdiction had sought a preliminary ruling from the Constitutional Court regarding the question whether the Law in issue was compatible with Articles 2 (inviolable rights), 3 (principle of equality), 29 (rights of the family), 31 (State’s obligations to protect rights of the family) and 32 (right to health) of the Constitution. One of those courts – the Milan Court – had also asked the Constitutional Court to rule on the compatibility of the Law in issue with Articles 8 and 14 of the Convention.
36. The Constitutional Court ruled the relevant legislative provisions unconstitutional.
37. It held in particular that the choice of the applicants in the proceedings to become parents and found a family with children was an aspect of their freedom of self-determination regarding the sphere of their private and family life which attracted the protection of Articles 2, 3 and 31 of the Constitution. It also observed that persons who were totally sterile or infertile had a right to protection of their health (Article 32 of the Constitution).
38. It found that, while the rights in question could be the subject of restrictions based on ethical considerations, those restrictions could not amount to a blanket ban unless it were otherwise impossible to protect other constitutionally guaranteed freedoms.
39. With regard to the compatibility of the legislative provisions in issue with Articles 8 and 14 of the Convention, the Constitutional Court confined itself to observing that the questions in that regard had been covered in the conclusions it had reached on the constitutionality of the provisions in issue (see above).
H. Orders of the domestic courts regarding access to pre-implantation diagnosis
1. Cagliari Court Order of 22 September 2007
40. In this Order the Cagliari Court observed that the claimants had first instituted urgent proceedings in the context of which a question of constitutionality had been raised. It added that this question had then been declared inadmissible by Order no. 369 of the Constitutional Court adopted on 24 October 2006 (see paragraphs 27-28 above), which had therefore not provided any guidance regarding the interpretation to be given to domestic law in the light of the Constitution.
41. With regard to the civil proceedings brought before it, the court pointed out that there was no explicit ban under domestic law on access to pre-implantation diagnosis, and that interpreting the Law in such a way as to construe that a ban existed would have been contrary to the claimants’ right to be duly informed of the medical treatment that they sought to undergo.
42. Furthermore, it noted that a ban on pre-implantation diagnosis had been introduced subsequently by secondary legislation, namely, Ministry of Health Decree no. 15165 of 21 July 2004 (particularly the part providing that “tests to determine the state of health of embryos created in vitro, within the meaning of section 14(5) [of Law no. 40 of 2004], cannot be carried out for purposes other than observation of those embryos (“ dovrà essere di tipo osservazionale ”). It held that this was contrary to the principle of legality and the Council of Europe’s Oviedo Convention.
43. It observed, lastly, that interpreting Law no. 40/2004 so as to allow access to pre-implantation diagnosis was consonant with the right to health accorded to the mother. Consequently, it granted the claimants access to pre-implantation diagnosis.
2. Florence Court Order of 17 December 2007
44. In this Order the Florence Court referred to the Order of the Cagliari Court cited above and stated that it agreed with its interpretation of the domestic law. Accordingly, it granted the claimants access to pre-implantation diagnosis.
3. Bologna Court Order of 29 June 2009
45. In this Order the Bologna Court granted the claimants access to pre-implantation diagnosis, stating that this was consonant with the protection of women’s health recognised by the Constitutional Court’s interpretation of domestic law in its judgment no. 151 of 1 April 2009 (see paragraphs 29-31 above).
4. Salerno Court Order of 9 January 2010
46. In this Order, adopted following urgent proceedings, the Salerno Court referred to the new developments introduced by Ministry of Health Decree no. 31639 of 11 April 2008, namely the fact that tests to determine the state of health of embryos created in vitro were no longer limited to observation of those embryos and that access to assisted reproduction was authorised for couples where the man was a carrier of sexually transmitted viral diseases.
47. It concluded that pre-implantation diagnosis had to be regarded as just one of the antenatal treatment techniques designed to determine the state of health of the embryo.
48. Consequently, it authorised pre-implantation diagnosis of the claimants’ embryo in vitro.
5. Cagliari Court Order of 9 November 2012
49. In this Order the Cagliari Court referred to the reasoning in the above-cited Orders. It indicated, further, that judgments nos. 348 and 349 delivered by the Constitutional Court on 24 October 2007 showed that interpreting the law with a view to guaranteeing access to pre-implantation diagnosis was compatible with the European Convention on Human Rights, especially having regard to the judgment delivered by the Strasbourg Court in Costa and Pavan v. Italy (no. 54270/10, 28 August 2012).
6. Rome Court Order of 15 January 2014
50. In this Order the court raised the question of the constitutionality of sections 1(1) and (2) and 4(1) of Law no. 40/2004, which prohibit couples who are neither sterile nor infertile from using assisted reproduction techniques with a view to obtaining a pre-implantation diagnosis. The court also considered the matter from the standpoint of Articles 8 and 14 of the Convention.
51. While having regard to the judgment in Costa and Pavan (cited above), it found that the Law should not be interpreted extensively, since it did expressly provide that access to assisted reproduction techniques was reserved to sterile or infertile couples.
I. Question of the constitutionality of section 13 of Law no. 40/2004 raised by the Florence Court
52. In a decision of 7 December 2012, the Florence Court raised the question of the constitutionality of the ban under section 13 of Law no. 40/2004 on donating surplus embryos to scientific research with regard to Articles 9 and 32 of the Constitution, which guarantee freedom of scientific research and the right to health respectively.
53. On 19 March 2014 the President of the Constitutional Court adjourned its examination of the case pending the decision of the Grand Chamber in the present application, Parrillo v. Italy (no. 46470/11).
III. COUNCIL OF EUROPE DOCUMENTS
A. Recommendation 1046 (1986) of the Parliamentary Assembly of the Council of Europe on the use of human embryos and foetuses for diagnostic, therapeutic, scientific, industrial and commercial purposes
6. Aware that the progress [of medical science and technology] has made the legal position of the embryo and foetus particularly precarious, and that their legal status is at present not defined by law;
7. Aware that adequate provisions governing the use of living or dead embryos and foetuses do not at present exist;
8. Convinced that, in view of scientific progress which makes it possible to intervene in developing human life from the moment of fertilisation, it is urgent to define the extent of its legal protection;
9. Having regard to the variety of ethical opinions on the question of using the embryo or the foetus or their tissues, and to the conflicts between values which arise;
10. Considering that human embryos and foetuses must be treated in all circumstances with the respect due to human dignity, and that use of materials and tissues therefrom must be strictly limited and regulated ... to purposes which are clearly therapeutic and for which no other means exist;
13. Stressing the need for European co-operation,
14. [The Parliamentary Assembly r]ecommends that the Committee of Ministers:
a. call on the governments of the member states:
14.1.2. to limit the use of human embryos and foetuses and materials and tissues therefrom in an industrial context to purposes which are strictly therapeutic and for which no other means exist, according to the principles set out in the appendix, and to bring their legislation into line with these principles or to enact rules in accordance therewith which should inter alia specify the conditions in which removal and use may be undertaken for a diagnostic or therapeutic purpose;
14.1.3. to forbid any creation of human embryos by fertilisation in vitro for the purposes of research during their life or after death;
14.1.4. to forbid anything that could be considered as undesirable use or deviations of these techniques, including:
research on viable human embryos;
experimentation on living human embryos, whether viable or not;
B. Recommendation 1100 (1989) of the Parliamentary Assembly of the Council of Europe on the use of human embryos and foetuses in scientific research
7. Considering that the human embryo, though displaying successive phases in its development ... displays also a progressive differentiation as an organism and none the less maintains a continuous biological and genetic identity;
8. Recalling the need for European co-operation and for the widest possible regulation in order to overcome the contradictions, risks and foreseeable shortcomings of exclusively national standards in these fields,
54. The relevant passages of the Appendix to that Recommendation read as follows.
“B. On live pre-implantation embryos:
4. In accordance with Recommendations 934 (1982) and 1046 (1986), investigations of viable embryos in vitro shall only be permitted:
for applied purposes of a diagnostic nature or for preventive or therapeutic purposes;
if their non-pathological genetic heritage is not interfered with.
5. ... research on living embryos must be prohibited, particularly:
if it is possible to use an animal model;
if not foreseen within the framework of projects duly presented to and authorised by the appropriate public health or scientific authority or, by delegation, to and by the relevant national multidisciplinary committee;
if not within the time-limits laid down by the authorities mentioned above.
H. Donation of human embryological material
20. The donation of human embryological material shall be authorised solely for scientific research on diagnostic, prevention or therapeutic purposes. Its sale shall be prohibited.
21. The intentional creation and/or keeping alive of embryos or foetuses whether in vitro or in utero for any scientific research purpose, for instance to obtain genetic material, cells, tissues or organs therefrom, shall be prohibited.
22. The donation and use of human embryological material shall be conditional on the freely given written consent of the donor parents.
23. The donation of organs shall be devoid of any commercial aspect. The purchase or sale of embryos or foetuses or parts thereof by their donor parents or other parties, and their importation or exportation, shall also be prohibited.
24. The donation and use of human embryological material for the manufacture of dangerous and exterminatory biological weapons shall be forbidden.
25. For the whole of this recommendation, ‘viable’ embryos shall be understood to mean embryos which are free of biological characteristics likely to prevent their development; however, the non-viability of human embryos and foetuses shall be determined solely by objective biological criteria based on the embryo’s intrinsic defects.”
C. Council of Europe Convention for the Protection of Human Rights and Dignity of the Human Being with regard to the Application of Biology and Medicine: Convention on Human Rights and Biomedicine (Oviedo Convention) of 4 April 1997
Article 2 – Primacy of the human being
“The interests and welfare of the human being shall prevail over the sole interest of society or science.”
Article 18 – Research on embryos in vitro
“1. Where the law allows research on embryos in vitro, it shall ensure adequate protection of the embryo.
2. The creation of human embryos for research purposes is prohibited.”
“None of the provisions of this Convention shall be interpreted as limiting or otherwise affecting the possibility for a Party to grant a wider measure of protection with regard to the application of biology and medicine than is stipulated in this Convention.”
D. Additional Protocol to the Convention on Human Rights and Biomedicine concerning Biomedical Research, of 25 January 2005
“1. This Protocol covers the full range of research activities in the health field involving interventions on human beings.
2. This Protocol does not apply to research on embryos in vitro. It does apply to research on foetuses and embryos in vivo.
E. Report by the Working Party on the Protection of the Human Embryo and Fetus of the Steering Committee on Bioethics, published on 19 June 2003 – Conclusion
“This report aimed at giving an overview of current positions found in Europe regarding the protection of the human embryo in vitro and the arguments supporting them.
It shows a broad consensus on the need for the protection of the embryo in vitro. However, the definition of the status of the embryo remains an area where fundamental differences are encountered, based on strong arguments. These differences largely form the basis of most divergences around the other issues related to the protection of the embryo in vitro.
Nevertheless, even if agreement cannot be reached on the status of the embryo, the possibility of re-examining certain issues in the light of the latest developments in the biomedical field and related potential therapeutic advances could be considered. In this context, while acknowledging and respecting the fundamental choices made by the different countries, it seems possible and desirable with regard to the need to protect the embryo in vitro on which all countries have agreed that common approaches be identified to ensure proper conditions for the application of procedures involving the creation and use of embryos in vitro. The purpose of this report is to aid reflection towards that objective.”
F. Resolution 1352 (2003) of the Parliamentary Assembly of the Council of Europe on human stem cell research
3. Human stem cells may be derived from a growing number of tissues and fluids from humans of any age and are not limited to embryonic sources.
5. The harvesting of embryonic stem cells for the time being necessitates the destruction of human embryos.
7. The Assembly points out that a number of embryonic human stem cell lines suitable for scientific research are already available worldwide.
10. The destruction of human beings for research purposes is against the right to life of all humans and against the moral ban on any instrumentalisation of humans.
11. Therefore the Assembly calls on member states:
11.1. to promote stem cell research as long as it respects the life of human beings in all states of their development;
11.2. to encourage scientific techniques that are not socially and ethically divisive in order to advance the use of cell pluripotency and develop new methods in regenerative medicine;
11.3. to sign and ratify the Oviedo Convention to make effective the prohibition of the production of human embryos for research;
11.4. to promote common European basic research programmes in the field of adult stem cells;
11.5. to ensure that, in countries where it is allowed, any research on stem cells involving the destruction of human embryos is duly authorised and monitored by the appropriate national bodies;
11.6. to respect the decision of countries not to take part in international research programmes which are against ethical values enshrined in national legislation and not to expect such countries to contribute either directly or indirectly to such research;
11.7. to give priority to the ethical aspects of research over those of a purely utilitarian and financial nature;
11.8. to promote the establishment of bodies where scientists and representatives from civil society can discuss different kinds of projects on human stem cell research with a view to strengthening transparency and democratic accountability.”
G. Recommendation Rec(2006)4 of the Committee of Ministers to member states on research on biological materials of human origin, adopted by the Committee of Ministers on 15 March 2006
55. This Recommendation, which does not apply to embryonic and foetal tissues (see Article 2, paragraph 3), aims to protect the fundamental rights of persons whose biological material might be used for a research project after having been removed and stored (i) for a specific research project prior to adoption of the Recommendation; (ii) for future unspecified research; or (iii) as residual material originally removed for clinical or forensic purposes. This Recommendation seeks, inter alia, to promote the establishment of practice guidelines on the part of the member States and to reduce to a minimum the risks related to research activities for the private life of the persons concerned. It also lays down rules about obtaining and collecting biological materials.
H. Resolution 1934 (2013) of the Parliamentary Assembly of the Council of Europe on ethics in science and technology
2. ... [T]he Assembly holds that more concerted ethical consideration should be given – at national, supraregional and global levels – to the goals and purposes pursued by science and technology, to the instruments and methods they employ, to their possible consequences and side effects, and to the overall system of rules and behaviour within which they operate.
3. The Assembly believes that having a permanent structure for ethical reflection at the global level would make it possible to address ethical issues as a ‘moving target’, rather than fixing an ‘ethical code’, and enable a periodic re-questioning of even basic assumptions, such as the definition of ‘human identity’ or ‘human dignity’.
4. The Assembly welcomes the initiative of UNESCO in setting up the World Commission on the Ethics of Scientific Knowledge and Technology (COMEST) with a view to engaging in ongoing ethical reflection and exploring the possibilities of drafting and periodically reviewing a set of fundamental ethical principles based on the Universal Declaration of Human Rights. It believes that the Council of Europe should contribute to this process.
5. In this respect, the Assembly recommends that the Secretary General of the Council of Europe consider establishing a flexible and informal structure for ethical reflection, through co-operation between relevant Assembly committees and members of relevant expert committees, including the Committee on Bioethics (DH-BIO), with a view to identifying emerging ethical issues and main ethical principles that could guide political and legal action in Europe.
6. To reinforce the common European framework of ethics in science and technology, the Assembly recommends that member States, which have not yet done so, sign and ratify the Convention for the Protection of Human Rights and Dignity of the Human Being with regard to the Application of Biology and Medicine: Convention on Human Rights and Biomedicine (ETS No. 164, ‘Oviedo Convention’) and its protocols and fully engage in the work of the Committee on Bioethics.
10. The Assembly invites the European Union and UNESCO to co-operate with the Council of Europe to reinforce the common European framework of ethics in science and technology and, to this end:
10.1 create European and regional platforms to regularly exchange experiences and best practice covering all fields of science and technology, using the experience acquired in the framework of the European Conference of National Ethics Committees (COMETH) initiated by the Council of Europe, and more recently the Forum of National Ethics Councils (NEC Forum) funded by the European Commission, and the meetings of the Council of Europe Committee on Bioethics;
10.2 draft and periodically review a set of fundamental ethical principles to be applied to all fields of science and technology;
10.3 provide further guidance to help member States harmonise ethical rules and monitoring procedures, building on the positive impact of ethical requirements under the European Commission’s Seventh Framework Programme for Research and Technological Development (2007-2013) (FP7).”
IV. RELEVANT EUROPEAN UNION LAW AND MATERIALS
A. European Group on Ethics in Science and New Technologies (EGE) to the European Commission
56. Set up by the European Commission in 1991, the EGE is an independent body composed of experts whose task is to advise the European Commission on ethical questions relating to science and new technologies. The EGE has provided two opinions on the use of embryos in vitro for research purposes.
1. Opinion no. 12: Ethical aspects of research involving the use of human embryo in the context of the 5th Framework Programme, 23 November 1998
57. This opinion was published at the request of the European Commission following the proposal of the European Parliament to exclude research projects that resulted in the destruction of human embryos from Community funding in the context of the 5th Framework Programme. The relevant passages read as follows.
“2.6 ... [I]n the scope of European research programmes, the question of research on the human embryo has to be approached, not only with regard to the respect for fundamental ethical principles, common to all Member States, but equally taking into consideration diverse philosophical and ethical conceptions, expressed through the practices and the national regulations in force in this field.
2.8 In the light of the aforementioned principles and specifications, the Group considers that according to the ethical dimension of the Community’s Fifth Framework Programme Community funding should not a priori exclude human embryo research which is the object of different ethical choices in different countries ...”
2. Opinion no. 15: Ethical aspects of human stem cell research and use, 14 November 2000
58. The relevant parts of this opinion read as follows.
“2.3. Pluralism and European ethics
... In the context of European pluralism, it is up to each Member State to forbid or authorise embryo research. In the latter case, respect for human dignity requires regulation of embryo research and the provision of guarantees against risks of arbitrary experimentation and instrumentalisation of human embryos.
2.5. Ethical Acceptability of the field of the research concerned
The Group notes that in some countries embryo research is forbidden. But when this research is allowed, with the purpose of improving treatment for infertility, it is hard to see any specific argument which would prohibit extending the scope of such research in order to develop new treatments to cure severe diseases or injuries. As in the case of research on infertility, stem cell research aims to alleviate severe human suffering. In any case, the embryos that have been used for research are required to be destroyed. Consequently, there is no argument for excluding funding of this kind of research from the Framework Programme of research of the European Union if it complies with ethical and legal requirements as defined in this programme.”
B. Regulation (EC) No 1394/2007 of the European Parliament and of the Council of 13 November 2007 on advanced therapy medicinal products and amending Directive 2001/83/EC and Regulation (EC) No 726/2004
(7) The regulation of advanced therapy medicinal products at Community level should not interfere with decisions made by Member States on whether to allow the use of any specific type of human cells, such as embryonic stem cells, or animal cells. It should also not affect the application of national legislation prohibiting or restricting the sale, supply or use of medicinal products containing, consisting of or derived from these cells.”
C. Judgment of the Court of Justice of the European Union (CJEU) of 18 October 2011 (C-34/10 Oliver Brüstle v. Greenpeace eV )
59. In this judgment, delivered following a referral for a preliminary ruling from the German Federal Court of Justice ( Bundesgerichtshof ), the CJEU ruled on the interpretation to be given to Directive 98/44/EC of the European Parliament and of the Council of 6 July 1998 on the legal protection of biotechnological inventions.
60. In issue was the part of the Directive which, tempering the principle that the use of human embryos for industrial or commercial purposes could not be patented, specified that this exclusion from patentability did not affect “inventions for therapeutic or diagnostic purposes which are applied to the human embryo and are useful to it”.
61. The CJEU observed that the purpose of the Directive in question was not to regulate the use of human embryos in the context of scientific research. It was limited to the patentability of biotechnological inventions. The CJEU then considered that inventions involving the use of human embryos continued to be excluded from patentability even where they purported to serve scientific research (those purposes being indistinguishable, where patents were concerned, from other industrial and commercial aims). The CJEU indicated at the same time that this exclusion did not affect inventions for therapeutic or diagnostic purposes which were applied to the human embryo and were useful to it.
D. European Union funding of research and technological development
62. Since 1984 the European Union has provided funding for scientific research through framework programmes covering periods spanning several years.
63. The relevant parts of Decision No 1982/2006/EC of 18 December 2006 concerning the Seventh Framework Programme of the European Community for research, technological development and demonstration activities (2007-2013) read as follows.
“1. All the research activities carried out under the Seventh Framework Programme shall be carried out in compliance with fundamental ethical principles.
2. The following fields of research shall not be financed under this Framework Programme:
– research activity aiming at human cloning for reproductive purposes,
– research activity intended to modify the genetic heritage of human beings which could make such changes heritable,
– research activities intended to create human embryos solely for the purpose of research or for the purpose of stem cell procurement, including by means of somatic cell nuclear transfer.
3. Research on human stem cells, both adult and embryonic, may be financed, depending both on the contents of the scientific proposal and the legal framework of the Member State(s) involved.
64. The relevant parts of Regulation (EU) No 1291/2013 of the European Parliament and of the Council of 11 December 2013 establishing Horizon 2020 – the Framework Programme for Research and Innovation (2014-2020) and repealing Decision No 1982/2006/EC read as follows.
Article 19 – Ethical principles
“1. All the research and innovation activities carried out under Horizon 2020 shall comply with ethical principles and relevant national, Union and international legislation, including the Charter of Fundamental Rights of the European Union and the European Convention on Human Rights and its Supplementary Protocols.
3. The following fields of research shall not be financed:
(a) research activity aiming at human cloning for reproductive purposes;
(b) research activity intended to modify the genetic heritage of human beings which could make such changes heritable;
(c) research activities intended to create human embryos solely for the purpose of research or for the purpose of stem cell procurement, including by means of somatic cell nuclear transfer.
4. Research on human stem cells, both adult and embryonic, may be financed, depending both on the contents of the scientific proposal and the legal framework of the Member States involved. No funding shall be granted for research activities that are prohibited in all the Member States. No activity shall be funded in a Member State where such activity is forbidden.
E. Communication from the European Commission on the European Citizens’ Initiative “One of Us” COM(2014) 355 final (Brussels, 28 May 2014)
65. On 10 April 2014 the citizens’ initiative “One of Us” had proposed legislative amendments to exclude from European funding scientific projects involving the destruction of human embryos.
66. In its Communication of 28 May 2014, the European Commission stated that it could not uphold the request on the ground that its proposal to fund the projects in question took account of ethical considerations, potential health benefits and support at European Union level for stem-cell research.
V. RELEVANT INTERNATIONAL LAW MATERIALS
A. Report of the Unesco International Bioethics Committee (IBC) on the ethical aspects of human embryonic stem cell research (6 April 2001)
67. The relevant parts of the conclusions of this report read as follows.
“A. The IBC recognises that human embryonic stem cell research is a subject on which it is desirable for a debate to occur at national level to identify which position on this issue is to be adopted, including abstaining from this research. It urges that debates be conducted at appropriate national regulatory levels, enabling expression of a range of views, and whenever possible allowing a consensus to be reached on the limits of the permissible in this important new therapeutic research field. There should be an on-going process of education and information in this area. States should take appropriate measures to initiate an on-going dialogue within society on the ethical issues raised by such research, involving all actors concerned.
B. Whatever form of research involving embryos is allowed, steps should be taken to ensure that such research be carried out within the framework of a State-sponsored regulatory system that would give due weight to ethical considerations, and set up appropriate guidelines. When authorisation of donations of supernumerary pre-implantation embryos from IVF treatments for therapeutic embryonic stem cell research is under consideration, particular attention should be given to the dignity and rights of both parental donors of embryos. Thus, it is essential that the donation be made only after the donors should have been given full information as to the implications of the research and have given their prior, free and informed consent. The purposes for which such research is carried out, and the way of its performance, should be subject to assessment by the appropriate ethics committees, which should be independent of the researchers involved. This assessment should include ex post facto ethical evaluation of such research.”
B. Judgment of the Inter-American Court of Human Rights in Artavia Murillo et al. ( in vitro fertilization) v. Costa Rica (preliminary objections, merits, reparations and costs), judgment of 28 November 2012, Series C No. 257
68. In this case the Inter-American Court gave a ruling on the ban on carrying out in vitro fertilisation in Costa Rica. It held, inter alia, that an embryo could not be regarded as a “person” within the meaning of Article 4 § 1 of the American Convention on Human Rights (protecting the right to life), “conception” occurring only from the moment the embryo was implanted in the uterus.
69. According to the information available to the Court on the legislation of forty member States [1] regarding the use of human embryos for scientific research, three countries (Belgium, Sweden and the United Kingdom) allow scientific research on human embryos and the creation of embryos for that purpose.
70. The creation of embryos for scientific research is banned in fourteen countries [2]. However, research using surplus embryos is generally allowed in those countries, subject to certain conditions.
71. Like Italy, three member States (Slovakia, Germany and Austria) prohibit scientific research on embryos in principle, and permit it in very restricted cases, such as for the protection of the health of the embryo or where the research is carried out on cell lines imported from abroad.
72. In Slovakia any research on embryos is strictly forbidden, other than research for medical purposes for the benefit of the health of the persons directly participating in the research in question.
73. In Germany the importation and use for research purposes of embryonic cells is in principle banned by law and authorised only exceptionally and subject to strict conditions.
74. In Austria the law provides that “viable cells” cannot be used for purposes other than in vitro fertilisation. However, the concept of “viable cells” is not defined in the law. According to practice and legal commentary, the statutory ban concerns only “totipotent” embryonic cells [3].
75. In four countries (Andorra, Latvia, Croatia and Malta) the law expressly prohibits any research on embryonic stem cells.
76. In sixteen countries (Armenia, Azerbaijan, Bosnia and Herzegovina, Georgia, Ireland, Liechtenstein, Lithuania, Luxembourg, the Republic of Moldova, Monaco, Poland, Romania, Russia, San Marino, Turkey and Ukraine) the matter is not regulated. Some of these States take a rather restrictive approach in practice (for example, Turkey and Ukraine), while others have a rather non-prohibitive practice (for example, Russia).
77. The Court notes at the outset that the Government raised a number of objections to the admissibility of the present application. They submitted that the applicant had not exhausted the domestic remedies available to her in domestic law; that she had failed to lodge her application within the six-month time-limit provided for in Article 35 § 1 of the Convention; and that she did not have victim status. The Court will examine these objections below before analysing the other aspects of the application.
I. NON-EXHAUSTION OF DOMESTIC REMEDIES
A. The Government’s submissions
78. The Government submitted that the applicant could complain of the prohibition on donating her embryos to scientific research before an ordinary civil court on the ground that the ban was contrary to the Italian Constitution and the Convention. In support of that submission, they cited a number of domestic decisions in which the national courts had interpreted Law no. 40/2004 in the light of the Constitution and the European Convention on Human Rights, in particular regarding access to pre-implantation diagnosis (Orders of the Cagliari Court of 22 September 2007 and 9 November 2012 and those adopted by the Florence, Bologna and Salerno Courts on 17 December 2007, 29 June 2009 and 9 January 2010 respectively, see paragraphs 40-49 above).
79. According to the Government, the court in question would then have had to interpret the Law prohibiting the donation of embryos in the light of the Convention, as required by Constitutional Court judgments nos. 348 and 349 of 24 October 2007.
80. If the court had considered that there was an insurmountable conflict between its interpretation of the Law and the rights asserted by the claimant it would have had to submit a question of constitutionality to the Constitutional Court. That court would then have examined the issue of compatibility with human rights on the merits and would have been able to annul the domestic provisions with retroactive and erga omnes effect.
81. Moreover, several cases concerning the constitutionality of Law no. 40/2004 had already been brought before the Constitutional Court. A number of decisions had been delivered in that regard, particularly Constitutional Court Orders nos. 369, 97 and 150 (adopted on 24 October 2006, 8 March 2010 and 22 May 2012 respectively), judgment no. 151 delivered on 1 April 2009, a decision of the Florence Court of 7 December 2012 and an Order of the Rome Court adopted on 15 January 2014 (see paragraphs 27-33 and 50-53 above).
82. In the Government’s submission, the applicant had also breached the principle of subsidiarity laid down in Protocol No. 15 of 24 June 2013 because she had failed to use domestic remedies before lodging her complaints with the Court.
83. Lastly, a question of constitutionality concerning an identical case to the present one had been raised by the Florence Court before the Constitutional Court (see paragraphs 52-53 above). If the Constitutional Court’s decision were to go against the claimant, the latter would still be able to lodge an application with the Court.
84. The applicant submitted that any action in the ordinary courts would have been bound to fail because domestic law imposed a blanket ban on donating embryos to scientific research.
85. She also submitted that a constitutional remedy could not be regarded as a remedy that had to be used for the purposes of Article 35 § 1 of the Convention, since the Italian legal system did not provide for direct application to the Constitutional Court.
86. Lastly, she indicated that on 19 March 2014 the President of the Constitutional Court had adjourned its examination of the question raised by the Florence Court to which the Government referred pending the Grand Chamber’s decision in the present case.
87. The Court reiterates first of all that under Article 35 § 1 it may only deal with a matter after all domestic remedies have been exhausted. Applicants must have provided the domestic courts with the opportunity, in principle intended to be afforded to Contracting States, of preventing or putting right the violations alleged against them. That rule is based on the assumption that there is an effective remedy available in the domestic system in respect of the alleged breach. The only remedies which Article 35 § 1 requires to be exhausted are those that relate to the breach alleged and are available and sufficient. The existence of such remedies must be sufficiently certain not only in theory but also in practice, failing which they will lack the requisite accessibility and effectiveness: it falls to the respondent State to establish that these conditions are satisfied (see, among many other authorities, McFarlane v. Ireland [GC], no. 31333/06, § 107, 10 September 2010; Mifsud v. France (dec.) [GC], no. 57220/00, § 15, ECHR 2002 ‑ VIII; Leandro Da Silva v. Luxembourg, no. 30273/07, §§ 40 and 42, 11 February 2010; and Vučković and Others v. Serbia (preliminary objection) [GC], nos. 17153/11 and 29 others, §§ 69-77, 25 March 2014).
88. In the instant case, relying on the system of constitutional review instituted by Constitutional Court judgments nos. 348 and 349 of 24 October 2007, the Government submitted that the remedies available to the applicant in domestic law had not been exhausted. They cited examples of decisions on the merits and decisions of the Constitutional Court concerning Law no. 40/2004.
89. The Court observes at the outset that, in the above-mentioned judgments nos. 348 and 349, the Constitutional Court defined the place assigned to the Convention in the Italian legal system, considering that it was of intermediate rank between an ordinary law and the Constitution. It also found that it was incumbent on the judges of the ordinary courts to interpret domestic law in a manner compliant with the Convention and the Court’s case-law. It stated that, where such an interpretation was impossible or the ordinary court had doubts as to the compatibility of domestic law with the Convention, it was bound to raise a question of constitutionality before it.
90. The Court also reiterates that in the absence of a specifically introduced remedy, the development and availability of a remedy said to exist, and its scope and application, must be justified by the Government with reference to the domestic courts’ case-law (see, mutatis mutandis, Melnītis v. Latvia, no. 30779/05, § 50, 28 February 2012; McFarlane, cited above, §§ 115-27; Costa and Pavan v. Italy, no. 54270/10, § 37, 28 August 2012; and Vallianatos and Others v. Greece [GC], nos. 29381/09 and 32684/09, §§ 52-58, 7 November 2013).
91. In the instant case the Court observes that the Government referred to a number of cases concerning Law no. 40/2004 but did not provide any examples of domestic decisions in which the question of donating surplus embryos to research was determined. Moreover, the Court cannot properly criticise the applicant for failing to lodge an application for a measure prohibited by law.
92. With regard to the Government’s submission that, since the adoption of judgments nos. 348 and 349, the ordinary courts are obliged to interpret the Law giving rise to the prohibition in the light of the Convention and Strasbourg case-law whereas they were not formerly bound by such an obligation, a number of considerations lead the Court to conclude that this statement is not actually being followed, by established judicial practice, in, among others, the sphere of assisted reproduction.
93. The Court notes first of all that in a similar case to the present one, which concerned the ban on donating surplus embryos to scientific research, the Florence Court decided, on 7 December 2012, to raise before the Constitutional Court the question of the constitutionality of section 13 of Law no. 40/2004 with regard to Articles 9 and 32 of the Constitution, which guarantee the freedom of scientific research and the right to health respectively (see paragraph 22 above). The Court observes, however, that the lower court did not raise any question regarding the compatibility of the ban in question with the rights guaranteed by the Convention.
94. It notes, secondly, that, barring a few exceptions, the decisions of the lower courts and of the Constitutional Court regarding Law no. 40/2004 cited by the Government (see paragraphs 78 and 81 above) do not refer to the Convention. This is the case regarding Orders nos. 369/2006 and 97/2010 of the Constitutional Court and its judgment no. 151/2009, the Orders of the Cagliari, Florence, Bologna and Salerno Courts adopted on 22 September 2007, 17 December 2007, 29 June 2009 and 9 January 2010 respectively, and of the decision of the Florence Court of 7 December 2012.
95. Admittedly, in Order no. 150 of 22 May 2012, in which it remitted to the lower court a case concerning the ban on heterologous fertilisation, the Constitutional Court did refer, inter alia, to Articles 8 and 14 of the Convention. The Court cannot fail to observe, however, that in its judgment no. 162 of 10 June 2014 in the same case the Constitutional Court examined the prohibition in question only in the light of the Articles of the Constitution that were in issue (namely, Articles 2, 31 and 32). With regard to Articles 8 and 14 of the Convention, invoked by only one of the three lower courts (see paragraph 35 above), it merely observed that the questions raised under those provisions were covered by the conclusions it had reached regarding the constitutionality issue (see paragraph 39 above).
96. Accordingly, the Orders of the Cagliari Court (of 9 November 2012) and the Rome Court (of 15 January 2014) were the only two exceptions to the failure to take account of the Convention and its case-law. Having regard to the Court’s conclusions in Costa and Pavan (cited above), the Cagliari Court authorised access by the claimants to pre-implantation diagnosis and the Rome Court raised a question of constitutionality on that point before the Constitutional Court. The fact remains that these are just two isolated cases out of the eleven referred to by the Government, which concern a different subject from the one in issue here and one in respect of which the Court has already ruled.
97. Furthermore, as the compatibility of section 13 of Law no. 40/2004 with the rights guaranteed by the Convention is a new issue, the Court is not convinced that the possibility open to the applicant to bring her complaints before an ordinary court constitutes an effective remedy.
98. Judgments nos. 348 and 349 themselves clarify the difference between the respective roles of the Strasbourg Court and the Constitutional Court, finding that the former has the task of interpreting the Convention while the latter must determine whether there is a conflict between a particular domestic provision and the rights guaranteed by the Convention, inter alia, in the light of the interpretation provided by the European Court of Human Rights (see paragraph 26 above).
99. Moreover, the decision taken on 19 March 2014 by the President of the Constitutional Court to adjourn its examination of the question raised on 7 December 2012 by the Florence Court pending a ruling by the Court in the instant case (see paragraph 53 above) is consonant with this approach.
100. In this context the Court observes that, in a recent judgment (no. 49, deposited on 26 March 2015) in which it analysed, inter alia, the place of the Convention and the Court’s case-law in the domestic legal order, the Constitutional Court indicated that the ordinary courts were only bound to comply with the Court’s case-law where it was “well established” or expressed in a “pilot judgment”.
101. In any event the Court has observed on many occasions that, in the Italian legal system, litigants are not entitled to apply directly to the Constitutional Court. Only a court which is hearing the merits of a case has the possibility of making a reference to the Constitutional Court, at the request of a party or of its own motion. Accordingly, such an application cannot be a remedy whose exhaustion is required under the Convention (see, among other authorities, Brozicek v. Italy, 19 December 1989, § 34, Series A no. 167; Immobiliare Saffi v. Italy [GC], no. 22774/93, § 42, ECHR 1999 ‑ V; C.G.I.L. and Cofferati v. Italy, no. 46967/07, § 48, 24 February 2009; Scoppola v. Italy (no. 2) [GC], no. 10249/03, § 75, 17 September 2009; and M.C. and Others v. Italy, no. 5376/11, § 47, 3 September 2013). However, the Commission and the Court have held, with regard to other member States, that direct application to the Constitutional Court was a domestic remedy that had to be used (see, for example, W. v. Germany, no. 10785/84, Commission decision of 18 July 1986, Decisions and Reports (DR) 48, p. 102, at p. 105; Union Alimentaria Sanders S.A. v. Spain, no. 11681/85, Commission decision of 11 December 1987, DR 54, p. 101, at 107; S.B. and Others v. Belgium (dec.), no. 63403/00, 6 April 2004; and Grišankova and Grišankovs v. Latvia (dec.), no. 36117/02, ECHR 2003 ‑ II).
102. Having regard to the foregoing, the Court cannot consider that the system requiring domestic provisions to be interpreted in the light of the Convention established by judgments nos. 348 and 349 constitutes a turning point capable of refuting that conclusion (see, by converse implication, the recent decisions of the Court acknowledging the effectiveness of applications to the Turkish Constitutional Court following the creation of a system of direct application to that court: Hasan Uzun v. Turkey (dec.), no. 10755/13, §§ 25-27, 30 April 2013, and Koçintar v. Turkey (dec.), no. 77429/12, 1 July 2014).
103. The principles established in judgments nos. 348 and 349 of 24 October 2007 are to be welcomed, particularly regarding the place assigned to the Convention in the Italian legal system and the encouragement given to the national judicial authorities to interpret domestic standards and the Constitution in the light of the Convention and the Court’s case-law. The Court also notes that, in areas other than assisted reproduction, there have been many decisions in which the Constitutional Court has ruled a domestic provision unconstitutional on the basis, inter alia, of its incompatibility with the rights guaranteed under the Convention and the Court’s case-law (see, for example, judgment no. 39 of 5 March 2008 regarding legal incapacities following bankruptcy, judgment no. 93 of 17 March 2010 on the public nature of hearings in proceedings for enforcement of interim measures, and judgment no. 210 of 3 July 2013 concerning the retrospective application of criminal law).
104. However, it should first be noted that the Italian system provides only for indirect application by individuals to the Constitutional Court. Furthermore, the Government have not shown, backed up by established case-law and practice, that, where the donation of embryos to research is concerned, an action by the applicant before the ordinary courts combined with the duty on those courts to raise a question of constitutionality before the Constitutional Court in the light of the Convention amounted to an effective remedy in the present case that the applicant should have used.
105. Having regard to the foregoing and to the fact that the Constitutional Court decided to suspend its examination of a similar case pending the Court’s decision in the instant case, the objection raised by the Government must be rejected.
II. COMPLIANCE WITH THE SIX-MONTH TIME-LIMIT
A. The Government’s submissions
106. At the hearing the Government objected that the application had been lodged out of time, submitting that the Law banning embryo donations for scientific research had come into force on 10 March 2004 and that the applicant had not sought release of her embryos for the purpose of donating them until 14 December 2011, in a letter sent on that date to the centre for reproductive medicine where the embryos were cryopreserved.
107. The applicant replied to this objection during the hearing, submitting that she had indeed made a written request to the centre for reproductive medicine for release of her embryos on 14 December 2011, but had earlier made other identical requests verbally.
108. At all events the applicant maintained that any request to the centre for reproductive medicine was bound to fail, since the applicable Law categorically prohibited the donation of embryos to scientific research.
109. The Court has already acknowledged that where an interference with the right relied on by an applicant emanates directly from legislation, the very maintenance in force of the impugned legislation may constitute a continuing interference with the right in question (see, for example, Dudgeon v. the United Kingdom, 22 October 1981, § 41, Series A no. 45, and Norris v. Ireland, 26 October 1988, § 38, Series A no. 142, in which the applicants, who were homosexuals, complained that laws making homosexual practices criminal offences infringed their right to respect for their private life).
110. The Court has recently proceeded on that basis in Vallianatos and Others (cited above, § 54), in which the applicants complained of a continuing violation of Articles 14 and 8 of the Convention on account of their inability, as same-sex couples, to enter into a “civil union”, whereas different-sex couples were legally able to do so. Further, in S.A.S. v. France ([GC], no. 43835/11, § 110, ECHR 2014), which concerned the statutory ban on wearing clothing designed to conceal one’s face in public places, the Court observed that the applicant’s situation was similar to that of the applicants in Dudgeon and Norris (both cited above), in which it had found a continuing interference with the exercise of the rights protected by Article 8 of the Convention.
111. The Court acknowledges that in the above-cited cases the effect of the legislative measures complained of on the daily lives of the applicants was more substantial and more direct than in the present case. Nevertheless, the statutory ban on donating embryos to scientific research in issue here does undeniably have an impact on the applicant’s private life. That impact, which results from the biological link between the applicant and her embryos and the plan to start a family that was at the origin of their creation, is a direct result of the entry into force of Law no. 40/2004 and constitutes a continuing situation in that it has continuously affected the applicant since then (see the final report of the Study Commission on embryos of 8 January 2010, which refers to potentially indefinite cryopreservation of frozen embryos, paragraph 21 above).
112. In this type of case, according to the Court’s case-law, the six-month period does not start to run until the situation complained of has come to an end (see, among other authorities, Çınar v. Turkey, no. 17864/91, Commission decision of 5 September 1994, DR 79-B). Consequently, the Court does not accept the Government’s argument that the time period runs from the date on which the Law in issue came into force.
113. Moreover, the Government’s submission is tantamount to considering that the applicant wanted to donate her embryos from the date on which the Law in issue came into force, which is not a matter that is open to speculation by the Court.
114. The objection on the ground of delay in lodging the application, raised by the Government under Article 35 § 1 of the Convention, cannot therefore be upheld.
III. THE APPLICANT’S VICTIM STATUS
A. The Government’s submissions
115. The Government also objected on the ground that the applicant did not have victim status, submitting that, during the period from 12 November 2003 – the date of her partner’s death – to 10 March 2004, when Law no. 40/2004 came into force, the applicant could have donated her embryos to research since there were no regulations governing the matter at that time and a donation of that sort was therefore not prohibited.
116. The applicant submitted at the hearing that a very short period of time had elapsed between the date of her partner’s death and the date when the Law came into force – approximately four months – and that she had not been able to make a clear decision during that time as to what she wanted to do with the embryos obtained from the IVF treatment she had undergone.
117. The Court reiterates that where an interference with an applicant’s private life emanates directly from legislation, the maintenance in force of the impugned legislation constitutes a continuing interference with the exercise of the right in question. In the personal circumstances of the applicant, the very existence of this legislation continuously and directly affects her private life (see Dudgeon, § 41, and Norris, § 34, both cited above).
118. In the instant case the applicant has been unable to donate her embryos to research since Law no. 40/2004 came into force (see also paragraph 113 above). As the situation has remained unchanged since then, the fact that the applicant wanted to donate her embryos to research at the time of lodging her application is sufficient for the Court to find that she has victim status. Furthermore, with regard to the Government’s argument that the applicant could have donated her embryos to scientific research during the period between her partner’s death and the entry into force of the Law, the Court takes note of the information submitted by the applicant according to which, during the short period referred to above, she had not been able to make a clear decision concerning the fate of the embryos.
119. The Government’s objection on the ground of the applicant’s lack of victim status must therefore be dismissed.
IV. ALLEGED VIOLATION OF ARTICLE 8 OF THE CONVENTION
120. Relying on Article 8 of the Convention, the applicant alleged that the ban under section 13 of Law no. 40/2004 on donating embryos to scientific research resulted in a violation of her right to respect for her private life. The relevant parts of Article 8 provide:
“1. Everyone has the right to respect for his private ... life ...
2. There shall be no interference by a public authority with the exercise of this right except such as is in accordance with the law and is necessary in a democratic society in the interests of national security, public safety or the economic well-being of the country, for the prevention of disorder or crime, for the protection of health or morals, or for the protection of the rights and freedoms of others.”
1. The Government’s submissions
121. The Government submitted at the outset that the question whether human embryos could be donated to scientific research did not fall within the concept of “right to respect for private life”.
122. At the hearing the Government contended that Article 8 of the Convention could have applied only “indirectly” in the present case, that is, only if the applicant had wanted to start a family by having her embryos implanted and had been prevented from doing so by the application of Law no. 40/2004.
123. In any event they maintained that the alleged interference with the applicant’s private life was in accordance with the law and pursued the legitimate aim of protecting the embryo’s potential for life.
124. With regard to the proportionality of the impugned measure, the Government confined themselves in their written observations to referring to the arguments they had submitted under Article 1 of Protocol No. 1. However, at the hearing the Government submitted that the Italian legislation was not inconsistent, arguing that the applicant had wrongly affirmed that cryopreserved embryos could not develop into human lives. In that connection they submitted that, if properly carried out, cryopreservation was not limited in duration and that there were currently no scientific means by which the viability of a cryopreserved embryo could be determined without thawing it.
125. The Government also submitted that Italian law, which allowed abortion, was not incompatible with the ban on donating embryos to research, since in the event of an abortion the protection of the life of the foetus clearly had to be weighed against the situation and interests of the mother.
126. During the hearing they also observed that embryos were definitely protected under European law. In their submission, the Council of Europe Convention on Human Rights and Biomedicine (Oviedo Convention) of 4 April 1997 certainly did not require States to authorise destructive scientific research on embryos, since, in their submission, the choice as regards carrying out such research fell within the wide margin of appreciation of the States in this sphere.
127. They went on to observe that the preparatory works to Law no. 40/2004 showed that it was the end-product of a substantial amount of work that had taken account of a range of scientific and ethical opinions and questions on the subject. Moreover, the Law in question had been the subject of several referendums, regarding, inter alia, maintaining section 13, which had been declared invalid because the required threshold of votes had not been reached.
128. Furthermore, while acknowledging that Italian scientific research used embryonic cell lines imported from abroad and resulting from the destruction of the original embryos, they pointed out that the production of these cell lines was not carried out at the request of Italian laboratories and observed that there were approximately 300 embryonic cell lines in the world that were made available to the entire scientific community. In that connection they pointed out that the deliberate destruction of a human embryo could not be compared with the use of cell lines from human embryos that had already been destroyed.
129. With regard to European Union funding for scientific research, the Government submitted that the Seventh Framework Programme for research, technological development and demonstration activities and the Horizon 2020 Framework Programme for Research and Innovation (see paragraphs 63-64 above) did not provide for funding of projects involving the destruction of embryos, whether these had been created in Europe or imported from third countries.
130. They observed, lastly, that in its opinion of 18 November 2005 on adoption for birth (see paragraphs 19-20 above), the National Bioethics Committee had already tackled the subject of the fate of surplus embryos with a view to finding solutions that would respect their lives.
131. In their view, this solution could now become a reality having regard to judgment no. 162 of 10 June 2014 in which the Constitutional Court had declared the ban on heterologous fertilisation unconstitutional, thus allowing the use of surplus embryos from an in vitro fertilisation for non-destructive purposes, in accordance with the objective pursued by Italian legislation in this area.
132. The applicant affirmed at the outset that according to the Court’s case-law “private life” was a broad concept (she referred to Pretty v. the United Kingdom, no. 2346/02, § 61, ECHR 2002 ‑ III, and Evans v. the United Kingdom [GC], no. 6339/05, § 71, ECHR 2007 ‑ I).
133. She went on to submit that she had lost her partner in tragic circumstances, which was why she had not been able to start a family as she had wished. At the hearing she explained that only four months had elapsed between her partner’s death and the Law’s entry into force, so she had not had the necessary time to reflect on her plans to start a family, and that in any event the implantation of embryos post mortem was illegal.
134. Accordingly, she considered that the State also required her to witness the destruction of her embryos rather than allowing her to donate them to research, which would pursue a noble cause and be a source of comfort to her after the painful events that had occurred in her life. In those circumstances she submitted that her right to her private life was in issue.
135. She also maintained that the ban on donating embryos was completely illogical, since the only alternative offered by the system was the death of the embryos. At the hearing she pointed to the inconsistencies in the Italian legal system, submitting that the embryo’s right to life relied on by the Government was irreconcilable with the possibility available to women to abort up until the third month of pregnancy and with the use by Italian laboratories of embryonic cell lines obtained from the destruction of embryos created abroad.
136. Furthermore, she considered that the possibility of donating embryos not destined for implantation also fulfilled a public interest since research on induced pluripotent stem cells had not yet replaced research on stem cells, which was why the latter continued to feature among the most promising research methods, particularly regarding the treatment of certain incurable diseases.
137. She also submitted that the State did not have a wide margin of appreciation in the present case, particularly given the existing European consensus regarding the possibility of donating to scientific research embryos that were not destined to be implanted.
138. At the hearing she referred to the judgment of 18 October 2011 of the Court of Justice of the European Union in Oliver Brüstle v. Greenpeace eV (see paragraphs 59-61 above). Noting that this judgment was limited to prohibiting the patentability of inventions involving the destruction of human embryos, she inferred that the inventions themselves – and the prior research – were not banned at European level.
139. Lastly, she submitted that the Communication from the European Commission on the European Citizens’ Initiative “One of Us” of 28 May 2014 (see paragraphs 65-66 above) confirmed that the funding of research on embryonic human stem cells was permitted.
3. Observations of the third-party interveners
(a) The European Centre for Law and Justice (ECLJ)
140. The ECLJ submitted that in the present case the interests of science – to which the applicant attached importance – did not take precedence over the respect due to the embryo, in line with the principle of the “primacy of the human being” enshrined in Article 2 of the Oviedo Convention.
141. It also observed that in all the cases raising questions related to assisted reproduction that had been brought before the Court the interference with the applicants’ private and family life stemmed from a law that prevented the couple or the mother from having a child. The situation was different here in that the applicant had decided not to have the embryos implanted even though at the time she had undergone the IVF treatment there had been no law prohibiting gestation post mortem.
142. Lastly, referring to S.H. and Others v. Austria and Evans, both cited above, it observed that the member States were afforded a wide margin of appreciation in this area.
(b) The associations Movimento per la vita, Scienza e vita and Forum delle associazioni familiari, represented by Mr Casini
143. These associations submitted that destructive experiments on human embryos, which were “subjects”, were banned by law and that the Oviedo Convention did not impose any obligation to authorise such experiments.
144. They also observed that the member States enjoyed a wide margin of appreciation in this area.
(c) The associations Luca Coscioni, Amica Cicogna Onlus, L’Altra Cicogna Onlus and Cerco Un Bimbo and forty-six members of the Italian Parliament, represented by Ms Gallo
145. These third-party interveners submitted that the concept of “private life” was an evolving one, that it was not susceptible to exhaustive definition, and that the applicant claimed, inter alia, the right to respect for her choice to donate her own biological matter to research, namely, embryos that were no longer destined for a parental project and were in any event bound for destruction.
146. They added that the interference in question was not justified by the purpose relied on, since Italian law did not afford absolute protection to the embryo’s life.
(d) The associations VOX – Osservatorio italiano sui Diritti, SIFES (Society of Fertility, Sterility and Reproductive Medicine) and Cittadinanzattiva, represented by Ms D’Amico, Ms Costantini, Mr Clara, Ms Ragni and Ms Liberali
147. These associations pointed out that section 13 of Law no. 40/2004 curtailed the freedom of individuals to decide the fate of their own embryos, which had to be cryopreserved indefinitely, thus incurring substantial costs.
148. According to them, cryopreservation was not in any way useful to embryos destined to die, nor to couples, who were not generally keen to use embryos that had been cryopreserved for a long time for implantation, as the “quality” of these embryos diminished over time. Cryopreservation was just as useless for the medical centres where the embryos were stored.
1. Applicability to the present case of Article 8 of the Convention and admissibility of the complaint raised by the applicant
149. In the present case the Court is called upon for the first time to rule on the question whether the “right to respect for private life” guaranteed by Article 8 of the Convention can encompass the right invoked before it by the applicant to make use of embryos obtained from in vitro fertilisation for the purposes of donating them to scientific research.
150. The Government submitted that the provision in question could have applied only indirectly in the instant case and exclusively under its “family life” aspect, that is, only if the applicant had wanted to start a family by means of cryopreservation and the subsequent implantation of her embryos and had been prevented from doing so by the application of Law no. 40/2004.
151. However, the applicant indicated in the application form (see paragraph 14 above) and repeated at the hearing (see paragraph 116 above) that, since the death of her partner, she was no longer intending to start a family. Moreover, she did not at any time allege before the Court that there had been a violation of her right to respect for her family life under Article 8 of the Convention.
152. In reality the subject matter of the case brought before the Court concerns the restriction of the right asserted by the applicant to decide the fate of her embryos, a right which at the very most relates to “private life”.
153. Like the applicant, the Court observes at the outset that, according to its case-law, the concept of “private life” within the meaning of Article 8 of the Convention is a broad one not susceptible to exhaustive definition and embraces, among other things, a right to self-determination (see Pretty, cited above, § 61). The concept also incorporates the right to respect for both the decisions to become and not to become a parent (see Evans, cited above, § 71, and A, B and C v. Ireland [GC], no. 25579/05, § 212, ECHR 2010).
154. In the cases examined by the Court that have raised the particular question of the fate of embryos obtained from assisted reproduction, the Court has had regard to the parties’ freedom of choice.
155. In Evans, when analysing the balance to be struck between the conflicting rights that the parties to in vitro fertilisation may rely on under Article 8 of the Convention, the Grand Chamber “[did] not consider that the applicant’s right to respect for the decision to become a parent in the genetic sense should be accorded greater weight than [her ex-partner]’s right to respect for his decision not to have a genetically related child with her” (see Evans, cited above, § 90).
156. Furthermore, in Knecht v. Romania (no. 10048/10, 2 October 2012), where the applicant complained, inter alia, of the refusal of the national authorities to authorise the transfer of her embryos from the medical centre where they were being stored to a specialised clinic of her choice, the Court held that Article 8 was applicable only from the standpoint of respect for the applicant’s private life (ibid., § 55) even though the applicant had also alleged an infringement of her right to respect for her family life (ibid., § 51).
157. With regard to domestic law, the Court observes that, as submitted by the Government at the hearing, judgment no. 162 of 10 June 2014 in which the Constitutional Court declared unconstitutional the ban on heterologous fertilisation (see paragraphs 34-39 above) should now allow “adoption for birth”, a practice which consists in a couple or a woman adopting surplus embryos in order to have them implanted, and had been envisaged by the National Bioethics Committee in 2005. Furthermore, the Court notes that in the judgment in question the Constitutional Court found that the applicants’ choice to become parents and found a family with children was an aspect of “their freedom of self-determination regarding the sphere of their private and family life” (see paragraph 37 above). This means that the Italian legal system also attaches importance to the freedom of choice of parties to in vitro fertilisation regarding the fate of embryos not destined for implantation.
158. In the instant case the Court must also have regard to the link existing between the person who has undergone in vitro fertilisation and the embryos thus conceived, which link is due to the fact that the embryos contain the genetic material of the person in question and accordingly represent a constituent part of that person’s genetic material and biological identity.
159. The Court concludes that the applicant’s ability to exercise a conscious and considered choice regarding the fate of her embryos concerns an intimate aspect of her personal life and accordingly relates to her right to self-determination. Article 8 of the Convention, from the standpoint of the right to respect for private life, is therefore applicable in the present case.
160. The Court observes, lastly, that this complaint is not manifestly ill-founded within the meaning of Article 35 § 3 (a) of the Convention and cannot be declared inadmissible on any other grounds. It must therefore be declared admissible.
2. Merits of the complaint raised by the applicant
(a) Whether there has been an “interference” “in accordance with the law”
161. Like the parties, the Court considers that the ban under section 13 of Law no. 40/2004 on donating to scientific research embryos obtained from an in vitro fertilisation and not destined for implantation constitutes an interference with the applicant’s right to respect for her private life. It points out in this connection that at the time when the applicant had recourse to in vitro fertilisation there were no legal provisions regulating the donation of non-implanted embryos obtained by that technique. Consequently, until the Law came into force the applicant was not in any way prevented from donating her embryos to scientific research.
(b) The legitimacy of the aim pursued
162. During the hearing the Government submitted that the objective pursued by the measure complained of was to protect the “embryo’s potential for life”.
163. The Court reiterates that the enumeration of the exceptions to the individual’s right to respect for his private life, as listed in Article 8 § 2, is exhaustive and that their definition is restrictive. For it to be compatible with the Convention, a limitation of this freedom must, in particular, pursue an aim that can be linked to one of those listed in this provision (see S.A.S. v. France, cited above, § 113).
164. The Court observes that neither in their written observations nor in the reply to the question asked at the hearing did the Government refer to the provisions of paragraph 2 of Article 8 of the Convention.
165. However, in their written observations on Article 8 of the Convention the Government referred to the considerations they had set out regarding Article 1 of Protocol No. 1 (see paragraph 124 above) according to which, in the Italian legal system, the human embryo is considered as a subject of law entitled to the respect due to human dignity (see paragraph 200 below).
166. The Court also notes that, similarly, two third-party interveners (the ECLJ and the associations Movimento per la vita, Scienza e vita and Forum delle associazioni familiari) submitted that the human embryo had the status of “subject” (see paragraphs 140 and 143 above).
167. The Court acknowledges that the “protection of the embryo’s potential for life” may be linked to the aim of protecting morals and the rights and freedoms of others, in the terms in which this concept is meant by the Government (see also Costa and Pavan, cited above, §§ 45 and 59). However, this does not involve any assessment by the Court as to whether the word “others” extends to human embryos (see A, B and C v. Ireland, cited above, § 228).
(c) Necessity of the measure in a democratic society
(i) The principles established in the Court’s case-law regarding assisted reproduction
168. The Court reiterates that in determining whether an impugned measure was “necessary in a democratic society”, it will consider whether, in the light of the case as a whole, the reasons adduced to justify that measure were relevant and sufficient for the purposes of paragraph 2 of Article 8 (see, among many other authorities, S.H. and Others v. Austria, cited above, § 91; Olsson v. Sweden (no. 1), 24 March 1988, § 68, Series A no. 130; K. and T. v. Finland [GC], no. 25702/94, § 154, ECHR 2001 ‑ VII; Kutzner v. Germany, no. 46544/99, § 65, ECHR 2002 ‑ I; and P., C. and S. v. the United Kingdom, no. 56547/00, § 114, ECHR 2002 ‑ VI).
169. Furthermore, a number of factors must be taken into account when determining the breadth of the margin of appreciation to be enjoyed by the State in any case under Article 8. Where a particularly important facet of an individual’s existence or identity is at stake, the margin allowed to the State will usually be restricted (see Evans, cited above, § 77, and the other authorities cited therein, and Dickson v. the United Kingdom [GC], no. 44362/04, § 78, ECHR 2007 ‑ V). Where, however, there is no consensus within the member States of the Council of Europe, either as to the relative importance of the interest at stake or as to the best means of protecting it, particularly where the case raises sensitive moral or ethical issues, the margin will be wider (see S.H. and Others v. Austria, cited above, § 94; Evans, cited above, § 77; X, Y and Z v. the United Kingdom, 22 April 1997, § 44, Reports of Judgments and Decisions 1997 ‑ II; Fretté v. France, no. 36515/97, § 41, ECHR 2002 ‑ I; Christine Goodwin v. the United Kingdom [GC], no. 28957/95, § 85, ECHR 2002 ‑ VI; and A, B and C v. Ireland, cited above, § 232).
170. The Court has also observed that in any event “the solutions reached by the legislature are not beyond [its] scrutiny. It falls to the Court to examine carefully the arguments taken into consideration during the legislative process and leading to the choices that have been made by the legislature and to determine whether a fair balance has been struck between the competing interests of the State and those directly affected by those legislative choices” (see S.H. and Others v. Austria, cited above, § 97).
171. In the above-mentioned case the Court also observed that the Austrian Parliament had not yet “undertaken a thorough assessment of the rules governing artificial procreation, taking into account the dynamic developments in science and society” and pointed out that “this area, in which the law appear[ed] to be continuously evolving and which [was] subject to a particularly dynamic development in science and law, need[ed] to be kept under review by the Contracting States” (see S.H. and Others v. Austria, cited above, §§ 117-18).
172. In Costa and Pavan (cited above, § 64), the Court held that Italian legislation on pre-implantation diagnosis lacked consistency in that it did not permit implantation to be limited to the embryos not affected by the disease of which the individuals concerned were healthy carriers but did allow the applicant to abort a foetus which would have been born with the disease in question.
173. It also considered that it was not its task to substitute its own judgment for that of the national authorities in choosing the most appropriate regulations governing assisted reproduction, observing in particular that the use of in vitro fertilisation techniques raised sensitive moral and ethical questions in an area that was constantly evolving (see Knecht, cited above, § 59).
(ii) Application of the above-mentioned principles to the present case
174. The Court observes at the outset that, unlike the above-cited cases, the instant case does not concern prospective parenthood. Accordingly, while it is of course important, the right invoked by the applicant to donate embryos to scientific research is not one of the core rights attracting the protection of Article 8 of the Convention, as it does not concern a particularly important aspect of the applicant’s existence and identity.
175. Consequently, and having regard to the principles established in its case-law, the Court considers that the respondent State should be afforded a wide margin of appreciation in the present case.
176. Furthermore, it observes that the question of the donation of embryos not destined for implantation clearly raises “delicate moral and ethical questions” (see Evans; S.H. and Others v. Austria; and Knecht, all cited above) and that the comparative law materials available to the Court (see paragraphs 69-76 above) show that, contrary to the applicant’s affirmations, there is no European consensus on the subject (see paragraph 137 above).
177. Admittedly, certain member States have adopted a non-prohibitive approach in this area: seventeen of the forty member States about which the Court has information allow research on human embryonic cell lines. In some other States there are no regulations, but the relevant practices are non-prohibitive.
178. However, certain States (Andorra, Latvia, Croatia and Malta) have enacted legislation expressly prohibiting any research on embryonic cells. Others allow research of this type only subject to strict conditions, requiring for example that the purpose be to protect the embryo’s health or that the research use cells imported from abroad (this is the case in Slovakia, Germany, Austria and Italy).
179. Italy is therefore not the only member State of the Council of Europe which bans the donation of human embryos to scientific research.
180. Furthermore, the above-cited Council of Europe and European Union materials confirm that the domestic authorities enjoy a broad margin of discretion to enact restrictive legislation where the destruction of human embryos is at stake, having regard, inter alia, to the ethical and moral questions inherent in the concept of the beginning of human life and the plurality of existing views on the subject among the different member States.
181. An example of this is the Oviedo Convention, Article 27 of which provides that none of its provisions should be interpreted as limiting the possibility for a Party to grant a wider measure of protection with regard to the application of biology and medicine. Opinion no. 15, adopted on 14 November 2000 by the European Group on Ethics in Science and New Technologies to the European Commission (see paragraph 58 above), Resolution 1352 (2003) of the Parliamentary Assembly of the Council of Europe on human stem cell research (see Part III, point F above) and Regulation (EC) No 1394/2007 of the European Parliament and of the Council of 13 November 2007 on advanced therapy medicinal products (see Part IV, point B above) contain similar provisions.
182. The limits imposed at European level aim rather to temper excesses in this area. This is the case for example of the ban on creating human embryos for scientific research provided for in Article 18 of the Oviedo Convention, or the ban on patenting scientific inventions where the process involves the destruction of human embryos (see the judgment of the Court of Justice of the European Union in Oliver Brüstle v. Greenpeace eV of 18 October 2011).
183. That being said, the State’s margin of appreciation is not unlimited and it is the Court’s task to examine the arguments to which the legislature has had regard in reaching the solutions it has retained and to determine whether a fair balance has been struck between the interests of the State and those of the individuals directly affected by the solutions in question (see Evans, cited above, § 86, and S.H. and Others v. Austria, cited above, § 97).
184. The Court notes in this context that, relying on documents relating to the preparatory works to Law no. 40/2004, the Government submitted at the hearing that the drafting of the Law had given rise to discussions that had taken account of the different scientific and ethical opinions and questions on the subject (see paragraph 127 above).
185. It can be seen from a report by the XIIth Standing Committee submitted to Parliament on 26 March 2002 that doctors, specialists and associations working in the field of assisted reproduction had contributed to the discussions and that the liveliest part of these had in general concerned the sphere of individual freedoms, pitting the advocates of a secular conception of the State against those in favour of a denominational approach.
186. Furthermore, during the discussions of 19 January 2004, Law no. 40/2004 had also been criticised on the ground, among others, that recognition of the embryo as a legal subject under section 1 of the Law gave rise, according to some, to a series of prohibitions, such as the use of heterologous fertilisation and the use of cryopreserved embryos not destined for implantation for scientific research.
187. Like the Government, the Court reiterates that Law no. 40/2004 was the subject of several referendums that were declared invalid for failure to reach the required threshold of votes cast. In order to promote the development of scientific research in Italy in the area of diseases that are difficult to cure, one such referendum proposed to repeal the part of section 13 that made authorisation to carry out scientific research on embryos conditional on protecting their health and development.
188. The Court therefore observes that, during the drafting process of the Law in question the legislature had already taken account of the different interests at stake, particularly the State’s interest in protecting the embryo and that of the persons concerned in exercising their right to individual self-determination in the form of donating their embryos to research.
189. The Court notes the applicant’s allegation that Italian legislation on medically assisted reproduction is inconsistent, in support of her submission that the interference complained of is disproportionate.
190. In her written observations and at the hearing, the applicant observed that it was difficult to reconcile the protection of the embryo advocated by the Government with a woman’s legal ability to terminate a pregnancy on therapeutic grounds up until the third month and also the use by Italian researchers of embryonic cell lines obtained from embryos that had been destroyed abroad.
191. The Court’s task is not to review the consistency of the Italian legislation in the abstract. In order to be relevant for the purposes of the Court’s analysis, the inconsistencies complained of by the applicant must relate to the subject of the complaint that she raises before the Court, namely, the restriction of her right to self-determination regarding the fate of her embryos (see, mutatis mutandis, Olsson, cited above, § 54, and Knecht, cited above, § 59).
192. With regard to the research carried out in Italy on imported embryonic cell lines taken from embryos that had been destroyed abroad, the Court observes that, while the right asserted by the applicant to decide the fate of her embryos relates to her wish to contribute to scientific research, that cannot however be seen as a circumstance directly affecting the applicant.
193. Furthermore, the Court takes note of the information provided by the Government during the hearing, according to which the embryonic cell lines used in Italian laboratories for research purposes are never produced at the request of the Italian authorities.
194. It agrees with the Government that the deliberate and active destruction of a human embryo cannot be compared with the use of cell lines obtained from human embryos destroyed at an earlier stage.
195. It concludes from the foregoing that, even supposing that there are inconsistencies in the legislation as alleged by the applicant, these are not capable of directly affecting the right invoked by her in the instant case.
196. Lastly, the Court observes that in this case the choice to donate the embryos in question to scientific research emanates from the applicant alone, since her partner is dead. The Court does not have any evidence that her partner, who had the same interest in the embryos in question as the applicant at the time of fertilisation, would have made the same choice. Moreover, there are no regulations governing this situation at domestic level.
197. For the reasons outlined above, the Court considers that the Government have not overstepped the wide margin of appreciation enjoyed by them in the present case and that the ban in question was “necessary in a democratic society” within the meaning of Article 8 § 2 of the Convention.
198. There has therefore been no violation of the applicant’s right to respect for her private life under Article 8 of the Convention.
V. ALLEGED VIOLATION OF ARTICLE 1 OF PROTOCOL No. 1
199. Relying on Article 1 of Protocol No. 1, the applicant complained that she was unable to donate her embryos and was obliged to keep them in a state of cryopreservation until their death. Article 1 of Protocol No. 1 provides:
“Every natural or legal person is entitled to the peaceful enjoyment of his possessions. No one shall be deprived of his possessions except in the public interest and subject to the conditions provided for by law and by the general principles of international law.
The preceding provisions shall not, however, in any way impair the right of a State to enforce such laws as it deems necessary to control the use of property in accordance with the general interest or to secure the payment of taxes or other contributions or penalties.”
1. The Government’s submissions
200. The Government submitted at the outset that the human embryo could not be regarded as a “thing” and that it was in any event unacceptable to assign an economic value to it. They observed that in the Italian legal system the human embryo was considered as a subject of law entitled to the respect due to human dignity.
201. They also submitted that the Court afforded member States a wide margin of appreciation regarding the determination of the beginning of human life (they referred to Evans, cited above, § 81), particularly in areas such as this, where complex moral and ethical questions were in issue that were not the subject of a consensus among the member States of the Council of Europe.
202. They concluded that there had been no violation of Article 1 of Protocol No. 1 in the present case.
203. The applicant submitted that embryos conceived by in vitro fertilisation could not be regarded as “individuals” because if they were not implanted they were not destined to develop into foetuses and be born. She concluded that, from a legal point of view, they were “possessions”.
204. In the circumstances she considered that she had a right of ownership of her embryos and that the State had imposed restrictions on that right that were not justified on any public-interest grounds. In her view, the protection of the embryos’ potential for life could not reasonably be invoked in that regard since they were destined to be eliminated.
3. Observations of the third parties
(a) The European Centre for Law and Justice (ECLJ)
205. The ECLJ submitted that embryos could not be regarded as “things” and accordingly could not be deliberately destroyed. It also argued that the concept of “possession” had an inherently economic connotation which had to be ruled out in the case of human embryos.
206. Referring to Vo v. France ([GC], no. 53924/00, § 82, ECHR 2004 ‑ VIII), it pointed out, lastly, that the Court allowed States to determine in their domestic legal order “when the right to life begins” and that it afforded them a wide margin of appreciation in this area (see A, B and C v. Ireland, cited above, § 237).
(b) The associations Movimento per la vita, Scienza e vita and Forum delle associazioni familiari, represented by Mr Casini
207. These third-party interveners submitted that the human embryo could never be regarded as a “thing”.
208. They submitted, further, that Italian legislation on the subject was consistent. While they acknowledged that abortion on therapeutic grounds was legal, they observed that this was not because the embryo could be regarded as a “thing” but because account was taken of the different interests involved, particularly those of the mother.
(c) The associations Luca Coscioni, Amica Cicogna Onlus, L’Altra Cicogna Onlus and Cerco Un Bimbo and forty-six members of the Italian Parliament, represented by Ms Gallo
209. Ms Gallo reiterated the arguments submitted by the applicant concerning the status of the embryo.
(d) The associations VOX – Osservatorio italiano sui Diritti, SIFES (Society of Fertility, Sterility and Reproductive Medicine) and Cittadinanzattiva, represented by Ms D’Amico, Ms Costantini, Mr Clara, Ms Ragni and Ms Liberali
210. These third-party interveners did not submit any observations under Article 1 of Protocol No. 1.
1. The principles established in the Court’s case-law
211. The Court reiterates that the concept of “possessions” within the meaning of Article 1 of Protocol No. 1 has an autonomous meaning which is not limited to ownership of material goods and is independent from the formal classification in domestic law: certain other rights and interests constituting assets can also be regarded as “property rights”, and thus as “possessions” for the purposes of this provision. In each case the issue that needs to be examined is whether the circumstances of the case, considered as a whole, conferred on the applicant title to a substantive interest protected by Article 1 of Protocol No. 1 (see Iatridis v. Greece [GC], no. 31107/96, § 54, ECHR 1999 ‑ II; Beyeler v. Italy [GC], no. 33202/96, § 100, ECHR 2000 ‑ I; and Broniowski v. Poland [GC], no. 31443/96, § 129, ECHR 2004 ‑ V).
212. Article 1 of Protocol No. 1 applies only to a person’s existing possessions. Future income cannot be considered to constitute a “possession” unless it has already been earned or is definitely payable. Further, the hope that a long-extinguished property right may be revived cannot be regarded as a “possession”; nor can a conditional claim which has lapsed as a result of a failure to fulfil the condition (see Gratzinger and Gratzingerova v. the Czech Republic (dec.), no. 39794/98, § 69, ECHR 2002 ‑ VII).
213. However, in certain circumstances a “legitimate expectation” of obtaining an asset may also enjoy the protection of Article 1 of Protocol No. 1. Thus, where a proprietary interest is in the nature of a claim, the person in whom it is vested may be regarded as having a legitimate expectation if there is a sufficient basis for the interest in national law, for example where there is settled case-law of the domestic courts confirming its existence (see Kopecký v. Slovakia [GC], no. 44912/98, § 52, ECHR 2004 ‑ IX).
2. Application of the above principles to the present case
214. The Court notes that the present case raises the preliminary question of the applicability of Article 1 of Protocol No. 1 to the facts of the instant case. It notes that the parties have diametrically opposed views on this matter, especially regarding the status of the human embryo in vitro.
215. It considers, however, that it is not necessary to examine here the sensitive and controversial question of when human life begins as Article 2 of the Convention is not in issue in the instant case. With regard to Article 1 of Protocol No. 1, the Court considers that it does not apply to the present case. Having regard to the economic and pecuniary scope of that Article, human embryos cannot be reduced to “possessions” within the meaning of that provision.
216. As Article 1 of Protocol No. 1 is not applicable in the instant case, this part of the application must be rejected as incompatible ratione materiae with the provisions of the Convention, in accordance with Article 35 §§ 3 and 4 thereof.
1. Rejects, unanimously, the objection raised by the Government on the ground of non-exhaustion of domestic remedies;