Committee on Economic, Social and Cultural Rights

Views adopted by the Committee under the Optional Protocol to the International Covenant on Economic, Social and Cultural Rights, concerning communicationNo. 22/2017 *

Communication submitted by:	S.C. and G.P. (represented by counsel, Cesare Romano)
Alleged victim s :	The authors
State party :	Italy
Date of communication :	20 March 2017
Date of adoption of Views :	7 March 2019
Subject matter:	Regulation of in vitro fertilization
Procedural issues :	Committee’s competence ratione temporis; exhaustion of domestic remedies; status of victim
Substantive issues:	Right to sexual and reproductive health and informed consent
Articles of the Covenant :	3, 10, 12 and 15
Articles of the Optional Protocol:	3 (2) (b), (d) and (e)

1.1The authors of the communication are S.C. and G.P., a woman and a man of Italian nationality born in 1969 and 1978 respectively. The authors submit that the State party has violated their rights under articles 10, 12 (1) (2) (c) and (d) and 15 (1) (b), (2) and (3), all read in conjunction with article 2 (1), of the Covenant. The Optional Protocol entered into force for the State party on 20 February 2015. The authors are represented by counsel.

1.2In the present Views, the Committee first summarizes the information and the arguments submitted by the parties (paras. 2.1–5.2 below), then considers the admissibility and the merits of the communication, and lastly, draws its conclusions and issues recommendations.

A.Summary of the information and arguments submitted by the parties

The facts as submitted by the author

2.1In 2008, the authors visited a private clinic in Italy specializing in assisted reproductive technology to seek assistance to conceive a child. A first in vitro fertilization cycle was carried out. The authors requested to the clinic that at least six embryos be produced through the in vitro fertilization procedure, that those embryos be subject to pre-implantation genetic diagnosis to identify possible “genetic disorders”, and that the embryos with such disorders not be transferred into the uterus of S.C. The clinic replied that such a request was not authorized under Law 40/2004 and could therefore not be accepted.

2.2Law 40/2004 regulates the use of assisted reproductive technology in Italy. It prohibits any clinical and experimental research on human embryos. Originally, Law 40/2004 limited the number of embryos to be produced during an in vitro fertilization cycle to three; it also prohibited pre-implantation genetic diagnosis, mandated the simultaneous transfer into the uterus of all embryos, regardless of their viability or genetic disorders, and prohibited the cryopreservation of embryos. However, over the years, the scope of the law was reduced by a series of decisions by the Constitutional Court, which found parts of it incompatible with the Constitution of Italy and with the Convention for the Protection of Human Rights and Fundamental Freedoms (European Convention on Human Rights).

2.3The authors filed a lawsuit against the clinic before the Court of Florence (Tribunale di Firenze). On 12 July 2008, the Court issued provisional measures, ordered the clinic to carry out pre-implantation genetic diagnosis, and referred the matter to the Constitutional Court for its ruling. While waiting for the decision on the constitutionality of Law 40/2004, only three embryos were produced. Pre-implantation genetic diagnosis revealed that all three embryos were affected by hereditary multiple osteochondromas, and, thus, they were not transferred into S.C.’s uterus.

2.4On 8 May 2009, the Constitutional Court declared that articles 14.2 and 14.3 of Law 40/2004 were unconstitutional, insofar as article 14.2 imposes the creation of a maximum of three embryos per in vitro fertilization cycle, and the duty to transfer all of them simultaneously into the uterus, and article 14.3 does not provide that the transfer of the embryos should be made without prejudice to the health of the woman.

2.5In October 2009, the authors tried a second in vitro fertilization cycle at the same clinic. This time, ten embryos were produced. For technical reasons, pre-implantation genetic diagnosis could only be carried out on six of the ten embryos. Only one out of the six diagnosed embryos was determined to be free of hereditary multiple osteochondromas, but was graded “average quality”, with a low chance of nesting if transferred into the uterus. S.C. declined to have the “average quality” embryo transferred into her uterus. However, the clinic’s personnel insisted that, according to their understanding of Law 40/2004, consent to transfer embryos into the uterus can only be revoked before fertilization has taken place. The authors submit that the personnel threatened S.C. with a lawsuit if she insisted on not having the embryo transferred. Because of this threat, S.C. agreed to have the embryo transferred into her uterus, but she eventually suffered a miscarriage.

2.6The other nine embryos were cryopreserved. The authors requested that the clinic surrender the cryopreserved embryos that were affected by hereditary multiple osteochondromas or had been untestable, in order to be able to donate them to be used in scientific research. However, the clinic refused the authors’ request, holding that article 13 of Law 40/2004 prohibited research on embryos.

2.7On 30 March 2012, the authors filed a lawsuit against the clinic and the State party, represented by the President of the Council of Ministers, before the Court of Florence. They requested the Court to order the clinic to surrender the embryos, and to determine the validity of S.C.’s decision not to have the embryos transferred into her uterus. They also requested the Court to declare the State responsible for violating its own Constitution, and to order pecuniary compensation of €5,000 and non-pecuniary compensation as the Court found appropriate.

2.8On 7 December 2012, the Court of Florence referred the matter to the Constitutional Court, pursuant to article 700 of the Code of Civil Procedure. The Constitutional Court was called upon to determine the compatibility of articles 6.3 (regarding the revocation of the consent before fertilization) and 13 (regarding the prohibition of research on embryos) of Law 40/2004 with the Constitution, as a matter of urgency.

2.9On 22 March 2016, the Constitutional Court found the Court of Florence’s request inadmissible. Firstly, it stated that the claim concerning the irrevocability of the consent was moot, after S.C. eventually agreed to have the embryo transferred into her uterus. It also stated that the claim relating to the possible withdrawal of S.C.’s consent in the context of future in vitro fertilization treatments was speculative. Thirdly, the Court found that the conflict had multiple ethical and juridical implications related to the balance between the right to enjoy the benefits of scientific progress, and its applications (and the related benefits), and the rights of the embryo, and that those issues divided jurists, scientists and society. The Court stated that legislators were the proper authority to strike the balance between the rights of the embryo and the right to enjoy the benefits of scientific progress and its applications, not the Constitutional Court itself; it called on legislators to consider “the views and calls for action… deeply rooted at any given moment in time within the social conscience”.

2.10The authors claim that they have exhausted all domestic remedies, since the decision of the Constitutional Court is final and not subject to appeal. Concerning the requirement established in article 3 (2) (b) of the Optional Protocol, the authors claim that although the main events occurred prior to 20 February 2015, the date of entry into force of the Optional Protocol for the State party, the decisions adopted thereafter reflect a continuing violation of their rights.

The complaint

3.1The authors claim that the State party has violated their right under article 15 (1) (b) of the Covenant to enjoy the benefits of scientific progress and its applications. By prohibiting research on embryos, Law 40/2004 interferes with scientific progress, slowing down the search for a cure for various diseases, which, the authors allege, is a violation of their right to enjoy the benefits of scientific progress and its applications.

3.2The authors also consider that this prohibition has violated their right to participate in scientific research. In this connection, they argue that Law 40/2004 has prevented them from participating in scientific research through the donation of their embryos affected by a genetic disorder. The cumulative effect of the prohibition of research on embryos and the declaration of unconstitutionality of the prohibition of pre-implantation genetic diagnosis has created a situation where embryos affected by a genetic disorder, which will not be transferred, cannot be used for scientific research, nor disposed of. In the State party, it is legal for scientific research to use stem cell lines that have been created abroad through the destruction of embryos, which results in a contradictory situation. The authors submit that the effectiveness of embryo research depends both on the characteristics and the quantity of available embryos. The prohibition of research on embryos is arbitrary because it is based on a notion of an embryo that is not scientific. According to scientific research, an embryo is formed between 10 and 12 days after the fertilization, whereas in Italian law, it is considered that an embryo exists from the day of fertilization. The authors explain that human embryos are widely used for the production of stem cells, which is essential for scientific research on life-threatening illnesses such as diabetes, Alzheimer’s disease, Parkinson’s disease, cancer and heart diseases, among many other purposes. The great potential of stem cell research is yet to be realized. The authors note that in Parrillo v. Italy, the European Court of Human Rights considered that the complainant’s ability to exercise a choice regarding the fate of the embryos concerned an intimate aspect of her personal life and related to her self-determination. It was considered that the application of Law 40/2004 had resulted in interference with the applicant’s right to private life. Furthermore, the Universal Declaration of Human Rights, in its Spanish and French versions, provides the right to “participar” or “participer” (take part) in scientific advancement and its benefits. Although the wording in the Covenant differs slightly, the authors allege that it should be interpreted in light of the Universal Declaration of Human Rights and holistically, taking into account articles 15 (2) and 15 (3) of the Covenant. In view thereof, the authors consider that the Covenant protects the right of everyone to participate in scientific research.

3.3The authors also consider that Law 40/2004 violates their right to enjoy the benefits of scientific progress because they suffer the consequences of this research being slowed down. S.C. is an asymptomatic carrier of hereditary multiple osteochondromas and nine out of ten of the embryos the authors have produced were either affected by this genetic disorder or could not be tested. Unless a cure for hereditary multiple osteochondromas is found, their chances of conceiving a child are slim. S.C. also has family members who are affected by the illness. Nonetheless, the authors are prevented from contributing to the scientific research to find a cure through the donation of affected embryos for that research.

3.4The authors further argue that their rights under article 15 (2) of the Covenant have been violated. In this connection, they submit that Law 40/2004 prevents the State party from fulfilling the duty to develop science and disseminate scientific developments. Prohibiting research on human embryos makes it harder for scientists to realize the potential of research on stem cells and hinders the spreading of scientific knowledge and applications within the scientific community and society at large. The authors note that in Artavia Murillo et al. v. Costa Rica, the Inter-American Court of Human Rights determined that the right to enjoy the benefits of scientific progress includes accessing medical technology necessary to exercise the right to private life and reproductive freedom to found a family.

3.5The authors claim that article 15 (3) of the Covenant has also been violated by the State party because the State party blocks the research on embryos without a legitimate purpose. While freedom of research is not absolute, the authors submit that it can only be restricted to protect other rights, and in the present case there is no contradicting right to be protected as the embryos concerned will never grow and have been left forever in a frozen limbo.

3.6The State party has violated the authors’ right to health under article 12 of the Covenant, in particular 12 (1) and (2) (c) and (d), because Law 40/2004 cannot provide for adequate physical and mental health. Firstly, Law 40/2004 is arbitrary and introduces a restriction that is not reasonable or justified, as the ban on research does not distinguish between viable and non-viable embryos. Law 40/2004 has become increasingly incoherent over the years following successive decisions of the Constitutional Court, resulting in clinics and practitioners not having a clear understanding of the applicable legislation and leading to a violation of the authors’ right to access information on their reproductive rights. In S.H . and others v. Austria, the European Court of Human Rights observed that artificial reproductive treatments were an area in which contracting States must constantly review their legislation. Italy has failed to develop and adapt its legislation on this issue. This was also noted by the Constitutional Court of Italy in its judgment of 22 March 2016.3

3.7Secondly, the law prohibits scientific research on embryos, even when they are affected by genetic disorders that make them not transferable. Thirdly, it hinders scientific research on hereditary multiple osteochondromas, other transmissible genetic disorders and stem cells. The authors point out that as a result, their right to health is violated since they cannot attempt to conceive again, unless a cure for hereditary multiple osteochondromas is found.

3.8Fourthly, the law does not specify whether consent to transfer an embryo into the uterus can be withdrawn after fertilization. In this connection, the authors consider that S.C.’s right to health was violated when she was forced to endure transfer into her uterus of an embryo against her will and was not given the opportunity to withdraw her consent. If the State party’s concern is that the withdrawal of consent may be used to circumvent the prohibition of production of embryos for scientific research, there are less restrictive ways to achieve this end, such as limiting the frequency with which a person can donate embryos or the total number of embryos that can be donated. The transfer of the embryo resulted in a miscarriage, which causes long-term physical and long-term psychological effects. The authors note that, according to Committee on Economic, Social and Cultural Rights general comment No. 14 (2000) on the right to the highest attainable standard of health,the obligation to respect everyone’s right to health requires States to refrain from “denying or limiting equal access for all persons”, which includes refraining from “applying coercive medical treatments” and deliberately “limiting access to contraceptives and other means of maintaining sexual and reproductive health”. The authors argue that this uncertainty regarding whether or not consent to transfer can be withdrawn after fertilization has prevented them from trying to conceive again, thus violating their right to health, and in particular reproductive health.

3.9Finally, the applicable law violates the obligation to take steps for “the prevention, treatment and control of epidemic, endemic, occupational and other diseases” and those necessary for “the creation of conditions which would assure to all medical service and medical attention in the event of sickness” as mandated by article 12 (2) (c) and (d), for the reasons stated in paragraphs 3.3 and 3.4 above.

3.10The authors claim that Italy violated article 10 of the Covenant because it failed to provide the widest possible protection and assistance to the authors, as a family, as well as to other couples in Italy who are or will be in similar situations. The authors have the desire to try in vitro fertilization treatments again with the aim of conceiving a healthy child, but only if pre-implantation genetic diagnosis confirms that the newly produced embryos are viable. Since Law 40/2004 is silent as to whether consent to transfer can be withdrawn after fertilization, and the Constitutional Court has not weighed in on the issue, they are deterred from trying to conceive again. The authors further claim that if a woman cannot decline the transfer into her uterus of an embryo that, on the basis of objective criteria, is deemed to have “low chances of success”, and if she does not want to take the high risk of a miscarriage, then she cannot freely decide the number, spacing and timing of her children. The continuing silence of the State party on the question of the withdrawal of consent to embryonic transfer after in vitro fertilization violates the rights of S.C., as well as of any woman in a similar situation, to choose if, when and how to establish her family.

3.11In terms of reparations, the authors request the State party to take measures to ensure non-repetition, including replacing Law 40/2004 with a new law that takes into consideration all international human rights obligations that the State party has committed to, and all relevant decisions of the Constitutional Court of Italy, the European Court of Human Rights and the Committee. Alternatively, the authors consider that some provisions of Law 40/2004 must be amended to ensure non-repetition: articles 13 and 14.1 must contain a definition of embryo that allows research and experimentation on blastocysts and embryos up to 14 days after fertilization or when they are affected by a genetic disorder or are otherwise non-transferrable into the uterus. Article 6 must specify that consent to transfer an embryo into the uterus can be withdrawn. Finally, the authors request compensation for physical, psychological and moral suffering, and to have their legal costs reimbursed.

State party’s observations on admissibility and the merits

4.1On 12 March and 16 April 2018, the State party submitted its observations on the admissibility and the merits of the communication.

4.2The State party notes that the authors prevailed in their challenge to the limit of three embryos per in vitro fertilization cycle as, on 1 April 2009, the Constitutional Court declared article 14.2 of Law 40/2004 unconstitutional insofar as it imposed the creation of a maximum of three embryos and article 14.3 unconstitutional insofar as it did not provide that the transfer of the embryos should be made without prejudice to the health of the woman. The unconstitutionality of these articles stems from the principles of reasonableness and equality (art. 3 of the Constitution) and the right to health (art. 32 of the Constitution). The authors also raised the question of the irrevocability of consent for the transfer of the embryos into the uterus after fertilization, but this question was ruled inadmissible as it was irrelevant to the authors’ case.

4.3On 22 March 2016, the Constitutional Court ruled on the authors’ second lawsuit against the clinic and the State party and declared inadmissible the authors’ request for the unconstitutionality of article 6.3 (regarding the prohibition on withdrawing consent after fertilization) and of article 13 (1) (3) (regarding the prohibition of research on embryos other than with the aim of protecting such embryos).

4.4The State party further asserts that the Constitutional Court has found many of the provisions of Law 40/2004 unconstitutional. On 29 April 2014, the Constitutional Court declared article 4 (3), article 9 (1) and (3) and article 12 (1) of the law unconstitutional insofar as they ruled out recourse to heterologous fertilization. On May 2015, it declared article 1 (1) and (2) and article 4 (1) unconstitutional, and on 21 October 2015 it also declared article 13 (3) (b) and (4) unconstitutional.

4.5The State party recalls the status of the Constitutional Court as one of the highest guardians of the Constitution. It may receive complaints from public authorities regarding the constitutionality of regional or State norms or acts. It therefore monitors how authorities respect the Constitution and arbitrates when there are disagreements between central and local authorities. Courts may also raise questions of constitutionality to the Constitutional Court when their decisions depend on a law whose constitutionality is questioned. The Constitutional Court’s decisions cannot be appealed. When the Court declares a law or an act to be unconstitutional, it ceases to have effect in the Italian legal order.

4.6The State party considers that the facts of the authors’ case do not indicate any violation of the Covenant. It, does not question, however, the competence of the Committee to examine the admissibility and the merits of the communication.

Authors’ comments on the State party’s observations

5.1On 27 March 2018, the authors submitted that the State party had merely restated the domestic remedies pursued by the authors and had presented the role of the Constitutional Court without replying to their allegations.

5.2They requested that the Committee proceed to examine the communication on its admissibility and merits without further delay.

B.Committee’s consideration of admissibility

6.1Before considering any claim contained in a communication, the Committee must decide, in accordance with the Optional Protocol, whether or not the communication is admissible.

6.2The Committee notes that the State party has not challenged the admissibility of the communication. It nonetheless considers it necessary to clarify various elements in that regard.

6.3The Committee notes that the authors filed a civil suit against the Centre for Assisted Reproduction and the State party before the Court of Florence, which referred the matter to the Constitutional Court. The Constitutional Court ruled on the matter on 22 March 2016. The Committee notes that the Constitutional Court’s decisions cannot be appealed. The Committee concludes that the authors have exhausted domestic remedies in accordance with article 3 (1) of the Optional Protocol.

6.4The Optional Protocol entered into force in the State party on 20 February 2015. In accordance with article 3 (2) (b) of the Optional Protocol, the Committee must declare a communication inadmissible when the facts that are the subject of the communication occurred prior to the entry into force of the Optional Protocol for the State party concerned unless those facts continued after that date. Other human rights treaties include a similar ratione temporisprovision, giving rise to various interpretations; therefore, the Committee deems it useful to clarify the meaning of this condition of admissibility.

6.5The Committee notes that, in order to determine whether a communication satisfies the admissibility criterion established in article 3 (2) (b) of the Optional Protocol, it is necessary to distinguish between the facts allegedly amounting to a violation of the Covenant, and the consequences or effects that flow from those facts. As the Committee has noted, an act that may constitute a violation of the Covenant does not have a continuing character merely because its effects or consequences extend in time. Therefore, when the facts constituting a violation of the Covenant occurred before the entry into force of the Optional Protocol for the State party concerned, the mere fact that their consequences or effects have not been extinguished, after the entry into force, is not sufficient grounds for declaring a communication admissible ratione temporis. If no distinction were made between the acts that gave rise to the alleged violation and its ongoing consequences or effects, the ratione temporisadmissibility criteria established in the Optional Protocol, relating to the Committee’s competence to consider individual communications, would be virtually irrelevant.

6.6For the purposes of article 3 (2) (b) of the Optional Protocol, the facts are the sequence of events, acts or omissions which are attributable to the State party and may have given rise to the alleged violation of the Covenant. As the Committee has noted in previous Views, the judicial or administrative decisions of the national authorities are also considered to be part of the facts when they are the outcome of proceedings directly related to the initial events, acts or omissions that gave rise to the violation and could have provided reparation for the alleged violation in accordance with the law in force at the time. When these proceedings take place after the entry into force of the Optional Protocol for the State party concerned, the admissibility requirement established in article 3 (2) (b) does not prevent a communication from being found admissible. Indeed, when a victim exercises these remedies, the national authorities have been provided with an opportunity to put an end to the violation in question and to provide reparation.

6.7The Committee notes that all claims raised by the authors are related to two facts: first, the transfer of the authors’ embryo into S.C.’s uterus without her consent; and second, the refusal by the clinic to surrender the embryos so that they could be donated for use in scientific research.

6.8Regarding the refusal to accept S.C.’s withdrawal of her consent to having the embryo transferred to her uterus, the fact that the author continues to suffer the consequences of the transfer and of the miscarriage she suffered does not, as such, lead to this transfer losing its instantaneous character. The Committee notes, however, that in its ruling of 22 March 2016, the Constitutional Court addressed the authors’ civil claim regarding the transfer of the embryo into S.C.’s uterus against her will, through a question of constitutionality. In accordance with the rule recalled in paragraph 6.6 above, the Committee notes that the decision of the Constitutional Court was issued after the Optional Protocol had entered into force on 20 February 2015. Consequently, the claims related to the consequences of the transfer of the embryo to S.C.’s uterus despite the wish that she clearly expressed to the clinic’s doctors to withdraw her consent, are admissible ratione temporis .

6.9As regards the refusal by the clinic to surrender the embryos, the Committee notes that the clinic is still in possession of these embryos and that the authors still have the intention to donate them for scientific research. The refusal to surrender them could be waived at any time and the refusal to do so therefore has a continuing character. All claims in that regard shall hence be considered as falling within the jurisdiction of the Committee ratione temporis .

6.10The Committee therefore considers that the authors’ claims cannot be considered inadmissible under article 3 (2) (b) of the Optional Protocol.

6.11The Committee notes that the authors present two different claims with very different legal grounds. The first claim is that their right to health has been violated because the woman was compelled to have an embryo with low possibilities of nesting transferred into her uterus, against her will, and that she eventually suffered a miscarriage. They also argue that the uncertainty created by the law regarding whether the consent to the transfer can be withdrawn after fertilization prevents them from trying to conceive again through an in vitro fertilization procedure, thus violating their right to health and to form a family. In relation to this claim, the Committee considers that the authors have sufficiently substantiated that they may be victims of a violation of rights enshrined in the Covenant, under article 3 (2) (e) of the Optional Protocol.

6.12The second of the authors’ claims concerns the prohibition on their donating the nine embryos left to scientific research. They argue that this prohibition violates their rights to enjoy the benefits of scientific progress and restricts freedom of research under article 15 of the Covenant, and their right to health under article 12 (2) (c) and (d).

6.13The Committee considers that this second claim is inadmissible, as the authors have not sufficiently substantiated that they may claim to be victims of a violation of their rights enshrined in the Covenant as a result of being prohibited from donating the embryos to scientific research. The reasons are contained in the following paragraphs.

6.14Article 2 of the Optional Protocol restricts the locus standi for submitting communications to the real or potential victims of a violation of Covenant rights. The Committee may not examine a communication in abstracto: it may not assess whether an action or an omission of a State party is compatible with the Covenant, unless such action or omission has affected the author. The Optional Protocol does not establish an actio popularis that would allow persons, other than those who can arguably be considered as victims, to ask the Committee to analyse in abstracto the compatibility with the Covenant of a law or a policy of the State party. The burden of substantiating their status as real or potential victims of a violation of the rights in question is on the authors. A failure to meet this requirement leads to the communication being considered inadmissible.

6.15The Committee understands that communications may be filed by authors who are not in all cases represented by lawyers or jurists trained in international human rights law. Therefore, the admissibility requirements have to be interpreted in a flexible manner, without resulting in the imposition of unnecessary technical requirements, to avoid creating obstacles to the presenting of communications to the Committee. However, in order for the Committee to enter into the merits of a communication, it is necessary for the facts and the claims presented to show, at least prima facie, that the authors might be actual or potential victims of the violation of a right enshrined in the Covenant.

6.16The Committee takes note of the authors’ allegation that Law 40/2004 violates their rights under articles 12 (2) (c) and (d) and 15 of the Covenant because, by preventing them from donating their embryos to science, it “slows down” the research on hereditary multiple osteochondromas, an illness of which S.C. is an asymptomatic carrier. The authors also argue that some members of their family suffer this illness and might benefit from the research carried out on these embryos. Thus, the authors’ argument is that the donation of these specific embryos would benefit them directly, as it would have a clear impact on the research on hereditary multiple osteochondromas which would allow a cure or a better treatment to be found for this disease, or would make it possible to avoid hereditary transmission by asymptomatic carriers such as S.C. Had the authors provided sufficient evidence that there was a probable, or at least a reasonable, link between the donation of these specific embryos and the development of better treatments for the disease or the reduction of the probability of its hereditary transmission, that would benefit them personally, their claim would have been admissible. However, the petition does not substantiate the existence of this link. The submission is very detailed in showing the possibilities that research on embryos or stem cells may have for the advancement of medical science or the treatment of certain diseases, such as Alzheimer’s disease. But the petition does not provide any minimum level of evidence that the donation of these specific embryos would produce any concrete benefit for the authors in relation to hereditary multiple osteochondromas. It is not even clear at all that the embryos would be used in research on this disease. Thus, the argument about the benefits for the authors remains speculative. Consequently, the Committee concludes that this first argument is not enough to sufficiently substantiate their claim regarding the prohibition of the donation of embryos to scientific research.

6.17The second argument proposed by the authors to support their claim is in fact a recognition that they want to donate the embryos to scientific research in general, even if that research does not have any meaningful possibility of benefiting them directly. Thus, they argue that the restriction on the possibility of their donating their embryos, imposed by Law 40/2004, violates their right to participate in scientific research, which they consider to be part of the Covenant. It is not necessary for the Committee to analyse on this occasion whether or to what extent the Covenant incorporatesa right for every person to take part in scientific research; in any case, the burden is on the authors to show that they really intended to take part in a scientific endeavour. However, the authors have not substantiated this claim, as they simply argue that they wanted to donate their embryos to science, so that others would be able to perform scientific research. The petition is detailed concerning the nature and possible impact on science of research on embryos, and develops legal arguments to defend the existence of a right in the Covenant to participate in science. However, the authors do not substantiate in any meaningful manner that a donation of an embryo is really a form of participation in scientific research. The Committee concludes that this second argument also does not sufficiently substantiate the authors’ claim that the prohibition on donating their embryos violated their rights under the Covenant.

6.18The third argument made by the authors regarding the prohibition on donating the embryos is that freedom of research was infringed, because the restriction imposed by Law 40/2004 violates the obligation of States “to respect the freedom indispensable for scientific research”, thereby violating article 15 (3) of the Covenant. However, the authors have never claimed that they intended to perform any scientific research themselves, so in reality they are not claiming that they might be victims of a violation of their freedom of research. In that respect, they do not have the status of victims or potential victims, because their intent was that the Committee evaluate in the abstract whether the limitations established by Law 40/2004 were in conformity with the Covenant, which goes beyond the competence of the Committee under the Optional Protocol.

6.19For the reasons stated above, the Committee concludes that the authors have not sufficiently substantiated their first two arguments in relation to their claim regarding the prohibition on donating the embryos. The Committee also considers that the authors do not have the status of victims that would be required in order for them to make a claim in a communication in relation to their third argument regarding the prohibition on donating the embryos. Thus, under articles 2 and 3 (2) (e) of the Optional Protocol, the Committee declares the communication inadmissible in relation to the claim that the prohibition on donating the embryos violated the rights of the authors under article 15 of the Covenant.

6.20The Committee notes that the rest of the communication meets the admissibility requirements established in the Optional Protocol and, accordingly, declares the remainder of the claims under articles 10 and 12 of the Covenant admissible and proceeds to their consideration on the merits.

C.Committee’s consideration of the merits

Facts and legal issues

7.1The Committee has considered the present communication taking into account all the information provided to it, in accordance with the provisions of article 8 of the Optional Protocol.

7.2The authors submit that they undertook two in vitro fertilization cycles: the first one with three embryos, all of which were affected by hereditary multiple osteochondromas, which were therefore not transferred into S.C.’s uterus, and the second one with ten embryos, out of which only one was determined to be free of hereditary multiple osteochondromas, but was graded as being of “average quality”, that is, having a low chance of nesting. S.C. declined to have the “average quality” embryo transferred into her uterus but she was informed that she could not waive her consent to transfer the embryo into her uterus, and was threatened with a lawsuit if she refused to have this done. Because of the threat of litigation, S.C. felt compelled to agree to have the embryo transferred, but she subsequently suffered a miscarriage. The other nine embryos were cryopreserved. The Committee notes that the State party does not challenge the author’s account of the facts as presented.

7.3The authors submit that the transfer of the embryo into S.C.’s uterus against her will constitutes a violation of their right to the highest attainable standard of health. They further submit that the uncertainty created by the lack of clarity of the current provisions regarding the right of women to waive their consent to the transfer of embryos violates their rights under articles 10 and 12 of the Covenant because it prevents them from trying to conceive again through an in vitro fertilization procedure.

7.4In the light of the Committee’s conclusion on the relevant facts and on the claims made by the authors, the communication raises two central questions: whether the transfer of an embryo into S.C.’s uterus without her consent was a violation of her right to health; and whether the uncertainty created by the law regarding whether consent to the transfer of embryos can be withdrawn after fertilization constitutes a violation of the authors’ right to the highest attainable standard of health under article 12 and to the protection of their family under article 10. These basic legal questions necessitate the prior examination of two other questions: (a) the scope of the right to the highest attainable standard of health and its relation with gender equality; and (b) what the permitted limitations to article 12 are.

Access to reproductive health and gender

8.1The Committee recalls that “the right to sexual and reproductive health is also indivisible from and interdependent with other human rights. It is intimately linked to civil and political rights underpinning the physical and mental integrity of individuals and their autonomy, such as the rights to life; liberty and security of person; freedom from torture and other cruel, inhuman or degrading treatment”. The Committee also recalls that “the right to sexual and reproductive health entails a set of freedoms and entitlements. The freedoms include the right to make free and responsible decisions and choices, free of violence, coercion and discrimination, regarding matters concerning one’s body and sexual and reproductive health.” Additionally, “violations of the obligation to respect occur when the State, through laws, policies or actions, undermines the right to sexual and reproductive health. Such violations include State interference with an individual’s freedom to control his or her own body and ability to make free, informed and responsible decisions in this regard… Laws and policies that prescribe involuntary, coercive or forced medical interventions, including forced sterilization or mandatory HIV/AIDS, virginity or pregnancy testing, also violate the obligation to respect.”

8.2The Committee indeed considers it necessary to examine separately the specific allegations raised by the authors that are related to the right to reproductive health and physical integrity of S.C. In that regard, the Committee recalls that “the experiences of women of systemic discrimination and violence throughout their lives require comprehensive understanding of the concept of gender equality in the right to sexual and reproductive health. Non-discrimination on the basis of sex, as guaranteed in article 2 (2) of the Covenant, and the equality of women, as guaranteed in article 3, require the removal of not only direct discrimination but also indirect discrimination, and the ensuring of formal as well as substantive equality. Seemingly neutral laws, policies and practices can perpetuate already existing gender inequalities and discrimination against women. Substantive equality requires that laws, policies and practices do not maintain, but rather alleviate, the inherent disadvantage that women experience in exercising their right to sexual and reproductive health.”

8.3The Committee recalls that, as part of State party’s obligations under article 3, “it is incumbent upon States parties to take into account the effect of apparently gender-neutral laws, policies and programmes and to consider whether they could result in a negative impact on the ability of men and women to enjoy their human rights on a basis of equality”.

Permitted limitations to the right to the highest attainable standard of health

9.Article 12 of the Covenant is not absolute and may be subject to such limitations as permitted by article 4 of the Covenant. The Committee recalls that the Covenant’s limitation clause, article 4, is primarily intended to protect the rights of individuals rather than to permit the imposition of limitations by States. Consequently, a State party imposing a restriction on the enjoyment of a right under the Covenant has the burden of justifying such serious measures in relation to each of the elements identified in article 4. Such restrictions must be in accordance with the law, includinginternational human rights standards, compatible with the nature of the rights protected by the Covenant, in the interest of legitimate aims pursued, and strictly necessary for the promotion of the general welfare in a democratic society.

Lack of consent and violation of the right to health

10.1The Committee notes the first claim presented by the authors under article 12, namely that S.C.’s right to health was violated when she was compelled to have an embryo transferred into her uterus against her will. The Committee notes that this transfer led to a miscarriage, which she has considered traumatizing. The Committee recalls that the right to health includes the right to make free and informed decisions concerning any medical treatment a person might be subjected to. Thus, laws and policies that prescribe involuntary, coercive or forced medical interventions violate the State’s responsibility to respect the right to health. The Committee further observes that forcing a woman to have an embryo transferred into her uterus clearly constitutes a forced medical intervention. The Committee concludes that, in the circumstances of the present case, the facts presented before it constitute a violation of S.C.’s right to health, as enshrined in article 12 of the Covenant.

10.2The Committee considers that when relevant information presented in a communication indicates, prima facie, that a law that disproportionately affects women violates the obligation of the State party to ensure the equal right of men and women to the enjoyment of the right that has allegedly been violated, it is for the State party to show that it has fulfilled its obligations under article 3 of the Covenant.

10.3The Committee recalls that the requirement of equality between women and men, as guaranteed by article 3 of the Covenant, requires that laws, policies and practices do not maintain, but rather alleviate, the inherent disadvantage that women experience in exercising their right to sexual and reproductive health, and that seemingly neutral laws can perpetuate already existing gender inequalities and discrimination against women. The Committee notes that Law 40/2004, as interpreted in the authors’ case, restricts the right of women undergoing the treatment to waive their consent, leading to the possibility of forced medical interventions or even pregnancies for all women undergoing in vitro fertilization treatments. It considers that, even if, on the face of it, this restriction on the right to withdraw one’s consent affects both sexes, it places an extremely high burden on women. The Committee notes that the possible consequences on women are extremely grave, constituting a direct violation of women’s right to health and physical integrity. It concludes that the transfer of an embryo into S.C.’s uterus without her valid consent constituted a violation of her right to the highest attainable standard of health and her right to gender equality in her enjoyment of her right to health, amounting to a violation of article 12, read alone and in conjunction with article 3, of the Covenant.

Legal uncertainty regarding withdrawal of consent and violation of the right to health

11.1The Committee notes the second claim presented by the authors under article 12: that the uncertainty created by the law regarding whether the consent to the transfer can be withdrawn after fertilization prevents them from trying to conceive again, thus violating their right to health. As experienced by the authors, S.C. was unable to withdraw her consent after fertilization, and the authors have reasons to fear that they might experience a similar situation if they attempt an in vitro fertilization again. Consequently, the Committee acknowledges that the authors are prevented from accessing in vitro fertilization treatments. The Committee considers that it follows that Law 40/2004 imposes a restriction on the authors’ right to health, as it prevents their access to a health treatment that is otherwise available in the State party.

11.2Restrictions to rights protected under the Covenant must comply with the limitations provided in article 4 of the Covenant. The Committee recalls that, according to article 4, restrictions must be “compatible with the nature of these rights”. The Committee has found that the prohibition on withdrawing one’s consent to the transfer of an embryo constitutes a violation of the right to health, as it can lead to forced medical interventions or even forced pregnancies. This prohibition touches upon the very substance of the right to health and goes beyond the kind of restriction that would be justified under article 4 of the Covenant. This prohibition, or at least the ambiguity concerning the existence of this prohibition, is at the origin of the author’s inability to access in vitro fertilization treatments. Consequently, the Committee finds that the restriction is not compatible with the nature of the right to health and that the facts presented before it disclose a violation of article 12 of the Covenant in respect of both authors.

11.3Having found that the restriction on the authors’ access to in vitro fertilization treatment violates the authors’ rights under article 12 of the Covenant, the Committee does not consider it necessary to examine the authors’ claims under article 10.

11.4Finally, the Committee notes that most of the problems raised by the authors in their petition are associated with the ambiguities, and possibly even inconsistencies, of the regulation of the State party in relation to in vitro fertilization and possible research on embryos and stem cells. These ambiguities are due, in part, to the fact that Law 40/2004, passed in 2004, has been subject to important but piecemeal modifications made by several decisions of the Constitutional Court. Besides, the Committee is aware that this is a field in which the views of society have evolved significantly, and that science and techniques are in a constant state of development. For those reasons, and as stressed by other human rights bodies, States should update their regulations regularly to harmonize them with their human rights obligations and with the evolution of society and scientific progress. In the State party, this seems even more urgent.

D.Conclusion and recommendations

12.1In the light of the information provided and the particular circumstances of the case, the Committee considers that the prohibition on the withdrawal of S.C.’s consent to have an embryo transferred into her uterus and the restriction of both authors’ access to reproductive rights constitute a violation of article 12 of the Covenant in respect of both authors, and of article 12 read in conjunction with article 3 of the Covenant in respect of S.C.

12.2The Committee, acting under article 9 (1) of the Optional Protocol, is of the view that the State party violated article 12, and article 12 read in conjunction with article 3, of the Covenant. In the light of the Views contained in the present communication, the Committee makes the following recommendations to the State party.

Recommendations in respect of the authors

13.The State party is under an obligation to provide the authors with an effective remedy, including by: (a) establishing the appropriate conditions to enable the authors’ right to access in vitro fertilization treatments with trust that their right to withdraw their consent to medical treatments will be respected; (b) ensuring that S.C. is protected from any unwanted medical intervention and that her right to make free decisions regarding her own body is respected; (c) awarding S.C. adequate compensation for the physical, psychological and moral damages suffered; and (d) reimbursing the authors for the legal costs reasonably incurred in the processing of the present communication.

General recommendations

14.The Committee considers that the remedies recommended in the context of individual communications may include guarantees of non-repetition and recalls that the State party has an obligation to prevent similar violations in the future. The Committee considers that the State party should ensure that its legislation and the enforcement thereof are consistent with the obligations established under the Covenant. In particular, the State party has the obligation to:

(a)Adopt appropriate legislative and/or administrative measures to guarantee the right of all women to take free decisions regarding medical interventions affecting their bodies, in particular ensuring their right to withdraw their consent to the transfer of embryos into their uterus;

(b)Adopt appropriate legislative and/or administrative measures to guarantee access to all reproductive treatments generally available and to allow all persons to withdraw their consent to the transfer of embryos for procreation, ensuring that all restrictions to access to these treatments comply with the criteria provided in article 4 of the Covenant;

15.In accordance with article 9 (2) of the Optional Protocol and rule 18 (1) of the provisional rules of procedure under the Optional Protocol, the State party is requested to submit to the Committee, within a period of six months, a written response, including information on measures taken in follow-up to the Views and recommendations of the Committee. The State party is also requested to publish the Views of the Committee and to distribute them widely, in an accessible format, so that they reach all sectors of the population.