Medically-assisted procreation
II. RELEVANT DOMESTIC AND COMPARATIVE LAW A. Health-Care Reform Act (Law no. 95/2006) 39. The Act is divided into seventeen titles, covering a wide array of subjects specific to the public health area. Title VI contains provisions covering the procurement and transplant of organs, tissues and cells of human origin used for therapeutic purposes, the donors of organs, tissues and human-origin cells, the donation and transplant thereof and the financing of transplant activity. It transposes into national legislation Directive 2004/23/EC of the European Parliament and of the Council of 31 March 2004 on setting standards of quality and safety for the donation, procurement, testing, processing, preservation, storage and distribution of human tissue and cells. It also defines the role and responsibilities of the National Transplant Agency, as the main competent authority in the field of the procurement and transplant of organs, tissues and cells of human origin, including the accreditation, designation, authorization or licensing of tissue establishments and tissue and cell preparation processes. Section 143 The National Transplant Agency shall be responsible for the coordination, supervision, approval and implementation of any provisions regarding transplant activities. Section 148 (4) Any transplant of tissue and cells of human origin may be processed only from the banks accredited or approved by the National Transplant Agency... (9) Imports or exports of tissue and cells shall be possible only if specifically authorised by the National Transplant Agency. B. Order of the Minister of Public Health no. 1763 of 12 October 2007 40. This sets out provisions governing the mechanisms to be put into place to ensure the quality and safety of tissues and cells and their traceability, in compliance with the relevant European law requirements. C. Order of the Minister of Public Health no. 1225 of 1 July 2008 41. This lists the tissue establishments accredited, designated, authorized or licensed to function as tissue and human cell banks and/or users. Neither the clinic S., nor the IFM appear in this Act. D. Romanian Criminal Procedure Code 42. In its relevant parts concerning the procedure on the sequestration of goods pending criminal investigation, the code reads as follows: Article 165 (1) The authority that enforces the sequestration ( sechestru ) must identify and evaluate the goods in question; it may, if need be, make recourse to experts. [...] (9) If there is the danger of estrangement, other movables sequestered will be sealed or taken away, and a custodian can be appointed. Article 166 (1) The body that enforces the sequestration draws up an official report on all acts performed under Section 165, including a detailed description of the goods sequestered and specifying their value... Article 168 (1) Against this measure taken and of its enforcement means, the defendant, the party bearing the civil responsibility, as well as any other interested person may complain to the criminal investigation body who ordered the measure or to the prosecutor who supervises the criminal investigation, before summoning the court, after which the complaint is addressed to the relevant court. (2) The court decision may be appealed against separately. The appeal does not suspend the execution. (3) After the final settlement of the criminal trial, if no complaint has been lodged against the enforcement of the assurance measure, it may be contested under the civil law. Article 169 (1) If the criminal investigation body or the court finds that items taken away from the defendant, or from any other person who received them in custody, are the property of the victim or have been wrongly taken away from him/her, it orders the return of those items to the victim. Any other person who claims a right over the things taken away may ask under Article 168 for enforcement of this right and return of the items taken. (2) The items taken away are returned only if this does not impede the revealing of the truth and the just settlement of the cause, and imposes upon the person to whom they are returned the obligation to keep them until the decision is declared final. E. Comparative Law 43. An overview of the law and practice concerning artificial procreation in general and on the standards of quality and safety for the donation, procurement, testing, processing, preservation, storage and distribution of human tissue and cells in Europe is included in S. H. and Others v. Austria ([GC], no. 57813/00, §§ 35-44, 3 November 2011). THE LAW I. ADMISSIBILITY OF THE APPLICATION 44. In their observations submitted on 2 September and 6 October 2010, the Government raised three preliminary objections, as follows. 45. Firstly, the Government cited the lack of victim status for the applicant, in so far as her claim to retrieve her embryos from the IFM had already been allowed by the Prosecutor in the decision of 12 November 2009. 46. Secondly, the Government contended that the applicant became the client of S. Clinic, a private clinic, in June 2008, when the clinic did not have a proper licence, either as a bank for genetic material or as a clinic specialising in IVF. It is submitted that the clinic was apparently accredited by the NTA to carry out tissue banking activities (processing, deposit and distribution) only on 15 July 2009; however, the accreditation itself is currently under criminal investigation (see also paragraph 8 above). In any event, the clinic has never received authorization – which would imply authority to carry out removals and transplants - as a few days after its accreditation the DIICOT launched their investigation and the activity of the clinic was suspended. It followed that the State could not be held responsible ratione personae for the applicant’s choice, which determined certain subsequent effects on her right to a private life, in so far as it was the applicant who had freely chosen the services of S., in spite of the fact that the clinic did not comply with the legal and medical requirements for its proper functioning in the IVF field. From that respect, in making her choice the applicant proved to have shown a certain lack of diligence ( culpa in eligendo ) in so far as any diligent person would normally make minimal preliminary inquiries about a clinic which she/he intends to entrust with the safeguarding of their embryos. 47. Finally, the Government contended that the applicant had at her disposal the legal provisions of Law no. 554/2004 regarding administrative proceedings, which allowed her to contest the NTA’s refusal to authorise a transfer of embryos from the IFM into a private clinic, a legal remedy which she had not used. 48. The applicant argued that in spite of the prosecutor’s decision of 12 November 2009, she was still not able to transfer her embryos to a specialised clinic where she would be able to undergo another IVF procedure. She further contended that when she approached the S. Clinic she was in fact following her doctor, who used the facilities of that clinic. Furthermore, the applicant disagreed that a patient had the obligation to check a priori all the authorisations and licences of a clinic he/she intended to approach; it was the responsibility of the State to make sure that a clinic which is allowed to function operates in compliance with the applicable legal and medical requirements, and yet, in June 2008 when she underwent the IVF at S., the latter had been allowed to function for almost a decade, in a building 500 m away from the NTA’s headquarters, but apparently without the required licence. From that respect and in view also of the state authorities’ hesitations when handling her case, the State’s failure to provide and properly implement a sufficiently clear legal framework in this area of expertise could not be denied. 49. The Court firstly notes that pending proceedings before it, namely on 28 July 2010, the applicant lodged a request with the domestic administrative courts, asking them in accordance with Law no. 554/2004 to oblige the NTA to authorise the transfer of her embryos from the IFM into a specialised clinic, whether in Romania or abroad. The proceedings ended on 17 May 2011, when the Romanian highest court allowed the applicant’s claims. From that respect, the Court considers that the Government’s preliminary objection concerning the exhaustion of domestic remedies has been left without object. Secondly, having regard to the final judgment given in the above-mentioned proceedings, which confirmed that it was impossible for the applicant to retrieve and transfer her embryos on account of the NTA’s obstructive interventions which have thus infringed the applicant’s rights and interests protected by Article 8 of the Convention (see paragraph 30 above), the Court estimates that the Government’s remaining objections have lapsed. 50. The Court then considers that the applicant’s complaints are not manifestly ill-founded within the meaning of Article 35 § 3 of the Convention. It further notes that they are not inadmissible on any other grounds. They must therefore be declared admissible. II. ALLEGED VIOLATION OF ARTICLE 8 OF THE CONVENTION 51. The applicant’s complaint essentially concerns a breach of her right to a private and family life in so far as she was prevented from becoming a parent by means of an IVF procedure using her frozen embryos, on account of the State’s failure to offer her the assistance she required in the matter, namely by allowing her to transfer her embryos into a specialised clinic of her choice. Article 8 of the Convention reads as follows: “1. Everyone has the right to respect for his private and family life, his home and his correspondence. 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.” A. The parties’ submissions 52. The applicant denied any responsibility for the events that took place from July 2009, in so far as it was the Prosecutor who had decided at the time to transfer her embryos into an unauthorised clinic, which triggered the NTA’s subsequent refusal to allow her to retrieve and transfer her embryos into a specialised and authorised clinic. It was the responsibility of the state institutions to be aware of the fact that, once transferred into an unauthorised location, the embryos would have to remain there, in conformity with the European and national regulations in this sensitive field of processing and depositing human cells and tissue. The applicant further contended that it was the lack of communication or even conflict between the state institutions involved in this area of expertise that obstructed her from placing her embryos in a specialised clinic where she would be able to start a new IVF procedure. These conflicts were all the more prejudicial to her, in view also of the fact that she was turning 45, and had therefore less and less chance of a successful IVF procedure. 53. The Government submitted that even assuming that there has been an interference with the applicant’s right to private life in the present case, such interference was prescribed by the law and it was necessary in a democratic society, as it was aimed at the protection of public order, namely the prevention of crime, at protecting health and the rights and liberties of others. Furthermore, the interference complained of was proportional, for the following reasons. At the outset, it was the applicant who freely placed herself in a risky situation by using, in June 2008, the facilities of a clinic that was neither authorised to operate in the IVF field, nor to function as a bank of genetic material. According to the information provided by the NTA, at the time of the IVF procedure neither the clinic S., nor the applicant complied with the existing legal and medical requirements. There was no information in the applicant’s medical file prepared at the S. Clinic regarding the collection of the respective sex cells, their origin, the procedures followed in their subsequent handling, nor any data on the storage of the embryos, steps which were obligatory for IVF procedures. The S. Clinic was the only body responsible for keeping and providing data concerning the traceability of the genetic material, and without that information no medical procedure should have taken place. In this context, the applicant’s choice of S. rendered applicable the principle according to which nemo auditor propriam turpitudinem allegans. The measures subsequently taken by the authorities in connection with the closing of the S. Clinic were aimed at putting an end to an activity which raised suspicions as to its lawfulness and medical safety. Even in such a context, the interests of the applicant were accommodated, in so far as her request to retrieve her embryos was promptly allowed by the prosecutor, a decision that was never contested by the applicant. B. The Court’s assessment 54. The Court firstly notes that it is not disputed between the parties that Article 8 is applicable and that the case concerns the applicant’s right to respect for her private life. The Court agrees, since “private life”, which is a broad term, encompassing, inter alia, elements such as the right to respect for the decisions both to have and not to have a child (see Evans v. the United Kingdom [GC], no. 6339/05, § 71, ECHR 2007 ‑ IV, and A, B and C v. Ireland [GC], no. 25579/05, § 212, 16 December 2010) or the right of a couple to conceive a child and to make use of medically assisted procreation to that end, such a choice being clearly an expression of private and family life (see S. H. and Others v. Austria, cited above, § 82). 55. The Court pinpoints that the issues complained of in the present case particularly relate to the NTA’s refusal to authorise the applicant to transfer her embryos from the IFM into a specialised clinic of her choice, where she could make use of these embryos via an IVF procedure. The reason given by the Romanian authorities for that refusal was that such an authorisation would be in breach of European and national legislation concerning the standards of quality and safety for the processing and depositing of human tissue and cells. In this context, the Court reiterates that although the object of Article 8 is essentially that of protecting the individual against arbitrary interference by the public authorities, it does not merely compel the State to abstain from such interference. In addition to this primarily negative undertaking, there may be positive obligations inherent in an effective respect for private and family life. These obligations may involve the adoption of measures designed to secure respect for private and family life, even in the sphere of the relations of individuals between themselves. The boundaries between the State’s positive and negative obligations under Article 8 do not lend themselves to precise definition. The applicable principles are nonetheless similar. In particular, in both instances regard must be had to the fair balance to be struck between the competing interests (see Evans, cited above, § 75). In the present case, the Court will approach the case as one involving an interference with the applicant’s right to a private life, since she was in fact prevented from using her embryos by the state authorities, who, in their turn, relied on the legal provisions applicable in the matter and established specific and strict requirements, that were not met in the applicant’s case. In any event, as noted above, the applicable principles regarding justification under Article 8 § 2 are broadly similar for both the analytical approaches adopted ( see S. H. and Others v. Austria, cited above, § 88). 56. Such interference will be in breach of Article 8 of the Convention unless it can be justified under paragraph 2 of Article 8 as being “in accordance with the law”, pursuing one or more of the legitimate aims listed therein, and being “necessary in a democratic society” in order to achieve the aim or aims concerned. 1. In accordance with the law and legitimate aim 57. The Court considers that the measure at issue, namely the prosecutor’s decision made in the context of criminal proceedings started against S. Clinic, to seize the embryos and place them “in custody” in a State institution, was in accordance with the provisions of Article 165 of the Romanian Criminal Procedure Code. The measure was taken with the approval and in cooperation of the Ministry of Public Health (see paragraph 23 above). At the same time, the measure pursued a legitimate aim, namely the prevention of crime, the protection of health or morals and the protection of the rights and freedom of others in the context of a clinic operating without the required licence necessary in such a sensitive field as assisted reproduction procedures. The aim of the measure as such has not been in dispute between the parties, who concentrated their arguments on the necessity for the interference. 2. Necessity in a democratic society and the relevant margin of appreciation 58. In that connection the Court reiterates that in order to determine whether the measures taken were “necessary in a democratic society” it has to consider whether, in the light of the case as a whole, the reasons adduced to justify them were relevant and sufficient for the purposes of Article 8 § 2 (see, among many other authorities, P., C. and S. v. the United Kingdom, no. 56547/00, § 114, ECHR 2002-VI). 59. In cases arising from individual applications, the Court’s task is not to review the relevant legislation or practice in the abstract; it must as far as possible confine itself, without overlooking the general context, to examining the issues raised by the case before it (see Olsson v. Sweden (no. 1), 24 March 1988, § 54, Series A no. 130). Consequently, the Court’s task is not to substitute itself for the competent national authorities in determining the most appropriate policy for regulating matters of artificial procreation, in respect mainly of procedures to be followed or authorities to be involved and to what extent, especially since the use of IVF treatment gave rise then and continues to give rise today to sensitive moral and ethical issues against a background of fast-moving medical and scientific developments. It is why in such a context the Court considered that the margin of appreciation to be afforded to the respondent State is a wide one (see S.H. and Others v. Austria, cited above, § 97). The State’s margin in principle extends both to its decision to intervene in the area and, once it has intervened, to the detailed rules it lays down in order to achieve a balance between the competing public and private interests (see Evans, cited above, § 82). 60. Having this in mind and turning to the circumstances of the present case, the Court finds that it has not been shown that the decision of the prosecutor to confiscate the genetic material found at S. Clinic and to deposit it with a custodian (namely, the IFM) was arbitrary or unreasonable. However, the subsequent effects on the applicant’s right to private life of this measure taken in the context of criminal proceedings launched against S. were, as underlined by the national courts, aggravated by the NTA’s obstructive and oscillatory attitude, which triggered the impossibility for the applicant to transfer her embryos into a clinic specialising in assisted reproduction procedures (see paragraphs 29-30 above). 61. The Court nevertheless notes that in the judgment of 17 May 2011, the highest Romanian court expressly acknowledged that the applicant had suffered a breach of her rights under Article 8 on account of the NTA’s refusal to allow an embryo transfer from the IFM to a specialist clinic, and offered her the required redress for the breach, namely that the embryos be transferred into a specialised and authorised clinic. This transfer was enforced in a relatively short period of time following the pronouncement of the High Court’s judgment and consequently, the applicant’s embryos have now been transferred and deposited in a specialist clinic, namely in the Department for Assisted Reproduction within the Prof. Dr. Panait Sârbu public hospital. It follows that the applicant’s initial complaint, that it was impossible for her to retrieve and transfer her embryos from the IFM, has remained without object in so far as the domestic authorities have adopted and implemented measures albeit with some delay designed to secure respect for the applicant’s right to a private life and consequently the transfer as required by the applicant was made and the embryos have now been deposited in a specialised and authorised clinic. 62. The applicant’s further complaint refers to the fact that in the new clinic she would not be able to proceed with another IVF on account of her past bad experiences in that same place. However, while refraining from any speculation on the matter, which falls outside its competence, but having regard to the latest information received from the parties (see paragraphs 34-38 above), the Court considers that it has not been provided with sufficient evidence that the applicant would not be able to have her interest accommodated in relation to the desired IVF procedure in so far as to sustain her claims under Article 8. 63. Therefore, having regard to the developments of the applicant’s situation, the Court finds that it has not been shown that the State failed to strike a fair balance between the competing interests. Accordingly, there is no appearance of a failure to respect the applicant’s right to private life. 64. There has therefore been no violation of Article 8 of the Convention. III. RULE 39 OF THE RULES OF COURT 65. In view of its findings set out above, the Court considers it is appropriate to lift the interim measure indicated to the Government of Romania under Rule 39 of the Rules of Court (see paragraph 4 above).
The Court held that there had been no violation of Article 8 (right to respect for private and family life) of the Convention. The domestic courts had expressly acknowledged that the applicant had suffered a breach of her rights under Article 8 on account of the refusal by the authorities to allow the embryo transfer, and had offered her the required redress for the breach, which led to the transfer of the embryos in a relatively short time. Therefore the requisite steps had been taken to secure respect for the applicant’s right to respect for her private life.