THIRD
SECTION
(Application no. 10048/10)
JUDGMENT
STRASBOURG
2 October 2012
11/02/2013
This
judgment has become final under Article 44 § 2 of the Convention. It may be
subject to editorial revision.
In
the case of Knecht v. Romania,
The European Court of Human Rights (Third
Section), sitting as a Chamber composed
of:
Josep
Casadevall, President,
Egbert Myjer,
Alvina Gyulumyan,
Ineta Ziemele,
Luis López Guerra,
Nona Tsotsoria,
Kristina Pardalos, judges,
and Santiago Quesada, Section Registrar,
Having deliberated in private on 11 September
2012,
Delivers the following judgment, which was
adopted on that date:
PROCEDURE
1. The case originated in an application (no. 10048/10) against Romania
lodged with the Court under Article 34 of
the Convention for the Protection of Human Rights and Fundamental Freedoms
(“the Convention”) by a German and American
national, Ms Daniela Knecht (“the applicant”), on 18 February 2010.
2. The applicant was represented by Ms Diana Elena Dragomir, a lawyer
practising in Bucharest. The Romanian
Government (“the Government”) were represented by their Agent, Mrs I. Cambrea,
from the Ministry of Foreign Affairs.
The German Government, to whom a copy of the
application was transmitted under Rule 44 § 1 (a) of the Rules of Court, did
not exercise their right to intervene in the proceedings.
3. The applicant alleged in particular a
breach of her private and family life with regard to
her inability to have a child by means of IVF
using the embryos she had previously deposited in a private clinic, S.,
from where, having regard to criminal investigations launched with respect to
S. Clinic, the embryos were seized by the state authorities and deposited
at the Institute of Forensic Medicine, which was not authorised to function as
a genetic bank.
4. On
22 February 2010, the President of the Chamber decided to indicate to the
Government, under Rule 39 of the Rules of Court, that, without prejudice to any
decision of the Court as to the merits of the case, it was desirable in the
interests of the proper conduct of the proceedings that the Government take
appropriate measures to ensure that the embryos were preserved until the Court
had completed its examination of the case. On the same day, the President
decided that the application should be given priority treatment under Rule 41.
5. On 6 July 2010, the Chamber decided
to give notice of the application to the
Government. It also decided to rule on the
admissibility and merits of the application at the same time (Article 29 § 1). The
applicant requested the Chamber to hold a hearing. The Government objected to a
hearing. The Chamber decided, pursuant to Rule 54 § 3, that no hearing was
required.
6. As Mr Corneliu
Bîrsan, the judge elected in respect of Romania, had withdrawn from the case (Rule
28 of the Rules of Court), the President of the Chamber appointed Mrs Kristina Pardalos to sit as ad hoc
judge (Article 26 § 4 of the Convention and Rule 29 § 1 of the
Rules of Court).
THE FACTS
I. THE CIRCUMSTANCES OF THE
CASE
7. The applicant was born in 1967. After numerous
previous failed attempts, the applicant became the mother of a child, conceived
as the result of an in vitro
fertilisation (IVF) procedure with donated gametes. The procedure was performed
in S. Medical Centre in Bucharest; and produced nineteen embryos, three of which were implanted on 8
June 2008.
The remaining sixteen embryos obtained on the
same occasion were frozen until the applicant was considered fit by her
physician to undergo another pregnancy. A protocol was concluded between the
applicant and S., in which the applicant acknowledged that she had been
informed that in
15-20% of cases, after thawing, the embryos proved not to be viable, and
that if that were the case the embryo transfer would be impossible.
8. According to a document
issued by the National Transplant Agency (“the NTA”), on 15 July 2009 the S.
Medical Centre was authorised to function as a bank for genetic material.
However, the circumstances in which that document was issued are currently
under the scrutiny of the domestic criminal court, in view also of the fact
that it was the Ministry of Public Health, and not the NTA, which had exclusive
competence to give such authorisations.
9. On 24 July 2009, the
Directorate for the Investigation of Organised Crime and Terrorism attached to
the Prosecutor General’s Office (DIICOT) closed the S. Medical Centre, seized
all the genetic material found there and deposited it at the Mina Minovici
Institute of Forensic Medicine (IFM). This decision was not contested before
the courts.
10. On 25 August 2009, the
applicant wrote to DIICOT in her capacity as “owner of the sixteen embryos”,
expressing concerns as to the state of her frozen embryos and asking to be
informed of the practical procedure to be followed in order to urgently
retrieve her embryos.
11. On 7 September 2009, the
applicant was informed by DIICOT that it was not aware of any technical means
of identifying the embryos in question, given that an inventory was still being
made of all the material seized and no document relating to the applicant’s
embryos had been identified.
In any event, in order to be able to retrieve
her genetic material from the Institute, the applicant was advised to appoint a
doctor specialising in embryology, who would then contact the IFM for that
purpose.
12. In attempts to find an
embryologist the applicant addressed her request to the Ministry of Health, the
Embryologists’ Association and the National Doctors’ Association.
In its reply, the Ministry of Health gave the
applicant a list of the medical institutions accredited as banks for genetic
material, by virtue of ministerial Order no. 1225 of 1 July 2008; the S.
Medical Centre and the IFM were not mentioned in the list. The Ministry also
informed the applicant that it could not intervene in any way in the
contractual relationship between her and S., assuming that such a contract
existed and included specific provisions as to who could retrieve the embryos
and under what circumstances. Referring to the letter of 7 September 2009 from
DIICOT, the Ministry suggested that the applicant should contact S. and, on the
basis of the contract she had concluded with the clinic, ask for support in
identifying and retrieving her embryos.
The Embryologists’ Association replied to the
applicant on 12 October 2009, informing her that an embryo transfer
could be performed only by a specialist in assisted reproduction, and that such
transfers could not be carried out until the relevant embryos had been properly
identified.
13. The applicant finally
contacted two doctors from the P. Clinic in Sibiu (300 km from Bucharest). On 2 November 2009, in accordance with the legal requirements,
the P. Clinic requested the authority of the NTA to perform the retrieval, but
received no answer. The request was reiterated on 29 January 2010; on
1 February the NTA informed the P. Clinic that it could not grant the requested
authority, since such authority could only be given in respect of a tissue and
cell bank accredited by the NTA, which the IFM was not.
14. On 10 February 2010,
DIICOT informed the applicant that the NTA’s refusal was not binding on DIICOT;
the IFM had been appointed as the legal custodian of the genetic material
pending a criminal investigation. Once the investigation was terminated and the
S. Clinic was indicted, the file was to be sent before the criminal courts on
24 February 2010. Consequently, an order was issued authorising the
applicant to retrieve her embryos by 25 February 2010, since after that date
the Institute for Forensic Medicine would cease to act as a deposit bank
appointed by the investigating authorities. The applicant was required to be
accompanied by an embryologist and to provide a special container with liquid
nitrogen for the transfer.
15. The applicant managed to
obtain from a clinic in Austria a special container with liquid nitrogen of the kind required for
such transfers and asked the clinic to carry out the transfer.
On 12 February 2010, the P. Clinic informed
the applicant that the NTA had refused to consent to the transfer for the following
reasons: the IFM had never been authorised by the NTA to store such materials
and therefore there could be no guarantee as to the quality of the material
stored there (against contamination, deterioration, and so on); moreover, the
storage of such material in the Institute did not comply with the legal
requirements (Order of the Minister of Public Health no. 1763/2007) concerning
the traceability of the genetic material.
In view of the NTA’s refusal, of the fact that
the P. Clinic carried out its activities under the authority of the NTA, and in
so far as it could not guarantee the quality and security of the genetic
material, the clinic informed the applicant that it could not proceed with the
retrieval.
16. On 19 February 2010 the
applicant wrote again to DIICOT, asking it to issue an order allowing the IFM
to continue to store her embryos until the NTA had consented to their
retrieval. As justification of the need for such an urgent measure, the
applicant pointed out that an inability to transfer the embryos would have
serious repercussions on the right to life of her embryos and on her right to
have a family.
On the same day, the applicant sent a similar
letter to the NTA, asking it to re-evaluate the circumstances of her case and
consequently to authorise the transfer of her embryos to the P. Clinic.
17. The NTA replied on 23
February 2010, informing the applicant as follows: the IFM had been appointed
as custodian in complete disregard of the legal provisions of Directive
2004/23/EC and of Article 148 (4) of the Health Reform Act (Law no. 95/2006);
the IFM had never been accredited, nor had it been given approval by the NTA to
operate as a bank for genetic material; the S. Medical Centre had been accredited
to operate as a bank of genetic material only on 15 July 2009, and not in June
2008, when the embryos had been frozen and stored; the Code of Criminal
Procedure, invoked by DIICOT, did not provide any safeguards as to the security
and safety of the embryos while they were stored at S. (for one year) and
subsequently at the IFM (for six months).
The NTA also contended that it did not have
any information regarding the way in which the embryos had been transported
from S. to the IFM, and was thus unable to guarantee that the minimum sanitary
conditions had been complied with.
The NTA could therefore not authorise the
transfer of the embryos from the IFM to another clinic, either within Romania
or internationally; furthermore, according to the provisions of Article 19 (3)
of Directive 2004/23/EC, “all tissue and cells that do not comply with
[the legal] provisions shall be discarded.”
A. Proceedings before
the Court under Rule 39
18. On
18 February 2010, the applicant requested the Court under Rule 39 of the
Rules of Court to direct the Romanian authorities to allow her to retrieve her
sixteen embryos stored at the Institute of Forensic Medicine.
19. On
22 February 2010, the President of the Chamber to which the case had been
allocated decided, in the interests of the parties and the proper conduct of
the proceedings before the Court, to indicate to the Government of Romania,
under Rule 39 of the Rules of Court, that the embryos should not be destroyed
after 25 February 2010, for the duration of the proceedings before the Court.
The
President also decided to request the Government, under
Rule 54 § 2 (a) of the Rules of Court, to submit information
as to the legal status of the embryos after 25 February 2010 and on the
domestic law and procedure which would allow the applicant to obtain a court
transfer order quickly.
20. In
reply, the Government informed the Court as follows.
21. In
its letter of 26 February 2010, the IFM informed the Government that it was
merely the authorised depository of a receptacle seized by DIICOT from S., and
that its only obligation was to make sure that the receptacle was preserved at
a temperature of -80 degrees Celsius. The IFM therefore could not dispose of
the biological material stored in the receptacle in any way.
22. The
Ministry of Public Health informed the Government on 8 March 2010
that they had asked the IFM to take all necessary measures to adequately
preserve the applicant’s embryos. The Ministry also asked the NTA to share with
the IFM all relevant information concerning the appropriate procedure for
preserving the above-mentioned embryos.
23. With
regard to the information required under Rule 54 § 2 (a), the Government
appended the letter of 8 March 2010 from DIICOT, which stated that the
applicant’s request to have her genetic material returned had already been
granted by the prosecutor on 12 November 2009. The decision had been taken
after the applicant’s embryos had been identified on 5 November 2009;
the applicant had been given until 25 February 2010 to retrieve her embryos,
the same deadline having been set for four other individuals who were in a
situation similar to the applicant’s, in view of the necessity of avoiding
repeated interferences with the contents of the receptacles and the fact that
since an indictment had already been issued, the investigation authorities
could no longer pay the IFM the cost of storage.
DIICOT also
informed the Government that the seizure, transport and handover of the genetic
material to IFM had been carried out with the agreement of the Ministry of
Public Health, whose representative – the manager of the NTA at that time – had
cooperated directly with the investigation authorities.
24. In conclusion, the
Government contended that the applicant already had a decision allowing the
transfer of the embryos, which could be carried out at any time provided the
applicant was accompanied by an embryologist and had the appropriate
receptacle.
25. In response to the
Government’s reply, the applicant asked the Court to note that it was not
specified whether the applicant would be able to retrieve her embryos in the
absence of authorisation from the NTA. In practice, as she had already shown,
the embryo transfer was not possible unless the NTA authorised it.
B. Proceedings seeking
to obtain authorisation for the embryo transfer
1. Request lodged with
the criminal courts
26. On
20 April 2010, the applicant formulated before the Bucharest County Court civil
claims in the criminal proceedings pending before the domestic courts following
the indictment issued by DIICOT (see paragraph 14 above); she thus
asked the court to allow an embryo transfer from the IFM to a Romanian or
foreign authorised clinic.
The
applicant’s request was dismissed on 6 July 2010; the court considered that
given that the prosecutor’s decision of 12 November 2009 had already
granted her claim, the actual implementation and enforcement of the decision
exceeded the framework of the criminal trial. The court also held that the applicant
had the opportunity, if she so wished, to contest the NTA’s refusal to
authorise the embryo transfer before the civil courts.
The
applicant contested this ruling; on 23 July 2010 her appeal was dismissed as
inadmissible by the Bucharest Court of Appeal. In the court’s reasoning it was
stated that there was no legal basis to respond to her request within the
criminal proceedings, the civil courts having jurisdiction to examine her
complaints.
In his
dissenting opinion, Judge D.D. estimated that the applicant’s request was well
founded, in so far as, in spite of the prosecutor’s decision ordering the
restitution of her embryos, the authorities were refusing to implement the
decision. Having regard to the fact that the confiscation of the embryos was
carried out within criminal proceedings, it was only natural that the
restitution should also be carried out within the same proceedings. At the same
time, considering that the applicant could not be held responsible for the
confiscation, which had been ordered by the investigating authorities in the
absence of any authorisation from the NTA, it was excessive to ask the
applicant to pursue yet another set of proceedings in order to be able to
obtain authorisation for transfer from the NTA.
2. Request lodged
before the administrative courts
27. On 28 July 2010 the
applicant lodged with the Bucharest Court of Appeal a request seeking to
obtain, in accordance with the provisions of Law no. 554/2004 regulating
administrative proceedings, the NTA’s authorisation for the transfer of her
embryos to a specialised and authorised clinic, whether in Romania
or abroad.
In their defence, the NTA reiterated their
arguments, according to which the fact that the embryos had been deposited
firstly at S., and then at the IFM, where they had been transported under
unknown conditions, neither of the two institutions being at the time
accredited as banks for genetic material, created uncertainty with regard to
the safety and quality of the embryos (see also paragraph 17 above). In such
circumstances, it was not possible to authorise transfer under the relevant
legislation. Furthermore, if any clinic from Romania
agreed to deposit the sixteen embryos, the NTA would have to revoke that
clinic’s accreditation for non-compliance with the law.
The applicant’s request was dismissed as
ill-founded on 10 December 2010. The court considered that in view of
the relevant legislation, requiring specific standards of quality and safety
with regard to the genetic material and in so far as neither the S. Clinic at
the time of the original deposit of embryos nor the IFM, was accredited or
authorised to function as banks of genetic material, the NTA’s refusal was
justified and in accordance with the law.
28. The applicant contested
this judgment before the High Court of Cassation and Justice, reiterating that
according to the Government’s submissions before the Court, the transfer of the
embryos from the S. Clinic into the IFM was carried out with the approval of
the Ministry of Health and of the NTA’s manager; in that respect, the NTA’s
refusal to authorise a further transfer appeared unjustified. Furthermore, the
applicant’s few visits to the IFM for the purposes of checking the state of her
embryos revealed that the embryos were being kept in precarious conditions, in
the absence of any trained staff able to properly supervise their preservation.
29. The High Court gave its ruling
on 17 May 2011, allowing the applicant’s request and obliging the NTA to
authorise the transfer of the sixteen embryos from the IFM to an authorised
clinic in Romania or abroad.
In its reasoning, the court mainly held that
in so far as the NTA’s attribution was to coordinate the activities of
procurement, processing, preservation, storage, validation and distribution of
human tissue and cells in Romania,
there was no legal ground for it to interfere in the implementation of the
prosecutor’s decision to restore the embryos.
The fluctuating attitude of the NTA concerning
its participation and/or cooperation with the criminal investigation
authorities, namely, confirming that the retrieval of the embryos from S. had been
done with the approval of the NTA’s manager, while also holding that the
transfer had been made without its consent, proved once more that the NTA was
confused and uncertain about the scope of its own authority. The NTA’s
cooperation with the criminal investigation authorities was certain, as it came
out especially from the observations submitted by the Government’s Agent before
the Court (see paragraph 23 above). Such cooperation was, in any event,
natural, having regard to the specific nature of the confiscated goods. In this
context, the NTA should have advised the investigation authorities to deposit
the embryos in an authorised clinic, which they did not do. On the contrary,
the NTA proved to be excessively formalistic only when it came to the restitution
of the embryos to the applicant, considering, unfoundedly, that it was within
its competence to intervene in the enforcement of the prosecutor’s decision:
“This behaviour on the part of the NTA
breached the applicant’s right to retrieve her embryos and to make use of them
as urgently as possible, in view of the special characteristics of the genetic
material and also of the applicant’s age, in the context of her desire to
become a mother.”
30. The NTA’s allegations,
that in 2008, when the applicant underwent the IVF, she did not comply with the
relevant legal requirements, were not in themselves relevant, in so far as the
criminal proceedings regarding the activity of the S. Clinic were still
pending; moreover, in 2008, when the applicant deposited her embryos at S., the
clinic was in the process of being accredited, as shown by the inspections
organised to that end on 24 June 2008, and 15 April and 13 July 2009
by the NTA and the Department for the Control of Public Health, culminating
with the accreditation apparently having been granted to the clinic by the NTA
on 15 July 2009.
In spite of all these factors, and of the fact
that the prosecutor decided that the embryos should be given back to the
applicant, the NTA unjustifiably intervened and blocked the restitution
procedure; the NTA unlawfully arrogated to itself an authority it did not have,
while also threatening any medical institution which could have received the
embryos even without the NTA’s authorisation that in such a case their licence
would be suspended or even revoked.
Furthermore, the NTA could not cite any doubt
as to the security and quality of the genetic material because it had been
deposited at the IFM, an unauthorised clinic, having regard to the fact that at
the moment of the deposit their agreement had been given, and afterwards,
following the Court’s request that the embryos should be preserved and
protected pending the proceedings before this Court, the NTA was expressly
solicited by the Ministry of Health to provide expertise so as to satisfy the
Court’s request.
Referring to the case of Ternovszky v. Hungary (no. 67545/09, 14 December 2010),
the High Court held that when there was no
domestic law able to adequately define the specific circumstances in the
relationship between an individual and the state, the latter was bound to
protect fundamental human rights, such as, in the present case, the right to
respect for private life and the right to life.
For this reason, the court considered that:
“By its obstructive attitude, the NTA
infringed the applicant’s rights and interests linked to the right to a private
life and the right to life, by not properly balancing the public interest that
the NTA is bound to protect and the legitimate interests of the applicant.”
It therefore allowed the applicant’s claims as
formulated, holding that
“the NTA was obliged to authorise the transfer
of the sixteen embryos from the IFM to an authorised and specialised clinic in Romania
or abroad, a clinic which would be able to receive the embryos in its bank and
which would be able to assist the applicant with the desired embryo transfer.”
3. Enforcement of the judgment of 17 May 2011
31. In accordance with the
High Court’s ruling, on 15 June 2011 the NTA issued a decision in which it
“authorised the transfer of the sixteen embryos from the IFM Mina Minovici to
an authorised clinic in Romania, in accordance with the relevant legal framework”.
The NTA further held that the second
alternative mentioned in the High Court’s judgment, namely that the transfer
could also be authorised abroad, could not be implemented, in so far as the
appropriate authorisation for a transfer abroad was not an ordinary
authorisation for transfer, but “an authorisation for export”, which was never
requested as such by the applicant; moreover, authorisation for export had a
very particular character, and in its absence the export of human tissues and
cells was prohibited.
32. Subsequently, the
applicant unsuccessfully attempted to transfer her embryos to the B. clinic (a
private clinic in Bucharest). In their response to the Government on why the transfer was not
possible, on 6 October 2011 the B. Clinic informed that they could
not proceed with the transfer without relevant medical information concerning
the embryos and their medical history, including data on how they had been
preserved from the very beginning. Consequently and having regard to the fact
that the clinic did not have the special quarantine conditions needed for
deposit of the embryos, the transfer could not be carried out in compliance with
the applicable legal provisions.
33. On 12 October 2011, a
DIICOT prosecutor issued a decision, in which it was held that having regard to
the High Court’s ruling and to the fact that the only State medical
institutions accredited to function as “human cells and/or tissue banks” were
respectively the Prof. Dr. Panait Sârbu Obstetrics and Gynaecology Hospital in
Bucharest and the Emergency County Hospital in Cluj, for reasons of efficiency
the first institution was to become the new custodian of the applicant’s
embryos. The embryo transfer was to be carried out by a specialist transport
company, the costs being borne by the DIICOT. All documents regarding the
maintenance of the embryos were to be transferred to the new custodian.
The prosecutor’s decision was not contested by
the applicant.
34. In accordance with this
decision, on 19 October 2011 the embryo transfer was carried out and the
embryos placed in the Assisted Reproduction Laboratory within the Prof. Dr. Panait Sârbu Hospital,
the newly appointed custodian. According to a letter sent by the Ministry of
Health to the Government on 15 December 2011, the new custodian was accredited
as a genetic bank and human cell and tissue bank, and was also authorised to
assist the applicant with any procedure related to artificial insemination.
35. In a letter of 11
November 2011, the applicant submitted that the transfer of the embryos had
once more been carried out without her consent and even without her being
consulted or informed in advance. She further stated that in the Prof. Dr. Panait Sârbu Hospital
she had had bad experiences, in so far as in 2007 she underwent two
unsuccessful IVF procedures there and therefore she could no longer trust the
professional capacity of those doctors. She considered that she was entitled to
be assisted for future IVF by doctors of her choice, in whom she trusted;
therefore the transfer of her embryos into the above-mentioned clinic had
denied her that right.
The applicant requested the opportunity to
transfer her embryos to a clinic of her choice, at the expense of the Romanian
authorities, who were responsible for the situation created and also for the
well-being of her embryos.
36. By a letter of 23
December 2011, the Prof. Dr. Panait Sârbu Hospital informed the applicant’s
representative that from 16 January 2012 they could be contacted to set a date
on which the applicant, in the presence of an embryologist, could come to take
possession of her genetic material in order to transfer it elsewhere, in
accordance with the applicable rules and regulations set by the NTA.
By a letter sent to the Court on 3 March 2012,
the applicant stated that she had found a clinic outside Bucharest “willing
to help” her and that a date of transfer was “hopefully” imminent. In the
meantime, she had also tried to set up a new procedure in the hope of a new
pregnancy. She further stressed the trauma she had gone through on account of
the State’s successive interferences with her right to have another child by
IVF.
37. On 14 May 2012, the
applicant alleged that she had contacted many clinics in Romania regarding the
transfer of her embryos, but in spite of the fact that they were open to the
idea at the beginning, “after further evaluation, the risk for them seemed to
high” and no transfer was agreed.
38. The Government replied
that on one hand, the applicant’s assertions were too vague and
unsubstantiated, and on the other hand, that she had not acted with specific
diligence to transfer her embryos from Prof. Dr. Panait Sârbu clinic, either to
start an IVF procedure or at least to get more information about how her
embryos were being taken care of in that clinic.
On 19 June 2012, the Government sent a
document issued by the Prof. Dr. Panait Sârbu clinic in which it was confirmed
that the applicant could initiate an IVF procedure in that clinic, with the
assistance of a doctor and an embryologist of her choice, whether from Romania
or from abroad, in so far as these two had a license to practice in Romania.
Furthermore, a letter from the private clinic M.N.L. in Bucharest was
appended, stating that the clinic was willing to take the applicant’s embryos
while its doctors would monitor both the patient and the embryo-transfer.
On 22 June 2012, the applicant met the manager
of the M.N.L. clinic; following their discussion, she wrote a letter to the
clinic in which she asked for more information concerning the concrete stages
envisaged for the embryo transfer, as well as a precise date on which such a
transfer could be accomplished.
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).
FOR THESE REASONS, THE COURT UNANIMOUSLY
1. Declares the application
admissible;
2. Holds that there has been no violation of Article 8 of the
Convention;
3. Decides to discontinue the interim
measure indicated to the Government under Rule 39 of the Rules of Court.
Done in English, and notified in writing on 2 October 2012, pursuant
to Rule 77 §§ 2 and 3 of the Rules of Court.
Santiago Quesada Josep Casadevall
Registrar President
