Communicated on 9 February 2017

FOURTH SECTION

Application no 14709/07 Lyudmyla Ivanivna MAYBORODA against Ukraine lodged on 15 March 2007

STATEMENT OF FACTS

The applicant, Mrs Lyudmyla Ivanivna Mayboroda, is a Ukrainian national who was born in 1952 and lives in Svalyava. She is repres ented before the Court by Mr S. V. Shklyar, a lawyer practising in Kyiv.

A. The circumstances of the case

1. The background facts

On 8 April 1998 the Lviv Regional Clinical Hospital ( Львівська обласна клінічна лікарня ; hereafter “the hospital” ) concluded a partnership agreement with the Lviv State Medical University (hereafter “the university”) whereby doctors on the university staff were to treat patients in the hospital. This agreement provided, in particular, as follows:

“[The university] faculty members, who, by a joint order of the [university] and the [hospital] have been allowed to diagnose and treat patients and have been familiarised with the technical safety rules, shall bear personal legal responsibility for the diagnostics and the results of patients ’ treatment.”

On 2 March 2000 the applicant, who had been diagnosed with autoimmune thyroiditis, was admitted as an in-patient to the hospital, where Dr I.P., an adjunct faculty member of the university ’ s surgical medicine department, was appointed as her primary consulting doctor.

On an unspecified date the applicant consented to the surgical removal of an adrenal gland as advised by I.P.

On 7 March 2000 a team of doctors, including I.P. and led by M.P. (chairman of the university ’ s surgical medicine department and apparently I.P. ’ s father) performed the surgery and removed the adrenal gland.

On 8 March 2000 the applicant consented to a second surgical procedure with a view to stopping the constant bleeding that had resulted after the first surgery.

On 9 March 2000 a team of doctors, including I.P. and led by M.P., performed the surgery, in the course of which the applicant ’ s left kidney was removed. Neither the applicant nor those of her relatives who were present at the hospital were informed before the surgery that there was a risk of kidney removal, nor were they told after the surgery that the kidney had been removed.

On 14 April 2000 the applicant was discharged from the hospital. Upon discharge, she was provided with a certificate attesting that she had undergone the surgical removal of an adrenal gland. The surgery of 9 March 2000 was described as “removal of blood clots from the left adrenal bed, [and] cessation of haemorrhage from small branches of the kidney artery.” It was further recommended that the applicant be “monitored by an endocrinologist/physician at her place of residence; [and come] for a check-up at the [hospital] in September 2000.” The certificate was issued on the hospital ’ s headed notepaper, had the hospital seal affixed to it, and was signed by I.P.

O n an unspecified date in spring 2000 the applicant received an anonymous telephone call notifying her that her kidney “had been stolen”.

By 30 August 2000 the applicant, who had undergone various examinations to verify the information received during the anonymous call, had received medical confirmation that her left kidney, which had previously been diagnosed as healthy, was missing.

On several occasions the applicant unsuccessfully attempted to contact I.P. and M.P. and the hospital staff to obtain an explanation, and subsequently complained to the media.

On 14 November 2000, after the applicant ’ s story had been published in various newspapers, M.P. wrote a letter to the applicant acknowledging that he had been responsible for concealing from her that her kidney had been removed during the second operation. He apologised for this concealment, which, in his opinion, had been necessary to assist in the applicant ’ s recovery, and assured her that he had been going to provide her with the information during her planned hospital appointment in September 2000, but she had failed to attend. He also explained that the removal of the kidney had been urgent and necessary, as in the course of the surgery it had been established that there was no other way to stop the incessant haemorrhage endangering the applicant ’ s life.

On 13 April 2001 the Chief Doctor of the Lviv Regional Clinical Hospital posted to the applicant a corre cted certificate dated 14 April 2000, which included the information concerning the kidney removal and apologised for the previous failure to communicate this information to the applicant.

2. Official investigations into the applicant ’ s complaints

On an unspecified date the applicant requested that the Lychakivskiy District Prosecutor ’ s Office prosecute I.P. and M.P. and other members of the hospital staff for purportedly illegally removing her kidney without her informed consent and for concealing this fact from her. She alleged that the kidney could have been removed with a view to selling it for transplantation purposes.

On 29 December 2000 the Lviv Regional Prosecutor ’ s Office refused to institute criminal proceedings for want of evidence that a crime had been committed. It found, in particular, that there was sufficient evidence that the applicant ’ s kidney had been removed in her best interest and had subsequently been destroyed. The applicant did not provide a copy of this refusal.

On April 2001 , G., a member of parliament, addressed the Ministry of Health of Ukraine on the applicant ’ s behalf, seeking their reaction to her medical malpractice allegations. Subsequently (on 23 June 2001) the ministry informed G. that they had carried out an investigation and had established that the removal of the kidney had been urgent and necessary to stop the haemorrhage and save the applicant ’ s life. They also noted that the chief physician of the hospital had been reprimanded for insufficient supervision of the maintenance of medical records and observance of medico-ethical norms in his establishment.

In the meantime, on 25 April 2001, the Lviv Regional Prosecutor ’ s Office instituted criminal proceedings against I.P. on suspicion of abuse of a position of authority and forgery of an official document. The applicant joined these proceedings as an injured party.

On 23 December 2002 I.P. was charged with forgery of an official document in respe ct of having signed on 14 April 2000 a medical certificate which represented an incomplete account of the applicant ’ s medical treatment in the hospital.

On several occasions between December 2002 and July 2005 the case was discontinued, re-opened, sent to a court for examination and sent back for further inquiry.

Eventually, on 29 July 2005 the Lviv Regional Prosecutors ’ Office discontinued the proceedings for want of evidence that I.P. had committed a crime. In particular, the prosecutor ’ s office concluded that it was impossible to charge I.P. with “forgery of an official document” as he did not qualify as an “official” for the purposes of the relevant criminal-law provision. In particular, being a university employee, I.P., practised in the hospital on the basis of the partnership agreement between the two institutions. There was neither a specific order issued by the two partner institutions in respect of his permission to practice, nor a job description or any other document on the basis of which it was possible to define the scope of his official responsibilities and confirm that he was authorised to sign official certificates on the hospital ’ s behalf. Accordingly, he could not be classified as an “official” and could therefore not be charged with forgery of an “official document”. The decision read as follows:

“Neither the Law ... [nor] any other regulatory document lists or listed in April 2000 any of the official duties of a surgical medicine faculty assistant ... , namely [ Dr I.P], with respect to the drafting and preparation of medical documentation, in particular, [the preparation] of an excerpt from a medical record ... and its proper and correct presentation”.

The applicant did not appeal against the above decision by the prosecutor ’ s office.

3. Civil proceedings

On 12 September 2002 the applicant lodged a civil claim against the hospital, the university, and M.P. and I.P. seeking compensation in respect of non-pecuniary damage for alleged medical malpractice.

On 29 December 2005 the Svalyava District Court awarded the applicant UAH 50,000 hryvnias (UAH) in compensation in respect of non-pecuniary damage against I.P. on account of his concealment of information and UAH 1,000 in respect of pecuniary damage and rejected all the other claims. It noted, in particular, that the applicant had provided no evidence to prove that the kidney had been removed for reasons other than saving her life or that its removal could reasonably have been postponed or avoided in the circumstances. Accordingly, there were no grounds for finding the defendants at fault for not seeking the applicant ’ s consent to the intervention at issue. At the same time, the court considered that the applicant should have been informed about the removal of the organ after the operation. Even assuming that the applicant ’ s mental or physical state had warranted concealment of that information, I.P. should have conveyed it to a relative or someone in her circle. The court next found that there was no basis to hold either the hospital or the university responsible for I.P. ’ s conduct because, according to the partnership agreement between these institutions, the university doctors bore personal responsibility for their diagnostic and treatment activities. As regards M.P., he had not been involved in compiling the applicant ’ s medical record, so there were likewise no grounds for holding him responsible for concealing the information from the applicant.

On 4 January 2006 the applicant lodged an appeal against that judgment. She argued, in particular, that the trial court had not properly considered her arguments concerning the liability of the hospital, even though the Ministry of Health had concluded that the chief physician ’ s supervision of the maintenance of medical records was poorly organised . Likewise, it had not considered the applicant ’ s argument that the state of her left kidney had not been assessed before the second operation and the possibility of its removal during the second operation had not been discussed either with the applicant or with the members of her family who had been present in the hospital during the operations.

On 18 April 2006 the Zakarpattya Regional Court of Appeal dismissed the applicant ’ s appeal.

On 21 September 2006 the Supreme Court of Ukraine rejected the applicant ’ s request for leave to appeal on points of law.

B. Relevant domestic law

1. Constitution of Ukraine of 1996

The relevant provisions of the Constitution of Ukraine read as follows:

Article 32

“...

Every citizen has the right to examine information about himself or herself, as long as it is not a State secret or other secret protected by law, held by the State authorities, local government bodies, institutions and organisations ...”

Article 49

“Everyone has the right to health protection, medical care and medical insurance.

Health protection is ensured through State funding of the relevant socio-economic, medical and sanitary, health improvement and prophylactic programmes .

The State shall create the conditions required for an effective medical service accessible to all citizens. ...”

2. Civil Code of Ukraine of 2003

The relevant provisions of the Code read as follows:

Article 285. Right to information concerning the state of one ’ s health

“ 1. A physical person who has come of age shall be entitled to [obtain] accurate and comprehensive information concerning the state of his or her health, including familiarisation with relevant medical documents that concern his or her health.

...

3. If information concerning a physical person ’ s illness may adversely affect his or her state of health ... or adversely affect the treatment process, medical personnel may provide incomplete information concerning the state of health of that physical person, restricting their ability to familiarise themselves with particular documents. ...”

3. Law of Ukraine “On Guidelines with respect to the Legislation of Ukraine concerning the Protection of Health” of 1992

The relevant provisions of the above act, as read at the material time, are as follows:

Ar ticle 39. Duty to provide medical information

“The doctor is obliged to explain to patients in a comprehensible manner the state of their health, the purpose of proposed examinations and treatment measures, and the prognosis of the possible dynamics of the disease, including the existence of a risk to life and health.

Patients shall be entitled to familiarise themselves with their medical record and other documents that may serve further treatment.

In special circumstances where full information might adversely affect the health of a patient, the doctor may restrict it. In this event the doctor shall notify the family members or the statutory agent of the patient, taking into account the personal interests of the patient. The doctor shall act in the same manner if the patient is in an unconscious state.”

Article 43. Consent to medical intervention

“The consent of the patient, informed according to Article 39 of these Guidelines, is necessary for the application of the methods of diagnostics, prevention, and treatment ...

In urgent cases, where there is a real threat to the life of the patient, the consent of the patient or his or her statutory agent to a medical intervention is not necessary ...”

C. Relevant International material

1. The Convention for the Protection of Human Rights and Dignity of the Human Being with regard to the Application of Biology and Medicine (“Oviedo Convention,” Council of Europe Treaty Series no. 164)

The aforementioned Convention en tered into force on 11 December 1999. To date, it has been signed by thirty-five States and has entered into force in respect of twenty-nine States. Ukraine si gned the Convention on 22 March 2002, but has not yet ratified it. The relevant provisions of the Convention read as follows:

Article 5. General rule

“An intervention in the health field may only be carried out after the person concerned has given free and informed consent to it.

This person shall beforehand be given appropriate information as to the purpose and nature of the intervention as well as on its consequences and risks.

The person concerned may freely withdraw consent at any time.”

Article 8. Emergency situation

“When, because of an emergency situation, the appropriate consent cannot be obtained, any medically necessary intervention may be carried out immediately for the benefit of the health of the individual concerned.”

Article 10. Private life and right to information

“1. Everyone has the right to respect for private life in relation to information about his or her health.

2. Everyone is entitled to know any information collected about his or her health. ...

3. In exceptional cases, restrictions may be placed by law on the exercise of the rights contained in paragraph 2 in the interests of the patient.”

Section 35 of the Explanatory report to the aforementioned Convention reads as follows:

“ 35. The patient ’ s consent is considered to be free and informed if it is given on the basis of objective information from the responsible health care professional as to the nature and the potential consequences of the planned intervention or of its alternatives, in the absence of any pressure from anyone. Article 5, paragraph 2, mentions the most important aspects of the information which should precede the intervention but it is not an exhaustive list: informed consent may imply, according to the circumstances, additional elements. In order for their consent to be valid the persons in question must have been informed about the relevant facts regarding the intervention being contemplated. This information must include the purpose, nature and consequences of the intervention and the risks involved. Information on the risks involved in the intervention or in alternative courses of action must cover not only the risks inherent in the type of intervention contemplated, but also any risks related to the individual characteristics of each patient, such as age or the existence of other pathologies. Requests for additional information made by patients must be adequately answered.”

2. WHO Declaration on the Principles of the Rights of Patients in Europe

The World Health Organisation (WHO) European consultation meeting on the rights of patients, held in Amsterdam in March 1994, endorsed a document entitled “Principles of the rights of patients in Europe” as a set of principles for the promotion and implementation of patients ’ rights in the European Member States of the WHO. Its relevant parts read as follows:

2. Information

“2.2. Patients have the right to be fully informed about their health status, including the medical facts about their condition; about the proposed medical procedures, together with the potential risks and benefits of each procedure; about alternatives to the proposed procedures, including the effect of non-treatment; and about the diagnosis, prognosis and progress of treatment. ...”

3. Consent

“3.1. The informed consent of the patient is a prerequisite for any medical intervention.

3.2. A patient has the right to refuse or to halt a medical intervention. The implications of refusing or halting such an intervention must be carefully explained to the patient.”

3. Universal Declaration on Bioethics and Human Rights

The Universal Declaration on Bioethics and Human Rights was adopted by UNESCO ’ s G eneral Conference on 19 October 2005. Its relevant provisions read as follows:

Article 5. Autonomy and individual responsibility

“The autonomy of persons to make decisions, while taking responsibility for those decisions and respecting the autonomy of others, is to be respected. For persons who are not capable of exercising autonomy, special measures are to be taken to protect their rights and interests.”

Article 6. Consent

“1. Any preventive, diagnostic and therapeutic medical intervention is only to be carried out with the prior, free and informed consent of the person concerned, based on adequate information. The consent should, where appropriate, be express and may be withdrawn by the person concerned at any time and for any reason without disadvantage or prejudice.”

COMPLAINTS

The applicant complains that the State authorities have not put in place a regulatory framework that would have protected her from the arbitrary concealment by medical professionals attending her in Lviv Regional Clinical Hospital of important information concerning her medical condition and treatment. The applicant invokes Article 3 of the Convention in respect of this complaint.

The applicant also complains under Article 13 of the Convention that there was no effective remedy available to her for ventilating the above complaint. Specifically, the complaints she lodged against the hospital in civil proceedings were arbitrarily rejected by the domestic courts.

QUESTIONS

1. Has the State complied with its positive obligation to put in place a regulatory framework so as to ensure the applicant ’ s right under Article 8 of the Convention to obtain information relating to her health and to decide on her medical treatment? (see, in particular, K.H. and Others v. Slovakia , no. 32881/04, ECHR 2009 (extracts); R.R. v. Poland , no. 27617/04, §§ 196 ‑ 197, ECHR 2011 (extracts); V.C. v. Slovakia , no. 18968/07, § 141, ECHR 2011 (extracts); and A.K. v. Latvia , no. 33011/08, § 64, 24 June 2014).

The Government are requested to comment, in particular on the following aspects:

(a) Did Lviv Regional Clinical Hospital put in place necessary procedures and take all measures that could be reasonably expected of it to

( i ) enable the applicant to exercise her consent rights with respect to kidney removal either personally or through a representative?

(ii) ensure that she obtains full information concerning the outcome of the second surgery either personally or through a representative?

(b) Did the domestic courts provide relevant and sufficient reasons for dismissing the applicant ’ s claims against the Lviv Regional Clinical Hospital?

2. Did the applicant have at her disposal an effective domestic remedy for her complaint under Article 8, as required by Article 13 of the Convention?