Communicated on 29 September 2018
FOURTH SECTION
Application no. 53176/17
Edita GRAŽULEVIČIŪTĖ
against Lithuania
lodged on 21 July 2017
STATEMENT OF FACTS
The applicant, Ms Edita Gražulevičiūtė, is a Lithuanian national, who was born in 1971 and lives in Vilnius. She is represented before the Court by Ms L. Meškauskienė, a lawyer practising in Vilnius.
A. The circumstances of the case
The facts of the case, as submitted by the applicant, may be summarised as follows.
The applicant is a rheumatologist; she has been carrying out individual activities as a doctor since 2004.
The applicant was carrying out several clinical trials. One of them concerned a medicinal product, tocilizumab. During one of the trials, the patient V.S. died and her daughters asked the State Medicines’ Control Agency (SMCA) to investigate whether the applicant had carried out her duties properly during the clinical trial. The good clinical practice inspection (GCPI) was carried out and the SMCA found some shortcomings, some of which were considered as serious, and by the order of 10 January 2012 the applicant and another investigator were suspended from the clinical trial of tocilizumab, the applicant was also prohibited from taking up new clinical trials until the ones that had been already started were finished.
The applicant lodged a complaint with the Vilnius Regional Administrative Court alleging that the orders to suspend her were unreasoned and only based on the results of the GCPI, which were unlawful and ungrounded.
On 6 December 2013 the Vilnius Regional Administrative Court allowed the applicant’s claim. The applicant stated that legal regulations did not provide for an obligation to organise an unplanned visit to the patient’s house if the patient had refused to come to the medical institution. The applicant found out about the deterioration of V.S.’s state of health on 11 April 2011 and was considering various options but the patient assured the applicant that she had been examined by a doctor she knew. As a rheumatologist, the applicant could only diagnose and treat sepsis after the consultation of another doctor, thus she had recommended that V.S. immediately come to the hospital, which V.S. had failed to do. After the phone call with V.S.’s daughter, during which the latter stated that her mother had to be hospitalised rather than go to the doctor for examination. The applicant then consulted her colleague and told V.S.’s daughter to take her mother to the hospital’s accident and emergency service, where she was examined and directed to another hospital by the doctor, J.R. The SMCA based its conclusions on the explanations given by V.S.’s daughters, an allegation in the GCPI was made that the applicant could have intended to fill in the medical card incorrectly in order to conceal some procedural violations, but this conclusion of GCPI was not based on any facts. In its decision the court described the results determined by the expert, which stated that it was not possible to establish whether V.S.’s sepsis was a result of a separate illness or of the clinical trial of tocilizumab. The expert concluded, however, that V.S. had died because of acute sepsis and not because of the applicant’s actions. The court questioned J.R. who confirmed that she heard the telephone conversation between V.S. and the applicant, during which the applicant suggested that V.S. go to the hospital to a traumatology specialist. J.R. stated that when V.S. finally went to the hospital, she examined her together with the applicant and they saw that V.S.’s leg was dark grey, the complication was at least four days old. The court established that both the applicant and J.R. examined V.S., and thus the conclusion of the GCPI that the applicant did not participate in that examination was unfounded. The court also found that although the conclusions of the GCPI were mainly based on the testimony of V.S.’s daughters, the testimony had been taken after V.S.’s death and could be very subjective. The court also found that V.S. had signed an agreement to participate in the clinical trial and was informed whom to address in case of complications. That agreement did not indicate the applicant’s contacts, but the contacts of J.R. and those of another investigator A.V., thus the court could not understand why V.S. had failed to contact the other investigators (J.R. or A.V.). Also, the fact that the applicant was on maternity leave was not important because she was not the only one performing the clinical trial. The court also noted that even though V.S. was obliged to inform the investigating doctors about any deterioration of her health, she had addressed a doctor she had known and she had contacted the applicant only several days later. The court found that the conclusions of GCPI were incorrect and they were contradicting the factual circumstances. The GCPI had also found violations in the applicant’s actions because she did not inform the clinical study manager about the issues with V.S.’s health within twenty-four hours. The court established that the applicant had not breached any requirements because at first V.S. had experienced pain in her ankle and it was not a symptom of any serious side effect. The applicant had also immediately informed the clinical study manager when it was suspected that V.S. had septic arthritis. As a result, the court found that the suspension was applied unlawfully and ordered that the orders to suspend the applicant from the clinical trials and not to perform new ones be annulled.
This decision was not appealed against and became final on 21 December 2013.
The applicant lodged a claim in respect of pecuniary and non-pecuniary damage, 142,815 euros (EUR) in total, 5 per cent of late payment interest and costs and expenses.
On 4 November 2015 the Vilnius Regional Administrative Court allowed the applicant’s claim in part. The court established that on 17 August 2010 an agreement was concluded regarding the clinical trial and the amount to be paid for one person for a complete trial in the intravenous group could be EUR 7,182 maximum and in hypodermic group – EUR 5,771 maximum. The applicant had six patients, one of which had died and because of that incident an investigation was opened into the applicant’s activities, as a result of which she was removed from the clinical trial of the medicinal product, tocilizumab, and she was prevented from taking up new clinical trials until the ones that had been already started were over. The applicant also had permission to perform another clinical trial, from which she was later removed because she herself had refused to participate. It was later found that no patients had been involved in the latter clinical trial and that it had not been started. As regards the investigation into the applicant’s activities, on 6 December 2013 the Vilnius Regional Administrative Court annulled the orders for the applicant’s suspension. This decision was not appealed against and became final on 21 December 2013. The court held that the applicant considered her future income as pecuniary damage. By a decision of 6 December 2013 the Vilnius Regional Administrative Court held that the results of the investigation against the applicant were unlawful, the court in the present case considered this decision to be res judicata and decided that conditions for responsibility did not have to be newly determined. The court further found that the first clinical trial, in the course of which V.S. had died, and which had six patients in total, was finished and if the applicant had not been suspended, she would have received remuneration of EUR 6,128. As regards the other clinical trial, the court held that the applicant had refused to participate in it herself, thus there were no grounds to believe that she had suffered any pecuniary damage. As regards non-pecuniary damage, the court held that the applicant was unlawfully suspended from the first clinical trial for two years; she had suffered non-pecuniary damage, and decided to award her EUR 200 in compensation. The court also awarded the applicant late payment interest.
The applicant and the authorities appealed. On 30 January 2017 the Supreme Administrative Court held the following: the annulment of an administrative act did not in itself imply the unlawful actions of the authorities and the civil responsibility of the State. Also, in accordance with the principle of res judicata, the factual and legal aspect established in another decision of the court, had to be accepted and parties to the proceedings or another interested party could rely on them. Nevertheless, in cases regarding damage, the court had to assess the alleged unlawful actions in the context of civil liability because the assessment of the circumstances in accordance with Article 6.271 of the Civil Code was not a denial of the decision’s res judicata effect. The first-instance court had incorrectly applied the material legal norms and had adopted an unreasoned and unlawful decision. At the material time, provisions of the Directive 2001/20/EC of the European Parliament and of the Council of 4 April 2001 on the approximation of the laws, regulations and administrative provisions of the Member States relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use (the Directive) were relevant. The Directive was implemented by the Law on Ethics of Biomedicinal Experiments, Law on Pharmacy and other relevant legal acts. The Directive established the principle of protection of persons participating in the clinical trials. The clinical trial could not be opened until the committee on ethics agreed. In Lithuania, the relevant authorities to approve clinical trials were the SMCA and the Committee on Bioethics. In the present case, it was important to establish whether agreements by the authorities to carry out two clinical trials were in accordance with the law. The Vilnius Regional Administrative Court annulled the relevant part of the order concerning the applicant because it had assessed the conclusions of the investigation against the applicant as insufficient to substantiate the violations of the good clinical practice rules and it held that too much weight had been put on the subjective explanations of V.S.’s daughters. These conclusions of the court were not enough to establish the unlawful actions of the SMCA. It had to be assessed, whether the SCMA’s actions ordering to perform the investigation and the investigation procedure against the applicant had been in accordance with the law. The SMCA’s actions were in accordance with the law, the information about V.S. was received lawfully and the results had also been described in a lawful manner. The adoption of the order to suspend the applicant had also been lawful because the SMCA had aimed to prevent the violations of the rights of the patients, to ensure their safety and to ensure that the clinical trial at issue was performed in accordance with relevant regulations and the information received was reliable and of high quality. After conclusions of the GCPI against the applicant were received, the SMCA could only adopt the order to suspend her. The mere fact that part of this order concerning the applicant was later annulled by the Vilnius Regional Administrative Court, did not mean that the SMCA’s actions had been unlawful. Also, the order regarding the applicant had not been unlawful ab initio. There was information in the case that the applicant had failed to take relevant actions to ensure the quality, entirety and the reliability of the documents of the clinical trial. During the investigation against the applicant, a critical violation of the good clinical practice rules was established and the SMCA was able take measures against the applicant. The SMCA had an obligation to perform the investigation into the applicant’s other activities, i.e., the other clinical trials, and to adopt the final decision. In the applicant’s case, the final decision was to annul the part of the order by which the applicant had been suspended because the suspension had only been temporary. As a result, SMCA had not performed any unlawful actions and there were no grounds for the civil liability to arise. Consequently, the Supreme Administrative Court overturned the first-instance decision, satisfied the appeal of the authorities and dismissed the applicant’s claim.
The applicant then asked for the reopening of the proceedings but on 8 June 2017 the Supreme Administrative Court dismissed her request. The court dismissed the applicant’s claims that it had been decided on rights and obligations of the Committee on Bioethics, which was not a party to the proceedings. The court held that the applicant was not a representative of the Committee on Bioethics and could not require the reopening on its behalf. The court also dismissed the applicant’s claim that a breach of the material legal norms had been done because the applicant’s subjective interpretation of the legal norms could not lead to the reopening of the proceedings. Finally, the court dismissed the applicant’s argument that it was necessary to ensure the uniform application of the case-law of the administrative courts because the applicant had not provided any similar decisions of the Supreme Administrative Court regarding the application and interpretation of the same legal norms.
B. Relevant domestic law and practice
Article 2 of the Convention on Human Rights and Biomedicine establishes the principle that the interests and welfare of the human being shall prevail over the sole interest of society and science. This principle is also reflected in the Law on Ethics of Biomedicinal Experiments, Good clinical practice rules and Description of Order of Agreement to Perform a Clinical Experiment of a Medicinal Product and Issue of Licences to Perform a Clinical Experiment of a Medicinal Product, Carrying Out of Experiments and their Control, approved by the Minister of Health on 31 May 2006, Order No. V-435 (the Order).
Inspectors performing the investigation into a person’s activities draw up a protocol and define the shortcomings they have found and the breaches of the Good Clinical Practice Rules, especially those that can have negative consequences (Point 77 of the Order). If serious violations of the Good Clinical Practice Rules are found and it is established that they occurred because of the actions of the researcher, the SMCA can take actions (Point 78). One of the actions is suspension of the researcher from the investigation and publishing about it on the webpage of the SMCA (ibid.). If a researcher is suspended, he or she is also automatically removed from other experiments he or she is conducting as a main researcher until unplanned inspections are over in respect of that researcher.
Article 6.246 § 1 provides that civil responsibility arises from a failure to perform an obligation established in domestic law or a contract (unlawful failure to act) or from execution of acts that are prohibited by law or a contract (unlawful acts), or from a violation of a general obligation to act with due diligence.
Article 6.271 § 1 of the Civil Code provides that damage resulting from unlawful acts of institutions of public authority must be compensated for by the State from the State budget, irrespective of the responsibility of a particular public servant or other employee of public authority institutions. Damage resulting from unlawful actions of municipal authority bodies must be redressed by the municipality from its own budget, irrespective of whether an employee is at fault. Article 6.271 § 2 provides that for the purposes of the Article, the notion “an institution of public authority” means any public-law body (a State or municipal institution, official, public servant or any other employee of those institutions, and so forth), as well as a private person executing the functions of a public authority. Article 6.271 § 3 provides that for the purposes of the Article, the notion “act” means any act (active or passive) by an institution of public authority or its employees, that directly affects people’s rights, liberties and interests (legal acts or individual acts enacted by the institutions of state and municipal authority, administrative acts, physical acts, and so forth, with the exception of court judgments – verdicts in criminal cases, decisions in civil and administrative cases and orders). Article 6.271 § 4 provides that civil liability on the part of the State or a municipality subject to the Article arises when the employees of public authority institutions fail to act in the manner prescribed by law for those institutions and their employees.
The Supreme Administrative Court held that the annulment of an administrative act was not a precondition to state that the actions of the administrative subject had been unlawful and civil liability of the State could arise (decisions of the 12 October 2009, no. A146-1155/2009, 6 June 2011, no. A662-2265/2011, 14 July 2011, no. A502-3034/2011, 9 May 2013, no. A442-308/2013, 8 October 2015, no. A3155-624/2015).
The Supreme Administrative Court held that the control and verification of alleged unlawful actions could be performed without questioning the facts and their assessment in another case between the same parties (decisions of 14 July 2011, no. A502-3034/2011, 8 October 2015, no. A3155-624/2015).
COMPLAINTS
The applicant complains under Article 6 § 1 of the Convention about the fairness of the proceedings, alleging that the domestic courts which had decided the issue on compensation did not take into account the conclusions already established by a final decision regarding the applicant, and that she was not awarded compensation in respect for pecuniary and non-pecuniary damage for her unlawful suspension. She also claims that she had not had an effective remedy for her Article 6 § 1 complaint. She also complains under Article 8 of the Convention that for two years when she was suspended she could not carry out her activities as a researcher, she also complains that because of the proceedings against her potential clients did not rely on her anymore and that decisions to suspend her damaged her reputation.
QUESTIONS TO THE PARTIES
1. Was the refusal to award the applicant compensation in respect of pecuniary and non-pecuniary damage by dismissing the applicant’s complaint and newly interpreting the facts of the case although there was a decision that the applicant’s suspension had been unlawful in line with Article 6 § 1 of the Convention?
2. Has there been an interference with the applicant’s right to respect for her private life, within the meaning of Article 8 § 1 of the Convention, on account of her suspension from her job for two years? If so, was that interference in accordance with the law and necessary in terms of Article 8 § 2 of the Convention?
3. Did the applicant have at her disposal an effective domestic remedy for her complaints under Article 6 § 1 and Article 8 of the Convention, as required by Article 13 of the Convention?
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