Information Note on the Court’s case-law 265
August-September 2022
Traskunova v. Russia - 21648/11
Judgment 30.8.2022 [Section III]
Article 2
Positive obligations
Death of participant in clinical trial of new medicine, failure to effectively implement regulatory framework and ensure informed consent: violation
Facts – The applicant’s daughter (Ms A.T.) died while participating in a clinical trial for a new medicinal product intended for treatment of schizophrenia, a mental illness from which she had suffered for many years. It was the second clinical trial of this kind in which she had participated.
The applicant’s attempt to have disciplinary proceedings brought against those responsible was unsuccessful. An expert clinical commission examined the case and found that the clinical trials had been conducted in compliance with all required conditions and that there was no direct causal link between the death and the taking of the drug. The authorities also refused to open criminal proceedings and the applicant’s challenge to this decision was dismissed by the domestic courts. During the pre-investigation inquiry, however, expert reports revealed that Ms A.T. had an undetected cardiovascular disease and that the taking of the experimental medicine in question could have aggravated her condition and thus could have indirectly led to her death.
Law – Article 2:
(a) Substantive aspect – The circumstances of the present case had gone beyond the scope of a mere medical negligence. What was at stake was Ms A.T.’s safety during clinical trials of a new medicine approved by the authorities. Clinical trials of such products entailed inherent risks to their participants’ health and lives, and were, as such, a form of dangerous activity which must engage States’ positive obligation to adopt and implement measures designed to ensure the safety of those involved in such trials.
The key question was thus whether, when engaging the applicant’s daughter in clinical trials of a new medicinal product, the authorities had fulfilled their positive obligation to ensure, through a system of rules and through sufficient control, that the risk to her life had been reduced to a reasonable minimum.
No deficiencies in the regulatory framework applicable in the respondent State at the relevant time could be discerned, but its practical implementation in the present case was open to doubt:
Firstly, it did not appear that a comprehensive medical check-up, as required by the relevant domestic protocols, had been carried out on Ms A.T. before she had been admitted to the clinical trials and there was a lack of any information regarding monitoring of her state of health throughout the whole period of both clinical trials. Despite displaying symptoms after the first clinical trial which had argued against her participation in the second trial, she had nevertheless been invited to take part therein without the state of her health being duly examined.
It was not for the Court to speculate whether Ms A.T.’s cardiovascular disease could have been detected if she had undergone the relevant medical examination and monitoring. However, bearing in mind what had been at stake for her, it was unacceptable that she had been admitted to, and continued to participate in, the clinical trials in breach of the rules and safeguards created by the domestic system itself.
Secondly, the Court took issue with Ms A.T.’s consent to her participation in the trials. Although in the circumstances she could be regarded as having been duly informed about general risks inherent in the trials, the health professionals in charge of the clinical trials had remained unaware of her actual state of health, including her cardiovascular disease, as a result of their failure to perform the most basic medical check-ups. Ms A.T. had therefore not received full information which would have enabled her to assess potential risks in her particular situation, and to make an informed choice regarding her participation in either of the clinical trials.
Further, in view of their vulnerability, it was important that mentally ill patients enjoyed a heightened protection and that their participation in clinical trials be accompanied by particularly strong safeguards, with due account given to the particularities of their mental condition and its evolution over time. It was essential, in particular, that such patients’ decision-making capacity be objectively established in order to remove the risk that they have given their consent without a full understanding of what was involved. Ms A.T. had suffered from a serious mental illness for many years which had worsened during the first clinical trial. A mental illness such as the one from which she had suffered could manifest itself, among other things, by disordered thinking and difficulties in communicating with others. Yet there was no evidence that, when inviting her to take part in the second trial and accepting her consent thereto, the doctors in charge had duly assessed whether Ms A.T. had indeed been able to take rational decisions regarding her continued participation.
Conclusion: violation (unanimously).
(b) Procedural aspect – For the assessment of the case, it had been relevant to examine whether the clinical trials in question had been carried out in compliance with the relevant legal framework and in particular had respected the safeguards in place. However, the authorities had not done so. Among other things, they had not considered the experts’ conclusions regarding the apparent lack of a comprehensive medical examination or health monitoring of Ms A.T. before or during either of the two trials. They had also made no assessment of the experts’ findings in so far as they had pointed to counter-indications to Ms A.T.’s participation in the second clinical trial. Accordingly, the criminal-law remedy in question could not be said to have been effective in the circumstances of the present case.
The applicant had never brought a civil claim against the relevant healthcare professionals or the institution. It was unclear whether any such avenue had been available to the applicant and, if so, whether it would have achieved the result sought by Article 2 by establishing the circumstances surrounding the death of her daughter, holding those responsible accountable and providing appropriate redress to the applicant. It was also unclear whether a civil-law remedy would have pursued the same objective as the criminal-law remedy, or, in other words, whether it would have added any essential elements unavailable through the use of the criminal-law remedy.
Conclusion: violation (unanimously).
Article 41: EUR 20,000 in respect of non-pecuniary damage.
(See also Arskaya v. Ukraine, 45076/05, 5 December 2013)
© Council of Europe/European Court of Human Rights
This summary by the Registry does not bind the Court.
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