Mental Capacity Case

Traskunova v. Russia


In Traskunova v Russia, the Third Section of the Strasbourg Court revisited the issue of capacity and informed consent, this time in the context of experimental treatment and a breach of Article 2 ECHR.  

The applicant’s daughter, Ms AT, died age 59 of complications arising out of cardiac and respiratory arrest following participation in clinical trials for a drug, Asenapine. Asenapine was being trialled for the treatment of schizophrenia, a condition from which Ms AT had suffered since early adulthood. 

The court was told that part of the mandate for the trial was monthly check-ups by a doctor and six-monthly ECGs and 3 monthly blood tests. Having taken part in one year-long trial, from 2004-5, following which she was hospitalised as a result of her worsening mental health, Ms AT was signed up for a further trial in December 2005. On both occasions she signed consent forms agreeing to take part in the study.
In April 2006 Ms AT suffered a cardiac and respiratory arrest. She lapsed into a coma and died a few days later. Subsequent to her death it was revealed that not only was Ms AT not provided with the relevant check-ups, after agitation and insomnia all increased during the trial in addition to weight gain, no steps were taken to remove her from the study. 

Expert evidence indicated that her death was as a result of pneumonia (overlooked by her doctors), the cardiotoxic effect of Asenapine, and latent cardiovascular disease. An indirect causal link between her death and the taking of Asenapine was found [38]. Further investigation revealed a lack of general health monitoring and no recognition of the fact that she had suffered side-effects in the first trial. 

Reiterating the limited scope of Article 2 in so-called “healthcare cases”, the court held [69] 

the States’ substantive positive obligations relating to medical treatment are limited to a duty to regulate, that is to say, a duty to put in place an effective regulatory framework compelling hospitals, whether private or public, to adopt appropriate measures for the protection of patients’ lives. The Court has, moreover, emphasised that the States’ obligation to regulate must be understood in a broader sense which includes the duty to ensure the effective functioning of that regulatory framework. The regulatory duties thus encompass necessary measures to ensure implementation, including supervision and enforcement (see Lopes de Sousa Fernandes v. Portugal [GC], no. 56080/13, §§ 186 and 189, 19 December 2017 and Sarishvili-Bolkvadze, cited above, § 74; see also, for the summary of the applicable principles regarding effective functioning of relevant framework in the broader context of unintentional taking of life, Smiljanić v. Croatia, no. 35983/14, § 66, 25 March 2021).”

The Court went on to emphasise [70] the importance for individuals facing risks to their health 

to have access to information enabling them to assess those risks. It has held in particular that States are bound to adopt the necessary regulatory measures to ensure that doctors consider the foreseeable impact of a planned medical procedure on their patients’ physical integrity and to inform patients of these consequences beforehand in such a way that the latter are able to give informed consent (see Ioniță v. Romania, no. 81270/12, § 84, 10 January 2017, in the context of the Article 2 complaint; and Csoma v. Romania, no. 8759/05, § 42, 15 January 2013; and Botoyan v. Armenia, no. 5766/17, § 93, 8 February 2022, in the context of the Article 8 complaint).

Notwithstanding that Ms AT was deemed to have “retained her legal capacity” throughout the trials, the Court was critical of the failures to provide her with the heightened protection her vulnerability mandated: 

79.  The Court furthermore notes that Ms A.T. suffered from a serious mental illness for many years. It considers that, in view of their vulnerability, it is important that mentally ill patients enjoy 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 is 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 (compare Arskaya v. Ukraine, no. 45076/05, §§ 87-90, 5 December 2013). The facts of the case reveal that Ms A.T.’s mental illness worsened during the first clinical trial (see paragraphs 24-25 above). It is noteworthy in this connection that a mental illness such as the one which the applicant’s daughter suffered from could manifest itself, among other things by disordered thinking and difficulties in communicating with others (see paragraphs 5 and 9 above). Yet there is no evidence in the case file that, when inviting her to take part in the second clinical trial and accepting her consent thereto, the doctors in charge duly assessed whether the applicant’s daughter was indeed able to take rational decisions regarding her continued participation in the trial.

80.  Bearing in mind the above shortcomings, Ms A.T.’s vulnerability, and the serious consequences of those decisions for her, the Court finds that the practical implementation of the existing framework was deficient and that the existing guarantees ensuring the informed consent of participants of clinical trials were not complied with in the present case, with the result that there has been a breach the State’s substantive positive obligations under Article 2 of the Convention.”


The court ultimately awarded damages for breach of both the substantive and procedural obligations under Article 2.  This is an interesting judgment in an expanding area of law – one which is shortly to be debated before the Supreme Court in the appeal of R (Maguire v HM Senior Coroner for Blackpool & Fylde [2020] EWCA Civ 738. A substantive breach of Article 2 was found, not because of deficiencies in the legal or regulatory framework but rather because of a failure to implement the same [76]. This underlines a point made previously by the Grand Chamber in the leading case of Lopes de Sousa v. Portugal [GC], no. 56080/13, at [189] – “that the States’ obligation to regulate must be understood in a broader sense which includes the duty to ensure the effective functioning of that regulatory framework. The regulatory duties thus encompass necessary measures to ensure implementation, including supervision and enforcement.” We consider this an important message for decision-makers to take home: the fact of the Mental Capacity Act 2005 is not enough; it must be properly implemented and adhered to if rights are to be protected.