Published on 28 June 2021

THIRD SECTION

Application no. 18590/20 Ada Gurgenovna KESHISHYANTS against Russia and 7 other applications (see list appended) communicated on 11 June 2021

STATEMENT OF FACTS

The applicants are Russian nationals. Their details are set out in the Appendix. They are represented before the Court by Ms V. Kogan, director of the NGO Astreya based in Moscow, Mr E. Wesselink , Chair of the NGO Stichting Justice Initiative based in the Netherlands, and by Ms D. Latypova residing in the town of Lyubertsy , the Moscow Region.

The facts of the cases, as submitted by the applicants, may be summarised as follows.

The applicants suffer from spinal muscular atrophy (“SMA”), a rare genetic disease which results in motor neuron death causing inefficiency of the major bodily organs. There are four types of SMA which have different severity.

Ms Keshishyants has the most severe form of the illness (type 1 SMA) with the life expectancy up to two years. The illness resulted in floppy infant syndrome and breathing difficulties. Ms Keshishyants went into coma in August 2020. Later, her condition was stabilised by attending doctors.

Ms Dedkova , Mr Belyayev and Ms Khomenko suffer from intermediate form of the illness (type 2 SMA), with shortened life expectancy, which can range from early childhood to adulthood. Ms Dedkova has scoliosis and deformity of feet, she cannot sit without support or walk, her muscle strength and reflexes are decreased. Mr Belyayev suffers from deformity of the spine, tetraparesis and contractures of joints. He experiences breathing difficulties at night. Ms Khomenko also experiences breathing difficulties at night. She cannot sit without support, stand or walk.

The remaining applicants were diagnosed with a juvenile form of the illness (type 3 SMA), which does not affect life expectancy. Ms Tonkonogova has joint contractures, delayed motor development, chest deformity and a respiratory disorder. Ms A. Azarchenkova and Ms V. Azarchenkova suffer from kyphosis and tremor. They are able to sit, but not to run or jump. Mr Yesayan and Mr Minyazov suffers from various spine conditions. They are able to sit and walk. The manner of their walk is affected by the illness and their muscle strength is decreased.

On various dates the applicants were assigned the status of people with disabilities and prescribed treatment with Spinraza ( Nusinersen ), one of the very few curative treatments available for that condition. It costs around 635,000 euros (EUR) in the first year and around EUR 318,000 each year thereafter.

According to domestic law, minors with disabilities are entitled to receive such treatment free of charge, if a medical board composed of several medical specialists from a State hospital, prescribes it (see below).

Being unable to afford treatment with Spinraza for their children the applicants ’ parents applied to competent medical boards which acknowledged the applicants ’ entitlement to treatment with Spinraza at the expense of the State. The dates of the relevant decisions are indicated in the Appendix.

After the medical boards ordered the applicants ’ treatment with Spinraza , their parents unsuccessfully requested the authorities to give such treatment. Their requests were dismissed with reference to the lack of budgetary means or the lack of the applicants ’ entitlement to that treatment.

On unspecified dates the applicants ’ parents acting on behalf of the applicants, or prosecutors acting in the applicants ’ interests lodged with the courts, indicated in the Appendix (“District Courts”) civil claims against the regional healthcare authorities. The claimants asked the courts to impose on the authorities an obligation to provide the applicants with Spinraza free of charge.

The District Courts granted the claims on the dates indicated in the Appendix. They held that the applicants were entitled to medical treatment with Spinraza free of charge. The District Courts also imposed an obligation on the regional healthcare authorities to provide the applicants with Spinraza in line with the decision of the medical boards.

In the cases of Ms Tonkonogova and Mr Minyazov the healthcare authorities sought the adjournment of the enforcement of the judgments in favour of the applicants. The request was granted in the first case and dismissed in the second. The judgments became enforceable on the dates listed in the Appendix.

Owing to the non-enforcement of the judgments in their favour the applicants applied for interim measures under Rule 39 of the Rules of Court.

The applications were granted on the dates indicated in the Appendix. The Court indicated to the Russian authorities that they should ensure the applicants ’ access to the medical treatment appropriate to their conditions as determined by their attending medical practitioners and to secure enforcement of the District Courts ’ judgments insofar as they are binding upon the national authorities.

On the dates indicated in the Appendix Ms Keshishyants , Ms Dedkova and Ms Khomenko received treatment with Spinraza .

On 16 August 2019 Spinraza was included in the State Register of Medicines in the group of “Other medication for treatment of diseases relating to musculoskeletal system”. The instruction for the use of Spinraza stated that it is indicated for the treatment of SMA in paediatric and adult patients.

SMA is not included in the list of “Life threating and chronic rare (orphan) diseases resulting in the shorten longevity or disability” (approved by the Russian Government on 26 April 2012 by its Order no. 403), which entitles people with the relevant medical condition to free medication.

Until 1 January 2021 Spinraza was not in the list of “Vitally important and essential medicines” (approved by the Order of the Russian Government no. 2406-p of 12 October 2019). On 23 November 2020 the Government ordered Spinraza to be included in that list from 1 January 2021 (Order no. 3073-p of 23 November 2020).

According to Decree no. 890 of 30 July 1994 by the Government of the Russian Federation (“Decree no. 890”), people having a first-degree disability and disabled minors are provided with all medicinal products free of charge. Regional executive authorities are obliged to timely pay the medicines provided to the population free of charge on medical prescription (§§ 3-4 of the Decree). In addition, on 5 January 2021 the Russian President issued Order no. 16 establishing the fund “Krug Dobra” to support children with grave life-threatening and chronic illnesses (including Orphan illnesses). It may receive budgetary means and private donations to arrange medical treatment for seriously ill children.

Section 37 § 15 of the Federal Health Care Act no. 323-FZ of 21 November 2011 provides that prescription and use of medicinal products not included in a relevant “standard of medical assistance” are allowed on medical grounds, upon a decision of a medical board.

The composition of a medical board and the scope of its competence are set out in Regulation of the Ministry of Health of the Russian Federation no. 502н of 5 May 2012 “On establishing and functioning of a medical board”. According to sections 8, 12 and 14 of the Regulation, a medical board is composed of its head, one or two deputy heads, a secretary, and several members (medical specialists).

COMPLAINTS

1. Ms Keshishyants , Ms Tonkonogova , Ms A. Azarchenkova , Ms V. Azarchenkova , Ms Dedkova , Mr Yesayan , Mr Belyayev , and Ms Khomenko complain that the lack of access to treatment with Spinraza and indifference of the authorities resulted in their physical and mental sufferings, amounted to treatment proscribed by Article 3 of the Convention. Ms Keshishyants , Ms A. Azarchenkova , Ms V. Azarchenkova , Ms Dedkova and Mr Yesayan also allege that the State failed to take measures aimed at preventing risks to their lives linked to the lack of the prescribed medical treatment.

2. Ms Tonkonogova , Mr Belyayev , and Mr Minyazov claim that continuous non-enforcement of the judgments delivered in their favour breached Article 6 of the Convention.

3. Ms Tonkonogova , Mr Belyayev , Mr Minyazov and Ms Khomenko allege a violation of Article 8 of the Convention, in particular on account of the stay in the enforcement proceedings in favour of Ms Tonkonogova ; inaction of the healthcare authorities and bailiffs in respect of Mr Belyayev ; request for adjournment of the enforcement in favour Mr Minyazov ; and on account of the belated provision of Ms Khomenko with Spinraza .

4. Ms Tonkonogova , Ms Dedkova , Mr Yesayan , Mr Belyayev , Mr Minyazov and Ms Khomenko allege a violation of Article 13 of the Convention on account of the lack of effective response in respect of the complaints which they submitted to various domestic authorities.

5. Lastly, Ms Keshishyants , Ms Tonkonogova , Ms A. Azarchenkova , Ms V. Azarchenkova , Mr Yesayan , and Mr Belyayev complain under Article 34 of the Convention of the authorities ’ failure to comply with the interim measures issued by the Court.

COMMON QUESTIONS

Were the domestic judgments in the applicants ’ favour duly enforced and if so, when? What were the reasons and the legal basis for the alleged delays in the enforcement proceedings? What was the risk for the applicants associated with those delays? Were the applicants ’ rights under Article 6 of the Convention violated on account of the alleged delays in the enforcement of the judgments in their favour (see Gerasimov and Others v. Russia , nos. 29920/05 and 10 others, § 167-74, 1 July 2014)? Did Ms Tonkonogova , Ms Dedkova , Mr Yesayan , Mr Belyayev , Mr Minyazov and Ms Khomenko have at their disposal, in accordance with Article 13 of the Convention, effective domestic remedies in order to ensure proper and timely enforcement of the domestic judgments in their favour or to obtain adequate redress for late enforcement (see Gerasimov and Others v. Russia , nos. 29920/05 and 10 others, §§ 167-66, 1 July 2014)?

CASE SPECIFIC QUESTIONS

1. What has been the long-term effect of the delayed treatment with Spinraza on the health of Ms Keshishyants , Ms Dedkova and Ms Khomenko and of the lack of such treatment in respect of Ms Tonkonogova , Ms A. Azarchenkova , Ms V. Azarchenkova , Mr Yesayan and Mr Belyayev ? Did the alleged failure to give treatment with Spinraza in a timely fashion result in physical and (or) mental sufferings of the aforementioned applicants ? If yes, did they reach the “minimum level of severity” to fall within the ambit of Article 3 of the Convention, taking due account of the length of the delay and the effects of this delay on the applicants ’ health? If yes, has there been a violation of Article 3 of the Convention on account of the lack of access to the prescribed treatment by the said eight applicants?

2. Has there been a violation of Article 8 of the Convention on account of the adjournment of the enforcement proceedings in favour of Ms Tonkonogova ; on account of the domestic authorities ’ attempt to have the enforcement of the judgment in favour of Mr Minyazov postponed; on account of the alleged inaction of the healthcare authority and the bailiffs during the enforcement proceedings in respect of Mr Belyayev ; delayed enforcement of the domestic judgment in respect of Ms Khomenko; or lack of treatment with Spinraza in respect of Ms A. Azarchenkova , Ms V. Azarchenkova and Mr Yesayan ?

3. Given the Government ’ s response to the Court ’ s decisions to indicate interim measures under Rule 39 of the Rules of Court, has there been a hindrance by the State with the effective exercise of the right of application, ensured by Article 34 of the Convention in respect of Ms Keshishyants , Ms Tonkonogova , Ms A. Azarchenkova , Ms V. Azarchenkova , Mr Yesayan , Mr Belyayev and Mr Minyazov (see, mutatis mutandis , Salakhov and Islyamova v. Ukraine , no. 28005/08, §§ 216-24, 14 March 2013)?

APPENDIX

No.

Application No.

Lodged on

Applicant name

Year of birth

Place of residence

Represented by

Date of the decision by a medical board

Date of the domestic judgment

The name of the court

Date when it became enforceable (if other than the date of the judgment)

Date of the decision to apply interim measure

Date of receipt of Spinraza by the applicant

18590/20

05/05/2020

Ada Gurgenovna KESHISHYANTS

2019Kislovodsk

V. KOGAN

E. WESSELINK

05/02/2020

14/04/2020

Leninskiy District Court of Stavropol

06/05/2020

02/07/2020

28594/20*

11/07/2020

Yelena Sergeyevna TONKONOGOVA

2014Romny

D. LATYPOVA

01/10/2019

09/04/2020

Romny District Court of the Amur Region

31/12/2020

16/07/2020

-

34138/20

10/08/2020

Aleksandra Denisovna AZARCHENKOVA

2013Moscow

Valeriya Denisovna AZARCHENKOVA

2013Moscow

V. KOGAN

E. WESSELINK

20/12/2019

28/04/2020

Sovetskiy District Court of Bryansk

12/08/2020

-

36566/20*

24/08/2020

Mariya Valeryevna DEDKOVA

2011Bryansk

V. KOGAN

E. WESSELINK

17/02/2020

11/06/2020

Sovetskiy District Court of Bryansk

03/09/2020

18/09/2020

38685/20*

03/09/2020

Yegor Yuryevich YESAYAN

2009Zavetnyy

V. KOGAN

E. WESSELINK

14/10/2019

18/05/2020

Armavir Town Court of the Krasnodar Region

04/09/2020

-

45333/20

14/10/2020

Vitaliy Eduardovich BELYAYEV

2008Sochi

D. LATYPOVA

04/09/2019

21/07/2020

Pervomaiyskiy District Court of Krasnodar

15/10/2020

-

2393/21*

11/01/2021

Gleb Marselevich

MINYAZOV

2012Leninogorsk

D. LATYPOVA

19/03/2020

16/06/2020

Vakhitovskiy District Court of Kazan

28/09/2020

13/01/2021

-

3110/21*

13/01/2021

Mariya Aleksandrovna KHOMENKO

2010Orenburg

D. LATYPOVA

08/07/2020

15/09/2020

Tsentralniy District Court of Orenburg

14/01/2021

28/01/2021