Communicated on 4 June 2020 Published on 22 June 2020

THIRD SECTION

Application no. 56735/19 A.K. against Russia lodged on 25 October 2019

STATEMENT OF FACTS

The applicant, Ms A.K., is a Russian national, who was born in 2001 and lives in Ufa, Bashkortostan.

The facts of the case, as submitted by the applicant, may be summarised as follows.

The applicant suffers from short bowel syndrome, “ultra-short” variant: as a result of several bowel-lengthening surgeries, the length of her small intestine is 35 cm instead of an average 5-6 m. This is a rare condition occurring in about three per million people each year. People with short bowel syndrome cannot absorb enough water, vitamins, minerals, protein, fat, calories, and other nutrients from food. Accordingly, the applicant has to receive parenteral nutrition on a regular basis. The applicant has developed various complications, including maldigestion and malabsorption syndromes, first-degree nutritional deficiency, steatogepaphitis , fibrosis, chronical calculous cholecystitis, vitamin D insufficiency, diffuse osteoporosis and intestinal bacterial overgrowth. According to the applicant, without a due treatment she is at risk of dehydration and malnutrition, which can be severe and potentially life-threatening.

S he has a first-degree disability.

According to the applicant, the only long-term therapy indicated for treatment of patients suffering from short bowel syndrome is the agent teduglutide , a gluagon -like peptide-2 analog, marketed in Europe as Revestive (referred to as “ Revestive , Shire ” in subsequent domestic decisions, see below; hereinafter, Revestive ). In 2012 the European Medecines Agency recommended the authorisation of Revestive in the EU.

Revestive is not registered in the Russian Federation. In accordance with the domestic law, medicinal products not registered in Russia can be imported on the basis of a decision of a medical commission if required by life-saving indications ( по жизненным показаниям ).

On 14 May 2018 the medical commission of the Pirogov Republican Clinical Children ’ s Hospital prescribed the Revestive treatment to the applicant as required by life-saving indications . After a seven-week Revestive treatment her condition significantly improved. In particular, she switched from parenteral nutrition to normal one, and the number of intoxication episodes considerably reduced. The medical commission accordingly renewed the prescription on several occasions. Each time the specialists recommended continuing the Revestive treatment, on account of the absence of an alternative treatment in the applicant ’ s clinical case.

In June 2018 the authorities of the Republic of Bashkortostan rejected the applicant ’ s family ’ s request to provide the applicant with Revestive as it was not registered on the territory of the Russian Federation, and as no budget funds had been allocated for purchase of the unregistered product.

The cost of Revestive treatment per patient per year is approximately 280,000 euros. The applicant ’ s family is unable to purchase the medication.

On 25 September 2018 the medical specialists of the Pirogov Republican Clinical Children ’ s Hospital, on request of the Ministry of Health of the Republic of Bashkortostan, issued a conclusion that the applicant had to continue the Revestive treatment, as there existed no alternative treatment in her clinical case.

A prosecutor of the Sovetskiy District of Ufa brought the proceedings in the interests of the applicant (who was a minor at the time of the events) claiming to declare the authorities ’ inaction unlawful and to provide the applicant with Revestive .

On 20 February 2019 the Kirovskiy District Court of Ufa granted the claim. Referring to the domestic law provisions cited below, the court established that it was incumbent on the Ministry of Health of the Republic of Bashkortostan to provide the applicant with relevant medicinal products. The court declared unlawful the failure by the Ministry to take measures to provide the Revestive ( teduglutide ), Shire treatment to the applicant on life ‑ saving indications. It ordered the Ministry of Health of the Republic of Bashkortostan to provide the applicant with the Revestive treatment in the amount necessary for life support ( в объеме , необходимом для жизнеобеспечения ) .

On 22 April 2019 the Supreme Court of the Republic of Bashkortostan upheld the judgment on appeal.

The judgment became enforceable but the authorities did not comply with it. On 12 April 2019 the enforcement proceedings were opened. Between May and June 2019 the bailiffs on several occasions fined the debtor authority for the failure to comply with the judgment.

In the meantime, the Ministry of Health of the Russian Federation issued an authorisation to import Revestive in Russia for treatment of the applicant.

In 2019 the Ministry of Health of Bashkortostan on several occasions informed the applicant ’ s representatives that, even though the applicant ’ s parents possessed the above import authorisation, the republican budget did not provide for expenses for purchase of medications not registered on the territory of the Russian Federation.

The applicant submits that the Revestive treatment had allowed her to live a normal life, attend school and eat on her own, not depending on either a parenteral nutrition or taking a sodium bicarbonate solution. As a result of the interruption in the Revestive treatment, her health has significantly deteriorated. In particular, she has no longer been able to attend school, meet friends, and eat on her own. She has again become dependent on parenteral nutrition and has re-developed a number of serious metabolic complications. In particular, due to nutrient malabsorption she regularly suffers from abnormal accumulation of harmful substances in her body which results in recurrent “euphoric attacks”, followed by lethargy episodes and extreme fatigue. The applicant has to receive sodium bicarbonate, in difficult cases intravenously, to stabilise her condition.

Article 41 of the Constitution of the Russian Federation provides that everyone has the right to health protection and medical aid. Medical aid in State and municipal health institutions is rendered to individuals free of charge, at the expense of the corresponding budget, insurance contributions, and other proceeds.

According to section 16(1(2)) of the Federal Health Care Act No. 323-FZ ( Закон № 323- ФЗ « Об основах охраны здоровья граждан в Российской Федерации » ) of 21 November 2011, organisation of provision of medicines to citizens is within the competence of the subjects of the Russian Federation.

Issues of organisation of health care in the subjects of the Russian Federation– in accordance with territorial programmes of State guarantees of free health care for citizens of the Russian Federation – are determined by the subjects independently, at the expense of the federal budget (section 26.3(2(21)) of the Federal Law No. 184-FZ of 6 October 1999 “On General Principles of Organisation of Legislative and Executive Bodies of the Subjects of the Russian Federation”).

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 and means of rehabilitation free of charge (Appendix I to the Decree). Executive authorities of the subjects of the Russian Federation are obliged to timely pay the medicines provided to the population free of charge on medical prescription (§§ 3-4 of the Decree).

The relevant competent authority in Bashkortostan was the republican Ministry of Health (Decree of Republic of Bashkortostan No. 310 of 9 July 2014 setting out an obligation to provide the population with medicinal products for medical use, as well as medical nutrition for disabled children).

According to sections 6.1(8-9) and 6.2 of the Federal Law no. 178-FZ of 17 July 1999 “On State Social Assistance”, disabled persons including disabled children are entitled to receive necessary medicines for medical use and specialised nutrition for disabled children, on prescription and in accordance with relevant health care standards. A list of such medicines, including those prescribed by medical commissions of medical organisations is established every year by an Order ( распоряжение ) of the federal government (section 6.2(2) of the Law no. 178-FZ).

Section 13 of Federal Law No. 181-FZ of 24 November 1995 “On Social Protection of Disabled Persons” provides that qualified health care to disabled persons is provided in accordance with federal and regional legislation within the framework of a programme of State guarantees of free health care for citizens of the Russian Federation. In line with section 80(3(2)) of the Federal Health Care Act, within the framework of such programs citizens are not bound to pay prescription and use of medicinal products (1) included in the list of vitally important and essential medicines ( « жизненно необходимых и важнейших лекарств ») in line with the medical assistance standard; and (2) not included in that list, in case of “replacement on account of individual intolerance, on life-saving indications”. The list of vitally important and essential medicines is established every year by the federal government.

According to the Decree of the Government of Bashkortostan of 19 April 2017, adopted in implementation of the above Decree no. 890, social assistance in the form of provision of medicinal products free of charge is ensured at the expense of the budget of the Republic of Bashkortostan.

Prescription and use of medicinal products not included in a relevant “standard of medical assistance” are allowed on medical grounds (including life-saving indications), upon a decision of a medical commission (section 37(5) of the Federal Health Care Act setting out the standards of medical assistance as in force at the material time; currently section 37(15)). The composition of the commission and the scope of its competence are set out in Regulation of the Ministry of Health of the Russian Federation No. 494 of 9 August 2005 on Use of Medicinal Products for Patients on Life-Saving Indications.

In accordance with section 47 (3) of Federal Law No. 61-FZ of 12 April 2010 “On Circulation of Medical Drugs” and the Regulation of the Government of Russia of 29 September 2010 No. 771 on the Order of Importing of Medicinal Products in the Russian Federation, medicinal products not registered in Russia can be imported on the basis of a decision of a medical commission if required by life-saving indications.

COMPLAINTS

The applicant complains under Article 2 of the Convention that the failure to provide her with a medication of vital importance such as Revestive , in breach of the domestic court ’ s final order, deprives her of access to medical care and puts her life and limb at risk.

She complains under Article 3 of the Convention that the failure to provide her with the Revestive treatment coupled with the authorities ’ attitude amounted to inhuman and degrading treatment.

She complains under Article 6 about the non-enforcement of the judgment in her favour obliging the authorities to provide the applicant with Revestive at the expense of the republican budget.

Finally, she complains under Article 8 that as a result of the authorities ’ failure to provide her with the above medication the quality of her life has drastically deteriorated.

QUESTIONS TO THE PARTIES

1. What is the applicant ’ s current state of health? The parties are invited to submit copies of relevant recent medical documents and, if available, copies of expert reports and/or secondary opinions from medical specialists assessing the applicant ’ s health.

2. Has the judgment of 20 February 2019 issued by the Kirovskiy District Court of Ufa in the applicant ’ s favour been enforced? If not, has there been a breach of Article 6 of the Convention on account of the failure to enforce the final judgment of 20 February 2019 in the applicant ’ s favour?

3. Does the applicant ’ s complaint about the authorities ’ failure to provide her with the Revestive treatment fall to be examined under Article 2, and/or 3, and/or 8 of the Convention?

4. Has there been a breach of Article 2 of the Convention on account of the authorities ’ failure to provide the applicant with the Revestive treatment despite a valid court order, and bearing in mind that the treatment was prescribed to her on life-saving indications (see, in so far as relevant, Panaitescu v. Romania (no. 30909/06, §§ 27-38, 10 April 2012)? Has her life been put at risk as a result of that failure (compare Pentiacova and Others v. Moldova ( dec. ), no. 14462/03, ECHR 2005 ‑ I)?

5. Did the above ‑ mentioned failure amount to inhuman or degrading treatment within the meaning of Article 3 of the Convention?

6. Did the above ‑ mentioned failure constitute a violation of the applicant ’ s right to respect for her private life within the meaning of Article 8 § 1 of the Convention?