Communicated on 14 February 2020 Published on 2 March 2020

FIRST SECTION

Application no. 17101/17 Lucyna Agata and Marek SMOLARKIEWICZ against Poland lodged on 23 February 2017

STATEMENT OF FACTS

The applicants, Ms Lucyna Agata Smolarkiewicz and Mr Marek Smolarkiewicz , are Polish nationals, who were born in 1969 and 1968 respectively and live in Kórnik . They are represented before the Court by Ms P. Kieszkowska-Knapik , a lawyer practising in Warsaw.

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

The applicants ’ son, M., was born in 1996. In 2001 he was diagnosed with mucopolysaccharidosis type II (“MPS II”), a rare genetic disorder also known as Hunter ’ s syndrome.

On 14 September 2009 M. was included in the program run by the National Health Fund ( Narodowy Fundusz Zdrowia “NHF”) relating to the treatment of MPS II and was prescribed an enzyme replacement therapy with a drug Elaprase .

M. ’ s treatment was monitored by the panel of experts on ultra ‑ rare diseases ( Zespół Koordynacyjny do spraw Chorób Ultrarzadkich ) (“the Panel”). His condition was reviewed every six months by a group of experts and on each occasion detailed reports were prepared.

In their initial reports (of 15 November 2010, 27 February 2012, 3 September 2012 and 5 March 2013) the experts stated that M. had tolerated Elaprase well and no adverse effects had been observed. They noted several beneficial effects; in particular that, the patient had grown, his face features had changed and his respiratory functions had improved.

In subsequent reports (prepared in March and August 2014) it was observed that the positive changes in M. ’ s condition had been less significant than initially, however these changes had also been noted by other people who had known the boy, i.e. medical staff, carers and family friends.

In the report of February 2015 it was noted that M. had again grown, he walked with help; his respiratory functions had improved and he was calm. As regards neurological functions, there was no deterioration, he was stable and only rarely suffered from epileptic seizures.

In a letter of 14 May 2015, titled “certificate” ( za ś wiadczenie ), the Panel informed the hospital treating M., that it was decided to discontinue the enzyme replacement therapy for him. The experts briefly noted that the treatment with Elasprase had not had any beneficial impact on M. ’ s health.

The doctor in charge of the boy ’ s treatment complained about this decision. She stressed, that M. ’ s neurological and mental health functions had improved as a result of treatment with Elasprase . She further submitted, relying on results of clinical research, that discontinuation of enzyme replacement therapy would most probably cause significant deterioration of M. ’ s condition and, in consequence, his death.

On 14 July 2015 the Panel confirmed its decision to discontinue treatment in respect of the applicants ’ son. The experts noted that some of the improvements in M. ’ s physical condition could have been natural physical developments linked to growing up and going through the puberty phase. Likewise the changes in his mental and emotional condition could have been caused by the same factors. They stated that as Elasprase did not penetrate the brain it could not have caused any improvement of M. ’ s neurological condition. They concluded, referring to medical opinions, that the enzyme replacement therapy did not cause any significant change in M. ’ s condition.

On 14 August 2015 the applicants applied on their son ’ s behalf to the NHF in order to confirm his entitlement to health care financed from public funds.

In reply, on 16 September 2015 the Head of the Wielkopolska Regional Branch of the NHF ( Dyrektor Wielkopolskiego Oddzia ł u Wojewódzkiego NFZ ) informed the applicants that their son was entitled to care provided by the national health service. However, as regards specialised therapy, that is whether or not he was to be included in the enzyme replacement therapy program, the decision was to be taken by the Panel.

The applicants lodged an appeal.

On 15 January 2016 the Head of the Department of Drug Management of the NHF ( Dyrektor Departamentu Gospodarki Lekami NFZ ) informed the applicants that no administrative decision in their case had been issued, and therefore their appeal was unfounded. The letter of 16 September 2015 only contained information about their son ’ s situation as regards the national health care.

The applicants lodged an appeal with the Warsaw Regional Administrative Court.

On 16 August 2016 the Warsaw Regional Administrative Court gave a decision and rejected the applicants ’ appeal as inadmissible in law. The court held that the letter of 15 January 2016 did not constitute an administrative decision and therefore could not have been challenged before an administrative court. The decision was served on the applicants ’ lawyer on 25 August 2016.

The applicants ’ son died on 3 September 2016.

The applicants submit that given that their son died during the time-limit for lodging an appeal they did not lodge a cassation appeal with the Supreme Administrative Court.

On 17 December 2015 the applicants attempted to institute criminal proceedings against the medical experts who had participated in the Panel. They submitted that the decision to discontinue the specialised therapy had exposed their son to an immediate danger of loss of life.

On 20 January 2016 the Środa Wielkopolska District Prosecutor refused to institute the proceedings. It was noted that the experts ’ opinion was lawful and the experts ’ conduct was not in breach of any legal provisions.

On 17 January 2017 the Åšroda Wielkopolska District Court dismissed a further appeal by the applicants.

Article 68 of the Constitution reads in so far as relevant:

“1. Everyone shall have the right to have his health protected.

2. Equal access to health care services, financed from public funds, shall be ensured by public authorities to citizens, irrespective of their material situation. The conditions for, and scope of, the provision of services shall be established by statute.

3. Public authorities shall ensure special health care to children, pregnant women, handicapped people and persons of advanced age.”

The Act on health care services financed from public funds of 27 August 2004 ( ustawa o swiadczeniach opieki zdrowotnej finansowanych ze srodków publicznych ) defines the conditions for and the scope of health care services financed from public funds.

Pursuant to its provisions, the Minister of Health set out in an ordinance of 11 January 2010 ( rozporządzenie w sprawie świadczeń gwarantowanych z zakresu programów zdrowotnych ) the rules concerning treatment of MSII – the Hunter ’ s syndrome. According to the ordinance, as in force at the material time, patients were qualified for treatment by the panel of experts on ultra-rare diseases ( Zespół Koordynacyjny do spraw Chorób Ultrarzadkich ) (“the Panel”), composed of medical specialists from various fields. The treatment could have been discontinued by the decision of the Panel or a medical consultant in charge of the treatment for the following reasons: pregnancy or breastfeeding, presence of serious malformations or co-morbidities and significant progression of disease despite the treatment.

COMPLAINTS

1. The applicants complain under Article 2 of the Convention that the Panel ’ s decision to discontinue the specialised therapy in respect of M. was arbitrary and amounted to denial of healthcare. They allege that a serious deterioration of M. ’ s condition occurred after discontinuation of treatment with Elaprase . They also submit that the procedure before the Panel lacks procedural safeguards.

2. Lastly, the applicants complain under Articles 2 and 13 of the Convention that they did not have any domestic remedies in respect of their complaints under Article 2 of the Convention. In particular, they submit that the administrative proceedings proved unsuccessful and that the State authorities failed to conduct an effective investigation into their allegations of misconduct on the part of the medical experts sitting in the Panel.

QUESTIONS TO THE PARTIES

1. Do the facts of the case give rise to a breach of Article 2 of the Convention? In particular, was the applicants ’ son ’ s life put at risk by the authorities ’ decision to discontinue the enzyme replacement therapy (compare and contrast Cyprus v. Turkey [GC], no. 25781/94 , § 219, ECHR 2001 ‑ IV; Nitecki v. Poland ( dec. ), no. 65653/01 , 21 March 2002; Pentiacova and Others v. Moldova ( dec. ), no. 14462/03 , ECHR 2005 ‑ I; and Gheorghe v. Romania ( dec. ), no. 19215/04, 22 September 2005; Hristozov and Others v. Bulgaria , nos. 47039/11 and 358/12, ECHR 2012 (extracts) )?

2. Have the applicants complied with the six-month time limit laid down in Article 35 § 1 of the Convention as regards their complaint relating to the decision of the panel of experts on ultra ‑ rare diseases of 14 July 2015?

3. Did the applicants have at their disposal an effective domestic remedy for their complaints under Article 2 as required by Article 13 of the Convention?