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FOURTH
SECTION
DECISION
Application no.
42290/08
Edward WIATER
against Poland
The
European Court of Human Rights (Fourth Section), sitting on 15 May
2012 as a Chamber composed of:
David
Thór Björgvinsson,
President,
Lech
Garlicki,
Päivi
Hirvelä,
George
Nicolaou,
Ledi
Bianku,
Nebojša
Vučinić,
Vincent
A. De Gaetano,
judges,
and
Fatoş Aracı, Deputy
Section Registrar,
Having
regard to the above application lodged on 19 August 2008,
Having
deliberated, decides as follows:
THE FACTS
- The
applicant, Mr Edward Wiater, is a Polish national, who was born in
1931 and lives in Szczecin. He was represented before the Court by
Mr B. Sochański, a lawyer practising in Szczecin.
A. The circumstances of the case
- The facts of the case, as submitted by the applicant,
may be summarised as follows.
1. The applicant’s medical condition
- In
1977 the applicant was initially diagnosed with narcolepsy
(chronic sleep disorder). That diagnosis was confirmed in 1987.
Narcolepsy is characterised by excessive sleepiness and sleep
attacks. Since 1988 the applicant has been followed by a psychiatrist
and received pharmacological treatment. In the following years the
applicant was diagnosed with diabetes and hypertension (1989), sleep
apnoea (1996) as well as epilepsy (1998). He was hospitalised
following an epileptic seizure (1998 and 2003) and a cardiac
arrest (1999).
- In 1998 a psychiatrist treating the applicant advised
the applicant to take Vigil (Modafinil) which, in contrast to
previous drugs, had positive effects on his condition. The drug was
initially provided by a pharmaceutical company free of charge to
the applicant’s doctor. Subsequently, the drug became available
in pharmacies but was not listed on the Ministry of Health’s
register of refunded drugs. The applicant could buy the drug at his
own expense.
- In
September 2003 the applicant was admitted to the Sleep Disorder
Clinic at the Nowowiejski Hospital in Warsaw. He was diagnosed with
narcolepsy and breathing difficulties while sleeping. On the
certificate dated 26 September 2003 Doctor MS stated that Vigil
(Modafinil) was the basic drug used in the treatment of narcolepsy.
- In July 2006 the applicant underwent a bypass surgery
in the Pomorska Medical Academy. In 2009 he was hospitalised for
pneumonia.
2. Requests for reimbursement
- On
3 December 2003 the applicant requested the Szczecin Branch of the
National Health Fund (“the NHF”) to refund him the cost
of the drug. He submitted that he suffered from narcolepsy as well as
from diabetes. He also had a stroke. He had frequently lost
consciousness and was hospitalised on account of those ailments. He
claimed that the psychiatrists and neurologists treating narcolepsy
were of the view that Vigil (Modafinil) was the only effective drug
for his condition. He submitted opinions of two doctors from private
practice to that effect. The applicant was not able to afford to buy
the drug and submitted that there was no generic drug available.
- By
a letter of 22 December 2003 the applicant was informed that the NHF
refunded the cost of drugs in accordance with the Ordinance of the
Minister of Health on the register of drugs which were distributed
free of charge, against the payment of a lump sum or against a
partial payment (“the Ordinance”). The contents of the
register of the refunded drugs and related matters were determined by
the Minister of Health. The applicant was informed that there was no
possibility to refund the cost of those drugs which were
non-refundable according to the Ordinance. Lastly, he was advised
that he could be assisted by the social services.
- On
20 January 2004 the applicant requested the Forensic Medicine
Department of the Pomorska Medical Academy to prepare an opinion as
to whether Vigil (Modafinil) could be considered a life-saving drug
in his case. In the opinion of 30 April 2004 Doctor EK, having regard
to the applicant’s medical history, replied in the affirmative.
She noted that Vigil (Modafinil) was the basic drug used in the
treatment of narcolepsy and that it had improved the applicant’s
condition. The expert established that the first attacks of
narcolepsy had been diagnosed in 1977 and that from 1988 he has been
under psychiatric care.
- It appears that on an unspecified date in 2004 the
applicant again requested to be refunded the cost of the drug. On 12
August 2004 the NHF informed him that according to the opinion of the
regional consultant in neurology, Professor PN, Vigil (Modafinil) was
not a drug routinely used in the treatment of narcolepsy and that it
was not a life-saving drug. Furthermore, the limited financial
resources of the Regional Branch of the NHF did not permit the
refunding of all expensive drugs which were fully at the charge of a
patient.
- In
an opinion dated 20 August 2004, which appears to have been
commissioned by the applicant, Doctor JW noted that Vigil (Modafinil)
was the only tested and widely used drug in the treatment of
narcolepsy.
- On
23 August 2004 the applicant sued the Szczecin Branch of the NHF for
reimbursement of expenses incurred in purchasing Vigil (Modafinil)
between November 2003 and August 2004 (PLN 4,690.21). In support of
his claim he relied on the opinions of 20 January and 20 August 2004.
The Szczecin District Court ordered that an opinion be prepared with
a view to determining whether Vigil (Modafinil) was a life saving
drug given the applicant’s condition.
- The
opinion was submitted to the court on 17 November 2005. The expert
established that the applicant suffered from narcolepsy
(he had been diagnosed in the 1980s), sleep behaviour
disorder and breathing difficulties in sleep. In addition, the
applicant suffered from hypertension, ischaemic heart disease, type 2
diabetes and epilepsy. The applicant’s sleep disorders
increased the risk of strokes. The expert concluded that the
applicant’s narcolepsy together with his numerous ailments
required that he was treated with Vigil (Modafinil), which in his
case was a life-saving drug. The conclusions of the opinion were
similar to those in the opinion of 20 April 2004.
- In its letter of 7 October 2004 the Regional Branch of
the NHF again informed the applicant that, despite the positive
opinion of the regional consultant in neurology, there was no
possibility of individual reimbursement of the cost of the drug which
remained fully at the patient’s charge since Vigil (Modafinil)
was not a life-saving drug and narcolepsy was not a fatal condition.
The drug Vigil (Modafinil) was not listed on the Minister of Health’s
register of refunded drugs and thus it was to be purchased
exclusively at the expense of the patient. He was further informed
that persons in a difficult financial situation could have recourse
to social services.
- On
an unspecified date the Civil Section of the District Court
transmitted the case to the Labour and Social Security Section of the
court, since the latter instance was competent to hear the case. The
Labour and Social Security Section of the District Court found that
it did not have jurisdiction to hear the case since it examined
appeals against administrative decisions, and in the applicant’s
case the NHF had not issued any such decision. On 29 May 2006 the
District Court found that it did not have jurisdiction to hear the
case and transmitted it to the Szczecin Branch of the NHF for a
decision in respect of the reimbursement of the cost of the therapy.
- On
27 January 2006 the applicant requested the Szczecin Branch of the
NHF to reimburse him for the cost of the drug. In reply, he was
informed that no decision could be given until the delivery of a
decision in the case pending before the District Court.
- On
17 May 2006 the applicant submitted a similar request. On 12 July
2006 the NHF refused his request. It found that Vigil (Modafinil) was
neither included on the relevant register of refunded drugs of the
Minister of Health nor on the separate register of specific serious
diseases and drugs which could be refunded in the treatment of those
diseases. The drugs which were not listed in those registers were
non refundable and remained fully at the patient’s charge.
The applicant was further advised that the regional branch of the NHF
could, in necessary cases, authorise non-standard medical treatment
at the request of the Szczecin Psychiatric Clinic, the establishment
where he was treated.
- The
applicant appealed, arguing, inter alia, that he was unable to
afford to buy Vigil (Modafinil).
- On 3 August 2006 the President of the NHF upheld the
contested decision. He noted that Article 68 § 2 of the
Constitution provided that citizens were ensured equal access to
health care services, financed from public funds. However, the
conditions and the scope of the provision of services should be
established by statute. At the material time those issues were
regulated by the 2004 Health Care Services Financed from Public Funds
Act (“the 2004 Act”). In accordance with the Act, the NHF
was to refund to a pharmacy the price of a drug which appeared on the
list of fully or partially refunded drugs.
The
Act introduced the rule that patients were to pay a part of the price
of drugs sold by pharmacies and designated the Minister of Health as
the competent authority to determine the scope of the partial payment
as well as of the financing from public funds. It was noted that the
NHF had no discretion to exercise in this respect. The Minister of
Health was competent to establish the list of drugs which were to be
fully or partially refunded in his two ordinances of 17 December 2004
and the drug Vigil (Modafinil) did not
appear on that list. Lastly, it was noted that the refund of the cost
of a drug by the NHF was only allowed in cases of administering
the drug in the framework of the provision of health services by
health establishments to patients in accordance with contracts
concluded between the NHF and those establishments.
- The
applicant filed a complaint against that decision with the Warsaw
Regional Administrative Court. He alleged that the refusal to refund
the cost of Vigil (Modafinil) amounted
to a violation of Articles 32 (equality), 38 (protection of life) and
68 of the Constitution (equal access to health care
services) and a breach of section 15 and 65 of the 2004 Act. He
pointed out that for thirty years he had been suffering from a rare
neurological disease and that according to medical expert opinions
Vigil (Modafinil) was a life-saving drug
in his case. Furthermore, the cost of the monthly intake of the drug
was in the region of PLN 1,000, while the joint income of the
applicant and his wife (both retired) was PLN 2,685.40 and they were
already spending monthly PLN 700 on various medications.
- On 4 December 2006 the Warsaw Regional Administrative
Court declared the decision of the President of the NHF and the
preceding decision null and void for the lack of competence on the
part of that authority to deal with the matter. It noted that the
2004 Act did not envisage the possibility that a patient could seek
reimbursement of the cost of medical treatment. Such a possibility
was reserved exclusively for entities providing health care services.
The court observed that there was no legal basis for the NHF’s
decision in respect of the refund for a particular drug. It appears
that the applicant did not lodge an appeal with the Supreme
Administrative Court.
- On
14 February 2007 the applicant again requested the President of the
NHF to refund the cost of Vigil (Modafinil). In his reply of
31 October 2007 the Director of the Regional Branch of the
NHF informed the applicant that, in accordance with the Regional
Administrative Court’s judgment, the NHF was not competent to
issue decisions in respect of the refund of costs of health care
services.
- On
3 July 2007 the Constitutional Court declined to examine the
applicant’s constitutional complaint.
- On
18 January 2008 the applicant again sued the Regional Branch of the
NHF for reimbursement of expenses incurred in purchasing the drug. On
25 January 2008 the Szczecin District Court rejected his statement of
claim, having found that the branch of the NHF did not have standing
in the proceedings.
- On
21 April 2008 the applicant unsuccessfully requested the President of
the NHF to refund the cost of the drug. His request was forwarded to
the Minister of Health as the competent authority to list a drug on
the register of drugs which were partially or fully refunded.
- On
20 June 2008 the Ministry of Health informed the applicant that the
company making Vigil (Modafinil) had not applied for the listing of
the drug on the register of refunded drugs and therefore the Ministry
could not act on the matter.
- By
a decision of 24 June 2008 the Szczecin Branch of the NHF, acting in
line with the Warsaw Regional Administrative Court’s judgment,
discontinued the proceedings in respect of the applicant’s
request for refund.
- It
appears that the applicant continues to buy Vigil (Modafinil) at his
own expense.
B. Relevant domestic law
1. Constitutional provisions
- 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.”
2. The 2004 Health Care Services Financed from Public
Funds Act (“the 2004 Act”)
- The
2004 Act defined the conditions for and the scope of health care
services financed from public funds. It stipulated that the Minister
of Health shall set out in an ordinance the list of basic and
complementary drugs and the rules concerning payment for those drugs
(section 36.5) and the list of drugs in respect of certain serious
conditions which were prescribed free of charge, against payment of a
lump sum or against a partial payment (section 37.2)
COMPLAINT
- The applicant alleged a breach of Article 2 of the
Convention in that the authorities failed to take appropriate steps
to safeguard his life through the denial of health care which the
authorities were required to make available to the population
generally. He argued that the authorities had been aware of the real
risk to his life expressed in the medical opinions in his case but
they refused to refund the cost of the drug needed for his therapy
and thus failed to avert the risk to his life. The applicant relied
on the case of Nitecki v. Poland ((dec.), no. 65653/01,
21 March 2002).
THE LAW
- The
applicant complained that the refusal to reimburse him the cost of
the drug amounted to a violation of Article 2 of the Convention.
This provision reads in its relevant part:
“1. Everyone’s right to life
shall be protected by law.”
- The
first sentence of Article 2, which ranks as one of the most
fundamental provisions in the Convention and also enshrines one of
the basic values of the democratic societies making up the Council of
Europe, enjoins the State not only to refrain from the “intentional”
taking of life, but also to take appropriate steps to safeguard the
lives of those within its jurisdiction (see, among
other authorities, Calvelli and Ciglio v. Italy [GC], no.
32967/96, § 48, ECHR 2002 I; Jasińska v. Poland,
no. 28326/05, § 57, 1 June 2010).
- The
Court has accepted that it cannot be excluded that the acts and
omissions of the authorities in the field of health care policy may
in certain circumstances engage their responsibility under the
positive limb of Article 2. However,
where a Contracting State has made adequate provision for securing
high professional standards among health professionals and the
protection of the lives of patients it cannot accept that matters
such as error of judgment on the part of a health professional or
negligent co-ordination among health professionals in the treatment
of a particular patient are sufficient of themselves to call
a Contracting State to account from the standpoint of its
positive obligations under Article 2 of the Convention to protect
life (see, Powell v. the United Kingdom
(dec.), no. 45305/99, ECHR 2000 V; Byrzykowski v.
Poland, no. 11562/05, § 104, 27 June 2006; Trzepałko
v. Poland (dec.), no. 25124/09, 13 September 2011, § 23).
- Furthermore, with respect to the scope of the State’s
positive obligations in the provision of health care, the Court has
stated that an issue may arise under Article 2 where it is shown that
the authorities of a Contracting State put an individual’s
life at risk through the denial of health care which they have
undertaken to make available to the population generally (see, 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; Gheorghe v. Romania (dec.), no.
19215/04, 22 September 2005).
- The Court notes that the present case bears
considerable similarity to the case of Pentiacova and Others v.
Moldova in which it declared inadmissible the complaints about
the insufficient public funding for the applicants’
haemodialysis. When examining the case under Article 8, the Court
observed that the Convention did not guarantee as such a right to
free medical care and that the State’s margin of appreciation
when it came to the assessment of priorities in the context of
limited public resources was a wide one. The national
authorities were in a better position to carry out this assessment
than an international court in view of their familiarity with the
competing demands made on the health care system as well as with the
funds available to meet those demands. The Court further held that
while it was clearly desirable that everyone should have access to a
full range of medical treatment, including life-saving medical
procedures and drugs, lack of resources meant that there were,
unfortunately, many individuals in the Contracting States who did not
enjoy them, especially in cases of permanent and expensive treatment.
In that case the Court also declared inadmissible the applicants’
complaint under Article 2 for failure to adduce evidence that their
lives had been put at risk while having regard to its findings in
respect of the complaint under Article 8.
- In
the instant case the Court notes that the applicant suffered from
narcolepsy first diagnosed in 1977 as well as a considerable number
of other ailments (type 2 diabetes, hypertension, epilepsy, ischaemic
heart disease). It transpires from the documents produced by the
applicant that over the years he benefited from the medical care
provided by the public health service in Poland, including
psychiatric care and surgical interventions. It does not appear
that the applicant has ever been refused the standard care provided
by the public health care establishments in Poland.
- The
applicant claims that the refusal to refund the cost of Vigil
(Modafinil) has exposed his life to risk. The Court notes that
according to some medical experts the drug could be considered
life-saving having regard to the applicant’s specific medical
condition and ailments (see paragraphs 9 and 13 above). It does
not find it established, however, that the impossibility to obtain
public funding for the drug at issue could be regarded as a breach of
the authorities’ duty to protect the applicant’s right to
life.
- The
Court observes that the applicant essentially demands public funding
for a particular type of medical treatment. However, there is no
support in the Court’s case-law (see, in particular, Pentiacova
and Others (dec.), cited above) for the proposition that an
applicant can lay claim to public funds in order to be treated with a
particular drug. The allocation of public funds in the area of health
care, which is a fervently debated issue in a number of European
States, is not a matter on which the Court should take a stand. It is
for the competent authorities of the Member States to consider and
decide how their limited resources should be allocated
(see, mutatis mutandis, Osman v. the United
Kingdom, 28 October 1998, § 116, Reports of Judgments
and Decisions 1998 VIII; O’Reilly and Others v. Ireland
(dec.), no. 54725/00, 28 February 2002; and Sentges
v. the Netherlands (dec.), no. 27677/02, 8 July 2003).
Those authorities are after all better placed than the Court to
evaluate the relevant demands in view of the scarce resources and to
take responsibility for the difficult choices which have to be made
between worthy needs (see, Pentiacova and Others; and
Gheorghe v. Romania (dec.), both cited above). The Court
further considers that the Nitecki v. Poland decision, in
which it declared inadmissible the complaint under Article 2
concerning the authorities’ refusal to refund the full price of
a life-saving drug
which resulted in the applicant’s inability to follow the
prescribed pharmaceutical treatment does not provide support for Mr
Wiater’s case.
- The Court notes that at the material time the issues
related to the financing of health care services were comprehensively
regulated in the 2004 Act which came into effect on 1 October 2004.
In accordance with the Act, the NHF refunded (partly or fully) to a
pharmacy the price of a prescribed drug provided that such drug
appeared on the Minister of Health’s list of drugs which were
prescribed free of charge, against the payment of a lump sum or
against partial payment. The list of refunded drugs, the rules
concerning the payment for them and the applicable price ceilings
were determined each year by the Minister of Health in the relevant
ordinance. Furthermore, it appears from the information relayed to
the applicant by the Ministry of Health that the pharmaceutical
company which produced the drug at issue did not apply for it to be
included on the list of refunded drugs (see paragraph 26 above). The
applicant was informed that the drug, which was not included on the
list of refunded drugs, was to be fully financed by the patient.
Furthermore, there was no possibility for a patient to apply
individually to the NHF for a refund. For those reasons, the
applicant’s attempts to seek a refund directly from the NHF or
by means of civil proceedings were bound to fail.
- Moreover,
there existed an alternative possibility of having the costs of the
drug refunded by the NHF under a contract signed by the former with a
health care establishment under the so-called “non-standard
pharmacological treatment”. That procedure required that a
health care establishment applied to the NHF for authorisation to
treat the applicant with the drug at issue. However, no such request
has been made in the applicant’s case. It is also evident that
the above rules were applicable to all users of the public health
care system and therefore there is no merit in the applicant’s
claim that he was denied health care which was otherwise generally
available in Poland.
- Having
regard to the foregoing, the Court finds that the present case does
not disclose any appearance of a breach of the respondent State’s
obligation to protect the applicant’s right to life on account
of the lack of public funding for the drug at issue (see, mutatis
mutandis, Nitecki v. Poland (dec.), cited
above).
- It
follows that the complaint under Article 2 is manifestly ill-founded
and must be rejected in accordance with Article 35 §§ 3 (a)
and 4 of the Convention.
For these reasons, the Court unanimously
Declares the application inadmissible.
Fatoş Aracı David
Thór Björgvinsson
Deputy Registrar President
