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FOURTH
SECTION
DECISION
Applications nos.
47039/11 and 358/12,
HRISTOZOV and STAYKOVA PETERMANN against
Bulgaria
and MISHEVA AND OTHERS against Bulgaria
The
European Court of Human Rights (Fourth Section), sitting on
21 February 2012 as a Chamber composed of:
Lech
Garlicki, President,
David
Thór Björgvinsson,
Päivi
Hirvelä,
George
Nicolaou,
Zdravka
Kalaydjieva,
Nebojša
Vučinić,
Vincent
A. De Gaetano, judges,
and Lawrence Early, Section
Registrar,
Having
regard to the above applications lodged on 15 July and 5 December
2011 respectively,
Having
regard to the President’s decision of 9 February 2012 to grant
priority to the applications under Rule 41 of the Rules of Court,
Having
deliberated, decides as follows:
THE FACTS
- The
applicants in the first application (no. 47039/11), Mr Zapryan
Hristozov Hristozov and Ms Anna Staykova Petermann, are
Bulgarian nationals who were born in 1977 and 1954 respectively and
live in Plovdiv.
- The
applicants in the second application (no. 358/12), Ms Boyanka
Tsvetkova Misheva, Mr Petar Dimitrov Petrov, Ms Krastinka Marinova
Pencheva, Ms Tana Tankova Gavadinova, Ms Blagovesta Veselinova
Stoyanova, Mr Shefka Syuleymanov Gyuzelev, Mr Yordan Borisov Tenekev
and Mr David Sabbatai Behar, are Bulgarian nationals who were born in
1948, 1947, 1948, 1973, 1948, 1966, 1935 and 1947 respectively and
live in Godech, Dobrich, Kazanlak, Plovdiv, Ruse, Samokov and Sofia
respectively.
- All
applicants were represented before the Court by Mr M. Ekimdzhiev,
Ms K. Boncheva and Ms G. Chernicherska, lawyers practising in
Plovdiv.
A. The circumstances of the case
- The
facts of the case, as submitted by the applicants, may be summarised
as follows.
- The
first applicant in application no. 47039/11 and all eight applicants
in application no. 358/12 have various types of cancer and appear to
be in the terminal phase of the illness (the second applicant in
application no. 47039/11 is the first applicant’s mother).
Having either tried a host of conventional treatments (surgery,
chemotherapy radiotherapy, hormone therapy, etc.) or obtained a
medical opinion that such forms of treatment would not work in their
respective cases or were not available in Bulgaria, all of them
approached a private clinic in Sofia, the Medical Centre for
Integrative Medicine OOD (“Медицински
център Интегративна
Медицина ООД”),
where they were informed about an experimental anticancer product
(MBVax Coley Fluid) which is being developed by a Canadian company –
MBVax Bioscience Inc. According to information from that company,
their product has not been licensed for use in any country, but has
been approved for compassionate use (for a definition of the term,
see paragraph 27 below) in a number of countries (the Bahamas, China,
Germany, Ireland, Israel, Mexico, Paraguay, South Africa,
Switzerland, the United Kingdom, and the United States of America).
In a letter of 9 January 2011 to the Bulgarian Ministry of Health,
the company said that within its pre clinical development phase
it would be willing to provide the product free of charge to Medical
Centre for Integrative Medicine OOD, for use on cancer patients who
could no longer benefit from conventional therapies, in return for
data on the treatment’s adverse and beneficial effects in each
patient. It appears that Medical Centre Integrative Medicine OOD has
on a number of occasions in the past few years applied for permission
to import and use the product, to no avail.
- According
to the applicants, MBVax Coley Fluid has been used with some success
on patients in clinics in Germany, Ireland, the United Kingdom, and
the United States of America.
- It
appears that on 23 July 2011 one of the applicants, Mr Petrov,
travelled to Germany, where he had the product provided by MBVax
Bioscience Inc. free of charge and administered seven times. However,
shortly after that the applicant returned to Bulgaria because he
could no longer afford to pay his living expenses in Germany and the
fees of the medical institution which administered the treatment.
- Each
of the applicants applied to the Executive Drugs Agency
(“Изпълнителна
агенция по
лекарствата”)
for permission to use MBVax Coley Fluid. In letters of 20 June, 15
July and 1 and 31 August 2011 the Director of the Agency pointed out
that MBVax Coley Fluid was an experimental product not yet licensed
or undergoing clinical trials in any country, which meant that it
could not be authorised for use in Bulgaria under Regulations no. 2
of 2001 (see paragraph 14 and 15 below). He went on to say that
Bulgarian law made no provision for the use of unlicensed medicines
outside clinical trials, and that, unlike the situation in other
European countries, under the current legal framework in Bulgaria the
compassionate use of unlicensed medicines was not possible. Under the
law of the European Union, there was no obligation to have a
harmonised approach to the compassionate use of unlicensed medicines.
In some of the letters the Director added, without going into detail,
that the information the applicants had about MBVax Coley Fluid was
incorrect.
- Some
of the applicants appealed to the Minister of Health, who in a letter
of 13 July 2011 fully agreed with the position expressed by the
Executive Drugs Agency.
- Three
of the applicants in application no. 358/12 applied to the Ombudsman
of the Republic. In letters of 22 July and 4 and 14 September 2011,
the Ombudsman also informed them that MBVax Coley Fluid had not been
licensed in any country, which meant that the only way in which they
could obtain access to it in Bulgaria was within the framework of a
clinical trial.
- The
applicants have not sought judicial review.
- On
27 October 2011 the Sofia Regional Health Directorate decided to
strike Medical Centre for Integrative Medicine OOD out of the
register of health institutions, citing its carrying out of
activities in breach of established medical standards. The clinic
sought judicial review of the decision. The proceedings are currently
pending before the Sofia Administrative Court. A hearing was held on
8 December 2011 and a second hearing is listed for 24 February 2012.
B. Relevant domestic law
1. The Medical Products in Human Medicine Act 2007 and
regulations issued under it
- Section 9(1) of the Medical Products in Human Medicine
Act 2007 (Закон
за лекарствените
продукти в
хуманната
медицина)
provides that a patient may be treated with a medical product that
has not been duly licensed if a hospital makes a request in that
respect. The manner and the conditions for doing so are to be laid
down in regulations by the Minister of Health.
- The regulations governing that issue at the time when
the applicants made their requests to be allowed to use MBVax Coley
Fluid were Regulations no. 2 of 10 January 2001 (Наредба
№ 2 от 10 януари
2001 г. за условията
и реда за лечение
с неразрешени
за употреба
в Република
България лекарствени
продукти).
- Regulation 2 of those Regulations provided that
medical products that had not been licensed in the country could be
prescribed if they had been licensed in other countries and were
intended for the treatment of rare diseases or diseases having
specific symptoms, when treatment with licensed medicines had proved
fruitless.
- The procedure for this was as follows. A panel of
three medical doctors appointed by the head of the hospital (one of
the doctors being a specialist in the treatment of the disease in
issue) had to prescribe the unlicensed product (regulations 3(1) and
3(2)). The prescription could not cover a period of more than three
months (regulation 3(4)). After that the prescription had to be
approved by the head of the hospital (regulation 3(3)) and sent to
the Executive Drug Agency, along with a declaration by the patient
(or his or her parent or guardian, as the case might be) that he or
she agrees to be treated with the unlicensed product (regulation
4(2)). The Executive Drug Agency had ten working days to decide
whether to grant authorisation. If the relevant requirements had not
been met, the Agency would issue a negative decision, which could be
appealed within seven days before the Minister of Health who had to
decide the appeal within seven days (regulation 5(1)).
- If the need for an unlicensed life saving product
arose in a medical institution other than a hospital, the head of
that institution could draw up a document specifying the product and
the required quantity and, having obtained the assent of the
Executive Drug Agency, apply for permission to the Minister of
Health. The Minister could then make a decision setting out the
product, the quantity and the recipients (regulation 8(1)).
- In early December 2011 those regulations were
superseded by Regulations no. 10 of 17 November 2011 (Наредба
№ 10 от 17 ноември
2011 г. за условията
и реда за лечение
с неразрешени
за употреба
в Република
България лекарствени
продукти, както
и за условията
и реда за включване,
промени, изключване
и доставка на
лекарствени
продукти от
списъка по чл.
266а, ал. 2 от Закона
за лекарствените
продукти в
хуманната
медицина).
- Regulation 1(2) provides that only medical products
that can be prescribed by a doctor in another country can be
authorised for use under the Regulations. Regulation 2(1) provides
that medical products intended for use by an individual patient may
be prescribed if they are allowed for use in other countries and
treatment with medicines licensed in Bulgaria is impossible or has
failed. Regulation 3(1) provides that hospitals may also obtain
unlicensed medical products if those have been made available under
“international and national programmes” or by an
international organisation which is the only entity in a position to
procure those products.
- The procedure under the new regulations is as follows.
A panel of three medical doctors appointed by the head of the
hospital (one of the doctors being a specialist in the treatment of
the disease at issue) must prescribe the unlicensed product
(regulations 4, 5(1) and 6(1)). The prescription has to be
accompanied by the written informed consent of the patient (or his or
her parent or guardian, as the case may be) (regulations 5(2)
and 6(4)), and cannot cover a period of more than three months
(regulations 5(3) and 6(2)). The prescription must then be approved
by the head of the hospital (regulation 7(1)). After that the
Executive Drug Agency must either grant permission or issue a
reasoned refusal (regulation 8(1)). It must issue such a refusal
if the form of the prescription or the medical products at issue do
not meet the requirements of the Regulations (regulation 8(2)). The
Agency’s refusal is subject to appeal and judicial review
(regulation 8(3)).
- On 21 July 2011 Parliament added a new section 266a to
the 2007 Act. It came into force on 5 August 2011 and provides, in
subsection 1, that where it is not possible to treat a disease with
medicines available in the country, an individual patient may be
treated with a product that has been licensed in another Member State
of the European Union and under the Act, but is not being marketed in
Bulgaria. The Minister of Health must keep a list of such products
and update it annually (subsection 2). The explanatory notes to the
amendment bill referred to the need to allow Bulgarian patients
access to licensed medicines that are not available on the Bulgarian
market but are available in other Member States of the European
Union.
2. The Code of Administrative Procedure
- Under the Code of Administrative Procedure, individual
administrative decisions may be challenged by those affected by them
before a court on grounds of unlawfulness (Articles 145 § 1 and
147 § 1). As a rule, there is no requirement to first exhaust
administrative remedies (Article 148).
- Statutory instruments, such as regulations, may also
be challenged before the Supreme Administrative Court (Articles 185 §
1 and 191 § 1). Any individual or organisation whose rights,
freedoms or legal interests have been or could be affected by such an
instrument may do so (Article 186 § 1). The court’s
decision has effect erga omnes (Article 193 § 2). If
the court annuls a statutory instrument, it is deemed repealed from
the date on which the court’s decision becomes final (Article
195 § 1).
C. Relevant European Union law
- Article 5 of Directive 2001/83/EC of the European
Parliament and of the Council of 6 November 2001 on the Community
code relating to medicinal products for human use, as amended,
provides, in so far as relevant:
“1. A Member State may, in accordance
with legislation in force and to fulfil special needs, exclude from
the provisions of this Directive medicinal products supplied in
response to a bona fide unsolicited order, formulated in accordance
with the specifications of an authorised health care
professional and for use by an individual patient under his direct
personal responsibility.
...
3. Without prejudice to paragraph 1, Member
States shall lay down provisions in order to ensure that marketing
authorisation holders, manufacturers and health professionals are not
subject to civil or administrative liability for any consequences
resulting from the use of a medicinal product otherwise than for the
authorised indications or from the use of an unauthorised medicinal
product, when such use is recommended or required by a competent
authority in response to the suspected or confirmed spread of
pathogenic agents, toxins, chemical agents or nuclear radiation any
of which could cause harm. Such provisions shall apply whether or not
national or Community authorisation has been granted.
4. Liability for defective products, as
provided for by Council Directive 85/374/EEC of 25 July 1985 on the
approximation of the laws, regulations and administrative provisions
of the Member States, concerning liability for defective products
(1), shall not be affected by paragraph 3.”
- Article 6 § 1 of the same Directive provides as
follows:
“No medicinal product may be placed on the market
of a Member State unless a marketing authorisation has been issued by
the competent authorities of that Member State in accordance with
this Directive or an authorisation has been granted in accordance
with Regulation (EC) No 726/2004, read in conjunction with Regulation
(EC) No 1901/2006 of the European Parliament and of the Council of 12
December 2006 on medicinal products for paediatric use and Regulation
(EC) No 1394/2007.”
- Recital 33 of Regulation no. 726/2004 of the European
Parliament and of the Council of 31 March 2004 laying down Community
procedures for the authorisation and supervision of medicinal
products for human and veterinary use and establishing a European
Medicines Agency says the following:
“In order to meet, in particular, the legitimate
expectations of patients and to take account of the increasingly
rapid progress of science and therapies ... [i]n the field of
medicinal products for human use, a common approach should also be
followed, whenever possible, regarding the criteria and conditions
for the compassionate use of new medicinal products under Member
States’ legislation.”
- Article 83 of the Regulation provides as follows:
“1. By way of exemption from Article 6
of Directive 2001/83/EC Member States may make a medicinal product
for human use belonging to the categories referred to in Article 3(1)
and (2) of this Regulation available for compassionate use.
2. For the purposes of this Article,
‘compassionate use’ shall mean making a medicinal product
belonging to the categories referred to in Article 3(1) and (2)
available for compassionate reasons to a group of patients with a
chronically or seriously debilitating disease or whose disease is
considered to be life threatening, and who can not be treated
satisfactorily by an authorised medicinal product. The medicinal
product concerned must either be the subject of an application for a
marketing authorisation in accordance with Article 6 of this
Regulation or must be undergoing clinical trials.
3. When a Member State makes use of the
possibility provided for in paragraph 1 it shall notify the Agency.
4. When compassionate use is envisaged, the
Committee for Medicinal Products for Human Use, after consulting the
manufacturer or the applicant, may adopt opinions on the conditions
for use, the conditions for distribution and the patients targeted.
The opinions shall be updated on a regular basis.
5. Member States shall take account of any
available opinions.
6. The Agency shall keep an up to date
list of the opinions adopted in accordance with paragraph 4, which
shall be published on its website. Article 24(1) and Article 25 shall
apply mutatis mutandis.
7. The opinions referred to in paragraph 4
shall not affect the civil or criminal liability of the manufacturer
or of the applicant for marketing authorisation.
8. Where a compassionate use programme has
been set up, the applicant shall ensure that patients taking part
also have access to the new medicinal product during the period
between authorisation and placing on the market.
9. This Article shall be without prejudice to
Directive 2001/20/EC [the Clinical Trials Directive] and to Article 5
of Directive 2001/83/EC.”
- On 19 July 2007 the European Medicines Agency adopted
a Guideline on compassionate use of medicinal products pursuant to
Article 83 (EMEA/27170/2006).
D. Relevant comparative material
1. Compassionate use programmes
- According to a survey published on 12 November 2010 by
the European Clinical Research Infrastructures Network (“Whitfield
et al.: Compassionate use of interventions: results of a European
Clinical Research Infrastructures Network (ECRIN) survey of ten
European countries. Trials 2010 11:104.”, available at
http://www.trialsjournal.com/content/11/1/104),
Austria, Denmark, France, Germany, Ireland, Italy, Spain, Sweden,
Switzerland and the United Kingdom have compassionate use programmes
in place.
- In the United States of America, regulations were
issued in May 1987 laying down conditions under which promising new
drugs that had not yet been licensed could be made available to
persons with serious and life threatening illnesses, for whom no
comparable or satisfactory alternative drug or therapy was available.
Those regulations were revised and expanded in 2009. They are
currently contained in the Code of Federal Regulations, Title 21,
Part 312, Subpart I (Expanded Access to Investigational Drugs for
Treatment Use), §§ 312.300 320, and make provision for
an “expanded access” programme, under which the Food and
Drug Administration (“the FDA”) may, under certain
conditions, authorise the use of an “investigational new drug”
in respect of patients suffering from “a serious or immediately
life threatening disease or condition, [when] there is no
comparable or satisfactory alternative therapy to diagnose, monitor,
or treat the disease or condition” (21 CFR 312.305(a)(1)). The
general criteria governing FDA’s decision is whether “[t]he
potential patient benefit justifies the potential risks of the
treatment use and those potential risks are not unreasonable in the
context of the disease or condition to be treated” and whether
“[p]roviding the investigational drug for the requested use
will not interfere with the initiation, conduct, or completion of
clinical investigations that could support marketing approval of the
expanded access use or otherwise compromise the potential development
of the expanded access use” (21 CFR 312.305(a)(2) and (3)). The
regulations contain separate provisions for individual patients (21
CFR 312.310), intermediate size patient populations (21 CFR
312.315), and widespread treatment use (21 CFR 312.320).
- In Canada, sections C.08.010 and C.08.011 of the Food
and Drug Regulations make provision for a “special access
programme” allowing medical practitioners to request access to
drugs that are unavailable for sale in Canada, for the treatment of
patients with serious or life threatening conditions on a
compassionate or emergency basis when conventional therapies have
failed, are unsuitable, or are unavailable.
- In Australia, the Therapeutic Goods Administration of
the Department of Health and Ageing runs a “special access
scheme”, which allows, under certain conditions, the
importation or supply of an unlicensed medicines for a single
patient, on a case by case basis (section 18 of the Therapeutic Goods
Act 1989 and regulation 12A of the Therapeutic Goods Regulations
1990).
2. Relevant case law
- In United States v. Rutherford, 442 U.S. 544
(1979), the United States Supreme Court unanimously dismissed a
request by terminally ill cancer patients to enjoin the authorities
from interfering with the distribution of an unlicensed drug. The
court held that the statutory scheme governing drug licensing did not
contain an implicit exemption for drugs intended for use by the
terminally ill. In its view, the safety and effectiveness standards
laid down in the legislation applied equally to such drugs, because
the legislature could be regarded as intending to protect terminal
patients from ineffectual or unsafe drugs. For such patients, as for
anyone else, a drug was unsafe if its potential for inflicting death
or physical injury was not offset by the possibility of therapeutic
benefit. In relation to terminally ill people, unlicensed drugs
carried a further risk – that the individuals concerned might
eschew conventional therapy in favour of a drug with no demonstrable
curative properties, with potentially irreversible consequences. In
that connection the court noted, on the basis of expert evidence
presented to it, that with diseases such as cancer it was often
impossible to identify a patient as terminally ill except in
retrospect. It went on to say that acceptance of the proposition that
the statutory safety and efficacy standards have no relevance for
terminal patients would be tantamount to denying the authorities’
power to regulate all drugs, however toxic or ineffectual, for such
individuals, which would allow abusive marketing of many purportedly
simple and painless cures. Lastly, the court observed that its ruling
did not foreclose all resort to experimental cancer drugs by patients
for whom conventional therapy was unavailing, because the statutory
scheme exempted from premarketing approval drugs intended solely for
investigative use if they satisfied certain preclinical testing and
other criteria.
- In the more recent case of Abigail Alliance for
Better Access to Developmental Drugs et al. v. von Eschenbach et al.,
in a decision of 2 May 2006 (445 F.3d 470) a three member panel
of the United States Court of Appeals for the District of Columbia
Circuit held, by two votes to one, that under the due process clause
of the United States Constitution terminally ill patients had the
right to decide whether to take un unlicensed drug that was in Phase
2 or Phase 3 clinical trials and that the producer was willing to
make available. The court found that that right was deeply rooted in
the traditional doctrines of self defence and interference with
rescue, and that federal regulation of the effectiveness of drugs was
too recent and haphazard “to establish that the government has
acquired title to [that] right by adverse possession”. The
panel went on to say that that right was “implicit in the
concept of ordered liberty”.
- On an application by the FDA, the same court reheard
the case en banc and in a decision of 7 August 2007 (495 F.3d
695) held, by eight votes to two, that federal regulation of drugs
was “consistent with [the] historical tradition of prohibiting
the sale of unsafe drugs”. The “arguably limited”
history of efficacy regulation prior to 1962, when such regulation in
the United States had taken its current shape, did not establish a
fundamental right, because the legislature and the executive had
“continually responded to new risks presented by an evolving
technology” and because the legislature had a “well established
power to regulate in response to scientific, mathematical, and
medical advances”. The court went on to say that self defence,
the tort of interference with rescue, and the United States Supreme
Court’s “life or health of the mother” abortion
cases provided no support for a right to seek investigational drugs,
because those doctrines protected only “necessary”
life saving measures, whereas the claimants sought “access
to drugs that [were] experimental and [had] not been shown to be
safe, let alone effective at (or ‘necessary’ for)
prolonging life”.
- On 14 January 2008 the United States Supreme Court
denied certiorari (552 U.S. 1159).
- In Abney et al. v. Amgen, Inc., 443 F.3d 540,
on 29 March 2006, the United States Court of Appeals for the Sixth
Circuit upheld the lower court’s decision not to issue an
injunction sought by the claimants, individuals involved in a
clinical drug trial sponsored by the defendant, a drug manufacturer,
to require the defendant to keep on providing them with the drug even
though the clinical trial had come to an end.
- In Delisle v. Canada (Attorney General), 2006
FC 933, the Federal Court of Canada had to deal with applications for
judicial review of decisions taken by the Canadian federal health
authorities under the above mentioned special access programme
(see paragraph 31 above). The court held that in deciding to restrict
access to a drug previously available under the programme, the
authorities had failed to strike a proper balance because they had
not taken due account of humanitarian or compassionate concerns. It
referred the matter back to the authorities with instructions to
weigh the “valid objectives of public policy against the
humanitarian factor”. The judgment was not appealed against,
and in 2008 the case was settled, with the authorities agreeing to
follow the court’s recommendations.
- In B (a minor), R. (on the application of) v.
Cambridge Health Authority [1995] EWCA Civ 43 (10 March 1995),
the England and Wales Court of Appeal held that the courts could not
disturb a properly reasoned decision by the competent health
authorities not to fund a round of experimental treatment of a
terminally ill child. The Master of the Rolls, Sir Thomas
Bingham (as he then was) made two general comments. He firstly
pointed out that the case involved the life of a young patient, which
was a fact which had to dominate all consideration of all aspects of
the case, because British society was one in which a very high value
was put on human life and no decision affecting human life could be
regarded with other than the greatest seriousness. He secondly
observed that the courts were not arbiters as to the merits of cases
of that kind, because if they expressed opinions as to the likelihood
of the effectiveness of medical treatment, or as to the merits of
medical judgment, they would be straying far from their domain. He
went on to say that difficult and agonising judgments had to be made
as to how a limited budget was best allocated to the maximum
advantage of the maximum number of patients. That was not a judgment
which a court could make.
COMPLAINTS
- The
applicants complain under Article 2 § 1 of the Convention that
under Bulgarian law there is no possibility whatsoever for
individuals who are in the terminal phase of a disease and who have
unsuccessfully exhausted all conventional methods of treatment to
obtain authorisation to use unlicensed medicines (the so called
“compassionate use”). They further complain of the
allegedly incoherent and slow actions of the authorities in relation
to their requests to obtain such authorisation, arguing that that was
due to the lack of clear rules in that domain.
- The
applicants complain under Article 3 of the Convention that the
authorities’ refusal to grant authorisation to use the
unlicensed medicine in their case amounted to inhuman and degrading
treatment.
- The
applicants complain under Article 8 of the Convention that the
above mentioned refusal amounted to an unjustified interference
with their right for respect for their private and family life.
- The
applicants complain under Article 14 of the Convention that they are
being discriminated against vis à vis
individuals residing in countries in which it is possible to use
unlicensed medicines in respect of terminally ill patients on a
“compassionate use” basis.
- The
applicants complain under Article 13 of the Convention that they do
not have effective remedies in respect of the above mentioned
breaches of the Convention.
THE LAW
- As
the two applications are based on similar facts and as they contain
identical complaints, the Court considers it appropriate to join them
under Rule 42 § 1 of the Rules of Court.
- In
respect of their complaint that under Bulgarian law there was no
possibility for individuals who were in the terminal phase of a
disease and who had unsuccessfully exhausted all conventional methods
of treatment to obtain authorisation to use unlicensed medicines, the
applicants relied on Article 2 § 1 of the Convention which, in
so far as relevant, provides as follows:
“Everyone’s right to life shall be protected
by law.”
- In
respect of their complaint that the authorities had refused to grant
authorisation to use the unlicensed medicine in their cases, the
applicants relied on Article 3 of the Convention which provides as
follows:
“No one shall be subjected to torture or to
inhuman or degrading treatment or punishment.”
- In
respect of their complaint that the refusal to grant authorisation to
use the unlicensed medicine in their case had amounted to an
unjustified interference with their right for respect for their
private and family life, the applicants relied on Article 8 of the
Convention which, in so far as relevant, provides as follows:
“1. Everyone has the right to respect
for his private and family life...
2. There shall be no interference by a public
authority with the exercise of this right except such as is in
accordance with the law and is necessary in a democratic society in
the interests of national security, public safety or the economic
well being of the country, for the prevention of disorder or
crime, for the protection of health or morals, or for the protection
of the rights and freedoms of others.”
- The
Court considers that it cannot, on the basis of the case file,
determine the admissibility of the above complaints and that it is
therefore necessary, in accordance with Rule 54 § 2 (b) of the
Rules of Court, to give notice of this part of the application to the
respondent Government.
- In
respect of their complaint that they are discriminated against
vis à vis individuals residing in countries
in which it was possible to use unlicensed medicines in respect of
terminally ill patients on a “compassionate use” basis,
the applicants relied on Article 14 of the Convention, which provides
as follows:
“The enjoyment of the rights and freedoms set
forth in [the] Convention shall be secured without discrimination on
any ground such as sex, race, colour, language, religion, political
or other opinion, national or social origin, association with a
national minority, property, birth or other status.”
- The
Court observes that Article 14 protects against a discriminatory
difference in the treatment of persons in analogous positions in the
exercise of the rights and freedoms recognised by the Convention and
its Protocols. It notes in this connection that in different
countries there is no uniform approach to legislation in particular
areas. Whether or not a person can assert a right derived from
legislation may accordingly depend on that legislation’s
territorial reach and the person’s location at the material
time. For the Court, the difference in treatment between the
applicants, as individuals residing in Bulgaria, and individuals
residing in other countries is not to be explained in terms of
personal characteristics, such as national origin, but rather in
terms of the geographical location where a particular form of medical
treatment is authorised and available. Differences between the laws
of the Contracting States stem from their sovereign right to regulate
differently similar domains and does not amount to discriminatory
treatment within the meaning of Article 14 (see, mutatis mutandis,
Magee v. the United Kingdom, no. 28135/95, § 50,
ECHR 2000 VI).
- It
follows that this complaint 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
Decides unanimously to join the applications;
Decides by a majority to adjourn the examination of the
applicants’ complaints under Articles 2, 3 and 8 of the
Convention concerning the authorities’ refusal to grant
authorisation to use the unlicensed medicinal product that they
wished to use for treatment, and their complaint under Article 13 of
the Convention concerning the alleged lack of effective remedies in
that respect;
Declares unanimously the remainder of the applications
inadmissible.
Lawrence Early Lech Garlicki
Registrar President
