[e-drug] Access to essential medicines as a human right

e-drug
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E-DRUG: Access to essential medicines as a human right
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Dear all,

I would like to draw your attention to two papers which have recently
been published by our department. One of these is called "Is access to
essential medicines as part of the fulfillment of the right to health
enforceable through the courts?" and will appear in next The Lancet of
22 July. Here is the abstract:

**Hogerzeil HV, Samson M, Casanovas J, Rahmani-Ocora L. Is access to
essential medicines as part of the fulfillment of the right to health
enforceable through the courts?
Lancet 2006; 368: 305-311.

Background
Most countries in the world have become States parties to one or more
international human right treaties, thus creating an obligation by the
State to its people towards the realization of the right to health,
which includes access to essential medicines. But whether such access is
enforceable in practice is unknown.
Methods
We did a systematic search to identify completed court cases in low and
middle-income countries in which individuals or groups had claimed
access to essential medicines with reference to the right to health in
general, or to specific human rights treaties ratified by the
government. We identified and analysed 71 court cases from 12 countries
in which access to essential medicines was claimed with reference to the
right to health.
Findings
In 59 cases, access to essential medicines as part of the fulfilment of
the right to health could indeed be enforced through the courts, with
most coming from Central and Latin America. Success was mainly linked to
constitutional provisions on the right to health, supported by the human
rights treaties. Other success factors were a link between the right to
health and the right to life, and support by public-interest
non-governmental organizations. Individual cases have generated
entitlements across a population group, the right to health was not
restricted by limitations in social security coverage, and government
policies have successfully been challenged in court.
Interpretation
Skilful litigation can help to ensure that governments fulfil their
constitutional and international treaty obligations. Such assurances are
especially valuable in countries in which social security systems are
still being developed. However, redress mechanisms through the courts
should be used as a last resort. Rather, policy-makers should ensure
that human rights standards guide their health policies and programmes
from the outset.

Personal comment:
As far as we know this the first systematic analysis of the effect and
impact of such court cases in developing countries. Besides identifying
these cases for further legal study, the analysis shows that some of
these cases are legal landmarks which have changed government policies
with great impact on many patients. As far as I am concerned, the main
conclusion of this study is therefore that such court cases can indeed
make a difference. The fact that most successful cases so far have taken
place in Central and Latin America may encourage individuals and patient
groups in other continents.

The other paper, which appeared in the WHO Bulletin of May 2006,
describes how policy makers could incorporate the human rights approach
in their national medicine programmes. Here is the abstract:
[This abstract was also posted on E-drug May, 7]

**Hogerzeil HV. Essential medicines and human rights: what can they
learn from each other? WHO Bull 2006; 84: 371-375
Abstract
Most countries have acceded to at least one global or regional covenant
or treaty confirming the right to health. After years of international
discussions on human rights, many governments are now moving towards
practical implementation of their commitments. A practical example may
be of help to those governments who aim to translate their international
treaty obligations into practice. WHO's Essential Medicines Programme is
an example of how this transition from legal principles to practical
implementation may be achieved. This programme has been consistent with
human rights principles since its inception in the early 1980s, through
its focus on equitable access to essential medicines. This paper
provides a brief overview of what the international human rights
instruments mention about access to essential medicines, and proposes
five assessment questions and practical recommendations for governments.
These recommendations cover the selection of essential medicines,
participation in programme development, mechanisms for transparency and
accountability, equitable access by vulnerable groups, and redress
mechanisms.

Personal comment: The key question in this paper is what the
rights-based approach can add to a good public health programme. The key
answer is that most essential medicines programmes do not do badly, but
could still do better. Here are the five assessment questions, for
reflection:

Five assessment questions (from Bulletin article)
1) Which essential medicines are covered by the right to health?
Does the national constitution, or any other national law, recognize the
right of everyone to the enjoyment of the highest attainable standard of
health? Are there laws which specify the government's responsibility in
ensuring equitable access to essential medicines? Is there a national
list of essential medicines, updated within the last two years?

2) Have all beneficiaries of the medicine programme been consulted?
Is there a national medicines policy updated within the last 10 years?
Were patients' organizations and rural communities consulted when the
national medicines policy and programme were developed?

3) Are there mechanisms for transparency and accountability?
Does the national medicines policy describe the obligations of the
various stakeholders? Are there baseline and target data on access to
essential medicines against which progress can be measured?

4) Do all vulnerable groups have equal access to essential medicines?
How do you know?
Are disaggregated access statistics available for girls, boys, women and
men, and for urban and rural populations? Are essential medicines
available in prisons? Are training materials and drug information
leaflets available in all common ethnic languages?

5) Are there safeguards and redress mechanisms in case human rights are
violated?
Are legal mechanisms available and have they been used to file
complaints about lack of access to essential medicines?

I am looking forward to a discussion on how these thoughts can be
translated into practice.

With best regards,

Dr Hans V. Hogerzeil
Director
Medicines Policy and Standards
World Health Organization
CH-1211 Geneva 27
Switzerland
Tel: +41-22-791-3528
Fax: +41-22-791-4730
email: hogerzeilh@who.int

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E-DRUG: Access to essential medicines as a human right (2)
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Hans,

Litigation can also be used by drug companies to force governments to pay
for non-essential drugs that are expensive and thus not cost effective. This
can divert resources and thus reduce access to essential drugs. Part of the
problem is that courts, like many health professionals, tend to focus on
individual cases rather than the community as a whole.

For example Joana Ramos ( Social Worker, Health Policy; Cancer Resources &
Advocacy, Seattle, USA http://ramoslink.info/ ) has told me that “because
Brazilian citizens have the constitutional right to health care, there have
been increasing numbers of civil suits brought by patients to require their
municipal health units provide them with medicines that are not available,
or not readily available under the Brazilian national health service
(Sistema Único de Saúde, or SUS). Due to the law, the courts are almost
always obliged to order the municipal health units to provide these new
drugs. These drugs are usually imported and very expensive. Many of the
initial requests came from patients with AIDS and cancer.”

According to a report published by the Brazilian National Council of
Municipal Secretaries of Health in May 2005:

“It is a fact that the Law guarantees the right of people… and
administrators do not deny that they are right in seeking their rights in
the Court. But they complain that, precisely because of its coverage, the
Law does not anticipate a series of other situation. For instance: the
provision of medications that are not registered with the Health Ministry
yet or that are not on the list of SUS’s medications, the lawsuits for
treatment and surgery overseas; legal demands for patients who are not users
of the public network, and abuses of all kinds against the system. The flood
of legal actions caused by gaps in the legislation ends up causing the
non-compliance with preliminaries. Whatever the case, the patient is always
the one most harmed.

‘The situation here has got to such a point that, there are preliminaries
for [legal action about] the provision of special milk, geriatric diapers
and even Viagra’, reveals the municipal secretary of health in Goiânia,
Otaliba Libânio. ‘To satisfy these preliminaries, we have to create
re-management mechanisms for resources, even being subject to interrogation
from the Accountancy Tribunal later on’, he argues. ‘That is without
mentioning the number of patients who are left without Basic Care assistance
who go without being attended to satisfactorily due to a lack of resources.’
The most serious problems, however, are the demands for high cost
medications or ones that do not figure in clinical protocols from the Health
Ministry. A great many legal actions against SUS demand medications that are
in trial phases, which are not registered in the Ministry and that cost a
great deal more that conventional medicines. Administrators attribute a
great deal of blame on marketing from the pharmaceutical industry and the
lack of conscience from doctors who prescribe these treatments.

‘The truth is that large laboratories perceive the gap in the legislation,
an attraction for sales, from which we cannot escape. After all, legal
demands have to be satisfied’, says Libânio. ‘There are doctors who
prescribe the most expensive medications and together with the prescription
they even provide a business card of some law firm so that the patient can
get the medications in the Court’, he reveals. The Federal Council of
Medicine has already been approached, but it did not want to make a
statement on this question. The press advisory from the Council in Brasília
explained that the issue had not been debated in plenary and that there was
no consensus from the category.

For the consultant, at the Health Ministry, Paulo Picon, pressure from large
laboratories is the sole responsible factor for such high demand for
medications not on SUS’s clinical protocols. The specialist, who is also a
technical coordinator for the medication policy in Rio Grande do Sul,
reveals that, of the 450 lawsuits that are in progress against the State,
70% request medicines that are not part of SUS’s list. Many of them,
medicines recently launched by large laboratories, are still in the testing
phase.

‘It is secular marketing, aggressive and almost perfect. The laboratories
give handouts to physicians, sponsor trips, finance congresses and even
provide juridical assistance to patients’, lists in detail Picon. This
pressure, according to him, generates a vicious and difficult to break
circle: ‘The physician prescribes the medication that the laboratory wants
and the patient never questions the physician. The Public Ministry cannot
change the prescription and the Justice always decides for the right
guaranteed in the Constitution. In this way, the State has to put up with a
much higher expenditure to provide that medication and lacks resources for
basic care patients’, he says.”<1>

1. Health as the Defendant. Brazilian National Council of Municipal
Secretaries of Health (CONASEMS) 2005 May 4
www.conasems.org.br/mostraPagina.asp?codServico=1555&codPagina=2455

regards,

Peter

Dr Peter R Mansfield
GP
Director, Healthy Skepticism Inc. Countering misleading drug promotion.
www.healthyskepticism.org
peter@healthyskepticism.org
Research Fellow, Discipline of General Practice, University of Adelaide.
www.adelaide.edu.au/directory/peter.mansfield
peter.mansfield@adelaide.edu.au