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Date: Wed, 27 Mar 2002 14:36:01 -0800
From: charlotte utting <[log in to unmask]>
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Subject: [WASAN] FW: Africa: Treatment Access Updates
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From: "Africa Action" <[log in to unmask]>
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Date: Wed, 27 Mar 2002 15:00:15 -0500
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Subject: Africa: Treatment Access Updates
Africa: Treatment Access Updates
Date distributed (ymd): 020327
Document reposted by Africa Action
Africa Policy Electronic Distribution List: an information
service provided by AFRICA ACTION (incorporating the Africa
Policy Information Center, The Africa Fund, and the American
Committee on Africa). Find more information for action for
Africa at http://www.africaaction.org
+++++++++++++++++++++Document Profile+++++++++++++++++++++
Region: Continent-Wide
Issue Areas: +economy/development+ +health+
SUMMARY CONTENTS:
This posting contains several documents on recent developments in
access to treatment for people with HIV/AIDS. Additional
information can be found in previous postings and sites noted at:
http://www.africaaction.org/action/access.htm
The documents included here refer to several different arenas: (1)
purchasing policy by international institutions, (2) the policy
of the South African government on prevention of
mother-to-child-transmission of HIV/AIDS, and (3) international
trade talks on export of generic drugs,
+++++++++++++++++end profile++++++++++++++++++++++++++++++
World Health Organization Press Release
20 March 2002
http://www.who.int
Joint Press Release WHO/UNAIDS/UNICEF
INITIATIVE TO PROMOTE ACCESS TO QUALITY HIV MEDICINES RELEASES
FIRST BATCH OF RESULTS TODAY
For further information, journalists can contact: Daniela Bagozzi,
Communications, Heath Technology and Pharmaceuticals, WHO, Geneva,
tel. (+41 22) 791 4544; mobile (+41) 79 475 5490, e-mail
[log in to unmask]
A new effort to assess the quality of HIV medicines could make
treatment services more accessible to poor countries. The World
Health Organization (WHO) has evaluated several HIV-related
medicines and today publishes the first list of products which
were found to meet WHO recommended standards. This initial phase
of the project includes forty products from eight branded and
generic manufacturers. Managed by WHO, the initiative counts on
the expertise of UNICEF and the UNAIDS Secretariat, and is
supported by the UN Population Fund (UNFPA) and the World Bank.
"The project demonstrates the vital contributions research-based
and generic companies can make to innovation, quality, and access
to life-saving medicines," says Gro Harlem Brundtland,
Director-General of WHO. "We want to see an expansion in people's
access to quality health care, particularly in relation to those
diseases, like HIV/AIDS, that keep them poor and prevent the
economic development of their communities."
The Access to Quality HIV/AIDS Drugs and Diagnostics project is
part of a UN-wide strategy to improve access to HIV treatment. The
strategy is meant to promote rational use of drugs; affordable
prices for medicines and diagnostics; sustainable financing; and
reliable health and supply systems.
"This process will assist countries, as well as UNICEF and other
agencies, in the procurement of quality products for HIV
treatment," says Carol Bellamy, Executive Director of UNICEF.
"This UN initiative marks an important step in increasing the
number of qualified suppliers of HIV medicines and improving the
procurement of these drugs for people living with HIV/AIDS in
developing countries," says Dr Peter Piot, UNAIDS Executive
Director. "We hope this project will help HIV-positive people gain
greater access to affordable HIV medicines of good quality."
The list released today includes eleven anti-retrovirals (ARVs) and
five products for opportunistic infections. The ARVs on the list
allow for several triple therapy combinations.
The pilot project evaluates pharmaceutical products according to
WHO recommended standards of quality and for compliance with Good
Manufacturing Practices. It is just the beginning of an ongoing
process that will keep adding products and suppliers to its list,
as and when they are found to meet the set standards. The list is
now available on the web sites of WHO and the other collaborating
agencies. So far, eight companies have been evaluated but another
13 suppliers and 100 products are currently under review.
"We are involved in a dynamic process," explains Jonathan Quick,
Director of Essential Drugs and Medicines Policy at WHO. "We expect
that the list will grow steadily as more companies take an
interest in participating and countries expand their HIV/AIDS
programmes."
Appropriate diagnostic support is essential to monitoring the
progression of AIDS, the success of medical treatment and the
extent of viral resistance to medication. Through its department
of Blood Safety and Clinical Technology, WHO is also evaluating
HIV test kits and technologies to monitor HIV drug treatment.
In addition, guidelines on minimum requirements for laboratory
monitoring of HIV drug treatment are being developed. WHO is also
developing training and quality assessment programmes for health
care workers to ensure correct use of diagnostic tests.
HIV/AIDS has become the leading cause of mortality in Africa; out
of the 40 million people living with AIDS in the world, 28 million
are in Africa. In Asia and the Pacific, AIDS is rapidly spreading.
An estimated 7.1 million people are now living with HIV/AIDS in
the region.
The first list of products and suppliers assessed by the Access to
Quality HIV/AIDS Drugs and Diagnostics project is available on WHO
web site: http://www.who.int/medicines/
********************************************************
Comments by Medecins Sans Frontieres to the WHO report
20 March, 2002
[excerpts. For more details please contact
the MSF Access to Essential Medicines Campaign
at +41-22-8498 405 or http://www.accessmed-msf.org]
MSF welcomes the initiative by WHO, supported by Unicef and UNAIDS,
to prequalify HIV/AIDS drugs. Comprehensive advice on quality
medicines provided by the WHO is a much needed tool not only for UN
agencies but also for the governments of developing countries, as
well as any NGO dealing with drug procurement, attempting to
purchase quality drugs. MSF believes that the WHO is the only
organization with the role and mandate to be doing this.
However, MSF also has some concerns.
MSF especially welcomes the fact that generic manufacturers are
involved and that some generic drugs appear on the first list
published on March 20, 2002. ...
But MSF regrets that the WHO prequalification process was started
too late and that it has been so slow, considering that the first
expressions of interest from producers were received in December
2000.
MSF realises that the list will be updated as companies submit or
complete their dossiers, but regrets the absence of some essential
drugs (such as fluconazole) to treat HIV/AIDS and/or opportunistic
infections, and the false impression this absence may give to users
as to the quality of particular drugs or manufacturers.
Completing the existing list rapidly is particularly important
since it will help include quality generics in projects supported
by the Global Fund -- this isn't the case at the moment as the
following quote from the Malawian proposal to the Global Fund
demonstrates:
"At present, we are assuming that the Global Fund will only finance
patented drugs. This is in line with consultations with WHO and the
donor community and initial documents from the technical Support
Secretariat. If however, Global Fund rules, post-Doha, permit the
use of generic drugs, the proposal and programme budget will be
amended to reflect this."
MSF urges the WHO and its member states to ensure that there are
enough resources to continue and speed up the prequalification
process in the short, medium and long term. The project should also
be expanded to include drugs for other diseases such as malaria and
TB.
********************************************************
Background Document on Treatment Access in South Africa
Prepared by Africa Action
March 25, 2002
[for updated coverage see http://allafrica.com/aids; for
background on the TAC court case see http://www.tac.org.za]
Background
Almost 5 million people in South Africa are living with HIV/AIDS.
It is estimated that 70,000 HIV-positive children are born in
South Africa every year. Up to one-third of HIV-positive mothers
pass the virus to their babies. The rate of
mother-to-child-transmission (MTCT) of HIV can be significantly
reduced through the use of anti-retroviral drugs, and Nevirapine is
one of the cheapest and easiest to use. Medical studies have shown
that the provision of one tablet of Nevirapine to the mother at the
onset of labor, and another dose to the baby up to 72 hours after
birth, can reduce the risk of vertical transmission of HIV by 50%.
The use of Nevirapine is supported by the World Health Organization
and UNAIDS. The drug is being offered to developing countries for
free for five years by its manufacturer, Boehringer Ingelheim.
Court case on Treatment Access
In August 2001, AIDS activists from Treatment Action Campaign
(TAC), the Children's Rights Centre and Save Our Babies took the
government of South Africa to the High Court in Pretoria. They
claimed that the government was acting unconstitutionally by
failing to provide Nevirapine to all HIV-positive pregnant women
in order to reduce the rate of transmission of the virus to their
babies. TAC and its co- applicants challenged the government's
decision to provide Nevirapine to pregnant women at only in a
small number of pilot sites, and they were suing to have the
program accelerated.
The government defended its position stating that the gradual
introduction of the drug was more responsible, and that it was
necessary to do more research on Nevirapine to ensure its safety.
The government was offering HIV-positive pregnant women access to
Nevirapine at only 18 test sites, claiming that it could not
implement a nationwide program until the results from the test
sites became available, which would be the end of 2003 at the
earliest. The government also challenged the right of the High
Court to rule on government policy decisions, based on the
separation of the powers of the state and the judiciary.
The ruling: On December 14, 2001, Judge Botha ruled in favor of
the AIDS activists, ordering the government to make Nevirapine
available all over the country as soon as possible. Judge Botha
said "About one thing there must be no misunderstanding: a
countrywide MTCT prevention program is an ineluctable obligation
of the state". Specifically, the ruling ordered the government to
produce a time-tabled roll-out plan to provide HIV-positive
pregnant women access to Nevirapine at all state health facilities
with the capacity to do so, and where this was medically
indicated. The court set the government a deadline of March 31,
2002 for launching a comprehensive national MTCT plan.
Recent Developments
* Court case - Following the December judgement, the South African
government requested leave to appeal the ruling to the
Constitutional Court. Granting leave to appeal would usually
suspend the original ruling. Therefore, in response TAC went to
court seeking a "compulsion order" (or an "execution order"),
which would force the government to obey the original ruling
pending the constitutional appeal.
In early March 2002, Judge Botha simultaneously granted the
government leave to appeal to the Constitutional Court, and acceded
to TAC's request for a compulsion order. This meant that the
government should provide Nevirapine in terms of the earlier
order, outside the existing pilot sites, pending the outcome of
the appeal to the Constitutional Court. Therefore, for example,
if state health facilities that had the capacity to do so failed to
provide Nevirapine where medically indicated, the relevant minister
of health would be in contempt of court. Last week, the government
appealed against the decision and the interim compulsion order.
This appeal was presented at the High Court in Pretoria on Friday,
March 22. TAC presented a counter-application, attempting to
prevent the government's appeal of the compulsion order.
On May 2 and 3, the Constitutional Court will consider whether to
hear the appeal against the original order by Judge Botha. If the
Constitutional Court hears the case, judgement is unlikely before
late June, and that decision will be binding.
* Several Provinces Defy the National Government: As the court case
continues, several South African provinces have defied the
government's restrictions on the provision of Nevirapine to
pregnant women to help protect their babies from contracting the
HIV virus. During the court case last year, KwaZulu-Natal pulled
out of the defense (the government side), stating that it intended
to provide universal access to Nevirapine. The Western Cape has
been accelerating its program towards the provision of Nevirapine
at all public health facilities. Gauteng, which is
ANC-controlled, announced in February 2002 that it was expanding
access beyond the 2 pilot sites, and that its provincial hospitals
will provide Nevirapine to all pregnant women infected with HIV.
* The MCC and Nevirapine: On March 20, the Medicines Control
Council (MCC) - the South African equivalent of the FDA - indicated
that it is considering reviewing the registration of Nevirapine,
following reports of irregularities in documenting the results of
NIH-sponsored trials of the drug in Uganda two years ago. The MCC
addressed a letter to the South African Minister of Health
Tshabalala-Msimang, saying that it had been contacted by the U.S.
FDA, which expressed concern at the findings earlier this month of
irregularities in a study on the use of Nevirapine to prevent MTCT
of the HIV virus in Uganda. The MCC said it was seeking further
information from the NIH, the FDA and the pharmaceutical company
Boehringer Ingelheim, but would have to review the drug in light of
these concerns and may ultimately decide on its de-registration in
South Africa. Nevirapine was registered for use in
mother-to-child-transmission prevention in South Africa last year.
The SA Health Minister said on March 21st that the irregularities
being investigated by the NIH and the FDA were proof that Africans
are "being experimented on", and that Nevirapine is unsafe.
Nathan Geffen at TAC commented to Africa Action that TAC is very
concerned that the Health Minister is trying to capitalize on this
latest development as a pretext to withdraw Nevirapine's South
African licence at the MCC, thus sabotaging the entire legal
process in which the government and TAC are engaged. He said
that the issues with Nevirapine from the Ugandan trials were based
on inadequate documentation rather than any problems with the
drug or research study. The NIH, WHO, and UNAIDS have all issued
statements reaffirming that Nevirapine is indeed safe and
effective.
* ANC Backs the Government's AIDS Policy: Following a three-day
meeting of the party's National Executive Committee, at which
former President Mandela urged the accelerated provision of
anti-AIDS medicines, the ANC on March 20 declared its support for
the government's controversial go-slow approach to the provision
of anti-retroviral treatment. The executive committee of the ANC
also said it was only an "assumption" - not a known scientific
fact - that HIV caused AIDS, but it said government policy should
proceed on that assumption, at least for now. On March 21, Health
Minister Tshabalala-Msimang articulated this position, stating
that the government's response to AIDS is based on the premise
that HIV causes AIDS.
* Top SA Scientists Pressure Government on Nevirapine: In a
Declaration published in the British Medical weekly The Lancet on
Saturday, twenty-two of the leading members of South Africa's
scientific and medical community say that the scientific evidence
in favor of the drug Nevirapine is incontrovertible, and they call
on the South African government to distribute the drug to
HIV-positive pregnant women without delay. This increases
pressure on the government just ahead of the March 31 deadline for
launching a program to prevent mother-to-child-transmission of
HIV.
* SA Trade Unions call for the Provision of Nevirapine: The
Congress of South African Trade Unions has reiterated its view
that antiretrovirals should be provided by the government to
HIV-positive women.
************************************************************
Brief report on TRIPS Council Meeting on Public Health on 5th March
posted on March 7, 2002 by Ruth Mayne of Oxfam GB to Ip-health
listserv (http://lists.essential.org/pipermail/ip-health)
[Note: More detailed background on this meeting can be found in
other postings on the same listserv. See particularly the Africa
Group and developing countries statement on March 5
(http://lists.essential.org/pipermail/ip-health/2002-March/
002762.html - type long URL on one line)
and the statement by HealthGap on March 8 with a critique of the
position taken by the U.S.:
http://lists.essential.org/pipermail/ip-health/
2002-March/002758.html - type long URL on one line]
The TRIPS Council has to find a solution to the problem recognised
at Doha that 'WTO members with insufficient or no manufacturing
capacity in the pharmaceutical sector could face difficulties in
making effective use of compulsory licence provisions' and
instructed WTO members 'to find an expeditious solution to this
problem and report to the General Council before the end of 2002'.
On the plus side, developing countries were very much united. The
African Group (41 members) made a statement supported by many
developing countries including Brazil, India, Peru, Ecuador,
Malaysia and Indonesia (some are still missing). There was
agreement on the part of developing countries to oppose any narrow
interpretation of paragraph 6 of the Doha Declaration, or to divide
developing countries into separate categories. A lot of emphasis
was put on the issue of technology transfer, including by China
which supported the developing countries.
Both developing countries and the EC agreed that the two options
were interpretation of art 30 or amendment or deletion of 31F.
In relation to an amendment of 31 the EU said that any solution
must be subject to conditions including: the need to provide
safeguards against exports to countries which do not face serious
public health problems the need to provide safeguards against
re-exportation from the country of destination, especially to rich
countries, to avoid creating 'black-markets' for the productins
concerned; and the need to make the system transparent, in order to
allow other Member to be informed if a Member makes use of this
mechanism.
In relation to a possible interpretation of Article 30 the EU said
that minimum conditions would include:
* The entirety of the production must be imported by the Member
having granted the license
* the product must be commercialised or distributed solely in the
Member having granted the license and for the sole purpose for
which the licence was issued, and must not be re-exported
* both Members would need to take all necessary measures to avoid
trade measures
The US position was different. Taking a very narrow approach of the
Doha declaration, the US said that they opposed a reinterpretation
of Article 30. Doing so would contradict the meaning of this
article which deals only with pre-expiration testing, research
exemptions and prior user right. Article 30 also contains no
requirements for notifying a patent owner of use, for establising
particular terms and conditions, for expiration if circumstances
change, or for remuneration to the patent holder.
The US favours consideration of solutions under Article 31, but
does not like the idea of amending TRIPS. It therefore proposed a
moratorium on dispute settlement instances for compulsory licensing
related to exports to a poor country that lacks or has insufficient
manufacturing capacities in the pharmaceutical sector.They
described this as a solution under Article 31.
The US also argued that solutions must be focused on improving
access to pharmaceuticals to treat disease refered to in the
Declaration, such as HIV/AIDS, malaria, tuberculosis and other
epidemics. That the phrase 'insufficient or no manufacturing
capacities in the pharmaceutical sector' should not be extended to
developed countries or to countries that choose not to manufacture
certain drugs based on policy, economic or other reasons. It also
seriously questioned whether there are any circumstances under
which this solution should be employed by commercial entities on a
for-profit basis.
Oxfam GB, 274 Banbury Road, Oxford OX2 7DZ. http://www.oxfam.org.uk
************************************************************
This material is being reposted for wider distribution by
Africa Action (incorporating the Africa Policy Information
Center, The Africa Fund, and the American Committee on Africa).
Africa Action's information services provide accessible
information and analysis in order to promote U.S. and
international policies toward Africa that advance economic,
political and social justice and the full spectrum of human rights.
Documents previously distributed, as well as a wide range of
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