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Date: Mon, 24 May 2004 12:20:43 -0700
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Subject: Africa: AIDS Treatment Update
Africa: AIDS Treatment Update
AfricaFocus Bulletin
May 24, 2004 (040524)
(Reposted from sources cited below)
Editor's Note
The World Health Assembly has unanimously affirmed the continuation
of World Health Organization (WHO) programs to assist countries in
obtaining low-cost, high-quality essential medicines. The May 22
resolution endorsed the drug prequalification program, which
includes generic fixed-dose-combination antiretroviral drugs. According to Agence France-Press, the United States did not oppose the
resolution, although it has not endorsed the WHO program.
Earlier, at the beginning of the assembly in Geneva, the U.S.
announced an "expedited" procedure under which generic as well as
patented fixed dose combinations could be approved by the U.S. Food
and Drug Administration in "as little as two or six weeks"
(http://www.hhs.gov/news/press/2004pres/20040516.html). The new
move followed intense pressure for the U.S. to adopt international
best practice and allow purchase of generic drugs under President
Bush's AIDS plan. It was cautiously welcomed by international
agencies for its potential to allow such purchase, but fell far
short of activist demands that the U.S. join in supporting
international standards without further delay. It is unclear when
and if generic companies will be able to satisfy the FDA
requirements (http://www.fda.gov/oc/initiatives/hiv).
There will still be more delay, therefore, in the use of U.S.
funds for the least expensive and most effective anti-HIV drugs.
Funding for international initiatives still falls far short of what will be needed. However, the WHO framework is now in place, and funding streams are available for such treatment from the Global Fund, the World Bank, the Clinton Foundation, and others. Bureaucratic and practical obstacles to implementation, at national as well as international levels, are now probably even more important than policy issues in determining how many people will actually get treatment.
In Latin America, for example, such delays have blocked treatment
long after approval of funding from the Global Fund (see
http://www.aidspan.org/gfo/archives/newsletter/GFO-Issue-22.htm).
In Africa, as well, one of the most critical variables seems to
be the political will and capacity of national institutions.
As of November 2003, according to WHO estimates, 400,000 of the
5.9 million people needing antiretroviral treatment worldwide
were receiving treatment. In Africa, only 100,000 (2 percent) of
4.4 million were receiving treatment. News reports indicate that
in many countries the numbers are now increasing as programs are
rolled out, but there are as yet no comparative statistics
available on the results achieved to date by countries or
programs. If the WHO goal of having 3 million people on
treatment by the end of 2005 is to become more than a slogan, it
seems long past time that to have such data publicly available.
Activists, practitioners, and the public alike need to know to
what extent policy changes, promises, and announcements are being
translated into lives saved.
The e-mail version of this AfricaFocus Bulletin contains (1) an
excerpt from a WHO press release describing the latest resolution on HIV/AIDS, (2) a statement from Medecins Sans Frontieres on the new U.S. procedure for approving fixed-dose- combination drugs, (3) a news report on new AIDS treatment commitments in Mozambique and the official dispatch from Mozambique of a compulsory license for local manufacture of a generic triple-dose combination, and (4) a new summary description released last week of the World Health Organization's prequalification program.
The web version of this bulletin
(http://www.africafocus.org/docs04/acc0405.php) also contains
additional material: a press release from the Council on Foreign
Relations on a new report urging that President Bush's AIDS plan
be broadened to support basic health systems, and a section with
other recent related links.
++++++++++++++++++++++end editor's note+++++++++++++++++++++++
World Health Assembly on HIV/AIDS
Excerpt from press release on resolution passed May 22, 2004
http://www.who.int/mediacentre/releases/2004/wha4/en/
The Assembly welcomed the Director-General's "3 by 5 strategy" to
support developing countries in their response to HIV/AIDS by
increasing access to prevention, care and treatment and securing
access to antiretroviral treatment for three million people
living with HIV/AIDS by the end of 2005. The Assembly confirmed
WHO's leading role in supporting countries in delivering
prevention, care, support and treatment for HIV/AIDS within
strengthened national health systems. Member States urged the
Director-General to improve the access of developing countries to
antiretroviral medicines and other products used in the
diagnosis, treatment and care of HIV/AIDS, including by
strengthening the WHO prequalification project. WHO should also
help countries strengthen their supply chain management and
procurement of good quality products. The resolution also
encouraged countries entering into bilateral trade agreements to
take into account the flexibilities relating to public health as
laid down in TRIPS agreement of the World Trade Organization and
the Doha Ministerial Declaration on the TRIPS Agreement and
Public Health.
*************************************************************
MSF statement on US government announcement of new procedure for
reviewing the safety and efficacy of fixed-dose combinations and
co-blisters of antiretrovirals
18 May, 2004
Campaign for Access to Essential Medicines
Medecins Sans Frontieres (MSF)
http://www.accessmed-msf.org
On May 16, the United States announced that the US Food and Drug
Administration would set up a "rapid process" for reviewing fixed
dose combinations (FDCs), co-packaged products, and single
ingredient antiretrovirals (ARVs) for the treatment of HIV/AIDS,
particularly for use in programmes financed by the US President's
Emergency Plan for AIDS Relief (PEPFAR).
It is positive that the US has finally recognized the importance
of treatment simplification and the central role of FDCs in
scaling up ARV therapy and promoting adherence in developing
countries. This recognition is long overdue.
However, MSF believes that, rather than creating a unilateral
system which unnecessarily complicates and delays matters, the US
should support the existing WHO prequalification system, and lend
the technical expertise of FDA officials to the process. The US
has repeatedly been invited and encouraged to take part in the
prequalification project and has consistently refused to
collaborate.
The WHO pre-qualification process is based on international
standards, guidelines and norms that allow quality and safety
assessment of medicines. These standards have been developed and
approved by the WHO Expert Committee system involving all WHO
member states and WHO governing bodies, and the prequalification
project has ongoing technical input from regulatory authorities
in both developed and developing countries.
It is the World Health Organization, and not the US Food and Drug
Administration, which has the mandate to set international
standards for quality, safety, and efficacy. There is no
justification for further delaying the availability of medicines
that are already saving lives and that are already certified by
the WHO as meeting stringent international standards for quality,
safety, and efficacy.
Médecins Sans Frontières provides ARV therapy to more than 13,000
people with HIV/AIDS in over 20 countries in Africa, Asia, Latin
America, and Eastern Europe. More than half of our patients are
on WHO prequalified generic triple FDCs. We know from our direct
field experience that these generic FDCs are prolonging lives.
Patients' CD4 cell counts are rising, they are gaining weight,
they are experiencing fewer opportunistic infections, and they
are adhering to their two-pill-a-day regimens at unusually high
rates in short, these ARVs are transforming HIV from a death
sentence into a somewhat manageable illness, even in some of the
poorest and most remote settings.
***************************************************************
Kaiser Daily HIV/AIDS Report
http://www.kaisernetwork.org/dailyreports/hiv
May 24, 2004
Mozambique Launches Pilot Program To Provide Free Antiretroviral
Drugs to 8,000 People
Mozambique President Joaquim Chissano on Saturday announced that
the country has launched a pilot program to provide free
antiretroviral drugs to 8,000 HIV-positive adults, Reuters
reports. The program is funded by the William J. Clinton
Presidential Foundation and the World Bank. Although the program
will cover only a "very small number (of people)," Chissano said
he is seeking more funding to expand distribution, according to
Reuters. Mozambique is one of the 16 African and Caribbean
countries that will receive money from the five-year, $15 billion
President's Emergency Plan for AIDS Relief. Mozambique has a
population of 18 million people, approximately 1.5 million of
whom are HIV-positive. Chissano said Mozambique is negotiating
with Western donors and pharmaceutical companies to lower prices
for antiretroviral drugs, help train medical staff and build new
testing and treatment facilities, according to Reuters. Chissano
added that Mozambique and several other countries are discussing
plans to build manufacturing plants to produce generic
antiretroviral drugs. Marie-Pierre Poirier, Mozambique resident
representative for UNICEF, criticized the pilot program because
it is not expected to provide antiretroviral drugs to HIV-
positive children (Esipisu, Reuters, 5/22).
****************************************************************
[Ip-health] Mozambique compulsory license
James Love [log in to unmask]
May 18, 2004
http://lists.essential.org/pipermail/ip-health/2004-May/
006419.html [type URL on one line]
...
COMPULSORY LICENCE no. 01/MIC/04
The Government of Mozambique, conscious that the HIV/AIDS
pandemic constituted a serious handicap in the national struggle
against hunger, illness, under-development and misery and,
taking into consideration that.
high rates of morbidity and mortality have put Mozambique among
the ten countries in Africa worst hit by this disease. Current
estimates are that at the end of 2002 over 1,5 million
Mozambicans were infected by HIV, of whom more than 100.000 are
suffering from full-blown AIDS. The AIDS death toll is so far
well over 200.000 and about 360.000 children have been orphaned
by the pandemic,
and that,
In spite of multiplication and diversification of vigorous
prevention campaigns the spread of the virus is still on a
climbing trend as shown by the high number of infections,
considering further that,
Anti-retroviral drugs are already available, which prolong lives
of those infected with HIV/AIDS, and that until now, at this day,
the international patent owners have failed to make such drugs
accessible at affordable prices to most of the Mozambican people,
and for such reason
on 14 November 2001 the World Trade Organization declared the
right of each Member State to protect public health and in
particular to promote access for medicines for all, by granting
compulsory licenses in cases which constitute a national
emergency or other circumstances of extreme urgency and of public
health crisis, including those relating to HIV/AIDS,
tuberculosis, malaria or other epidemics can represent a national
emergency or other circumstances of extreme urgency.
Considering further that
a triple compound of lamivudine, stavudine and nevirapine has
proved, in the last few years, to be one of the most effective
and economical anti-retroviral treatment, but the three different
international owners of such single drugs failed to reach an
agreement to produce this combination,
therefore,
The Ministry of Commerce and Industry of the Republic of
Mozambique, making use of the provision of article 70 no.1 point
b), of Decree no. 18/99 of 4 May, has decided to grant the
compulsory license no. 1/MIC/04 to the company Pharco Mocambique
Lda, which has already presented a project for local manufacture
of the mentioned triple compound under the names of PHARCOVIR 30
and PHARCOVIR 40.
Communication of this decision will be given to the applicant and
to the patent owners.
In consideration that the mentioned product, a triple combination
of drugs, is not marketed in Mozambique by the international
patent owners and that it is in the national interest to keep the
final price as lowest as possible, the total amount of royalties
due to the patent owners shall not exceed 2% of the total
turnover of the mentioned products, at the end of each financial
year of Pharco Mocambique Lda.
This Ministry of Industry and Commerce, in accordance to
provisions of Art. 70 point 6 of Decree no. 18/99 will notify the
concerned parties of the expiration of the present compulsory
license as soon as conditions of national emergency and extreme
urgency created by the HIV/AIDS pandemic will come to an end.
The Government of the Republic of Mozambique reserves the right
to review this compulsory license, in case the conditions in
which it was issued are changed.
signed by
Salvador Namburete, Deputy Minister
*****************************************************************
Key Facts about the WHO Prequalification Project
http://www.who.int/3by5/prequal/en/
21-May-2004
The Prequalification project, set up in 2001, is a service
provided by the World Health Organization (WHO) to facilitate
access to medicines that meet unified standards of quality,
safety and efficacy for HIV/AIDS, malaria and tuberculosis.
From the outset, the project was supported by UNAIDS, UNICEF,
UNFPA and the World Bank as a concrete contribution to the United
Nations priority goal of addressing widespread diseases in
countries with limited access to quality medicines.
How it works
Prequalification was originally intended to give United Nations
procurement agencies, such as UNICEF the choice of a range of
quality medicines. With time, the growing list of products (i.e.
medicines) that have been found to meet the set requirements has
come to be seen as a useful tool for anyone bulk purchasing
medicines, including countries themselves and other
organizations. For instance, the Global Fund to Fight AIDS,
Tuberculosis and Malaria disburses money for medicines that have
been prequalified by the WHO process.
Any manufacturer wishing their medicines to be included in the
prequalified products list is invited to apply. Each manufacturer
must present extensive information on the product (or products)
submitted to allow qualified assessment teams to evaluate its
quality, safety and efficacy. The manufacturer must also open its
manufacturing sites to an inspection team which assesses working
procedures for compliance with WHO Good Manufacturing Practices
(GMP). Alternatively, the inspections carried out by stringent
regulatory bodies are recognized and their work is not duplicated
by WHO.
The standards against which the assessment teams evaluate both
the quality specifications of medicines and the manufacturing
sites are based on the principles and practices agreed by the
worldÆs leading regulatory agencies and adopted by the WHO Expert
Committee on Specification for Pharmaceutical Preparations. In
other words:
* The manufacturer provides a comprehensive set of data about the
quality, safety and efficacy of its product, including details
about the purity of all ingredients used in manufacture, data
about finished products, such as information about stability, and
the results of in vivo bioequivalence tests (clinical trials
conducted in healthy volunteers).
* The team of assessors evaluates all the data presented and if
satisfied with the evidence sends the product to professional
control testing laboratories contracted by WHO in France, South
Africa or Switzerland for analytical verification of quality.
* If the product is found to meet the specified requirements, and
the manufacturing site complies with GMP, both the product linked
to this manufacturing site and company are added to a list hosted
by WHO on a public web site.
The list of medicines
All product and manufacturing site requirements, standards used
in evaluating the product and the profile of the inspection teams
are outlined on the following web site:
http://mednet3.who.int/prequal/ . The site also includes the list
of prequalified medicines and their manufacturers.
The assessment teams evaluating the products and manufacturers
include experts from some of the national regulatory authorities
of the European Union as well as Canada and Switzerland. These
teams ensure that high quality, international standards are
respected. The teams work with regulators from the developing
countries where the medicines will be used to make sure that the
process and results are at all times transparent and trusted by
the end-users.
The prequalification process takes a minimum of three months if
the product meets all the required standards. When products do
not meet the appropriate standards the process can be longer and
if the manufacturer fails to prove the quality, safety and
efficacy of its medicine it will not be prequalified. Inclusion
in the list does not mean that the prequalified status of a
product lasts forever. All medicines are requalified after three
years, or earlier, if needed. WHO also carries out random quality
control testing of prequalified medicines that have been supplied
to countries.
Medicines which have been found to meet the required standards so
far are from both brand name (42 medicines) and generic (61
medicines) manufacturers. These include 62 antiretrovirals and 33
medicines for HIV/AIDS related diseases; two antimalarials and
six drugs for the treatment of tuberculosis.
Both medicines containing one active ingredient and those
combining several active ingredients in one pill, usually called
fixed-dose combination drugs, have been prequalified. For
tuberculosis, there is one quadruple (four-in-one pill) and one
double (two-in-one) fixed dose combination drug and for malaria
one double fixed dose combination drug has been approved.
In the case of AIDS medicines, two different triple
(three-in-one) fixed-dose combination drugs have recently been
approved; one from an originator company and the other from two
different generic companies.
The principles for assessing the quality of fixed-dose
combination drugs are the same as those used by the European
Agency for the Evaluation of Medicinal Products (EMEA) and the
USA Food and Drug Administration (FDA). In other words, the
prequalification assessment team evaluates the required data,
including in vivo bioequivalence tests carried out by the
manufacturers. The fixed-dose combination drug is tested against
the separate medicines taken together in the same dosage as is
present in the fixed-dose combination pill.
In soliciting applications from companies, WHO does not question
whether the products presented are patented or generic, since
patent laws vary according to different national legal systems.
It suffices that a company is duly authorized for pharmaceutical
manufacture in its own country and that the final product meets
stringent standards of quality, efficacy and safety.
An integrated process
The availability of quality, safety and efficacy of medicines is
a major concern of WHO. To ensure that quality pharmaceuticals
are available, WHO sets norms and standards, develops guidelines
and advises Member States on issues related to quality assurance
of medicines in national and international markets. WHO assists
countries in building national regulatory capacity through
networking, training and information sharing. These activities
have been endorsed and supported by Member States through
numerous World Health Assembly resolutions.
The Prequalification project is part of these activities and
mandate. It does not intend to replace national regulatory
authorities or national authorization systems for importation of
medicines. Prequalification draws from the expertise of some of
the best national regulatory authorities to provide a list of
prequalified products that comply with unified international
standards.
This is why, both in 2002 and in 2004, the International
Conference of Drug Regulatory Authorities (ICDRA), made up of
more than 100 national medicines regulatory authorities, made a
formal recommendation that "WHO should continue the
Pre-qualification Project of medicines for priority disease
programmes, particularly for HIV/AIDS, malaria and tuberculosis".
For more information: http://mednet3.who.int/prequal
*************************************************************
AfricaFocus Bulletin is an independent electronic publication
providing reposted commentary and analysis on African issues,
with a particular focus on U.S. and international policies.
AfricaFocus Bulletin is edited by William Minter.
AfricaFocus Bulletin can be reached at [log in to unmask]
Please write to this address to subscribe or unsubscribe to the
bulletin, or to suggest material for inclusion. For more information about reposted material, please contact directly the original source mentioned. For a full archive and other resources, see http://www.africafocus.org
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