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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-dosecombination
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 tripledose
combination, and (4) a new summary description released last
week of the World Health Organization's prequalification program.
The web version of this bulletin 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.
M‚decins Sans FrontiŠres 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 A service of kaisernetwork.org
http://www.kaisernetwork.org/dailyreports/hiv
Monday, 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 james.love@cptech.org
May 18, 2004
http://lists.essential.org/pipermail/ip-health/2004-May/006419.html
- Mozambique has issued a compulsory license for AIDS medicine.
The license defensive in nature, providing that if any patents
exist on the AIDS product in mozambique, the generic drug compay
can use the patents for 2 percent of the generic price. I believe
the license was effective 29 Mar 04, but signed 5 April 04. Jamie
- "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."
- "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."
http://www.cptech.org/ip/health/c/mozambique/4apr04-moz-cl.pdf
http://www.cptech.org/ip/health/c/mozambique/moz-cl-en.pdf
http://www.cptech.org/ip/health/c/mozambique/moz-decree-18-99.pdf
English translation............
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/
Last update: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 world’s 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
Addressing the HIV/AIDS Pandemic: A U.S. Global AIDS Strategy for
the Long Term
Council on Foreign Relations
Press Release
Press release at http://allafrica.com/stories/200405180603.html
Full report available at
http://allafrica.com/resources/view/00010215.pdf
President's AIDS Plan Too Narrow to Achieve Long-Term Goals,
Conclude 30 Government and Private Organization Experts
May 17, 2004 - The Bush administration's $15 billion AIDS
initiative, while laudable, will not succeed unless it is folded
into a broader- and longer-term commitment to developing basic
health systems in affected countries. To successfully battle
AIDS--one of the most pressing threats known to mankind--the effort
must also go beyond health to address social and economic factors
that drive the spread of the disease. These are the central
findings of Addressing the HIV/AIDS Pandemic: A U.S. Global AIDS
Strategy for the Long Term, released today by the Council on
Foreign Relations and the Milbank Memorial Fund.
The report calls attention to the President's initiative (signed
into legislation one year ago on May 27) and other international
programs, which together constitute a major international
commitment to assure treatment for the world's more than 40 million
HIV-infected people, most of them in very poor countries. While
this pledge is commendable from a humanitarian and human rights
perspective, the report concludes that the long-term costs of
treatment ($9-$12 billion a year) and allocation of
responsibilities need to be spelled out to the public, the
Congress, and the entire international community as they will run
well into the middle of the 21st century. "A humanitarian
catastrophe of incomparable proportions, the pandemic is also a
threat to global economic and geopolitical stability and a critical
strategic threat to the United States," the report asserts.
Addressing the HIV/AIDS Pandemic was directed by Ambassador
Princeton N. Lyman, the Council's Ralph Bunche Senior Fellow in
Africa Policy Studies, and Daniel M. Fox, president of the Milbank
Memorial Fund, in consultation with experts from more than 30
private and government health organizations.
The report was issued in response to President George W. Bush's
initiative--known as the President's Emergency Program for AIDS
Relief (PEPFAR)-- which provides $15 billion over five years to
combat HIV/AIDS and to fight tuberculosis and malaria.
Specifically, the program aims to treat two million AIDS victims,
prevent seven million new infections, and provide care for ten
million children and others affected by the disease. While it
places the United States clearly in the forefront of the
international battle against AIDS, experts find it is too near-term
and narrow in scope to achieve the objective of eradicating the
disease, which is expected to infect 100 million people and orphan
25 million children worldwide by 2010. "The United States should
begin to mobilize international support for broader health systems
in the countries that PEPFAR focuses on so that such systems are in
place in five years. Otherwise, five years from now, not only will
the broader health needs not have been addressed, but PEPFAR
investment into programs directed to HIV/AIDS may fail to achieve
its goals," the report warns.
The Council/Milbank report makes seven specific recommendations for
the United States to make the program sustainable and successful:
- Launch a long-term effort to build politically and financially
sustainable basic health systems in the affected countries. "It
will not be possible to reach the vast majority of people who do
not know they are infected with HIV without having basic health
facilities that can make HIV testing a routine part of general
health services."
- Form a high-level international commission to address the
long-term issues associated with broad-based AIDS treatment
programs. "The long-term costs of lifetime antiretroviral treatment
for all those who need it could reach $9 to $10 billion annually
for decades to come." The commission should seek to clarify the
respective roles and responsibilities of host countries, donors,
pharmaceutical companies, and other possible sources of support for
this lifetime treatment regimen.
- Pursue a comprehensive approach to HIV/AIDS, paying particular
attention to the factors fundamental to the pandemic's spread, such
as the vulnerability of women and girls and the importance of the
military in these countries as both victims and spreaders of the
infection. "In acutely affected regions, HIV/AIDS is eviscerating
national military forces. . . and rendering [them] increasingly
unable to safeguard their national interests and to participate in
regional peacekeeping."
- Be guided by the best available scientific evidence and be
"ideology-free" in selecting and administering prevention and
treatment programs. "This is especially important in prevention
where ideological controversy exists. . . [and] in selection of
drug regimens, determination of safe drug sources, and other
aspects of the program."
- Structure monitoring and evaluation from the start of programs.
"It is particularly important to monitor resistance and related
outcomes of treatment regimens in order to measure compliance,
assess the costs and benefits of different regimens, and identify
new strains of the virus that may be developing."
- Utilize flexible and innovative funding devices to reach
community-based groups and local non-governmental organizations.
"Embassies must engage local people affected by the pandemic, NGOs,
and community-based programs in planning and reviewing strategies
and in implementing projects."
- Avoid speaking glibly about "graduation" from these programs as
they will require decades of commitment. Developing countries
should not be left with the impression that once these programs are
under way the entire burden will fall on them--a burden they cannot
sustain. "Combating this pandemic will require decades of
international involvement and the funding of programs well beyond
the emergency focus of the next five years."
Additional Related Links (U.S. government and business)
Office of the U.S. Global AIDS Coordinator
http://www.state.gov/s/gac
Health and Human Services Press Release offering "expedited review
process" by U.S. Food and Drug Administration (FDA)for fixed-dose
combinations of antiretroviral drugs.
http://www.hhs.gov/news/press/2004pres/20040516.html
Congressional Testimony of U.S. Global AIDS Coordinator
May 18, 2004
http://www.state.gov/s/gac/rl/rm/2004/32558.htm
"With just this first round of grants, an additional 50,000 people
living with HIV/AIDS in the 14 focus countries will begin to
receive anti-retroviral treatment."
Bristol-Myers Squibb, Gilead Sciences an Merck & Co., Inc. Announce
Plans to Develop Fixed-Dose Combination of Three HIV Medicines
http://lists.essential.org/pipermail/ip-health/2004-May/006399.html
Additional Related Links (Multilateral)
World Health Organization 3 by 5 Initiative
http://www.who.int/3by5/en
Includes full set of background documents.
Global Fund announcement (April 4) on low-cost purchasing agreement
in cooperation with World Bank, UNICEF, and the Clinton Foundation
http://www.theglobalfund.org/en/media_center/press/pr_040406.asp
Additional Related Links (NGO)
Medecins Sans Frontieres
Campaign for Access to Essential Medicines
http://www.accessmed-msf.org
This site includes the newly updated report (19 April 2004) on
Untangling the web of price reductions: a pricing guide for the
purchase of ARVs for developing countries (6th Edition)
HealthGap on U.S. procurement policies and the effort to shut out
generic drugs and fixed-dose combinations
http://www.healthgap.org/camp/pepfar.html
Aidspan Global Fund Observer - latest issue May 21, 2004
http://www.aidspan.org/gfo/archives/newsletter/GFO-Issue-24.htm
Includes the latest data on funding from different countries for the Global Fund, in comparison with calculated equitable contributions.
Recent Issues of AfricaFocus Bulletin
USA/Africa: Health Unilateralism
http://www.africafocus.org/docs04/hgap0312.php
Africa: Questions on AIDS Plans
http://www.africafocus.org/docs04/hiv0402c.php
Africa: Generic Drugs under Threat
http://www.africafocus.org/docs04/gen0403.php
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 africafocus@igc.org. Please
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