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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:

  1. 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."
  2. 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.
  3. 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."
  4. 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."
  5. 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."
  6. 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."
  7. 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.

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