Annex 8.1.2.3 Partnership Summaries Accelerating Access Initiative to HIV Care (AAI) Background: Announced in May 2000, the initiative involves a dialogue between the UN and the pharmaceutical industry with the intention of making HIV/AIDS medicines and diagnostic equipment more available and affordable in the hardest hit regions of the world. It is a cooperative endeavor involving five UN organisations (WHO, UNICEF, UNFPA, the World Bank, and UNAIDS Secretariat) and six pharmaceutical companies (Abbott Laboratories, Boehringer Ingelheim, Bristol-Myers Squibb, F. Hoffman-La Roche, GlaxoSmithKline and Merck and Co., Inc.). AAI is involved in negotiating deeply discounted drug prices for countries that can provide proof they have the health services to handle the complicated HIV/AIDS medicines. Funding: Major funding comes from the individual countries. Achievements: More than 70 countries from Africa, Latin America and the Caribbean, Europe and Asia, have indicated their interest in collaborating with UNAIDS on access to care and support. Indeed, more than 25 countries have completed and or are in the advanced stages of developing national care and treatment plans. Significant price reductions have been achieved on an expanded range of HIV/AIDS medicines. For some drugs, prices are higher outside sub-Saharan Africa, despite price levels much lower than those in industrialised countries. 8.1.2.3-1 1 Annex 8.1.2.3 Action TB Programme (ATBP) Background: Action TB is a multinational, interdisciplinary research initiative into TB, funded by GlaxoSmithKline (GSK). Scientists in the United Kingdom, South Africa, Canada and the United States of America are collaborating with scientists employed by GSK to study all aspects of tuberculosis. ATBP is aimed at identifying new drug targets and vaccine candidates for TB, and surrogate markers for use in clinical trials. Launched in 1993, Action TB is a ten-year programme funded by GSK. Twenty million pounds sterling (20 million) is being spent in academic laboratories in the UK, South Africa, The Gambia, and the USA. The academic groups work closely with GSK researchers to ensure that basic research findings are quickly translated into high throughput drug screens and into the vaccine development pipeline within the company. In addition to this industry-academia partnership, GSK has entered into partnership with a number of public bodies including the US National Institutes of Health. The programme has come to the end of the period when GSK had committed funds to Action TB. Funding Funding was provided by GSK in the amount of $3 million per year for ten years for a total of $30 million. Achievements Action TB attained its objective of identifying new targets for TB drugs, which are now being exploited internally. The programme stirred as well as stimulated basic research into drug and vaccine development activities. In addition to identifying targets, new tools were developed that can now be used to identify and validate drug targets, and progress has been made towards identifying surrogate markers that will facilitate clinical trials. 8.1.2.3-2 2 Annex 8.1.2.3 African Comprehensive HIV/AIDS Partnerships (ACHAP) Background: The African Comprehensive HIV/AIDS Partnerships (ACHAP) is an initiative between the Government of Botswana (GOB), the Bill & Melinda Gates Foundation and The Merck Company Foundation/Merck & Co., Inc. to support the goals of the GOB to decrease HIV incidence by rapidly advancing HIV/AIDS prevention programs, healthcare access, patient management and treatment of HIV/AIDS in Botswana in a sustainable and comprehensive manner. The Bill & Melinda Gates Foundation and the Merck Company Foundation have each dedicated 50 million dollars over five years for a total ACHAP commitment of 100 million dollars. Overall, ACHAP aims to be a model for other public-private partnerships and in this regard, documentation work is being carried out so that lessons learned may be communicated globally and applied in other settings. Funding: For each year from and including 2000 – 2004, the Bill & Melinda Gates Foundation has contributed $10 million and Merck & Co. has contributed $10 million for a total contribution over five years of $100 million. Achievements: More than 12,000 have been enrolled into the national ARV program, making Botswana’s program the largest public ARV treatment program on the continent of Africa. ACHAP assisted with the national HIV/AIDS strategy, including the development of a national monitoring and evaluation system and a needs assessment toolkit that is guiding HIV/AIDS interventions at the district level. ACHAP has trained more than 500 Government, NGO and other key players on project development, monitoring and evaluation, leadership skills, proposal development, media training and computer skills. Health care worker training programs - both through classroom teaching and hands-on training and coaching at clinics and hospitals - have been provided to over 1200 health care workers. A number of other ACHAP programs focus on skill-building for HIV/AIDS education as a means to increase awareness and knowledge and to de-stigmatize the disease. For example, a distance-learning initiative conducted in collaboration with UNDP, Botswana TV and the Botswana Ministry of Education is reaching teachers and students in more than 400 educational institutions. Key interventions include: · alcohol abuse and HIV transmission; · development of behavior change communications through market segmentation; · routine and diagnostic HIV testing; · condom education and marketing program including installation of more than 10,500 dispensers providing free condoms throughout the country; · small grants to fund communitybased initiatives; · support for the construction of health resource centers at hospitals; · daycare facilities for orphans; · support and counseling services, including faith-based services, pre-and post-test counseling, leadership development, the establishment of district responses to mobility; · strengthen blood safety practices; · disease prevention programs for highly mobile populations · working with traditional healers; · mobilizing private firms in Botswana to provide HIV/AIDS services for their employees and families, as well as for the communities where they conduct business. 8.1.2.3-3 3 Annex 8.1.2.3 African Programme for Onchocerciasis Control (APOC) Background One of the best known and oldest public-private partnerships for health, OCP was launched in 1974 and closed its operations on 31 December 2002 having met its objective to eliminate onchocerciasis as a problem of public health importance and an impediment to socioeconomic development in West Africa. It was a co-sponsored program by WHO, World Bank, UNDP, and the Food and Agriculture Organization (FAO) with WHO as Executive Agency and World Bank in charge of the OCP Trust Fund and fundraising. The strategy of the program was to control river blindness in 11 countries in West Africa by breaking the cycle of transmission by eliminating the vector, the black fly. To complement the vector control activities OCP distributed the drug ivermectin (see Mectizan Donation Program) where needed through a community-directed approach. OCP was funded by a coalition of over 20 donor countries and agencies. APOC extends the control of river blindness into 19 other endemic countries in Africa based almost exclusively on community-directed treatment with ivermectin (CDTI). Funding: The programme is closed. Achievements: Eighteen million people had received annual treatment with ivermectin up through May 2000. Over 34,440 communities have begun to be actively involved in planning and managing the distribution of ivermectin. Eventual distribution of ivermectin to 60 million people per annum, thereby protecting them from the devastating consequences of onchocerciasis. By 2000, National Onchocerciasis Task Forces (NOTFs) and communities, assisted by other partners, had established CDTI systems in 91 % of its projects. 8.1.2.3-4 4 Annex 8.1.2.3 Alliance for Health Policy and Systems Research (AHPSR) Background: The Alliance is born from the initiative of the Global Forum for Health Research launched in March 2000 at WHO headquarters. The Alliance aims to promote the generation, dissemination and use of knowledge for enhancing health system performance. The Alliance is open to producers and users of HPSR, as well as to contributors, such as financiers and technical institutions helping to foster the development of HPSR. The Alliance is governed by an 14-member Board representative of developing countries, experts, networks and donors; its secretariat is based in WHO's Global Programme for Evidence. Funding: DONORS/YEARS 1999 2000 2001 1,446,065 2002 2003 TOTAL 502,572 1,948,637 20,000 20,000 35,000 35,000 400,000 1,600,000 Norway, Government of Global Forum for Health Research COHRED 400,000 400,000 400,000 World Bank 25,400 25,400 World Health Organization (WHO) 300,000 300,000 50,750 253,745 10,000 10,000 1,318,322 4,192,782 Swedish International Development Agency (SIDA) 202,995 Canadian International Development Agency (CIDA) All other donors* TOTAL 2,049,060 400,000 425,400 Achievements: The Alliance has so far made contact with some 600 institutions that are producing health policy and systems research (HPSR) in more than 70 developing countries, over 70 HPSR institutions in the developed world (including private research organizations), and national and international agencies supporting HPSR. The Alliance runs a grants programme to support research in HPSR fields, carries out analytical work and capacity assessment and undertakes strategic research in high priority areas. 8.1.2.3-5 5 Annex 8.1.2.3 Alliance for Microbicide Development (AMD) Background: A coalition of biopharmaceutical companies, scientists, and advocates started in 1998 as an agent for change to catalyse scientific progress, funding, and policy change in the field of topical microbicides to prevent sexually-transmitted infections. The Alliance works to achieve its mission through research, education, and advocacy; networking and convening across constituencies, disciplines, and sectors; and strategizing to identify gaps and obstacles and working toward their elimination. Over 500 individual participants and colleagues from all sectors and many disciplines are involved. Funding: Support for the work of the Alliance comes from the William and Flora Hewlett Foundation, International Partnership for Microbicides (IMP), Moriah Fund, Rockefeller Foundation, Bill and Melinda Gates Foundation through the Global Microbicide Project (GMP), as well as from private contributions. The Alliance funding mechanism consists predominantly of grants and 2 contracts for core and specific projects. Achievements: The Alliance has played a sole or significant role in: 1) Growing the funding base for microbicides. The US Department of Health and Human Services provided in FY1998, $23.2 million and in FY2004, $73.1 million. The US Agency for International Development provided in FY1998, $2.1 million and FY2003, $15.0 million. 2) Public policy and legislative activities: Policy briefings (average, 1 per month); Microbicide Development Act of 2000: introduced, US House of Representatives; Microbicide Development Act of 2001: introduced, US House of Representatives and Senate; Microbicide Development Act of 2003: introduced, US Senate, April 2003; to be introduced in House of Representatives December 2003; Inclusion of support for microbicide research and development in a series of global HIV/AIDS bills (S.1230 and S.2525, H.R.2405 and S.1752, H.R.2069); Successive years of report language. 3) Partnerships and Collaborations; AIDS Vaccine Advocacy Coalition, Gay Men’s Health Crisis, Internastional AIDS Vaccine Initiative, National Organizations Responding to AIDS: legislative and joint advocacy initiatives; Global Campaign for Microbicides: 50/50 support of Senior Legislative Advisor joint legislative and advocacy activities; Global Microbicide Project: Science Advisory Committee brokering research and development initiatives; International Family Health: European Advocacy and Networking Project; International Partnership for Microbicides: Microbicide Research and Development Database, The Microbicide Quarterly; World Health Organization: international and regional regulatory meetings, document authorship. 8.1.2.3-6 6 Annex 8.1.2.3 Artesunate Suppository for Emergency Treatment of Severe Malaria Background: A product development project by WHO/TDR which involved extensive collaboration with pharmaceutical manufacturers, chemical processors and formulators, and packagers to create an antimalarial artesunate rectal suppository for patients, particularly children, suffering from severe malaria who are unable to take drugs by mouth or are unable to access injectible treatment. WHO submitted an application for assessment to regulatory authorities in the US and Europe under the orphan drug designation for the fast track approval process. Collaborators are discussing how to best take the drug into demonstration projects, resolve the significant follow-up treatment issues, address education/information programmes, and procurement/distribution of the product (possible partnership with UNICEF). Funding: Funding comes from the European Commission, World Health Organization (WHO), Sall Family Foundation, UNDP/WB/WHO Special Programme for Research & Training in Tropical Diseases (TDR) and USAID. The funding mechanism is via WHO, and directly to countries and participating institutions. Achievements: On-going. 8.1.2.3-7 7 Annex 8.1.2.3 Children's Vaccine Initiative (CVI) Background: The goal of CVI was to maximize protection against infectious diseases through the development and utilization of safe, effective, easy-to-deliver and widely available vaccines. CVI's secretariat was housed in WHO and attempted an innovative collaboration between public, nonprofit, and private sector (vaccine and biotech industry). It operated from 1990 through 1999. Funding: Major funding for this project was in the form of a multi-year grant in the amount of $125 million from the Bill & Melinda Gates Foundation. Other major funders include: Fondation Mérieux, Government of Ireland, Government of Japan, Rockefeller Foundation, Swiss Agency for Development and Cooperation, United Nations Children's Fund (UNICEF), United Nations Development Program (UNDP), US Agency for International Development (USAID), William H. Gates Foundation, and the World Bank. Achievements: 8.1.2.3-8 8 Annex 8.1.2.3 Children's Vaccine Programme at PATH (CVP at PATH) Background: CVP is a program run by the Program for Appropriate Technology and Health (PATH), a U.S. tax-exempt 501 (c )(3) not-for-profit organisation based in Seattle, Washington, USA. The goal of the program is to ensure that all children receive the full benefits of new, lifesaving vaccines without undue delay. CVP works to put immunization at the top of the global health agenda, develops new financing solutions for immunization, collaborates on research to provide reliable information for decision-makers, and supports new technologies to improve immunization delivery. Oversight is provided by the PATH board and a Strategic Advisory Council and Expert Review Group composed of international experts. Funding: Major funding for this project is in the form of a multi-year grant in the amount of $125 million from the Bill & Melinda Gates Foundation. Achievements: On-going. 8.1.2.3-9 9 Annex 8.1.2.3 Concept Foundation (CF) Background: The Concept Foundation, a non-profit foundation was established, through the initiative of UNDP/UNFPA/WHO/WB Special program in Reproductive Health (WHO/HRP), PATH, World Bank and other organizations in 1989 in Bangkok, Thailand, as a mechanism through which WHO’s rights associated with an injectable contraceptive, Cyclofem, could be licensed onwards to potential producers in developing countries. Under these licensing agreements the manufacturer was required to treat any government body, non-profit entities, or member of the United Nations system as the public sector and offer preferential pricing compared to private sector market pricing. Conditions of licensing also assess a reasonable rate of return for public sector sales, but prohibit the recovery of marketing, research, and development cost on public sector sales. Since that time the Concept Foundation has gone on to successfully introduce several new quality reproductive health technologies that address the needs of people living in developing countries, at affordable prices. The Foundation ensures that these health products are manufactured under international standards, properly registered and licensed, and distributed and marketed with appropriate training and counseling services. Funding: Year 1989 1991 1991 1992 1994 1994 1995 1995 1996 1996 1997 1997 1999 Total Amount of Funding $ 21,750 $ 29,968 $ 300,000 $ 85,000 $ 607,442 $ 19,000 $ 100,793 $ 19,000 $ 107,993 $ 3,000 $2,001,762 $ 164,151 $ 60,000 3,520,859 Name of Funder Program for Appropriate Technology for Health (PATH) UNDP/UNFPA/WHO/WB World Bank World Bank UNFPA PATH Rockefeller Foundation International Planned Parenthood Foundation (IPPF) Rockefeller Foundation IPPF Rockefeller Foundation Packard Foundation Packard Foundation Another major funder is the World Health Organization (WHO). The grants from PATH and IPPF provided the initial organizational support for institutional development to build up the Concept Foundation as well as helped expand know-how/experiences for the management of various projects. The grant from the World Bank and UNFPA facilitated the licensee selections process and technology transfer of Cyclofem. While the grant from Rockefeller and Packard Foundations, assisted in the clinical development of emergency contraception (EC) with various dedicated EC pills. Achievements: The Concept Foundation is currently an active partner in a total of 10 public-private partnerships involving the pharmaceutical manufacturers. Since its inception in 1989, more than 120 million doses of Cyclofem have been manufactured and sold as well as more than 40 million HIV dipsticks have been produced and sold by licensees world wide. To date, products have been manufactured in 8 different countries and are made available in more than 30 developing countries. 8.1.2.3-10 10 Annex 8.1.2.3 8.1.2.3-11 11 Annex 8.1.2.3 CONRAD Background: CONRAD is a research program established in 1986 at the Eastern Virginia Medical School (EVMS) under a cooperative agreement with USAID. The research supported by CONRAD is conducted at the EVMS laboratories and clinics and by investigators at research institutions around the world. CONRAD has included male methods of contraception and barrier contraceptives as its main priority areas; however, a major additional focus is now on developing microbicides and mechanical barriers to prevent the transmission of HIV/AIDS and other STDs. Funding: DONORS/YEARS 1998 1,500,000 1999 2000 25,000,000 2001 2002 TOTAL 11,912,100 38,412,100 60,000,000 60,000,000 71,912,100 98,412,100 Bill & Melinda Gates Foundation US Agency for International Development (USAID) TOTAL 1,500,000 25,000,000 Other funders include: the National Institute of Child Health and Human Development, US National Institute for Allergy & Infectious Diseases (NIAID), and US Centers for Disease Control & Prevention (CDC). The funding mechanism is based upon cooperative agreement from USAID and CDC (through USAID) and grants from foundations. Achievements: Several new vaginal physical barrier methods approved and effectiveness studies about to start on microbicides. 8.1.2.3-12 12 Annex 8.1.2.3 Consortium for Industrial Collaboration in Contraceptive Research (CICCR) Background: Established in 1995 as a project of CONRAD, CICCR promotes public-private sector partnerships in contraceptive research and development by granting awards to not-for-profit research institutions that either have an industrial partner or wish to seek one. The three priority areas for the development of new contraceptive methods are: 1) vaginal methods that prevent pregnancy and sexually transmitted infections (STIs), including HIV/AIDS; 2) male methods; and 3) monthly methods for women. Funding for CICCR was initiated by the Rockefeller Foundation, and subsequent funding has come from the Andrew W. Mellon Foundation, the Bill and Melinda Gates Foundation, the William and Flora Hewlett Foundation, the David and Lucile Packard Foundation, the United Nations Population Fund, and a foundation that wishes to remain anonymous. CICCR's strategic advisory board includes public, not-for-profit, and private representatives. Funding: Major funders include: Andrew W. Mellon Foundation, Bill & Melinda Gates Foundation, David and Lucile Packard, Rockefeller Foundation, United Population Fund (UNFPA) William, Flora Hewlett Foundation, and a foundation that wishes to remain anonymous. Achievements: On-going. 8.1.2.3-13 13 Annex 8.1.2.3 Corporate Council on Africa (CCA) The Corporate Council on Africa, established in 1992, is a non-partisan, tax-exempt membership organization of corporations and individuals dedicated to strengthening and facilitating relationships between African and American individuals and organizations by creating educational, cultural, and commercial exchange opportunities. The Council believes that it can accomplish this goal by educating constituencies about the different social customs, cultural traditions, and economic climates on both continents, and by utilizing a network of business executives and government officials to promote U.S. Africa relations. Funding: Funding was initiated in 2003 with a $875,000 grant from the Bill & Melinda Gates Foundation. Other sources of funding come from the United Nations Development Program (UNDP). Achievements: On-going. 8.1.2.3-14 14 Annex 8.1.2.3 Dengue Vaccine Project (DVP) Background: Mahidol University, Bangkok, Thailand and Aventis-Pasteur (formerly Pasteur Merieux Connaught) have entered into an agreement to develop commercially a prototype vaccine against Dengue originating from research at the Thai institution. Established in 1989. Funding: Major funding comes from Aventis SA. Achievements: On-going. 8.1.2.3-15 15 Annex 8.1.2.3 Diflucan Partnership Program Background: In December 2000, Pfizer Inc. launched a donation of the antifungal medicine Diflucan (fluconazole), in partnership with the South African Ministry of Health, for the treatment of fungal opportunistic infections such as cryptococcal meningitis and esophageal candidiasis in HIV/AIDS patients. In June 2001, the Diflucan Partnership Programme, in cooperation with the UN and WHO, was expanded to the world's least developed countries. As of April 2003, Pfizer has donated Diflucan to governments and nongovernmental organizations in countries hardest hit by HIV/AIDS including: Botswana, Ghana, Haiti, Kenya, Lesotho, Malawi, Mozambique, Namibia, Rwanda, South Africa, Swaziland, Tanzania, Uganda, Zanzibar, Zambia and Zimbabwe. Continued expansion of the program to additional countries in Africa, Asia and the Caribbean is planned for 2003 and 2004. Pfizer is also working closely with nongovernmental organizations. Besides treatment, the program will also seek to include education of patients and healthcare providers, appropriate dispensing of medicines, and ongoing monitoring and support for partner governments. The donation has no time or monetary limits on Pfizer's support. Funding: Pfizer Inc. provided $2 million in 2001 to fund the project. Pfizer Inc. not only provides funding to the partnership but also products since the partnership’s inception in 2000. Achievements: The program has distributed more than 3 million free doses of Diflucan to governments and NGOs. It processed more than 86,000 prescriptions and trained 11,000 healthcare workers in the diagnosis and treatment of opportunistic fungal infections in partnership with the International Association for Physicians in AIDS Care. 8.1.2.3-16 16 Annex 8.1.2.3 Drugs for Neglected Diseases Initiative (DNDi) Background: Launched on July 3 2003, DNDi is a new not-for-profit drug research organization, with secretariat based in Geneva-Switzerland. This is a new public-private partnership, the first of its kind to focus exclusively on some of the world's most neglected diseases: human African trypanosomiasis (sleeping sickness), leishmaniasis and Chagas’ disease. DNDi will engage in targeted drug R&D for the most neglected diseases. In fact, it plans to spend around US$250 million over the next 12 years to develop 6-7 drugs and several drugs in the pipeline. Furthermore, it will encourage the creation of global networks of research facilities and will help strengthen their research capabilities. Funding: DNDi funding will come from four major sources: public donors (national or regional governments), the European Union, international organizations, the World Bank, and UN agencies (WHO, UNDP); private foundations, individual donors; DNDi funders; and the general public. MSF has provided funding towards the launch phase of DNDi and will support it for 5 years. DNDi will in parallel begin its project-specific fundraising campaign from public and private sources. Achievements: On-going. For detailed information about this organization, please refer to Section 8.5.3, Part B, Case Studies and Needs Assessment of Five Public-Private Partnerships. 8.1.2.3-17 17 Annex 8.1.2.3 Eli Lilly Multi-Drug Resistant Tuberculosis Partnership (MDR-TB) Background: Established in June 2003, this is a new global effort headed by Eli Lilly and Company, the World Health Organization (WHO), the U.S. Department of Health and Human Services' Centers for Disease Control and Prevention (CDC), Brigham and Women's Hospital (BWH), an affiliate of Harvard Medical School, and Purdue University. The main components of this new collaboration are to increase the number of trained personnel, and drugs available to treat the expanding crisis of Multi-Drug Resistant-TB (MDRTB). Eli Lilly will invest a total of US $70 million until 2006 to make available its technologies to manufacture two antibiotics (capreomycin and cycloserine) necessary for the treatment of MDR-TB in high-risk nations where the disease is most prevalent as well as make available the drugs at a discounted price. Funding: Eli Lily & Co. supports this partnership funding in the amount of $70 million. Achievements: On-going. 8.1.2.3-18 18 Annex 8.1.2.3 European Malaria Vaccine Initiative (EMVI) Background: EMVI is an international programme of the European Commission and European Union Member States established at University of Bergen, Centre for International Health in 1998 with the secretariats in Copenhagen, Denmark and Paris, France. EMVI's mission is to contribute to the global efforts to control malaria by providing a mechanism for accelerated development and clinical trials of malaria vaccines in Europe and Developing Countries; and promoting affordability and accessibility of malaria vaccines in Developing Countries. EMVI provides a mechanism to facilitate concerted interaction between a European Commission core activity and Union Member States' investments and a mechanism to accelerate the process of bringing promising research results, i.e. experimental malaria vaccines, via limited industrial production to clinical evaluation in European volunteers; and subsequent clinical evaluation in Developing Countries in close collaboration with trials networks in malaria endemic areas. In a joint effort announced in June 2001, EMVI has joined forces with Malaria Vaccine Initiative (MVI) and the United States AID’s Malaria Vaccine Development Program (USAIDMVDP) via a Memoranda of Understanding, in order to strategize about how to break through technical and financial barriers to vaccine development. They will also share information useful for the design of clinical trials and malaria vaccine development. A Memorandum of Intent has since been signed with the World Health Organization (WHO). Funding: The major financial contributors are the European Commission and the EU Member States. Achievements: On-going. 8.1.2.3-19 19 Annex 8.1.2.3 Foundation for Innovative New Diagnostics (FIND) Background: The Foundation for Innovative New Diagnostics (FIND) was launched on 22 May 2003 at the World Health Assembly in Geneva. This is a new, independent, non-profit foundation based in Geneva, which will work in close collaboration with the World Health Organization (WHO), the Special Programme for Research and Training in Tropical Diseases (TDR), academia, the diagnostics industry and other organizations. FIND is building on the success of the former TDR program, the tuberculosis diagnostics initiative (see TBDI profile). With additional funding coming from the Bill and Melinda Gates Foundation, FIND will be further empowered to quickly turn methods into products, untested products into fully evaluated products, and promising tests into tools with demonstrated impact and feasibility. FIND will apply the latest biotechnology innovations to develop and validate high-quality yet affordable diagnostic tests, through the R&D pipeline, for diseases of the developing world. Ultimately, FIND aims to create a model for public action that resolves the current failure of market forces. FIND will focus initially on TB diagnostics - in order to replace the current cumbersome sputum test for TB with a faster, more practical test to detect the disease, including drug resistant forms – and eventually move onto other infectious diseases. Funding: The Gates Foundation has committed up to $30 million over the next five years to the initiative. Achievements: On-going. 8.1.2.3-20 20 Annex 8.1.2.3 Gates Foundation/U. of North Carolina Partnership for the Development of New Drugs (GFUNC) Background: The Overall goal of this partnership is to develop potent, safe, orally active and economical new drugs to treat African trypanosomiasis and leishmaniasis. This partnership was established in 2000 and has brought together experts researchers and clinicians from around the world, with academic, governmental, international, private institutions and industry all involved in the field of clinical development and drug discovery therapies to fight these diseases that are killing and infecting millions of people in Africanendemic countries. Funding: GFUNC was established in 2000 with a $15.1 million five-year grant. The US National Institutes of Health (NIH) is also a major funder. Achievements: On-going. 8.1.2.3-21 21 Annex 8.1.2.3 GlaxoSmithKline African Malaria Partnership (AMP) Background: The GlaxoSmithKline African Malaria Partnership (AMP) was established in April 2002, in order to develop effective malaria control behaviours in African communities. In the context of malaria control, behavioural development describes the modification of behaviour in order to reduce the likelihood or frequency of infections and/or improve the management of the illness. Africa has been chosen as the focus for the programme simply because it is one of the hardest hit continent with the highest disease burden. Through the AMP, GlaxoSmithKline is providing 'kick-start' funding – totaling US$1.5 million over next three years – to three programes which together will reach 2 million people in seven African countries. By working in partnership with national malaria control programmes and non-governmental organisations, the AMP will support the development of appropriate and effective behaviours that lead to better prevention and management of malaria, particularly for young children and pregnant women. Ultimately, it is hoped that the success of these initiatives will attract support for their expansion and replication in other affected communities. Funding: GSK is providing ‘kick-start’ funding over three years. AMP will use its funding to award grants to programmes identified through a competitive selection process. The process for selecting programmes to receive AMP grants will take place once only and recipients will share US$500,000 per year for each of the three years. Achievements: On-going. 8.1.2.3-22 22 Annex 8.1.2.3 Global Alliance for Improved Nutrition (GAIN) Background: GAIN is an alliance of public and private sector organizations. Launched on May 9, 2002, it seeks to save lives and improve health through the elimination of vitamin and mineral deficiencies by leveraging costeffective food fortification initiatives to improve health cognitive development and productivity in developing nations. GAIN will undertake different activities to achieve its objectives such as policy formulation and harmonization, standard setting, capacity building, advocacy, marketing and operational research. Funding: GAIN's partners will include bilateral donors, foundations, UN and other multilateral agencies, developing country governments, private sector companies, NGOs and academic institutions. Funds available for the first year of GAIN activities will be between US$20-25 million with more than US$70 million committed over 5 years, including US$50 million from the Bill & Melinda Gates Foundation, US$8 million from USAID, CDN$5.5 million from the Micronutrient Initiative and CDN$500,000 from the Canadian International Development Agency. Other funders include the Government of Germany and the Government of the Netherlands. Achievements: On-going. 8.1.2.3-23 23 Annex 8.1.2.3 Global Alliance for TB Drug Development (TB Alliance) Background: The Global Alliance for TB Drug Development is an international public-private partnership accelerating the discovery and development of faster-acting and affordable drugs to fight tuberculosis. The TB Alliance builds and manages a portfolio of promising compounds with partners worldwide and invests in platform technologies that improve the environment for TB drug development. By providing staged funding, expert scientific and management guidance, and clear pre-defined milestones, the TB Alliance can ensure the rapid development of compounds. The TB Alliance pursues intellectual property rights to ensure that new drugs are affordable to and adopted by those most in need. The promise of TB control efforts will only be met fully when healthcare workers are given the best tools that modern science can deliver. Funding: DONORS/YEARS 2000 2001 2002 8,000,000 TOTAL 8,000,000 Rockefeller Foundation 2,000,000 2,000,000 World Health Organization (WHO) 25,000,000 25,000,000 Bill & Melinda Gates Foundation TOTAL 33,000,000 2,000,000 35,000,000 The funding shown above represents the amounts pledged in a given year. The grants have various conditions such as periods of availability and future payments upon achievement of certain milestones. The amounts for Rockefeller and Gates are in US dollars; WHO is in Euros. For details consult TB Alliance annual report in the documents section of this report. Funding is expected to be shared evenly over time between public and private sectors including in-kind support from private and public laboratories, like the US National Institute for Allergy & Infectious Diseases (NIAID). Achievements: The accomplishments to date have significantly advanced the development of new TB drugs after a 40year delay. Through proactive business development and Requests for Proposals (RFP), the TB Alliance has assembled a portfolio of 10 promising anti-TB compounds. Additionally, the TB Alliance has been in active discussions with leading biotech and international pharmaceutical companies to explore partnerships and establish collaborations on new projects including direct licensing of compounds, in-kind donations of R&D capacity and technical expertise as well as other innovative arrangements. 8.1.2.3-24 24 Annex 8.1.2.3 For detailed information about this organization, please refer to Section 8.5.3, Part C, Case Studies and Needs Assessment of Five Public-Private Partnerships. 8.1.2.3-25 25 Annex 8.1.2.3 Global Alliance for the Elimination of Lymphatic Filariasis (GAELF) Background: The Global Alliance to Eliminate Lymphatic Filariasis was officially formed during a meeting at Santiago de Compostela, Spain, in May 2000. The Global Alliance brings together various parties in the quest to eliminate lymphatic filariasis (LF also known as elephantitis) as a public health problem by the year 2020; these include the ministries of health of the endemic countries, 39 organizations from various sectors of society, including the World Bank, UNICEF, CDC, Liverpool School of Tropical Medicine, SmithKline Beecham and Merck & Co., international development agencies and non-governmental organisations. The two principal goals of the program to Eliminate Lymphatic Filariasis are: to interrupt transmission of infection and to alleviate and prevent both the suffering and disability caused by the disease. In order to achieve these goals the program will share the information on progress and challenges, coordinate activities, fund-raise and advocate for the elimination of LF. The program works with the Albendazole and ivermectin (Mectizan) donation programs and has also secured supplies of diethylcarbamazine (DEC), a drug needed in some cases, at advantageous terms. Funding: In February 2001 the Bill and Melinda Gates Foundation gave $20 million to accelerate the goals of the alliance. Other funders include GlaxoSmithKline, and Merck & Co., Inc. Achievements: In 2001, GAELF reached its target coverage of more than 26 million people. The target for 2005 is to reach 350 million people at risk. 8.1.2.3-26 26 Annex 8.1.2.3 Global Alliance for Vaccines and Immunization (GAVI) Background: Established in 1999, the Global Alliance for Vaccines and Immunization is an historic alliance between the private and public sector committed to one goal: saving children's lives and improving people's health through the widespread use of vaccines. International organizations, governments, the vaccine industry, research institutions, and major philanthropists are joined in a dedicated partnership serving the shared GAVI objectives. Intent on increasing child immunization around the globe, GAVI and its financial arm, The Vaccine Fund, fuel poorer countries' long-term efforts to provide children with basic access to live saving vaccines. Support is provided based on country proposals which are reviewed by an independent group of experts – many are health officials from developing countries. Basic eligibility for support has been set according to national income: countries with GNI per capita below $1,000 – 75 in all – are eligible. The proposal review and other administrative work is handled by a small secretariat based in Geneva, which is supported by Board member dues. As of August 2003, The Vaccine Fund had committed more than a billion dollars to 68 countries to strengthen immunization services and deliver under-used vaccines. Simultaneously, GAVI aims to stimulate the vaccine industry to develop and produce vaccines vital to low-income countries. Funding: In 1999, the Bill & Melinda Gates Foundation established support in the amount of $750,000,000. Additional donors include: the United States government US$161 million (over 3 years), government of Norway US$109 million (over 5 years), the government of the Netherlands US$84 million (over 5 years), UK Department for International Development (DFID) US$59 million (over 5 years), Canadian International Development Agency (CIDA) US$31 million (over 5 years), the government of France US$17 million (over 3 years), the government of Sweden US$3 million (over 2 years), the government of Denmark US$1 million (over 1 year), the government of Ireland US$0.5 million (over 1 years), and private contribution totaling US$1.5 million. GAVI Board members are required to pay 300,000 USD per year to support the secretariat (developing countries are exempt). Achievements: Since its inception, GAVI and The Vaccine Fund have provided over 50 national health programs catalytic funding which they can use to strengthen their systems for delivering essential vaccines to the population. Additionally, approximately 30 million more of the world's children are now protected against hepatitis B, 4.3 million children are now protected against Haemophilus influenzae type b (Hib) and 1.6 million children are now protected against yellow fever. Furthermore, GAVI estimates that countries have been able to provide basic vaccination to 8.3 million children who would otherwise have not been reached with any vaccines at all. It is estimated that as many as 300,000 deaths will be prevented because of the resources provided so far. For detailed information about this organization, please refer to Section 8.5.3, Part D, Case Studies and Needs Assessment of Five Public-Private Partnerships. 8.1.2.3-27 27 Annex 8.1.2.3 Global Alliance to Eliminate Leprosy (GAEL) Background: The Global Alliance for the Elimination of Leprosy (GAEL) was created by WHO in 1999 to ensure that a common strategy of leprosy elimination efforts was adopted, intensively implemented and effectively monitored. GAEL is a partnership dedicated to ensuring that all leprosy patients, wherever they may live, and however poor, have free and equal access to the most modern treatment available. Multi-drug therapy (MDT), donated by Novartis has been made available free of charge to all endemic countries through WHO, and financial support has been provided by the Nippon and Sasakawa Foundations. MDT provides a simple yet highly effective cure for all types of leprosy in just six to twelve months. The goal of GAEL is to eliminate leprosy as a public health problem from every country by the year 2005 and to detect and cure all the remaining leprosy cases (currently estimated at over 2.5 million). At its creation, GAEL included WHO, governments of endemic countries, the International Federation of Anti-Leprosy Associations, NGOs, DANIDA, the World Bank, the Nippon Foundation and the Sasakawa Memorial Health Foundation. Funding: In 2000, the Nippon Foundation provided $24 million in funding. Other major funders include: the Danish Agency for Development Assistance (DANIDA), Novartis, Sasakawa Memorial Health Foundation, World Health Organization (WHO) and the World Bank. Achievements: By the beginning of 2002, more than 12 million cases were treated and had been cured; the numbers of relapses remain low, at less than one case per 1000; no drug resistance following multi drug therapy (MDT) has been reported. More and more programmes are being integrated within existing general health services; there are fewer uncovered areas, including those which are difficult to access; the gender imbalance has decreased significantly; and an increasing number of countries are requesting free supplies of MDT drugs. 8.1.2.3-28 28 Annex 8.1.2.3 Global Business Coalition on HIV & AIDS (GBC) Background: The Global Business Coalition on HIV/AIDS (GBC) is a rapidly-expanding alliance of international businesses dedicated to combating the AIDS epidemic through the business sector’s unique skills and expertise. GBC's mission is to increase significantly the number of companies committed to tackling AIDS, and to make business a valued partner in the global efforts against the epidemic. With the support of global leaders in government, business and civil society, GBC promotes the broad range of valuable contributions business can make, through policy development and identifying examples of good practice. Funding: The initial support came from the Bill and Melinda Gates Foundation, the Open Society Institute and the United Nations Foundation. Now the major source of funding comes from membership fees. Achievements: On-going. 8.1.2.3-29 29 Annex 8.1.2.3 Global Campaign for Microbicides (GCM) Background: The Global Campaign for Microbicides was officially launched in July 1998 at the XII International AIDS Conference in Geneva. The Global Campaign is a broad-based, international effort to build support among policymakers, opinion leaders, and the general public for increased investment into microbicides and other user-controlled prevention methods. Through advocacy, policy analysis, and social science research, the Campaign works to accelerate product development, facilitate widespread access and use, and protect the needs and interests of users, especially women. The Global Campaign pursues its work through a small core staff and by funding partner organizations to pursue activities that directly advance the Campaign goals and objectives. The Campaign Secretariat is housed at PATH (Program for Appropriate Technology in Health). Funding: DONORS/YEARS 2003 TOTAL 400,000 400,000 228,000 228,000 628,000 628,000 Ford Foundation International Partnership for Microbicides TOTAL GCM has received in the past financial support from individual donors and from the following foundations: General Services Foundation, John M. Lloyd Foundation, Moriah Fund, Richard and Rhoda Goldman Fund, Rockefeller Foundation and the Turner Foundation. Achievements: Two years after its establishment, the Global Campaign developed Action Kits for grassroots activists; raised awareness about microbicides via the media, workshops, and outreach to policymakers; and launched a major legislative strategy to increase US government investment in microbicide research and development. By 2001, the campaign had grown into a major global organizing effort, with more than 70 partner groups worldwide. The Campaign sponsored over 55 workshops, presentations and exhibit booths at conferences in the United States, Trinidad, Argentina, South Africa, Uganda, Canada, Burkina Faso, Australia, India and the United Kingdom as well as sponsored a four-day, international advocates meeting for 60 advocates from 28 countries. 8.1.2.3-30 30 Annex 8.1.2.3 Global Elimination of Trachoma (GET 2020), Background: A WHO Alliance for the Global Elimination of Trachoma (GET 2020) was established in 1996 to support the work of a broad spectrum of collaborating international organizations, nongovernmental development organizations (NGDOs) and Foundations with the Ministries of Health of endemic countries. Out of the spirit of GET 2020, VISION 2020 was developed. Under GET 2020, million of people will receive surgical and medical treatment as well as education and sanitation to prevent the transmission of the disease and its blinding consequences. Funding: Major funders include: Christoffeln Blinden Mission (CBM), Conrad N. Hilton Foundation, International Trachoma Initiative (ITI), International Agency for the Prevention of Blindness (IAPB), Pfizer Inc., Sight Savers International (SSI), Vision 2020, and other contributors. Achievements: On-going. 8.1.2.3-31 31 Annex 8.1.2.3 Global Fund to Fight AIDS, Tuberculosis and Malaria (Global Fund) Background: Established in January 2002, the Global Fund to Fight AIDS, Tuberculosis and Malaria (Global Fund) was created to help fight three of the world's most grave public health problems-AIDS, tuberculosis and malaria in endemic countries. The fund is an international, financial instrument that will leverage, manage and disburse additional resources through public-private partnership that reflect national ownership and respect country-led formulation and implementation processes. The fund will evaluate proposals based on their scientific and technical merit (through an independent review process), which takes into account local realities and priorities as well as the existence of a country coordination mechanism. The fund's consisting constituencies, include donor countries, developing countries, NGOs, civil societies, the private sector, bilateral and multilateral organizations. The fund aims to rapidly disburse grants to increase existing spending on the prevention and treatment of these three diseases while building on, complement, and coordinate with existing regional and national programs in support of national policies, priorities and partnerships. Funding: More than 40 countries, international foundations and private donors have made significant pledges to the Fund in excess of $4.5 billion. Achievements: On-going. 8.1.2.3-32 32 Annex 8.1.2.3 Global Guinea Worm Eradication Program (GWEP) Background: The Dracunculiasis Eradication Campaign operates, under the auspices of the Carter Center’s (a U.S., taxexempt 501(c )(3) not-for-profit organization) Global 2000 Program, Atlanta, USA, which has worked to eradicate guinea worm since 1986. The campaign brings together WHO, UNICEF, the CDC, the World Bank, other organizations, industry and countries in a programme of eradication efforts, training, and research. Dupont has donated more than 2 million square meters of nylon cloth to filter drinking water – a key step in interrupting transmission. Additionally, a larvicide is donated by American Cyanamid (now part of BASF). Funding: Major funders include: BASF, Bill & Melinda Gates Foundation, DuPont, Johnson & Johnson, and Precision Fabrics. Achievements: On-going. 8.1.2.3-33 33 Annex 8.1.2.3 Global Microbicide Project (GMP) (Also see CONRAD) Background: In 2000, CONRAD established the GMP to help develop new microbicidal agents that specifically address the needs and perspectives of women. The main objective of this project is to develop vaginal methods that would protect women against sexually transmitted infections (STIs), including HIV/AIDS. The GMP can provide funds for both pilot and major projects. Although there is no requirement for cost sharing by an industrial partner, it is strongly encouraged. Funding: At present, GMP funding comes solely from the Bill and Melinda Gates Foundation in the form of a $25 million grant to expedite microbicide development. Achievements: On-going. 8.1.2.3-34 34 Annex 8.1.2.3 Global Polio Eradication Initiative (GPEI) Background: GPEI is a multi-partner, informal coalition supporting the WHO goal and strategies for eradication of poliomyelitis. Early and significant partners included Rotary International who has mobilized resources, volunteers and political commitment, other partners include others UN Agencies, other NGOs, national development assistance and technical agencies. The spearheading partners are the WHO, Rotary International, the US Centers for Disease Control and Prevention (CDC) and UNICEF. Industry has donated polio vaccine and funds to support surveillance. Funding: Major funders include: The Governments of Australia, Belgium, Canada, Denmark, Germany, Ireland, Italy, Japan, Luxembourg, Malaysia, Netherlands, Norway, Russia, Switzerland, United Kingdom, United States of America, European Commission, Inter-American Development Bank, World Bank, UNICEF National Committees, Trick-or-Treat for UNICEF, UNICEF Regular Resources, United Nations Foundation, Rotary International, Bill and Melinda Gates Foundation, IFPMA, WHO Regular Budget, Aventis Pasteur, De Beers, and Wyeth. Since the end of 2002, the funding gap for 2003-2005 has been reduced from $275 million to $210 million. Achievements: In the 15 years since the Global Polio Eradication Initiative was launched, the number of polio cases has been reduced from greater than 350,000 in 1988 to 1918 reported cases in 2002, representing a greater than 99% reduction. The number of polio endemic countries has been reduced from more than 125 in 1988, to just 7 in 2002. In June 2002, the WHO European Region was certified polio-free. With the certification of the Americas (1994) and the Western Pacific (2000), more than three billion people are living in certified polio-free zones. 8.1.2.3-35 35 Annex 8.1.2.3 Global Public-Private Partnership for Hand Washing with Soap (GPHW) Background: The Public-Private Partnership for Hand Washing is a global hygiene educational program established in 1998 by Colgate-Palmolive Company, to reduce the incidence of diarrhoeal diseases in poor communities through public-private partnerships promoting hand washing with soap and to implement large scale hand washing interventions and use lessons to promote the approach a the global level. Core partners of the initiative include government ministries of health and education, academic institutions, the private sector in collaboration with multilateral organizations. Funding: Unavailable Achievements: Since the initiative began, there has been improved increase in hygienic hand washing behavior and the incidence of diarrhoeal diseases has decreased. The number of local partnerships with industry associations has also increased. More countries have joined the program following the success in Ghana and India. International interest in hand washing as an intervention has grown in the past years, increasing the need for well-documented trials of new approaches. 8.1.2.3-36 36 Annex 8.1.2.3 Global Reporting Initiative (GRI) Background: The GRI secretariat is located in Amsterdam, The Netherlands. The Initiative promotes international harmonization in the reporting of relevant and credible corporate environmental, social and economic performance information to enhance responsible decision-making. The Bill and Melinda Gates Foundation has awarded a $950,000 grant to develop an HIV/AIDS reporting protocol for corporate policies and programs. This HIV/AIDS information disclosure standard is being developed in a multi-stakeholder fashion, with a consultative process in place. The grant brings to a total of $6.4 million that numerous funding organizations have committed to the GRI over the past three years. Funding: DONORS/YEARS 2001 2002 950,000 TOTAL 950,000 Bill & Melinda Gates Foundation All other donors* TOTAL 950,000 100,000 100,000 100,000 1,050,000 Achievements: There are now 300 organizations issuing sustainability reports referencing the GRI Guidelines-doubling the total number of self-declared GRI reporters since last August 2002. The 300 target is an important milestone in GRI’s development, demonstrating continued interest and uptake from around the world. 8.1.2.3-37 37 Annex 8.1.2.3 Health InterNetwork (HIN) Background: HIN is an UN initiative led by WHO which was launched in September 2000 to improve developing country access to health information, using the Internet. The initiative is targeted to health professionals, researchers and policy makers, and focuses on content, internet connectivity, and training. The partnership includes UN agencies, governments, aid agencies, foundations, public health institutions and private sector companies. Funding: Major funders include the Bill & Melinda Gates Foundation, United Nations Foundation, and other private partners. Achievements: Health InterNetwork has become a model for other sectors. The success of the Health InterNetwork Access to Research initiative has engaged other UN agencies, in extending the cooperation with publishers to other sectors such as agriculture and education. Plans are under way to expand the initiative with access to other scientific journals in related fields, based on WHO's experience. The initiative has been cited as an exciting and promising public-private partnership, using the outreach of the UN in making available global public goods. 8.1.2.3-38 38 Annex 8.1.2.3 Hope for African Children Initiative (HACI) Background: Created in 2000, the Initiative is a community based, pan-African effort created to address the enormous challenges faced by millions of African children who have either been orphaned by AIDS or live with parents who are sick or dying from illness associated with HIV/AIDS and to improve the capacity of the African communities to raise awareness, combat stigma, provide care and support, and deliver muchneeded services. HACI is a unique partnership which brings together six leading humanitarian organizations: CARE, Plan International, Save the Children, the Society for Women and AIDS in Africa, World Conference on Religion and Peace, and World Vision. The Hope for African Children Initiative has its headquarters in Nairobi, Kenya and is currently operational in nine countries. Funding: The Bill and Melinda Gates Foundation awarded the Initiative a US$ 10 million grant to get started and to leverage additional funding. Since the Gates grant, HACI has received substantial financial support from the Government of the Netherlands for a 5-year period ending December 2006. Smaller amounts of funding have been received from Artists Against AIDS Worldwide (AAAW), Plan US National Office, the Norwegian Agency for International Cooperation (NORAD), the Chrysalis Foundation, and from individual personal donations, many through the website. All these funds-totaling almost $15 million to date- have flowed through a centralized HACI account. Fundraising is carried out at the global level by the PPC and the HACI Secretariat; at the regional level by the HACI Secretariat, and at the national level by the CPCs with assistance from the HACI Secretariat. Achievements: HACI has been in existence for 3 years now and expanded from 3 start-up countries in the first year to 9 at the moment. HACI program activities are only fully operational in Kenya, Malawi, and Uganda and this for the last 15 months effectively. During this reporting period, HACI has put structures and systems in place in 6 more countries – Cameroon, Ethiopia, Ghana, Mozambique, Senegal, and Zambia. Program implementation will commence in July 2003 in all 9 HACI countries. 8.1.2.3-39 39 Annex 8.1.2.3 Human Hookworm Vaccine Initiative (HHVI) Background: The Albert B. Sabin Vaccine Institute (SVI) is a U.S. 501(c)(3) non-profit educational and research organization dedicated to saving lives by stimulating the development of new vaccines, and increasing domestic and global immunization rates. Its programs advance development of new vaccines and improved ways to produce and administer them. Founded in 1993, SVI is committed to continuing the work of polio vaccine developer Dr. Albert Sabin, who envisioned the enormous potential of vaccines to prevent deadly diseases. The Institute currently operates from three sites: the national headquarters in New Canaan Connecticut, the Washington, DC office of International Programs/Public Affairs, and the Rockville, Maryland headquarters for the Human Hookworm Vaccine Initiative. The Institute is developing a vaccine to prevent an infection that afflicts almost one billion individuals, and is the leading cause of anemia and malnutrition in the developing world. Research is conducted by a world class vaccinologist, Peter Hotez, M.D., Ph.D., a Senior Fellow at the Sabin Institute and the Professor and Chair of the Department of Microbiology and Tropical Medicine at The George Washington University. The research laboratories are located at The George Washington University Medical Center. Other aspects of vaccine development are being outsourced to several academic and industrial organizations. Funding: The Human Hookworm Vaccine Initiative, with the generous assistance of the Bill & Melinda Gates Foundation, sponsors vaccine research and development, under an $18 million commitment started in April 2000. Achievements: Significant developments have been made in expressing the lead vaccine antigen Na-ASP-2 using Pichia pastoris yeast expression and in purifying the antigen. Process development is on schedule with technology transfer for cGMP manufacture expected in the first quarter of 2004. Discussions with FDA will also commence in first quarter leading to a planned Phase 1 clinical trial late in the year 2004. 8.1.2.3-40 40 Annex 8.1.2.3 Infectious Disease Research Institute (IDRI) Background: A joint industry research program of the Infectious Disease Research Institute, which is a U.S., tax-exempt 501(c )(3) not-for-profit scientific organization supported by public funds. In 1994 IDRI established a collaborative partnership with Corixa Corporation, a research and development-based biotechnology and vaccine company. The goal of the partnership is to optimize the development of vaccines, therapeutics, and diagnostics against leishmaniasis and diagnostics against diseases of developing countries. This program is being carried out in collaboration with Corixa, and supported in part by funding from the NIH. In January of 2003 IDRI and Corixa announced initiation of a US based Phase 1 clinical trial of a candidate vaccine against leishmaniasis. Funding: In March 2000, IDRI announced receipt of a $15 million grant from the Bill & Melinda Gates Foundation to fund their effort. The US National Institutes of Health (NIH) is also funding this endeavor. Achievements: On-going. 8.1.2.3-41 41 Annex 8.1.2.3 Institute for OneWorld Health (IOWH) Background: The Institute for OneWorld Health (IOWH) is a 501(c)(3), tax-exempt non-profit pharmaceutical company launched in 2000 and based in San Francisco, California. Its mission is to develop safe, effective, and affordable, new medicines for diseases affecting people in the developing world, for which there are either no existing therapies or inadequate therapies. Staffed with pharmaceutical scientists with international drug development and regulatory expertise, IOWH identifies promising drug and vaccine candidates and executes preclinical development, with the goal of regulatory approval of therapies in the most affected countries. Throughout the development process, from discovery through clinical trial to regulatory approval and manufacturing, IOWH collaborates closely with a range of global health players, including the World Health Organization, major research universities, the Walter Reed Army Institute of Research, the National Institutes of Health and the various pharmaceutical companies. IOWH seeks public sector funds to pursue projects that could be promising for the developing world but which may not attract private investment funds. Once new drugs are approved for use by regulatory agencies, manufacturing and distribution are outsourced to quality corporations in the developing world to maintain IOWH's focus on drug development. It is anticipated that differential pricing will be applied to all of IOWH's drugs, to ensure affordability. Funding: The partnership is supported by $8.8 million provided by the Bill & Melinda Gates Foundation. Achievements: On-going. 8.1.2.3-42 42 Annex 8.1.2.3 Intercompany Collaboration for AIDS Drug Development (ICCADD) Background: The ICCADD was established in April 1993 as a consortium of pharmaceutical and biotechnology companies involved in AIDS drug development. The ICCADD serves as a forum for exchanging clinical data, spurring independent collaborations among member companies and giving the industry an opportunity to interact with important outside groups involved in AIDS drug development. The objective is to expedite the development of effective drugs so that they are available as soon as possible to both physicians and patients. In the governance of the ICCADD, each company retains its autonomy while collaborating with its peers, careful to steer clear of antitrust issues, having filed under the National Cooperative Research and Production Act. The secretariat is currently held at Triangle Pharmaceuticals in North Carolina, US. Funding: The pharmaceutical members are amongst the major funders for this endeavor. Achievements: Review information. 8.1.2.3-43 43 Annex 8.1.2.3 International AIDS Vaccine Initiative (IAVI) Background: IAVI is a U.S., tax-exempt 501(c )(3) not-for-profit scientific organization established in 1996 to ensure the development of safe, effective and accessible preventative HIV vaccines for use throughout the world. IAVI is a collaborating center of UNAIDS and collaborates with both public and private sector organizations in pursuing its mission. IAVI’s work focuses on four areas: creating global demand for AIDS vaccines through advocacy and education; accelerating scientific progress; encouraging industrial involvement in AIDS vaccine development; and assuring global access. IAVI funds and sponsors fasttracked product development and clinical testing of promising AIDS vaccine candidates developed for the countries most affected by the disease. Funding: Since it’s inception, IAVI has received in excess of $271 million dollars in support. IAVI’s major financial supporters include the Bill & Melinda Gates Foundation; the Rockefeller, Sloan and Starr foundations; the World Bank; Becton, Dickinson & Co. and the Canadian International Development Agency (CIDA), the government of the Netherlands, United Kingdom, United States, Ireland, Denmark, Norway and Sweden. IAVI has now secured commitments totaling US$310 million, toward a goal of US$655 million by 2008. Achievements: Since its founding in 1996, IAVI has brought new leadership to the AIDS vaccine field and has: created and begun implementing the widely acclaimed Scientific Blueprint for AIDS Vaccine Development a strategic plan to guide the world's scientific effort. Invested more than US$280 million in the several innovative international vaccine development partnerships, bringing together researchers and scientists in industrialized and developing countries, to move promising vaccine candidates toward clinical testing. Negotiated important intellectual property agreements to help ensure that the fruits of IAVI's research will be readily available in developing countries. Established the first periodical devoted to chronicling HIV vaccine research, IAVI Report, which has more than 10,000 readers in 115 countries. Laid the foundation for national AIDS vaccine programs in South Africa, India, and China. Put AIDS vaccines onto the global policy agenda and won significant increases in government funding for AIDS vaccine research and development. Helped establish a World Bank task force to study new financial mechanisms to spur the development, and eventual purchase, of AIDS vaccines for developing countries. For detailed information about this organization, please refer to Section 8.5.3, Part E, Case Studies and Needs Assessment of Five Public-Private Partnerships. 8.1.2.3-44 44 Annex 8.1.2.3 International Partnership for Microbicides (IPM) Background: The International Partnership for Microbicides (IPM) is a public private partnership formed in 2002 to accelerate the discovery, development and accessibility of microbicides to prevent transmission of HIV, especially among women in low-resource settings. Through review and prioritization, the IPM provides resources and expertise for targeted, milestone driven projects in its core areas of product development and access. IPM is supporting development initiatives across the microbicide pipeline, especially agents with new modes of action; and investing in efforts to provide the field with shared technologies (e.g., novel long-acting formulations) and resources (e.g., expanded clinical research capacity.) IPM is also identifying and supporting policy and programmatic initiatives that will facilitate rapid approval and introduction once effectiveness has been demonstrated; initial work is in the areas of financing, regulatory affairs, and country preparedness. Finally, IPM works to raise awareness and resources for microbicide development. A recent analysis conducted by experts at the London School of Hygiene and Tropical Medicine, based on real data from 73 low-income countries, concluded that a 60% efficacious microbicide, used by 20% of people easily reached through existing health services, in one-half of the occasions when condoms are not used, would avert 2.5 million new infections over three years in women, children, and men. Funding: See next page 8.1.2.3-45 45 Annex 8.1.2.3 DONORS/YEARS 2002 2003 2004 2005 4,013,944 2,250,000 8,000,000 9,599,742 13,087,521 14,822,149 980,000 2,832,250 2,802,000 468,812 510,150 468,812 696,334 746,411 1,442,745 136,929 637,426 774,355 763,056 2006 TOTAL 15,027,000 Rockefeller Foundation 13,117,907* 60,127,319 Bill & Melinda Gates Foundation 6,614,250 Ireland, Government of 468,812 1,916,586 UK Department for International Development (DFID) Norway, Government of Danish Agency for Development Assistance (DANIDA) 100,000 100,000 United Nation Population Fund (UNFPA) 145,000 225,000 490,000 1,835,100 2,450,000 3,430,000 3,780,131 20,400,023 21,058,333 26,720,961 370,000 World Bank 8,205,100 Netherlands, Government of TOTAL ï‚· 13,117,907 94,577,355 The Gates Foundation has pledged $9.5 million in 2007. Achievements: On-going. 8.1.2.3-46 46 Annex 8.1.2.3 International Programme on Chemical Safety (IPCS) Background: An intergovernmental cooperative undertaking between WHO/IPCS and the Canadian Centre for Occupational Health and Safety (CCOHS). IPCS is a joint activity of WHO, ILO and UNEP. The programme was launched in June 2001 and aims at offering electronic access to a database of searchable full text, peer-reviewed chemical safety-related publications and records from international bodies. The programme supports the long-term objectives of the United Nations Conference on Environment and Development. The services offered by the programme allows developing countries or organizations with limited resources to a vast range and quantity of chemical safety information in an understandable form. It is aimed at various user groups such as government departments, commercial sectors of society and the general public. This strategy is aimed at managing chemicals in an environmental friendly manner and creating a safe healthy work environment. Funding: Major funders are IPCS donors. Achievements: On-going. 8.1.2.3-47 47 Annex 8.1.2.3 International Trachoma Initiative (ITI) Background: The ITI is a U.S. tax-exempt 501(c )(3) not-for-profit organization based in New York, founded in November 1998 by Pfizer, Inc and the Edna McConnell Clark Foundation. Its mission is to eliminate blinding trachoma, the world's leading preventable cause of blindness, by the year 2020. The program has implemented its strategy in nine countries thus far, using the WHO-endorsed four-part protocol called SAFE for Surgery, Antibiotics, Face washing, and Environmental changes. Since 1998 more than 8 million doses of the oral antibiotic Zithromax(R) have been donated by Pfizer and administered to people at risk of infection. Funding: DONORS/YEARS 1998 1999 2000 0 1,400,000 0 6,000,000 2003 TOTAL 1,400,000 UK Department for International Development (DFID) 1,250,000 7,250,000 2,500,000 2,500,000 Edna McConnell Clark Foundation (EMCF) 0 Starr Foundation 1,000,000 0 20,000,000 4,000,000 25,000,000 0 20,000,000 2,000,000 22,000,000 0 47,400,000 9,750,000 58,150,000 Bill & Melinda Gates Foundation Pfizer Inc. TOTAL 1,000,000 Achievements: Early evaluations in Tanzania, Ghana, and Vietnam indicate that acute disease in children has generally been reduced by 50 percent or more. Overall, 50,000 individuals have received sight-preserving surgery, more than 5 million have received antibiotic treatment, and 20 million have received health education. 8.1.2.3-48 48 Annex 8.1.2.3 Int'l. Conf. on Harmonization of Technical Reqs for Registration of Pharmaceuticals Human Use (ICH) Background: The International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) is an initiative that brings together experts from the regulatory authorities and the research-based industries of Europe, Japan and the United States to discuss scientific and technical aspects of product registration. The project has produced approximately 50 guidelines to facilitate compatible regulatory procedures in the three regions, and thus reduce duplication of testing carried out during the research and development of new medicines. Implementation of these guidelines leads to a more economical use of human, animal and material resources, and the elimination of unnecessary delay in the global development and availability of new medicines, while maintaining safeguards essential to public health. Funding: Major funders include six co-sponsoring parties: the European Union, the European Federation of Pharmaceutical Industries Associations, Japanese Ministry of Health, Labour and Welfare (MHLW) the Japanese Pharmaceutical Manufacturers Association, the, the United States Food and Drug Association (FDA), Pharmaceutical Research and Manufacturers of America (PhRMA) as well as three observers namely: the World Health Organization (WHO), the European Free Trade Association (EFTA) and the Health Canada. Achievements: On-going. 8.1.2.3-49 49 Annex 8.1.2.3 Int'l. Partnership Against Aids in Africa (IPAAA) Background: The International Partnership Against AIDS in Africa is a coalition that works under the leadership of African countries to save and improve lives. It is made up of African governments, the United Nations, donors, and the private and community sectors. The Partnership's mission is to reduce the number of new HIV infections in Africa, promote care for those who suffer from the virus, and mobilise society to stop the advance of AIDS. Funding: Major funders include: Bill & Melinda Gates Foundation, Canadian International Development Agency (CIDA), European Union, UK Department for International Development (DFID), Government of Belgium, Government of Finland, Government of France, Government of Germany, Government of Ireland, Government of Italy, Government of Japan, Government of the Netherlands, Government of Norway, Government of Sweden, United Nations Foundation, US Agency for International Development (USAID), and World Bank. Achievements: On-going. 8.1.2.3-50 50 Annex 8.1.2.3 Japanese Pharmaceutical, Ministry of Health, WHO Malaria Drug Partnership (JPMW) Background: Launched in October 1999, this unique collaborative research involves fourteen Japanese pharmaceutical companies, the UNDP/World Bank/WHO Special Programme for Research and Training in Tropical Diseases (TDR) and Japan's Ministry of Health, Labour and Welfare. JPMW, as it is called, is a joint TDR/industry project whose objective is to screen and identify potential new compounds that could combat drug-resistant strains of malaria in developing countries. The agreements provide that the companies allow their chemical libraries to be tested by the Kitasato Institute in Japan through massscreening techniques and compounds showing antimalarial potential could then be further studied and possibly developed into new drugs for the public sector. The Kitasato Institute also tests its own natural products such as microbial metabolites within the framework of JPMW project. Funding: Funding is provided by the Japanese government and Japanese pharmaceutical companies. Achievements: Benefits to the Japanese pharma companies: anti-malarial testing is done free of charge and companies receive any new IPRs established as a result of such testing. If subsequent drug development is successful, the companies can provide the drugs at discounted prices to the endemic country market but can receive market-determined royalties on sales to the traveler market. Benefits to WHO/TDR and MHW Japan: public sector gains unprecedented access to Japanese private sector’s chemical libraries for potential discoveries and development of anti-malarials at preferential prices. 8.1.2.3-51 51 Annex 8.1.2.3 Lapdap Antimalarial Product Development (LAPDAP) Background: A joint research agreement was signed in March 2001 between WHO through its UNDP/World Bank/WHO Special Programme for Research and Training in Tropical Diseases (WHO/TDR) and GlaxoSmithKline to develop a new effective oral treatment for uncomplicated malaria, primarily for use in Sub-Saharan Africa, at preferential prices for public health programmes. The aim is to develop chlorproguanil-dapsone (Lapdap™) for regulatory submission as a safe alternative to chloroquine and sulfadoxine-pyrimenthamine (SP) for treatment of malaria caused by the Plasmodia falciparum malaria parasite in Africa. To date, clinical phase III trials on LAPDAP were conducted in Gabon, Kenya, Malawi, Nigeria and Tanzania. The File was submitted to the British Medicines and Healthcare products Regulatory Agency (MHRA) in November 2002. A Marketing Authorisation was issued by the MHRA in July 2003. The Dossier has been submitted to many African national authorities, and marketing approval has been granted in some countries. Lapdap™ has been launched commercially in several countries. Funding: Funding is provided by WHO/TDR, GSK, and UK Department for International Development. Achievements: The partnership has completed product registration in the United Kingdom and in malaria endemic nations. 8.1.2.3-52 52 Annex 8.1.2.3 Lassa Fever Initiative (LFI) Background: This partnership is in its early stages of formation and has the goal of improving the management and control of Lassa fever. The focus will be on gaining a better understanding of the disease burden and improving knowledge of how the disease can be most cost-effectively controlled through an integrated approach to its diagnosis, treatment and prevention. Ensuring that new and affordable interventions are being developed for its treatment and prevention involves both the public and private sector. Lassa fever is one of the most deadly and widespread viral hemorrhagic fevers and occurs in certain countries of West Africa. The partnership includes an Expert Working Group as well as funding partners such as Office of US Foreign Disaster Assistance (OFDA), Rockefeller Foundation and Jersey Overseas Aid (JOA). The Expert Working Group is comprised of Merlin, UN organizations, the International Committee Red Cross (ICRC), the Sierra Leone Ministry of Health, the Royal Army Medical Corps (RAMC), experts in Lassa fever from the Center of Disease Control (CDC), public health laboratory experts from CPHL and experts in health economics from the LSHTM and directs activities and develops strategies to achieve the overall goal. Funding: Major funders include: the Humanitarian Aid Ministry in the Dutch government (BUZA), UK Department for International Development (DFID), the Office of the United States Foreign Disaster Assistance (OFDA). Achievements: On-going. 8.1.2.3-53 53 Annex 8.1.2.3 Malaria Vaccine Initiative (MVI) Background: Based in Rockville, Maryland and Seattle, Washington, MVI is administered by Program for Appropriate Technology in Health (PATH), a U.S. tax-exempt 501 (c) (3) not-for-profit organization. MVI's mission is to accelerate the development of malaria vaccines and ensure their availability in the developing world. Funds are directed to Vaccine Development partnerships with industry, biotechnology firms, government agencies and academia. Each project may support process development, production, and/or clinical trials in malaria-endemic regions. MVI is guided by Technical Advisory Groups and PATH's board. Partners include malaria experts around the world, government agencies, academia, public and private research institutions, and vaccine producers. Business development, communication, and policy activities support the vaccine development partnerships and seek to improve the environment for malaria vaccine development and introduction. Funding: MVI was started with seed funding of $50 million from the Bill & Melinda Gates Foundation in June 1999. An additional $100 million was provided in 2003 by the Gates Foundation. Achievements: MVI has established a series of carefully crafted partnerships with pharmaceutical and biotech companies, governments, and research institutions around the world. MVI is currently supporting the development of 17 vaccine constructs, of which nine are in vials. Six of the vaccine candidates have been moved into a total of 12 vaccine trials (in endemic and non-endemic countries). Today more malaria vaccines are moving into clinical trials than ever before. Difficulties in overcoming this barrier have impeded malaria vaccine development for decades. New funding will allow more of what has been discovered over the past 10-15 years to finally be evaluated in people-currently the only way to know if potential malaria vaccines might work. 8.1.2.3-54 54 Annex 8.1.2.3 Malarone Donation Program Background: Set up in 1997 as a collaborative agreement between The Task Force for Child Survival and Development (TFCSD), Georgia, USA, a U.S. tax-exempt 501(c)(3) not-for-profit organization, and GlaxoSmithKline (formerly Glaxo Wellcome). The secretariat is housed within TFCSD. The pilot phase of the controlled donation of Malarone (a combination of atovaquone and proguanil) was established at seven pilot sites in Kenya and Uganda to develop a locally sustainable donation program that ensured control over and appropriate use of Malarone in order to preserve its utility as a valuable antimalarial agent. Partners included Ministries of Health in Kenya and Uganda, WHO, World Bank, GlaxoSmithKline, Wellcome Trust, and CDC all of whom were represented on the Advisory Committee. The pilot phase of the Malarone Donation Program was found to have had a positive effect at the seven pilot sites by improving diagnosis and management of malaria and enhancing the understanding of the challenges of malaria control. However, the pilot phase demonstrated that the Donation Programme is not an efficient and effective use of resources to achieve the objective of reducing suffering and death from malaria. The program ended upon completion of the pilot phase on 30 September 2001. Funding: Major funders included the pharmaceutical company GlaxoSmithKline and the Task Force for Child Survival and Development. Achievements: Improving diagnosis and management of malaria at pilot test sites. 8.1.2.3-55 55 Annex 8.1.2.3 Maternal and Neonatal Tetanus, Global Elimination of (MNT) Background: Established in 1998, this campaign involves a donation program of Becton Dickinson & Company (BD), which produces an auto-disable syringe (ADs), used by UNICEF in its efforts towards the global elimination of tetanus as a public health problem for women and newborns. Till now BD and Biofarma, an Indonesian vaccine manufacturer, have donated 9 million UniJects jointly. BD supplies the blank UniJects and Biofarma fills them with the tetanus toxoid vaccine. Other participants include WHO, UNFPA, BASICS, a programme of USAID, Johns Hopkins University, the Program for Appropriate Technology for Health (PATH), the Bill & Melinda Gates Foundation and the US Centers for Disease Control (CDC). The later has agreed to donate 135 million syringes, including ADs syringes and 9 million UniJects, while UNICEF purchases the remaining syringes. Funding: To be confirmed Achievements: Currently, of the 240 million women at risk for tetanus, 33 million women in high-risk areas have been protected with two doses of the tetanus toxoid vaccine since 1999. An estimated 207 million women are still at risk for tetanus and need to be targeted with three doses of TT vaccine. As a result of accelerated activities for MNT elimination, 15,000 additional neonatal deaths were prevented in 2000, down from 215,000 in 1998. An additional four countries (Malawi, Namibia, South Africa, and Zimbabwe) will soon join the list of eliminated countries, bringing the number of MNT elimination priority countries down to 53. As of April 2003, 32 national plans of action (POAs) to eliminate MNT are either finalized or in draft. 8.1.2.3-56 56 Annex 8.1.2.3 Mectizan Donation Program (Mectizan) Background: The Mectizan Donation Program was launched in 1987 when Merck & Co., Inc. made the unprecedented announcement that it would donate as much Mectizan (ivermectin) as necessary, for as long as necessary, to treat river blindness (onchocerciasis) and to bring the disease under control as a public health problem. The donation of Mectizan was later expanded in 1998 to include the treatment of lymphatic filiariasis (LF) in African countries where LF and onchocerciasis co-exist. Governance is provided by the Mectizan Expert Committee, an independent advisory board consisting of seven internationally recognized experts in public health and tropical diseases, two advisors on lymphatic filariasis, and non-voting liaison representatives of APOC, CDC, Merck, the NGDO Coordination Group for Onchocerciasis Control, World Bank,. The secretariat for the Mectizan Expert Committee is housed within the Task Force for Child Survival and Development, Atlanta, Georgia, a U.S 501 (c)(3) not-for-profit organization, in a collaborative agreement with Merck & Co., Inc. Funding: Merck & Co., funds the Mectizan Donation Program, but spending for country level implementation is channeled through a World Bank Trust Fund from bilateral donors and NGOs. Achievements: 2003 marked the 16th anniversary of the Mectizan Donation Program for the treatment of onchocerciasis. To date Merck has donated more than 250 million treatments worldwide reaching more than 30 million people a year in 34 countries in Africa, and Latin America. Furthermore, in 2002 Mectizan was provided for Lymphatic Filariasis prevention to more than 12 million people in 8 countries. 8.1.2.3-57 57 Annex 8.1.2.3 Medecins Sans Frontieres Drugs for Neglected Diseases Working Group (MSF DND) Also see: Drugs for Neglected Diseases Initiative (DNDi) Background: MSF DND is an independent expert working Group that advises Medecins Sans Frontieres and the MSF Access to Essential Medicines Campaign. Organized in October 1999, the objective of the group is to ensure research and development (R&D) and equitable access to medicines developed for the treatment of diseases predominantly affecting impoverished populations. The strategy includes detailed problem analysis, raising public awareness, gaining political support, and recommending new strategies to relaunch drug R&D for currently neglected patients in the South. Major participants include representatives from WHO and other public health specialists, individual scientists, tropical medical experts, interested NGOs, and industry. The Working group is also studying the feasibility of creating a major new not-forprofit R&D initiative that will focus on developing drugs for neglected diseases (the DNDi). Funding: Major funders include: the European Union, Medecins Sans Frontieres (MSF), Rockefeller Foundation and the World Health Organization (WHO). Achievements: Launch of Drugs for Neglected Diseases (DNDi) in 2003. For detailed information about DNDi, please refer to Section 8.5.3, Part B, Case Studies and Needs Assessment of Five Public-Private Partnerships. 8.1.2.3-58 58 Annex 8.1.2.3 Medicines for Malaria Venture (MMV) Background: The Medicines for Malaria Venture (MMV) was created in 1999 as a Geneva-based not-for-profit organization under Swiss law, to discover, develop and deliver new antimalarial drugs that are effective and affordable. Funding: MMV receives funding and support from the following organizations: the Bill and Melinda Gates Foundation, ExxonMobil Corporation, Global Forum for Health Research, International Federation of Pharmaceutical Manufacturers Associations (IFPMA), WHO, the Rockefeller Foundation, the World Bank, Roll Back Malaria Global partnership, TDR, the United Kingdom Department for International Development (DFID), Swiss Agency for Development and Cooperation, the Netherlands Minister for Development Cooperation and the Wellcome Trust. MMV also receives contributions in-kind, such as management expertise, access to chemical libraries, high throughput screening and data handling, from pharmaceutical companies, biotech firms, universities and research institutes. Achievements: MMV’s goal is to identify one new drug every five years with the first one by 2010. In order to reach its goal, MMV has built up the largest antimalarial drug research and development portfolio in history which currently consists of 21 projects in different developmental stages. Within its eleven discovery and ten development projects, MMV has eight completely new therapeutic targets in the pipeline. The clinical development projects are gaining momentum and several of preclinical projects are set to move into clinical studies in 2004. For detailed information about this organization, please refer to Section 8.5.3, Part A, Case Studies and Needs Assessment of Five Public-Private Partnerships. 8.1.2.3-59 59 Annex 8.1.2.3 Meningitis C Vaccine Development and Supply in UK Background: David Salisbury, head of Immunizations for UK Department of Public Health, managed an innovative public-private cooperation to develop this vaccine and get it manufactured at competitive prices. Funding: Major funding comes from the UK Department of Health. Achievements: Development of a Meningitis C vaccine manufactured at competitive prices. 8.1.2.3-60 60 Annex 8.1.2.3 Meningitis Vaccine Project at WHO/PATH (MVP) Background: MVP is a partnership between the World Health Organization (WHO) and the Program for Appropriate Technology in Health (PATH) created with the technical advice of the U.S. Centers for Disease Control and Prevention, to eliminate epidemic meningitis in sub-Saharan Africa. The project aims to develop a viable serogroup A meningococcal conjugate vaccine within five years by leveraging the strengths of the public and private sectors to commission the development of a vaccine that would not otherwise be commercially feasible. This ten-year project will ensure the delivery of this vaccine through mass and routine immunization programs for children and adults in affected countries. Key partners include vaccine companies and international and national groups working to prevent and respond to meningococcal meningitis epidemics in Africa. Funding: The project is a ten-year program, with initial funding of $70 million from the Bill & Melinda Gates Foundation in May 2001. Achievements: On-going. 8.1.2.3-61 61 Annex 8.1.2.3 Microbicides Development Programme (MDP) Background: MDP is a partnership to accelerate the evaluation and development of vaginal microbicides for the prevention of HIV transmission. Established in 2001, the programme is funded by the UK Department for International Development and administered by the Medical Research Council Clinical Trials Unit and Imperial College London. The central goal of the partnership is to complete a phase III effectiveness trial of candidate microbicides in multiple sites in sub-Saharan Africa. Currently, feasibility studies to estimate incidence and assess condom usage are currently being conducted in Tanzania, Zambia, Uganda and three sites in South Africa. Furthermore, MDP aims to develop new products to enter safety studies in the UK and Africa; to conduct social science research into the acceptability and possible barriers concerning the uptake of the products, as well as to facilitate marketing and access to a successful microbicide. Funding: Major funding comes from the UK Department of International Development (DFID), $27 million over 5 years. MDP funding mechanism is through grants. Achievements: On-going. 8.1.2.3-62 62 Annex 8.1.2.3 Micronutrient Initiative (MI) Background: The Micronutrient Initiative (MI) is an international development agency specializing in micronutrient nutrition. MI supports and promotes food fortification and supplementation programs in developing countries and provides technical, financial and operational support in those areas where micronutrient malnutrition is prevalent. MI is based in Ottawa, Canada and maintains a regional office in New Delhi, India. MI is governed by an international Board of Directors. Funding: Major funding comes from the Canadian International Development Agency (CIDA). Achievements: On-going. 8.1.2.3-63 63 Annex 8.1.2.3 Mother-to-Child-Transmission-Plus Initiative (MTCT-Plus) Background: Launched at a meeting of leaders of private foundations with the UN Secretary General, Kofi Annan in December 2001, the mother-to-child transmission (MTCT)-Plus Initiative is a new HIV/AIDS treatment program coordinated by the Mailman School of Public Health at Columbia University and supported by a coalition of 9 private foundations. The MTCT-Plus Initiative will support the provision of HIV-specific care, including access to a number of standardized antiretroviral options when clinically indicated, to HIV-infected women and children identified in existing MTCT programs, and to their HIV-infected family members as appropriate. The MTCT-Plus Initiative aims to decrease morbidity and mortality, further reduce mother-to-child transmission of HIV, lessen orphanage, and strengthen local health care capacity in eight African and Asian countries. Funding: Major funders include the Bill & Melinda Gates Foundation, Henry J. Kaiser Family Foundation, the William and Flora Hewlett Foundation, John D. and Cathrine T. MacArthur Foundation, Robert Wood Johnson Foundation, Rockefeller Foundation, Starr Foundation and the United Nations Foundation. Achievements: Patient enrollment has only recently begun, so data on program performance is not yet available. However, a variety of lessons have been learned concerning the design and implementation of care and treatment programs in resource poor settings. 8.1.2.3-64 64 Annex 8.1.2.3 Multilateral Initiative on Malaria (MIM) Background: MIM is a coalition of organizations and individuals established in 1997 and coordinated by a Secretariat that rotates every few years among partner organizations. MIM's current secretariat is hosted by the Karolinska Institutet and Stockholm University and housed in Stockholm University having been passed from the Fogarty International Center in January 2003. The objective of MIM is to strengthen and sustain, through collaborative research and training, the capability of malaria endemic countries in Africa to carry out research required to develop and improve tools for malaria control. MIM aims to raise international public awareness of the problem of malaria, to promote global communication and co-operation, and to ensure that research findings are applied to malaria treatment and control. Funding: DONORS/YEARS 2003 TOTAL 945,000 945,000 200,000 200,000 787,000 787,000 250,000 250,000 500,000 500,000 2,682,000 2,682,000 US National Institutes of Health (NIH) UNDP/WB/WHO Special Programme for Research & Training in Tropical Diseases (TDR) Swedish International Development Agency (SIDA) World Bank National Library of Medicine (NML), US TOTAL Achievements: Capacity building of African malaria scientists. 8.1.2.3-65 65 Annex 8.1.2.3 NetMark PLUS, a Regional Partnership for Sustainable Malaria Prevention Background: NetMark Plus represents the cutting edge in public-private partnerships for sustainable business and development. Funded by the US Agency for International Development (USAID) and implemented by the Academy for Educational Development (AED), NetMark Plus is an eight-year (September 1999 through September 2007), $65.4 million dollar project designed to reduce the impact of malaria in sub-Saharan Africa through the increased use and sustainable supply of insecticide treated mosquito nets (ITNs), and insecticide treatments kits for nets, through partnership and joint investment with a wide range of international and local commercial partners. AED’s core partners on NetMark include the Malaria Consortium (UK), Group Africa, and FCB Advertising. Commercial partners include BASF, Bayer AG, Siamdutch Mosquito Netting Company, A-Z Textiles and Vestergaard Frandsen. AED is currently in negotiations with these and other international and Africa-based companies for the expansion of the program throughout sub-Saharan Africa. Funding: Various donors have contributed $2.6 million to this partnership. Achievements: Commercial partnerships formed with over 25 international and African companies; regional and national communications campaigns developed and launched; commercial sales of ITN products increased in 6 countries to date; new ITN products are coming into the market; support to ITN policy development continues; new models for targeted subsidies have been developed and tested. 8.1.2.3-66 66 Annex 8.1.2.3 Norplant, Development of Background: The development of a long-acting contraceptive implant, suitable for use in developing countries through collaborations between academic research institutions, technology developers, and manufacturers, led and funded largely by the Rockefeller Foundation. Funding: Funding came primarily from the Rockefeller Foundation. Achievement: Successful product development. 8.1.2.3-67 67 Annex 8.1.2.3 Onchocerciasis Control Programme in West Africa (OCP) Background: The Onchocerciasis Control Programme (OCP) in West Africa began operations in 1974 in seven countries and later extended operations to eleven countries. The program was initially planned for completion in twenty years. This time frame was needed to ensure the continuation of vector control (larviciding to prevent reproduction of blackfly) for a period long enough that the adult warm reservoir in the human population would die out in the absence of renewed infection. The program has virtually eliminated river blindness from a 10-country program area through aerial application of environmentally-safe insecticides to breeding sites of the blackfly. Little progress has been made in Sierra Leone due to continuing civil unrest. More recently, OCP has been assisting efforts to ensure that the beneficiary countries are in a position to safeguard this achievement. The countries rely principally upon multi-disease surveillance and CDTI to ensure control maintenance. The principal tool has been vector control. By halting reproduction of the intermediate host by destroying blackfly larvae, vector control effectively interrupts transmission of the disease. In the late eighties, the program initiated the distribution of Ivermectin (Mectizan) as a complementary method of control. Mectizan is a microfilaricide which effectively kills off 95% of the microscopic worms for up to a year, with virtually no side effects. However, it does not kill the adult worm. OCP has brought together a wide range of partners, including donor governments, the private sector, participating countries and non-governmental organizations. OCP will come to a conclusion in FY2003, and all external donor support will cease by then. DGF support is expected to end in FY2003. At that point, control maintenance responsibilities -- multi-disease surveillance and control -- will have been passed on to the 10 Participating Countries. The transfer of these activities is currently underway and projects for capacity building are under preparation or implementation in Senegal (Bank), Cote d'Ivoire (Bank), Guinea (Bank), Burkina Faso (Bank), Mali (Belgium), and Niger (Netherlands). It is fully recognized by OCP management, the Sponsoring Agencies, and the donors that "transfer" activities must be given the highest priority if OCP is to be brought to a lasting and successful conclusion on schedule. Funding: Major funding came from Merck & Co., Inc. as well as from 20 donor countries and agencies through a World Bank Trust Fund. Achievements: The OCP program has been hailed as one of the most successful partnerships in the history of development assistance. The results of the program include: (i) Virtually halting transmission of onchocerciasis throughout the eleven-country program area; (ii) Preventing 600,000 cases of blindness by the conclusion of the program in FY03; (iii) Sparing 18 million children born since the program's inception from any risk of contracting onchocerciasis; and (iv) Freeing up an estimated 25 million hectares of arable land for resettlement and cultivation. 8.1.2.3-68 68 Annex 8.1.2.3 Oral Rehydration Salts (ORS) Commercialisation in Bolivia Background: A public-private partnership led by BASICS, a USAID funded project and consisting of Ministry of Health, UNICEF, and commercial drug manufacturers was formed to expand the market for Oral Rehydration Therapy (ORT) as a consumer product to reduce deaths from dehydration due to diarrhea. Description of process to stimulate the commercial sector to develop commercial production, marketing, and distribution network by providing publicly funded planning, market research, and public health promotion. The objective of this project was to create incentives for commercial entities to undertake calculated risks and develop a market for ORT in Bolivia. Funding: The project was funded primarly by USAID. Achievements: The partnership created demand for the product through multi-faceted approaches to caregivers, health professionals and drug sellers. It also established a conducive environment in which two companies mobilised their capabilities to produce new ORS products that were well-received in the market, meeting public health goals, and yet were profitable enough to ensure a sustainable supply in the private health care market. 8.1.2.3-69 69 Annex 8.1.2.3 Pediatric Dengue Vaccine Initiative (PDVI) Background: The Pediatric Dengue Vaccine Initiative (PDVI) represents a public-private effort to raise awareness of the need for and accelerate the development of a dengue vaccine that is appropriate, safe, and accessible to poor children in endemic countries. Dengue is a mosquito-born viral disease that burdens tropical regions around the world. Yearly, in addition to tens of millions of cases of severe dengue fever, an average of 500,000 persons, mostly children, are hospitalized with dengue hemorrhagic fever with high case fatality rates. No specific, effective treatment is available and vector-control strategies have been insufficient to counter the pandemic. This led Rockefeller Foundation and the International Vaccine Institute to convene a meeting in 2001 to focus on the challenges and opportunities for the development of a pediatric dengue vaccine. The meeting, and related working-group processes, have energized the field and built unprecedented momentum to bring about a coordinated global effort. This coincides with a 2002 resolution by the World Health Assembly that stresses the negative impact of dengue on health and development. Funding: DONORS/YEARS 2000 2002 2003 1,000,000 TOTAL 1,000,000 Rockefeller Foundation 75,000 75,000 Ellison Medical Foundation 55,000,000 55,000,000 55,000,000 56,075,000 Bill & Melinda Gates Foundation TOTAL 1,000,000 75,000 Achievements: On-going. 8.1.2.3-70 70 Annex 8.1.2.3 Pharmaceutical Security Institute (PSI) Background: The Pharmaceutical Security Institute (PSI) is an initiative launched by major multi-national pharmaceutical companies to investigate and provide government and law enforcement agencies information on pharmaceutical counterfeiting. The Institute is a non-profit organization established in 1997, however the consortium was dissolved in 2001 and a new organization PSI Incorporated was established as a non-profit organization in Dalaware on November 1 2001. Operations begun on 1 January 2001 with the mission to protect the public health from criminal groups involved in counterfeit pharmaceuticals and initiate enforcement actions through the appropriate authorities. Funding: Major funding comes primarily from commercial partners. Achievements: On-going. 8.1.2.3-71 71 Annex 8.1.2.3 Pneumococcal Vaccines Accelerated Development and Introduction Plan (PneumoADIP) Also see: GAVI Background: The Pneumococcal Vaccines Accelerated Development and Introduction Plan, Pneumo ADIP is an independent group located at Johns Hopkins School of Public Health and funded by The Global Alliance for vaccines and Immunizations GAVI. Its mission is to improve child health by accelerating the evaluation of and access to, new life saving pneumococcal vaccines for the world’s poorest children. Pneumo ADIP aims to shorten the time lag between the use of a new vaccine in rich countries and its use in poor countries by working to achieve a sustainable, affordable supply of quality vaccines by reducing the uncertainty of demand for the vaccine in the world’s poorest countries. Funding: Global Alliance for Vaccines Immunization (GAVI) has provided $30 million in funding for this project. Funding is for a period from February 1, 2003 until December 31, 2007. Achievements: The PneumoADIP project is driven by a milestone approach where each function in the team has clearly defined targets and objectives and a timeline attached to them. The partnership is currently undertaking a survey among 4 developing countries and the donor community to determine the current perceptions of and attitudes to acute respiratory infections. This survey will be repeated on an annual basis to track measurable change in awareness levels and attitude. 8.1.2.3-72 72 Annex 8.1.2.3 Praziquantel Manufacturing Project Background: During the late 1970s and early 1980s, the pharmaceutical company Shin Poong worked with Korean government research institutes and governmental grant support to develop a new, less costly manufacturing process for the schistosomiasis drug, praziquantel. This drug was originally developed by Bayer and E. Merck collaboratively and the product and initial production process patented, first in 1973, and ultimately in 38 countries. Shin Poong received a Korean patent for its production process and designation as a protected product giving it a legal duopoly in Korea, with Bayer, from 1983 to 1988. Shin Poon aggressively marketed its product, undercutting Bayer pricing in a number of markets. Despite the improved affordability of praziquantel to poorer markets, it was not taken up for schistosomiasis control in many poorer countries because of the low priority accorded this disease. Partnership is terminated. Funding: Major funding came from the Government of South Korea. Achievements: Successful development of less costly drug. 8.1.2.3-73 73 Annex 8.1.2.3 Roll Back Malaria Global Partnership (RPS) Background: A partnership launched in October 1998 and hosted by a WHO Secretariat which aims to provide global leadership, strategy, and overall coordinating mechanisms to reduce the global malaria burden by 50% by the year 2010 through interventions adapted to local needs and strengthening of the health sector. RPS seeks to strengthen health systems to ensure better delivery of health care, especially at district and community levels; ensure the proper and expanded use of insecticide-treated mosquito nets; ensure adequate access to basic healthcare and training of healthcare workers; encourage the development of simpler and more effective means of administering medicines, such as training of village health workers, mothers and drug sellers on early and appropriate treatment of malaria, especially for children; encourage the development of more effective and new anti-malaria drugs and vaccines. An independent evaluation of Roll Back Malaria was conducted in late 2002 to determine the effectiveness of the partnership. The results of the evaluation indicated that organizational and structural changes were needed to make partners more accountable and to accelerate malaria control efforts at the country level. Consequently, as of January 2003, Roll Back Malaria has been restructured and now consists of multiple entities. The Geneva based entities supporting Roll Back Malaria now consist of a Roll Back Malaria Partnership Secretariat (RPS) and a WHO Malaria Control Department (RBM). The Partnership Secretariat (RPS) is primarily responsible for supporting the scaling-up operations of the partnership, providing secretariat support to Roll Back Malaria Partnership Working Groups and linking with different WHO Programmes. The Roll Back Malaria Control Department (RBM) is responsible at Headquarters level for WHO's work to promote malaria control in the world, within the global Roll Back Malaria partnership. WHO's work includes the establishment of international consensus on policies, strategies, standards and norms, support to programme implementation in countries in coordination with other partners, as well as monitoring and evaluation of the malaria situation in the world. Funding: Major funding inludes: Bill & Melinda Gates Foundation, European Commission, UK Department for International Development (DFID), Government of Germany, Government of Italy, Government of Japan, Government of Luxemburg, Government of the Netherlands, Government of Norway, US Agency for International Development (USAID), United Nations Children's Fund (UNICEF), World Bank, and World Health Organization (WHO). Achievements: Five years after the launch of Roll Back Malaria in 1998, this groundbreaking health initiative has matured into a functional global partnership of governments, civil society and non-governmental organizations, research institutions, professional associations, UN and development agencies, development banks, the private sector and the media. The initial phase (1998-mid 2002) succeeded in raising global awareness of malaria, generating increased resources, and achieving consensus on the priority interventions required to fight the disease. 8.1.2.3-74 74 Annex 8.1.2.3 Safe Injection Global Network (SIGN) Background: In 1999 this coalition of stakeholders was formed facilitated by a WHO secretariat. SIGN participants are collaborating to create and maintain a common strategic framework; to promote exchange of ideas and information to encourage research on innovative, cost-effectiveness solutions; and to coordinate advocacy and communication strategies. Participants include UNICEF, UNAIDS, CDC, BASICS/USAID, PATH, non-governmental organizations, universities, consultants, and industry representatives. Funding: Major funding comes from the World Health Organization (WHO). Achievements: On-going. 8.1.2.3-75 75 Annex 8.1.2.3 Schistosomiasis Control Initiative (SCI) Background: In June 2002, the Bill and Melinda Gates Foundation awarded $30 million for the establishment of the Schistosomiasis Control Initiative (SCI). This award will be used primarily to bring treatment against schistosomiasis and intestinal worms (where appropriate) to many individuals in Africa at high risk of serious disease. Thus this new partnership will continue to contribute to the World Health Organisation's work in schistosomiasis research and control activities. Other partners include Harvard University, which will be responsible for some of the operational research, the Danish Bilharziasis Laboratories which will oversee in-country training, and the countries themselves. Funding: The Bill and Melinda Gates Foundation awarded $30 million for this project. Co-funding has been guarantted from all the governments who have applied for support, and co-funding from external agencies has been leveraged in a number of countries. Achievements: SCI was successful in placing schistosomiasis high on the national health agendas of 11 countries namely: Burkina Faso, Cameroon, Ghana, Kenya, Malawi, Mali, Niger, Nigeria, Tanzania, Uganda and Zambia. Uganda was pre-selected as the first SCI country and as of July 2003 over 300,000 cases of schistosomiasis have been treated. Q4 2003 will target another 500,000 individuals and in 2004 it is hoped that 2 million individuals will be treated. 8.1.2.3-76 76 Annex 8.1.2.3 Secure the Future (SF) Background: This five-year, $100 million program started in May 1999 as a philanthropic project of Bristol-Myers Squibb Company, and was increased to $115 million in 2001. The overall objective is to provide care and support for women and children with HIV/AIDS. Current programs aim to help alleviate the HIV/AIDS crisis in five hard-hit countries in southern Africa: South Africa, Botswana, Namibia, Lesotho, and Swaziland, as well as four countries in West Africa: Senegal, Cote d'Ivoire, Mali and Burkina Faso. The program provides grants for medical research, community outreach, and education programs. It also encourages and funds capacity-building educational programs in medicine, healthcare and public health. The program is governed through partnerships with national governments, educational, NGOs medical institutions, faith based organizations and people living with HIV/AIDS in Africa and the US. Funding: Bristol-Myers Squibb Company has provided $115 million in financial support. Achievements: To date, over 150 projects have been funded in all five southern African countries for a total of $65 million and 14 programs totaling almost five million in West Africa. 8.1.2.3-77 77 Annex 8.1.2.3 Single Nucleotide Polymorphisms Consortium Ltd (SNP) Background: The SNP Consortium Ltd. is a 501 (c)(3) non-profit foundation organized for the purpose of providing public genomic data. Its mission is to develop up to 300,000 SNPs distributed evenly throughout the human genome and to make the information related to these SNPs available to the public without intellectual property restrictions. The project started in April 1999 and is anticipated to continue until the end of 2001. Participants include research institutions, pharmaceutical companies and biotech companies. Funding: None available Achievements: Unavailable. 8.1.2.3-78 78 Annex 8.1.2.3 Step Forward Program Background: Step Forward Program is a long-term, international program to help improve the lives of AIDS orphans and vulnerable children, families and communities affected by AIDS around the world. Created and funded by the Abbott Laboratories Fund in July 2000, Step Forward Program assists children, by improving local health care services, providing voluntary HIV counseling and testing, supporting primary and secondary education programs and providing for basic community needs. It works closely with community health services in poor countries affected by HIV/AIDS and with the International Association of Physicians in AIDS Care (IAPAC) in Chicago and the Baylor International Pediatric AIDS Initiative (BIPAI) in Houston, Texas. Funding: Funding is provided by The Abbott Laboratories Fund, a U.S. 501(c)(3) not-for-profit organization, administered and managed independent of Abbott Laboratories. Achievements: On-going. 8.1.2.3-79 79 Annex 8.1.2.3 Stop TB Partnership (Stop TB) Background: A partnership hosted by the World Health Organization (WHO), which aims to provide global leadership, strategy, and coordinating mechanisms. Its objective is a TB free world: the first children born this millennium will see TB eliminated in their lifetime. Over twenty high TB burden countries have adopted the Amsterdam Declaration to Stop TB, as well as numerous UN organizations and bilateral donors. Other partners include educational and research institutions, TB associations and NGOs, and pharmaceutical companies. A governance structure is in place (Stop TB Framework), plans and activities are coordinated by the Stop TB Coordinating Board. Funding: Major funders include: The United Nations Children's Fund (UNICEF), World Bank, World Health Organization (WHO), over 200 partner-organizations, the International Union for TB and Lung Diseases (IUATLD), American Thoraic Society, American Lung Association and the Royal Netherlands TB Association (KNCV). Achievements: The Global Stop TB Partnership has established itself in a very short time as a widely respected global health partnership. It has built and is sustaining a network of partners; established a partnership architecture which commands broad support; marshalled widespread commitment to a detailed Global Plan to Stop TB; highlighted work on new diagnostics, drugs and vaccines; and operationalized in a remarkably short time a complex Global TB Drug Facility covering grant-making, procurement and partner mobilisation for technical assistance. 8.1.2.3-80 80 Annex 8.1.2.3 Strategies for Enhancing Access to Medicines (SEAM) at Management Sciences for Health (MSH) Background: Launched in October 2000, SEAM is a program of Management Sciences for Health, which is a U.S. taxexempt 501 (c )(3) not-for-profit organization based in Boston, Massachusetts, USA. The SEAM Program has offices in Washington, D.C. and Ferney-Voltaire, France. Its aim is to improve the drug supply systems of developing countries and to create new public-private models designed to promote access to drugs and vaccines throughout the world. SEAM country programs are being implemented in El Salvador, Ghana, Kenya and Tanzania. Funding: Major funding in the amount of US $29,957,826.00 comes from the Bill & Melinda Gates Foundation. Achievements: On-going. 8.1.2.3-81 81 Annex 8.1.2.3 Syringes - Autodestruct Development Background: The driving force behind the development of autodestruct syringe has at first not come from the field of drugs. The main impetus came from the United Nations Children's Fund (UNICEF), supported by the World Health Organization (WHO), that ceased to supply disposable syringes to the developing countries from April 1987, except to those that have developed a system of effective disposal of these after one use. Within this framework autodestruct syringe in immunization programs serve to prevent people to remain unvaccinated because of fear for attracting AIDS or other blood-transmissible diseases. Since 1987 the WHO has tested 273 different models, and rejected more than three quarters of them. The partnership is now terminated. Funding: Major support was provided by WHO. Achievements: In 1988 a partnership between UNICEF and WHO’s Vaccines Department (HTP/VAB) forged an alliance with inventors and vaccine manufacturers to develop and produce single-use, self-destructing syringes for use in immunization programs. The partnership solicited product ideas by inventors (over 300 applied), provided startup funding to top ideas (20 selected), and found three device designs that met all criteria. Included in the arrangement was that the intellectual property rights would go to WHO. Once the partnership had an accepted and marketable product design, it opened the bidding process up to syringe manufacturers and negotiated production, purchasing agreements, and maximum pricing levels. The manufacturers currently (1999) sell approximately 500 million syringes per year. 8.1.2.3-82 82 Annex 8.1.2.3 TROPIVAL Background: Tropival was established in 2001 with the support of funding from the “Conseil Regional d’Aquitaine” and works under the University Victor Segalen Bordeaux 2, France. Tropival coordinates R&D projects conducted between public laboratories and pharmaceutical companies, with the goal of improving the treatment of neglected diseases such as malaria, trypanosomiasis and tuberculosis. Through the creation of a scientific and economic network, Tropival intends to guide the pharmaceutical industry towards the development of molecules, which, at first glance, might seem to be of humanitarian interests, but present a real economic challenge. Funding: DONORS/YEARS 2001 2002 82,000 2003 TOTAL 148,000 230,000 World Health Organization (WHO) 155,000 155,000 European Commission 50,000 50,000 Conseil Régional d’Aquitaine TOTAL 132,000 155,000 148,000 435,000 Achievements: On-going. 8.1.2.3-83 83 Annex 8.1.2.3 Tuberculosis Diagnostics Initiative (TBDI) The Tuberculosis Diagnostic Initiative (TBDI) was established in 1996 by the former Global TB Programme of the World Health Organization, and in August 1998, received a five-year $10 million grant from the Bill & Melinda Gates Foundation and funding from the Rockefeller Foundation and USAID. Housed within TDR, this initiative operates through broad partnership with public health officials, academic researchers, expert clinicians and commercial test developers, in order to develop faster, simpler diagnostics for tuberculosis. The strategy of the TBDI is to work jointly with industry to facilitate commercial development of necessary tools, rather than funding of diagnostics research and development directly. This is in recognition of the high volume of tests needed, together with the moderate test development costs for diagnostics. The partnership is terminated. Funding: DONORS/YEARS 1999 2000 2001 1,000,000 TOTAL 1,000,000 Rockefeller Foundation 10,000,000 10,000,000 10,000,000 11,000,000 Bill & Melinda Gates Foundation TOTAL 1,000,000 USAID also provided funding. Achievements: Unavailable. 8.1.2.3-84 84 Annex 8.1.2.3 UNFPA Contraceptives Access Project (UNFPA/Industry) Background: Recently started collaboration with UNFPA as broker to focus on the role of the commercial sector in marketing affordably-priced contraceptives to those who can afford to buy them and thereby enable governments to focus scarce resources on the poor and disadvantaged members of society. This stemmed from earlier meetings in Cairo in 1994 and again in Bellagio, Italy, in November 1998 to review progress of the initiative. They affirmed the contributions of the commercial sector and concluded that an expanded role is desirable. It was recommended that UNFPA consider institutionalizing this initiative in its programme development process. Funding: Major funders include: David and Lucile Packard Foundation, Rockefeller Foundation, UK Department for International Development (DFID), and the US Agency for International Development (USAID). Achievements: On-going. 8.1.2.3-85 85 Annex 8.1.2.3 Vaccine Fund (VF) Background: The Vaccine Fund is a financing mechanism designed to help the Global Alliance of Vaccines and Immunization (GAVI) increase children’s access to vaccines in poor countries. It helps GAVI achieve its objectives by raising new resources and swiftly channeling them to developing countries. The Vaccine Fund was created as a 501 (c)(3) organization in late 1999, with a $750 million donation from the Bill & Melinda Gates Foundation to narrow the immunization gap between rich and poor countries and to leverage support from donor governments. Through the Vaccine Fund, countries receive needed new or under-used vaccines or financing to strengthen their health infrastructures based on the recommendations of the GAVI Board. Funding: The Vaccine Fund has received commitments of more than $1 billion to date toward its goal of raising $2 billion over the next five years to meet immunization needs throughout the world. Initiated with a grant from the Bill & Melinda Gates Foundation of $750 million, The Vaccine Fund has received $400 million in commitments from governments including: the United States government US$159 million (over 3 years), government of Norway US$107 million (over 5 years), the government of the Netherlands US$85 million (over 5 years), UK Department for International Development (DFID) US$60 million (over 5 years), Canadian International Development Agency (CIDA) US$30 million (over 5 years), the government of France US$18 million (over 3 years), the government of Sweden US$3 million (over 2 years), the government of Denmark US$1 million (over 1 year), the government of Ireland US$0.5 million (over 1 years), and private contribution totaling US$3 million. Achievements: Results achieved since 2000:$255 million has been disbursed to over 60 countries; 8 million more children have been reached with basic vaccines, including diphtheria, tetanus, pertussis, BCG, measles and polio; 30 million more children have been reached with new vaccines, including hepatitis B, Hib and yellow fever; and, over 300,000 lives will be saved. 8.1.2.3-86 86 Annex 8.1.2.3 Vaccine Vial Monitors (VVMs), Development of Background: The development of vaccine vial monitors (VVMs) begun in 1996 as an informal collaboration amongst WHO, USAID, and the Programs for Appropriate Technology for Heath (PATH). WHO set desired specifications for a tool that can detect and register temperature fluctuations over time during vaccine storage. Funding was predominantly from USAID via PATH, and WHO facilitated field testing and eventually requested vaccine manufacturers to supply VVMs on vaccines sold to UNICEF. Funding: Major funding comes from the US Agency for International Development (USAID). Achievements: The benefits have been greatest during national immunization days, when large volumes of vaccine are transported into the community. VVMs can also cut wastage in routine programs, especially in remote rural areas where teams must travel far from base to reach children. Furthermore, the technology is inexpensive, with each VVM adding only a few cents to the cost of a vial and bringing net savings. 8.1.2.3-87 87 Annex 8.1.2.3 Viramune® Donation Programme (VDP) Background: This donation programme for the antiretroviral drug nevirapine (Viramune®) which prevents mother-tochild transmission (MTCT) of HIV-1 was announced by Boehringer Ingelheim Pharmaceuticals on July 7 2000. The company committed to providing the drug free of charge for use in prevention of MTCT for a period of five years to developing countries. All MTCT prevention programs in eligible countries (World Bank classification of low and lower middle Economies) can apply for the donation. Viramune® is offered free of charge to the governments of eligible countries, as well as to NGOs, charitable organizations and other health practioners in those countries with the expressed approval from the local governement. The distribution and administration of Viramune® at the country level will be carried out through interested governments, nongovernmental organizations, and UN organizations. The management and monitoring of the drug donation programme has been contracted to a third independent party, Axios International. Funding: Major funding comes from the pharmaceutical company Boehringer-Ingelheim. Achievements: On-going. 8.1.2.3-88 88 Annex 8.1.2.3 Vision 2020 Background: In order to make a concerted worldwide effort, WHO and a Task Force of international NGOs have jointly prepared and launched a common agenda for global action: "VISION 2020 -- The Right to Sight. - Vision 2020 is based on the concept of a broad coalition of all international, nongovernmental and private organizations, which collaborate with WHO in the prevention of blindness and eye care delivery. They share the objective of eliminating avoidable blindness as a public health problem by the year 2020, provided adequate resources are available. These organizations will also jointly work to mitigate the implications of blindness in developmental, social, economic and quality-of-life terms. Funding: Major funders include: the pharmaceutical companies Merck & Co., Inc., Pfizer Inc., national governments, international NGOs and the World Health Organization (WHO). Achievements: On-going. 8.1.2.3-89 89 Annex 8.1.2.3 Vitamin A Global Initiative (VITA) Background: On March 16, 1999, Hillary Clinton, the First Lady of the United States officially launched the US commitment to the Global Vitamin A Initiative; an effective public and private sector partnership to focus on combating vitamin A deficiency (VAD) and improving child survival by engaging in global coordination, technical support, advocacy and communication. Funding: Major funders include: the Canadian International Development Agency (CIDA), UK Department for International Development (DFID) and the US Agency for International Development (USAID). Achievements: Vitamin A supplementation programs are being implemented in more than 70 countries worldwide; Focused efforts of this initiative ensure program coverage in countries with the greatest need. 8.1.2.3-90 90 Annex 8.1.2.3 WHO Programme to Eliminate Sleeping Sickness (WPESS) Background: A new Partnership with Aventis SA was established on 3 May 2001 and with Bayer AG on 4 November 2002 under WHO/Communicable Diseases, which provides global coordination for negotiating and ensuring drug supplies, disease surveillance and management, treatment, and research activities for human African trypanosomiasis. Aventis donated $25 million for the next five years and will work in close collaboration with WHO on a three-point strategy including drug donations (eflornithine, pentamidine, melarsoprol), disease management, and research and development. Bristol-Myers Squibb has committed to fund the cost of supplying the bulk material for eflornithine (one year and 400 000 USD for a two years period) and Bayer has agreed to restart production and donate two other drugs used to treat sleeping sickness: suramin and nifurtimox. Médecins sans Frontières, which acted with WHO to bring these drugs back into production, will provide storage, packaging, distribution, and administration of the drugs, in accordance with WHO’s directions, to national control programmes and nongovernmental organizations. Funding: Aventis Pharmaceuticals Inc. provided initial funding of $25 million. Other major funders include: Bill & Melinda Gates Foundation via the University of North Carolina Consortium, Government of Belgium, Government of France, World Health Organization (WHO), and Bristol-Myers Squibb Company. Achievements: Implementation involves enhanced surveillance capabilities and the development of national plans. These aims will be addressed concurrently. The goal is to obtain 100% of countries developing a plan of action with specific milestones. The Steering Committee has contracted with consultants to provide reviews, including issues related to drug production and availability. 8.1.2.3-91 91 Annex 8.1.2.3 WHO/Novartis Coartem® Background: As part of the mission to provide essential medicines at affordable prices, WHO has entered into an agreement with Novartis, which will supply a new therapy for drug resistant malaria at reduced cost. Codeveloped by Novartis and called Coartem®, (a combination of artemether plus lumefantrine), the drug will be introduced as a first or second-line treatment for malaria, in areas where traditional treatment is no longer efficacious. Furthermore, this partnership aims at improving treatment regimens in malariaendemic countries. Novartis will supply the drug in specially designed packs to facilitate adherence to treatment regimens by non-literates. This partnership was launched in 2001 and is supported by WHO/Roll Back Malaria, WHO/TDR, WHO Procurement Office and public health sector agencies in developing countries. WHO will develop demand forecasts to provide Novartis with data for production scheduling, a WHO-appointed technical advisory group (TAG) will review requests for supplies, and drug distribute through the ministries of health in malaria endemic countries, government aid agencies and NGOs. Funding: Major funders include the World Health Organization (WHO) and Novartis company. Achievements; On-going. 8.1.2.3-92 92 Annex 8.1.2.3 WHO-Pharmaceutical Industry Associations-NGO Anti-Counterfeit Drug Initiatives Background: From the early 1990s, IPFMA and WHO have collaborated in various ways including cosponsored meetings and joint training schemes to strengthen regulatory activities on pharmaceuticals in developing countries especially (but not limited to) Africa. Substantial attention was devoted to the problems of counterfeit medicines. Funding: Funding is provided by WHO and IPFMA. Achievements: On-going. 8.1.2.3-93 93