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Financing Treatment Programs: Bilateral Funding PEPFAR: Promises, Pitfalls, and the Need for Change

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Financing Treatment Programs: Bilateral Funding PEPFAR: Promises, Pitfalls, and the Need for Change

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    1. Financing Treatment Programs: Bilateral Funding PEPFAR: Promises, Pitfalls, and the Need for Change

    2. BILATERAL FUNDING FOR HIV/AIDS Breakdown of projected bilateral disbursements in 2004 for global HIV/AIDS Unfortunately we don't have time to go through all the donor bilateral HIV/AIDS programs, so i will be focusing mostly on the U.S. * One reason to talk about US policies is because with US money, comes US policies and this chart from UNAIDS shows that the US was, by far, the largest bilateral donor in 2004. The total money spent in 2004, from all sources--including national governments and private sources--was $6.1 billion according to UNAIDS Unfortunately we don't have time to go through all the donor bilateral HIV/AIDS programs, so i will be focusing mostly on the U.S. * One reason to talk about US policies is because with US money, comes US policies and this chart from UNAIDS shows that the US was, by far, the largest bilateral donor in 2004. The total money spent in 2004, from all sources--including national governments and private sources--was $6.1 billion according to UNAIDS

    3. ARV COVERAGE: PEPFAR & GFATM TX NUMBERS WORLDWIDE 700,00 (reported in November 2004) PEPFAR 155,000 (in its first eight months through, 15 countries, as of September 2004) GOALS: 200,000 people by June 2005 (1 year into program) 2 million people in 2008 (doubling ARV in sub-Saharan Africa) GFATM 130,000 (240K totaled with PEPFAR, including 67K in addition to those supported by PEPFAR) Another reason to focus on the US is the number of people PEPFAR has put on TREATMENT since money was disbursed in FEB 2004. In november WHO announced 700K ppl on TX world wide PEPFAR and GFATM financing combined have put 240K people on TX. PEPFAR has put 155k ppl on TX as of September. GFATM 130K ------------------ MEETING THE TX TARGETS We do know that the OGAC feels the pressure from activists, the bush administration, and Congress to meet its annual treatment targets. OVERLAP As you can see there is clear overlap between GFATM and PEPFAR IN DIRECT We want to know the number of patients for whom the U.S. is only paying non-ARV costs- presumably because countries' stood firm in insisting up their treatment protocols specify therapy with non-PEPFAR approved medicines, e.g., generic FDCs from India; ABSORBED Another reason is to be a skeptical about these numbers is because we know PEPFAR identified the mission hospitals, CBOs, and NGOs that were already providing treatment and simply absorbed their treatment rolls. NEW NUMBER? Certainly the criteria for measuring success of PEPFAR is the new number of people on tx, which they have not released. LOW PERFORMERS We have heard instances where OGAC considered dropping or curtailing country programs that simply were not "high performers." in other words, whether because of lack of infrastructure or capacity, these countries weren't able to rapidly get people on TX to OGAC's liking. OGAC has since agreed to continue support, but we have to monitor the situation to make sure the funding is not flatlined or decreased in the 2nd year of the program. **** As of July 31, 2004: PEPFAR was supporting ART for 24,900 people (18,800 directly funding ART at the point of service delivery and 6,100 receiving indirect treatment support) so 155K represents a huge increase. Another reason to focus on the US is the number of people PEPFAR has put on TREATMENT since money was disbursed in FEB 2004. In november WHO announced 700K ppl on TX world wide PEPFAR and GFATM financing combined have put 240K people on TX. PEPFAR has put 155k ppl on TX as of September. GFATM 130K ------------------ MEETING THE TX TARGETS We do know that the OGAC feels the pressure from activists, the bush administration, and Congress to meet its annual treatment targets. OVERLAP As you can see there is clear overlap between GFATM and PEPFAR IN DIRECT We want to know the number of patients for whom the U.S. is only paying non-ARV costs- presumably because countries' stood firm in insisting up their treatment protocols specify therapy with non-PEPFAR approved medicines, e.g., generic FDCs from India; ABSORBED Another reason is to be a skeptical about these numbers is because we know PEPFAR identified the mission hospitals, CBOs, and NGOs that were already providing treatment and simply absorbed their treatment rolls. NEW NUMBER? Certainly the criteria for measuring success of PEPFAR is the new number of people on tx, which they have not released. LOW PERFORMERS We have heard instances where OGAC considered dropping or curtailing country programs that simply were not "high performers." in other words, whether because of lack of infrastructure or capacity, these countries weren't able to rapidly get people on TX to OGAC's liking. OGAC has since agreed to continue support, but we have to monitor the situation to make sure the funding is not flatlined or decreased in the 2nd year of the program. **** As of July 31, 2004: PEPFAR was supporting ART for 24,900 people (18,800 directly funding ART at the point of service delivery and 6,100 receiving indirect treatment support) so 155K represents a huge increase.

    4. OTHER BILATERALS:WHAT THEY DO THAT THE U.S. WON’T DO (and vice-versa) DFID FUNDING BREAKDOWN 54% on bilateral (and 43% spent on multilaterals) Emphasis on reproductive health and HIV/AIDS Supports comprehensive prevention (rather than just ABC) Direct government support Prefer multisectoral support and SWAPs 10% direct budget support (DBS) 3% to/through UK Civil Society Organizations Invest in buildup of public healthcare workforce (e.g. Malawi) TREATMENT: “All the US talks about is ARVs” Prefer health sector , accuse PEPFAR and TX activists of “medicalizing AIDS” UK * Is the second largest bilateral donor 45% of financing goes to sub-Saharan Africa 43% spent on various health multilaterals (minimum support for global fund which DFiD considers too vertical) . But the support for multilateral is much better than the U.S. balance. 54% of its AIDS funding went to bilateral programs which unlike the US provides support for reproductive health and HIV/AIDS the UK supports comprehensive prevention, unlike the US A-B-C prevention strategy, that is abstinence, be faithful, and condom use but only for high-risk populations. Unlike PEPFAR, the UK provides direct government support through multisectoral financing, sector wide, and direct budget support. Unlike PEPFAR the UK provides channels only a small percentage of funds through british civil society organization Unlike PEPFAR, DfiD is willing to invest in the build up through public health care workforce, such as the pooled fund it established for salaries and training in Malawi. BUT LET's BE CLEAR--i am not suggesting the DfID model is the answer for a number of reasons, including this is still the same agency that lobbied at early Global Fund meetings--before the Fund even had a name--that money should go to build hospitals in rural areas before it filled any of the existing empty medicine cabinents with ARVs. IN FACT, DfiD complains about PEPFAR and TX activists as "medicalizing AIDS" CANADA-Increases in multilateral and bilateral funding : Largest supporter of 3x5 now exceeds "fair share" of GFATM contribution FRANCE early proponent of TX financing to the GFATM and support the european-global south Ester hospital twinning proogram as well as embassy support to HIV projects. JAPAN-2nd wealthiest country, but also the stingiest. has never paid fair share to the GFATM does not support 100% debt cancellation for poor countries. UK * Is the second largest bilateral donor 45% of financing goes to sub-Saharan Africa 43% spent on various health multilaterals (minimum support for global fund which DFiD considers too vertical) . But the support for multilateral is much better than the U.S. balance. 54% of its AIDS funding went to bilateral programs which unlike the US provides support for reproductive health and HIV/AIDS the UK supports comprehensive prevention, unlike the US A-B-C prevention strategy, that is abstinence, be faithful, and condom use but only for high-risk populations. Unlike PEPFAR, the UK provides direct government support through multisectoral financing, sector wide, and direct budget support. Unlike PEPFAR the UK provides channels only a small percentage of funds through british civil society organization Unlike PEPFAR, DfiD is willing to invest in the build up through public health care workforce, such as the pooled fund it established for salaries and training in Malawi. BUT LET's BE CLEAR--i am not suggesting the DfID model is the answer for a number of reasons, including this is still the same agency that lobbied at early Global Fund meetings--before the Fund even had a name--that money should go to build hospitals in rural areas before it filled any of the existing empty medicine cabinents with ARVs. IN FACT, DfiD complains about PEPFAR and TX activists as "medicalizing AIDS" CANADA-Increases in multilateral and bilateral funding : Largest supporter of 3x5 now exceeds "fair share" of GFATM contribution FRANCE early proponent of TX financing to the GFATM and support the european-global south Ester hospital twinning proogram as well as embassy support to HIV projects. JAPAN-2nd wealthiest country, but also the stingiest. has never paid fair share to the GFATM does not support 100% debt cancellation for poor countries.

    5. PEPFAR FACTS TX GOALS “2-7-10” Provide anti-retroviral therapy to 2 million individuals Provide care to 10 million people Prevent 7 million infections TX NUMBERS 155,000 (in its first eight months, target is 200K by June) PEPFAR FUNDING (on an annual basis but authorized to receive $9 billion in new funding on the 15 PEPFAR focus countries broken out by programs: 55% for treatment programs 20% earmarked for prevention (one third for abstinence-only programs) FOCUS COUNTRIES: Botswana, Ivory Coast, Ethiopia, Kenya, Mozambique, Namibia, Nigeria, Rwanda, South Africa, Tanzania, Uganda and Zambia, Guyana , Haiti, Vietnam. More than 100 countries through regular bilateral programs. (e.g. For India in 2004 USG provided $20.5 million to NGOs and government). OVERALL FINANCING ON GLOBAL AIDS: $2.4 billion in 2004 | $3.7 billion in 2005 ``````````

    6. How It Works Track 1: “centrally funded cooperative agreements” with US-based NGOs or academic institutions. e.g Catholic Relief Services, Harvard University, Columbia University, Elizabeth Glaser Track 1.5: Supplemental funding for existing agreements by US agencies. Track 2: US Embassies and agencies in the field develop “country operational plan” in target countries for OGAC approval. THE PLAYERS: OGAC, HHS, USAID, DOD, STATE DEPT (Ambassadors), “Twinning Center” AIDSCorps/Volunteers for Prosperity "...this success is possible only because this is a strong vertical program. The decisions are being made in the US and a very detailed system, managed by mainly US organizations, has been introduced resulting in minimal bureaucracy at country level. This practical and result-oriented way of working has allowed for a very quick identification of hospitals and an immediate supply of the needed drugs. ... But what are the pitfalls of this system?” (EPN Newsletter article) HOW IT WORKS Track 1 Grants are awarded to "centrally funded cooperative agreements" which are usually US-based NGOs or academic institutions Track 1.5 Funding supplements existing agreements that were made by the Department of Health and Human Services, USAID, and the Department of Defense Track 2 Teams from the Department of Health and Human Services, USAID, the Department of Defense and the Office of the Global AIDS Coordinator work with US Embassies in target countries to fund additional programs, which may or may not build on existing programs. Country Operational Plans (COPs) Set targets for each of the 15 countries Identify funding mechanisms & potential partners Describe partner activities GETS approval from Washington Generate progress reports----semi--annual Document results Track obligation of funds by partner Track progress toward 2--7--10 targets Inform next programming cycle THE PLAYERS:OGAC, HHS, USAID, DOD, STATE DEPT (Ambassadors), “Twinning Center” , AIDSCoprps/Volunteers for Prosperity"...this success is possible only because this is a strong vertical program. The decisions are being made in the US and a very detailed system, managed by mainly US organizations, has been introduced resulting in minimal bureaucracy at country level. This practical and result-oriented way of working has allowed for a very quick identification of hospitals and an immediate supply of the needed drugs. ... But what are the pitfalls of this system?” (EPN Newsletter article) HOW IT WORKS Track 1 Grants are awarded to "centrally funded cooperative agreements" which are usually US-based NGOs or academic institutions Track 1.5 Funding supplements existing agreements that were made by the Department of Health and Human Services, USAID, and the Department of Defense Track 2 Teams from the Department of Health and Human Services, USAID, the Department of Defense and the Office of the Global AIDS Coordinator work with US Embassies in target countries to fund additional programs, which may or may not build on existing programs. Country Operational Plans (COPs) Set targets for each of the 15 countries Identify funding mechanisms & potential partners Describe partner activities GETS approval from Washington Generate progress reports----semi--annual Document results Track obligation of funds by partner Track progress toward 2--7--10 targets Inform next programming cycle THE PLAYERS:OGAC, HHS, USAID, DOD, STATE DEPT (Ambassadors), “Twinning Center” , AIDSCoprps/Volunteers for Prosperity

    7. FDA FAST TRACK IN A NUTSHELL May 16, 2004: U.S. government announces an FDA Fast Track process for reviewing generic and brand-name AIDS drugs whether FDC, co-packages, or single ingredient Concerns: Needless duplication with WHO prequalification project Data Exclusivity barrier to new ARVs (e.g. atazanavir, FTC, TDF) as well as generic copies of proprietary FDCs (e.g.Truvada, Epzicom ) Regulatory delays & barriers: drug companies refusing or trying to link “right of reference”for BE studies to voluntary licenses More delay--WHO or EU dossier cannot substitute for the FDA application Bioequivalence and other studies may have to be repeated Raw materials review may have to be repeated Inspection of manufacturing sites will have to be repeated For companies that have not been approved for WHO, or applied, then of course the burden & delay is even greater: time/money/lawyers. "It now appears, however, that the "two to six weeks" timetable promised by the Administration was highly misleading." -- U.S. Representative Henry Waxman. In an attempt to deflect mounting criticism challenging the U.S. refusal to purchase generic AIDS drugs with U.S. dollars, on May 16, 2004, the U.S. government announced an FDA Fast Track process for reviewing generic and brand-name AIDS drugs whether FDC, co-packages, or single ingredient.....According to the INTERIM REPORT: ."The FDA accelerated review program encourages the development of newer, more flexible approaches to treatment, which will offer more treatment options for those who have failed other regimens or are faced with issues of resistance.” The U.S. has set up an unnecessary and duplicative regulatory apparatus to redo a job that has already been well-done elsewhere according to internationally agreed-upon standards. At the same time that it champions its desire to ensure that sick people in developing countries get access to the very best medicines, it has adopted a procedure that will preclude, or at least delay, PEPFAR approval for cheaper generic equivalents of the newest AIDS medicines. The effect the new program is to shield the Administration from criticism while creating significant hurdles for generic producers. Barriers To The Newest ARVs Including (Perhaps) Generic Copies Of Proprietary FDCs. Data exclusivity rules in the U.S. prevent the FDA from comparing bioequivalence files from generic medicines against the previous clinical data filed by the originator for a period of five years for new chemical entities and for a period of three years for medicines having a new use. Although the 3-5 year ban on final marketing approval can be circumvented to file for tentative approval one year earlier, in effect there is still a 2-4 year monopoly period. This will impact some of the newer ARVs including atanazavir, tenofovir, and emicitrilbine. Regulatory Delays – Fast-Track for Whom? Finally, even the promise of speed is illusory. ....The Fast Track announcement stated that tentative approval could be granted in as little as two to six weeks. Although it may be difficult to reverse their pro-PhRMA FDA process, it’s not too late to challenge the process and/or to demand that its features blocking approval of the newest medicines be removed.In an attempt to deflect mounting criticism challenging the U.S. refusal to purchase generic AIDS drugs with U.S. dollars, on May 16, 2004, the U.S. government announced an FDA Fast Track process for reviewing generic and brand-name AIDS drugs whether FDC, co-packages, or single ingredient.....According to the INTERIM REPORT: ."The FDA accelerated review program encourages the development of newer, more flexible approaches to treatment, which will offer more treatment options for those who have failed other regimens or are faced with issues of resistance.” The U.S. has set up an unnecessary and duplicative regulatory apparatus to redo a job that has already been well-done elsewhere according to internationally agreed-upon standards. At the same time that it champions its desire to ensure that sick people in developing countries get access to the very best medicines, it has adopted a procedure that will preclude, or at least delay, PEPFAR approval for cheaper generic equivalents of the newest AIDS medicines. The effect the new program is to shield the Administration from criticism while creating significant hurdles for generic producers. Barriers To The Newest ARVs Including (Perhaps) Generic Copies Of Proprietary FDCs. Data exclusivity rules in the U.S. prevent the FDA from comparing bioequivalence files from generic medicines against the previous clinical data filed by the originator for a period of five years for new chemical entities and for a period of three years for medicines having a new use. Although the 3-5 year ban on final marketing approval can be circumvented to file for tentative approval one year earlier, in effect there is still a 2-4 year monopoly period. This will impact some of the newer ARVs including atanazavir, tenofovir, and emicitrilbine. Regulatory Delays – Fast-Track for Whom? Finally, even the promise of speed is illusory. ....The Fast Track announcement stated that tentative approval could be granted in as little as two to six weeks. Although it may be difficult to reverse their pro-PhRMA FDA process, it’s not too late to challenge the process and/or to demand that its features blocking approval of the newest medicines be removed.

    8. PEPFAR’s “Fast Track” FDA-Approved Drugs APPROVED Generic entera coated DDI from Barr Laboratories Aspen's 3 drug blister pack: AZT/3TC + NVP Gilead's Truvada FDC combines TDF (Viread/tenofovir) and FTC (Emtriva/emtricitabine). **DATA EXCLUSIVITY** Truvada would be used with Efavirenz (EFV) = $711/year GSK, August 2004. Epzicom combines 3TC (Epivir/lamivudine) and ABC (Ziagen/abacavir) STILL WAITING CIPLA, STRIDES, THAI GPO, RANBAXY 2 pills a day d4T 40mg/3TC/NVP FDC from generic companies at $215-270 a year Compared to PEPFAR d4T 40mg +3TC + NVP from originator companies: 6 pills a day, US$ 562/year AZT/3TC + NVP --not as widely used for first line. --Price will be lower than $562, possibly $200 --cuts down a bit of pill burden from the brand name individual pills but not as good as 2 pills twice a day FDC. --Not available to recipients yet. 2005 orders were already placed in oct 2004, so not sure…. --"permission" of the brand companies and license terms could limit availability. -- Is U.S. enabling another monopoly? --U.S. says blistering is best because allows switch from NVP to EFV. **TENOFAOVIR, FTC, and atazanavir ALL ARE PROTECTED UNDER DATA EXCLUSIVITY. abacavir, lamivudine??? Data exclusivity rules in the U.S. prevent the FDA from comparing bioequivalence files from generic medicines against the previous clinical data filed by the originator for a period of five years for new chemical entities and for a period of three years for medicines having a new use. Although the 3-5 year ban on final marketing approval can be circumvented to file for tentative approval one year earlier, in effect there is still a 2-4 year monopoly period. This will impact some of the newer ARVs including atanazavir, tenofovir, and emicitrilbine. ----- Gilead announces Truvada for 68 developing countries at not-for-profit price of 99 cents per patient, per day -- or $29.75 for a 30-day supply. TDF is replacement for d4t. FTC could replace 3TC. PRICING- On January 26, the US Government Accountability Office released a report which found that PEPFAR pays US$ 40-368 more than other AIDS initiatives per patient per year for first-line regimens because it relies only on FDA approved drugs. The report explains that for every 100,000 patients on this regimen [d4T+3TC+NVP] for 5 years, the plan could pay over US$ 170 million more than the other initiative. In other words, PEPFAR could be treating thousands more people with the funds it is spending. --- Clinton Foundation continues to work with producers and a number of countries and the GFATM to negotiate prices for as low as $140/year for CIPLA’s Triomune and Ranbaxy’s TrzivirAZT/3TC + NVP --not as widely used for first line. --Price will be lower than $562, possibly $200 --cuts down a bit of pill burden from the brand name individual pills but not as good as 2 pills twice a day FDC. --Not available to recipients yet. 2005 orders were already placed in oct 2004, so not sure…. --"permission" of the brand companies and license terms could limit availability. -- Is U.S. enabling another monopoly? --U.S. says blistering is best because allows switch from NVP to EFV. **TENOFAOVIR, FTC, and atazanavir ALL ARE PROTECTED UNDER DATA EXCLUSIVITY. abacavir, lamivudine??? Data exclusivity rules in the U.S. prevent the FDA from comparing bioequivalence files from generic medicines against the previous clinical data filed by the originator for a period of five years for new chemical entities and for a period of three years for medicines having a new use. Although the 3-5 year ban on final marketing approval can be circumvented to file for tentative approval one year earlier, in effect there is still a 2-4 year monopoly period. This will impact some of the newer ARVs including atanazavir, tenofovir, and emicitrilbine. ----- Gilead announces Truvada for 68 developing countries at not-for-profit price of 99 cents per patient, per day -- or $29.75 for a 30-day supply. TDF is replacement for d4t. FTC could replace 3TC. PRICING- On January 26, the US Government Accountability Office released a report which found that PEPFAR pays US$ 40-368 more than other AIDS initiatives per patient per year for first-line regimens because it relies only on FDA approved drugs. The report explains that for every 100,000 patients on this regimen [d4T+3TC+NVP] for 5 years, the plan could pay over US$ 170 million more than the other initiative. In other words, PEPFAR could be treating thousands more people with the funds it is spending. --- Clinton Foundation continues to work with producers and a number of countries and the GFATM to negotiate prices for as low as $140/year for CIPLA’s Triomune and Ranbaxy’s Trzivir

    9. Is It Churlish to Criticize PEPFAR? Opinions from the field: “D.C. is in the driver's seat. If you asked me I would have to say I am a passenger." --Mission hospital network (CHAZ) in Zambia. The journal the lancet posed the question "is it churlish to criticize PEPFAR" in an editorial after demonstrations against U.S. Global AIDS coordinator Randall Tobias during the International AIDS Conference in Bangkok. The Ecumenical Pharmaceutical Network (EPN) is comprised of Christian Health Associations and hospitals, non-profit drug supply organizations (DSOs) and church related development agencies, EPN members from 22 developing countries were polled (anonymously) on the negative and positive aspects of PEPFAR during EPNs annual meeting last October. The journal the lancet posed the question "is it churlish to criticize PEPFAR" in an editorial after demonstrations against U.S. Global AIDS coordinator Randall Tobias during the International AIDS Conference in Bangkok. The Ecumenical Pharmaceutical Network (EPN) is comprised of Christian Health Associations and hospitals, non-profit drug supply organizations (DSOs) and church related development agencies, EPN members from 22 developing countries were polled (anonymously) on the negative and positive aspects of PEPFAR during EPNs annual meeting last October.

    10. Is It Churlish to Criticize PEPFAR? Opinions from the field: Procurement policies: conflicting rules, limitations. Insistence on FDA approval of ARVs The "wrap around:" recipients purchase generic 1st line, PEPFAR pays for 2nd line and pediatrics. (e.g. TZ, MZ) Smaller selection and prices of drugs (e.g. difference of $40 to $368 ppy) FDA "expedited process” Procurement timetables (Oct 2004 orders for 2005) Shortages (e.g. BMS stavudine d4t found in 3 prequal products) "Buy American" restrictions on all non-ARV medicines, especially OI drugs. Parallel systems cause procurement chaos and strain on already stretched resources it's no big surprise the number one complaint was regarding PEPFAR Procurement policies Because of the US refusal to purchase medicines whose quality has been certified by the WHO. -"wrap arounds" must be negotiated w/ each major recipient or country where facilities purchase generic 1st line on their own resources (govt or GFATM or other) and PEPFAR pays for 2nd line and pediatrics. (Tanzania, Mozambique, Rwanda. not Zambia)- -Smaller selection of drugs for first line and high prices of drugs PRICING- On January 26, the US Government Accountability Office released a report which found that PEPFAR pays US$ 40-368 more than other AIDS initiatives per patient per year for first-line regimens because it relies only on FDA approved drugs. The report explains that for every 100,000 patients on this regimen [d4T+3TC+NVP] for 5 years, the plan could pay over US$ 170 million more than the other initiative. In other words, PEPFAR could be treating thousands more people with the funds it is spending. Procurement timetables (Oct 2004 orders for 2005) -- Shortages of drugs (e.g. BMS stavudine d4t found in 3 prequal products) the shortages are because of single sources of medicines. there are also supply problems w/ efavirenz (as reported in the boston globe), 3tc lamivudine, and combivir (according to pepfar recipients). --> "Buy american" restrictions on all non-ARV medicines, especially OI drugs. Facilties are doing private fundraising or seeking "wrap arounds" from DFID to pay for OI drugs in order to be free of restriction to buy only pricey american products. it's no big surprise the number one complaint was regarding PEPFAR Procurement policies Because of the US refusal to purchase medicines whose quality has been certified by the WHO. -"wrap arounds" must be negotiated w/ each major recipient or country where facilities purchase generic 1st line on their own resources (govt or GFATM or other) and PEPFAR pays for 2nd line and pediatrics. (Tanzania, Mozambique, Rwanda. not Zambia)- -Smaller selection of drugs for first line and high prices of drugs PRICING- On January 26, the US Government Accountability Office released a report which found that PEPFAR pays US$ 40-368 more than other AIDS initiatives per patient per year for first-line regimens because it relies only on FDA approved drugs. The report explains that for every 100,000 patients on this regimen [d4T+3TC+NVP] for 5 years, the plan could pay over US$ 170 million more than the other initiative. In other words, PEPFAR could be treating thousands more people with the funds it is spending. Procurement timetables (Oct 2004 orders for 2005) -- Shortages of drugs (e.g. BMS stavudine d4t found in 3 prequal products) the shortages are because of single sources of medicines. there are also supply problems w/ efavirenz (as reported in the boston globe), 3tc lamivudine, and combivir (according to pepfar recipients). --> "Buy american" restrictions on all non-ARV medicines, especially OI drugs. Facilties are doing private fundraising or seeking "wrap arounds" from DFID to pay for OI drugs in order to be free of restriction to buy only pricey american products.

    11. Is It Churlish to Criticize PEPFAR? Opinions from the field: 1) Procurement policies: conflicting rules, limitations. 2) Sustainability “PEPFAR is a 5-year program while treatment is for life. The degree to which it is donor driven and there is too little coordination chips away at sustainability.” SKIP IF TIME SHORT 2) Sustainability: PEPFAR is a 5-year program while treatment is for life. The degree to which it is donor driven and there is too little coordination chips away at sustainability. GRADUATION There is not a written or apparent long-term commitment. The strategy plan release in FEB 04 talked about "graduation" from PEPFAR (which has a host of implications including a reluctance on part of public sector to scale up workforce for what could be a "temporary" program). LARGER QUESTION --> THE LARGER QUESTION IS PEPFAR committed to laying ground for sustainable TX in addition to emergency vertical programs? Restrictions on funding for public sector hcare workers (i.e. UK directly funding salaries), buy american policies that shut out local agents from producers and DSOs, and under-utilization of existing capacity and expertise ALL point to "no. --- --> Who is going to pay for life-long treatment? 30 to 40 million people could be as costly as $9 to $12 billion a year.SKIP IF TIME SHORT 2) Sustainability: PEPFAR is a 5-year program while treatment is for life. The degree to which it is donor driven and there is too little coordination chips away at sustainability. GRADUATION There is not a written or apparent long-term commitment. The strategy plan release in FEB 04 talked about "graduation" from PEPFAR (which has a host of implications including a reluctance on part of public sector to scale up workforce for what could be a "temporary" program). LARGER QUESTION --> THE LARGER QUESTION IS PEPFAR committed to laying ground for sustainable TX in addition to emergency vertical programs? Restrictions on funding for public sector hcare workers (i.e. UK directly funding salaries), buy american policies that shut out local agents from producers and DSOs, and under-utilization of existing capacity and expertise ALL point to "no. --- --> Who is going to pay for life-long treatment? 30 to 40 million people could be as costly as $9 to $12 billion a year.

    12. Is It Churlish to Criticize PEPFAR? Opinions from the field: Procurement policies: conflicting rules, limitations. Sustainability Capacity: too little support for & under-utilization of existing capacity and expertise "the United States must be closed because all the Americans are in Kenya now" 3)Capacity: too little support for and under-utilization of existing capacity and expertise --> "the United States must be closed because all the Americans are in Kenya now” 3)Capacity: too little support for and under-utilization of existing capacity and expertise --> "the United States must be closed because all the Americans are in Kenya now”

    13. Is It Churlish to Criticize PEPFAR? Opinions from the field: Procurement policies: conflicting rules, limitations. Sustainability Capacity: too little support for & under-utilization “U.S. design undermines WHO & multilateral efforts. Very vertical program. The program is too much DC-driven with little to no coordination with national governments.” 4) U.S. approach design: undermines WHO and multilateral efforts. Very vertical program. Too much DC-driven. Little to no coordination with national governments. --> Health attache for RSA recently complained that the first briefing with the government about PEPFAR was 10 months after Bush's state of the union address. For Zambia the first briefing was 15 months after its role in PEPFAR was announced. --> Far and away PEPFAR cuts out governments from the equation. TASO (pepfar recipient in uganda is actually providing some money to the gov't) ------------- Dr. Debrework Zewdie, of the World Bank's Global says implementing the funding from these three sources (WB/PEPFAR/GFATM) has been "difficult" because differing "bureaucratic requirements" have "pulled these countries in three different directions," 4) U.S. approach design: undermines WHO and multilateral efforts. Very vertical program. Too much DC-driven. Little to no coordination with national governments. --> Health attache for RSA recently complained that the first briefing with the government about PEPFAR was 10 months after Bush's state of the union address. For Zambia the first briefing was 15 months after its role in PEPFAR was announced. --> Far and away PEPFAR cuts out governments from the equation. TASO (pepfar recipient in uganda is actually providing some money to the gov't) ------------- Dr. Debrework Zewdie, of the World Bank's Global says implementing the funding from these three sources (WB/PEPFAR/GFATM) has been "difficult" because differing "bureaucratic requirements" have "pulled these countries in three different directions,"

    14. Is It Churlish to Criticize PEPFAR? Opinions from the field: Procurement policies: conflicting rules, limitations. Sustainability Capacity: too little support for & under-utilization U.S. design undermines WHO & multilateral efforts. “Slowing down or destroying healthcare systems” Procurement policies harm local production efforts “Supply Chain Management System (SCMS) harms local capacity” “PEPFAR drains workers from local public health systems.” Sidelining of government and privatization (NGOivatization) of AIDS treatment and care 5)Slowing down or destroying healthcare systems: the procurement policies harm local production efforts (particularly of OI drugs) and puts drug supply organizations (DSOs) at risk, particularly the Supply Chain Management System (SCMS) The SCMS is a new parallel and U.S- controlled supply chain management system (SCMS) This is a multi billion dollar contract that will be awarded sometime soon to handle all procurement and supply and delivery for PEPFAR programs. But while it is likely to be used for FDA approved medicines only, The USG seeks to encourage national procurement mechanisms to shift to this US central system The SCMS threatens to undermine national and regional systems of pooled procurement. SCMS could be another case study for public health students in decades to come, like other similar international procurement systems that replaced local agencies and groups and then dissipated, leaving nothing in its place. HCW: When asked about PEPFAR and HCWs, and specifically the fact that PEPFAR facilities have lured away doctors and nurses from the public sector, Tobias responded PEPFAR is providing: * Training (but on an incredibly low scale---namibia to rsa medical school) Embedding NGO workers in public sector* providing cash incentives to get rural coverage Restrictions on funding for public sector hcare workers (i.e. UK directly funding salaries) so US will likely launch AIDSCorps sometime soon, and place volunteers in service. Even Mark Dybul said this will run more than $100,000 per volunteer. 4) The privatization/NGOivatization of AIDS treatment and care, and some might argue, at the expense of public health sector reform and enhancement. 5)Slowing down or destroying healthcare systems: the procurement policies harm local production efforts (particularly of OI drugs) and puts drug supply organizations (DSOs) at risk, particularly the Supply Chain Management System (SCMS) The SCMS is a new parallel and U.S- controlled supply chain management system (SCMS) This is a multi billion dollar contract that will be awarded sometime soon to handle all procurement and supply and delivery for PEPFAR programs. But while it is likely to be used for FDA approved medicines only, The USG seeks to encourage national procurement mechanisms to shift to this US central system The SCMS threatens to undermine national and regional systems of pooled procurement. SCMS could be another case study for public health students in decades to come, like other similar international procurement systems that replaced local agencies and groups and then dissipated, leaving nothing in its place. HCW: When asked about PEPFAR and HCWs, and specifically the fact that PEPFAR facilities have lured away doctors and nurses from the public sector, Tobias responded PEPFAR is providing: * Training (but on an incredibly low scale---namibia to rsa medical school) Embedding NGO workers in public sector* providing cash incentives to get rural coverage Restrictions on funding for public sector hcare workers (i.e. UK directly funding salaries) so US will likely launch AIDSCorps sometime soon, and place volunteers in service. Even Mark Dybul said this will run more than $100,000 per volunteer. 4) The privatization/NGOivatization of AIDS treatment and care, and some might argue, at the expense of public health sector reform and enhancement.

    15. Is It Churlish to Criticize PEPFAR? Opinions from the field: Procurement policies: conflicting rules, limitations. Sustainability Capacity: too little support for & under-utilization U.S. design undermines WHO & multilateral efforts. Slowing down or destroying healthcare systems “Implicit political agenda” “procurement policies are designed to benefit Big Pharma” “PEPFAR design is meant to provide more work and funding for U.S. workers and expats” “Buy American policies is meant to benefit the US economy.” “US seeks to use PEPFAR to export its domestic policy (including IPR and prevention) on Africa.” 6) Implicit political agenda: procurement policies are designed to benefit Big Pharma. PEPFAR design is meant to provide more work and funding for U.S. workers and expats. Buy American policies is meant to benefit the US economy. US seeks to use PEPFAR to export its domestic policy (including IPR and prevention) on Africa. --> What PEPFAR will do for PHARMACEUTICAL COMPANIES * $4 billion in pharmaceuticals and distribution systems * Stimulate Market in target countries * Increase interest in new manufacturers The creation of the Supply Chain and Management system, which will be available for use by other programs within a couple of years will push more business to big pharma. Also, whoever wins the contract for the SCMS, which will be announced soon, is expected to give TA on intellectual property issues. --> FBOs: We do know, however, that the Bush administration is using PEPFAR to push funds to evangelical groups and other FBOs Embassies are instructed to have a large percentage of FBO partners. The reality is most groups self-identifying as faith based organizations are US-Based evangelical organizations who have little knowledge of how to work in developing countries.PEPFAR also has special funding set aside for U.S. faith-based groups that have never received a government contract. it's called the New Partners initiative and this year it is around $10 Million. --> political agenda includes ----recipients must pledge their opposition to prostitution ----government MOUs agreeing not to take Americans to International Criminal Court ----pushing ABC approach to prevention. Almost 10% of 2004 $2.4 billion went to abstinence programs. While pepfar ostensibly allows condoms for "high risk" groups interviews by CHANGE have indicated that organizations are "getting the message" not to push for condom funding at all. ---lawmakers want to extend this to cut off funds to organizations that encourage clean-needle programs. Some also are pressing to ban federal funding of all AIDS organizations that fail to accept the president's social agenda on such issues as sexual abstinence and drug abuse.6) Implicit political agenda: procurement policies are designed to benefit Big Pharma. PEPFAR design is meant to provide more work and funding for U.S. workers and expats. Buy American policies is meant to benefit the US economy. US seeks to use PEPFAR to export its domestic policy (including IPR and prevention) on Africa. --> What PEPFAR will do for PHARMACEUTICAL COMPANIES * $4 billion in pharmaceuticals and distribution systems * Stimulate Market in target countries * Increase interest in new manufacturers The creation of the Supply Chain and Management system, which will be available for use by other programs within a couple of years will push more business to big pharma. Also, whoever wins the contract for the SCMS, which will be announced soon, is expected to give TA on intellectual property issues. --> FBOs: We do know, however, that the Bush administration is using PEPFAR to push funds to evangelical groups and other FBOs Embassies are instructed to have a large percentage of FBO partners. The reality is most groups self-identifying as faith based organizations are US-Based evangelical organizations who have little knowledge of how to work in developing countries.PEPFAR also has special funding set aside for U.S. faith-based groups that have never received a government contract. it's called the New Partners initiative and this year it is around $10 Million. --> political agenda includes ----recipients must pledge their opposition to prostitution ----government MOUs agreeing not to take Americans to International Criminal Court ----pushing ABC approach to prevention. Almost 10% of 2004 $2.4 billion went to abstinence programs. While pepfar ostensibly allows condoms for "high risk" groups interviews by CHANGE have indicated that organizations are "getting the message" not to push for condom funding at all. ---lawmakers want to extend this to cut off funds to organizations that encourage clean-needle programs. Some also are pressing to ban federal funding of all AIDS organizations that fail to accept the president's social agenda on such issues as sexual abstinence and drug abuse.

    16. Is It Churlish to Criticize PEPFAR? Opinions from the field: Procurement policies: conflicting rules, limitations. Sustainability Capacity: too little support for & under-utilization U.S. design undermines WHO & multilateral efforts. Slowing down or destroying healthcare systems Implicit political agenda Wasted resources. Not enough funds are going to the field. Much is wasted on overhead and duplicative processes. 7)Wasted resources. Not enough funds are going to the field. Much is wasted on overhead and duplicative processes. Stephen Gloyd: Though the accounting is difficult, it is likely that less than 25 percent of PEPFAR aid value actually goes to recipient-country people or institutions. The money actually making it to an African country might be even less if profits to drug companies are counted as going back to the United States. --> FOLLOW THE MONEY: You can follow the money to the big NGOs and universities and get some of the details in the country operational plans. However, we don't know where the rest of 2004 money went. Of the $865 million in the FY 2004 OGAC budget, OGAC has identified the grantee and PEPFAR country recipients for $350 million. OGAC is not saying how the remaining $515 million was used, explaining that this amount was under "procurement sensitivity.” 7)Wasted resources. Not enough funds are going to the field. Much is wasted on overhead and duplicative processes. Stephen Gloyd: Though the accounting is difficult, it is likely that less than 25 percent of PEPFAR aid value actually goes to recipient-country people or institutions. The money actually making it to an African country might be even less if profits to drug companies are counted as going back to the United States. --> FOLLOW THE MONEY: You can follow the money to the big NGOs and universities and get some of the details in the country operational plans. However, we don't know where the rest of 2004 money went. Of the $865 million in the FY 2004 OGAC budget, OGAC has identified the grantee and PEPFAR country recipients for $350 million. OGAC is not saying how the remaining $515 million was used, explaining that this amount was under "procurement sensitivity.”

    17. What’s Good about PEPFAR: Speed, Speed, Speed Opinions from the field: 1) Promise of massively increased funding 2) Responds to specific Africa crisis 3) Potential to rapidly increase the number of people on ART 4) Opportunity to improve infrastructure and training. Opportunity to improve and provide equipment, technical assistance. 5) PEPFAR is directly involved with FBOs and CBOs 6) "Wake up call to the GFATM"

    18. A NEW APPROACH: “Fighting AIDS Differently” "We will actively seek new approaches."...Our approach will not be "business as usual." (PEPFAR Interim Report) In need of analysis and discussion: Unilateral vs multilateral response Emergency, “stove-pipe” effort to put people on treatment vs sustainable universal access Ideology-driven vs indigenously led Coordination w/ govt and integration with national systems vs. NGO/CBO-only U.S. vs national TX protocol and procurement policies . A productive discussion: the good, the bad, and the ugly not just to apply to PEPFAR, but to all bilateral AIDS programs. (wolf in sheep clothing or sheep in wolf clothing??) Why is it important? Congress can demand change in its annual appropriation legislation Solidarity and support Worst practices for other bilateral initiatives PEPFAR "ends"in 2008 ------------- --Why discussion is important it's not too optimistic to talk about what should be changed in PEPFAR and it's not too soon to talk about 2008. Or for that matter on next year's appropriation legislation in Congress---while PEPFAR was authorized to be a $9bn over 5 year program, the money is appropriated on an annual basis. Changes in the programmatic details of PEPFAR could be made through legislative action. The essential first step is to share concerns w/ PEPFAR (both in terms of the macro policy issues and the impact on operations down to the facility level). A productive discussion: the good, the bad, and the ugly not just to apply to PEPFAR, but to all bilateral AIDS programs. (wolf in sheep clothing or sheep in wolf clothing??) Why is it important? Congress can demand change in its annual appropriation legislation Solidarity and support Worst practices for other bilateral initiatives PEPFAR "ends"in 2008 ------------- --Why discussion is important it's not too optimistic to talk about what should be changed in PEPFAR and it's not too soon to talk about 2008. Or for that matter on next year's appropriation legislation in Congress---while PEPFAR was authorized to be a $9bn over 5 year program, the money is appropriated on an annual basis. Changes in the programmatic details of PEPFAR could be made through legislative action. The essential first step is to share concerns w/ PEPFAR (both in terms of the macro policy issues and the impact on operations down to the facility level).

    19. A NEW APPROACH: “Fighting AIDS Differently” "We will actively seek new approaches."...Our approach will not be "business as usual." (PEPFAR Interim Report) PEPFAR is in many ways business as usual and indicative of problems with bilateral aid for AIDS A new paradigm for international assistance for global AIDS is overdue…and we need to change PEPFAR: Community advisory boards Monitoring and unclogging "fast track process" including problematic "right to reference" and data exclusivity. Transparency in reporting budgets, TX figures, programs, plans, drug protocols, COPs Gather evidence of harmful policies, including on capacity, etc. Change prevention policies Free treatment at the point of service PEPFAR is in many ways business as usual and indicative of problems with bilateral aid for AIDS A new paradigm for international assistance for global AIDS is overdue one that RAPIDLY scales up TX access but also Uses ARVs to raise all boats: revolutionizes the public health sector and the way aid is delivered ensures equity and empowers local groups based upon locally-defined strategies utilizes and expands local capacity WHERE investment in AIDS TREATMENT and interventions benefits social and health systems We challenge the Office of the Global AIDS Coordinator on this point: Is this not business as usual? Our version of fighting AIDS differently is drastically different than Randall Tobias and Thommy Thompson and George Bush. In PEPFAR we see examples of larger problems of U.S. global AIDS policies, bad development policies, inadequacy to finance global coordinated fight , IPR, trade policies, And PEPFAR itself hampered by problems in philosophies on how to deliver aid. Has PEPFAR set the larger movement for universal HIV/AIDS treatment and healthcare back from the way to fight AIDS properly while addressing underlying socioeconomic issues. We needed a new paradigm for international assistance. PEPFAR is not the solution. We still need a local and global program that revolutionizes the public health sector and the way aid is delivered, that ensures equity and empowers local groups.In the most cynical view: we did not need unique and creative ways to line pockets of U.S.-based entities and paristatel organizations that undermine the public sector (thereby making the public sector extant). While there have been countries that were able to negotiate with the U.S. somewhat, the largest AIDS treatment program in the world should not be game of manipulation of national medical authorities or local healthare providers or experts. Sovereign authority and local capacity should not be up for negotiation in order to qualify for desperately needed financing for ART programs. What about those places, mission hospitals, and NGO’s that were not able to to insist upon an alternative to USG programmatic restrictions crafted in Washington, DC?PEPFAR is in many ways business as usual and indicative of problems with bilateral aid for AIDS A new paradigm for international assistance for global AIDS is overdue one that RAPIDLY scales up TX access but also Uses ARVs to raise all boats: revolutionizes the public health sector and the way aid is delivered ensures equity and empowers local groups based upon locally-defined strategies utilizes and expands local capacity WHERE investment in AIDS TREATMENT and interventions benefits social and health systems We challenge the Office of the Global AIDS Coordinator on this point: Is this not business as usual? Our version of fighting AIDS differently is drastically different than Randall Tobias and Thommy Thompson and George Bush. In PEPFAR we see examples of larger problems of U.S. global AIDS policies, bad development policies, inadequacy to finance global coordinated fight , IPR, trade policies, And PEPFAR itself hampered by problems in philosophies on how to deliver aid. Has PEPFAR set the larger movement for universal HIV/AIDS treatment and healthcare back from the way to fight AIDS properly while addressing underlying socioeconomic issues. We needed a new paradigm for international assistance. PEPFAR is not the solution. We still need a local and global program that revolutionizes the public health sector and the way aid is delivered, that ensures equity and empowers local groups.In the most cynical view: we did not need unique and creative ways to line pockets of U.S.-based entities and paristatel organizations that undermine the public sector (thereby making the public sector extant). While there have been countries that were able to negotiate with the U.S. somewhat, the largest AIDS treatment program in the world should not be game of manipulation of national medical authorities or local healthare providers or experts. Sovereign authority and local capacity should not be up for negotiation in order to qualify for desperately needed financing for ART programs. What about those places, mission hospitals, and NGO’s that were not able to to insist upon an alternative to USG programmatic restrictions crafted in Washington, DC?

    20. A NEW APPROACH: “Fighting AIDS Differently” "We will actively seek new approaches."...Our approach will not be "business as usual." (PEPFAR Interim Report) PEPFAR is in many ways business as usual and indicative of the larger problems with U.S. global AIDS policies A new paradigm for international assistance for global AIDS is overdue - revolutionizes the public health sector and the way aid is delivered ensures equity and empowers local groups- based upon locally-defined strategies utilizes and expands local capacity integrates investment in AIDS into larger social and health systems We challenge the Office of the Global AIDS Coordinator on this point: Is this not business as usual? Our version of fighting AIDS differently is drastically different than Randall Tobias and Thommy Thompson and George Bush. In PEPFAR we see examples of larger problems of U.S. global AIDS policies, bad development policies, inadequacy to finance global coordinated fight , IPR, trade policies, And PEPFAR itself hampered by problems in philosophies on how to deliver aid. Has PEPFAR set the larger movement for universal HIV/AIDS treatment and healthcare back from the way to fight AIDS properly while addressing underlying socioeconomic issues. We needed a new paradigm for international assistance. PEPFAR is not the solution. We still need a local and global program that revolutionizes the public health sector and the way aid is delivered, that ensures equity and empowers local groups.In the most cynical view: we did not need unique and creative ways to line pockets of U.S.-based entities and paristatel organizations that undermine the public sector (thereby making the public sector extant). While there have been countries that were able to negotiate with the U.S. somewhat, the largest AIDS treatment program in the world should not be game of manipulation of national medical authorities or local healthare providers or experts. Sovereign authority and local capacity should not be up for negotiation in order to qualify for desperately needed financing for ART programs. What about those places, mission hospitals, and NGO’s that were not able to to insist upon an alternative to USG programmatic restrictions crafted in Washington, DC?We challenge the Office of the Global AIDS Coordinator on this point: Is this not business as usual? Our version of fighting AIDS differently is drastically different than Randall Tobias and Thommy Thompson and George Bush. In PEPFAR we see examples of larger problems of U.S. global AIDS policies, bad development policies, inadequacy to finance global coordinated fight , IPR, trade policies, And PEPFAR itself hampered by problems in philosophies on how to deliver aid. Has PEPFAR set the larger movement for universal HIV/AIDS treatment and healthcare back from the way to fight AIDS properly while addressing underlying socioeconomic issues. We needed a new paradigm for international assistance. PEPFAR is not the solution. We still need a local and global program that revolutionizes the public health sector and the way aid is delivered, that ensures equity and empowers local groups.In the most cynical view: we did not need unique and creative ways to line pockets of U.S.-based entities and paristatel organizations that undermine the public sector (thereby making the public sector extant). While there have been countries that were able to negotiate with the U.S. somewhat, the largest AIDS treatment program in the world should not be game of manipulation of national medical authorities or local healthare providers or experts. Sovereign authority and local capacity should not be up for negotiation in order to qualify for desperately needed financing for ART programs. What about those places, mission hospitals, and NGO’s that were not able to to insist upon an alternative to USG programmatic restrictions crafted in Washington, DC?

    21. Thank you salynch@healthgap.org www.healthgap.org RECOMMENDED RESOURCES: “Addressing the HIV/AIDS Pandemic: A U.S. Global AIDS Strategy for the Long Term,” Council on Foreign Relations (CFR), April 2004. “Global Health: U.S. AIDS Coordinator Addressing Some Key Challenges to Expanding Treatment, but Others Remain,” Government Accounting Office (GAO) Report, July 2004. RECOMMENDED RESOURCES: “Addressing the HIV/AIDS Pandemic: A U.S. Global AIDS Strategy for the Long Term,” Council on Foreign Relations (CFR), April 2004. “Global Health: U.S. AIDS Coordinator Addressing Some Key Challenges to Expanding Treatment, but Others Remain,” Government Accounting Office (GAO) Report, July 2004.

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