Financing Treatment Programs: Bilateral Funding PEPFAR

							Financing Treatment Programs:
       Bilateral Funding

          PEPFAR:
      Promises, Pitfalls,
   and the Need for Change
           Sharonann Lynch
   Health GAP (Global Access Project)

                  Realising the Right to Health
                                Mumbai, India
                                19 March 2005
  BILATERAL FUNDING FOR HIV/AIDS
Breakdown of projected bilateral disbursements in
  2004 for global HIV/AIDS




    Direct bilateral funding and bilateral contributions to the Global Fund to fight
    AIDS, TB and Malaria at 60% for AIDS
  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)
     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”
                        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
                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
        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.
  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
    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.
          Is It Churlish to Criticize PEPFAR?
                 Opinions from the field:
1) 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
     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.”
         Is It Churlish to Criticize PEPFAR?
                Opinions from the field:
1. Procurement policies: conflicting rules, limitations.
2. Sustainability
3. 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"
          Is It Churlish to Criticize PEPFAR?
                 Opinions from the field:
1.   Procurement policies: conflicting rules, limitations.
2.   Sustainability
3.   Capacity: too little support for & under-utilization
4.   “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.”
           Is It Churlish to Criticize PEPFAR?
                  Opinions from the field:
1.   Procurement policies: conflicting rules, limitations.
2.   Sustainability
3.   Capacity: too little support for & under-utilization
4.   U.S. design undermines WHO & multilateral efforts.
5. “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
           Is It Churlish to Criticize PEPFAR?
                  Opinions from the field:
1.   Procurement policies: conflicting rules, limitations.
2.   Sustainability
3.   Capacity: too little support for & under-utilization
4.   U.S. design undermines WHO & multilateral efforts.
5.   Slowing down or destroying healthcare systems
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.”
          Is It Churlish to Criticize PEPFAR?
                 Opinions from the field:
1.   Procurement policies: conflicting rules, limitations.
2.   Sustainability
3.   Capacity: too little support for & under-utilization
4.   U.S. design undermines WHO & multilateral efforts.
5.   Slowing down or destroying healthcare systems
6.   Implicit political agenda
7.   Wasted resources. Not enough funds are going to
     the field. Much is wasted on overhead and
     duplicative processes.
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"
                 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 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
                     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
  Thank you
salynch@healthgap.org

  www.healthgap.org