PEPFAR Promises Pitfalls and the Need for Change

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					       PEPFAR:
   Promises, Pitfalls,
and the Need for Change


        Sharonann Lynch
Health GAP (Global Access Project)

          EPN Meeting
         Moshi, Tanzania
         6 October 2004
U.S. NGO founded by healthcare providers, AIDS activists, human rights
                       and fair trade advocates
• Campaigns for changes to U.S. Administration and corporate policies
   obstructing access in poor countries to affordable medicines to treat
   HIV
• Campaigns for resources (money, technology transfer, other investments
   from governments and private sector) from donor countries to sustain
   medicines and treatment access in poor countries; and
• Educates and mobilizes the grassroots: networks include thousands of
   people living with HIV and other health care consumers in the United
   States
               PEPFAR TIMELINE
• January 2003: George Bush announced his plans for the
  President's Emergency Plan for AIDS Relief (PEPFAR), a
  bilateral AIDS program that is part of a 5 year, $9 billion
  initiative to combat AIDS in 15 countries.
• February 23, 2004: the Bush administration released a
  “strategic plan” to fight global AIDS, and announced the
  first round of grants totaling $350 million for care,
  treatment, and prevention programs.
• August 2004: the Office of the Global AIDS Coordinator,
  Randall Tobias--who is charged with overseeing all of the
  U.S. global AIDS policies, delivered to congress its interim
  report on progress of ARV component of PEPFAR.
             The U.S. Vision for PEPFAR

  "Our Vision: President Bush's Emergency Plan for AIDS
  Relief will turn the tide of this global pandemic.
• Released in February 2004, the global AIDS strategy identified
  four key interventions for achieving the Emergency Plan
  treatment goal:
       • Rapidly scale up treatment availability through network
  systems;
       • Build capacity for long-term sustainability of quality
  HIV/AIDS treatment programs;
       • Advance policy initiatives that support treatment; an
       • Collect strategic information to monitor and evaluate
  progress and ensure quality and compliance with Emergency
  Plan and national policies and strategies.(Source PEPFAR
  Interim Report)
                     PEPFAR FACTS
• TX GOALS
   – Provide anti-retroviral therapy to 2 million individuals
   – Provide care to 10 million people infected and affected
      by HIV/AIDS, including orphans and vulnerable
      children through 2008
• 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.
    DISBURSEMENTS FOR ARV TREATMENT: FIRST
                PEPFAR ROUND
• Catholic Relief Services
   – $335 million over five years, $24.7 million in year one
   – South Africa, Zambia, Nigeria, Kenya, Rwanda,
     Uganda, Tanzania, Haiti and Guyana
• Columbia University Mailman School of Public
  Health/MTCT-Plus Initiative Multicountry Columbia
  Antiretroviral Program (MCAP):
   – $125 million over five years
   – Kenya, Mozambique, Rwanda, South Africa, and
     Tanzania
• Harvard AIDS Institute, Harvard School of Public
  Health:
   – $107 million over five years, $17 million year one
   – Nigeria, Botswana, and Tanzania
   – Elizabeth Glaser Pediatric AIDS Foundation:
   – Côte d’Ivoire, South Africa, Tanzania and Zambia
    PEPFAR and TREATMENT:
       Where are We Now?
                                Direct Support for ART by Country
As of July 31, 2004:
  PEPFAR is supporting      •    Cote d’Ivoire: 400
• ART for 24,900 people     •    Kenya: 2,700
   – 18,800: directly
     funding ART at         •    Namibia: 2,500
     the point of service   •    Nigeria: 500
     delivery
                            •    Rwanda: 10
   – 6,100: receiving
     indirect treatment     •    South Africa: 3,700
     support                •    Tanzania: 100
• PEPFAR's goal:            •    Uganda: 7,300
  200,000 by June 2005
                            •    Zambia: 1,500
                            (Source: Interim Report, August 2004)
        Is it churlish to criticize PEPFAR? :
              U.S. Field Representatives
GAO interviewed 28 field staff from the U.S. Agency for
   International Development (USAID) and the Department of
   Health and Human Services (HHS), who most frequently cited
   the following five challenges to implementing and expanding
   ARV treatment in resource-poor settings:
   1. coordination difficulties among both U.S. and non-U.S.
        entities;
   2. U.S. government policy constraints;
   3. shortages of qualified host country health workers;
   4. host government constraints; and
   5. weak infrastructure, including data collection and reporting
        systems and drug supply systems.
These challenges were also highlighted by numerous experts GAO
   interviewed and in documents GAO reviewed.
      Is It Churlish to Criticize PEPFAR? :
             U.S. Field Representatives
U.S. Policy Constraints Limit Agencies’ Ability to Rapidly
   Expand Treatment Programs

   “Twenty-five of the 28 structured interview respondents
   identified U.S. policy constraints as a challenge that could
   limit the ability of the agencies implementing PEPFAR to
   rapidly expand treatment programs. In particular, unclear
   guidance on whether U.S. agencies can purchase generic
   ARV drugs, including FDCs, makes it difficult for the
   PEPFAR agencies to plan support for national treatment
   programs, some of which use these drugs.”
       Is It Churlish to Criticize PEPFAR?

But at a time when American power was being imposed and
  questioned in the military arena, the AIDS plan struck some as
  another kind of unilateralism. They feared that Mr. Bush's
  program would undermine the multilateral Global Fund, which
  assists eight times as many countries, including India, China and
  Russia, whose infection rates are rising rapidly.

And these experts thought it was retrogressive in its reliance on
  American universities, faith-based organizations and
  nongovernmental organizations, whose ability to pay higher
  salaries could drain workers from local public health systems that
  should be reinforced instead. (New York Times, 14 July 2004)
                 A NEW APPROACH:
              “Fighting AIDS Differently”
"We will actively seek new approaches."...Our approach will
  not be "business as usual." (PEPFAR Interim Report)

"When you're in a clinic in rural Haiti and someone comes in
  with a broken arm or in obstructed labor, you can't say,
  'Sorry, we only do AIDS prevention and care,' " said Dr.
  Farmer, a Harvard professor. "The massive loss of life due to
  H.I.V. disease is only one symptom of a very sick world in
  which hundreds of millions are going without any modern
  medical care at all. Addressing AIDS properly offers a
  chance to set some of this right." (New York Times, 14 July
  2004)
                 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
• U.S. vs national TX protocol and procurement policies
               A NEW APPROACH:
            “Fighting AIDS Differently”
• A productive discussion: the good, the bad, and the
  ugly
• Why is it important?
   – U.S. could face a regime change come November
   – PEPFAR "ends"in 2008
   – Congress can demand change in its annual
     appropriation legislation
   – Worst practices for other bilateral initiatives
   – Solidarity and support
     Unilateral vs Multilateral
             Response
"Our Mission: To work with leaders throughout the
  world to combat HIV/AIDS”

Reality: unilateral focus
• Death & delay in creating a new mechanism
• Underfunded (and undermined) multilateral efforts
   – GFATM
   – WHO
• Lack of coordination with international agencies
              “Emergency” & Chasing Numbers
               VS. Sustainable Universal Access
       “We will respond with urgency to the global HIV/AIDS crisis.”

    But what price, speed without long-term global commitment?
        •   who is going to pay for life-long treatment?
        •   where is the long term plan?
        •   will PEPFAR bolster healthcare infrastructure?
        •   will PEPFAR lead to sustainable, equitable care?

…[I]t seems that the goal to get 190,000 people in treatment by the end of this
  year will be reached. This is very encouraging! But 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. A
  number of EPN members are involved in the system and more are likely to
  join. But what are the pitfalls of this system? (EPN Newsletter article)
Ideology-driven vs Indigenously-led
   "We will make policy decisions that are evidence-based.”
• REALITY: "A retreat from science”
   –   abstinence-only
   –   limitations on condoms
   –   marriage as vaccine for women
   –   U.S. "Global Gag Rule”
   –   anti-generics policies
• INDIGENOUS OR NOT? FOLLOW THE MONEY:
   – Anyone but government
   – Ok, governments, but only if you sign on the dotted line
   – Ideology-driven disbursements and policies
   – Phrma companies win big over generic competitors
     More money to stateside groups
   – You're a FBO that's never worked outside the U.S.? No
     problem!
   – Over-reliance upon non-indigenous strategies
   Integration and Coordination:
"We will implement programs suited to local needs and host government
                      policies and strategies."

REALITY:
While there is a lot of support in the original legislation that created
  PEPFAR for integration with national health care systems and
  strategies, EPFAR still skipped the initial coordination with
  national governments, NAC's and CCM's, in large part b/c of the
  U.S. insistence upon brand-name drugs.

"For every Mozambique, however, where Washington has altered its
   plans to meet local objections, there is a Zambia, where local
   officials are in the dark. The Zambian health minister, Brian
   Chituwo, said his government did not have a formal meeting on
   the program with the American ambassador until May, 15 months
   after Zambia's role was announced. Further, he said, on
   everything but blood-transfusion services, which were negotiated,
   the Americans' plans for Zambia have "all come from
   Washington." (New York Times, 14 July 2004)"
      U.S. vs national TX protocol and
            procurement policies
• PEPFAR requires that drugs used in the program be approved by
  the FDA or a “stringent regulatory body” (but not the WHO
  prequalification program).
    – Likely to be expensive branded products, which may not
      necessarily be those on the national treatment protocol,
      and which cannot be sustained by the health system at
      the end of the project.
   – Bush administration derides quality of generics and the WHO
      Pre-Qualification Project even though Project is supported
      and/or used by GFATM, Clinton Foundation, World Bank,
      EU
• During the IAC, President Jacques Chirac of France accused the
  United States of blackmailing developing countries into bartering
  their right to produce generic H.I.V. drugs for free-trade
  agreements.
        FDC’s and GENERIC COMPETITION

              d4T 40mg/3TC/NVP FDC d4T 40mg +3TC + NVP
              from generic companies from originator
                                     companies
PRICE         US $270/year           US$ 562/year

PILL BURDEN   2 pills a day          6 pills a day


  FDA APPROVED: Gilead’s TRUVADA (FDC with
   VIREAD(tm) (tenofovir) and EMTRIVA(tm)
   (emtricitabine). Would be used with EFAVIRENZ (EFV)
   = $711/year
                             BENEFITS OF FDC’S
Jacqueline Patterson, Catholic Relief Services Consortium Statement in the FDC Meeting
                         in Gaborone, Botswana, March 30, 2004

  •   Eases pill burden which will help with adherence
  •   Currently using FDCs, following our national guidelines/protocols in accordance
      with WHO prequalification standards
  •   Positive clinical outcomes
  •   Lessen risk of sharing of pills among family members
  •   With the onset of resources from the Global Fund, Clinton Foundation, World
      Bank, national programs, etc, our already over-taxed institutions will suffer under
      the onerous management burden due to multiple programs with different drug
      requirements/allowances.
  •   Due to the lower pricing of FDCs, we can treat up to 4 times more people that we
      would be able to treat with non-FDC/branded drugs.
  •   What will happen at the end of the 5-year term of the PEPFAR initiative after
      we’ve all changed out protocols and practices to comply with regulations
      excluding FDCs and requiring high-priced regimens and the resources are
      withdrawn?
  •   In closing, “It is that you as governmental and regulatory agencies ensure that
      constraints are removed so that FDC ARVs are an option for our facilities and
      patients, as soon as possible.”
        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
   – Barriers To The newest ARVs including (perhaps) generic copies Of
      proprietary FDCs
   – Regulatory delays – fast-track for whom?
   – WHO 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.
MORE PROCUREMENT POLICY PROBLEMS?
• Implications for OI drugs:
    – what local producers would apply to the FDA process?
• Treatment protocols
    –   should be driven by health policy, not funding sources
• Procurement chaos burdens already over-burdened healthcare systems,
  workers, treatment educators, procurement agencies, etc.
• New parallel and U.S- controlled supply chain management system
  (SCMS)
    – Coordination with nat'l authorities and existing mechanisms not clear
    – Favors encouraging national procurement mechanisms to shift to using a
      "USG central system.”
    – Likely to be only used for FDA-approved medicines
    – -duplicative of efforts underway at WHO to develop global and regional
      systems for drug procurement and of efforts by the Clinton Foundation.
    – Could also undermine national and regional systems of pooled procurement.
    – "Contraceptives" are not among the categories of supplies that will be
      included in SCMS
• U.S. tech assistance to strengthen intellectual property protections
Sustainable Low-Prices: Threatened by U.S. Policies

    Generic      Differential        TRIPS     High      Local
  competition      Pricing         safeguards Volume   Production



          Prices of essential medicines
            in developing countries

                 Monopolies:         Low volume,
                   patents,          low demand
                    and/or
                data exclusivity
         MAKING A GO OF IT
• THE RUN-AROUND

• "THE WRAP-AROUND”
   – The national government officials in a half dozen or more of
     the focus countries, including Mozambique, Namibia,
     Rwanda, Tanzania, have resisted the distribution of brand
     name drugs as first-line therapy, and therefore the
     governments themselves or the GFATM are picking up most
     of the cost of generic ARV's
• PEPFAR’s END RUN AROUND NAT’L SYSTEMS
   – PEPFAR has the potential to make a difference. But to
     guarantee sustainable programmes and to break the yoke of
     dependence and build national dignity, support should ensure
     full participation and capacity building of the local partners
     and the existing health infrastructures. While PEPFAR
     rightly focuses on getting treatment to the patients as soon as
     possible, its vertical one-donor approach may collapse the
     very system it needs to strengthen. (EPN newsletter)
                   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

				
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