E-DRUG: Can we document experiences with PEPFAR please?
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Dear colleagues,
EPN recently gave out a statement on PEPFAR (below) expressed following the initial experiences with our members on the ground. We would like solicite a sharing of experiences from those involved in PEPFAR and to have views of those who do not agree with our concerns. Such a debate would be useful for those still in the preparation to join PEPFAR. I think this topic is likely to get more attention as more countries enter implementation stage and when the "supply chain management system" fate is known! So the earlier we can point out issues, the better.
Thanks a lot.
Sincerely,
Eva Ombaka
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A Statement of the Ecumenical Pharmaceutical Network (EPN) on the
US President's Emergency Plan for AIDS Relief (PEPFAR)
Moshi, Tanzania, October 7th, 2004
The Ecumenical Pharmaceutical Network (EPN), comprised of Christian Health Associations and hospitals, non-profit drug supply organisations and church related development agencies, from 22 countries attending our Annual General Meeting held from 5th - 7th October 2004 in Moshi, Tanzania issues this statement on the US President's Emergency Plan for AIDS Relief (PEPFAR).
We recognise and acknowledge that scaling up medical assistance and the care of the men, women and children in our communities who are infected and affected by the scourge of HIV/AIDS, must continue. Therefore, we welcome the initiative and the goals of the US emergency response to provide much needed resources for HIV/AIDS care and support; increase the number of patients under treatment; and, contribute towards the improvement of infrastructure required to fight HIV/AIDS. This gives hope for people living with HIV/AIDS.
However, as a network of health care service providers, we express our deep concern over some aspects of PEPFAR which have been identified as generally applicable, but to varying degrees in individual beneficiary countries:
1. PEPFAR's insistence on FDA approval for all medicines purchased and the 'buy American' requirement for medicines other than ARVs, causes needless delay in making life-saving drugs available and may be inconsistent with national treatment protocols.
2. PEPFAR's overwhelming preference for brand-name drugs and the barriers to the use of more affordable generic ARVs and drugs for opportunistic infections raise four major concerns:
a. It introduces a situation where patients are given different brands of the same drug thus creating a multi-cadre patient system in an institution, leading not only to misunderstandings but also a lot of additional work for an already overstretched health staff.
b. It will be difficult for the institutions to continue providing the same treatment at the end of the PEPFAR programme.
c. Using drugs approved only by the FDA may kill the local industries and threaten the sustainability of the already existing drug supply chains. This is particularly true of drugs against opportunistic infections, which are produced locally at affordable prices.
d. Use of expensive branded products, where equally good but cheaper alternatives are available, is not a cost effective use of resources.
3. In some cases, PEPFAR disregards national drug regulations and local supply chain management systems, which could damage national health systems, especially the pharmaceutical sector.
4. Treatment requires a lifetime commitment, yet there is currently no long-term strategy to provide a continuance of care at the end of the programme. The high level of donor control and little or no country or local ownership further undermines the sustainability of health care and other services.
5. In its current form, the implementation of PEPFAR promotes extensive use of US skills and capacities (personnel and institutions) to the detriment of available local expertise with greater understanding of the issues in their local contexts.
6. There is excessive delay caused by the inherent bureaucracy and conflicting operational rules and regulations. Cumbersome and time consuming documentation requirements; complicated procurement procedures for drugs and other needed items and restrictive expenditure regulations, frustrate and undermine the efforts of institutions trying to implement PEPFAR.
7. The implementation of PEPFAR is predominantly unilateral, undermining other international efforts such as the '3 ones' (one co-ordination, one strategy and one monitoring/evaluation) and the UN Prequalification Project managed by WHO.
In light of the above, we make the following recommendations:
a. PEPFAR should remove the restrictions of its funds to purchase only medicines approved by the FDA and the 'buy American' clause and instead allow the purchase of nationally approved medicines, generics or brand-name drugs, and antiretrovirals pre-qualified by the WHO.
b. PEPFAR should address fears of local drug management and supply institutions that they will be harmed by PEPFAR, and commit to strengthen and improve local structures and systems.
c. PEPFAR should hold extensive consultations with local partners in all areas of the programmes including policy formulation, planning, design, preparation of terms of reference and actual project implementation.
d. PEPFAR should regularly meet with community constituted advisory and oversight bodies comprised of people living with HIV/AIDS, FBO's involved in medical delivery, and health care experts among others.
e. Immediate discussions should start between PEPFAR, other donors, governments and implementing partners on the sustainability of services beyond 2008.
f. PEPFAR should actively identify and involve local experts resident in the partner countries for the effective implementation of activities.
g. PEPFAR should dialogue with local implementing partners with a view of recognising and accepting available and relevant local data or data collection systems and the simplification of documentation requirements.
h. PEPFAR should co-ordinate more effectively with existing international HIV/AIDS programmes including the Global Fund and the WHO '3 x 5' to ease implementation and avoid duplication at local level.
We the members of EPN, in the spirit of goodwill and solidarity, further affirm that the fight against HIV/AIDS deserves concerted effort from all partners to ensure sustainability, effective use of resources, expanded local capacity, empowerment of people living with HIV/AIDS and provision of treatment for as many people as possible. In view of the above, we commit ourselves to play our part in making sure that the PEPFAR programme is implemented to the best interest of those served, the implementing partners and the funding agency.
This statement has been signed on behalf of Ecumenical Pharmaceutical Network.
Mr. Albert Petersen Dr. Eva M A Ombaka
Chair EPN Board Coordinator EPN
Contact address: epn@wananchi.com