Déclaration de EPN sur le Système de Gestion des Chaînes d’Approvisionnement du PEPFAR

A Statement of the Ecumenical Pharmaceutical Network (EPN) on the US President’s Emergency Plan for AIDS Relief (PEPFAR) Supply Chain Management System

Tuebingen, Germany, May 2006

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The Ecumenical Pharmaceutical Network (EPN), comprising Christian Health Associations and hospitals, non-profit drug supply organisations and ecumenical agencies from 29 countries who attended EPN’s Annual Forum and General Meeting from 8th – 13th May 2006 in Tuebingen, Germany, issues this statement on the Supply Chain Management System (SCMS).

We recognise and acknowledge that scaling up medical assistance and care of the men, women and children in our communities who are infected and affected by HIV/AIDS require uninterrupted supply of high quality, low cost products that flow through an accountable system. Therefore, we welcome the intention of SCMS to strengthen existing or establish (where none exist) secure, reliable, cost-effective and sustainable supply chains that meet the care and treatment needs of the people living with and affected by HIV/AIDS.

1. We note that the SCMS was established 3 years after the launch of President Emergency program on AIDS Relief (PEPFAR). However, the number of patients on ARVs through PEPFAR had increased even before the launch of SCMS. This indicates that some well-functioning supply systems already exist. These should not be destabilized.
2. In the design of the SCMS, there has been little or no involvement of stakeholders from the countries targeted. There was therefore no opportunity to bring in country-specific issues.
3. The creation of such a large multi-country supply system will have a negative impact on the existing supply systems because of imbalance in the trading volumes. It is more than likely that manufacturers and suppliers shall give priority attention to this major client at the expense of the smaller existing clients. The plan of supplying more than 120 commodities will take up a large proportion of the Essential Drugs supply needs, rendering the existing supply organizations irrelevant.
4. There is no adequate assurance that in-country manufacturers and suppliers will be supported to ensure growth in capacity and sustainability.
5. Whereas the SCMS project proposes to supplement and strengthen the existing supply chain capacity and to collaborate closely with governments, non-governmental organizations and faith-based organizations to strengthen the public health systems, we see a danger of brain drain of human resources from the existing systems to the SCMS.
6. The SCMS project presents an alternative procurement system, which negates the principles of Sector Wide Approach Strategy (SWAps) of common management arrangements which include working through existing public procurement system.
7. While the objectives of SCMS may be beneficial to the needs of the people in short-term, there is a real danger in the long-term sustainability beyond the period of PEPFAR funding. There is no clear exit strategy to ensure that the capacity established will be sustained.
8. The suggestion of voluntary choice in the use of SCMS services for the PEPFAR recipients seems rather theoretical, since decisions will be made at US country missions and not by the recipients of the funds. We find it highly unlikely that a local PEPFAR funds sub- recipient would have the mandate to choose to procure products outside SCMS which is funded by US government.

Recommentations

In order for the SCMS project to succeed in delivering its objectives and to ensure that useful and sustainable capacity is established within the existing public health procurement systems, EPN makes the following recommendations for SCMS action:

1. An in-country mechanism and forum for continuous dialogue and communication should be established for key stakeholders to review country issues on the system design, identify collaborating stakeholders and provide monitoring feedback. This should include MOH, National AIDS Control Program, public andFBO/NGO Drug Supply Organizations, Pharmaceutical Societies, representatives of Pharmaceutical Manufacturers and PEPFAR awardees, and other donors such as Global Fund, World Bank –MAP programme etc.
2. There should be clarity in the strategies for addressing the two different situations: countries with in-country supply structures and those without such structures. In the countries with already existing systems, needs/gaps analyses should be the first step in strengthening the existing systems.
3. Capacity building should target strengthening of the existing Public and FBO/NGO Supply organizations and should be started before the supply activities are started. The capacity building should include recruitment of qualified staff, skills development in logistics (e.g. transport) and other supply chain management issues, contract negotiation, quality assurance and M&E. Capacity building should be a continuous exercise that focuses on use and strengthening of existing local experts.
4. The SCMS should ensure good knowledge and understanding of the country specific laws, policies and regulations to ensure integration or harmonization since this has a bearing on systems strengthening and sustainability.
5. Transparency and accountability should be enhanced through participatory M&E. The M&E plan should be clear to all stakeholders from the onset. There should be a strategy for in-country capacity building for M&E of the performance of the country SCMS activities and its impact on the other existing systems.
6. A clear exit strategy should be designed for each targeted country before the start of the project. This should clearly define the targets to be achieved during the project to ensure that after the end of the project the achievements will be sustained and no crisis situation will occur. This should also include management succession planning by including and developing capacities of local human resources.
7. The SCMS project must incorporate a comprehensive risk management strategy since the lives of many people will be dependent on its efficient and uninterrupted performance irrespective of environmental and political changes.

We, the members of EPN, in the spirit of goodwill and solidarity, further affirm that the fight against HIV/AIDS deserves concerted efforts. Efforts that bring out the best from all stakeholders to ensure sustainability, effective use of resources, expanded local capacity and the empowerment of people. In view of the above, we urge you to respect the reality on the ground, to give attention to the concerns expressed and to consider the recommendations as the SCMS prepares to implement its plan.

Thank you.

This statement has been signed on behalf of the Ecumenical Pharmaceutical Network (EPN).

Mr. Albert Petersen                     Dr Eva M A Ombaka

Chair, EPN Board                       Coordinator EPN

EPN Statement on PEPFAR - October 2004

A Statement of the Ecumenical Pharmaceutical Network (EPN) on the US President’s Emergency Plan for AIDS Relief (PEPFAR)

Moshi, Tanzania, October 7th, 2004

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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:
• 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.
• It will be difficult for the institutions to continue providing the same treatment at the end of the PEPFAR programme.
• 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.
• 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:

1. 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.
2. 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.
3. 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.
4. 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.
5. Immediate discussions should start between PEPFAR, other donors, governments and implementing partners on the sustainability of services beyond 2008.
6. PEPFAR should actively identify and involve local experts resident in the partner countries for the effective implementation of activities.
7. 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.
8. 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