Dear E - druggers,
The Ecumenical Pharmaceutical Network (EPN) would like to open a
discussion on the "US Presidents Emergency Plan For AIDS Relief"
(PEPFAR). EPN members in African countries are noting some positive and
negative aspects about that program, some of which we elaborate in the
article below. In light of this, the board of EPN meeting on 29th - 30th
July 2004 in Abuja / Nigeria, decided to organize a forum for discussion
of PEPFAR and have included a day for this during their annual members'
meeting. This discussion will take place on October 6th, 2004 in Moshi /
Tanzania and will bring together various actors to discuss and learn
about this important initiative to fight HIV/AIDS. EPN would like to
share with you the statement that brings together some of EPN members'
experiences with PEPFAR and some of the concerns. We invite readers of
E-drug to participate in this discussion. What are your experiences or
comments? We hope to take the reactions of E-Druggers to our discussions
in Moshi.
Thank you.
For more information about EPN or the PEPFAR day please contact: Dr. Eva
Ombaka, email epn@wananchi.com.
RAISING CONCERNS:
IS PEPFAR A KNIGHT IN SHINING ARMOUR OR A TROJAN HORSE?
It is estimated that today more than 38 million people are living with
HIV/AIDS, of whom 6 million are in urgent need of treatment and only
400,000 are getting the life-prolonging antiretroviral treatment. The
world's reaction to this disaster, through a number of funding
mechanisms including the US President's Emergency Plan for AIDS relief
(PEPFAR) can only be welcomed. But is PEPFAR a knight in shining armour
in these times of great need or a Trojan horse, likely to cause harm in
the long run? This is a question that was of concern to the Ecumenical
Pharmaceutical Network (EPN) Board whose members come from
church-related health services and their drug supply units.
Worldwide solidarity funds such as the Global fund for HIV/AIDS,
Tuberculosis and Malaria, while providing funds for drug procurement,
have also been working through strengthening of infrastructure and the
development of platforms for governments and civil society to define
country-specific priorities. All this is meant to make for sustainable
health care systems. The drawbacks on this have been the complexities in
applying for the funds and the slow implementation of the plans in
situations where urgency is needed. Partners have therefore gotten
disappointed and are looking for, and open to, alternatives.
In 2003, the US Government (USG) started a 15 billion dollar
5-years-program (PEPFAR) to fight against HIV/AIDS and to get 2 million
people on treatment by the year 2008. In 2004 many local contacts and
contracts between PEPFAR and hospitals, NGOs and Faith Based
Organizations (FBO)s have been developed and it 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?
The EPN board members meeting on 29th to 30th in Abuja, Nigeria after
analysing available documents and learning from experiences of some of
its members, strongly proposes that there are several issues in the
PEPFAR model that need to be negotiated or even changed if
sustainability and independence is to be maintained. Implementing
partners at local level need to be particularly cautious so as to ensure
that they get sustainable support for their organizations and the best
care and treatment for the people they serve.
The board highlighted particularly these areas:
One-donor programmes are prone to political instability
PEPFAR is a US funded programme that can be influenced or terminated by
political changes between the country and the USA or by changes in US
policies. While one would hope this will not be the case, it is
none-the-less imperative for countries to continue supporting
multi-country programmes such as the GFATM whose decisions are not
dependent on a single country.
Decision on treatment protocols must be national
PEPFAR requires that drugs used in the programme be approved by FDA
(thus favouring US products) or a "stringent regulatory body" (but not
the WHO prequalification programme). This means that the drugs will 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.
It is therefore very important that the national AIDS programme or
similar body is consulted and national treatment protocols with drugs on
the national essential drugs list are followed. This will ensure that
patients are getting drugs they and the national health system can
afford even when the PEPFAR programme ends.
Exclude drugs for opportunistic infections (OI) from FDA approval.
The PEPFAR clause requiring approval by FDA also applies to drugs for
opportunistic infections (OI). Drugs for OI are, in many cases, produced
locally. Local initiatives to build and strengthen the local industry
have meant that many of these drugs are also available in good quality
generic forms. Using drugs approved only by FDA will make them very
expensive and in the long run may kill the local industries and threaten
the sustainability of the already existing drug supply chains. This must
not be allowed to happen.
Furthermore unlike ARVs, these drugs are not used exclusively for
HIV/AIDS patients and neither are all the HIV/AIDS patients who need
drugs for OI's going to be on PEPFAR funded ARV's. A condition where
certain patients are given different brands of the same drugs would
therefore create a multi cadre patient system in an institution, leading
to not only misunderstandings but also a lot of additional work for an
already overstretched health staff. This too must not be allowed to
happen.
Supporting the WHO pre-qualification system
PEPFAR is currently ignoring the WHO pre-qualification system that has
made it possible for good quality and less expensive generic
alternatives to be available to the many people needing treatment.
Furthermore the access campaigns supported by governments, UN agencies
including WHO, NGOs and many civil society groups succeeded in
encouraging generic manufacture. The resulting competition brought the
prices of both generics and branded ARVs down. The continuation of this
competition and the encouragement for production of more user-friendly
dosage forms face possible discontinuation should the PEPFAR programme
continue to ignore this global essential process. This must be resisted
at both local and international level.
This would also mean, at local level, encouraging and supporting local
industries to improve their quality and seek WHO pre-qualification.
Constrained Supply Chain Management Systems
PEPFAR is in the process of making plans for supply chain management
contracts that will provide the needed drug distribution system. Whilst
the final contract terms are still being negotiated, the draft has some
clauses that raise concern. These include the lack of clarity on local
capacity building where already there is an observed influx of
expatriates and foreign organizations into the earmarked
PEPFAR-supported countries. Others are the restriction on use of
PEPFAR-funded facilities, the exclusivity of data to the US government
and the commitment by partners to unspecified US government health and
development objectives. Efforts must be made to ensure that these
concerns are addressed in this early stage.
PEPFAR has a potential of making 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.
Currently available HIV/AIDS treatment options require that the drugs be
taken for life. Thinking long term must therefore be an essential
component of any funding programme.
Eva M A Ombaka, Coordinator EPN and Albert Petersen, Chair EPN Board
Ecumenical Pharmaceutical Network
P. O. Box 73860-00200
Nairobi, Kenya
Tel: 254-20-4444832/ 4445020
Fax: 254-20-4445095/4440306
Email: epn@wananchi.com
Website: www.epnetwork.org