[Ip-health] Paris Declaration: ARV treatment priorities and funding

Sat, 08 Dec 2001 08:41:02 -0800

The declaration below, the result of a meeting of health experts on
access to care for people living with HIV/AIDS, clearly spells out
the need for the Global Health Fund for AIDS, TB, and malaria to
prioritize financing for AIDS treatment, inclusive of antiretroviral
drugs.

>From the declaration:

V. Conclusions:

*  A real opportunity to impact on the HIV/AIDS epidemic now exists

*  Care, treatment, and prevention of HIV/AIDS are strongly linked.

*  Care constitutes an entry point and a key element for effective
prevention.

*  In low and middle income countries a wide array of life-prolonging
care and treatment interventions are feasible and cost-effective
today.

*  The sharp drop in the prices of antiretroviral drugs in these
countries has dramatically improved their cost-effectiveness. Several
nationwide and smaller ARV programs have shown adherence levels and
efficacy outcomes of therapy that are similar to those in the
developed world.

*  Governments, the private and not-for profit sector, and the
international community must now commit the required financial
resources commensurate with the need as identified by the UNGASS
declaration.

*  Failing to seize this opportunity to expand care and treatment
will perpetuate untold human suffering and increase poverty and
inequity on a worldwide scale.

>From the meeting participants:
We propose that this declaration be circulated to all international
and national partners in the fight against HIV/AIDS with the view
toward endorsement by appropriate forums, governments and concerned
organizations.  We hope that it will serve as a basis for immediate
action.

---

MEETING ON ACCESS TO CARE  FOR PEOPLE LIVING WITH VIH/SIDA
29th-30th November & 1st December 2001

This international experts meeting was held in Paris at the
invitation of the French Ministry of Foreign Affairs, with  the
support of UNAIDS Secretariat and WHO.

1 December 2001

Paris, France

DECLARATION FOR A FRAMEWORK FOR ACTION:
IMPROVING ACCESS TO HIV/AIDS CARE IN DEVELOPING COUNTRIES

I. Introduction and Purpose of the Document

With an estimated 40 million people infected with HIV worldwide and
26 million accumulated deaths, HIV now stands as the worst infectious
disease pandemic in recorded history. The threat imposed by HIV is
reflected not only in the tragedy of each individual case and his/her
affected loved ones but on the global scale of human health and the
potential for demographic, economic and political destabilization in
many countries. Access to HIV prevention and care services have long
been championed by international organizations, governments,
non-governmental organizations and community groups. However, we are
far short of providing HIV-infected people worldwide with appropriate
care. In the last two years, an extraordinary juxtaposition of events
has given us an opportunity that must be seized. Since the
International AIDS Conference in Durban in July 2000 and the United
Nations General Assembly Special Session  (UNGASS) in June 2001, the
world is mobilized as never before to address the issue of HIV/AIDS
in developing countries.  The tools which can change the course of
the epidemic are in our grasp. The benefits of treatment in terms of
preventing illness and death from HIV infection have now been well
demonstrated. Access to HIV medications must now be ensured for the
millions of infected persons in the developing world within the
broader context of appropriate care, prevention and support.  Current
resource allocations are woefully inadequate, substantially less than
25% of the annual estimated need, to meet this goal. Future
generations will judge us harshly if we fail moving rapidly toward
the minimum 7-10 billion dollar per year allocation that was called
for in June 2001.

The purpose of this document is two-fold. The first is to set forth a
clear framework for improving and accelerating access to care for
HIV-infected women and men in the developing world. In particular,
the document proposes near-term goals that are achievable. Specific
priorities are outlined with a timeline of 18-36 months. The second
purpose is to serve as a start for mobilizing organizations and
people to an ongoing, progressive, sustainable action plan that will
help to make the UNGASS  declaration become a reality.

This document is the product of a year long consultative process
involving 155 experts from 27 countries and 57 national and
international organizations.  It is the consensus of the participants
who convened in Paris at the invitation of the French Ministry of
Foreign Affairs, UNAIDS and WHO on 29 November - 1 December 2001.

II.  Current Status of HIV/AIDS Care in Developing Countries
(Including Achievements Thus Far)

A.  Prevention, Care and Support (Emphasizing Synergy)

As already shown by successful local and community responses to
HIV/AIDS, prevention and treatment are synergistic : access to HIV
treatment enhances the effectiveness of prevention as well as
voluntary counselling and testing (VCT) programs. Prevention, or the
reduction of new infections in the seronegative population, should
not be pitted against care for those who are already HIV-infected.
The idea that prevention could be more effective than treatment
ignores their interdependence and indivisibility.

There is no disputing that targeted prevention strategies that take
into consideration poverty, discrimination, inadequate education and
gender inequality are effective in reducing HIV transmission.
However, they will not be able to curb the pandemic in the absence of
parallel efforts toward persons living with HIV. It is estimated that
9 out of 10 HIV-infected persons in sub-Saharan Africa do not know
their serostatus. This is unlikely to change unless access to
adequate care in case of a positive test result is offered. In
addition, availability of effective care and treatment options
reduces HIV-AIDS related stigma and increases societal and local
responses to the epidemic.

B.  Economic Opportunities and Constraints

Assuming that 20%-25% of the HIV-infected persons world-wide are
symptomatic and/or in an advanced stage of immunodeficiency, 7.5 to 9
million living in developing countries are in urgent need of
antiretroviral treatment (ARV). In contrast, a total of only about
200,000 HIV-infected persons, of whom 100,000 live in Brazil, use
these treatments. This is less than 3% of those in need. At current
discounted prices of antiretroviral drugs plus other costs of
treatment (1,200 US$ per patient per year for both) the availability
of 240 million US$ in 2002 would result only in a doubling of the
number of treated persons, a positive but only a small step forward.

Clearly there is an urgent need for supplemental resources if
additional lives are to be saved. In order to reach at least a third
to one half of the 7.5 to 9 million people estimated to be in
immediate need of treatment, additional funding is required for the
Global Fund to Fight Against AIDS, TB and Malaria and from
international co-operation, the private sector and insurance, as well
as public budgets from national governments.

A number of national and smaller pilot programs in middle-income
(Argentina, Brazil, Chile, Thailand, etc.) and low-income (C=F4te
d'Ivoire, Senegal, Uganda, etc)  countries have demonstrated a
comparable feasibility, efficacy and adherence with antiretroviral
treatment to those obtained in high-income countries.

The Brazilian experience, which ensures universal access and enhances
domestic drug production, shows that ARVs can be cost-saving for the
health care system : extra costs of drugs are more than offset by
further savings due to the reduced number of episodes of
opportunistic infections and consequently reductions in
hospitalization (according to the Brazilian Ministry of Health net
savings through ARV use amounts to more than 140 million US$ per
year). Once indirect costs (i.e. productivity losses associated with
morbidity in HIV-infected patients) are taken into account,
antiretroviral treatment is clearly cost-saving for many economic
sectors of developing countries, as suggested by the increasing
number of private companies in Africa, Asia and South-America which
provide these treatments or subsidise their costs for their
workforce. Antiretrovirals for the prevention of mother-to-child
transmission of HIV and prophylaxis for tuberculosis and other
opportunistic infections are generally recognized to be
cost-effective, and must be implemented on a large scale everywhere
including in the countries with the lowest GDPs.

Even if they do not save money per se, new health interventions are
considered as cost-effective in the North as soon as their marginal
cost per additional life-year saved is below twice the GDP per capita
(50,000US$ in OECD countries). Applying  the same criterion to
developing countries with lower GDPs, means that antiretroviral
treatment should also be considered cost-effective for eligible
patients in low-resource settings. Moreover, human and social
benefits from increased life-expectancy and quality of life of
HIV-infected patients go far beyond their direct economic impact for
treated patients and include improved social and human development
for their families, communities and country as a whole.

III.  Key Issues and Opportunities

The care of HIV infected persons is multidimensional and the
components must be clearly delineated.  In this context, it is
important to re-emphasize that prevention of new infections and care
of those already infected are tightly linked and synergize with one
another.  National AIDS programs and international agencies have
outlined many of these critical features and it is not the point of
this draft declaration to reformulate these documents.  Rather, it is
to highlight the most critical areas which require resources, at the
country level, in order to scale up the most effective programs for
access to care.

1. Uniform availability of voluntary counselling and testing (VCT).
Where this does not exist, appropriate measures should be taken
immediately to scale up these programs.  Proper assessment of an
individual's HIV status permits educational measures to help negative
persons remain negative and positive persons to enter into care.  The
latter, in turn, facilitates prevention efforts through interventions
to prevent secondary transmission whether this be behavioral
modification or entry into mother-to-child transmission prevention
programs in the case of pregnant women.  Increased testing capacity
will also contribute to ensure a safe blood supply.  A key element of
strengthening VCT programs is the parallel availability of
antiretroviral drugs.  The hope of accessing life saving therapy will
encourage more people to seek VCT services and thereby directly
assist the prevention efforts.

2. Scaling up of MTCT prevention programs.  One of the greatest
achievements of the past decade is the demonstration that MTCT of HIV
can be dramatically reduced by antiretroviral drugs.  In the
developed world the rate of infection of newborns is less than 2
percent and is near zero in women who receive proper antenatal care.
Attaining this degree of success in the developing world will be
difficult because of the absence of uniform access to antenatal care
and the need for breastfeeding.  In spite of these difficulties,
reductions of MTCT by 50 percent have already been demonstrated in
the developing world through the use of nevirapine or short-course
zidovudine (AZT).  These programs must be put in place in every
health care setting.  The availability of this service will increase
the uptake of VCT in a synergistic fashion.  MTCT prevention programs
are also a crucial entry point for the introduction of antiretroviral
treatment of the mother and family when indicated.

3. Opportunistic infection (OI) prophylaxis and treatment.  The
proper management and prevention of opportunistic infections has been
proven to have a positive impact on morbidity.  Uniform access to
drugs, such as antituberculous drugs and cotrimoxazole, is a cost
effective intervention that is a mandatory component of care.
Antiretroviral therapy is by itself the best prophylaxis for
opportunistic infections. Scaling up antiretroviral treatment will
progressively reduce the need for anti-OI drugs.

4. Improving access to antiretroviral therapy.  The revolution in
care in the developed world is unquestionably linked to the
availability of powerful combinations of antiretroviral drugs.
Dramatic reductions in morbidity and mortality have been well
documented and this benefit needs to be made broadly available to
persons in the developing world.  It should be re-emphasized that
antiretroviral therapy is already being used in the developing world,
although on a small scale in low-income countries,  with the
demonstration that it is feasible and effective.  Further, drug
adherence appears to be comparable to the developed world and the
concern for the spread of drug resistance is not a valid reason to
delay introduction of therapy anywhere.  In addition, drug resistance
can be minimized by improving drug adherence and utilizing potent
drug combinations.  Further, there are plans already in place to
establish a Global HIV Drug Resistance Monitoring Project by the WHO
and the International AIDS Society which will be put in place in
parallel with the scale up of antiretroviral treatment programs.
Conversely, failure to expand treatment in a systematic way will
certainly increase the risk of non-rational prescription and use of
antiretrovirals ensuring a greater incidence of drug resistance.

It should also be recognized that the benefits of antiretroviral
therapy extend beyond the immediate medical result of an improved
physical health.  These benefits include an improved psychologic
status, stabilization of the family unit, increased uptake of VCT,
prevention of opportunistic infections and probable diminished
transmission in the population.

Antiretroviral treatment programs need to be scaled up as rapidly as
possible simultaneously with provision of health care worker and
facilities capacity to permit and facilitate care delivery.  Programs
which build on existing MTCT prevention (e.g., MTCT "plus") and
tuberculosis control programs are key entry points for antiretroviral
therapy programs.  In addition, attempts should be made early on to
put programs in place at regional centers, district centers and rural
settings as treatment needs to reach the affected population
throughout the developing world. Within each country, financial
sustainability and equity considerations imply that additional care
and treatment resources, as well as public subsidies for
antiretroviral drugs (where they exist), need to be targeted to those
who cannot afford them, or who can pay only a fraction of the costs.

5. Psychosocial Support.  A key element of care for all HIV infected
persons is psychosocial support, including palliative care.  The high
incidence of depression and other emotional illnesses should be
acknowledged in order for hope to be nurtured. Good quality care
requires sufficient numbers of properly trained health care workers,
traditional healers, religious and community leaders and volunteers
to help patients and their families to develop the best ways of
coping at all stages of HIV disease, and particularly with end of
life issues. Appropriate psycho-social support will more than ever be
needed to facilitate access and adherence to treatment.

IV. Framework for Implementation of Priority Programs

A. Approach for Efficient Implementation

While a demand-driven, participatory, and progressively decentralised
approach will enable broadening of health care services, a central
capacity is also needed at national levels for protecting people's
rights, promoting price reductions for HIV/AIDS drugs and services,
quality control of drug and service delivery, monitoring and
evaluation.

In order to create systems for delivering care to significantly more
people, training of personnel will be critical. In addition to
supporting clinics, hospitals and homecare programs, countries need
to aggressively work toward transforming existing volunteer and
community-based organisations into AIDS service organizations. Latent
capacities to demand and provide for care and treatment are
widespread in families, communities, and organizations. To fully
develop them requires a learning-by-doing approach in which the
human, technical, and organizational capacities are developed over
time to handle progressively more complex care and treatment
components.

Once reference centres in large cities are functioning, these centres
should be used to train people working in smaller cities or rural
communities as is being done in Brazil, C=F4te d'Ivoire Senegal and
Uganda. One innovative model for providing care is "Association-Based
Treatment" (e.g., Burundi, Zimbabwe, Venezuela). Within this model
the financial and material treatment resources are controlled and
managed by the associations of people living with HIV/AIDS, together
with doctors and other providers.  In this context HIV infected women
and men are directly involved in the decision making process and
organization of all aspects of HIV care.

Without medicines, reagents for diagnostic testing and monitoring,
improved human resources will be compromised and ineffective.
Therefore, how to offer international support to augment local and
national procurement efforts will be critical.  Since the
availability and sources of commodities will vary dramatically,
international funding sources should not attempt to dictate where and
how drugs and other inputs will be purchased.

Decisions on how to procure should be left to the country which may
decide to: conduct national tenders to foster competition between
generic and proprietary companies, take advantage of regional
procurement organizations or future international buying arrangements
managed by UNICEF (or other international, intergovernmental or
private procurement organisations). Efforts to build local capacity
for drug production, procurement and management of rational drug
delivery should also be supported by international funds. Creating
drug production capacity within developing countries can be an
important factor in increasing access to medicines.

Patents must not constitute a barrier to access. The use of
safeguards (such as compulsory licensing) to override patents is
legal within the TRIPS international trade agreement and has been
strongly reinforced in the 14 November 2001 WTO ministerial
conference declaration on the TRIPS agreement and public health. It
reads that "the TRIPS Agreement does not and should not prevent
Members from taking measure to protect public health." It also states
that "each Member has the right to grant compulsory licenses and the
freedom to determine the grounds upon which such licenses are
granted."

To offer treatment to the highest number of people possible, it is
essential that funds be used to buy quality commodities at the best
possible price. Using the lowest cost suppliers, whether proprietary
or generic companies, will increase the number of people who can be
treated and will allow for greater investments in other important
components of care and prevention.  Increased competition is a
powerful tool to reach this goal.

Next to mobilizing the financial resources, the testing of the tools
and of the logistics to roll them out in district-wide and ultimately
nation-wide programs is the greatest challenge to scaling up care,
treatment, and support.

B.  Partnerships

In the last two decades of the response to HIV/AIDS various forms of
partnerships have been built. They need to be strengthened and new
forms of partnerships, such as networking among hospitals in the
North and in the South, health care delivery centres, community
organisations and NGOs must be promoted to reduce the gaps in
knowledge and access to services, and create a solid basis for local,
national and global solidarity. Partnerships must be based on trust,
respect and shared vision. They add value to the process of providing
and utilizing care and support by taking advantage of their strengths
to scale up local response. Technical expertise already existing at
international level, notably in the UN system, and at country level,
should be mobilised to facilitate these partnerships. Partnerships
between the public and private sectors should be strongly encouraged
for delivery of care, mobilization of funding, and/or procurement of
commodities for HIV-AIDS care in order to optimise use of resources
and to the extent that they help promoting the goal of wider access
to care.

The potential of care partnerships have been demonstrated in Zambia
where a national facilitation team consisting of a resource group of
more than twenty people from national networks and organizations has
quickly increased local districts' capacity to deliver care to an
increased patient population. Only these types of networks can ensure
a continuum of care, from the home to the district clinic and
hospital or between the public, private and faith based health
facilities.

C.  Priorities for Operational Research

There are numerous questions that need to be answered in the context
of care delivery in the developing world.  The pressing need to
deliver antiretroviral treatment as quickly as possible to as many
persons means that care and treatment programs should never be
delayed pending the results of research projects.  Rather; the
opportunity should be taken to put practical, simplified data
gathering mechanisms in place so that outcomes research can be
successfully accomplished in parallel with the implementation of the
programs.  One advantage to pursuing operational research in this
manner is that the results will be directly applicable to the
countries in which the data are gathered.  Examples of the questions
that need to be quickly answered are:

*  What are the most relevant and cost effective ways to deliver and
monitor antiretroviral therapy including the identification of the
cheapest effective regimens, the simplification of monitoring for
toxicity and efficacy and the promotion of cheaper and simpler
methods for CD4 cell count and viral load measurements?

*  What are the best regimens for patients coinfected with
tuberculosis and/or hepatitis viruses?

*  What patterns of drug resistance will emerge and what is the
interplay of MTCT prevention programs with therapeutic antiretroviral
programs?

*  What are the best strategies to scale up personnel and facilities
infrastructure without delaying implementation of care programs?

*  What is the impact of improved access to care on behaviors and on
prevention of HIV transmission in the population notably among youths?

*  What is the impact of improved access to care on economic, social
and human development as well as on strategies for poverty
alleviation?

V. Conclusions

*  A real opportunity to impact on the HIV/AIDS epidemic now exists