[e-drug] Brazilian proposed resolutions to World Health Assembly

[hai@hai.antenna.nl]

E-drug: Brazilian proposed resolutions to World Health Assembly
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[Comment from Mike Palmedo who posted these on Ip-Health: 'These proposed 
resolutions are from the Brazilian
delegation.  The WHA said they would not circulate it. As far as I could 
tell, there was no decent reason given for this.  (I even heard something 
about the
time it would take them to translate and copy this four page document.)  If 
there is a decent reason, I hope someone can post it to the list.'
This morning (17 May), Sweden also announced that it had prepared a 
resolution on the HIV/AIDS. However, this is not yet available for review. 
As Sweden is the president of the EU at the moment, we expect that this 
version will reflect the more pro-industry view of that region. KM]

Warning: long message

DRAFT RESOLUTION Proposed by Brazilian Delegation to the Fifty-fourth World 
Health Assembly
-----------------------------

HIV/AIDS
The Fifty-fourth World Health Assembly: Considering that the AIDS epidemic
has become one of the biggest threats to public health in the world, that
this has reached pandemic levels, involving over 36 million people and that
the poor and developing countries are the most seriously affected by it, as
noted in Resolution 54/283 of the United Nations General Assembly;
Considering moreover that AIDS has caused:
1. The loss of countless human lives and countries'productive capacity;
2. Orphanhood (13 million orphans so far at least);
3. Lower life expectancy (up to 3 decades less);
4. Despair and unhappiness; Considering that AIDS was judged by the UN

Security Council in Resolution 1308 of 17 July 2000 as a question of
national security; Recalling that the 53rd World Health Assembly considered
that prevention and health promotion activities are as important for
confronting the epidemic as those focusing on care and treatment of people
living with HIV and AIDS and; Having moreover been considered by the
Declaration of the Head of African States in Abuja, Nigeria, on 27 April
2001, which in its paragraph 29 calls upon the International Community to
put into operation a Global Fund against AIDS with the aim of inter alia
providing access to antiretroviral therapy for populations affected by the
epidemic;

Considering that the Heads of State and Government of the Americas
emphasized in paragraph 25 of the Declaration of the 3rd Summit of the
Americas that good health and equality of access to medical care and to
health systems, together with medical drugs at accessible prices are vital
for human development and the implementation of new political, economic and
social objectives;

Bearing in mind that new techniques, especially those related to new
antiretroviral drugs, must be considered as a Human Rights issue and
therefore should be available on an equitable basis for all countries and
for the universe of people living with HIV and AIDS, as was agreed at the
57th World Human Rights Conference;

Considering that treatment of HIV/AIDS provides a positive incentive for
individuals to submit to voluntary counseling and HIV testing, which in 
turn
dramatically increases the efficacy of anti-HIV prevention and education
efforts necessary to retard the advance of the pandemic.

Considering that HIV/AIDS affects women with special severity.

Considering that levels of international aid finance to support HIV/AIDS
programs in poor countries has been greatly incommensurate with the
prevalence of the pandemic, at approximately $5 annually per HIV-infected
person in poor countries.

Emphasizing the key role that the WHO has performed at the world level,
especially in developing countries and in those relatively lesser developed
countries, to establish and implement policy initiatives centred on health
promotion, on prevention of relevant diseases, on organization of services,
on assembling and making available appropriate information to assist the
formulation of health policies, technical and financial support for 
national
health services, and on the development of ways and means of negotiating
better prices for the procurement of medical drugs;

Reiterating at the same time the forthright performance of UNAIDS in
combating the AIDS pandemic, through its support for National AIDS
Programmes, including for the least developed countries, and in the
organization of the Special Session of the UN General Assembly on HIV and
AIDS, and especially in the drafting and dissemination of documents which
have facilitated thoughtful appraisal of the most relevant issues 
concerning
the pandemic;

Ratifying:

1. The Declaration of the 3rd Summit of he Americas, which in its paragraph
25 states that good health and equality of access to medical care and to
health systems, together with medical drugs at accessible prices, are vital
for human development and for the implementation of new political, economic
and social objectives;

2. The Declaration of the Head of African States in Abuja, Nigeria on 27
April 2001, which in its paragraph 29 calls upon the International 
Community
to put into operation a Global Fund against AIDS with the aim inter alia of
providing access to antiretroviral therapy for peoples affected by the
epidemic;

3. The 57th World Human Rights Conference which declared that access to
medical drugs and especially access to antiretroviral drugs was a question
of Human Rights;

Calls Upon Member States to:

1. Make every effort in order to guarantee that the access to 
antiretroviral
and anti-opportunistic infection drugs should have as its point of 
reference
the principle of equity, thus guaranteeing supply and prices compatible 
with
the social and economic circumstances of individual countries as well as 
the
degree of HIV prevalence in each country

2. Make every effort to guarantee access of the population to currently
available techniques in the areas of health promotion, of prevention of the
main diseases and of care and treatment, with a view to reducing the
negative impact of the HIV and AIDS epidemic around the world.

3. Seek all available ways and means at both international and national
levels to increase access by populations to antiretroviral and
anti-opportunistic infection drugs;

4. Establish health policies which promote access to drugs through: a)
Policy initiatives which embrace the right to use technical and 
intellectual
capacity for the in-country production of AIDS drugs, under the auspices of
the agreements reached within the bounds of international law, such as the
TRIPS agreement;
b) Support for the establishment and financing of an International Fund for
the promotion of access to antiretroviral and anti-opportunistic infection
drugs, based upon the principle of equity;
c) Implantation of a policy to facilitate the supply of drugs, including 
the
production and distribution of generic drugs and the negotiation of prices
with pharmaceutical drugs companies, in accordance with the social and
economic development profiles of each country.

5. Guarantee participation by people living with HIV and AIDS in the
formulation of national policies as regards access to drugs.

6. Promote social control at the national level so as to guarantee better
quality control over antiretroviral drugs.

7. Provide international aid finance against HIV/AIDS as grants, not loans,
to the least developed countries.

Requests the Director General to:

1. Support, and participate in, the creation of an international Fund to
guarantee access to antiretroviral and anti-opportunistic infection drugs,
particularly for poor and developing countries, based on the principle of
equity. That this Fund should make drugs available at different prices in
line with Social Development Indices and according to the prevalence of HIV
in different countries, so that a policy based upon the principle of equity
can be attained.

2. Establish an expert committee under WHO auspices, consisting of an
expanded membership of physicians, scientists, public health practitioners,
and non-governmental AIDS advocates (including people with AIDS), drawn 
from
both developed and developing Member States, to review and assess on a
case-by-case basis the scientific, medical and operational feasibility of
proposals submitted by developing country Member States for funding payable
out of the International Fund.

3. Oppose any international proposals which would provide funding out of 
the
International Fund on the basis of interest-bearing loans, rather than
outright grants, to least developed Member States or other Member States
needing significant financial assistance because of he scale of the 
HIV/AIDS
epidemic in relation to their domestic wealth.

4. Create a Drugs Prices Data Bank, containing information about drugs
procurement and manufacturers, with a view to providing data for the
management of national policies in respect of access to antiretroviral 
drugs
and anti-opportunistic infection drugs.

5. Create parameters jointly with the Member States and the drugs industry,
including producers of generic drugs, in order to establish a worldwide
policy of differentiated prices for drugs according to social, economic, 
and
epidemiological indicators, with the principle of equity as a basic
reference point.

6. Create ways and means to permit better monitoring and quality control of
antiretroviral drugs.

7. Foster inter-country exchanges and international technical and legal
cooperation, with a view to establishing a global policy for the production
of generic drugs, as well as to implement care, treatment and prevention
policies in respect of AIDS, implying the strengthening of links between
public authorities and civil society.

8. Regard the access to antiretroviral drugs and those for treating
opportunistic infections a matter of the highest priority, and to develop
policies for:
a) Reducing the suffering of men, women and children living with HIV and
AIDS throughout the world;
b) Reducing mortality caused by AIDS, especially in the socially and
economically less developed countries;
c) Increasing life expectancy particularly in those countries where it has
been falling as the result of AIDS;
d) Helping to restore the process of social development in poor countries 
by
means of maintenance of productive capacity and the labor force.
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Proposed Resolution from the Brazilian Delegation on the Revised Drug
Strategy.
Revised Drug Strategy
The Fifty-fourth World Health Assembly:

Considering that access to health is a human right and that access to
essential drugs is part of the human right to health and depends on: a)
rational selection and use of medicines;
b) adequate financing;
c) affordable prices; and
d) reliable supply systems

Considering that international law, and particularly Article 12 or the
International Covenant on Economic, Social and Cultural Rights, recognizes
the right to the highest attainable standard of physical and mental health,
and that Article 12 thereof legally binds States to furnish economic and
technical assistance and cooperation to realize that right, as respects the
treatment of diseases;

Additionally, considering that access to medicines is particularly 
sensitive
to price, since most people in developing countries have to pay out of 
their
own pockets for health care, and that for achieving universal access it is
necessary to jointly ensure the commitment of Governments, the United
Nations Offices, the private sector and the civil society ;

Recalling Revised drug strategy Resolution WHA 52.19 and prior related
resolutions, nominally WHA39.27, WHA41.16, WHA43.20, WHA45.27, WHA47.12,
WHA47.16, WHA 47.17, and WHA 49.14;

Having considered the Report of the Executive Board on its 107th session;
Taking into account the Revised Drug Strategy Report by the Secretariat
(document A54/17), as well as the previous Report to the 53rd World Health
Assembly (document A53/10), that highlights challenges in the issues of
international trade agreements, access to essential drugs, drug quality and
rational use of medicines; that also takes into account that the very 
urgent
need to increase access to drugs for treating priority health problems such
as malaria, childhood illnesses, HIV/AIDS and tuberculosis, among others;

Taking into account that the aforementioned health problems present acute
crises which particularly affect the poor and vulnerable populations, and
which entrap them in poverty, substantially slowing the growth of national
and international economies to the detriment of all humanity;

Taking into account that the Revised Drug Strategy must be immediately
implemented, to realize the enormous health benefits that essential drugs
can offer to the one-third of the human population now lacking them;

Taking into account that the currently insufficient levels of international
economic and technical assistance do not ethically or legally justify 
delays
in the implementation of the Revised Drug Strategy;

Noting the importance that WHO and overall country governments are 
according
to the formulation, implementation and monitoring of national drug policies
in accordance to WHO guidelines;

Acknowledging the four main objectives incorporated in WHO Medicines
Strategy: framework for action in Essential drugs and Medicines policy
2000-2003 , being: to frame and implement policy; to ensure access; to
ensure safety, quality, and efficacy; and to promote rational use of
medicines;

Commending the strong leadership that WHO has shown in reemphasizing the
essential drugs concept, and the contributions of non governmental
organizations working on public health, toward the attainment of such
objectives as national drug policies, access to drugs, indicators for
monitoring access and policies, promotion of generic drugs, differential
pricing, supply of drug price information, methodology for drug pricing
surveys, sustainable financing of drug purchases, reliable supply systems,
studies of international trade agreements, harmonization of drug 
regulation,
good manufacturing practices, among others;

Noting that the impact of international trade agreements on the access to 
or
local manufacturing of essential drugs has scarcely been evaluated in most
developing countries, and that ongoing initiatives are needed to research
and develop drug policies vis-`-vis these agreements;

Recalling that the 9th point of the Revised Drug Strategy (Resolution
WHA52.19) requested the Director-General to report to the 53rd Assembly on
progress achieved, problems encountered, and recommendations for action, 
and
that the 107th Executive Board meeting further requested the Director
General to report on the actions of the Secretariat to this Assembly, as
noted in documents A53/10 and A54/17; Reaffirming the Commission of Human
Rights resolution 2001/33 approved by its 57th Session;

1. URGES Member States to:

(1) Ratify this Resolution and related documents as quoted herein, to
reaffirm their commitment and include the necessary actions within their
national health policies to ensure public health interests and equitable
access to medicines

(2) Guarantee access to medicines in the context of priority diseases and
pandemics, which must be considered as a fundamental human right at
international law, the full realization of which is indispensable to the
right to the highest attainable standard of physical and mental health

(3) Join efforts to cooperate into the implementation of all of the
Operative Paragraphs contained in the Commission of Human Rights resolution
2001/33;

(4) To confirm the Revised Drug Strategy Resolution WHA52.19 as an
imperative mandate for Member State actions directed toward the goal of
expanding access of populations to essential drugs

(5) Pursue measures directed to expanding access of their own populations 
to
essential drugs;

(6) Cease and desist immediately from bilateral actions that effectively
obstruct the efforts of other Member States to expand access and local
production of generic drugs, where doing so has the potential to improve 
the
health of millions of people, and particularly those in least developed
countries;

(7) Provide the requisite international financial and technical assistance,
as legally mandated in Article 2 of the International Covenant of Economic,
Social and Cultural Rights, to enable measures undertaken by less developed
Member States to expand access to essential drugs.

2. REQUESTS the Director-General to:
(1) Include as a permanent issue of the Agenda of the World Health
Assemblies for the next years of 2002, 2003, 2004, and 2005, the Revised
Drug Strategy, with yearly Reports by the Secretariat, in order to allow
developing countries to discuss and debate advances and constraints in
achieving expanded access to essential drugs to their populations, with a
view to facilitating the implementation of joint strategies and guidelines;
(2) To facilitate, jointly with Member States and non-governmental
organizations concerned with public health an in-depth evaluation of the
essential drugs concept and current guidelines; the development of new
pharmaceutical chemical entities for neglected diseases whose burden is
predominantly in poor countries; the identification of measures to protect
intellectual property which are consistent with and subordinate to the
concurrent goal of ensuring present and future access to essential drugs;
(3) Facilitate Member States in urgently implementing, in partnership with
non governmental organizations, database systems for monitoring and
reporting global drug prices and a consolidated worldwide database, in 
order
to make it feasible, especially for least developed countries, to have
reliable information and equity in access to essential drugs within their
health systems;
(4) Support the implementation of drug monitoring systems in order to 
better
identify adverse reactions and misuse of drugs within health systems, thus
promoting rational use of drugs
(5) Continue and enhance efforts to study and report on the pharmaceutical
and public health implications of international trade agreements
(6) Enhance funding to support Member States requesting assistance in
achieving the priorities stated in Revised Drug Strategy Resolution WHA
52.19, Reports by the Secretariat (document A53/10 and A54/17), and this
Resolution.
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