PAHO/WHO BRAZIL TECHNICAL COOPERATION IN
PHARMACEUTICAL ASSISTANCE: 2004-2007
Dr. James Fitzgerald. Manager of the Medicines and Technology Unit – PAHO/WHO BRAZIL
Dr. Orenzio Soler. National Professional for Pharmaceutical Assistance of the Medicines and
Technology Unit – PAHO/WHO BRAZIL (email@example.com)
Pan-American Health Organization PAHO/WHO
Medicines and Technology Unit
Setor de Embaixadas Norte – Lote 19 – CEP 70800-400 – Brasília DF – Brazil
Phone: (61) - 3251 9587 - fax: (61). 3251 9591
Pan-American Health Organization: Country Cooperation
The Pan-American Health Organization of the Health (PAHO), founded in 1902, is an
international organism of public health with over a century of experience. It is part of the American
States Organization systems (OEA). With the creation of the World Health Organization (WHO) in 1948,
PAHO started to be, also, the WHO Regional Office for the Americas and part of United Nations (UN). It
is dedicated to improve the heath conditions of countries of the Americas.
Its mission is to guide the efforts of cooperation between the Member-States and other
collaborating organs in order to promote equity, combat diseases, improve the quality of life and
increase life expectancy of the populations in the Americas (ORGANIZAÇÃO PANAMERICANA, 2005;
ORGANIZACIÓN PANAMERICANA, 2000). Its actions are founded in basic values of equity, excellence,
solidarity, respect and integrity for the development and consolidation of work programs. According to
this vision, it will always act as a catalytic agent, in the perspective that all of the inhabitants from the
Americas benefit from good health and contribute to the welfare of their family and the community.
The Country Cooperation Strategy (ECP) is a reference for the Organization as a whole as far
as activities in the countries are concerned. It is the starting point for the harmonization of WHO plans
and budgets in the countries, mobilizing human and financial resources with the intent of reinforcing its
technical support to the Member-States, contributing to the improvement of health and national
development. It is founded on a wide view of public health (ORGANIZACIÓN PANAMERICANA 2004). In
this context, the objective of this article is to contextualize the advances registered in Brazil during the
last few years in the area of the pharmaceutical assistance, presenting the coherence between the
political strategies adopted by Brazil and PAHO/WHO orientations, emphasizing PAHO’s contributions in
Reference mark for PAHO/WHO Technical Cooperation in pharmaceutical
The reference mark for the technical cooperation of the Pan-American Health
Organization/World Health Organization – PAHO/WHO is currently based on the Millennium
Development Objectives – ODM approved by all the Member-States of the United Nations – UN
in the Millennium Summit in 2000. ODM have ambitious goals to reduce poverty and improve
the populations’ quality of life (NAÇÕES UNIDAS, 2005; ORGANIZAÇÃO PANAMERICANA
ORGANIZATION, 2005). Health holds a central spot, with a direct relation in three of the
eight ODMs, eight of the eighteen goals, and eighteen of the 48 indicators (NAÇÕES UNIDAS,
2005). The promotion of access to essential drugs in developing countries stands out.
According to the Universal Declaration of Human Rights of the United Nations
(NAÇÕES UNIDAS, 1948), the access to essential drugs for the treatment of the main
diseases constitutes one of the largest challenges of public health (ORGANIZACIÓN
MUNDIAL, 2003). Moreover, it points out that every person has the right to an adequate
lifestyle that ensures health and welfare to him and his family.
The Member-States adopted several Resolutions on drugs in the World Health
Assembly (WHA). Among them are2:
1. The Revised Strategy with regards to drugs (WHA52.19);
2. The WHO Drugs Strategy (WHA54.11);
3. Ensuring Access to Essential Drugs (WHA55.14);
4. WHO’s contribution to the continuation of the extraordinary sessions period of the
United Nations General Assemblies on HIV/AIDS (WHA55.12);
5. WHO’s contributions for the achievement of Development Objectives of the United
Nations’ Millennium Declaration (WHA 55.19);
6. The Intellectual Property, Innovation and Public Health Rights (WHA56.27);
7. The Health's Sector World Strategy for HIV/AIDS (WHA 56.30)
8. The Broadening of Treatment and Care in a Coordinated Response, inclusive of
9. Progress in the rational use of drugs (WHA60.16);
10. Better drugs for children (WHA60.20)
11. Public health, Innovation and Intellectual property (WHA60.30)
1. Poverty; 2. Famine; 3. Education; 4. Gender; 5. Child mortality; 6. Maternal mortality; 7. HIV/AIDS; 8. Malaria
and other transmissible diseases; 9. Environment; 10. Drinkable water; 11. Housing/Sanitation; 12. Financial System;
13. Trade; 14. Emerging countries; 15. External debt; 16. Work; 17. Essential drugs; 18. Technology innovation.
Available in Spanish: http://www.who.int/gb/s/index.html; and English: http://www.who.int/gb/e/index.html.
Such resolutions promote health and support actions recommended with the purpose of
facing the challenges in the areas of public policies, management, regulation, quality, access
and rational use of drugs, among other objectives.
WHO Drug Strategy for 2004-2007 guides PAHO/WHO actions that are related to
pharmaceutical assistance in the Member-Countries, through technical cooperation strategies
for the improvement of access, safety, quality, supply and rational use of essential medicines,
as per Table 1 (WORLD 2004). Furthermore, with the purpose of following-up the
repercussion of those strategies, WHO prepared and applied a series of qualitative and
quantitative indicators to assess the situation of access, quality and rational use of drugs in
their Member-Countries and, as consequence, obtain a general evaluation of the trend in the
access to drug on a world scale.
TABLE 1. Priority Strategies for Drugs of the
World Health Organization 2004 – 2007
Priority Area Strategy
1. Policy Development and follow-up of drugs policies, promoting the essential drugs
concept, the monitoring of the trade agreements influence over access to
quality drugs, and development of the national pharmaceutical assistance.
Support to countries to promote the rational use of traditional, alternative and
supplementary drugs, with quality and efficacy.
2. Access Orientation on the financing of supply systems and the access to drugs in the
public and private sectors.
Development of drugs supply systems with a view to ensure the continued
availability of essential drugs.
3. Quality Development and promotion of rules and standards in order to ensure
quality, safety and efficacy of drugs.
Development of the regulatory authority’s capacity and systems to ensure
quality, and means for the effective regulation of drugs.
4. Rational Use Advocacy and support to promote the rational use of quality and low-cost
drugs, directed to both health professionals and users.
Source: World Health Organization, 2004.
With respect to access to essential drugs, it is recommended that countries
encourage and promote policies that favour generic drugs, develop strategies of costs
contention to ensure reasonable prices for drugs and reinforce the supply systems
(ORGANIZACIÓN PANAMERICANA 2004). In addition, there is a need to adapt drug policies
to ensure safety, efficacy and quality of drugs in a regulatory mark that favours access and
sustainability. (ORGANIZACIÓN PANAMERICANA, 2000; PAN-AMERICAN, 2000).
PAHO/WHO priority issues for the biennium 2006-2007
PAHO/WHO Directing Bodies’ orientations are articulated with the biannual work
program of the Organization at regional, sub-regional and local levels, with a differentiated
cooperation focus in each level: a regional focus with emphasis in the political and technical
aspects of the Americas; a sub-regional focus to link the orientations with the regional
integration processes, such as CARICOM,3 SICA,4 Mercosul and CAN,5 and extension of the
multilateral and bilateral trade agreements, Nafta6 and Cafta-RD7 and a national focus based
on the priorities of each country.
In this period, PAHO/WHO established three priority issues for the cooperation:
access to quality drugs and medical supplies, policies and regulation, and essential health
technologies, shown in Table 2 (ORGANIZACIÓN PANAMERICANA, 2004).
Table 2. Priority issues for drugs and health technologies
Priority Issues Strategy
1. Access to Quality Ensure access to quality basic health supplies (drugs, vaccines, blood and
Drugs and Supplies diagnostics, among others) for the more vulnerable populations of the Region,
facing obstacles with regard to financing and products supply.
2. Regulation PoliciesSupport Member States and the sub-regional integration engines in the
development of policies and regulation systems, promoting appropriate
harmonization in the regulations and standards that favour universal access and
rational use of drugs and health products, in conformity with and in an
integrated fashion with regard to WHO rules and policies.
3. Essential Health Promote and strengthen the capacity in the Region with respect to selection and
Technology use of appropriate technologies in public health, in radiotherapy and diagnosis,
in clinical laboratories, and the management of technology, the infra-structure
and medical supplies.
Source: (ORGANIZACIÓN PANAMERICANA, 2004).
In addition, there is a recommendation for drugs policy to be part of the national
heath policy, with a view to promote equity and sustenance for the pharmaceutical assistance
(WORLD 2001). There is an orientation stating that the main purposes related to equitable
access, quality and rational use of drugs need to be incorporated by the pharmaceutical
policies. According to World (2001), in order to guarantee access, quality and rational use
there is a need to ensure that the key components are structured: Essential Drugs Selection;
Sistema de Integración Centroamericana
La Comunidad Andina de Naciones
The North American Free Trade Agreement
Central America Free Trade Agreement - Dominican Republic
Drugs Offers and Price of Drugs; Financing; Supply System; Drug Regulation; Rational Use of
Drugs; Research; Development of Human Resources; Monitoring and Evaluation. However,
the final definition of the purposes and strategies in the countries depends on the context of
each country and the political decision regarding the needs, priorities and resources.
As already mentioned, among the components of a drugs policy, the promotion of the
rational use of drugs is emphasized (WHO 2001). It is known that the Rational Use of Drugs
occurs when "patients receive appropriate drugs for their clinical conditions, in appropriate
doses for their individual needs, for an appropriate period and at the lowest cost for
themselves and the community" (ORGANIZACIÓN PANAMERICANA, 1986; WORLD, 1996).
However, considering the proliferation of inappropriate technologies in the pharmaceutical
world markets, the challenges related to the implementation of the evaluation processes for
evidence-based technologies, and its incorporation in the health systems, the Rational Use of
Drugs is maintained in the unfinished health agenda. As such, resolution WHA 60.16 (WORLD
2007) recommends to WHO Member-States to develop strategies for the promotion of
rational use in their countries.
Main advances in the field of the pharmaceutical assistance in Brazil
Structuring actions in the area of drugs policies and pharmaceutical assistance have
taken place in Brazil during the last ten years, with the main events being the National Drugs
Policy – PNM (BRASIL, 1998), the creation of the National Health Surveillance Agency
(BRASIL 1999), the Generic Drugs Law (BRASIL, 1999), the decentralization of
Pharmaceutical Assistance (BRASIL, 1999; 2001) and the National Policy of Pharmaceutical
Assistance (BRASIL, 2004).
Following the approval of the National Policy of Pharmaceutical Assistance – Pnaf
(BRASIL, 2004), the Pharmaceutical Assistance Department – DAF was structured with the
creation of the of Science and Technology and Strategic Supplies Secretariat – SCTIE,
through Decree no. 4.726, of June 9, 2003, an important step towards the institutionalization
of Pharmaceutical Assistance in the Ministry of Health, with its own structure and with the
attribution to formulate and structure the referred policy, since earlier actions were developed
by a Technical Management directly linked to the Health Policy Secretary.
DAF’s mission is to formulate, structure, monitor and evaluate the National Drugs and
Pharmaceutical Assistance Policy, as a whole part of the National Health Policy, in order to
ensure population’s access to essential drugs, with a rational use, sustainable financing and
market regulation starting from a reliable health system. Table 3 (Main advances in
Pharmaceutical Assistance in Brazil 2004-2007) illustrates some of those actions, actions that
unfold in the area of access and rational use, with social inclusion through basic, special and
exceptional drugs programs.
To ensure the decentralization process, initiated through the Operational Basic Rules
– NOB and by the Operational Rules of Health Assistance – NOAS, another important action
was the Life Pact (BRASIL, 2006b), constituted by a set of health commitments, expressed in
processes and results objectives and deriving from the analysis of the health situation in the
country and the priorities defined by the federal, state and municipal governments. In the
Management Pact (BRASIL, 2006c), the Union, the States, the Municipalities and the Federal
District agreed a set of common and specific responsibilities with regards to decentralization,
regionalization, financing, planning, agreed and integrated programming, regulation, labour
management, health education, participation and social control. There was a change of focus
in the pharmaceutical assistance within the pacts.
Among other actions, Administrative Rule No. 698/GM (BRASIL, 2006c) approves the
guidelines for financing and transfer of federal funds for health actions and services, in the
form of financing blocks, with the respective monitoring and control. There is a financing
block for Pharmaceutical Assistance, organized in three components – basic, strategic and
exceptional dispensation drugs – that must be financed by the three managers of the Unified
Health System (SUS) and associate the acquisition of drugs and medical supplies and the
organization of the necessary pharmaceutical assistance actions, in accordance with the
organization of health services.
Also in this scenario, in order to assist the strategic lines of the National Policy of
Pharmaceutical Assistance – Pnaf (BRASIL 2004), especially regarding the definition and
agreement of intersectorial actions, the integration of the industrial policy with the science
and technology and health policies was sought through the Forum for the Competitiveness of
the Pharmaceutical Productive Chain – FCCPF (BRASIL, 2007a) in the area of formulation of
the Industrial, Technological and Foreign Trade Policy – PITCE. This integration culminated
with the actions developed in the regulation and quality of pharmaceutical substances and
drugs, which were of significant importance in the set of efforts, contributing to the
development of different segments of the pharmaceutical productive chain.
Table 3. Main advances in Pharmaceutical Assistance in Brazil 2004-2007
Establishment of engines and responsibilities for the financing of Pharmaceutical Assistance in
Basic Care (Administrative Rule GM 2084 of 26/11/2005), which unified the various existent
assistance programs at that time and doubled the financial resources for Pharmaceutical
Assistance in Basic Care;
Administrative Rule nº. 2.577, of 27/10/2006, which approves the Exceptional Dispensation
Drugs Component as part of the National Pharmaceutical Assistance Policy of the Unified
Health System, which has an objective to make drugs available for the treatment of health
conditions characterized as rare or low prevalence disease;
The Ministry of Health ensures as strategic all drug utilized in the treatment of endemic
profile diseases whose control and treatment follow a protocol and established rules and
which have a socioeconomic impact. Among these programs are: Tuberculosis, Hansen’s
Disease, Focal Endemics, HIV/Aids and Blood and Hemoderivatives.
Definition of the National Medicinal Plants and Phytotherapy Policy (2006);
Definition of the National Policy for Integrative and Supplementary Practices in the SUS
Edition of the 4th National List of Essential Drugs – RENAME-2006 (Administrative Rule nº.
2.475 of 13/10/2006);
Edition of 11 new Clinical Protocols and Therapeutic Guidelines – PCDT and Regulation of the
Exceptional Dispensation Drugs Component (2006);
Rational Use of Drugs Courses – 2000-2005 (Ministry of Health; Anvisa; PAHO/WHO;
I Brazilian Congress on Rational Use of Drugs (October 2005) and II Congress on Rational
Use of Drugs in October 2007;
Articulation of stakeholders in an effort towards the definition and implementation of a
National Policy of Health Technologies Management;
Institutionalization health technologies evaluation processes in order to incorporate them in
Source: Programas e projetos. DAF/SCTIE/MS. 2007
The consolidation of Pnaf (BRASIL, 2004), linked to a change of the Brazilian citizen's
behaviour, that is, larger mobilization, better access to information, ability to understand his
rights, increase of the complexity of needs and increased shortage of resources, culminated
with the use of judicial engines for to protect his rights. That situation has obliged the State
to incur in a high financial cost for the benefit of a small number of citizens, increasingly more
socially articulated than most, in other words, a debate over the prevalence or not of the
individual right versus the collective right has emerged. Probably, among other factors, this
has been a catalytic agent in the search of engines that provide evidence-based rational use
of drug strategies.
Another initiative is the establishment of the National Managing Committee for
Assistance Protocols, Therapeutic Guidelines and Health Technological Incorporation –
through Administrative Rule No. 816/GM (BRASIL, 2005) and of the National Committee for
the Promotion of Rational Use of Drugs – through Administrative Rule No. 1956 (BRASIL,
2006a). The latter has a collegiate coordination composed by a representative of DAF/SCTIE/
MS, a representative of the National Health Surveillance Agency – Anvisa and a
representative of the Medicines and Technologies Technical Unit of the Pan-American Health
Organization / World Health Organization – PAHO / WHO, indicated by the respective leaders
and nominated by the Minister of Health.
It is important to recall that, with the creation of the National Health Surveillance
Agency – Anvisa (BRASIL, 1999), the health regulation of drugs and other health substances,
Brazil has experienced significant changes in the last few years. Notwithstanding, there are
still important challenges ahead for National Health Surveillance System – SNVS in the area of
institutional and technological development. Among these, the following stand out: (i) the
decentralization of Health Surveillance and its consolidation in the SUS; (ii) The strengthening
of the inspection and control system of establishments; (iii) The strengthening of the
evaluation and registry system of drugs and other health supplies; (iv) The development of
an integral program for the promotion of rational use of health technologies (BRASIL, 2007).
There are joint actions to both support the consolidation of the National Health Surveillance
System – SNVS and ensure cooperation and technical support destined to the development of
health surveillance activities and the consolidation of health surveillance.
Technical Cooperation between PAHO and Brazil in the area of pharmaceutical
assistance 2004 - 2007
The partnership between the Brazilian Government and PAHO/WHO is founded on
the improvement of health conditions in all the States and Municipalities of the country based
on the concept that health does not only mean absence of diseases, but physical, emotional
and social welfare (PAN AMERICAN, 2002). In this perspective, PAHO/WHO promotes
technical, strategic and political orientations to the country, respecting its mission as part of
the OEA and the UN. This partnership became a strategic instrument in the construction of
new management practice of the pharmaceutical assistance, incorporating the social
conquests and the new technological knowledge, aggregator of positive values for the health
of the population, which is a permanent challenge.
The Medicines and Health Technologies Unit of PAHO in Brazil promotes policies for
the increase and regulation of the equitative access and rational use of drugs, strategic
supplies, and quality health technologies for the Unified Health System – SUS, and also
integrates actions in this knowledge area in the Mercosul countries and with PAHO
Headquarters. It is also responsible for the coordination of PAHO’s Strategic Fund8, a regional
initiative that links PAHO’s technical cooperation in the management of strategic supplies to
the processes of acquisition of drugs and strategic supplies.
Before presenting the actual advances of the quadriennium here focused, it is worth
registering that in Brazil, a transparent technical cooperation by PAHO for the structuring
actions in the area of drugs and pharmaceutical assistance policies has occurred during the
last ten years, such as: Consolidation of the National Drugs Policy – PNM (BRASIL, 1998);
Creation of the National Health Surveillance Agency – Anvisa (BRASIL, 1999): Regulation of
the Generic Drugs Law at the request of the National Health Council – CNS (BRASIL, 1999);
Decentralization of the Pharmaceutical Assistance (BRASIL, 1999; 2001) from 1999 to 2002.
This new political context, parallel to discussions on the strategy of the Pharmaceutical Care
in Brazil and the National Conference of Pharmaceutical Assistance (BRASIL, 2003),
propitiated the establishment of the National Pharmaceutical Assistance Policy (BRASIL,
2004). The model of drugs and pharmaceutical assistance policy approved by the country is
founded on PAHO/WHO guidelines (WORLD, 2001). A consonance among the model adopted
by Brazil and the guidelines proposed by PAHO/WHO (ORGANIZACIÓN PANAMERICANA,
2002; 2005) for the promotion of the access and rational use of drugs is also noted.
Within the mark of the technical cooperation for 2004-2007, PAHO Brazil is jointly
working with multiple partners in Brazil, in order to support the accomplishment of its
objectives with respect to pharmaceutical assistance and to sector regulation, focusing the
technical cooperation with the Ministry of Health and Anvisa.
A Cooperation Agreement (TC -24) between PAHO/WHO and the Ministry of Health
for the development of Pharmaceutical Assistance has been effective since 2002. At the end
of 2005, a new commitment was established between the Ministry of Health/DAF and PAHO
Brazil, in order to prioritize the technical cooperation with the following objectives: To qualify
the management of pharmaceutical assistance and the access to drugs in the SUS; To
promote the rational use of drugs and; To promote the technological development and the
assessment of health technologies. The following immediate results were:
Technical cooperation with the State of Goiás, which resulted in the approval of the
Goiás State Drugs Policy and its corresponding State List of Essential Drugs (2006);
Study of Levels I and II of the national pharmaceutical profile, which resulted in the
publishing of the book "Assessment of the Pharmaceutical Assistance in Brazil:
structure, process and results" (2005) (free title translation from Portuguese);
Support for the publishing of the National List of Essential Drugs – RENAME;
Preparation of the National Therapeutic Formulary – FTN (underway);
Support for the improvement of access to high cost drugs and consolidation of the
Exceptional Dispensation Character Drug Program through the collection of
information for analysis, assessment and proposal of guidelines, rules and follow-up
of the decentralization, dispensation, costs and patients aspects;
Supply and acquisition of drugs and strategic supplies (tuberculostatic, anti-malarial,
family planning drugs and devices) through the Strategic Fund and of other of
reimbursable purchases engines developed by PAHO/WHO;
Support to the purchase process of Efavirenz 600mg through the Compulsory License
in 2007 via the Strategic Fund;
Support to the National Health Surveillance Agency – Anvisa to strengthen the
management of the National Health Surveillance System – SNVS, at the three
government levels, and with regards to epidemiological, health and environmental
surveillance, so as to widen its capacity of analysis of health situation and response
to the needs of the population;
Support in the implementation of reorganization actions of the National Health
Surveillance System – SNVS, for the regulation, surveillance and assessment of the
use of drugs and other health supplies, blood, public health laboratories, health
services and ionizing radiations, as well as the incentive of the harmonization
processes in the region and the development of human resources of the area;
During the last few years, PAHO has been supporting the process of qualification of
technologies and health services, with a view to structure and organize the pharmaceutical
assistance at the three management administration levels, qualifying the access, the
sustainability and the rational use of drugs. In all these moments, it has been important to
count with the swift and transparent engines of PAHO/WHO, such as the Cooperation
Agreements with Anvisa and the Ministry of Health.
On a final note, the cooperation perspectives in the field of the pharmaceutical
assistance for the coming years are very positive. In other words, PAHO Brazil is concluding
the preparation of its Technical Cooperation Strategy with the Federal Republic of Brazil for
the period 2008-2012, which includes health priorities, the strategic focus and the technical
cooperation modalities. Such modalities, based in the priorities defined globally by the World
Health Assembly in the XI Medium Range Program 2008-2013 (WORLD, 2007), within the
regional scope of the Health Agenda of the Americas for 2008-2017 (ORGANIZACIÓN
PANAMERICANA, 2007a), PAHO Strategic Plan Proposal for 2008-2012 (ORGANIZACIÓN
PANAMERICANA, 2007b), the Pluriannual Plan for 2008-2011 (BRASIL, 2007b) and the
Growth Acceleration Plan – PAC (BRASIL, 2007c).
PAHO/WHO started the formulation of drugs cooperation strategies with the countries
in 1999. It is applying the learning criterion according to praxis that allows working with the
countries so as to develop integrated processes in pharmaceutical assistance in order to
improve the access to drugs and promote its rational use thereof and ensure quality of
products and services within an appropriate regulatory mark.
The cooperation strategies with the Member-Countries reflect a medium and long-
term perspective where the assessment and monitoring of the processes represent a key
element of their implementation. PAHO/WHO already started a global process to evaluate the
impact of the Drug Strategy for 2004-2007 based on the advances recorded in the countries
and in the implementation of public policies related to pharmaceutical substances, drugs and
the pharmaceutical assistance.
The development of a Global Strategy for Drugs for 2008-2011, based on the results
of the assessment of the 2004-2007 strategy, is also being proposed. The Global Strategy will
be internalized in the technical cooperation program between PAHO/WHO and Brazil during
the coming years, thus ensuring a growing synergy between the priorities of the country and
technical cooperation lines for pharmaceutical assistance.
Finally, the following needs have to be taken into consideration: To protect the gains
achieved during the current period; to resolve the unfinished agenda in the qualification area
of pharmaceutical assistance and rational use of drugs; To face the new challenges, among
which, the scientific and technological innovation, the industrial health compound and the
pharmaceutical assistance, in order to broaden the access to drugs and strategic supplies; to
stimulate, in an articulate fashion, the industrial development of pharmaceutical substances,
vaccines and equipments in agreement with the pharmaceutical assistance, health science,
technology and innovation policies, as well as the industrial, technological and foreign trade
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