WORLD TRADE  
ORGANIZATION  IP/C/W/513/Add.1 
10 December 2009 
 
 (09-6404) 
Council for Trade-Related Aspects 
of Intellectual Property Rights Original:   English 
 
 
 
TECHNICAL COOPERATION AND CAPACITY BUILDING: 
"CLUSTER" A OF THE DEVELOPMENT AGENDA 
 
BRAZIL 
 
Addendum  
   The present document reproduces additional info rmation, received from the delegation of 
Brazil by means of a communication dated 28 October 2009, as an addendum to 
document IP/C/W/513 of 20 June 2008. 
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  In the light of the document IP/C/W/513, Braz il presents the following form of stock-tacking 
of capacity building activities as an example of c ooperation that complies with WIPO's Development 
Agenda principles.  The aim of this addendum is  to demonstrate that the 14 recommendations from 
the cluster A of WIPO Development Agenda can be  easily fulfilled in capacity building activities. 
  
1. SUMMARY  
 
Project Code:  Project BRA04/044 S136 (Technical Cooperation Project between 
Developing Countries, financed by the Brazilian Cooperation Agency from the Ministry of External Relations of Brazil). 
Title:  Strengthening the Mozambican Drug Regulatory Authority  as a 
pharmaceuticals regulation agency – institutions involved: ANVISA (Brazil) and the Pharmaceuticals Department of the Ministry of Health (Mozambique).   
Development Agenda 
Recommendation:  
   WIPO technical assistance shall be, inter alia, development-oriented, demand-driven and transparent, taking into account the priorities and the 
special needs of developing countries,  especially LDCs, as well as the 
different levels of development of  Member States and activities should 
include time frames for completion.  In this regard, design, delivery mechanisms and evaluation processes of technical assistance programs should be country specific. IP/C/W/513/Add.1 
Page 2  
 
  Project Budget:  Overall costs:  US$ 453,236.00 
Project Duration:  
 16 months:  
Project start date:  October 2008  
Project end date:   February 2010 
Brief Description of 
Project:  The main purpose of the project is to strengthen the capacity of the 
Mozambican Drug Regulatory Authority in the regulation of the country's pharmaceutical sector, aiming at providing the society with medicines of assured quality, safety and efficacy.  The scope of the project is to provide 
a broad overview of the main regulatory functions of a National 
Regulatory Authority (NRA), according to ANVISA's expertise, such as registration of medicines, focused on generic drugs; economic regulation of medicines; pharmaceutical inspections; laboratories; combat falsified medicines and surveillance of medici nes under special control; clinical 
trials; pharmacovigilance; post-mark et surveillance of medicines and 
health services. 
2. PROJECT DESCRIPTION  
 
2.1.   INTRODUCTION TO THE ISSUE/CONCERN  
 
This project responds to WHO's recommendation re garding the creation of a national regulatory 
authority in Mozambique responsible for the hea lth surveillance and regulation of the pharmaceutical 
sector in the country.  Such authority should have technical as well as financial capacity to provide the society with products of  assured quality, safety and efficacy as well as accessible prices. 
Furthermore, the strengthening of the Mozambican NRA is associated with the bilateral project of 
construction of an antiretroviral plant in the count ry through the technology transfer of production of 
a Brazilian Public Laboratory (FIOCRUZ, Ministry of Health).  Considering the future production of 
medicines in the country, the State must be respons ible not only for the access of drugs but also for 
the health surveillance of the products being marketed , through a recognized health authority.  In this 
sense, the technical cooperation project aims at strengthening the national regulatory authority of 
Mozambique by structuring the institutio n and training its personnel and managers. 
This project is in accordance with article 67 of the TRIPS Agreement that deals with the need for 
technical cooperation in favor of developing and least-developed country Members.  In addition, as 
there is a specific activity under the project concerning capacity building on intellectual property matters and its relation to public health, the proj ect also contributes to the TRIPS Agreement by 
providing legal assistance for strengthening the cap acity of intellectual property offices within 
developing countries (Article 67 – Technical Coope ration - Such cooperation shall include assistance 
in the preparation of laws and regulations on the protection and enforcement of intellectual property 
rights as well as on the prevention of their abu se, and shall include support regarding the 
establishment or reinforcement of domestic offices and agencies relevant to these matters, including 
the training of personnel.) 
Capacity building on intellectual property rights and public health issues is also related to 
paragraph 6 of the Doha Declaration on the TRIPS Agreement and Public Health as well as to the 
Global Strategy on Public Health, Innovation and Intellectual Property. 
  IP/C/W/513/Add.1 
 Page 3 
 
 
  2.2. OBJECTIVES  
  
Development goal:   To support the Mozambican government initiative in promoting and protecting 
public health, through the sanitary control of products  and services submitted to health surveillance 
and regulation. 
Objective 1:   To strengthen the national drug regulatory authority of Mozambique, through capacity 
building of human resources and the exchange of  information and experiences on pharmaceutical 
regulation, such as organizational structure, qualit y control, marketing and licensing authorization, 
economic regulation of medicines, pharmaceutical in spections, clinical trials, pharmacovigilance and 
post-market surveillance.   
 
2.3. DELIVERY STRATEGY    
 
The bilateral technical cooperation project, financ ed by the Brazilian Cooperation Agency, is in 
accordance with the guidelines and pr iorities established by the Brazilian Foreign Policy.  It is aimed 
at strengthening the bonds of cooperation between de veloping countries, especially South American 
neighbors, Latin American countries and African countries, notably Portuguese speaking countries who are members of the Portuguese Speaking Countries Community (CPLP).  Furthermore the South-South cooperation is another priority of the go vernment that aims at fostering the exchange of 
information and experiences and the mutual know ledge amongst developing countries and Least 
Developed Countries. 
The principles of the Brazilian Foreign Policy and th e South-South cooperation directly related to it 
are the values of solidarity, mutual knowledge and respect, autonomy, sovereignty and independence. 
With that in mind, the technical cooperation seeks to  respect these values and aims at respecting the 
independence of Mozambique regarding decisi on-making procedures and on national needs and 
priorities.  In this sense, the ro le of Brazil is to support the African country in its decision making 
process, in accordance with its r eality.  ANVISA contributes to th is objective by sharing its 
experience and regulatory framework and also benefits from the Mozambican experience. 
Scope:  The project is limited to the financial resources a pproved to its implementation and to the timeframe 
of the project.  Besides that, the financial and hu man resources limitation of Mozambique might be a 
restriction to the acquisition of the knowledge be ing shared by ANVISA and by the implementation 
of the regulatory agenda within the country.  Also  the health difficulties that face the African country 
as well as the variety of actors that participate in the sanitary arena, including international donors, 
bilateral agencies, international organizations, non- governmental organizations might be an obstacle 
to the government's decision making procedures. 
Risks:  
(i) Limited financial resources and limite d qualified human resources to implement the 
regulatory functions of the NRA 
(ii) Financial resources and timeframe of the project might be insufficient to achieve the 
development goal of the project. 
(iii) Other priorities could restrict the capacity of the NRA to implement all the regulatory 
functions required by the WHO. 
 
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