2003-2004 |
The National Pharmaceutical Care Policy (PNAF) |
Strategic axes of the PNAF pointed to the need to build a health surveillance policy for people’s access to safe, effective, and quality services and products |
The establishment of the PNAF within the social con-trol of the SUS, from the First National Conference on Medicines and Pharmaceutical Care (CNMAF) The definition of the PNAF by the National Health Council (CNS) and ratification by the Minister of Health |
National Health Council Ministry of Health Pan American Health Organization. Delegates participating in the First CNMAF. |
2003- 2006 |
Strengthening the pharmaceutical production chain and technological development in the sector |
Need for the National Health Surveillance System (SNVS) to adopt mechanisms for the internalization of guidelines resulting from the consensus obtained in the Forum on Competitiveness of the Pharmaceutical Productive Chain |
Establishment of consensus at the Forum on Competi-tiveness of the Pharmaceutical Productive Chain: eco-nomic and strategic relevance of medicines for the SUS; pharmaceutical industrial policy as a government priority and state policy Inclusion of pharmaceuticals and medicines as one of the four priorities of Brazil’s Industrial, Technological, and Foreign Trade Policy (PITCE) |
Government representations, coordinated by the Ministries of Development, Industry and Trade and Health. Representations of the productive segments. Representations of workers. Representations of research institutions. |
2004 |
The National Policy on Science, Technology, and Innovation in Health (PNCTIS) |
Emphasis on the role of Anvisa regarding the prior consent for patenting health supplies |
Establishment of the PNCTIS took place within the social control of the SUS, based on the definitions of the Second National Conference on Science, Technology, and Innovation in Health (CNCTIS) and approval by the National Health Council |
National Health Council Ministries of Health, Science and Technology, and Education Researchers Social stakeholders that are part of the SUS social control |
2007 |
Reducing the vulnerability of the National STD/AIDS Program and ensuring access to ARVs in the SUS |
Edition of Ordinance No. 583/2007/Anvisa, which established the Technical-Regulatory Committee (CTR) within ANVISA to monitor the development, production and registration in Brazil of the drug object of Decree no. 6,108 of May 4, 2007
|
Statement by the Brazilian government regarding the public interest of patent rights over drug Efavirenz to grant a compulsory license for non-commercial use Edition of Presidential Decree No. 6.108/2007, establishing the compulsory licensing of Efavirenz Edition of Interministerial Ordinance No. 128/2008, which established the guidelines for contracting drugs and medicines by the bodies and entities that make up the Unified Health System |
Ministry of Health Ministry of Justice Civil House of the Presidency of the Republic ANVISA Oswaldo Cruz Foundation, including the direction of the Pharmaceutical Technology Institute - Farmanguinhos Non-governmental organizations representing the segments of people living with HIV/AIDS |
2008 |
The Productive Development Policy |
Executive Group of the Health Industrial Complex (GECIS) responsible for actions to ensure equality in health regulation, support for the quality of national production, modernization of health surveillance actions, simplification and streamlining of regulatory processes |
Resumption and expansion of the scope and depth of the Industrial, Technological and Foreign Trade Policy (PITCE) established in 2004, with the definition of CEIS as one of its priorities The national entity managing the SUS assumes the role of conducting intersectoral initiatives to regulate and improve the efficiency of the CEIS, involving the industrial, economic, and technological fields to meet the demands of the SUS |
Ministry of Health Civil House of the Presidency of the Republic Ministries of Development, Industry and Trade; Finance; Planning; Foreign Affairs; and Science, Technology, and Innovation ANVISA and other national regulatory and development agencies |
2009 |
Empowering the CEIS as an instrument of Brazilian industrial policy |
Edition of the Resolution of the Collegiate Board of ANVISA (RDC) No. 02/2011, establishing Technical-Regulatory Committees (CTR) to follow-up and monitor the Partnerships for Productive Development (PDP) |
GECIS defining the PDPs as industrial policy mecha-nisms used in health to internalize the production and transfer of drug technology, active pharmaceutical in-gredients, and products of interest to the SUS PDP as an instrument of the health policy to encour-age the CEIS and meet the demands of the SUS |
ANVISA’s technical and management body Representations of public pharmaceutical laboratories Representations of the private companies that are part of the PDP GECIS |
2012 |
Strengthening the national industry, with increased productive capacity, innovation, and competitiveness |
Inclusion of Anvisa in the managing committee of the Program for the Development of the Health Industrial Complex (PROCIS) and edition of ANVISA's RDC No. 50/2012, which provided for the procedures for registration of products in the process of developing or transferring technologies subject to public-public or public-private PDP of interest to the SUS |
Incorporating the GECIS into the “Brasil Maior” Plan, established in 2011 by Decree No. 7.540 Establishing the Program for the Development of the Health Industrial Complex (PROCIS) through the Ministry of Health Ordinance No. 506/2012 to strengthen the infrastructure of production and innova-tion in health in the public sector Defining the guidelines for the establishment of PDPs, through Ministry of Health Ordinance No. 837/2012 |
ANVISA’s technical and management body PROCIS Steering Committee Public and private producers participating in the PDPs |
2014 |
Rationalizing the State’s purchasing power |
Edition of RDC 43/2014/Anvisa: Approves the Technical Regulation for registrations granted to public or private entities resulting from PDP processes or technology transfers to internalize the production of the Ministry of Health strategic medicines, the binding conditions of the registration to the matrix process of that drug registration object of the clone primary petition, and the respective post-registration and registration renewal procedures |
The National Health Plan (2012 -2015), harmonized with the Annual Multi-Year Plan (PPA) and approved by the National Health Council, established, as one of its 16 (sixteen) guidelines, the guideline for strength-ening the production complex and science, technology and innovation in health as a structuring vector of the national agenda for economic, social and sustainable development, reducing the vulnerability of access to health Ministry of Health redefining the guidelines for the transfer and absorption of technology, acquisition of strategic products for the SUS within the PDPs |
ANVISA’s technical and management body Ministry of Health |