Health regulation and technological development: innovative strategies for accessing medicines in the SUS

Rech, Norberto; Farias, Mareni Rocha

doi:10.1590/1413-812320212611.03512021

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ARTICLE • Ciênc. saúde coletiva 26 (11) • Nov 2021 • https://doi.org/10.1590/1413-812320212611.03512021 copy

Health regulation and technological development: innovative strategies for accessing medicines in the SUS

Authorship SCIMAGO INSTITUTIONS RANKINGS

Abstract

Regulatory science involves articulating knowledge that can establish the scientific bases for the definition of adequate and efficient regulatory mechanisms and practices. The interfaces between systemic and sectoral health and technological development policies were studied based on documentary analysis, especially from the National Pharmaceutical Policy (PNAF), with impacts on health regulation and stimulating the production of medicines of interest to the Unified Health System (SUS). The initiatives for the nationalized production of ARV “Efavirenz”, which was the subject of a compulsory license in 2007, and the establishment of Partnerships for Productive Development (PDP), contributed to defining innovative regulatory frameworks and practices, emphasizing the Regulatory Technical Committees (CTR) for monitoring the internalization of technologies and health registration of the resulting products. The permeation capacity of the principles and strategic axes of the PNAF was identified in the sectoral policies that were analyzed. As of 2014, no macro or sectoral policies on expanding access to medicines in the SUS with impacts on regulations were identified.

Key words:
Pharmaceutical policy; Health surveillance; Medicines

Year	Macropolitics (Systemic policy)	Micropolitics (Sectoral policy)	Policy content
Year	Macropolitics (Systemic policy)	Micropolitics (Sectoral policy)	Desired situation	Actions	Ações
2003-2004	Formulating the National Phar-maceutical Care Policy (PNAF)	Institutionalizing the PNAF, at the different levels of management and performance of the SUS	Fragmented actions within the federal management of the SUS Users difficult access to medicines in the SUS Disconnection between access to medication and health care actions	Overcoming the fragmentation of actions involving planning, acquisi-tion, distribution and access to med-icines in the SUS The SUS as a guide for the demand for medicines from the pharmaceuti-cal productive sectors, with qualifi-cation of the health care process	Conducting a national thematic conference and identifying the PNAF assumptions Defining and institutionalizing the PNAF, with characteristics of intersectorality and guidance for other policies Qualifying the PNAF as a priority strategic policy within the scope of federal management
2003- 2006	Strengthening the pharmaceutical production chain and technological development in the sector	Including the Ministry of Health in conducting the Pharmaceutical Productive Chain Competitiveness Forum	Strong retraction of the Brazilian pharmaceutical industry and setting worsened by the adoption of the Industrial Property Law (1996)	Stimulus for sustainable development in the sector, with the aggregation of capacities for the internalization and development of technologies of interest to the SUS	Identification of consensuses to stimulate the development of the (private and public) pharmaceutical productive sectors and inclusion of Drugs and Medicines as priorities in the Brazilian Industrial, Technological, and Foreign Trade Policy
2004	Formulating the National Policy on Science, Technology, and Innovation in Health (PNCTIS)	Institutionalizing the PNCTIS	Incipient development of science, technology and innovation activities in the health-related structures.	Sustainable national development, with support for the production of knowledge adjusted to the country's needs	Organization of the Second National Conference on Science, Technology and Innovation in Health Definition and institutionalization of the PNCTIS
2007	Reducing the vulnerability of the National STD/AIDS Program and ensuring access to ARVs in the SUS	Maintaining the feasibility of financing for the acquisition of ARVs	The cost of drug Efavirenz aggravates the vulnerability of the SUS and fruitless negotiations for price reductions	Lower acquisition costs of drug Efavirenz, with a reduced vulnerability of the National STD/AIDS/SUS Program	Adoption of a Compulsory License for public and non-commercial use of patents on the drug Efavirenz to meet the demands of the SUS
2008	Formulating the Productive Development Policy	CEIS as a mobilizing program in the strategic area of health	Little encouragement to productive health-related structures	Increased investments in research, development, and innovation in health	Inclusion of the Economic-Industrial Health Complex (CEIS) in the development policy
2009	Empowering the CEIS as an instrument of Brazilian industrial policy	Articulation of the productive sectors with the demands of the SUS	Growing SUS demand for technologies and increased spending on medicines	Internalization of technologies of interest to the SUS, reducing technological dependence and costs	Adoption of “partnerships for productive development” (PDP) as a strategy for employing the purchasing power of the State and positive induction of the health productive system
2012	Strengthening the national industry, with increased productive capacity, innovation, and competitiveness	Structuring and modernization of public health technology and innovation infrastructure	Structural and financing difficulties for the internalization of high-priced technology with a great health impact	Encouraging local production of high-cost products or products with a high health and social impact	Strengthening public producers and expanding their role in market regulation, with local development of strategic technologies for the SUS
2014	Rationalizing the State’s purchasing power	Redefining the guidelines and criteria for the definition of strategic products for the SUS and establishment of PDPs	Need to improve the regulatory framework of PDPs and the process of defining strategic products	Expanding people's access to strategic products with cost-effectiveness and advantage, reducing the vulnerability of the SUS	Review of requirements for the definition of strategic products for the SUS and the formalization and monitoring of PDPs

Year	Macropolitics (Systemic policy)	Impact on health regulations	Processes identified	Stakeholders involved
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

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[1] Collaborations

N Rech and MR Farias worked on the conception and final writing of the paper.