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

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

Resumo

A ciência regulatória é o campo de articulação de saberes que visa estabelecer as bases científicas para a definição de mecanismos e práticas regulatórias adequadas e eficientes. Com base na análise documental, foram estudadas as interfaces entre as políticas sistêmicas e setoriais no campo do desenvolvimento tecnológico e da saúde, especialmente a partir da Política Nacional de Assistência Farmacêutica (PNAF), com impactos no campo regulatório sanitário e no estímulo à produção de medicamentos de interesse do Sistema Único de Saúde (SUS). As iniciativas para a produção nacionalizada do medicamento antirretroviral “efavirenz”, objeto de licença compulsória em 2007, bem como o estabelecimento das Parcerias para o Desenvolvimento Produtivo (PDP), contribuíram para a definição de marcos e práticas regulatórias inovadoras, com destaque para os Comitês Técnico-Regulatórios (CTR) de acompanhamento das internalizações das tecnologias e registro sanitário dos produtos resultantes. Foi identificada a capacidade de permeação dos princípios e eixos estratégicos da PNAF no campo das políticas setoriais analisadas. A partir de 2014 não foram identificadas de macropolíticas ou políticas setoriais relacionadas à ampliação do acesso aos medicamentos no SUS com impactos no campo regulatório.

Palavras-chave:
Assistência farmacêutica; Vigilância sanitária; medicamentos

Introduction

The Brazilian setting requires the consideration of health regulation and its permeation in the context of public policies in light of the process of construction of the right to health, the Unified Health System (SUS), and the formulation of the National Health Policy, which includes the National Pharmaceutical Policy (PNAF) as one of its components¹, and other sectoral policies.

In the field of health, the relationships of production and consumption of goods, services, or technologies are marked by their comprehensive interfaces, especially in the sectors underpinning the so-called Health Economic-Industrial Complex (CEIS). This complex can be defined as a selected set of productive activities that maintain cross-sector relationships for the purchase and sale of goods, services, or knowledge and technology, with a clear sector interdependence relationship². These relationships are subject to the actions of the State as a promoter of possible interfaces and regulator in the relationships established in the context of the CEIS³. This complex has a common institutionality, represented by the entities of health regulation, technological incorporation, and research ethics⁴.

The development of new technologies and their availability for global consumption requires regulatory definitions that transcend the limits of the countries of origin^5-7, generating constant challenges to the action of regulatory bodies and states^8-10, which calls for the strengthening of regulatory systems, components of health systems^11,12.

Although the term “Health Surveillance” is unique to Brazil, health regulation does not diverge from internationally accepted concepts^13,14. The dynamics of health surveillance are linked to scientific and technological development and the political processes that permeate the State, the market, and societies.

In this context, regulatory science is a field of knowledge in which the articulation and interfaces between different types of knowledge enable the development of scientific bases that can be used to ensure the safety, quality, and effectiveness of products and services made available to societies, and of instruments and practices that contribute to the decision and implementation of regulatory mechanisms^15-17. This field of knowledge has been the focus of attention of regulatory agencies recognized globally^18,19.

This study aimed to identify and analyze interfaces between sectoral policies geared to technological development for the production of medicines of interest to the Brazilian Unified Health System (SUS) and health regulation, guided by the PNAF, to identify regulatory actions and practices that can contribute to reducing SUS vulnerabilities and achieve sustainable access to medicines.

Methods

This study was carried out by documentary research, adopting the model proposed by Walt and Gilson²⁰ to analyze health policies (Health Policy Analysis, HPA). The analytical model is comprehensive and analyzes complex relationships, highlighting the interrelationship between the four constituent elements of the so-called “policy analysis triangle” and its categories, namely, context, content, and process, for which different stakeholders can contribute. Concerning the content analysis of the policies, the strategies defined in the Situational Strategic Planning method described by Matus²¹ were used. The association of different analytical tools is supported by different authors^22,23, which may contribute to the greater strength and scope of the analyses performed.

Given the polysemic nature of the term “policy”, the study adopted the understanding of “public policy” as a process in which public action programs are elaborated and implemented, considering political-administrative devices coordinated around the explicit objectives of the governmental action in a defined sector or geographic space²⁴.

The study covered the period from 2003 to 2019, referring to the formulation and 15 years of PNAF’s implementation. Documents were searched on the websites of the Ministries of Health, Economy and Science, Technology and Innovation, the National Health Council, the National Health Surveillance Agency (ANVISA), and the National Bank for Economic and Social Development (BNDES) and printed publications of these institutions.

The study included public actions related to the development and internalization of technologies to produce medicines of interest to the SUS, access to, and health regulation of medicines. Documents addressing only organizational aspects and administrative rules were excluded from the analysis. The search identified 212 documents, which were read in full. The inclusion and exclusion criteria shortlisted this number to 110 documents for analysis.

Results

Chart 1 presents the synthesis of the analysis regarding the typology and content of public policies with identified interfaces between technological development and health regulation during the study period. The contexts, processes, and stakeholders related to the policies mentioned above were analyzed from these data, the results of which are shown in Chart 2. References to health regulation or health surveillance held a prominent place in the analyses.

Chart 1
Summary of the analysis of public policies with interfaces between technological development in the area of medicines and health regu-lation, in the 2003-2019 period.

Year	Macropolitics (Systemic policy)	Micropolitics (Sectoral policy)	Policy content
			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

• Source: Elaborated by the authors, based on analytical models proposed by Walt and Gilson20 and Matus21.

Chart 2
Public policies with interfaces with technological development in the area of medicines, their impacts on the health regulatory field, and stakeholders involved, in the 2003-2019 period.

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

• Source: Elaborated by the authors, based on analytical models proposed by Walt and Gilson20 and Matus21.

Discussion

In 2003, pharmaceutical care was defined as one of the priorities of the Brazilian Ministry of Health, reflected in the establishment of the Secretariat of Science, Technology and Strategic Supplies (SCTIE), its Department of Pharmaceutical Care and Strategic Supplies (DAF)^25,26, and holding the First National Conference on Medicines and Pharmaceutical Policy^27,28. The National Pharmaceutical Policy (PNAF) was established in the National Health Council (CNS) by Resolution CNS No. 338/2004¹, and ratified by the Minister of Health²⁹, consolidating the permeations between access and rational use of medicines with the intersectoral policies of scientific, technological and industrial, development in Brazil^26,27.

The PNAF was the first public policy formulated and established within the social control of the SUS³⁰, assuming a strategic role beyond the health care process. Its principle is its guiding role in formulating other sectoral policies, emphasizing medicines, industrial development, and science and technology policies. Concerning health regulation, the PNAF defined the construction of a health surveillance policy to guarantee people’s access to safe, effective, and quality services and products¹ as one of its priority axes. This construction is still underway since Brazil has not yet advanced in establishing a national health surveillance policy. Regarding medicines, the PNAF assumes the strategic role of systemic policy (macropolitics), while the SUS guides the demand to the productive pharmaceutical sectors, whose capillarity began to influence the formulation or decision-making within other systemic public policies and sectoral policies (micropolitics).

From 2003 to 2006, the Ministry of Health worked painstakingly in joint coordination with the Ministry of Development, Industry, and Foreign Trade of the Forum on Competitiveness of the Pharmaceutical Productive Chain³¹, and the stakeholders involved advanced discussions on scientific, technological, and industrial development to meet the demands of the SUS. In a context marked by the search for consensus, the Forum identified the economic and strategic relevance of medicines for the SUS, characterizing the pharmaceutical industrial policy as a “government priority” and “State policy” and recommending the prioritization of public policies geared to modernization and training of public pharmaceutical laboratories to conduct research and development (R&D) activities, and the implementation of public-private partnerships as a mechanism for inducing industrial production in the sector³¹. These definitions were aligned with those indicated by the PNAF.

A relevant consequence of the Forum was the inclusion of the topic “pharmaceuticals and medicines” as one of the four priorities of the Industrial, Technological, and Foreign Trade Policy (PITCE), an important advance in the coordination of sectoral policies to support the development of productive health sectors^32,33. A more immediate result of such prioritization, in April 2004, the National Bank for Economic and Social Development (BNDES) launched the Pharmaceutical Chain Support Program (PROFARMA), initially to enable investments to adapt the national pharmaceutical park to new regulatory requirements and induce innovative activity in the pharmaceutical chain³⁴. Although the Forum’s recommendations indicated the need for the National Health Surveillance System (SNVS) to adopt mechanisms for internalizing the guidelines resulting from the consensus obtained³¹, no concrete actions in this regard had been identified until late 2006.

In 2004, the challenge of formulating a National Policy on Science, Technology, and Innovation in Health (PNCTIS) found a political-institutional context favorable to the resumption of discussions emanating from the First Thematic Conference held in 1994³⁵, insofar as science and technology policy in health is a component of the National Health Policy^35,36. The establishment of the Secretariat of Science, Technology, and Strategic Supplies (SCTIE)/MS contributed to this positive setting. The Second National Conference on Science, Technology and Innovation in Health (CNCTIS) held in July 2004 resulted in the proposed consolidated text of the PNCTIS, which was submitted for deliberation by the CNS³⁷. Many items defined by the PNCTIS had an unequivocal relationship with the definitions of the PNAF, and regarding health regulation, the PNCTIS highlighted the role of ANVISA regarding the prior consent for patenting of health supplies³⁷.

The instrument of prior consent by ANVISA in the requests to grant patents for pharmaceutical products and processes resulting from the introduction of art. 229-C to the Intellectual Property Law (Law No. 9,279/96) by Law No. 10.196, of February 14, 2001³⁸. The application of the provisions of art. 229-C was the object of Joint Ordinance No. 1, of April 2017, agreed upon by ANVISA and the National Institute of Industrial Property (INPI)³⁹. The definitions of this ordinance limit the application of the procedure of prior consent by ANVISA since it may submit subsidies to the INPI’s examination regarding the patentability criteria in applications of interest to drug policies or pharmaceutical care within the SUS, but no veto power over compliance with these criteria. This decision followed the opposite path to that indicated by the PNCTIS³⁷.

In April 2007, after fruitless negotiations with the company holding the patent, the Brazilian government declared the patent rights on Efavirenz a matter of public interest to grant a compulsory license for non-commercial use⁴⁰, which was followed by the enactment of the Presidential Decree Nº 6.108/2007, establishing the compulsory licensing of Efavirenz⁴¹, government response to the context of high vulnerability of the National STD/AIDS Program (PN DST/AIDS), established in 1986^42-44 and whose free access to medicines by people living with HIV was established by Law No. 9.313, of November 1996⁴⁵. The impacts of the Brazilian Patent Law⁴⁶ and the constant price hike of ARVs started to affect the sustainability of the Brazilian program, with around 70% of the PN STD/AIDS budget in the 2006-2007 period committed to the acquisition of imported ARVs⁴⁷. After adopting the compulsory license, the national production of Efavirenz was taken over by the Farmanguinhos/Fiocruz^4,48 Pharmaceutical Technology Institute, facilitated by partnerships with national pharmaceutical and pharmochemical companies.

This initiative was anchored in the 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^49,50. This productive arrangement was one of the pioneering examples of the use of the strategy that would later shape the Partnerships for Productive Development (PDP)⁴. These actions were aligned with the principles and strategic axes of PNAF¹.

In this scenario, ANVISA acted proactively and published Ordinance No. 583/2007, which established the Technical-Regulatory Committee (CTR) within ANVISA to monitor the development, production, and registration of the drug object of the Decree N° 6.108 in Brazil, dated May 4, 2007⁵¹. This definition was innovative in the Brazilian regulatory-health setting, enabling an early and collaborative interface between the regulatory authority and the productive entities responsible for technological development initiatives of national interest. In February 2009, Farmanguinhos/Fiocruz delivered to the Ministry of Health the first batches of nationalized production of ARV Efavirenz⁵², facilitated by the reduced regulatory times promoted by the CTR.

The National Policy for Productive Development was established in May 2008 as one of the initiatives to confront the marked acceleration of the deficit in the Brazilian trade balance in the pharmaceutical and medicine segments since the 2000s⁵³. It defined the Economic-Industrial Health Complex (CEIS) as one of its priorities, accompanied by the establishment of the Executive Group for the Health Industrial Complex (GECIS) through Decree/2008^54,55. As the national manager of the SUS, the Ministry of Health assumed the role of conducting intersectoral initiatives to regulate and improve the efficiency of the CEIS, involving the industrial, economic, and technological fields, and meet SUS demands^4,56. The development policy defined in 2008 resumed and expanded the breadth and depth of the PITCE established in 2004⁵⁷. As provided for in the Decree of its establishment⁵⁵, the setting of a permanent forum for articulation with civil society to provide advice to the GECIS was defined, which placed the premise for the different social stakeholders’ participation in proposing strategies actions for the development of the health sector⁵⁸. Regarding health regulation, GECIS’ competencies included actions to guarantee isonomic health regulation and support the quality of national production, including the modernization of health surveillance actions and the establishment of a support network for the quality and competitiveness of local production and the simplification and streamlining of regulatory processes^36,53. These definitions reinforced ANVISA’s initiatives to adopt the CTRs as a regulatory practice, especially from the positive results observed in the process resulting from the compulsory license adopted in 2007.

In the setting where public health policies were directed towards a virtuous articulation between health care and industrial development⁵⁹, public procurement has become a vital instrument for inducing technological training and development of the productive base to reduce the vulnerability of the SUS and generate investments, employment, and income⁴. These assumptions are aligned with the guidelines and strategic axes established in the PNAF. As of 2009, PDPs were defined as an instrument established within the health policy to stimulate the CEIS and meet SUS demands^4,36,60,61. They are, therefore, an industrial policy mechanism used in health to internalize production and transfer drug technology, active pharmaceutical ingredients, and products of interest to the SUS⁶². This initiative occurs under the coordination of the Ministry of Health presented under the GECIS in 2009⁶¹, through the establishment of a partnership between the technology holding company and a public producer entity qualified to supply the product to the SUS during the period of technological absorption, with the centralized acquisition by the Ministry of Health^4,63,64. This strategy was a practical consequence of the inclusion of CEIS among the strategic axes of national health planning, strengthening the national pharmacochemical industry and official pharmaceutical laboratories, based on the arrangement for the transfer of technologies demanded by the SUS²⁸. In building and implementing the PDPs, the Ministry of Health, primarily through the SCTIE, assumed a prominent role as an institutional actor, with significant results for the sustainability of access to medicines in the SUS. From 2011 to early 2017, the savings resulting from the centralized purchase of medicines covered by the PDP reached BRL 4.68 billion³⁶. In this context, ANVISA defined the establishment of Technical-Regulatory Committees (CTR) to follow up and monitor the different partnerships defined for each public pharmaceutical laboratory involved^61,63. Such CTRs were formally anchored in the Resolution of the Collegiate Board of Directors (RDC) of ANVISA of 02/2011⁶⁵, building on the successful regulatory practice experience adopted when the compulsory license of Efavirenz was issued in 2007.

The actions to include the CEIS in the national development policy and its strengthening to meet the demands of the SUS were reinforced with the incorporation of the GECIS into the Brasil Maior Plan, established in 2011 by Decree No. 7.540^66,67. In this new setting, the Ministry of Health established the Program for the Development of the Health Industrial Complex (PROCIS) through MS Ordinance No. 506/2012⁶⁸ to strengthen the infrastructure of production and innovation in health in the public sector. In this context, the guidelines for establishing PDPs were defined through the Ministry of Health’s Ordinance No. 837/2012⁶⁹, which was based on the National Health Plan⁷⁰.

The interfaces of PROCIS with health surveillance are shown by the inclusion of ANVISA in its management committee⁶⁸ and the actions of this agency geared to technological and industrial development, such as the edition of RDC No. 50/2012, which provided for the procedures for the registration of products in the process of developing or transferring technologies that are the object of public-public or public-private Productive Development Partnerships of interest to the Unified Health System⁷¹. This regulatory-sanitary definition innovated by setting mechanisms for the systematic internalization of all information related to the development of drugs subject to PDP, resulting in the gradual and monitored composition of product dossiers, with the reduced regulatory time required for the analysis and definition of the respective records and acceleration of their availability in the SUS.

The revision of the legal framework supporting the PDPs was defined by the Ministry of Health’s Ordinance No. 2.531/2014⁷². This regulation is related to the macro-policy of use and rationalization of the State’s purchasing power, including the criteria for defining strategic products for the SUS and fostering the development of the CEIS⁷³. The regulation of the use of the State’s purchasing power was the object of the National Policy for Technological Innovation in Health (PNITS), defined by Decree No. 9.245/2017⁷⁴, in a weakening Brazilian democracy promoted by the legal-parliamentary coup of 2016⁷⁵. However, the PNITS did not add any advances regarding health regulation. The context in which the PDP regulation was revised was marked by the need for greater transparency in the processes for its definition and the search for greater legal certainty for decision-making within public management. The initiatives adopted were strongly influenced by the recommendations resulting from the audit carried out by the Federal Court of Accounts (TCU), which assessed the regularity of the PDP signed by the Ministry of Health⁷⁶. The new legal framework was an evolution regarding the criteria for defining strategic products for the SUS established in 2008 by Ordinance MS No. 978⁷⁷. However, a recent study indicates that the criteria adopted for constructing a strategic list of products for the SUS do not incorporate elements of health technology assessment and the use of evidence, and the process lacks interactions between researchers and decision-makers^78,79. Concerning health regulation, the revised legal guidelines of the PDP reaffirmed the role of the CTR and included ANVISA in the Technical Assessment Committees (CTA), responsible for analyzing and evaluating the PDP proposals. Such definitions reinforce ANVISA’s strategic role in the context of the CEIS incentive policy and understanding CTR as a practice model in the health-regulatory field.

Final considerations

The study identified essential interfaces between the evolution of regulatory frameworks and practices with initiatives to foster technological development for the national production of medicines of interest to the SUS, based on the guidelines of the National Pharmaceutical Care Policy (PNAF).

Establishing the PDPs was an essential strategy for reducing SUS vulnerabilities. It implemented the Technical Regulatory Committees (CTR) as an innovative practice in health surveillance, considering the successful experience carried out during the compulsory license for the national production of Efavirenz in 2007. The incentives to the CEIS also boosted the adoption of new milestones and new regulatory practices regarding the internalization and development of technologies, keeping interfaces with PNAF’s guiding capacity on sectorial policies aimed at people’s access to medicines, with a reduction in time for its availability in the SUS, cost reduction, and addressing SUS vulnerabilities. However, as of 2014, no significant developments were identified in this context.

Although the study period was capped at year 2019, it was essential to refer to the current situation of the COVID-19 pandemic, which shows that investments in scientific and technological development and the adoption of milestones and new regulatory practices are fundamental for the country. Likewise, Brazil must overcome the gaps generated in the sectoral policies with the resumption and enhancement of the advances achieved. To this end, it is crucial to observe the principles defined in the national health policy and its social control, the strengthening of the national system of science, technology, and innovation, and the preservation of state companies with impacts on the health sector, where the State is a regulator that can prioritize national development, as opposed to subordinating it to particular economic interests or institutional neglect.

Referências

• Brasil. Conselho Nacional de Saúde. Resolução n°. 338, de 6 de maio de 2004. Aprova a Política Nacional de Assistência Farmacêutica. Diário Oficial da União 2004; 20 maio.
• ²
  Gadelha CAG. O complexo industrial da sau´de e a necessidade de um enfoque dinâmico na economia da sau´de. Cien Saude Colet 2003; 8(2):521-535.
• ³
  Gadelha CAG, Costa LS, Maldonado J. O Complexo Econômico-Industrial da Sau´de e a dimensa~o social e econômica do desenvolvimento. Rev Saude Publica 2012; 46(Supl.):21-28.
• ⁴
  Gadelha CAG, Temporão JG. Desenvolvimento, Inovac¸a~o e Sau´de: a perspectiva teo´rica e poli´tica do Complexo Econo^mico-Industrial da Sau´de. Cien Saude Colet 2018; 23(6):1891-1902.
• ⁵
  Barbui C, Addis A, Amato L, Traversa G, Garattini S. Can systematic reviews contribute to regulatory decisions? Eur J Clin Pharmacol 2017; 73:507-509.
• ⁶
  Spindler P, Bach KF, Schmiegelow M, Bedlington N, Eichler HG. Innovation of Medical Products: The Evolution of Regulatory Science, Research, and Education. Ther Innov Regul Sci 2016; 50(1):44-48.
• ⁷
  Tsukamoto K, Takenaka T. Role of Academia in Regulatory Science for Global Drug Development. Yakugaku Zasshi 2016; 136(4):543-547.
• ⁸
  Baldwin R, Black J, O'leary G. Risk Regulation and Transnationality: Institutional Accountability as a Driver of Innovation. Transnational Environmental Law 2014; 3(2):373-390.
• ⁹
  Lucchese G. Globalização e Regulação Sanitária: Os Rumos da Vigilância Sanitária no Brasil. [tese] Rio de Janeiro: Escola Nacional de Saúde Pública Sergio Arouca, Fundação Oswaldo Cruz; 2001.
• ¹⁰
  Silva APJ, Tagliari, POP. Iniciativas de convergência regulatória em saúde nas Américas: histórico, evolução e novos desafios. Rev Panam Salud Publica 2016; 39(5):281-287.
• ¹¹
  Allchurch MH, Barbano DBA, Pinheiro MH, Lazdin-Helds J. Fifty years of the European medicines regulatory network: reflections for strengthening intra-regional cooperation in the Region of the Americas. Rev Panam Salud Publica 2016; 39(5):288-293.
• ¹²
  World Health Organization (WHO). Member States. [acessado 2018 nov 16]. Disponível em: http://www.who.int/countries/en/.
  » http://www.who.int/countries/en
• ¹³
  Mendonça CS, Reis AT, Moraes JC, organizadores. A política de regulação do Brasil. Brasília: Organização Pan-Americana da Saúde; 2006.
• ¹⁴
  Silva JAA, Costa EA, Lucchese G. SUS 30 anos: Vigilância Sanitária. Cien Saude Colet 2018; 23(6):1953-1961.
• ¹⁵
  Meyer RJ. The Role of Academic Medical Centers in Advancing Regulatory Science. Clin Pharmacol Ther 2014; 95(51):29-31.
• ¹⁶
  Tominaga T, Asahina Y, Uyama Y, Kondo T. Regulatory Science as a bridge between Science and society. Clin Pharmacol Ther 2011; 90(1):29-31.
• ¹⁷
  Jasanoff S. Procedural choices in regulatory science. Technol Soc 1995; 17(3):279-293.
• ¹⁸
  Food and Drug Administration (FDA). Advancing Regulatory Science at FDA. 2011. [cited 2018 Set 24]. Available from: https://www.fda.gov/downloads/ScienceResearch/SpecialTopics/RegulatoryScience/UCM268225.pdf
  » https://www.fda.gov/downloads/ScienceResearch/SpecialTopics/RegulatoryScience/UCM268225.pdf
• ¹⁹
  Kurz X. Translating regulatory science into better processes. Eight Stakeholders forum on the implementation of the Pharmacovigilance legislation: Building on two years of operation. London: European Medicines Agency; 2018.
• ²⁰
  Walt G, Gilson L. Reforming the health sector in developing countries: the central role of policy analysis. Health Policy Plan 1994; 9(4):353-370.
• ²¹
  Matus C. Política, planejamento e governo. Brasília: Instituto de Pesquisa Econômica Aplicada; 1993.
• ²²
  Buse K. Addressing the theoretical, practical and ethical challenges inherent in prospective health policy analysis. Health Policy and Planning 2008; 23:351-360.
• ²³
  Walt G, Shiffman J, Schneider H, Murray S, Brugha R, Gilson L. Doing' health policy analysis: methodological and conceptual reflections and challenges. Health Policy Plan 2008; 23:308-317.
• ²⁴
  Muller P, Surel Y. Análise das políticas públicas. Pelotas: EDUCAT; 2002.
• ²⁵
  Rech N. Acesso aos medicamentos e à assistência farmacêutica. Brasília: Ministério da Saúde, Secretaria de Ciência, Tecnologia e Insumos Estratégicos; 2005.
• ²⁶
  Rech N, Farias MR. Assistência Farmacêutica, intersetorialidade, pesquisa e inovação. Newsletter ABCF 2015; 1:7-9.
• ²⁷
  Bermudez JAZ, Esher A, Osorio-de-Castro CGS, Vasconcelos DMM, Chaves GC, Oliveira MA, Silva, RM, Luiza VL. Assiste^ncia Farmace^utica nos 30 anos do SUS na perspectiva da integralidade. Cien Saude Colet 2018; 23(6):1937-1951.
• ²⁸
  Brasil. Ministério da Sau´de (MS). Conselho Nacional de Sau´de. 1ª Conferência Nacional de Medicamentos e Assistência Farmacêutica. Relatório Final: efetivando o acesso, a qualidade e a humanização na assistência farmacêutica, com controle social. Brasília: MS; 2005.
• ²⁹
  Brasil. Presidência da República. Decreto de 12 de novembro de 1991. Delega competência ao Ministro de Estado da Saúde para homologar as decisões do Conselho Nacional de Saúde. Diário Oficial da União 1991; 13 nov.
• ³⁰
  Leite SN, Manzini F, Veiga A, Lima MEO, Pereira MA, Araujo, SQ, Santos RF, Bermudez JAZ. Ciência, Tecnologia e Assistência Farmacêutica em pauta: contribuições da sociedade para a 16a Conferência Nacional de Sau´de. Cien Saude Colet 2018; 23(12):4259-4268.
• ³¹
  Brasil. Ministe´rio da Sau´de (MS). Ministe´rio do Desenvolvimento, Indústria e Comércio Exterior. Fórum de competitividade da cadeia produtiva farmacêutica 2003-2006: O desafio de prosseguir Brasília: MS; 2007.
• ³²
  Brasil. Casa Civil da Presidência da República. Diretrizes de politica industrial, tecnológica e de comércio exterior. Brasília: Casa Civil da Presidência da República; 2004.
• ³³
  Brasil. Agência Brasileira de Desenvolvimento Industrial (ABDI). Dez anos de política industrial: balanço e perspectivas 2004-2014. Brasília: ABDI; 2015.
• ³⁴
  Palmeira Filho PL, Pieroni JP, Antunes MAS, Martins JV. O desafio do financiamento a` inovac¸a~o farmace^utica no Brasil: a experie^ncia do BNDES Profarma. Revista do BNDES 2012; 37:67-90. [acessado 2019 maio 20]. Disponível em: http://www.bndes.gov.br/bibliotecadigital
  » http://www.bndes.gov.br/bibliotecadigital
• <sup>35</sup>
  Goldbaum M, Serruya SJ. O Ministério da Saúde na política de ciência, tecnologia e inovação em saúde. REVISTA USP 2007; 73:40-47.
• <sup>36</sup>
  Guimara~es R, Noronha J, Elias FTS, Gadelha CAG, Carvalheiro JR, Ribeiro A. Política de ciência, Tecnologia e Inovação em Saúde. Cien Saude Colet 2019; 24(3):881-886.
• <sup>37</sup>
  Brasil. Conselho Nacional de Saúde. Ministério da Saúde (MS). Secretaria de Ciência, Tecnologia e Insumos Estratégicos. 2a Conferência Nacional de Ciência, Tecnologia e Inovação em Saúde. Brasília: MS; 2005.
• <sup>38</sup>
  Tojal SBB, Pessôa PR. Anue^ncia pre´via na concessa~o de patentes de medicamentos e a regulac¸a~o econo^mica da indu´stria farmace^utica. Revista de Direito Sanitário 2008; 8(3):148-165.
• <sup>39</sup>
  Brasil. Agência Nacional de Vigilância Sanitária. Instituto Nacional de Propriedade Industrial. Portaria Conjunta n° 1, de 12 de abril de 2017. Regulamenta os procedimentos para a aplicação do artigo 229-C da Lei nº 9.279, de14 de maio de 1996, acrescido pela Lei nº10.196, de 14 de fevereiro de 2001, e dá outras providências. Diário Oficial da União 2017: 13 abr.
• <sup>40</sup>
  Brasil. Ministério da Saúde (MS). Portaria n° 886, de 24 de abril de 2007. Declara de interesse público os direitos de patente sobre o efavirenz, para fins de concessão de licença compulsória para uso não comercial. Diário Oficial da União 2007; 25 abril.
• <sup>41</sup>
  Brasil. Presidência da República. Decreto n° 6.108 de 4 de maio de 2007. Concede licenciamento compulsório, por interesse público, de patentes referentes ao Efavirenz, para fins de uso público não-comercial. Diário Oficial da União 2007; 5 maio.
• <sup>42</sup>
  Bermudez JAZ, Oliveira MA, Esher A. Acesso a Medicamentos: Derecho Fundamental, Papel del Estado. Rio de Janeiro: ENSP; 2004.
• <sup>43</sup>
  Granjeiro A, Laurindo da Silva L, Teixeira PR. Resposta a` aids no Brasil: contribuições dos movimentos sociais e da reforma sanitária. Rev Panam Salud Publica 2009; 26(1):87-94.
• ⁴⁴
  Hoirisch C. Licença Compulsória para Medicamentos como Poli´tica Pu´blica: O Caso do Antirretroviral Efavirenz [dissertação]. Rio de Janeiro: Fundação Getúlio Vargas; 2010.
• ⁴⁵
  Brasil. Lei n° 9.313 de 13 de novembro de 1996. Dispõe sobre a distribuição gratuita de medicamentos aos portadores do HIV e doentes de AIDS. Diário Oficial da União 1996; 14 nov.
• ⁴⁶
  Brasil. Presidência da República. Lei n° 9.279, de 14 de maio de 1996. Regula direitos e obrigações relativos a` propriedade industrial. Diário Oficial da União 1996; 15 mai.
• <sup>47</sup>
  Greco DB. Desafios da Epidemia de Aids após 10 anos de terapia antirretroviral. Brasília: Ministério da Saúde; 2007.
• <sup>48</sup>
  Rodrigues WCV, Soler O. Licenc¸a compulso´ria do efavirenz no Brasil em 2007: contextualizac¸a~o. Rev Panam Salud Publica 2009; 26(6):553-559.
• <sup>49</sup>
  Brasil. Ministério do Planejamento, Orçamento e Gestão, Ministério da Saúde, Ministério de Ciência, Tecnologia e Inovação. Portaria n° 128 de 29 de maio de 2008. Estabelece as diretrizes para a contratação de fármacos e medicamentos pelos órgãos e entidades integrantes do Sistema Único de Saúde. Diário Oficial da União 2008; 30 mai.
• <sup>50</sup>
  Viana ALD, Silva HP, Iban~ez N, Iozzi FL. A poli´tica de desenvolvimento produtivo da sau´de e a capacitação dos laboratórios públicos nacionais. Cad Saude Publica [periódico na Internet]. 2016 Nov [acessado 2019 maio 12]; 32(Supl. 2): [cerca de 14 p.]. Disponível em: http://www.scielo.br/scielo.php?script=sci_arttext&pid=S0102-311X2016001405003&lng=en&nrm=iso
  » http://www.scielo.br/scielo.php?script=sci_arttext&pid=S0102-311X2016001405003&lng=en&nrm=iso
• <sup>51</sup>
  Brasil. Agência Nacional de Vigilância Sanitária. Portaria n° 583 de 8 de agosto de 2007. Institui o Comitê Técnico-Regulatório no âmbito da Anvisa com a finalidade de acompanhar o processo de desenvolvimento, produção e registro no Brasil do medicamento objeto do Decreto n. 6.108, de 04 de maio de 2007. Diário Oficial da União 2007; 08 ago.
• <sup>52</sup>
  Brasil. Fundação Oswaldo Cruz (Fiocruz). Farmanguinhos entrega ao Ministério da Saúde o Efavirenz nacional. Rio de Janeiro: Fiocruz; 2009.
• <sup>53</sup>
  Vargas M, Gadelha CAG, Costa LS, Maldonado J. Inovação na indústria química e biotecnológia em saúde: em busca de uma agenda virtuosa. Rev Saude Publica 2012; 46(Supl.):37-40.
• <sup>54</sup>
  Brasil. Ministe´rio da Sau´de (MS). Mais Sau´de: direito de todos 2008-2011. Brasília: MS; 2008.
• <sup>55</sup>
  Brasil. Decreto de 12 de maio de 2008. Cria, no âmbito do Ministério da Saúde, o Grupo Executivo do Complexo Industrial da Saúde - GECIS e dá outras providências. Diário Oficial da União 2008; 13 mai.
• <sup>56</sup>
  Vargas MA, Almeida ACS, Guimarães ALC. Parcerias para desenvolvimento produtivo (PDPS-MS): contexto atual, impactos no sistema de sau´de e perspectivas para a poli´tica industrial. Rio de Janeiro: Fundação Oswaldo Cruz; 2017.
• <sup>57</sup>
  Departamento Intersindical de Estatística e Estudos Socioeconômicos (DIEESE). Política de desenvolvimento produtivo - nova política industrial do governo. São Paulo: DIEESE; 2008.
• <sup>58</sup>
  Brasil. Ministério da Saúde (MS). Portaria n° 1.942 de 17 de setembro de 2008. Aprova o Regimento Interno do Grupo Executivo do Complexo Industrial da Sau´de - GECIS e institui o Fórum Permanente de Articulação com a Sociedade Civil. Diário Oficial da União 2008; 18 set.
• <sup>59</sup>
  Gomes R, Pimentel Vitor, Losada M, Pieroni JP. O novo cenário de concorrência na indústria farmacêutica brasileira. BNDES Setorial 2014; 39:97-134.
• <sup>60</sup>
  Cassiolato JE, Szapiro M. Os dilemas da política industrial e de inovação: os problemas da região Sudeste são os problemas do Brasil. In: Leal CLCF, Linhares LRF, Lemos CR,Silva MML,Lastres HMM. Um olhar territorial sobre o desenvolvimento: Sudeste. Rio de Janeiro: BNDES; 2015.
• <sup>61</sup>
  Silva GO, Elias FTS. Parcerias para o desenvolvimento produtivo: um estudo de avaliabilidade. Com Cienc Saude 2017; 28(2):125-139.
• <sup>62</sup>
  Varrichio PC. As parcerias para o desenvolvimento produtivo da sau´de. In: Rauen AT (organizador). Políticas de inovação pelo lado da demanda no Brasil. Brasília: Ipea; 2017. p.179-234.
• <sup>63</sup>
  Silva GO, Rezende KS. Parcerias para o desenvolvimento produtivo: a constituição de redes sociotécnicas no Complexo Econômico-Industrial da Saúde. Vigil Sanit Debate 2017; 5(1):11-12.
• <sup>64</sup>
  Gadelha CAG, Braga PSC. Health and innovation: economic dynamics and Welfare State in Brazil. Cad Saude Publica 2016; 32(Supl. 2):e00150115.
• <sup>65</sup>
  Brasil. Agência Nacional de Vigilância Sanitária. Resolução de Diretoria Colegiada - RDC - n° 2 de 2 de fevereiro de 2011. Dispõe sobre os procedimentos no âmbito da ANVISA para acompanhamento, instrução e ana´lise dos processos de registro e pós-registro, no Brasil, de medicamentos produzidos mediante parcerias público-público ou público- privado e transferência de tecnologia de interesse do Sistema Único de Sau´de. Diário Oficial da União 2011; 3 fev.
• <sup>66</sup>
  Brasil. Presidência da República. Decreto n° 7.540 de e de agosto de 2011. Institui o Plano Brasil Maior - PBM e cria o seu sistema de gestão. Diário oficial da União 2011; 3 ago.
• <sup>67</sup>
  Bercovici G. Complexo industrial da sau´de, desenvolvimento e proteção constitucional ao mercado interno. Rev Dir Sanit 2013; 14(2):9-42.
• <sup>68</sup>
  Brasil. Ministério da Saúde (MS). Portaria n° 506 de 21 de março de 2012. Institui o Programa para o Desenvolvimento do Complexo Industrial da Saúde (PROCIS) e seu Comitê Gestor. Diário Oficial da União 2012; 22 mar.
• <sup>69</sup>
  Brasil. Ministério da Saúde (MS). Portaria n° 837 de 18 de abril de 2012. Define as diretrizes e os critérios para o estabelecimento as Parcerias Para o Desenvolvimento Produtivo (PDP). Diário Oficial da União 2012; 27 abr.
• <sup>70</sup>
  Brasil. Ministério da Saúde (MS). Plano Nacional de Saúde (PNS) 2012-2015. Brasília: MS; 2011.
• <sup>71</sup>
  Brasília. Agência Nacional de Vigilância Sanitária. Resolução da Diretoria Colegiada RDC - n° 50 de 13 de setembro de 2012. Dispõe sobre os procedimentos no âmbito da Anvisa para registro de produtos em processo de desenvolvimento ou de transferência de tecnologias objetos de Parcerias de Desenvolvimento Produtivo público-público ou público-privado de interesse do Sistema Único de Saúde. Diário Oficial da União 2012; 14 set.
• <sup>72</sup>
  Brasil. Ministério da Saúde (MS). Portaria GM/MS no 2.531 de 12 de novembro de 2014. Redefine as diretrizes e os critérios para a definição da lista de produtos estratégicos para o Sistema Único de Saúde (SUS) e o estabelecimento das Parcerias para o Desenvolvimento Produtivo (PDP) e disciplina os respectivos processos de submissão, instrução, decisão, transferência e absorção de tecnologia, aquisição de produtos estratégicos para o SUS no âmbito das PDP e o respectivo monitoramento e avaliação. Diário Oficial da União 2014; 13 nov.
• <sup>73</sup>
  Oliveira EJV, Vivan AL, Albuquerque FC, Silva GO, Rezende KS, Barbosa LP. A consolidação do marco regulatório das parcerias para o desenvolvimento produtivo. Revista Eletrônica Gestão em Saúde [periódico na Internet]. 2015 out [acessado 2016 mar 18]; 6(Supl. 4): [cerca 19 p.]. Disponível em: blob:https://periodicos.unb.br/7473880f-c9af-4da8-b0a1-3351a6ec1472
  » https://periodicos.unb.br/7473880f-c9af-4da8-b0a1-3351a6ec1472
• <sup>74</sup>
  Brasil. Presidência da República. Decreto n° 9.245 de 20 de dezembro de 2017. Institui a Politica Nacional de Inovação Tecnológica na Saúde. Diário Oficial da União 2017; 21 Dez.
• <sup>75</sup>
  Souza LEPF, Paim JS, Teixeira CF, Bahia L, Guimara~es R, Machado CV, Campos GW, Azevedo-e-Silva G. Os desafios atuais da luta pelo direito universal a` sau´de no Brasil. Cien Saude Colet 2019; 24(8):2783-2792.
• ⁷⁶
  Brasil. Tribunal de Contas da União. Sessão Extraordinária Reservada do Plenário - Ata 18, de 9 de agosto de 2017. Brasília: Secretaria da Sessões/TCU, 2017. Disponível em: http://www.tcu.gov.br/Consultas/Juris/Docs/CONSES/TCU_ATA_0_S_2017_18.PDF
• ⁷⁷
  Brasil. Ministério da Saúde (MS). Portaria nº 978 de 16 de maio de 2008. Dispõe sobre a lista de produtos estratégicos, no âmbito do Sistema Único de Saúde, com a finalidade de colaborar com o desenvolvimento do Complexo Industrial da Saúde e institui a Comissão para Revisão e Atualização da referida lista. Diário Oficial da União 2008; 17 mai.
• ⁷⁸
  Rezende KS, Silva GO, Albuquerque FC. Parcerias para o Desenvolvimento Produtivo: um ensaio sobre a construção das listas de produtos estratégicos. Saude Debate 2019; 43(2):155-168.
• ⁷⁹
  Silva GO, Elias FTS. Parcerias para o Desenvolvimento Produtivo: diagnóstico situacional da implementação na perspectiva dos atores envolvidos. Com Cienc Saude 2017; 28(3/4):313-325.

Edited by

Editors chief:

Romeu Gomes, Antônio Augusto Moura da Silva

Publication Dates

• Publication in this collection
  26 Nov 2021
• Date of issue
  Nov 2021

History

• Received
  24 Mar 2021
• Accepted
  02 Aug 2021
• Published
  04 Aug 2021