ABSTRACT

The objective was to point out the essential elements of logistics that contribute to the promotion of access in the context of the health production system to articulate national production, reduce external dependence to enable universal access and the strengthening of the Unified Health System (SUS) in the context of the pandemic and health crisis. Qualitative bibliographic-based research was used as a methodological strategy on the concepts of health system, public health, access to medicines, added to the profile of national logistics operators and the operationalization of the Ministry of Health’s national immunization plan against COVID-19. It was concluded that logistics plays a fundamental role in promoting access to health technologies and it is necessary to undertake research efforts that include the actors of the productive sector capable of contributing to the elaboration of public policies in the field of health. The central elements of logistics need to be highlighted in order to strengthen an agenda that articulates the Health Economic-Industrial Complex with universal access, considering logistical factors as critical elements without which access does not materialize. Logistical systems should be thought of as a resource of universal health systems to enable their integrality and sustainability.

KEYWORDS
Health Economic-Industrial Complex; Economic development; Unified Health System; Logistics; Pharmaceuticals

Introduction

When thinking about a universal health system, it is necessary to consider all social, political, and economic actors that can contribute to its sustainability, and logistics has become a central issue for health systems regarding the guarantee of access to their technologies, gaining even more relevance in the period of pandemic. Until then, it had been treated more as an engineering resource and less as an essential element for health policies when discussing with technical areas.

Logistics has even been neglected in the Health Economic-Industrial Complex (HEIC), which is dedicated to the articulation between technological advancement, productive development, and health promotion, and which reinforces the need for the participation of several areas of science for its strengthening.¹1 Gadelha CAG, Gadelha P, Noronha JC, et al., organizadores. Brasil saúde amanhã: complexo econômico-industrial da saúde. Rio de Janeiro: Editora Fiocruz; 2017. 227 p. Despite its importance for the productive health system, we do not see the participation of logistics in the formulation of health policies, despite its potential to contribute to strengthen the HEIC by supplying the industries that make up its subsystems and the movement of production through the territories, from the most developed to the most needy, contributing to a comprehensive effectiveness of access.

From the perspective of health systems²2 Lobato LVC, Giovanella L. Sistemas de Saúde: origens, componentes e dinâmica. In: Giovanella L, Escorel S, Lobato LVC, organizadores. Políticas e Sistemas de Saúde no Brasil. 2. ed. Rio de Janeiro: Fiocruz; 2012. p. 107-39., and in the scenario of the new coronavirus pandemic, logistics plays a fundamental role in the safe transportation of vaccines to preserve their characteristics and make them reach the population through the Brazilian immunization strategy. Another key role is to avoid interrupting supply chains at a time when the national production system needs to be strengthened to reduce external dependence on strategic health items in the face of COVID-19.

This work aims to deepen the importance of logistics for health policies and for the COVID-19 immunization strategy adopted in Brazil with regard to the operationalization of the Brazilian government’s vaccination plan by the Unified Health System (SUS), from the acquisition of vaccines to the distribution throughout the national territory, with the challenge of maintaining its efficacy and safety during all phases of the distribution chain, aiming to immunize the entire population, regardless of the region of the country. In addition, it is aimed at contributing to the debate on access and the need to strengthen the internal production of materials and strategic products for health and reducing external dependence and economic development addressed by HEIC, reinforcing the understanding that health and economic development are not in opposite fields³3 Gadelha CAG, Braga PSC, Montenegro KBM, et al. Acesso a vacinas no Brasil no conte xto da dinâmica global do Complexo Econômico-Industrial da Saúde. Cad. Saúde Pública. 2020 [acesso em 2021 fev 27]; 36(supl2). Disponível em: https://doi.org/10.1590/0102-311X00154519.
https://doi.org/10.1590/0102-311X0015451... .

The study was carried out through qualitative bibliographic-based research that sought to address the literature on health and public health systems that establish a dialogue with economic development and the scenario of the health crisis of the SARS-CoV-2 pandemic (COVID-19). The scientific database SciELO was used because it includes a wide range of articles related to health. The following descriptors were searched for: ‘health system, health economic-industrial complex, public health, public health, determinants in health, economy and health, pharmaceutical industry, medicines, vaccines, and immunization’. Searches were also made in non-specific health databases, to access references that have a dialogue with health to carry out the discussion of the article, such as: ‘supply chain, economic development, business logistics, logistics operators, pharmaceutical industry, production systems’. We found 425 references among articles, books, book chapters, theses, dissertations, technical notes, websites and legislation, 48 of which were selected because they contain topics related to the objective of the study.

The last survey carried out by the Brazilian Association of Logistics Operators (Abol) with technical-academic support from the Dom Cabral Foundation (FDC), in 2020, on the profile of national logistics operators was analyzed. Then, the national immunization plan of the Ministry of Health (MH) was analyzed to identify the logistical challenges of starting vaccinating the entire population at the same time, the specifications of quality of the vaccines that were authorized by the National Health Surveillance Agency (Anvisa) to be used in Brazil and the health legislation in force in the country related to good manufacturing practices, storage and transport/ distribution of Critical Inputs (API), followed by discussions and conclusions.

The participation of logistics in technological revolutions and development

The history of the industrial development in the world was marked by revolutions that transformed the technologies then employed⁴4 Hobsbawm EJ. Da revolução industrial inglesa ao imperialismo. 6. ed. Rio de Janeiro: Gen Forense Universitária; 2013.. The First Industrial Revolution, which took place in the second half of the eighteenth century, had artisanal labor replaced by wage labor in factories, establishing the first paradigm of production: large-scale production. This revolution was marked by the introduction of machines into the production process and the manufacture of chemicals. During this period, there was the first major change in logistics, with the expansion of transportation through the growth of the construction industry driven by steel production, resulting in an increase of populations in large industrial centers, which motivated the movement of products and people on a larger scale.

At that time, the great logistical challenge was the distribution of products that did not have an adequate means of transport for the disposal of their production, which began to happen in greater volumes with the development of industries, in addition to the triangular trade between Europe, Africa, and the Americas, with the export of weapons, textiles and beverages in exchange for slave labor to feed the production of sugar, tobacco, and cotton that took place between the continents.

The Second Industrial Revolution⁵5 Stearns PN. The industrial revolution in world history. 4. ed. Boulder: Westview Press; 2013. 318 p., in the nineteenth century, the so-called century of science, had as its great milestone the development of the chemical, electrical, and oil industries, together with the evolution of the means of transport and communication. Then, the second major transformation in logistics operations took place, enhanced by the inventions of the period, such as the airplane, electricity, mechanical refrigeration, and the telephone, together with innovations in the production lines that gave rise to mass production, in addition to shedding light to the importance of logistics with the expansion of the road network and the transport of loads by trucks, which enabled the distribution of industrialized products on a larger scale. Logistics was still limited to transportation and distribution, but without it, production would not reach the points of sale and consumption.

The Third Industrial Revolution was marked by the creation of the internet, which replaced analog with digital technology, the use of microcomputers, which provided the growth of file digitization⁶6 Rifkin J. The third industrial revolution: how lateral power is transforming energy, the economy, and the world. Basingstoke: Palgrave Macmillan; 2013. 291 p..

In addition to these great innovations, during this period, mobile phones were invented, which ended up being the great inspiration for the next revolution. With this, logistics becomes once and for all the protagonist of production processes, and logistics operators reinforce the role of logistics as an extension of the industry.

With globalization, production gains specific characteristics to meet product quality requirements, innovation becomes a necessity, and logistics planning activities are introduced into the concept of logistics management, which, in turn, leaves the transport/distribution area and starts to involve a broader process, ranging from the acquisition of raw materials, inventory management, production management, demand management to the control of operations, which include storage, quality, distribution, and transportation activities.

Health begins to show its participation in economic development, with the production of several innovative medicines and with the advancement of medicine, in addition to the development of genetic engineering and biotechnology in the area of science.

The creation of the internet and the invention of the mobile phone were the main ingredients for the transition from the third and fourth technological revolutions, maintaining the characteristics of disruption common to revolutions⁷7 Schwab K. A Quarta Revolução Industrial. São Paulo: Edipro; 2019.. These innovations enhanced the advent of digitization, mobility, and speed of information, allowing for the use of the various technologies available in the generation of knowledge and productivity that characterize the concept of the industry 4.0, and can be seen as a natural development of previous revolutions.

Table 1 shows the participation of logistics in technological revolutions over time and how it contributes to development, showing that, without the participation of logistics, production does not become accessible and is restricted to manufacturing areas, blocking the development process.

The productive sector of all segments of the economy has always relied on logistics to make its production reach the points of consumption, and health is not an exception. All inputs, materials, and products used in the generation of new technologies involve some logistics activity, if not all of them. In this pandemic scenario, where several locomotion restrictions are necessary to preserve social distancing as a way to control contamination, logistics plays a key role.

In the productive dynamics, goods and services are moved from one place to the other; and. Until they reach the end of the chain, it is necessary to add value in the various forms of movement, respecting the deadlines and the needs of users⁸8 Ballou RH. Logística Empresarial: transportes, administração de materiais e distribuição física. São Paulo: Atlas; 2012. 388 p.. The movement of goods and services is a concern of the operational management of logistics that comprises the initial shipment, regardless of where they are, until the destination⁹9 Bowersox DJ, Closs DJ. Logística empresarial: o processo de integração da cadeia de suprimento. São Paulo: Atlas; 2009., when the objective of the industry is effective because the entire effort of production in the generation of technologies will be of no use if they cannot reach those who need them. It is from this perspective that logistics is an essential element for health systems, allowing the continuity of the production of technologies and the effective access to them.

The Unified Health System and the confrontation of the pandemic of the new coronavirus

In addition to the challenges common to health systems, there are others that need specific actions. The most recent one has global consequences and has put health systems worldwide to the test is the SARS-CoV-2 (COVID-19) pandemic. Even in countries where health systems have a better structure to effectively promote a welfare state, the challenges have been great and have required from governments additional efforts.

When the first vaccines developed by the pharmaceutical industry became available, a new challenge arose. The logistical challenge of making the vaccine reach the entire population, regardless of where they are, becomes even more difficult in countries of large territorial dimensions and social inequalities such as Brazil.

The resilience of health systems is analyzed when their performance is affected by economic and health crises¹⁰10 Kruk ME, Ling EJ, Bitton A, et al. Building resilient health systems: a proposal for a resilience index. BMJ. 2017; (357):j2323.,¹¹11 Massuda A, Malik AM, Vecina Neto G, et al. A resiliência do Sistema Único de Saúde frente à COVID-19. Cad EBAPEBR. 2021; 19(esp):735-44.,¹²12 Ranzani RA, Mara ZC, Prado PR, et al. Resiliência de Sistemas de Assistência à Saúde no enfrentamento da COVID-19: relato de experiência. Rev Esc Enferm USP. 2022; (56):e20210210.. The SUS had its resilience tested when the ability to respond to the population’s health needs was impacted by the pandemic that shook the national logistics system, disrupting the supply chains of strategic health supplies and challenging both medical-hospital care services and the production of vaccines, to which the SUS proved to be able to provide the necessary responses even in times of crisis.

Health systems are composed of several actors whose activities are directly or indirectly related to the provision of healthcare²2 Lobato LVC, Giovanella L. Sistemas de Saúde: origens, componentes e dinâmica. In: Giovanella L, Escorel S, Lobato LVC, organizadores. Políticas e Sistemas de Saúde no Brasil. 2. ed. Rio de Janeiro: Fiocruz; 2012. p. 107-39.,¹³13 Loos GP, Roemer MI. National Health Systems of the World: v. 1: The countries. Asia Pac J Public Health. 1991; 5(4):366-366.. This concept reinforces the multidisciplinary profile of collective health that goes beyond those specific fields directly related to health, encompassing others that also contribute through their determinants, including the economic ones¹⁴14 Reis C, Pieroni JP. Perspectiva para o desenvolvimento da cadeia farmacêutica brasileira diante do enfrentamento da COVID-19. BNDS. 2021; 27(53):48.,¹⁵15 Santos AMA, Tejada CAO, Jacinto PA. Determinantes econômicos da demanda por importações de produtos farmoquímicos e farmacêuticos. Cad. Saúde Pública. 2017 [acesso em 2021 set 21]; 33(9). Disponível em: https://doi.org/10.1590/0102-311X00087916.
https://doi.org/10.1590/0102-311X0008791... , with regard to the provision of health services, which need to act in an integrated manner for the success of universal systems.

The products (goods and services) that health systems offer need to reach all users equally, and the main challenge is to prevent people who have fewer resources from having less access to health technologies in the quantity and quality they need to achieve Social Welfare State necessary to provide them with a dignified life¹⁶16 Costa LS, Bahia L, Gadelha CAG, et al. Saúde, Desenvolvimento e Inovação. 1. ed. Rio de Janeiro: CEPESC; IMS; UERJ; FIOCRUZ; IESC; UFR; 2015. (v. 1).. In this sense, when shaping health systems, the integration between actors, agents, values, ideals, interests, projects, and strategies needs to be prioritized taking into account political, economic, social, and institutional aspects, considering their main components and their management functions²2 Lobato LVC, Giovanella L. Sistemas de Saúde: origens, componentes e dinâmica. In: Giovanella L, Escorel S, Lobato LVC, organizadores. Políticas e Sistemas de Saúde no Brasil. 2. ed. Rio de Janeiro: Fiocruz; 2012. p. 107-39..

Through a well-structured health system, we seek to reduce social disparities by offering goods and services that cannot be accessed through work or lack of it¹⁷17 Viana ALD, Machado CV. Proteção social em saúde: um balanço dos 20 anos do SUS. Physis Rev Saúde Colet. 2008; (18):645-84.. Social policies have economic impacts, since, by minimizing social risks, economic stabilization is promoted by reducing uncertainties in consumption cycles, which contributes to a scenario of stability¹⁸18 Nogueira I, Bacil F, Guimarães JV. A caminho de um estado de bem-estar social na China? Uma análise a partir dos sistemas de saúde e de educação. Econ E Soc. 2020; (29):669-92..

The SUS is part of the Federal Constitution, which is seen as a Citizen Constitution¹⁹19 Bercovici G. Vinte anos da Constituição Federal: avanços e desafios para as políticas públicas e o desenvolvimento nacional. In: Cardoso Junior JC, Siqueira CHR, organizadores. Diálogos para o desenvolvimento. Brasília, DF: IPEA; 2009. p. 121-9.,²⁰20 Sampaio PA. Vinte anos da Constituição Federal: avanços e desafios para as políticas públicas e o desenvolvimento nacional. In: Cardoso Junior JC, Siqueira CHR, organizadores. Diálogos para o desenvolvimento. Brasília: IPEA; 2009. p. 91-7., contemplating economic, technological, industrial, and social policies²¹21 Castro MC, Massuda A, Almeida G, et al. Brazil’s unified health system: the first 30 years and prospects for the future. The Lancet. 2019; 394(10195):345-56. to guarantee its sustainability, uniting the social and economic dimensions for the social protection of the population. In addition, SUS has a set of actions²²22 Brasil. Ministério da Saúde. Programa Nacional de Imunização. Brasília, DF: MS; 1973.,²³23 Brasil. Ministério da Saúde. Resolução nº 338, de 6 de maio de 2004. Aprovar a Política Nacional de Assistência Farmacêutica. Diário Oficial da União. 6 Maio 2004. [acesso em 2021 fev 27]. Disponível em: https://bvsms.saude.gov.br/bvs/saudelegis/cns/2004/res0338_06_05_2004.html.
https://bvsms.saude.gov.br/bvs/saudelegi... that contribute to the principle of integrality²⁴24 Bermudez JAZ, Esher A, Osorio-de-Castro CGS, et al. Assistência Farmacêutica nos 30 anos do SUS na perspectiva da integralidade. Ciênc. saúde coletiva. 2018; 23(6):1937-49. and is supported by a HEIC²⁵25 Gadelha CAG. O complexo industrial da saúde e a necessidade de um enfoque dinâmico na economia da saúde. Ciênc. saúde coletiva. 2003; 8(2):521-35.,²⁶26 Gadelha CAG. Desenvolvimento, complexo industrial da saúde e política industrial. Rev Saúde Pública. 2006; 40(esp):11-23.,²⁷27 Gadelha CAG, Maldonado J, Vargas M, et al. A dinâmica do sistema produtivo da saúde: inovação e complexo econômico-industrial. Rio de Janeiro: Editora Fiocruz; 2012. 221 p.,²⁸28 Vargas M, Gadelha CAG, Costa LS, et al. Inovação na indústria química e biotecnológica em saúde: em busca de uma agenda virtuosa. Rev Saúde Pública. 2012; (46):37-40.,²⁹29 Gadelha CAG, Vargas MA, Maldonado J, et al. Complexo Econômico-Industrial da Saúde. In: Costa L, Bahia L, Gadelha CAG, et al., organizadores. Saúde, desenvolvimento e inovação. 1. ed. Rio de Janeiro: CE-PESC; IMS; UERJ; ENSP; FIOCRUZ; IESC; UFRJ; 2015. p. 41-63.,³⁰30 Gadelha CAG, Temporão JG. Desenvolvimento, Inovação e Saúde: a perspectiva teórica e política do Complexo Econômico-Industrial da Saúde. Ciênc. saúde coletiva. 2018; 23(6):1891-902. that brings together a dynamic focused on the sustainability of the system and contributes to social protection actions that depend on the organization and operation of the productive dynamics of goods and services in health and effective access to them, in which logistics has fundamental participation.

In Asia, the first region affected by the disease, the experience with previous epidemics has allowed the governments of that continent to give quick and efficient responses through public health policies, such as mass testing and isolation of those infected, as well as economic measures, such as financial support to vulnerable groups, and measures such as changes in the behavior of the population. In Europe, there were different responses, but all went through the structure of health systems in countries such as Germany, Italy, Spain, and the United Kingdom, where hospital capacity, including specialized beds, mass testing, social isolation measures to prevent spreading the virus among the community and the existence of effective Social Welfare systems helped reduce the consequences of the pandemic.

The American continent was the region where the population suffered with the highest number of contamination and deaths as a result of the delay of the authorities in taking measures to prevent the entry and spread of the virus. Many people in poverty, the fragility of health systems, and a low-responsive social welfare system have contributed to weaknesses that have resulted in a higher number of infections and deaths than in other countries³¹31 Remuzzi A, Remuzzi G. COVID-19 and Italy: what next? The Lancet. 2020; 395(10231):1225-8.,³²32 Garcia PJ, Alarcón A, Bayer A, et al. COVID-19 Response in Latin America. Am J Trop Med Hyg. 2020; 103(5):1765-72.,³³33 Legido-Quigley H, Mateos-García JT, Campos VR, et al. The resilience of the Spanish health system against the COVID-19 pandemic. Lancet Public Health. 2020; 5(5):e251-2.,³⁴34 Ahmed F, Ahmed N, Pissarides C, et al. Why inequality could spread COVID-19. Lancet Public Health. 2020; 5(5):e240.,³⁵35 Harzheim E, Martins C, Wollmann L, et al. Ações federais para apoio e fortalecimento local no combate ao COVID-19: a Atenção Primária à Saúde (APS) no assento do condutor. Ciênc. saúde coletiva. 2020; 25(supl1):2493-7..

Two years after the official confirmation of the first case of COVID-19 in Brazil, it is possible to better observe the actions and strategies carried out by the country to combat the disease. After the initial phase, where the strategies to combat the disease were basically aimed at avoiding the circulation of the virus in the community and at treating those already infected in the hospital network, while the pharmaceutical industry sought to discover a vaccine, the country already has some vaccines for its immunization strategy.

In this new phase, the Brazilian health system needs to count on an efficient logistics system to preserve the integrity of vaccines, in order to avoid losses and degradation of products throughout the distribution chain. According to the World Health Organization (WHO)³⁶36 World Health Organization. Immunization, vaccines and biologicals: IVB catalogue 2017. [acesso em 2021 set 22]. Disponível em: https://extranet.who.int/ivb_docs/reports/catalogue.
https://extranet.who.int/ivb_docs/report... , about 25% of all vaccines produced in the world are wasted before reaching citizens, and up to 50% may be ineffective due to storage problems or other logistical issues that impact the financial, material, and human resources involved in vaccine research, development, and manufacturing, as well as the number of people who no longer have access to vaccines that are lost. In this context, logistics is an important resource of the health system for its ability to strategically position vaccine stocks and take them safely to immunization places.

National logistics operators and the Brazilian logistics system

The conformation of the logistics systems of the countries demonstrates the organization of local economies and the degree of competitiveness in relation to the global economy. Logistics is a sector that grows year by year, which shows its ability to act in times of crisis, serving all essential sectors of the economy, from the main urban industrial centers to the most distant territories of the country. Traditionally, the logistics systems have acted as a competitive resource for companies and nations through the optimization of operating costs and the movement of production, with added value until its delivery to final consumption, contributing to the non-interruption of production chains.

The incorporation of technologies such as cargo tracking, technological integration with customers, integrated planning technologies between sales and operations and technologies for order processing by the sector demonstrate an alignment with the paradigm of the fourth technological revolution and with the initiatives globally implemented in logistics operations with a focus on technological integration of supply chains. However, all this expertise needs to be explored in the elaboration of economic development policies, and this has not happened, causing the logistics sector to act in isolation and focus its investments to retail and e-commerce³⁷37 Associação Brasileira de Operadores Logísticos e Fundação Dom Cabral. Perfil dos Operadores Logísticos no Brasil. Rio de Janeiro: Fundação Dom Cabral; 2020. p. 98. (Perfil dos Operadores Logísticos no Brasil). [acesso em 2021 set 22]. Disponível em: https://abolbrasil.org.br/new-uploads/perfil-dos-operadores-logisticos-no-brasil-edicao-2020.pdf.
https://abolbrasil.org.br/new-uploads/pe... .

At a time of health crisis, when economies worldwide have shown their fragility with the external dependence on strategic items to combat the pandemic, it is important to unite the segments of the industry that have the potential to change this scenario and contribute to the strengthening of local production. However, according to recent research carried out by Abol and FDC³⁷37 Associação Brasileira de Operadores Logísticos e Fundação Dom Cabral. Perfil dos Operadores Logísticos no Brasil. Rio de Janeiro: Fundação Dom Cabral; 2020. p. 98. (Perfil dos Operadores Logísticos no Brasil). [acesso em 2021 set 22]. Disponível em: https://abolbrasil.org.br/new-uploads/perfil-dos-operadores-logisticos-no-brasil-edicao-2020.pdf.
https://abolbrasil.org.br/new-uploads/pe... , the market of logistics operators in the country does not perceive the external dependence of the national industry on strategic items for local production as one of the factors that stand out as obstacles or challenges for national logistics operations, even though the human health segment (pharmaceuticals and medicines) is the second largest market of logistics operators.

This scenario draws attention to the necessity of improving the vision of national logistics operators to strengthen the issues related to the health sector with regard to the contribution they can make to the reorientation of domestic production.

Pharmaceutical logistics in the vaccine segment

In addition to highlighting the importance of logistics to overcome the crisis of the distribution chain of strategic inputs used in the production of items that meet the demands of various segments of the economy, the pandemic of the new coronavirus exposes the importance of the logistics branch that serves an important segment of the productive sector: health.

In the specific case of COVID-19 vaccines, the logistics operation gains even more prominence due to the complexity involved in this operation because they are health technologies that were produced in a much shorter time than the usual one, a situation that imposes a greater challenge to pharmacovigilance actions in the case of eventual failures in the distribution logistics chain that can impact effectiveness and safety, resulting in adverse reactions that make it difficult to identify the root cause and raise doubts about the research and development process³⁸38 World Health Organization. Fabrico, segurança e controlo de qualidade das vacinas. 2020. [acesso em 2021 set 22]. Disponível em: https://www.who.int/pt/news-room/feature-stories/detail/manufacturing-safety-and-quality-control.
https://www.who.int/pt/news-room/feature... . The vaccine route, from its development to delivery to be injected, is full of technological complexity that involves a cold chain in which logistics has an important participation, as illustrated in figure 1 ³⁸38 World Health Organization. Fabrico, segurança e controlo de qualidade das vacinas. 2020. [acesso em 2021 set 22]. Disponível em: https://www.who.int/pt/news-room/feature-stories/detail/manufacturing-safety-and-quality-control.
https://www.who.int/pt/news-room/feature... .

The pharmaceutical industry, as part of the health sector, is served by a branch of logistics responsible for responding to the challenges of moving products of high technical and technological complexity, such as pharmaceutical inputs, medicines, and vaccines that need particular care to preserve their quality, efficacy, and safety. This is pharmaceutical logistics, which has gained prominence in the economy because vaccines are a strategic market segment of the pharmaceutical industry¹1 Gadelha CAG, Gadelha P, Noronha JC, et al., organizadores. Brasil saúde amanhã: complexo econômico-industrial da saúde. Rio de Janeiro: Editora Fiocruz; 2017. 227 p.. A framework of laws, regulatory standards, and resolutions aimed at good manufacturing, warehousing, and distribution/transportation practices guides pharmaceutical logistics. Table 2 presents the main legislation of this legal framework and its relationship with logistical activities.

Over time, this legal framework has included specific nomenclatures and expressions of logistics operations in its documents, evidencing the protagonism of this activity in the health sector. Among the primary and support activities of the business logistics, there are transportation, inventory maintenance, order processing, storage, protective packaging, acquisitions, information maintenance, among others⁸8 Ballou RH. Logística Empresarial: transportes, administração de materiais e distribuição física. São Paulo: Atlas; 2012. 388 p.,⁹9 Bowersox DJ, Closs DJ. Logística empresarial: o processo de integração da cadeia de suprimento. São Paulo: Atlas; 2009.. These have been incorporated into laws and sanitary resolutions. Controls related to storage and transportation are the most used ones, but others, such as protective packaging, acquisitions, and maintenance of information, also appear in this legal framework, consolidating pharmaceutical logistics as a branch of logistics that has a relevant role in health. It is through this relationship between health legislation and logistics activities that the definition of pharmaceutical logistics is established.

When talking about vaccines and medicines, it is important to highlight that, in addition to price, which is one of the barriers to access, problems related to logistical issues are also among the weaknesses in the provision of this health technology by SUS³⁹39 Luiza VL, Silva RM, Mattos LV, et al. Fortalezas e desafios da provisão e financiamento no Brasil. In: Hasenclever L, Paranhos J, Chaves G, et al., organizadores. Vulnerabilidades do complexo industrial da saúde: reflexos das políticas industrial e tecnológica na produção local e assistência farmacêutica. 1. ed. Rio de Janeiro: E-papers; 2018. p. 309. [acesso em 2021 set 22]. Disponível em: https://www.arca.fiocruz.br/handle/icict/38351.
https://www.arca.fiocruz.br/handle/icict... . Considering the participation of pharmaceutical logistics in the set of elements that guarantee access in adequate quantity and quality³⁹39 Luiza VL, Silva RM, Mattos LV, et al. Fortalezas e desafios da provisão e financiamento no Brasil. In: Hasenclever L, Paranhos J, Chaves G, et al., organizadores. Vulnerabilidades do complexo industrial da saúde: reflexos das políticas industrial e tecnológica na produção local e assistência farmacêutica. 1. ed. Rio de Janeiro: E-papers; 2018. p. 309. [acesso em 2021 set 22]. Disponível em: https://www.arca.fiocruz.br/handle/icict/38351.
https://www.arca.fiocruz.br/handle/icict... and its participation in the phases of Research, Development (R&D), and production, it is possible to think of a way to negotiate the reduction in the final prices of products with industries despite the power of the pharmaceutical industry. This can be accomplished in the field of public policies and management and in the control of logistics activities, improving the service levels of manufacturing processes, aiming to reduce production costs that, as well as those of R&D, are charged in the final prices of products⁴⁰40 Bermudez JAZ. Acesso a medicamentos: impasse entre a saúde e o comércio! Cad. Saúde Pública. 2017; 33(9):1-3.. Logistics is an important component of the spending structure and needs to be considered as a way to reduce the costs of offering health technologies.

The operationalization of COVID-19 vaccination in Brazil

The National Immunization Program (PNI)²²22 Brasil. Ministério da Saúde. Programa Nacional de Imunização. Brasília, DF: MS; 1973. is a public policy in the field of health prevention that marks the history of Brazilian immunization policy and aims to coordinate immunization actions in the country through the capacity that a mass vaccination policy has to eradicate diseases. Since its creation, the PNI has been a space to develop technologies and improve the methodology of large vaccination campaigns seen as a strategy that has always been present as an instrument for disease control and that is still used in the development of public policies for health with great acceptance by the population, making Brazil gain the respect of countries with a smaller population and better social and economic conditions⁴¹41 Temporão JG. O Programa Nacional de Imunizações: origens e desenvolvimento. Hist. Ciênc Saúde-Manguinhos. 2003; 10(supl2):601-17..

Considered one of the largest vaccination programs in the world, recognized nationally and internationally, and with more than 47 years of expertise in mass vaccination, the PNI assumed the responsibility of promoting vaccination against the new coronavirus in the country⁴²42 Brasil. Ministério da Saúde. Plano nacional de operacionalização da vacinação contra a Covid-19. Brasília, DF: MS; 2021..

COVID-19 is the largest pandemic in the recent history of humanity, and several pharmaceutical industries around the world carry out research and developments seeking to produce safe and effective vaccines against the disease. Some are already being released for emergency use and/or definitively registered in some countries, when there is a large monitoring action by pharmacovigilance systems and adverse events that may have the root cause in any of the stages of vaccine manufacture, in which storage and transportation are included.

Among the measures adopted in Brazil to combat the pandemic is the creation of an immunization plan⁴²42 Brasil. Ministério da Saúde. Plano nacional de operacionalização da vacinação contra a Covid-19. Brasília, DF: MS; 2021. that involved the negotiation of commercial and political agreements for the acquisition of vaccines from manufacturers, in addition to production in the country, through technology transfer agreements for those who have already received authorization for emergency or definitive use.

With regard to operationalization, the plan addresses the logistics already involved in the population immunization strategy, which is a great challenge, considering the Brazilian climatic characteristics, different from other climatic zones in the world, with territorial dimensions that impose additional controls and care, both in preserving the efficacy and safety of vaccines and in giving access to them to the entire population.

Immunization of the population is an action not only to combat the disease, but also to restore normality, which will allow the resumption of the economy and development of the country. As well as the other events that led to the development throughout history, in this challenge, logistics also has an important participation with its activities and controls.

To date, four COVID-19 vaccines are authorized for use in Brazil, and, due to their characteristics, it is necessary to have a cold chain that meets the technical specifications of the manufacturers, especially with regard to temperature control, which should be in the range of 2ºC to 8ºC⁴³43 Brasil. Ministério da Saúde. Estratégia de vacinação contra o vírus SARS-COV-2 (Covid-19). Brasília, DF: MS; 2020.. According to the MH⁴⁴44 Brasil. Ministério da Saúde, Secretaria de Vigilância em Saúde, Departamento de Vigilância Epidemiológica. Manual Rede de Frios do Programa Nacional de Imunizações. Brasília, DF: Ministério da Saúde; 2013. [acesso em 2021 set 22]. Disponível em: http://bvsms.saude.gov.br/bvs/publicacoes/manual_rede_frio4ed.pdf.
http://bvsms.saude.gov.br/bvs/publicacoe... , the organization of the national cold chain used in the immunization plan has the logistics structure of the Logistics Department (DLOG) and the General Logistics Coordination (CGLOG) of Strategic Inputs for Health of the MH, and the performance of the logistics operator in this strategy is fundamental to achieve the objective.

Final considerations

Seen in isolation, logistics is not a specific field of study of health, but, from the multidisciplinary view of collective health, it makes an important contribution by moving health goods and services through the territories, serving as an important management resource for policies in the areas of health and economics, making access to technologies generated by the development process effective.

Over time, as industries were transformed through the industrial revolutions that guided the economic and social development of nations, important technological innovations were developed. During this period, the world was affected by crises with an impact on essential sectors of the economy that tested resilience and demanded a global effort to overcome it, and logistics participates directly in this scenario by moving the technologies generated in industries, positioning stocks at points of consumption according to the needs of universal health systems.

Health is an important segment of the economy with a HEIC that operates in the social and economic dimensions of development, producing high-tech goods and services. To fulfill this mission, the productive base of health depends on not interrupting the supply chains in which logistics has a strategic participation.

Despite the important participation of logistics in the development of countries, there is no participation of this sector in the discussion and formulation of health policies. In this sense, it is necessary that logistics specialists be part of the elaboration of public policies or be heard in decision-making, so that they can be aligned with the demands of health systems and the real needs of the population.

While there is an understanding that logistics and supply chain are important for industry development, there is little investment in these areas, and experts in supply chain management and logistics do not participate in policymaking involving the industry⁴⁵45 Deloitte Brasil. O paradoxo da Indústria 4.0. Deloitte Brazil. 2020. [acesso em 2021 set 22]. Disponível em: https://www2.deloitte.com/br/pt/pages/energy-and-resources/articles/paradoxo-industria-4-0.html.
https://www2.deloitte.com/br/pt/pages/en... . Thinking about the potential of health to contribute to an integrated vision of development⁴⁶46 Gadelha CAG. O Complexo Econômico-Industrial da Saúde 4.0: por uma visão integrada do desenvolvimento econômico, social e ambiental. Cad Desenvolv. 2021; 16(28):25-50., it is necessary to consider all aspects that enhance such contribution in a vision aligned with the concept of universal access to health.

In the case of medicines and vaccines, because they are health technologies with specific characteristics, they need to be moved within specific standards. Logistics, through pharmaceutical logistics, is the segment of the productive sector that contributes to health development reaching, in fact, those who need it, in the correct form and in the necessary place, giving it effectiveness, since development without equal access becomes incomplete or ineffective⁴⁷47 Costa LS, Bahia L, Gadelha CAG, organizadores. Saúde, Desenvolvimento e Inovação. Rio de Janeiro: CEPESC; IMS; UERJ; FIOCRUZ; IESC; UFR; 2015..

The protagonism of logistics in health is shown by its performance in two dimensions of development: economic – adding value to technologies during their movement – and social – allowing people who do not have conditions and locations that do not have infrastructure to have effective access to health.

COVID-19 vaccination evidenced the historical disarray in the distribution and access to vaccines, with the richest and most developed cities advancing faster in immunizing the population in relation to other cities, forcing their populations to occasionally travel up to 3,000 km⁴⁸48 Fundação Oswaldo Cruz, Instituto de Comunicação e Informação Científica e Tecnológica em Saúde. Nota Técnica 19 - Deslocamento da população em busca da vacina. Rio de Janeiro: Fiocruz; 2021. [acesso em 2021 set 22]. Disponível em: https://bigdata-covid19.icict.fiocruz.br/nota_tecnica_19.pdf.
https://bigdata-covid19.icict.fiocruz.br... to be vaccinated, or immunizing populations less in need before those more in need, because they are located in large centers with better development rates. This is a major challenge for SUS, and the participation of logistics minimizes the problem, moving vaccines to all necessary locations and providing equitable access.

Today’s worldwide discussion of what the post-pandemic economies will look like focuses on the need to internalize production to reduce external dependence on the supply of important items for the production of strategic goods to local economies.

The need for an industrial policy that strengthens domestic production as a strategy to overcome the health crisis involves the contribution of logistics, which, due to its historical importance and protagonism in the development of economies, cannot be left out of this agenda. In this debate, it is extremely important to participate in the sector that moves the inputs necessary for industries to produce their technologies, in addition to distributing production throughout the territories.

In the case of health, the need for the participation of logistics in the discussion on the way out of the health crisis and the resumption of economic growth is even more evident if we consider that, at the same time that it supplies the HEIC industries, it moves all the production, highlighting its importance for health policies.

The strengthening of the HEIC concept goes through its productive dynamics. The materials and inputs used by the chemical and biotechnology-based and mechanical-based industries need to have a guarantee that they will reach them. Also, the technologies generated in these subsystems need to reach the health services, turning the economy around and making the productive dynamics of the complex effective, and the performance of logistics is strategic for this process.

The production and innovation in health addressed by the complex, as a political, economic and social space, when materialized through a technology, need to be available to all. However, without a logistics structure that allows the supply of the HEIC production chain and the access of everyone to its production in an equitable way, this approach is impaired.

Innovation and development need to be accompanied by access. Universal health systems need the services offered to be accessible by all so that they are effectively universal, and logistics, through the capillarity of its activities, has great potential to contribute to more equal access to the benefits of development and health technologies.

Based on this study, the protagonism of logistics in technological revolutions over the years has been important for the development of nations, acting strategically in all segments of the economy with a prominent participation in health, and as an important resource for maintaining the operation of production chains and guaranteeing access.

This study sought to highlight the central elements of logistics that contribute to strengthen an agenda that articulates HEIC with universal access, thinking about the sustainability of SUS and logistical factors as critical elements without which access does not materialize.

Major challenges need to be faced to improve access to health services and their technologies, especially medicines and vaccines that are of great technical and technological complexity, requiring controls and special care. The challenges include the need to improve the national logistics operation on issues related to the health sector, and to think about improving infrastructure for the most distant regions of the country that do not yet have technologies in data collection to monitor, in real time, logistics operations and use them to make decisions that allow the distribution of health production more equally to the regions that need it most, ensuring that the population of the North and Northeast have access to it with the same quality and quantity as the population of the other regions with better infrastructure.

It is necessary that themes such as these be further explored in knowledge production environments to stimulate debate and the participation of other sciences in the formulation of policies that contribute to the economic development and sustainability of SUS.

The last logistics mile, which serves the supply of urban centers and residences, is a characteristic of logistics that was not included in this study, despite its importance for coping with the pandemic when it guaranteed the operation of essential activities and remote work during social isolation. This was a limitation of this study, which was dedicated to addressing the participation of logistics in health from the perspective of the production base and guarantee of access.

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