ABSTRACT

It is an experience report on the methodological construction of a strategic monitoring proposal from the Productive Development Partnerships (PDP), which comprises all of the process of establishing partnerships phases and provides elements for structuring a program of evaluating the initiative in order to verify the performance of the partnerships and their impact, bringing together the economic and social aspects. Such proposal integrates methodological procedures with different metrics and information sources (documentary analysis, logic models, inquiry with the actors involved in PDP and multiple case studies) with qualitative and quantitative approaches from a perspective of collective construction. The presented experience, yet to be validated by Unified Health System’s (SUS) governance, aims to offer a business oriented infrastructure intelligence that allows the conversion of data and information into useful knowledge for action, contributing to the success of the initiative, and, thus, to the strengthening of the Economic Industrial Health Complex and the increase of public production of medicines for the SUS.

KEYWORDS
Public-private sector partnerships; Technology transfer; Program evaluation

Introduction

Strategic monitoring is based on the search for knowledge through the recording, analysis and interpretation of the implementation of public policies reality, in order to produce timely information for decision-making by governance¹1 Cardoso Júnior JC. Monitoramento estratégico de políticas públicas: requisitos tecnopolíticos, proposta metodológica e implicações práticas para a alta administração pública brasileira. Rio de Janeiro: Ipea; 2015.. Although it is essential for all initiatives, programs and policies of the Public Administration, monitoring and evaluation are recent practices in many countries²2 Rua MG, Romanini R. Monitoramento e avaliação de políticas públicas e programas governamentais. In: Rua MG, Romanini R. Para Aprender Políticas Públicas. Conceitos e Teorias. Brasília: Igepp; 2013. p. 106-138. and are not institutionalized in most Brazilian government agencies. However, they have increasingly aroused the interest of the public sector, government and academia to promote effectiveness, efficiency, performance and accountability in public management³3 Ramos MP, Schabbach LM. The state of the art of public policy evaluation: concepts and examples of evaluation in Brazil. Rev Adm Pública. 2012; 46(5):1271-1294.^,44 Jannuzzi PM. Avaliação de Programas Sociais: conceitos e referenciais de quem a realiza. Est Aval Educ. 2014; 25(58) :22-42..

For Productive Development Partnerships (PDP), this scenario is no different. Although the Ministry of Health (MH) has indicators in many programs⁵5 Brasil. Ministério da Saúde. Dados e Indicadores da Saúde. [internet] Brasília, DF: Ministério da Saúde; 2019. [acesso em 2019 mar 31]. Disponível em: http://portalms.saude.gov.br/dados-e-indicadores-da-saude.
http://portalms.saude.gov.br/dados-e-ind... and an information and communication technology platform for monitoring⁶6 Brasil. Ministério da Saúde. SAGE - Sala de Apoio à Gestão Estratégica [internet] Brasília, DF: Ministério da Saúde; 2019. [acesso em 2016 nov 24]. Disponível em: http://sage.saude.gov.br/#.
http://sage.saude.gov.br/#... , these do not include the PDP initiative. Strategic monitoring of the initiative is also not institutionalized by governance, lacking a business intelligence infrastructure that enables the transformation of data and information into useful knowledge for action.

The launch of the PDP occurred in 2009 through the inter-governmental interinstitutional articulation⁷7 Brasil. Ministério da Saúde. Memória de reunião: 11a Reunião Ordinária do GECIS [internet]. Brasília, DF: Ministério da Saúde; 2009. [acesso em 2017 jan 14]. Disponível em: http://portalsaude.saude.gov.br/images/pdf/2014/maio/19/Ata---11---REUNI--O-2009.pdf.
http://portalsaude.saude.gov.br/images/p... as one of the first initiatives coordinated by the Industrial Complex and Innovation in Health Department (Deciis) of the Secretariat of Science, Technology and Strategic Inputs (SCTIE) of the MH.

Initially referred to as Productive Development Agreements, the PDP reflect the new position of the Brazilian State as a promoter of economic and social development, coming with the fourth Administration Reform, the Managerial Reform of the Brazilian State. Advocating the transfer of technology and knowledge developed in the private sector to the public sector, the PDP are shown as means to reverse the backwardness of national technological and productive industrial development in the health sector and the high dependence on imports of medicines, drugs and equipment⁸8 Guimarães R, Noronha J, Elias FTS, et al. Política de Ciência, Tecnologia e Inovação em Saúde. Ciênc. Saúde Colet. 2019; 24(3):881-886., reflections of the economy’s opening of the of neoliberalism in the 1990s. Associated with this, they aim to expand the access of the population to strategic products for the Unified Health System (SUS) and promote better resource management in the acquisition of these products – medicines, vaccines and equipment⁸8 Guimarães R, Noronha J, Elias FTS, et al. Política de Ciência, Tecnologia e Inovação em Saúde. Ciênc. Saúde Colet. 2019; 24(3):881-886..

The construction and improvement of the PDP occurred as they were implemented, based on the results arising from the strategies discussed at the National Conference on Science, Technology and Innovation in Health to consolidate the national production base and with the Executive Group of the Health Industrial Complex (Gecis) holding a central role in the construction and development of the initiative.

The revision of the PDP regulatory mark in 2014 brought new actors to the process⁹9 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):11-22., providing greater transparency and robustness, and consolidated instruments for the management monitoring of partnerships¹⁰10 Oliveira EJV, Vivan AL, Albuquerque FC, et al. A consolidação do marco regulatório das Parcerias para o Desenvolvimento Produtivo. Gest e Saúde. 2015; 6(4):3175-3193.. The technical monitoring of technological and productive activities, technology transfer and the development of capacities of the public producer to the new technological level, under the PDP, is foreseen in the new regulatory framework, being the responsibility of the MH, with the participation of the National Health Surveillance Agency (Anvisa), through the performance of the Technical and Regulatory Committees (TRC), and based on specific instruments and methodologies¹¹11 Brasil. Ministério da Saúde. Portaria no 2.531, de 12 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 [internet]. Diário Oficial da União, 13 Nov 2014 [acesso em 2016 jan 29]. Disponível em: http://bvsms.saude.gov.br/bvs/saudelegis/gm/2014/prt2531_12_11_2014.htm.
http://bvsms.saude.gov.br/bvs/saudelegis... . Different government agencies and institutions also make up the Technical Evaluation Committee (TEC) and the Deliberative Committee (DC), which are responsible for evaluating new proposals and requests for changes to ongoing projects¹¹11 Brasil. Ministério da Saúde. Portaria no 2.531, de 12 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 [internet]. Diário Oficial da União, 13 Nov 2014 [acesso em 2016 jan 29]. Disponível em: http://bvsms.saude.gov.br/bvs/saudelegis/gm/2014/prt2531_12_11_2014.htm.
http://bvsms.saude.gov.br/bvs/saudelegis... .

The existing management monitoring tools in the government sector are focused on monitoring each PDP project or the set of projects by public producer and private entity for the purpose of verifying and controlling the transfer, absorption and internalization of technology¹⁰10 Oliveira EJV, Vivan AL, Albuquerque FC, et al. A consolidação do marco regulatório das Parcerias para o Desenvolvimento Produtivo. Gest e Saúde. 2015; 6(4):3175-3193.

11 Brasil. Ministério da Saúde. Portaria no 2.531, de 12 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 [internet]. Diário Oficial da União, 13 Nov 2014 [acesso em 2016 jan 29]. Disponível em: http://bvsms.saude.gov.br/bvs/saudelegis/gm/2014/prt2531_12_11_2014.htm.
http://bvsms.saude.gov.br/bvs/saudelegis... ^-1212 Rezende KS. As parcerias para o desenvolvimento produtivo e estímulo à inovação em instituições farmacêuticas públicas e privadas. [dissertação]. Rio de Janeiro: Escola Nacional de Saúde Pública Sergio Arouca, Fundação Oswaldo Cruz; 2013..

Despite being a relatively recent strategy, with little more than nine years of implementation, the current stage of the initiative already does not require evaluative methods to analyze its scope and the necessary adjustment and control points¹³13 Gadelha CAG, Temporão JG. Desenvolvimento, Inovação e Saúde: a perspectiva teórica e política do Complexo Econômico-Industrial da Saúde. Ciênc. Saúde Colet. 2018; 23(6):1891-1902..

Measures to change this paradigm in public administration have been formulated, such as publications published nationally by the Institute for Applied Economic Research (Ipea)¹1 Cardoso Júnior JC. Monitoramento estratégico de políticas públicas: requisitos tecnopolíticos, proposta metodológica e implicações práticas para a alta administração pública brasileira. Rio de Janeiro: Ipea; 2015.^,1414 Cassiolato M, Gueresi S. Nota Técnica nº 6: Como elaborar Modelo Lógico: roteiro para formular programas e organizar avaliação. Brasília: Ipea; 2010. and international guides for conducting evaluative studies¹⁵15 Wholey JS, Hatry HP, Newcomer KE. Handbook of Practical Program Evaluation. 3. ed. San Francisco: John Wiley & Sons; 2010. 768 p.^,1616 W.K. Kellogg Foundation. Logic Model Development Guide. One East Michigan Avenue East Battle Creek, Michigan 49017-4012: W.K. Kellogg Foundation; 2004..

This paper presents a methodological proposal developed for strategic monitoring of PDP. This proposal comprises all phases of the partnership establishment process (Phase I – PDP project proposal, Phase II – PDP project, Phase III – PDP and Phase IV – technology internalization) and provides elements for structuring a program of evaluation of the initiative to verify the performance of the partnerships and their impact, bringing together the economic and social aspects. It is a management model for policy that allows SUS governance to ‘think’, ‘decide’ and ‘act’ as recommended by Matus¹⁷17 Matus C. Política, Planificación y Gobierno. Neuquén: Fundancion Altadir; 2008..

As part of the public policy cycle¹⁸18 Souza C. Políticas Públicas: uma revisão da literatura. Sociologias. 2016; 8(16):20-45., strategic monitoring of PDP can contribute to the effectiveness of the initiative by assisting in recognizing the challenges for effective implementation of PDP in Brazil and in finding strategies for addressing them through ongoing monitoring of the environment. Such challenges include, among others, factors associated with the technology absorption process characterized by difficulties in meeting PDP schedules and technology internalization¹²12 Rezende KS. As parcerias para o desenvolvimento produtivo e estímulo à inovação em instituições farmacêuticas públicas e privadas. [dissertação]. Rio de Janeiro: Escola Nacional de Saúde Pública Sergio Arouca, Fundação Oswaldo Cruz; 2013. ; the adhesion of the productive sector to the demands of SUS reflected in the reduced presentation of proposals for the production of orphan diseases and Neglected Diseases (ND) due to the great competitiveness in proposals of high cost and biological products¹⁹19 Silva GO, Elias FTS. Estudo de casos múltiplos das parcerias para o desenvolvimento produtivo: doenças negligenciadas versus doenças crônicas não transmissíveis. Tempus (Brasília). 2018; 11(4):147. ; the characteristics of health production²⁰20 Gadelha CAG, Costa LS. Saúde e desenvolvimento no Brasil: avanços e desafios. Rev. saúde pública. 2012; 46(esp):13-20. ; the undersized structure of public agencies for the execution and monitoring of the initiative¹²12 Rezende KS. As parcerias para o desenvolvimento produtivo e estímulo à inovação em instituições farmacêuticas públicas e privadas. [dissertação]. Rio de Janeiro: Escola Nacional de Saúde Pública Sergio Arouca, Fundação Oswaldo Cruz; 2013.^,2020 Gadelha CAG, Costa LS. Saúde e desenvolvimento no Brasil: avanços e desafios. Rev. saúde pública. 2012; 46(esp):13-20.^,2121 Santos GBF. O PES aplicado à análise estratégica das parcerias de desenvolvimento produtivo. [dissertação]. Rio de Janeiro: Escola Nacional de Saúde Pública Sergio Arouca, Fundação Oswaldo Cruz; 2016. ; the limitations of public producers regarding the development of technical skills, management capacity and investments⁸8 Guimarães R, Noronha J, Elias FTS, et al. Política de Ciência, Tecnologia e Inovação em Saúde. Ciênc. Saúde Colet. 2019; 24(3):881-886.^,1212 Rezende KS. As parcerias para o desenvolvimento produtivo e estímulo à inovação em instituições farmacêuticas públicas e privadas. [dissertação]. Rio de Janeiro: Escola Nacional de Saúde Pública Sergio Arouca, Fundação Oswaldo Cruz; 2013.^,2121 Santos GBF. O PES aplicado à análise estratégica das parcerias de desenvolvimento produtivo. [dissertação]. Rio de Janeiro: Escola Nacional de Saúde Pública Sergio Arouca, Fundação Oswaldo Cruz; 2016. ; the economic risks¹²12 Rezende KS. As parcerias para o desenvolvimento produtivo e estímulo à inovação em instituições farmacêuticas públicas e privadas. [dissertação]. Rio de Janeiro: Escola Nacional de Saúde Pública Sergio Arouca, Fundação Oswaldo Cruz; 2013. and the political disputes and contingencies so striking in an agenda of technology transfer and fostering innovation based on the purchasing power of the health sector¹³13 Gadelha CAG, Temporão JG. Desenvolvimento, Inovação e Saúde: a perspectiva teórica e política do Complexo Econômico-Industrial da Saúde. Ciênc. Saúde Colet. 2018; 23(6):1891-1902..

Material and methods

The protocol of this research was approved by the Research Ethics Committee of Fiocruz Brasília in the Brazil Platform system according to Opinion nº 1.549.078, of 05/17/2016.

The triangulation of methods was used, involving four stages: evaluability study through document analysis, situational diagnosis of the initiative, multiple case study and elaboration of a proposal for strategic monitoring of the PDP²²22 Silva GO. Parcerias para o desenvolvimento produtivo e a produção pública de medicamentos: uma proposta de monitoramento estratégico. [dissertação]. Brasília, DF: Fundação Oswaldo Cruz; 2017.. The first three stages provided baseline elements for the final proposal (figure 1).

In the evaluability study of the PDP, the following steps were performed: collection and analysis of normative documents and published literature, assembly and validation of logical models, vulnerability analysis and construction of monitoring and evaluation indicators. The methodology used by the Ministry of Planning, Budget and Management presented by Ipea¹⁴14 Cassiolato M, Gueresi S. Nota Técnica nº 6: Como elaborar Modelo Lógico: roteiro para formular programas e organizar avaliação. Brasília: Ipea; 2010. was adapted to elaborate three models: a) explanation of the problem that PDP seek to face; b) basic references of PDP; and c) structuring of PDP to achieve results. The built models were presented to managers and researchers with experience in the PDP theme, who discussed the adequacy and the relevant inclusions.

In the situational diagnosis, a survey was conducted with the application of electronic questionnaires prepared in FormSUS to actors involved with PDP signed since 2009 and in force in 2016, followed by qualitative and quantitative analysis²²22 Silva GO. Parcerias para o desenvolvimento produtivo e a produção pública de medicamentos: uma proposta de monitoramento estratégico. [dissertação]. Brasília, DF: Fundação Oswaldo Cruz; 2017.. The questionnaires were elaborated from the PDP theory organized by the logical models. A 51% response rate was obtained with the participation of 41 of the 81 guest actors members of the TEC, DC, TRC and public institutions and private companies participating in the PDP, with 17 respondents from the 18 managers and technicians of participating public producers of the PDP of medicines implemented from 2009 to 2016 invited; 10 of the 34 managers and technicians from private entities participating in the drug PDP implemented from 2009 to 2016; and 14 of the 29 members of the TEC, DC and TRC organs and secretariats in 2016 – Health Care Secretariat (SAS), Health Surveillance Secretariat (SVS), Executive Secretariat (ES) and SCTIE of the MH; Ministry of Industry, Foreign Trade and Services (MDIC); Ministry of Science, Technology, Innovations and Communications (MCTIC); National Bank for Economic and Social Development (BNDES); Finep Funding Authority for Studies and Projects; and Anvisa.

In the multiple cases study, documentary and literature research, and data from the situational diagnosis inquiry were used, followed by quantitative and content analysis. The method proposed by Yin²³23 Yin RK. Estudo de caso: planejamento e métodos. 2. ed. Porto Alegre: Bookman; 2001. was used, involving: a) development of a theory; b) case selection; c) planning; d) data collection and analysis of selected cases; e) preparation of reports of individual cases; and f) comparative analysis between the cases and of these with the elaborated theory.

The results of these first three steps were presented in scientific articles¹⁹19 Silva GO, Elias FTS. Estudo de casos múltiplos das parcerias para o desenvolvimento produtivo: doenças negligenciadas versus doenças crônicas não transmissíveis. Tempus (Brasília). 2018; 11(4):147.^,2424 Silva GO, Elias FTS. Parcerias para o desenvolvimento produtivo: um estudo de avaliabilidade. Comum ciênc. saúde. 2017; 28(2):125-139.^,2525 Silva GO, Elias FTS. Parcerias para o Desenvolvimento Produtivo: diagnóstico situacional da implementação na perspectiva dos atores envolvidos. Comum ciênc. saúde. 2017; 28(3/4):313-325.. The last stage involved the articulation of the results obtained in the previous three stages, in which a strategic monitoring proposal was conceived in a PDP business intelligence system, containing a PDP evaluation plan.

The proposition of the monitoring instruments was structured according to the Innovation Octagon²⁶26 Scherer FO, Carlomagno MS. Gestão da inovação na prática: como aplicar conceitos e ferramentas para alavancar a inovação. 2. ed. São Paulo: Atlas; 2016. dimensions – strategy, relationship, culture, people, structure, processes, funding and leadership – assuming that PDP are an innovative initiative in federal public management²⁷27 Brasil. Ministério da Saúde, Secretaria de Ciência, Tecnologia e Insumos Estratégicos. Parcerias para o Desenvolvimento Produtivo de produtos estratégicos do SUS. In: Andrade AFB, organizadora. Ações Premiadas no 20o Concurso Inovação na Gestão Pública Federal 2015. Brasília, DF: ENAP; 2016. p. 101-122..

Results and discussions

International Public-Private Partnerships versus Partnerships for Productive Development

Public-private partnerships have been explored as a mechanism for mobilizing additional resources for health activities, notably in low and middle-income countries²⁸28 Asante AD, Zwi AB. Public-private partnerships and global health equity: prospects and challenges. Indian J Med Ethics. 2007; 4(4):176-80.. Internationally, partnerships are identified in the health sector that focus on research and development of new technologies, medicines and other products for ND²⁹29 Jakobsen PH, Wang MW, Nwaka S. Innovative partnerships for drug discovery against neglected diseases. Plos negl. trop. dis. 2011; 5(9):1221.^,3030 Jannuzzi AHL. Sistemas de direitos de propriedade intelectual Sui Generis na indústria farmacêutica: um mecanismo de incentivo à inovação para doenças negligenciadas no Brasil? [tese]. Rio de Janeiro: Universidade Federal do Rio de Janeiro; 2015.. There are also economic and technology transfer agreements signed between some of the countries of the global South in order to enhance research and innovation, the exchange of economic, personal and scientific resources for the growth of countries and the expansion of the productive capacity of local laboratories³¹31 Feres MVC, Cuco PHO, Silva LA. Cooperação internacional e organizações não governamentais: releitura do papel institucional no combate às doenças negligenciadas. Sci Iuris. 2015; 19(2):181-198..

In Brazil, PDP are one of the initiatives in this field, but they differ, in a positive way from international partnerships. While Product Development Partnerships are one-off initiatives by some institutions and entities in a narrow scope of products and resources, PDP involve a large number of actors in the production and government sectors articulated in an expanded socio-technical network⁹9 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):11-22. for high impact interventions in the Health Economic-Industrial Complex (Ceis) regarding the productive, technological and innovation capacities, as well as in the generation of jobs and income in the Country. In the productive sector, there are 61 involved entities, public and private; and in the government sector, there are nine organs and secretariats that make up the 18 TRC, the TEC and the DC⁹9 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):11-22..

PDPs involve the transfer of technology from strategic products already launched in the market to train public producers in new health technology platforms for SUS. In this sense, they also differ from international initiatives that are associated, for the most part, with research and development of new innovative products. Further strategic and structuring effects are pursued through the PDP with the focus on the total manufacturing of the technology by the public producer regardless of the transferring private partner and the pharmaceutical input active by the national pharmochemical, and, subsequently, in the innovation of processes and products from new technological systems.

Productive Development Partnerships: a brief contextualization

The inclusion of the PDP in the political agenda occurred in a favorable environment in the political arena, provided by political bases led by different fronts that came to recognize the potential of productive development of Ceis in the economic and social perspectives to expand access to priority health technologies for the Country³²32 Costa LS, Metten A, Delgado IJG. As Parcerias para o Desenvolvimento Produtivo em saúde na nova agenda de desenvolvimento nacional. Saúde debate. 2016; 40(111):279-291..

The establishment of this initiative was initially based on the Innovation Law which allowed preferential treatment in the acquisition of goods and services by the public authorities to companies that invest in technology research and development in the Country³³33 Sundfeld CA, Souza RP. Parcerias para o desenvolvimento produtivo em medicamentos e a Lei de Licitações. Rev Dir Adm. 2013; 264(0):91-133. and the encouragement by the three spheres of government and the promotion agencies, the formation of strategic alliances focused on research and development activities aimed at generating innovative products, processes and services and the transfer and diffusion of technology³⁴34 Brasil. Lei nº 10.973 de 02 de dezembro de 2004. Dispõe sobre incentivos à inovação e à pesquisa científica e tecnológica no ambiente produtivo e dá outras providências [internet]. Diário Oficial da União, 3 Dez 2004. [acesso em 2016 jan 29]. Disponível em: http://www.planalto.gov.br/ccivil_03/_ato2004-2006/2004/lei/l10.973.htm.
http://www.planalto.gov.br/ccivil_03/_at... .

A major factor that enabled the PDP was the restructuring of the Pharmaceutical Assistance Program that centralized the acquisition of higher unit cost medicines by the MH³⁵35 Fonseca EM, Costa NR. Federalismo, complexo econômico-industrial da saúde e assistência farmacêutica de alto custo no Brasil. Ciênc. Saúde Colet. 2015; 20(4):1165-1176., which enabled the wider use of state purchasing power for technological health development³⁶36 Gadelha CAG, Maldonado JMSV, Costa LS. O Complexo Produtivo da Saúde e sua relação com o desenvolvimento: um olhar sobre a dinâmica da inovação em saúde. In: Giovanella L, Escorel S, Lobato LVC, et al., organizadores. Políticas e Sistema de Saúde no Brasil. 2. ed. Rio de Janeiro: Fundação Oswaldo Cruz; 2012. p. 209-237.. In this sense, the alterations of article 24, items XXV, XXXI and XXXII of the Bidding Law were important to enable PDP³³33 Sundfeld CA, Souza RP. Parcerias para o desenvolvimento produtivo em medicamentos e a Lei de Licitações. Rev Dir Adm. 2013; 264(0):91-133. by including the exemption from public bids for product acquisition when there is technology transfer of strategic products to SUS, introducing the use of State purchasing power as real factor of development and incentive to technological production in Brazil³⁷37 Silvestrow SP. Licitação e o uso do poder de compra do Estado como instrumento de incentivo a inovação [monografia (especialização)]. Brasília, DF: Instituto Brasiliense de Direito Público; 2015..

The first specific regulatory framework of the PDP was published in 2012 through Ordinance nº 837/MH, three years after the signing of the first partnerships. This Ordinance, then, brought the norms of an earlier practice, in order to favor the establishment of PDP³³33 Sundfeld CA, Souza RP. Parcerias para o desenvolvimento produtivo em medicamentos e a Lei de Licitações. Rev Dir Adm. 2013; 264(0):91-133..

Two years later, due to the need to improve the regulatory mark, Ordinance nº 2.531/2014/MH was published, which repealed the previous Ordinance, redefined the guidelines and criteria for the preparation of the list of strategic products for SUS and the establishment of PDP¹¹11 Brasil. Ministério da Saúde. Portaria no 2.531, de 12 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 [internet]. Diário Oficial da União, 13 Nov 2014 [acesso em 2016 jan 29]. Disponível em: http://bvsms.saude.gov.br/bvs/saudelegis/gm/2014/prt2531_12_11_2014.htm.
http://bvsms.saude.gov.br/bvs/saudelegis... . From this new regulatory mark, the PDP were consolidated as instruments for the promotion, incentive and development of Ceis and the improvement of partnership management by the federal government¹⁰10 Oliveira EJV, Vivan AL, Albuquerque FC, et al. A consolidação do marco regulatório das Parcerias para o Desenvolvimento Produtivo. Gest e Saúde. 2015; 6(4):3175-3193.^,3737 Silvestrow SP. Licitação e o uso do poder de compra do Estado como instrumento de incentivo a inovação [monografia (especialização)]. Brasília, DF: Instituto Brasiliense de Direito Público; 2015..

The revision of this regulatory framework resulted from the need, among others, to provide more transparency and security to the process of establishing PDP as recommended in audits of the Federal Audit Court (TCU) and the Comptroller General of the Union (CGU) following complaints and investigations that were associated with the PDP during its implementation, such as Operation Car Wash. These instances also recognized the importance of PDP monitoring given the proportion of projects under execution (81 PDP in force in 2016⁹9 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):11-22. ), the volume of public resources involved and the great relevance of the initiative.

Business intelligence system of Productive Development Partnerships

The monitoring proposal involves two components that make up the business intelligence system of the PDP: managerial and strategic. Figure 2 shows the systematized graphic representation, where much of the managerial component prioritizes the contractual instruments of partnerships and feeds the strategic component. It is structured in four subcomponents: logical models; monitoring and evaluation indicators, based on the models; vulnerability analysis that tests the models; and, finally, situational diagnosis of performance evaluation, structured by the models, to feed back the management monitoring component.

A feedback flow between the components is observed, compounding a business intelligence system for monitoring PDP, predicting the utilization of data and information obtained from different sources and qualitative and quantitative approaches.

Management monitoring

In managerial monitoring, most instruments and documents were established by the MH and the evaluation bodies, which were: a) reports on the analysis of new proposals and changes to projects under execution prepared by the TEC and the DC; b) monitoring reports sent every four months by public producers in conjunction with private entities; c) project risk analysis; d) technical notes for analysis of follow-up reports made by Deciis/MH; e) minutes of the meeting of technical-regulatory orientation of the TRC; and f) reports of technical visits to the manufacturing units of public producers and private entities, elaborated by Anvisa and Deciis¹⁰10 Oliveira EJV, Vivan AL, Albuquerque FC, et al. A consolidação do marco regulatório das Parcerias para o Desenvolvimento Produtivo. Gest e Saúde. 2015; 6(4):3175-3193.

11 Brasil. Ministério da Saúde. Portaria no 2.531, de 12 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 [internet]. Diário Oficial da União, 13 Nov 2014 [acesso em 2016 jan 29]. Disponível em: http://bvsms.saude.gov.br/bvs/saudelegis/gm/2014/prt2531_12_11_2014.htm.
http://bvsms.saude.gov.br/bvs/saudelegis... ^-1212 Rezende KS. As parcerias para o desenvolvimento produtivo e estímulo à inovação em instituições farmacêuticas públicas e privadas. [dissertação]. Rio de Janeiro: Escola Nacional de Saúde Pública Sergio Arouca, Fundação Oswaldo Cruz; 2013.. For some of these instruments, alteration needs were indicated by the actors interviewed in this study as will be presented in the following situational diagnosis.

These tools allow the management of PDP when verifying the advances in the technology transfer steps, compliance with regulatory and health requirements and the fulfillment of the schedules of product delivery to MH. Thus, they provide information on the feasibility or not of the scope of the internalization of technology by public laboratories throughout the project, serving as basis for decision-making on the restructuring of projects that are unsuitable or for the extinction of projects that are not viable for further development.

To complement this monitoring, other instruments are proposed such as: a) reports of price studies of the products under PDP to be prepared by the Department of Pharmaceutical Assistance and Strategic Inputs (DAF) and ES/MH; b) monitoring reports of the technological horizon to be constructed with the support of the Department of Management and Incorporation of Health Technologies (DGITS)/MH and the Brazilian Health Technology Assessment Network (Rebrats); and c) demand mapping and product delivery reports for joint elaboration of the DAF and SAS/MH or SVS/MH, depending on the type of product being transferred from technology.

The search for economicity, advantage and economic sustainability of SUS is among the objectives of the PDP, having as its guideline the gradual reduction of prices of the partnership’s product object. Since, throughout the projects, such prices may vary, price studies may provide important elements for monitoring and for the negotiation of MH with producers.

The monitoring of the technological horizon can help in the previous stages of building the list of strategic products for SUS, mapping future technologies in a prospective view, as well as, throughout the instituted projects, analyzing if the time already spent and if delays would make PDP unfeasible given the longevity of the technology.

The mapping of demands and deliveries, in turn, will provide producers with predictability of the required quantity of the product in the period, allowing them to adequately qualify for SUS care. In addition, it will indicate to the MH the need to seek other suppliers in advance if PDP producers are unable to meet all demand.

Strategic monitoring

In strategic monitoring, data and information come from the application of management monitoring tools implemented by the multiple actors involved in the management of PDP and own instruments developed for situational diagnosis. The four subcomponents are detailed below.

Three logical models were designed and organized the PDP theory, composing an evaluability study, to demonstrate that the PDP initiative was able to be evaluated²³23 Yin RK. Estudo de caso: planejamento e métodos. 2. ed. Porto Alegre: Bookman; 2001.. The first refers to the explanation of the problem ‘difficulties in guaranteeing access to strategic technologies in SUS’. The causes of this problem, their descriptors, consequences and their interrelationships were explained²³23 Yin RK. Estudo de caso: planejamento e métodos. 2. ed. Porto Alegre: Bookman; 2001..

The second contains the basic PDP references and explained how the initiative is structured to solve the problem. In addition to the problem and its descriptors, the general and specific objectives of the PDP, target audience and beneficiaries²³23 Yin RK. Estudo de caso: planejamento e métodos. 2. ed. Porto Alegre: Bookman; 2001. were presented.

The third model demonstrated the structuring of PDP to achieve results and helped in understanding how to make the initiative work²³23 Yin RK. Estudo de caso: planejamento e métodos. 2. ed. Porto Alegre: Bookman; 2001.. The actions, their products, results and effects have been defined in that model, with an indication of the size and stages of the PDP establishment process to which they correspond, and whether they relate to budgetary or non-budgetary resources. This latter model was tested by the second component of strategic monitoring (vulnerability analysis) and founded the creation of the third component (product indicators and results)²³23 Yin RK. Estudo de caso: planejamento e métodos. 2. ed. Porto Alegre: Bookman; 2001..

The vulnerability analysis matrix presented conditions of invalidation of the PDP structural model in order to identify eventual weaknesses in the initiative structure and allow control actions to be taken²³23 Yin RK. Estudo de caso: planejamento e métodos. 2. ed. Porto Alegre: Bookman; 2001..

The indicators suggested for monitoring and evaluation comprise two groups: product indicators and result indicators. The product indicators are: approval rate of PDP proposals, technology competitiveness rate, effectiveness of project actions, optimization of project actions, proportion of public producers with Good Manufacturing Practice and Quality Control Certificate (CBPF) in force, application of health purchasing power in PDP, and proportion of projects completed under the PDP²³23 Yin RK. Estudo de caso: planejamento e métodos. 2. ed. Porto Alegre: Bookman; 2001.. Such indicators focus on the verification of the execution of technology transfer projects, regarding the measure of expected product generation (as the actions performed have generated expected products), such as drug registration, national production of active pharmaceutical ingredient, factory suitability, product manufacturing (formulation, filling and packaging, in reverse logic), drug supply, among others²³23 Yin RK. Estudo de caso: planejamento e métodos. 2. ed. Porto Alegre: Bookman; 2001.. The focus of these indicators is on the implementation of the PDP, in order to analyze whether they are being performed satisfactorily.

Proposed outcome indicators are: public producer accession index for PDP, private entities adherence to PDP, economy of the MH with PDP, evolution of drug supply, coverage of the National List of Essential Medicines (Rename) by product list strategies, rejection rate of strategic products for SUS, and evolution of access to medicines²³23 Yin RK. Estudo de caso: planejamento e métodos. 2. ed. Porto Alegre: Bookman; 2001.. These indicators focus on the results achieved with the implementation of the PDP from the intended objectives, ranging from verification of fostering scientific and technological development by indirect indicator, to the analysis of evolution of access to medicines subject to PDP.

The business intelligence system incorporates as the fourth component of the strategic monitoring a diagnostic evaluation of the PDP performance through survey, whose questions must be answered by the productive sector and the government sector. The aim is to integrate the dimensions of the Innovation Octagon²⁶26 Scherer FO, Carlomagno MS. Gestão da inovação na prática: como aplicar conceitos e ferramentas para alavancar a inovação. 2. ed. São Paulo: Atlas; 2016., in order to better manage the outcome of the PDP.

The purpose of this diagnosis is to generate periodic information on the macro performance of the initiative in the perception of the actors involved with the governance of the PDP. The evaluative method of this diagnosis is exploratory research through an inquiry, with annual periodicity and total duration of about three months.

The methodological route for the application and analysis of this diagnosis comprises: a) construction of the FormSus questionnaire, based on the questions in charts 1 and 2, and sent by the evaluator to key actors in the productive and government sectors; b) response of respondents with grade assignment from 1 to 9 for each statement according to their assessment, with response time of one month; c) analysis of the data by the evaluator in the next two months, involving, calculation of the weighted average of the three questions of each dimension and construction of graphs; and d) publication of findings and recommendations.

The questions included in the diagnosis are reflexively based both on the results of this research and on the model proposed by Scherer and Carlomagno²⁶26 Scherer FO, Carlomagno MS. Gestão da inovação na prática: como aplicar conceitos e ferramentas para alavancar a inovação. 2. ed. São Paulo: Atlas; 2016.. It is understood that the application of these issues for strategic monitoring can be carried out by the PDP participants themselves, from the productive and government sectors, so as to reflect on the performance of each institution in the initiative. Furthermore, it is important that this proposed governance instrument be operationalized by a local government agency or an independent audit in order to impartially verify the performance of the strategy. Thus, there is the independence of the public manager who coordinates the PDP in the strategy evaluation, which becomes relevant in order to enhance the process.

The results of the situational diagnosis performed can be added to the monitoring and evaluation indicators applied for collective improvement construction to all those involved with the PDP. It is proposed that such activity be carried out within two months of the release of the results of the diagnosis at a meeting for this purpose.

Experience report of methodological application

The first application of the inquiry in 2016 allowed a situational diagnosis of the performance of PDP implementation between 2009 and 2016, from the perspective of the actors involved²⁵25 Silva GO, Elias FTS. Parcerias para o Desenvolvimento Produtivo: diagnóstico situacional da implementação na perspectiva dos atores envolvidos. Comum ciênc. saúde. 2017; 28(3/4):313-325.. It was performed through validated and expanded structured questionnaires, differentiated from those proposed in this article²²22 Silva GO. Parcerias para o desenvolvimento produtivo e a produção pública de medicamentos: uma proposta de monitoramento estratégico. [dissertação]. Brasília, DF: Fundação Oswaldo Cruz; 2017.. The summary of the results of this diagnosis according to each dimension of the Innovation Octagon is presented in chart 3.

By the situational diagnosis, as presented in chart 3, it was possible to recognize facts and problems that can generate an action plan by the governance of the PDP to improve the initiative. There are also recommendations from the investigation which need to be analyzed, particularly with regard to increasing the institutionality of the initiative and improving predictability on the issue of prices.

The other way to learn from the experience in this research was performed by the study of multiple cases, which allowed to understand the differences between drugs for ND and for Chronic Non-Communicable Diseases (NCDs) in terms of impact on the process of establishing partnerships and provided elements for the assertion that the therapeutic class and the economic and social aspects involved interfere with the implementation of the PDP projects¹⁹19 Silva GO, Elias FTS. Estudo de casos múltiplos das parcerias para o desenvolvimento produtivo: doenças negligenciadas versus doenças crônicas não transmissíveis. Tempus (Brasília). 2018; 11(4):147..

With the inquiry questions, in this other study¹⁹19 Silva GO, Elias FTS. Estudo de casos múltiplos das parcerias para o desenvolvimento produtivo: doenças negligenciadas versus doenças crônicas não transmissíveis. Tempus (Brasília). 2018; 11(4):147., the facilitating elements for both types of partnerships were mapped out, namely: the commitment to purchase the product during the PDP, the projected investments for the project, the team capacity and the time of the project. The hindering elements were also identified by the authors and differed between: a) common elements: resources for building the manufacturing unit and for training, uncertainties regarding the conduct of the policy; b) elements with the greatest impact on PDP of drugs for DCNT: productive platform, intellectual property and technology incorporation; c) elements with the greatest impact on PDP of drugs for ND: supply value and manufacturing cost, clinical studies and regulatory requirements; and d) elements with an impact exclusively on PDP of drugs for ND: variation in demand, technology obsolescence and difficulty in selecting private partners¹⁹19 Silva GO, Elias FTS. Estudo de casos múltiplos das parcerias para o desenvolvimento produtivo: doenças negligenciadas versus doenças crônicas não transmissíveis. Tempus (Brasília). 2018; 11(4):147.. The analysis of these factors allows governance to evaluate how to maintain and succeed in each type of PDP project.

The study also mapped²⁵25 Silva GO, Elias FTS. Parcerias para o Desenvolvimento Produtivo: diagnóstico situacional da implementação na perspectiva dos atores envolvidos. Comum ciênc. saúde. 2017; 28(3/4):313-325. assisting measures for the implementation of PDP of drugs for ND: linking high-value products with low added value, presentation of projects by technology platform, fulfillment of responsibilities, assessment of technology horizon, implementation of monitoring policies, differentiated pricing for ND drugs associated with investments and implementation of new strategies such as research, development and innovation PDP¹⁹19 Silva GO, Elias FTS. Estudo de casos múltiplos das parcerias para o desenvolvimento produtivo: doenças negligenciadas versus doenças crônicas não transmissíveis. Tempus (Brasília). 2018; 11(4):147..

As evidenced in the practical application of the elements of the PDP strategic monitoring proposal, this monitoring exposes weaknesses, generates recommendations and provides elements for the improvement of public policies.

Final considerations

PDP are characterized by the complexity of high technology risk projects, the large volume of resources involved and the involvement of multiple actors and interests. They, therefore, align the public and collective logic of well-being and social inclusion with the private and individual market logic in so far as gains are verified for all those involved in the PDP – the Brazilian State, in the figure of the MH and public producers, absorbing and having mastery over technology; the private sector, supplying the product on a large scale and, therefore, promoting the development of the national industry; and the society that has ensured the supply of SUS³³33 Sundfeld CA, Souza RP. Parcerias para o desenvolvimento produtivo em medicamentos e a Lei de Licitações. Rev Dir Adm. 2013; 264(0):91-133..

For such logics to be truly compatible and these gains to be equitable, during the technology transfer process of current projects, it is up to SUS governance to resolve the bottlenecks that involve such an initiative in different fields. To this end, PDP monitoring is a fundamental requirement for SUS governance so that resources and efforts are concentrated on what really needs to be improved or adjusted.

The presented proposal brings together, in a business intelligence system, management and strategic monitoring of PDP and diagnosis of performance evaluation from the perspective of key actors, productive sector, executor of PDP, and government sector, responsible for sustaining the initiative.

Based on references applied to public policies¹1 Cardoso Júnior JC. Monitoramento estratégico de políticas públicas: requisitos tecnopolíticos, proposta metodológica e implicações práticas para a alta administração pública brasileira. Rio de Janeiro: Ipea; 2015.^,1414 Cassiolato M, Gueresi S. Nota Técnica nº 6: Como elaborar Modelo Lógico: roteiro para formular programas e organizar avaliação. Brasília: Ipea; 2010.^,1717 Matus C. Política, Planificación y Gobierno. Neuquén: Fundancion Altadir; 2008., the presented proposal articulates three main attribute groups of a business intelligence system: a) informative and formative, represented by the logical models and product and result indicators, which produce dense and thorough knowledge of the reality and implementation of daily management of PDP; b) analytical and evaluative, represented by the diagnosis and performance evaluation, involving a dynamic, systemic and multidisciplinary verification of the implementation of the partnerships; and c) prospective and corrective, represented by the relationship between the situational diagnosis structured in the dimensions of the Innovation Octagon and case studies, as it generates harmonized information and useful indicators for improving the initiative¹1 Cardoso Júnior JC. Monitoramento estratégico de políticas públicas: requisitos tecnopolíticos, proposta metodológica e implicações práticas para a alta administração pública brasileira. Rio de Janeiro: Ipea; 2015..

The first application of this tool was through the study of multiple cases and situational diagnosis previously published¹⁹19 Silva GO, Elias FTS. Estudo de casos múltiplos das parcerias para o desenvolvimento produtivo: doenças negligenciadas versus doenças crônicas não transmissíveis. Tempus (Brasília). 2018; 11(4):147.^,2525 Silva GO, Elias FTS. Parcerias para o Desenvolvimento Produtivo: diagnóstico situacional da implementação na perspectiva dos atores envolvidos. Comum ciênc. saúde. 2017; 28(3/4):313-325..

The classification of PDP projects as secret by the Access to Information Law is identified as limitations of this work, and it is not possible to make more in-depth evaluations on the projects; the professional performance of the first author in SCTIE/MS, not having the desired distance in scientific studies of the research object; and the rate of participation achieved in the investigation should take into account the institutional political moment in which the period of performance of the work took place. However, these limitations do not invalidate the results found, and it is up to the next researchers to test or minimize the possible biases in new studies.

The implementation of this proposal can benefit from the improvement and integration of existing information and communication systems in MH. As an example, the Support System for PDP, launched in 2017 for project submission, could include the proposed analysis and monitoring modules and be integrated into the Strategic Management Support Room (Sage) and e-CAR Strategic Planning. Such integration may promote greater process transparency, control and social participation, and greater efficiency in management processes. Given the scope of the strategy, the migration of the system, which currently uses a private domain to house the platform (http://www.parceriaspdp.com.br), into a public domain of the federal government, is urgent²²22 Silva GO. Parcerias para o desenvolvimento produtivo e a produção pública de medicamentos: uma proposta de monitoramento estratégico. [dissertação]. Brasília, DF: Fundação Oswaldo Cruz; 2017..

It is important to consider that the indicators are not limited to the proposed ones and that the built models should not be understood solely in a cartesian way, considering the multiple variables that make up the execution of the PDP, such as the economic, macropolitical, sanitary and regulatory context and the elements of the technology itself as an object of the transfer²²22 Silva GO. Parcerias para o desenvolvimento produtivo e a produção pública de medicamentos: uma proposta de monitoramento estratégico. [dissertação]. Brasília, DF: Fundação Oswaldo Cruz; 2017.. As Portes³⁸38 Portes JVA. O processo de transferência internacional de tecnologia no setor de imunobiológicos: um estudo de caso. [dissertação]. Rio de Janeiro: Instituto Alberto Luiz Coimbra de Pós-Graduação e Pesquisa de Engenharia (Coppe), Universidade Federal do Rio de Janeiro; 2012. points out, in a real context, the scopes and schedules of technology transfer projects are modified in function of these variables in case of inefficiency or inefficiency of stages of the production process or the adequacy of infrastructure. Thus, SUS governance should be aware of these variables and have flexibility to understand the peculiarities of each process²²22 Silva GO. Parcerias para o desenvolvimento produtivo e a produção pública de medicamentos: uma proposta de monitoramento estratégico. [dissertação]. Brasília, DF: Fundação Oswaldo Cruz; 2017..

The monitoring proposal can be applied to PDP based on the culture of transparency and accountability in public administration³⁹39 Vaitsman J, Rodrigues RWS, Paes-Sousa R. O Sistema de Avaliação e Monitoramento das Políticas e Programas Sociais: a experiência do Ministério do Desenvolvimento Social e Combate à Fome do Brasil. Policy Papers/17. Brasília, DF: Organização das Nações Unidas para a Educação, a Ciência e a Cultura; 2006.. By proposing a theoretical and instrumental mechanism of strategic monitoring, it is possible to analyze the management and implementation of technology transfer projects in public producers and their results in the economy for the MH, in national technological development and in the public production network, reducing the vulnerability of SUS to the international market and its impact on the trade balance, and the production, supply and access of the population to strategic products for SUS.

References

Publication Dates

History