Policies for fostering health science, technology and innovation in Brazil and the role of clinical research

Tenório, Marge; Mello, Guilherme Arantes; Viana, Ana Luiza D’Ávila

doi:10.1590/1413-81232017225.33342016

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ARTICLE • Ciênc. saúde colet. 22 (5) • May 2017 • https://doi.org/10.1590/1413-81232017225.33342016 copy

Policies for fostering health science, technology and innovation in Brazil and the role of clinical research

Authorship SCIMAGO INSTITUTIONS RANKINGS

Abstract

The purpose of this article is to highlight a number of underlying issues that may be useful for a comprehensive review of the management of Health-Related Science, Technology and Innovation policies (ST&I/H), and its strategies and priorities. It is an analytical study supported by an extensive review of the technical and journalistic literature, clippings, legislation and federal government directives. The results show that the Healthcare Production Complex undeniably and increasingly needs science to maintain itself. One may infer that a framework of institutional milestones is being built in Brazil, to strengthen, guide and encourage Research and Development, and that clinical research creates scientific knowledge to address public healthcare issues by generating new inputs or enhancing existing techniques, processes and technologies that will be produced, marketed and used in the different segments, thus feeding the Healthcare Productive Complex.

Policies; Healthcare administration and planning; Management of science; Technology and innovation in health; Clinical trials

Year	Instrument	Comment
1990	Law 8,080/1990 (Art. 15 § XIX)	Defines that it is the responsibility of SUS to foster research and studies in health-related areas.
1994	1st CNCTIS	1^st National Conference on Science, Technology and Innovation in Health - promoted the institutionalization of the political debate of SUS responsibilities in fostering R&D/H.
1999	Sector Funds	Funding for research, development and innovation projects. The Healthcare area is responsible for: CT-Health, CT-Infrastructure, CT-Biotechnology, CT-Green/Yellow, and for all cross-sectional activities involving more than one fund.
2001	Millennium Institute Programs	Stimulates the development of inter-laboratory research networks to capture all of the potential of the existing physical infrastructure.
2004	2nd CNCTIS	2nd National Conference on Science, Technology and Innovation in Health - brought together the goals of the National Healthcare Policy and those of the National Policy for Science and Technology, increasing the interaction between Health, Education, Science and Technology.
	PNCTIS	National Policy for Science, Technology and Innovation in Health - defines that national development in ST&I/H proceed sustainably, supported on the production of technical and scientific knowledge adjusted to the economic, social, cultural and political needs of the country.
	ANPPS	The National Agenda of Healthcare Research Priorities guides the research priorities to be promoted, according to the principles of the unified system (SUS).
	Law 10,973/20204 - Innovation Law	Defines measures to incentivize ST&I within the productive environment for developing capabilities and enabling the country to achieve technological and industrial development autonomy.
	PITCE	The National Policy for Industry, Technology and Foreign Trade defines innovation as a core dimension of the manufacturing and foreign trade policy.
	Law 11,105/2004 Biosafety Law	Sets safety guidelines and defines mechanisms to oversee activities involving Genetically Modified Organisms (GMO) and their derivatives.
2005	Law 11,196/2005 “Lei do Bem” (Law of the Good)	Provides tax incentives for technological innovation.
2006	Economic Subvention Program	Fosters innovation and increased competition among the nation’s companies and its economy.
2007	PACTI (2007- 2010)	Action Plan for Science, Technology and Innovation, sought to increase scientific and technological production in the country.
2008	PDP	Production Development Policy - improves the various sectors of Economic Industrial Complex, including partnerships between businesses and universities.
	GM/MS Directive 1,942/2008 GECIS	Created the Industrial Healthcare Complex Executive Group to implement the Brazilian framework governing strategies to strengthen the CEIS, the Production and Innovation in Healthcare Complex.
	INCT Program	Program of the National Institutes for Science and Technology. 82 INCT in health-related areas, out of 252 incentivized in 2016.
	GM/MS Directive 978/2008	Selects the projects that are strategic for SUS. Prioritizes promotion of RD&I and the manufacture of vaccines, blood derivatives and products for neglected diseases.
2009	PNGTS	The National Policy for Technology Management in Healthcare promotes management activities related to the assessment, incorporation, disclosure, management, use and withdrawal of technologies within the healthcare system.
2009	Law 12,101/2009 Proadi - SUS	Created the Program to Support the Institutional Development of SUS (Proadi - SUS), supporting research strategic for SUS with tax exemption funds. This includes the Hospitals of Excellence program.
2010	Law 12,349;2010 - Government Purchases Law	Promotes the replacement of imported manufactured goods and services with domestic ones resulting from technological innovation and development performed in Brazil.
2010	National Graduate Studies Plan (2011-2020)	Prioritizes R&D in health-related areas, promotes research combining graduate studies, businesses and society, stimulates university-business partnerships, promotes international cooperation, contributes to strengthening the National Institutes of Science and Technology and the Research, Dissemination and Innovation Centers; promotes a stronger National Network of Clinical Research.
2011	PESS Agenda	The agenda for Research Strategic to the healthcare System defines the SUS lines of research to meet the strategic goals of the 2012- 2015 Multi-Year Plan.
	The 2011-2014 Greater Brazil Program	Strengthened the manufacturing, innovation and national competitive chains, following the PDP and PITCE lines of action to support, develop and implement business technology portfolios.
	Law 12,401/2012	Created Conitec, the SUS National Committee to Incorporate Technologies. This committed advises the MoH in the incorporation, exclusion or changes in new healthcare technologies within SUS.
2012	National CTI Strategy for 2012-2015	Enhanced business innovation and consolidated the National Innovation System.
	GM/MS Directive n°. 4/10	Defined guidelines and criteria for production development partnerships; fostered partnerships between public and private institutions, encouraging technology transfer to Brazil.
	CNS Resolution 466/2012	Governs guidelines and standards of research involving human beings.
	Law 12,715/2012 Pronon and Pronas/ PCD	Created the National Program to Support Oncological Care (Pronon) and the National Program to Support Healthcare for People with Special Needs (Pronas/PCD), which encourages actions and services developed by private, non-profit entities, associations and foundations in the areas of oncology and people with special needs, using funds coming from Income Tax deductions.
2013	INOVA-SAÚDE (2013-2017)	This program supports RD&I in public and private institutions working within CEIS, enabling continued funding of projects with the potential of reducing the nation’s technological dependence in inputs used for healthcare.
	GM/MS Directive n°. 3,089	Prioritizes scientific and technological development of biomaterials and items related to oncology, non-transmissible chronic diseases, neglected diseases, viral diseases, STDs and AIDS.
	Decree 8.065/2013 § 31	Stipulates that the Department of Science and Technology (Decit) will be involved in formulating, implementing and assessing PNCTIS, based on the requirements of the PNS and within the SUS principles and guidelines; coordinate and execute MoH activities in health-related R&D and promote inter-sector articulation within the National System of Science and Technology.
	GM/MS Directive n°. 2,531/2013	Redefines the list of priority items for SUS investments in R&D and manufacture, and creates the PDP.
	PNPC	National Knowledge Platform Program, supports partnerships between businesses and science and technology research institutions in Brazil and abroad for on-demand technology and innovative products, processes or services involving a technological risk.
2015	CNS Resolution nº. 506/ 2016	Regulates the accreditation of Research Ethics Committees (REC), which make up the REC/CONEP System and provides other guidelines.
2015	Constitutional Amendment nº. 85/2015	National S&T Code - amends and adds provisions to the Federal Constitution to update how the activities of Science, Technology and Innovation are handled.
2016	Law 13,243;2016	SC&I Legal Framework governing stimulus to scientific development, research, and the development of capabilities in science, technology and innovation.

Actions	2011	2012	2013	2014	2015
Strategic medicines	162.000.000	124.000.000	134.834.524	164.730.448	340.000.000
Basic medicines	1.060.000.000	1.077.448.725	1.213.500.000	1.292.642.028	1.230.000.000
Exceptional medicines	3.521.496.999	4.082.150.000	4.977.534.000	4.890.845.854	5.867.474.795
AIDS Medicines	804.802.000	823.600.000	770.200.000	864.187.200	1.101.000.000
Immuno-biologicals	1.613.204.809	1.676.500.000	2.181.900.000	2.296.719.000	3.300.672.000
Coagulopathy medicines	412.565.000	552.300.000	747.915.000	583.432.574	802.500.000
Budget drugstores	774.605.000	1.410.000.000	1.856.600.000	2.460.838.514	3.261.328.000
SUB-TOTAL – MEDICINES	8.348.673.808	9.745.998.725	11.882.483.524	12.553.395.618	15.902.974.795
Innovation and Production	56.860.300	64.900.000	72.720.000	55.525.381	50.160.000
Modernization of the Manufacturing Park	0	130.000.000	160.000.000	106.400.000	46.800.000
Laboratories Official	0	70.000.000	0	0	0
Research	77.337.653	81.392.000	93.685.000	90.305.000	84.128.000
Structing – A.F.	10.972.576	25.000.000	39.000.000	69.399.580	84.152.000
GRAND TOTAL	8.493.844.337	10.117.290.725	12.247.888.524	12.875.025.579	265.240.000
MoH Budget	63.113.634.859	78.361.160.095	84.051.839.071	108.393.354.888	121.154.205.789
%	13%	12%	14%	12%	13%

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[1] Collaborations

M Tenório helped design and outline the study, gathered and analyzed data, selected the references, drafted the initial version of the manuscript, and revised and approved the final version. GA Mello and ALD Viana helped design the study and participated in the methodological outline of the study. They also helped select literature references, reviewed the initial version and approved the final version.