Productive Development Partnerships: an essay on the construction of strategic product lists

Rezende, Kellen Santos; Silva, Gabriela de Oliveira; Albuquerque, Flávia Caixeta

doi:10.1590/0103-11042019S212

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ESSAY • Saúde debate 43 (spe2) • Nov 2019 • https://doi.org/10.1590/0103-11042019S212 copy

Productive Development Partnerships: an essay on the construction of strategic product lists

Authorship SCIMAGO INSTITUTIONS RANKINGS

ABSTRACT

This is an essay on the construction of strategic product lists for the Brazilian Unified Health System (SUS) eligible for the submission of proposals for Productive Development Partnerships (PDP). The objective of this study was to critically analyze the process of constructing these lists, reviewing the criteria used, the interaction currently existing with the evaluation of health technologies, the collaboration between decision makers and researchers or reference institutions, and the influence of the composition of the list on the outcome of the projects and reach of the objectives of the initiative. It was found that the use of scientific evidence and collaborative actions of researchers are reduced in decision making, and that the composition of the list has a great influence on the outcome of the PDP, and its construction is a key factor for the success of this initiative and the internalization of technologies. A suggestion for organizing the list-making work is the regimental definition of the use of an independent rapid response program organized between the government, the academy, and institutions involved in PDP approvals, so that the best scientific evidence is available to policy decision makers in the short term.

KEYWORDS
Public-private sector partnerships; Technology assessment, biomedical; Evidence-informed policy

Criteria groups	Detailing
Necessary criteria	a) importance of the product for SUS, according to policies and programs for health promotion, prevention and recovery; b) centralized acquisition of the product by the Ministry of Health or subject to centralization; c) national production interest of the product and its active pharmaceutical ingredients or critical technological components relevant to Ceis;
Additional criteria (at least one of the criteria is required)	a) high acquisition value for SUS; b) expressive dependence on the import of the product for the programs and actions of promotion, prevention and health care in the scope of SUS in the last three years; c) recent technological incorporation into SUS; d) product neglected or potentially at risk of shortage.

Commitment Term	Year of extinction	Medicine	Public partners	Private partners	Year of establishment of the PDP	Reason for the extinction - Deliberation of the Deliberative Committee
Nº 02/2009	2018	Raloxifene	LFM	Blanver Farmoquímica e Farmacêutica S.A, Nortec Química S.A.	2009	Lack of perspective for medicine centralization.
Nº 03/2009	2018	Formoterol + Budesonide	Farmanguinhos	Chemo Iberica S.A. Nortec Química S.A.	2009	Absence of a centralization perspective, and the fact that the partnership does not present evolution.
Nº 04/2012	2017	Lopinavir + Ritonavir	FURP, Farmanguinhos, IQUEGO	Cristália Produtos Químicos Farmacêuticos Ltda.	2012	Medicine does not meet the definition of 'strategic for SUS, and national production is no longer relevant for the Industrial Health Complex due to the reduction of demand for the financial area' (Health Surveillance Secretariat).
Nº 06/2012	2014	Budesonide + Formoterol, Salbutamol, Budesonide	Farmanguinhos	Chron Epigen	2012	Failure to comply with the requirements and constraints set out in the signed Commitment Term and the regulations in force during the extinction period.
Nº 07/2012	2015	Ritonavir (Soft capsule)	LAFEPE	Cristália Produtos Químicos Farmacêuticos Ltda.	2012	Public Institution reported, through Letter, the withdrawal of the PDP project, because Ritonavir presents lower storage and transport costs and for internalization it would be necessary high investment to adapt the manufacturing area to the need of equipment acquisition.
Nº 08/2012	2017	Entacapone	FURP, Lifal, IQUEGO	EMS S.A. Nortec	2012	Impossibility to centralize the purchase of this medicine at the time of the evaluation of the committee.
Nº 11/2012	2017	Tolcapone	Lifal	Cristália Produtos Químicos Farmacêuticos Ltda.	2012	Non-absorption of technology by the Public Institution, low added value of the product and non-centralized acquisition by the Ministry of Health, considering also that there are other therapeutic options available in the market.
Nº 17/2012	2017	Selegiline	Lifal	Cristália Produtos Químicos Farmacêuticos Ltda.	2012	Non-absorption of technology by the Public Institution, low added value of the product and non-centralized acquisition by the Ministry of Health, considering also that there are other therapeutic options available in the market.
Nº 19/2012	2014	Docetaxel	Farmanguinhos	Libbs, Quiral	2012	Failure to comply with the requirements and constraints set out in the signed Commitment Term and the regulations in force during the extinction period.
Nº 03/2013	2015	Chloroquine phosphate	LAFERGS	Cristália Produtos Químicos Farmacêuticos Ltda.	2013	The Public Institution did not have a manufacturing plant (needed investments in the production line) and the existence of chloroquine production in two other public institutions.
Nº 08/2013	2018	Hearing aid	FURP	Politec Importações e Comércio Ltda	2013	Non-evolution of the process of transfer and absorption of product technology; Manifestation of the public institution regarding the lack of interest of the private partner for the continuity of the PDP; Manifestation by Conjur/MS regarding the impracticability of direct acquisition of the product in the forms presented for this PDP.
Nº 11/2013	2015	Cetuximab	IVB, Bio-Manguinhos	Bionovis, Merck Serono	2013	The product was not incorporated by Conitec for the treatment of metastatic colorectal cancer.
Nº 12/2013	2015	Cetuximab	Butantan	Libbs, Mabxience	2013	The product was not incorporated by Conitec for the treatment of metastatic colorectal cancer.
Nº 29/2013	2017	Allergenic Extracts	Bahiafarma	BioCen	2013	Impossibility to centralize the purchase of this drug at the time of the evaluation of the committee.
-	2016	Docetaxel	Farmanguinhos, LAQFA	Cristália Produtos Químicos Farmacêuticos Ltda, Quiral Química do Brasil S.A.	2015	It is impossible to centralize the purchase of this medicine.
Nº 10/2018	2018	Simeprevir	Farmanguinhos	Blanver Farmoquímica e Farmacêutica S.A., Microbiológica Química e Farmacêutica Ltda.	2018	The Health Surveillance Secretariat (SVS) reported that there are no expectations that Simeprevir will be presented as a therapeutic option in the next Clinical Protocol and Therapeutic Guidelines (PCDT).

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[1] kellen.s.rezende@gmail.com