Since the beginning of this year, the Federal Executive has been working, led by the Executive Group of the Economic-Industrial Health Complex (GECEIS) – established by Decree 11,464/2023, to strengthen the domestic production of essential items for the Unified Health System (SUS) and reduce Brazil’s dependency on inputs, medicines, vaccines, and other products. The goal is to reduce SUS´s vulnerability through the development and adoption of health technologies, with a focus on universal access to healthcare.
In this context, on September 27, 2023, the National Strategy for the Development of the Economic-Industrial Health Complex (CEIS) was established by Decree 11,715/2023, with the purpose of guiding public and private investments in health production and innovation sectors. On the same date, Decree 11,714/2023 was published, addressing the Deliberative Committee and the Technical Evaluation Commission within the Economic-Industrial Health Complex, with the objective of analyzing and evaluating Partnerships for Productive Development (PDPs) and projects stemming from the Local Development and Innovation Program.
To implement the National CEIS Development Strategy, guidelines were established in GM/MS Ordinance 1,354, dated September 27, 2023, which also outlines the following programs:
I – Partnerships for Productive Development Program (PDPs): aims to guide national efforts in innovation and production, both public and private, through technological transfers of strategic products to reduce SUS´s vulnerabilities and expand access to healthcare;
II – Local Development and Innovation Program (PDIL): aims to promote local development of innovative solutions to health challenges, reducing production and technological vulnerabilities, promoting SUS´s sustainability, and expanding access to healthcare;
III – Vaccines, Sera, and Blood Derivatives Preparation Program (PPVACSH): aims to stimulate national production of technologies necessary to expand access and ensure the supply of vaccines, serums, and blood derivatives, facilitating the promotion and coordination of public production investments in partnership with the private sector, using PDP, PDIL, or similar program instruments when applicable;
IV – Production and Technological Development Program for Neglected Populations and Diseases (PPDN): aims to stimulate national production of technologies needed to expand access to prevention, diagnosis, and treatment for neglected populations and diseases as a public health and equity issue, facilitating the promotion and coordination of public production investments in partnership with the private sector, using PDP, PDIL, or similar program instruments when applicable;
V – Modernization and Innovation in Healthcare Program (PMIA): aims to stimulate local production and innovation within the CEIS by promoting modernization and innovation in healthcare institutions’ services, potentially establishing incentive mechanisms and commitments for program participation; and
VI – Infrastructure Expansion and Modernization Program for the Economic-Industrial Health Complex (PDCEIS): aims to develop CEIS infrastructure to enable the productive, technological, and innovation capacity necessary for the execution of the other programs.
An investment of approximately R$ 42 billion is estimated for the coming years, with a focus on PDPs. However, it is important to consider that both PDPs and PDCEIS have been part of Brazilian government public policies for nearly two decades and have faced scrutiny from the Federal Court of Auditors (TCU). Specifically regarding the PDPs, the TCU identified issues related to the lack of objective criteria for defining the list of strategic products for SUS, the absence of mechanisms to ensure legality and morality in the selection of private laboratories, and the lack of objective criteria for evaluating PDP proposals, recommending that the Ministry of Health suspend new partnerships until these issues are addressed.
We are currently awaiting the federal government’s next steps to resume the program and address the TCU’s recommendations. If you have any questions or would like to get more information, do not hesitate to get in touch with our team.