On April 15, 2024, the Secretariat of Science, Technology and Innovation and the Department of  Industrial-Economic Health Complex (CEIS) presented clarifications on the measures taken by the Ministry of Health (MoH) to comply with the determinations of the Federal Audit Court (TCU) made on October 2022. These measures were adopted after the suspension of Productive Development Partnerships (PDPs), as decided by the TCU, in response to the release of the new strategy for the CEIS by the government (check out our previous analysis on the topic here).

The PDP is a type of governmental partnership that aims to establish cooperation between public and private laboratories for the development, training and transfer of technologies considered strategic for the Unified Health System (SUS).

Since 2017, the TCU's Specialized Health Audit Unit (AudSaúde) has been supervising the issue, and had already issued recommendations to the MoH to improve the regulatory framework applicable to partnerships (TCU Ruling 730/17).

At the end of 2022, the TCU Ruling 2.015/23 (case TC 034.653/2018-0) established, among other topics, that it would be up to the MoH to instruct public laboratories on the need to conduct a selection or pre-qualification process of the private partner, or adequately justifying when its realization is not feasible.

In addition, a reformulation of the Technical Committee (CTA) and the Deliberative Committee (CD) regiments was determined, establishing:

  • objective parameters for the analysis of projects and the assignment of grades to proposals;
  • criteria for the division of responsibilities of public laboratories – when more than one PDP project proposal is approved for the same product; and
  • the need for the CTA to re-examine proposals for the same drug and tie-breaking criteria and to readjust market percentages.

Main points presented by the  MoH to the TCU

The  MoH argued that certain TCU determinations were based on a normative act that has already been revoked – Decree No. 9,245/2017, which instituted the National Policy for Technological Innovation in Health and was replaced by Decree No. 11,715/2023, the current National Strategy for CEIS’ Development.

In this sense, the MoH requested that the deadlines for compliance with certain actions should start from the publication of the PDP program’s future ordinance ( the results of Public Consultation 54/23 are still in the analysis phase).

In addition, the MoH also reported that:

  • the topic was put into public consultation to broaden the discussion, support decisions, promote dialogue, and legitimize transparency and social participation to obtain information, opinions, and criticisms about the PDP Program;
  • the update of the internal regulations of the CTA and the CD will be made after the publication of the PDP’s new ordinance;
  • the merit points that were the subject of the TCU's determinations were addressed in the ordinance’s draft subjected to public consultation; and
  • All public institutions were informed, by letter via e-mail, of the need to conduct a selection or pre-qualification process of the private partner, or adequate justification in case of unfeasibility.

Case TC 034.653/2018-0 had been included in the plenary agenda of April 17, 2024, but was then removed without justification.

Public Consultation 54/23 Status

The MoH received 1,489 contributions to Public Consultation 54/23. Currently, they are being consolidated by CEIS’ Department, and, once consolidated, an administrative proceeding will be initiated to regulate the proposition and processing of the normative act.

This process will be forwarded to the Federal Attorney General's Office, which, through the MoH’s Legal Counsel (Conjur/MoH), will analyze the feasibility of the new rule and issue an opinion for the edition of the final version of  PDPs ordinance, as established in the manual for the preparation, proposal, processing and consolidation of normative acts of the MoH (Ordinance 2,500/17).

At the same time, the process must be forwarded for analysis by the Executive Secretariat and the  MoH office for signature and subsequent publication in the Official Union Gazette.

 Public Consultation 53/23, which presented a draft regulation for the Local Innovation Development Program (PDIL) within the scope of the CEIS, should also follow the same procedure.

The Life Sciences & Health practice can provide more information on the topic.