On December 18, the Ministry of Health (MoH) published Ordinance GM/MoH 6.097/24, which establishes the functioning of the Deliberative Committee (CD) within the scope of the Brazilian Health Industrial Complex (Ceis). The ordinance also defines criteria for analysis and jurisdiction for the process of evaluation and deliberation of project proposals for the Productive Development Partnership (PDP) and the Local Innovation Development Program (PDIL).

The new MoH strategy for Ceis aims to stimulate collaborations between public and private entities to develop strategic solutions for the Unified Health System (SUS). This includes medicines and vaccines, as well as diagnostic reagents, advanced therapies, medical devices (including software), technology, and digital health, as well as treatments and health services.

The reformulation of the internal regulations of the CD and the Technical Evaluation Committee (CTA)[1] was one of the requirements established by the Federal Audit Court (TCU) for the resumption of PDPs[2]. Both regulations are already in effect. This allows deliberations on PDP and PDIL proposals submitted to the MoH by September 30 of this year to occur in the first half of 2025.

Below are the main aspects of the CD's internal regulations.

Jurisdictions and Functioning

According to Ordinance GM/MoH 6.097/24, CD’s coordination is responsible for:

  • Summoning the main and alternate members to participate in meetings;
  • Inviting representatives from other public or private bodies and entities, as well as specialists in related subjects, whose presence is deemed necessary;
  • Presenting ongoing PDP projects, as well as requests for changes and adjustments;
  • Presenting the CTA's recommendations on PDP and PDIL project proposals in the proposal submission phase; and
  • Sending communication to PDP and PDIL partners about the deliberations made by the CD.

The CD is composed of representatives from the MoH, Ministry of Science, Technology and Innovation, Ministry of Development, Industry, Commerce and Services, Ministry of Management and Innovation in Public Services, and the National Health Council. Coordination will be the responsibility of a representative from the Secretariat of Science, Technology, Innovation, and Health Complex of the MoH.

The committee should meet monthly on a regular basis, and extraordinary meetings can be held when convened by the coordinator. The quorum for its establishment is an absolute majority. For the approval of recommendations, a simple majority is sufficient. In case of a tie, CD’s coordinator has the casting vote.

Evaluation of PDP and PDIL Proposals

Administrative processes related to PDP and PDIL project proposals will be presented to CD members for evaluation 15 days before the meeting. The CD will only evaluate project proposals containing CTA's evaluation and the preliminary analysis conducted by the Secretariat of Science, Technology, and Innovation and Ceis.

For deliberation, the CD should consider the feasibility of executing more than one proposal for the same product, based on the recommendations issued by the CTA, the national strategy for the development of Ceis, and applicable industrial policies.

In the case of administrative appeals, the CD's deliberation will depend on the evaluation of the CTA appeal.

Evaluation of Ongoing PDPs

The CD will conduct new evaluations of PDPs before the start of Phase III, considering updates in price and product demand.

In the case of suspended PDPs or those in Phase II or III, proposed changes will be analyzed based on the CTA's recommendation and the technical evaluations of the Secretariat of Science, Technology, and Innovation and Ceis.

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

 

[1] For more information: New rules for Ceis’ technical committee activities issued by the MoH;

[2] For more information: TCU recommends the ministry of health to suspend new PDPs.