On December 10, the Brazilian Ministry of Health (“MoH”) published Resolution SECTICS/MoH 1/24, which provides for the internal regulations of the Technical Evaluation Committee (CTA) of the Brazilian Health Industrial Complex (Ceis), in addition to establishing procedures for the evaluation and deliberation of project proposals for the Productive Development Partnerships Program (PDP) and the Local Innovation Development Program (PDIL).
The new CEIS strategy was instituted by the Federal Government in September 2023, under Decree 11.715/23, aiming to stimulate collaborations between public and private entities to develop strategic solutions for the Brazilian Public Health System (SUS). This includes medicines and vaccines, as well as diagnostics reagents, advanced therapies, medical device (including software), technology and digital health, and health treatments and services.
The CTA is a technical advisory body to the Deliberative Committee (CD) of Ceis, which is responsible for evaluating and making recommendations on PDP and PDIL projects related to:
- approval or disapproval of proposals or on the continuity, restructuring, modifications or extinction of projects;
- deadlines, criteria and conditions for the execution of partnerships and projects;
- stages and schedule for the absorption and internalization of technologies;
- application of sanctions;
- reduction of productive and technological dependence with the development of the national productive park; and
- possibility and feasibility of executing more than one PDP related to the same product, considering aspects such as technical and economic feasibility, production capacity and investments.
Skills and functioning
According to SECTICS/MoH Resolution 1/24, the CTA coordination is responsible for the following responsibilities:
- summon its members to meetings;
- invite proposing institutions to present their PDP and PDIL project proposals, as well as experts and representatives of other bodies and entities, public or private, when necessary;
- send communications to public institutions with CTA requests for information;
- coordinate the oral presentation of PDP and PDIL project proposals;
- present the PDP projects in force, requests for changes and adjustments; and
- prepare and send the agenda and minutes of the CTA meetings to the members.
At the first meeting of the year, the CTA must disclose the annual schedule of ordinary meetings, which must be held monthly, without prejudice to the convening of extraordinary meetings by the coordination.
The CTA is composed of five representatives from the Brazilian Ministry of Health and six other different entities, including other ministries, the National Brazilian National Sanitary Agency (Anvisa) and the National Bank for Economic and Social Development (BNDES).
Evaluation of PDP and PDIL project proposals
The new ordinance establish that the evaluation of proposals by the CTA will depend on the presentation of a technical note for each project referring to the prior analysis carried out by the technical area of the Department of Ceis and Innovation for the SUS of the Secretariat of Science, Technology and Innovation and Ceis/MoH -which must be done at least 15 days in advance.
If there is more than one PDP or PDIL project proposal with the same object, the technical areas of the CEIS must also present a technical document on the feasibility of executing more than one proposal.
PDP projects will be evaluated considering the following criteria and scores:
| Category | Criteria | Note |
| Technical feasibility | Adequacy of the schedule to the complexity of the technology involved and to regulatory and sanitary requirements. | 0 to 10 (minimum pass: 5) |
| Provision for the internalization of the technology, considering: a) internalization of the technology with national production; and b) national production of Active Phamaceutical Ingredient (API), component or device associated with the pharmaceutical form. | 0 to 10 (minimum pass: 7) | |
| Productive and technological capacity of the proposing institution and partner companies. | 0 to 10 (minimum pass: 5) | |
| Rationality of the planned investments, with indication of the source, schedule compatible with the evolution of activities and the need for resources. | 0 to 10 (minimum pass: 5) | |
| Projection of savings generated for SUS in the acquisition of the product object of the PDP. | 0 to 10 (minimum pass: 5) | |
| Availability of human resources for the feasibility of the project. | 0 to 10 (minimum passing: N/A) | |
| Sustainable development | Governance, professionalization and integrity program | 0 to 10 (minimum pass: 10) |
| Anti-racist, gender equality and diversity promotion policies. | 0 to 10 (minimum pass: 5) | |
| Positive externalities | Contribution to other markets after meeting the demand of the SUS. | 0 to 10 (minimum passing: N/A) |
| Contribution to strengthening the local supply chain. | 0 to 10 (minimum passing: N/A) |
PDP project proposals with an overall minimum score of less than 60% will be eliminated.
The classification of the proposals will consider the following aspects:
| Criteria | Note |
| Shorter time for internalization of technology and production by Public Laboratory/ICT, according to the proposed production arrangement | 0 to 10 |
| Availability of certified technological, productive platforms compatible with the proposed project and activities performed by the proponent | |
| Presentation of productive and technological solutions for the SUS in addition to technology transfer, with synergy for future technologies | |
|
Shorter timeframe for production of API, component or device |
|
| Alignment with the Production and Technology Development for Neglected Populations and Diseases’ Program (PPDN) or Preparation for Vaccines, Serums and Blood Products’ Program (PPVACSH) | |
| Scientific, technological, social, economic, territorial and environmental impacts | |
| Degree of verticalization of production stages of the API, component or device associated with the pharmaceutical form for the national industrial park. | |
| History of internalization of PDP products to the Public Laboratory/ICT portfolio | 0 to 20 |
| Forecast of public investment for the execution of the PDP | |
| Investments applied by the private entity to implement the PDP that contribute to regional or national development | |
| Lowest overall price proposal, considering initial price, representativeness of the decreasing scale of values and feasibility of the project | |
| Technological development carried out, in whole or in part, in the country, with the contribution of public resources |
In the case of the evaluation of PDIL proposals, the merit criteria and scores are as follows:
| Criteria | Note |
| adequacy of the execution schedule of the project stages and detailed plan for the application of resources |
0 to 10 |
| technological and productive capacity of the proponent and the partners to execute the project proposal, considering the existing capacities and the investments planned by the partners | |
| availability of qualified human resources for the execution of the project, considering the existing capacities and the investments planned by the partners | |
| novelty, clinical benefit, or benefit to the health system | |
| relevance of counterparts for the SUS | |
| forecast of other sources of funds to make the project viable | |
| technical-economic reasonableness of the detailed application plan |
PDIL project proposals with a minimum overall score of less than 70% will be eliminated.
The classification of the proposals will consider the following criteria:
| Criteria | Note |
| Competence and experience of the partners in the insertion of technologies or products inserted in the market, including ongoing investments | Texto do corpo |
| partners' experience with the incorporation of products into the SUS, when applicable, including ongoing investments in health technology management | Texto do corpo |
| Increased level of technological maturity | Rodapé |
| project proposals that have already been supported by the Brazilian Ministry of Health or other Public Administration bodies, in previous stages of technological development | |
| project proposals that contribute to the expansion of technological and innovation capacity to meet Preparation for Vaccines, Serums and Blood Products’ Program (PPVACSH) or the Production and Technology Development for Neglected Populations and Diseases’ Program (PPDN) | |
| competence and experience of the partners in the development of a productive and technological solution linked to the specific theme of the project proposals | |
| social, economic, territorial, technological and environmental impacts of health technology and any actions that can enhance the positive impacts or mitigate the negative impacts |
PDP in force
The CTA will carry out a new evaluation of the PDP before starting Phase III, considering the price and demand updates of the product subject to the PDP, as well as a new technical analysis by the Department of CEIS and Innovation for the SUS. However, there is no deadline set for deliberation.
Proposals to change PDP in Phase II or III or suspended PDP analyses will also depend on the Brazilian Ministry of Health sending a technical note. The ministry must indicate the proposed change and its impacts on the execution or the reasons that led to the suspension.
In the case of a suspended PDP, the CTA must evaluate and recommend the restructuring or termination of the partnership, forwarding a technical opinion and the respective motivation for CD deliberation. In the case of a PDP automatically suspended due to the end of the deadline approved for Phase II, the CTA must assess the feasibility of continuing the project.
The Life Sciences & Healthcare practice can provide more information on the topic.
