The Ministry of Health (MoH) published yesterday (December 10, 2024) SECTICS/MoH's Rule #1/2024, which approves the new CTA's Internal Regulations within the framework of the Development of the Health Economic-Industrial Complex (CEIS). This was expected since regulations of the Product Development Partnerships (PDP) Program and Local Development and Innovation Program (PDIL) established that the Internal Regulations would complement them on important issues, such as the criteria for analyzing and classifying proposals.
The Internal Regulations address: (i) CTA's roles and operational procedures (Articles 2 to 10); (ii) the review of ongoing PDPs prior to the start of phase III (under the terms of Article 33, Paragraph 5 of the Annex to MoH's Ordinance #4,472/2024), analysis of requests to change PDP's schedules, and evaluation of suspended PDPs (Articles 27 and 28); and (iii) the procedure and criteria for evaluating PDP and PDIL proposals (Articles 12 to 26 and Annex I).
Regarding CTA's roles and operational procedures, there are no major changes. The changes were made in order to align the previous Internal Regulations with the rules enacted in 2023 and 2024, following the establishment of the National Strategy for the Development of CEIS.
Regarding the review of ongoing PDPs before the start of phase III, the analysis of proposals to modify PDPs in phase II or III, and the evaluation of suspended PDPs, the Internal Regulations merely state that the CTA will carry out the respective evaluations, without further details.
Regarding the evaluation of PDP and PDIL proposals, the regulation establishes a scoring system for each criterion set forth in Article 16 of MoH's Ordinance #4,472/20241 and Article 13 of to MoH's Ordinance #4,473/20242:
- For PDP proposals, based on Article 19 of CTA's Internal Regulation, the merit criteria are divided into three groups: technical feasibility (listed in Article 16, items I, II, III, IV, V, and VIII of MoH's Ordinance #4,472/2024); sustainable development (listed in Article 16, items VI and VII of MoH's Ordinance #4,472/2024); and positive externalities resulting from the project (listed in Article 16, items IX and X of MoH's Ordinance #4,472/2024). The criteria in the first group have a specific minimum score which, if not reached, will result in the proposal being eliminated. The criteria in the second group must reach at least ten points together, otherwise the proposal will be eliminated. The criteria in the third group do not have a minimum score, so zeroing them does not eliminate the proposal (as applies individually in the first group or jointly in the second). The proposal will be eliminated if it does not reach the minimum overall score of 60 points (60% of the maximum 100 points).
- For PDIL proposals, based on Article 21 of CTA's Internal Regulation, all seven criteria (listed in Article 13 of MoH's Ordinance #4,473/2024) can be scored from zero to ten. If one of the criteria is scored zero, the proposal will be eliminated. The proposal will also be eliminated if it does not achieve the minimum overall score of 49 points (70% of the maximum 70 points).
The Internal Regulation does not clarify which parameters will be applied to score each of the criteria. For example, one of the criteria for PDP proposals is “productive and technological capacity of the parties involved”, which can be scored from zero to 20. What will it look like in practice? What will be assessed to conclude whether or not each partner has productive and technological capacity? How will the score be determined, i.e., which level of productive and technological capacity will receive a zero, a ten or a twenty? Perhaps this will be addressed in the new Internal Regulations of the Deliberative Committee (DC), which is yet to be published.
In any case, after this merit analysis, the CTA will move on to the classification phase of the proposals in which there is more than one PDP/PDIL proposal for the same product or proposals for different products, but which are aimed at meeting the same health challenge. The classification phase will be based on the criteria established in Article 17 of MoH's Ordinance #4,472/2024 (PDPs)3 and in Article 14 of MoH's Ordinance #4,473/2024 (PDIL)4, to which the Internal Regulation also assigns a scoring system:
- For PDP proposals (Article 20), some of the 12 criteria can be scored from zero to ten (items I, V, VII, VIII, IX, XI, and XII) and others from zero to twenty (II, III, IV, VI, and X). The final result will be the sum of the points for each criterion, with each proposal achieving a maximum of 170 points.
- For PDIL proposals (Article 22), the seven classification criteria can be scored from zero to ten. The final result will be the sum of the points for each criterion, with each proposal achieving a maximum of 70 points.
All things considered, the wait for the CTA's new Internal Regulations is now over but players are still waiting for the DC's new Internal Regulations, which will also have the role of complementing the PDP and PDIL Programs on important matter, such as the analysis of the proposals received by the MoH and the definition of the market share for PDPs. It's important that this happens as soon as possible, as the MoH has received 147 PDP proposals and 175 PDIL proposals for analysis.
For more information on this subject, please contact us at lifesciences@lickslegal.com.
1 Article 16. The merit assessment of the PDP project proposal should consider the following criteria: I - adequacy of the schedule to the complexity of the technology involved and to the regulatory and health requirements; II - forecast for internalization of the technology, considering: a) internalization of the technology with national production; and b) national production of the API, CTC, or DT associated with the pharmaceutical form. III - the productive and technological capacity of the proposing institution and partner companies; IV - the rationality of the planned investments, with an indication of the source, a timetable compatible with the evolution of the activities and the need for resources; V - a projection of the savings generated for the Brazilian Public Healthcare System (SUS) in purchases of the product covered by the PDP; VI - a governance, professionalization, and integrity program; VII - anti-racism, gender equality, and diversity promotion policies; VIII - availability of human resources to make the project viable; IX - contribution to other markets, in an additional way, especially those focused on global health, after the SUS demand has been met; and X - contribution to strengthening the local supply chain.
2 Article 13. The criteria for assessing the merit of the PDIL project proposal comprise: I - adequacy of the timetable for carrying out the stages of the project and a detailed plan for applying the resources; II - technological and productive capacity of the applicant and partners to carry out the project proposal, taking into account existing capacities and the investments planned by the partners; III - availability of qualified human resources to carry out the project, taking into account existing capabilities and the investments planned by the partners; IV - innovative nature, clinical benefit or benefit for the health system; V - relevance of the counterparts for the SUS; VI - provision for other sources of funds to make the project viable; and VII - technical and economic reasonableness of the detailed application plan.
3 Article 17. PDP proposals will be ranked according to the following criteria: I - shortest timeframe for the technology internalization and production by the IP/ICT, according to the proposed production arrangement; II - history of internalizing products subject to PDP into the IP/ICT portfolio; III - forecast of public investment for PDP execution; IV - investments made by the private entity for PDP execution that contribute to regional or national development; V - availability of technological platforms, certified production facilities compatible with the proposed project and activities carried out by the proposer; VI - lowest overall price proposal, considering the initial price, representativeness of the decreasing scale of values, and the project's feasibility; VII -presentation of additional productive and technological solutions for the SUS beyond technology transfer, with synergy for future technologies; VIII - shortest timeframe for production with national API, CTC, or DT; IX - alignment with the Production and Technological Development Program for Neglected Populations and Diseases - PPDN - or the Program for Preparation in Vaccines, Serums and Blood Products - PPVACSH; X - technological development carried out, in whole or in part, in the country, with public funding; XI - scientific, technological, social, economic, territorial, and environmental impacts; and XII - degree of verticalization of production stages of the API, CTC, or DT associated with the pharmaceutical dosage form for the national manufacturing plant.
4 Article 14. PDIL proposals will be ranked according to the following criteria: I - competence and experience of the partners in the insertion of technologies or products into the market, including ongoing investments; II - experience of the partners with the incorporation of products into the SUS, where applicable, including ongoing investments in health technology management; III - higher level of technological maturity; IV - project proposals that have already been supported by the MoH or other public administration bodies, in previous stages of technological development; V - project proposals that contribute to the expansion of technological and innovation capacity to meet the Program for Preparation in Vaccines, Serums and Blood Products - PPVACSH or the Production and Technological Development Program for Neglected Populations and Diseases - PPDN; VI - competence and experience of the applicant and partners in the development of a productive and technological solution linked to the specific theme of the project proposals; and VII - social, economic, territorial, technological, and environmental impacts of health technology and any actions that may enhance positive impacts or mitigate negative impacts.
