On December 18, the Brazilian Ministry of Health (MoH) published MoH's Ordinance #6,097/2024, which approves the new Internal Regulations of the Deliberative Committee (DC) within the scope of the Health Economic-Industrial Complex (CEIS). The publication was expected, since the regulations of the Product Development Partnership (PDP) Program and the Local Development and Innovation Program (PDIL) established that the internal regulations of the Technical Assessment Commission (CTA), published on December 10¹, and the DC would complement them regarding the evaluation process of PDP and PDIL proposals.

The Internal Regulations provide for (i) the DC's roles and operational procedures (Articles 2 to 11), (ii) the review of ongoing PDPs before the start of phase III (pursuant to Article 33, paragraph 5 of the Annex to MoH's Ordinance #4,472/2024), analysis of proposals to amend PDPs in phase II or III, and evaluation of suspended PDPs (Articles 17 and 18), and (iii) the evaluation of PDP and PDIL proposals (Articles 12 to 16).

Regarding DC's roles and operational procedures, there are not major changes. Just like CTA's Internal Regulations, the changes were in order to adapt the old Internal Regulation to the new rules that provide for the National Strategy for the Development of the CEIS.

With regard to the review of ongoing PDPs before the start of phase III, the analysis of proposals to amend PDPs in phase II or III, and the evaluation of suspended PDPs, the Internal Regulations are limited to reaffirming DC’s role to make the final decision based on the analyses conducted by the CTA and the technical area of the CEIS Department within the MoH. Also as seen in the CTA's Internal Regulations, the Ordinance does not establish criteria for decision-making by the DC in these cases.

As for the evaluation of the PDP and PDIL proposals, more specific and detailed forecasts were expected. For example, the PDP regulation (MoH's Ordinance #4,472/2024) provides that the division of the market share of the partnerships would take place “according to criteria established by the DC in its internal regulations” (Article 19).² However, the Internal Regulations of the DC only provide that the division “will take into account the National Strategy for the Development of the Health Economic-Industrial Complex and of industrial policies" (Article 15, sole paragraph)³. In other words, in practice, it does not establish any objective and concrete criteria for the distribution of the MoH's demand when there is more than one partnership for the same product.

In addition, after the publication of the CTA's Internal Regulations, it was thought that the DC's Internal Regulations could complement it in terms of which parameters will be used by the CTA to assign the score for each of the merit and classification criteria in the evaluation of PDP and PDIL proposals. This is because the CTA's Internal Regulations define a scoring system for each of the criteria provided for in the program regulations but do not provide for the parameters defining this score. However, there is also no such provision in the DC's Internal Regulations. Therefore, it will be necessary to wait for the conclusion of the analysis of the proposals by the MoH for a better understanding of how the score will be assigned in practice.

For more information on this subject, please contact us at lifesciences@lickslegal.com.