Ministry of Health calls for contributions on new PDP regulations

December 12, 2023

Ministry of Health calls for contributions on new PDP regulations

On December 8, 2023, the Ministry of Health published a call for contributions (#54), to receive suggestions on the draft ordinance aimed at revising the regulations governing the Product Development Partnerships (PDP) Program.

The new ordinance should entirely replace the current regulations outlined in Annex XCV of Consolidated Ordinance #5/2017. As per the Ministry of Health, this review seeks to adapt the current regulation to the legislation in force and to the recommendations made by oversight bodies during the Program's existence.

The market had anticipated this new regulation, considering the statements made by the Ministry of Health, particularly after the publishing of Decision #2015/2023 by the General Accounting Office (“TCU” in the Portuguese acronym), which criticized the current implementation of the PDP program. And it seems to make sense to call for contributions to the proposed regulation at this moment when the program is being restructured as part of the National Strategy for the Development of the Economic-Industrial Health Complex.  

While the draft submitted for public consultation does not overhaul PDPs’ arrangement and objectives, it does introduce relevant changes in terms of partnership execution. The proposal establishes more defined milestones for the evolution of technology transfer stages, which must be observed by partners. Additionally, it aims to theoretically enhance the monitoring of this execution by the Ministry of Health, including, for instance, a mandatory review of the viability of the entire PDP at the end of the deadline set for the completion of phase II. However, the draft is rather vague on several points which are critical to the program's definition, and such gaps may be fulfilled by society through the public consultation.

In addition, also on December 8, the Minister of Health issued Ordinance #2.261/2023 (link), establishing the “Matrix of Productive and Technological Challenges in Healthcare”. According to the draft’s provisions, products listed in said Matrix are the ones which will be eligible for PDPs (only if the product meets all eligibility criteria set out in article 4 of the draft).

The deadline for submitting contributions started on December 11, 2023, and will continue until January 9, 2024. Submission should be made through the Participa + Brasil page, in which the draft submitted for public consultation is available in full (link).

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