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On December 8^th,another step was taken towards the return of the Partnerships for Productive Development (PDPs) Program through (i) the call for contributions on the draftnew regulation, which, if approved, will replace the current Ministry of Health (MoH) regulations set forthin Annex XCV of Consolidation Ordinance No. 5/2017; and (ii) MoH’s Ordinance No.2,261/2023, which lists drugs that may be eligible for new PDPs. Both published in the Federal Official Gazette. Formally, this return started in September 2023, when the MoH created the National Strategy for the Development of the Economic-Industrial Health Complex - CEIS, from which PDPs are one of itsstructuring programs (Decree No. 11.715/2023 and MoH’s Ordinance No.1.354/2023).

Created in 2008, the PDPs Programreached its peak in 2017, when the most recent agreements were signed. However, during the last administration, although the program did not cease to exist (R$9 billion have been spent on drug procurement between 2019 and 2022), it certainly lost intensity. No new PDPs were signed and 19 were stayed because the MoH had to reassess their compliance with regulations (at least 9 suspensions were recommended by the Government’s Accountability Office (“TCU”) and the Office ofthe Comptroller General (“CGU”) to be stayed). The need for changing the Program’s course became evident when, on the same day that said National Strategy was created TCU recommended that the MoH should “refrain fromsigning new PDPs until mechanisms are established to objectively assess the completion and effectiveness of the technology transfer”.

Thus, there was expectations that the new regulation would seek to resolve weaknesses already pointed out by oversight bodies like TCU and CGU. This was MoH’s stated intention. Looking at the draft (not if MoH will duly apply its provisions), it seems that some of these weaknesses have been tackled, but not all of them. Structural weaknesses responsible for the failure to achieve the program`s objectives related to productive and technological autonomy have not been solved. After all, considering 131 PDPs signed, only 23 reached Phase IV (last phase), of which only 8 were100% completed, with the Government-owned Pharmaceutical Industry (GoPI) manufacturing the product and the Private Entity (PE) locally manufacturing the API.

Read the full article at: Lexology