New developments in the PDP Program: The 2017 list of PDP proposals is announced

August 24, 2017The Ministry of Health (“MoH”) announced the list of proposals for future Partnership for Productive Development (“PDP”) Agreements, submitted in the 2017`s round, indicating the related public institutions, companies and products.On August 10 th , 2017, the MoH made available in its website the Technical Note #02/2017 announcing the full list of proposals filed in the 2017’s round of proposals for the PDP Program. The Technical Note #02/2017 contains a list indicating the respective Government-owned pharmaceutical industries (“public institutions”) and companies (“private entity”) that filed the joint proposals, as well as their products of interest. Please, click here to access the full list.The proposals were submitted taking into account the last List of Strategic Products of the National Healthcare System (“SUS”) eligible to receive PDP proposals (Annex I of MoH’s Ordinance #704/2017, published on March 8 th , 2017). From the 56 available products, only 34 (approx. 60%) received proposals.The list of proposals shows a substantial participation of both Brazilian-based and big pharma companies. According to the MoH’s Technical Note #02/2017, in this year’s round, 83 proposals were presented by 15 different public institutions and 25 companies. From the 83, 65 proposals involved small-molecule drugs, 14 were related to biologicals. Only three to medical devices and one to bloodrelated products.According to the Technical Note #02/2017, the result of the MoH`s preliminary review of those proposals would be published in the last two weeks of September. However, in a recent public event held on August 16 th , 2017, Mr. Marco Fireman (head of the MoH`s department responsible for the PDP Program) affirmed that all PDP proposals will be reviewed until September 6, 2017.Mr. Fireman also made some important comments regarding the MoH`s upcoming analysis of the PDP proposals.Firstly, only two PDP projects will be approved for each product (or three, in the case of biological products). The PDP Agreements already approved by the MoH in the 2015`s round and before that will be reviewed to take that into consideration. Thus, the approval of PDP proposals submitted in the 2017`s round can lead to PDP Agreements previously approved being cancelled and replaced.Secondly, the MoH will take into consideration the area of expertise of the public institutions when deciding which PDP proposal will be approved. Thus, for instance, public institutions that do not manufacture oncology products will most likely not receive any PDP for those products.Furthermore, in respect to proposals for biologicals, only proposals from the public institutions Tecpar, Fiocruz (Biomanguinhos) and Butantan will be considered by the MoH for review. The rest will be summarily rejected. This is the result of the MoH`s decision to concentrate the PDP for complex biological products with Tecpar, Fiocruz (Biomanguinhos) and Butantan. Such preference has been reflected in the market share allocations of PDPs related to MABs and etanercepts, announced by the MoH during this year (for more information about the last market share allocation, please check our client alert here).Once the preliminary analysis of the PDP proposals is published by September 6, 2017, the MoH will schedule meetings with the public institutions, allowing them to make presentations regarding the proposals before the Technical Evaluation Commission. For a birds-eye view of all the next steps after said review, please check our flowchart with the entire review-process of a PDP proposal by the MoH.Announced by Mr. Fireman in the abovementioned event, the MoH intends to issue a new regulation dealing with the PDPs. The regulation would take the form of a Presidential Decree (like US`s executive order), which the MOH`s expects to be ready by mid-September.