June 28, 2024
The Ministry of Health (MoH) published Technical Statement #1/20241, informing that it has opened a 90-days deadline for interested parties to file proposals for new Partnerships for Productive Development– PDPs (from June 24, 2024 to September 23, 2024). Last Friday, MoH issued the new regulation of the PDP Program (Ordinance #4,472/20242).
Proposals must be drafted in accordance with the new template, which is available at MoH’s website3, and be submitted exclusively via e-mail to the following adress: projeto.ceis@saude.gov.br.
In this new phase, PDPs must involve products listed in the Matrix of Productive and Technological Challenges in Health, which is set out in Annex I of MoH’s Ordinance #2,261/2023. At least in theory, the Program's scope seems to have been expanded, as products are now described per category (e.g. blood products, drugs, and new therapeutic schemes for the treatment of HIV/AIDS and viral hepatitis). Previously, drugs considered eligible for new PDPs were listed by their active pharmaceutical ingredient, which reduced the possibilities.
In addition to being listed in said Matrix, products have to also meet additional criteria, such as: (i) marketing approval (MA) granted or estimate to submit a MA application within 36 months from the proposal filing date; (ii) lack of patent protection affecting the arrangement or existence of patent that expires within 36 months from the proposal filing date; (iii) procurement by the MoH in a centralized manner (not by states or cities), or through specific programs coordinated by the MoH; (iv) high dependence on importation or expected withdrawal of the product from the domestic market (article 4 of the Annex of Ordinance #4,472/2024).
For more information on this subject, send an e-mail to info@lickslegal.com.
