On December 17, 2014, the Ministry of Health (Ministry) published a new list of strategic products replacing the previous list established by Ordinance #3089/2013. Interestingly, the Ministry published the list without allowing for any comment and/or suggestion by industry.  The publication of the new list follows the November 13, 2014 publication of the new Productive Development Partnership (PDP) guidelines.

The list contains 11 pharmaceutical drugs and 10 medical devices.  In 2015, these drugs and devices will be the focus of the government for new PDPs partnerships.  Specifically, from January 1st until April 30, 2015, public and private industries will have an opportunity to submit partnership proposals for the PDP program as provided by Article 13 of Ordinance #2531/2014.

Included within the list of pharmaceutical drugs are six biologics which are likely to grab the attention of the industry.  These biologics are:  adalimumab (Humira®), filgrastim (Neupogen®), infliximab (Remicade®), rituximab (Rituxan®), somatropin and L-asparaginase.  Companies developing biosimilars of these biologics can contact a Brazilian public institution in order to discuss the possibility of submitting a PDP proposal (up to April 30, 2015) for approval by the Brazilian government.  The selection of the right public institution coupled with the submission of a well prepared proposal that follows the guidelines established by Ordinance #2531/2014 is of paramount importance in obtaining the government approval needed to start a PDP project.

Please find attached the full text of Ordinance #2531/2014 as well as the new list of strategic products. Ordinance List.