For the third time in less than 6 months, the Ministry of Health (MoH) changes the market share of PDPs involving monoclonal antibodies and etanercept.
On July 14, 2017, the MoH republished Ordinance #542 of 2017 (Ordinance #542), allocating for the third time the market shares of the PDPs involving monoclonal antibodies (adalimumab, bevacizumab, infliximab, rituximab and trastuzumab) and etanercept.
The following public institutions (government-owned pharmaceutical industries) received market shares in this last allocation: Tecpar, Fiocruz and Butantan. As far as the private entities, Libbs, Orygen, Bionovis, Biocad, Cristalia and Axis Biotec received market shares.
Ordinance #542 had been previously published on February 24 and February 20, 2017 (for more information regarding the first market allocation, please check our client alert here). For a full comparison of the market shares through the evolution of their allocation, please check the table in annex I.
The MoH’s explanation for publishing Ordinance #542 once again was to undo some clerical mistake in the Ordinance #542’s wording. However, there were substantial changes in the market share allocation.
First, the company Axis Biotec was included as one of the private entities and received 20% of the market share regarding adalimumab. The math, however, apparently does not add up with the other market share of the private entities. Second, Libbs lost 20% of its market share regarding rituximab, going from 30% to 10%. Here the math apparently does not add up either, since this 20% of market share was not allocated to any other private entity.
Finally, from the new market share allocation, it’s not possible to determine which public institution has partnered with which private entity. In this regard, article 2nd of Ordinance #542 sets a deadline for the public institutions to submit before the MoH their private entity for each PDP (July 28, 2017).