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MoH’s Ordinance #542 of 2017 – Market share reallocation of PDPs involving monoclonal antibodies and etanercept

February 21, 2017

(Federal Official Gazette of February 20, 2017)

On February 20 th , 2017, the Ministry of Health (MoH) issued Ordinance #542 of 2017 (Ordinance
#542), reallocating the market shares of the PDPs involving monoclonal antibodies (adalimumabe,
bevacizumab, infliximab, rituximab and trastuzumab) and etanercept. The market share of the
PDPs was distributed between Tecpar, Fiocruz and Butantan, which are government-owned
pharmaceutical industries (GOPIs or public institutions), and the private entities Cristalia, Libbs,
Orygen, Bionovis and Biocad (table 1).

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The MoH has not determined the new pairings between GOPIs and private entity. In fact, Article 2 of Ordinance #542 suggests that the above GOPIs and the private entities are to enter negotiations to decide on the new pairings for the partnerships. The GOPIs have a 60-day term counted from the publication date of Ordinance #542 (February 20 th , 2017) to file their PDP proposals, which shall be reviewed by the Technical Evaluation Commission (TEC) and the PDPs Deliberative Committee (DC).

A comparison between the scenarios before and after the reallocation (table 2) allows for some
conclusions regarding the GOPIs and private entities that were excluded from the PDPs (indicated as text strikethrough in red). It is not yet clear if the private entities not mentioned in Ordinance #542 such as Pfizer, Merck Serono, Mabxience and Alteogen (indicated in grey) remain in their respective PDPs after the reallocation.

1 Biomanguinhos is just the name of one of Fiocruz’s facilities.

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Despite the changes, most GOPIs and private companies benefited by the reallocation were already part of PDPs for these products. The exceptions are: (i) Butantan and Bionovis for adalimumab, (ii) Tecpar for etanercept, (iii) Tecpar and Orygen for infliximab, and (iv) Tecpar and Butantan for trastuzumab.

The MoH’s intention to have strong PDPs for monoclonal antibodies and etanercept is clear considering that Tecpar, Fiocruz and Butantan have been favored with the reallocation. The MoH has stated it will concentrate efforts and investments from the Federal Government in these three GOPIs, suggesting that the PDP projects will most likely move forward in the near future.

The original Portuguese version of MoH’s Ordinance #542 can be downloaded here.
The English translation of MoH’s Ordinance #542 can be downloaded here.

For more information, please contact lifesciences@lickslegal.com