On December 13, 2013, the Brazilian Ministry of Health published Ordinance 3089/2013 (Ordinance) which revoked previous Ordinances 978/2008 and 1284/2010.  This new Ordinance redefines the list of drugs considered to be of strategic interest to the Brazilian Universal Healthcare System (SUS).  Specifically, the Ordinance creates new categories of therapeutic designations considered to be strategic (such as antihypertensives and sickle-cell disease).  Additionally, it almost doubles the number of active pharmaceutical ingredients considered to be of strategic interest to the SUS.

The Ordinance clearly stipulates that the drugs listed may be part of future Productive Development Policy (PDP) projects as well as other projects and initiatives aimed towards transferring technology, innovation and local production of drugs to Brazil in an effort to strengthen the local industry sector.  However, the Ordinance fails to mention that the National Sanitary Vigilance Agency (ANVISA), pursuant to Resolution 21/2013, now has a larger bucket of strategically important compounds to potentially justify its analysis of patent applications under the guise of protecting public health.  Accordingly, we expect there to be an increase in the number of patent applications that ANVISA examines as being of strategic interest to the SUS.

Interestingly, the Ministry of Health did not, as it has done previously, attach a list of strategically important drugs and therapeutic destinations to the Ordinance.  Rather, Article 6 of the Ordinance states that:  “The products of strategic interest to the SUS may be found at the Ministry of Health’s homepage – http://www.saude.gov.br”.

It is rather surprising that a list of strategically important drugs and therapeutic destinations was not attached to the Ordinance.  Because a specific list was not attached to the Ordinance, it is possible that the Ministry of Health may, without publication of any notice, alter the list on its webpage by its own volition.  Additionally, it is even more surprising that the link provided is not directed to a specific page of the Ministry of Health’s web portal, but instead, to its home page.  One significant problem is that it is difficult to find any information as to which drugs are considered strategic on the home page of the Ministry of Health.  In fact, at this time, navigation to the list of strategic drugs is contained in a link (which is not highlighted as being a hyperlink) at the bottom of an article published on the Ministry of Health’s website that refers to a news story that does not relate to the new Ordinance.  The link to the news story can be found at: http://portalsaude.saude.gov.br/index.php/cidadao/principal/agencia-saude/7470-sus-tera-medicamento-para-transplantados-produzido-no-pais.  A link to the new list of strategic drugs can be found at the bottom of this news story:http://portalsaude.saude.gov.br/images/pdf/2013/dezembro/16/ANEXO-DA-PORTARIA-3089-11DEZ13.pdf.  The list is also attached (ANEXO-DA-PORTARIA-3089-11DEZ13).

The above actions clearly demonstrate that the Ministry of Health has not made available to the public a list of the drugs considered to be strategic to the SUS.  We believe that an argument can be made that the actions by the Ministry of Health, namely, failing to include the list of strategically important drugs and therapeutic destinations as an attachment to the Ordinance, as well as providing a link in the Ordinance that directs the public to the home page of the Ministry of Health instead of the list itself violates the Principle of Legality in which administrative rules are to be clearly communicated and ascertainable to the public.  Additionally, this lack of clarity creates legal uncertainty regarding the content of the list of strategic drugs given the possibility (at least theoretically) that the Ministry of Health may revise a page on its website on its own volition.

This post was written by Lisa Mueller and Gustavo de Freitas Morais of Danneman Siemsen.