Brazil And The Defence Of Public Health: Do As I Say, Not As I Do

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By Felipe Carvalho of the Brazilian Network for the Integration of Peoples

If words could save lives, the Brazilian government would have done a great job over the last ten years. Unfortunately, they can’t. Medicines can. But guaranteeing access to them in a post-TRIPS world requires more than words. And with the prospect of lost lives from decisions undermining mechanisms created to prevent undue patents, words are worth nothing.

In October 2009, the Brazilian government managed to approve a resolution on access to medicines at the United Nations Human Rights Council. The document stresses that ensuring access to affordable medicines is a duty of States. It also encourages States to provide for safeguards against abuses of measures enforcing IPRs.

However, just a few days later, on 16 October, Advocacia Geral da União (AGU, the Advocacy-General of the Union) issued a decision undermining a mechanism aligned with these two guidelines: Anvisa’s (National Agency for Health Surveillance) prior consent (anuência prévia, in Portuguese). Despite claims of reconsideration, Brazilian Advocate-General of the Union Luis Inácio Adams confirmed the decision last month.

Ruled by Article 229-C of Brazilian IP law, Anvisa’s prior consent represents the participation of the health authority in the patent examining process. Applications approved by the Instituto Nacional de Propriedade Industrial (INPI – the Brazilian patent office) are submitted for Anvisa’s examination and can be denied if patentability requirements are not properly addressed.

This original safeguard was introduced on the premise that patents for pharmaceuticals should receive special examination because of their implication for access to medicines. Its genesis in 2001 coincided with new understandings of TRIPS (the World Trade Organization Agreement on Trade-Related Aspects of Intellectual Property Rights), such as the need to use its flexibilities to defend public health, an agenda in which Brazil had a leading role during the 4th WTO Ministerial Conference, in Doha, Qatar .

Ten years later, Brazil’s international reputation as a public health defender remains, Anvisa’s role is widely recognized as a positive example , and the need for flexibilities like this is higher than ever. And yet, prior consent is about to end. This contradiction is mainly explained by INPI’s (and industry’s ) displeasure with Anvisa’s role.

The expected collaboration between the two organs gave way to a ten-year dispute, in which the victims are the users of the public health system and people in need of medicines in Brazil. This can be measured, for example, by the 119 patent applications in which Anvisa denied its prior consent, that could have already opened the way to generic production if wasn’t for INPI’s refusal to make Anvisa’s denial public.

INPI takes the view that Anvisa’s exam invades its authority and needlessly duplicates its work. In 2007, INPI sought the intervention of AGU, which is the competent authority to settle disputes between public organs. The final decision issued in January takes Anvisa out of the analysis of the patentability requirements and restricts Anvisa’s analysis to the assessment of potential harmful effects to human health.

But, as specialists agree, this kind of analysis can’t be done over a patent application. Additionally, this assessment must be done in a later stage anyway, when the medicine applies for market authorization. Even more, the analysis of potential harmful effects during the examination of a patent application could be seen as a fourth patentability requirement , exposing Brazil to a panel at WTO.

So, if what is being suggested is that Anvisa’s role must shift from an internationally applauded performance preventing undeserved monopolistic practices, to an impossible and unnecessary task, maybe the Brazilian government forgot to announce that access to medicines is not a priority anymore.

A study by Anvisa using 2001 to 2009 data reveals that of the 1,346 patent applications passed to the agency, 119 were rejected. In another 90 cases, Anvisa’s participation made INPI change its decision, denying applications that otherwise would have been granted. Among the 988 cases approved so far, 40 percent had to follow Anvisa’s exigencies.

ANVISA’s activity is crucial to detect and prevent evergreening methods by patent applicants (as in ‘me too’ drugs or ‘patent clusters’), to correct inaccuracies in applications and to clarify the object of protection. This collaboration is a measure to enhance the examination of pharmaceutical patents from a public health perspective, preventing undeserved patents that can delay the entry of generic drugs into the market, causing a great harm to the public programs of distribution of medicines and to consumers in general.

These numbers were used in a civil society complaint sent to UN Special Rapporteur on the right to health Anand Grover, to prove that Anvisa’s contribution isn’t “needless”, as INPI says. This complaint classifies AGU decision as the biggest retrogression that has happened in Brazil in this area, and as a huge setback for international commitments made by the country.

It is easier to defend public health with words than with actions. Fortunately, the Brazilian government knows how to act. The AIDS treatment program, seen around the world as a model, is just one of the main examples. And as authorities must know, the sustainability and expansion of this great initiative relies on stricter standards of patent granting, not on discourses. Patients will survive having access to medicines, not to promises. In this sense, Anvisa’s prior consent always has been a proof that Brazil is applying at home the prevalence of the right to health over private interests, as defended in international meetings.

So, there are clear reasons to justify why Anvisa’s prior consent was created and maintained, but there is a lack of reasons to explain why this mechanism is being undermined since the Brazilian commitment to public health has not changed over the last years. On the contrary, it has been reaffirmed more and more.

Civil society groups have been supportive of Anvisa’s prior consent since its implementation. Their appeal to the UN Special Rapporteur on the right to health reinforces their support and aims to make the Brazilian government remember that more important than having a good international reputation is to deserve it at the national level. That’s what is at stake in AGU decision over Anvisa’s prior consent.

Felipe Carvalho is a graduate of the Universidade Federal do Rio de Janeiro (UFRJ) School of Communication and works as press officer of the Secretariat of the Working Group on Intellectual Property of the Brazilian Network for the Integration of Peoples (GTPI/REBRIP).

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  1. Benny Spiewak says

    ANVISA is always entitled to keep denying market authorizations for health-related products. That’s actually its role and it should focus on it, so ensure efficacy and safety of products. There’s no need to have ANVISA reviewing INPI’s patent work. ANVISA could easily implement a training program, if it really thought that INPI misses state of the art education when it comes to analyzing health-related patents. Education is not the problem. It never was and it will never be. The duck-behind-health routine is not fooling anyone, anymore.

  2. ks says

    Denying market authorizations, whatever its merit as a strategy here might be (subject for another post), is ANVISA’s role, as Benny Spiewak says, but it’s not it’s only role. The fact of the matter is that the Brazilian patent law requires ANVISA to approve patents — not just address health risks in granting/denying market authorizations for products that are ready to be placed on the market, but also to assess patents. These are two different roles (of course ANVISA has many more roles than these two, as well). The debate then is over how ANVISA should examine patents, if it should apply standard criteria of novelty and inventiveness or if it should be examining health risks. The AGU’s ruling is for the latter. I don’t understand how, other than in exceptional cases, it is possible to examine health risks at the time of patent application. When the applicant applies for a patent and INPI approves and then passes the application along to ANVISA for “prior consent,” the information that ANVISA receives is not the sort of information that would allow it to make a determination of health risk. If someone could please explain that to me, I’d be very grateful.


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