Top Official Discusses Resignation From Brazil’s ANVISA Over Patent Policy

Luis Carlos Wanderly Lima, a senior official responsible for Brazil’s policy of giving a voice to its health ministry in the examination of patent applications with potential impact on public health, recently resigned in protest about changes to the policy. In a Q&A with Intellectual Property Watch, he discussed his decision, the changes at the Brazilian Health Surveillance Agency (ANVISA), and potential violations of the World Trade Organization Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS). The following is an English translation of his answers.

Intellectual Property Watch (IPW): You recently resigned from your position at ANVISA in Brazil, where there is the unique arrangement of a health agency examining patent applications in the country. Could you explain your role at ANVISA and why you resigned?

Wanderly Lima (WL): During almost 8 years (from Sept/2003 to June/2011), I was the coordinator at the Office of Coordination of Intellectual Property, COOPI, of the National Health Health Surveillance Agency, ANVISA, part of the Brazilian Ministry of Health. My resignation was due to the fact that the prior consent* mechanism, since the issuance of the opinion of the Federal General Counsel’s office, AGU, in January of 2011, ceased to exist – even if it was not officially terminated – because COOPI will no longer be able to examine the patentability criteria of a patent application for pharmaceutical products or processes. Thus, it makes no sense to talk about the prior consent mechanism any longer.
Translator’s Note: Throughout this text, the term “prior consent” is used. This is the term applied by the Brazilian legislation being discussed that gave the COOPI the power to review and approve on an interim basis certain patent application prior to a full review by the National Institute of Intellectual Property –INPI.

IPW: How will the patent examination process be different in Brazil going forward and why?

WL: The process for granting of medication patents in Brazil will revert to the same characteristics that were in place prior to the creation of the prior consent. In other words, one single entity, the National Institute of Intellectual Property, INPI, an agency linked to the Ministry of Development, Industry and Foreign Trade, MDIC, is responsible for the review of any application. This process was and continues to be very slow – today, it takes approximately 10 years for a patent to be granted in the country, the INPI examiners have very little time to analyze application merits, and review guidelines are not stringent enough to prevent the granting of applications without merit and/or of poor quality (the granting of second use, polymorphs, selection and Markush structure patents is stimulated), which results in an obvious conflict between private and public interests.

IPW: What are your suggestions for what ANVISA and Brazil can do to address the problem you raise?

WL: The “abolishment” of the prior consent was a decision taken at the Government level, because the AGU is a governmental agency. Therefore, the problems that were created cannot be resolved with suggestions or measures as if this were a question that is outside the realm of the government, something that happened against its will. Rectifying the problem is simple: All that is needed is to revoke the decision that removed ANVISA’s jurisdiction to review the merit of patent applications and indicate to the public and to the various agents within the intellectual property system that the prior consent is an important instrument of public health and a priority of the State and that it was created to prevent the granting of patents to applications without merit and of bad quality. The government would then reinforce the National Policy of Pharmaceutical Assistance of the Brazilian Unified Health System (SUS), its commitment to ensuring that the population at large has access to medication and the country’s successful program of generic medicines.

IPW: Is it compatible with the WTO TRIPS Agreement to have ANVISA assess pharmaceutical patent applications according to standard patentability criteria (novelty, inventive step, industrial utility)?

WL: ANVISA’s prior consent was instituted by Article 229 C of law 9279/96.Therefore, it does not contradict the law, nor the Federal Constitution. The TRIPS Agreement provides for the sovereign right of every nation to organize its administrative and legal structure so as to meet the provisions of the agreement as it deems fit. Thus, the prior consent is perfectly compatible with the undertakings agreed to by Brazil when it became a party to such agreement. This has been recognized by legal specialists in Brazil as well as a result of international consulations (WTO, etc).

IPW: Is it TRIPS-compatible to have ANVISA assess pharmaceutical patent applications in terms of health risks, the way that the Brazilian IP office (INPI) and government now want ANVISA to do?

WL: The Brazilian intellectual property legislation does not require that any Health Surveillance information be provided as part of the process for the granting of a medication patent. Therefore, in Brazil, as in any other place in the world, it will not be possible to evaluate health risks of any patent application, because, quite apart from the lack of such information in the application, this review/requirement would contradict Brazilian law and the TRIPS Agreement.

IPW: So has the Brazilian government, in responding to the interests of the transnational pharmaceutical sector, ironically adopted a position that is effectively in violation of TRIPS?

WL: I cannot state the reasons that caused the AGU, which ultimately represents the Brazilian government, to adopt the position that the prior consent should be abolished, but I am of the opinion that the proposed solution, in addition to it not being supported by law 9279/96, breaches the TRIPS Agreement and will leave the country in a fragile position in the face of a potential dispute resolution at the level of the WTO.

IPW: Who in Brazil – such as political parties, industry organizations , civil society groups – actively defends prior consent and supports ANVISA’s past role in patent examination?

WL: The public has very little information on the process of prior consent. Even among professionals in the health sector there is a lack of knowledge about its meaning. Active support, as far as I know, comes from some NGOs such as the Brazilian Interdisciplinary Association of AIDS (ABIA), Doctors Without Borders/MSF and Conectas Human Rights. Among political parties, there is no official position on the matter. Even though it was created by the PSDB when it was the incument party, today I would not be able to say if there is support from some of its members. Only in some members of PT and PPS have I identified support for the prior consent in the last few years. In respect of the pharmaceutical industry, we have, on the one hand, the strong and absolute opposition from INTERFARMA. On the other hand, to the extent that still stands, there was a timid amount of support from ABIFINA. Pró-Genéricos, despite having similar interests, does not clearly demonstrate its support.

IPW: Why did the ANVISA and the Ministry of Health accept these rulings rather than fighting to retain ANVISA’s role?

WL: I cannot speak for ANVISA nor for the Ministry of Health as to why there was such a calm and peaceful acceptance of the AGU’s opinion. I can risk an interpretation of the events which is as good as any other, which is either that they did not consider the topic important enough to go against a measure adopted by their own government, because in both cases the top level executives are within the incumbent party, or, alternatively, they were not sufficiently informed about or convinced of the importance of the prior consent.

It was because of that, because of feeling the lack of a firmer position in defense of the prior consent that I asked to leave the Coordination, because I noticed my position was not the same that ANVISA’s management had fought for in the past. One of the issues with political action is the confusion that takes place between the commitment to government policies vis-à-vis the commitment to State policies. Another common difficulty is being able to make the right choice when faced with the challenge of having to choose between what is correct and what is adequate. This dilemma reminds me of an Italian movie from the 70s called Illustrious Corpses (“Cadaveri Eccellentia”), at the end of which the main character says: “The truth is not always revolutionary….”

[Note: a Portuguese translation of this interview is available here.]

[Editor’s Note: An article on this situation was recently published by Prof. Ken Shadlen of the London School of Economics, see here.]