Por: GTPI

To: Federal Attorney General

We, the undersigned organizations and individuals, claim your Excellency Federal Attorney General of the Attorney’s General Office, Dr. Marcelo Siqueira, to immediately revise the opinion paper n. 210/PGF/AE/2009, related to the supposed “conflict” in roles between the National Health Surveillance Agency (ANVISA, in Portuguese) and the National Industrial Property Institute (INPI, in Portuguese) in regards to the analysis of patent requests for pharmaceutical products and procedures.

ANVISA’s prior consent mechanism is intended to protect public health and is backed by an international agreement which regulates intellectual property  the Agreement on Trade Related Aspects of Intellectual Property Rights (TRIPS)  under the World Trade Organization (WTO). The measures to protect public health aim minimizing the negative or abusive effects resulting from patent protection.

In the pharmaceutical sector, patent protection has important implications for public health, since not only the government, but also consumers, are restricted to purchasing medicines from a single producer. The industry, in turn, may charge high prices, affecting public budgets and people’s access to medicines. Therefore, it is essential that only patent requests which really fulfill the requirements be considered for granting protection.

From the public health perspective, patent protection should follow a stricter standard in order to privilege genuine innovations and avoid the unmerited protection of materials which only contribute to limit competition and access to existing medicines.

The opinion paper bases its position in the argument that it is not ANVISA’s institutional role to analyze the patentability requirements. In order to reach this conclusion, Dr. Marcelo Siqueira relies on a restricted point of view of public health, limiting its understanding to the harmful effects of a specific product to human health. However, this understanding, in addition to being harmful to Brazilians’ public health, it contradicts the widely defended position of the Brazilian government in international forums and may lead to a international litigation involving Brazil, since it would create a new patentability requirement, going against the TRIPS Agreement.

From the public health perspective, the inclusion of ANVISA in the analysis of patent requests in the pharmaceutical sector was a great triumph. The removal or weakening of this mechanism would be a step back.

The slowness of the Federal Attorney General in issuing a final position paper causes several serious problems to society, since ANVISA’s decisions in not granting patents, in general, aren’t recognized, therefore generating a true monopoly situation and blocking the competition brought by generic versions of medicines. in summary, the burden will be felts by society, and not by companies.

Dr. Marcelo Siqueira, we, organized civil society, students, people living with HIV/AIDS, and other citizens, believe in your commitment with public interest. Therefore, we request the immediate revision of the position paper n.210/PGF/AE/2009 in order to affirm ANIVSA’s capacity to analyze the patentability requirements for pharmaceutical patent requests in the institution’s exercise of the prior consent mechanism.

Sincerely,

The Undersigned

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