Por: O Estado de São Paulo

O Estado de São Paulo – 20/09/2011

The speech made by the Brazilian President, Dilma Roussef, at the United Nations (U.N) is far from being in accordance with the patent policy undertaken by her government. The defense of compulsory licenses, for example, has lost relevance on the internal debates – in part because of the lack of a leading role by her team. The president also is away from important debates, including those that may represent a setback on the access to medicines policy in the country.

The absence is most felt in the dispute over the prior consent, a mechanism provided in law that allows the National Health Surveillance Agency (Anvisa) to evaluate patent applications reviewed and approved by the Patnet Office (National Institute of Industrial Property – INPI).

Entities defending policies for expanding access to medicines in the country take the view that this mechanism is essential to prevent undue patenting of medicines that don`t fulfil innovation and inventiveness requirements. That’s because Anvisa would have more stringent criteria than INPI in evaluating drugs patents. But, for considering Anvisa`s analisys a threat to it`s autonomy, INPI has always been contesting this mechanism.

The war between these two government institutions had an outcome in the first month of Dilma’s mandate, when the Advocacy General of the Ubnion – AGU- issued an opinion restricting the powers of Anvisa. Something that, in the evaluation of analysts and members of Anvisa, transformed the prior consent in a mere legal fiction. This dead-lock of the government could have been avoided by the president. Or resolved, with a clear position about the role of Anvisa.

Another silence is felt around the Direct Unconstitutionality Action (Adin) which is in the Supreme Court and refers to the “pipeline”, the automatic recognition made by the Brazilian government to drug patents granted in other countries in the period before the entry into force of the Brazilian Patent Law in 1996.

If the action is upheld by the Supreme Court, patents granted automatically to at least 440 medicines in Brazil will become invalid – a passport needed to start the generic version of these drugs.

Calculation released by “O Estado de S.P” in February showed that over a period of 19 months, Brazil has spent R$ 123 million more to buy the patented version of only four drugs (with “pipeline” patents) distributed on the public health system. The value refers to the money the government would have saved if the same drugs were boughtb in countries where they are sold in generic version.

Although the judiciary has it’s independence, nothing would prevent the government to endorse the rapid assessment of this action. Something done, for example, regarding the so-called "judicialization". But for now, no clear signal was issued.
 

By Lígia Formenti