Representatives of the National Health Surveillance Agency (Anvisa) and the National Institute of Industrial Property (INPI) clashed in a public hearing at the Chamber of Deputies on the role of these entities in granting patents for medicines. The INPI argues that the role of Anvisa should be limited, as set out in Bill 3709/08, introduced by Deputy Rafael Guerra (PSDB-MG). Anvisa, on the other hand, has criticized the proposal, arguing that it does not serve the public interest.

The current law allows the interpretation that Anvisa must give prior consent to all patent applications for pharmaceutical products and processes, but the INPI and Deputy Guerra disagree with that prerogative.

On Tuesday (24th), the second public hearing requested by Deputy Moreira Mendes (PPS-RO) to discuss the bill was held.

Confusion of responsibilities
According to the President of INPI, Jorge Ávila, the legislation has caused a confusion between the powers of INPI and Anvisa.

"When we send out a patent for analysis by Anvisa it is because INPI has already given its approval. So every time they refuse to grant this patent we have different reports", he said.

Ávila said that INPI rejects between 60% and 70% of patent applications. "We are among the countries that reject most aplications, that's part of our culture, which is very demanding with regard to the granting of patents", he declared.

He also stated that the duplication of responsibilities must have arisen from a misinterpretation of the rules: "It is quite reasonable that, if necessary, INPI should ask for the opinion of Anvisa or some other organ , but it is unreasonable that the legislation has determined that this should be the case on all occasions”.

Also according to Ávila, the institute currently has 130 researchers. "It's a small group, yet it is much broader and better prepared than the group of only 18 researchers that Anvisa has", he said.

Public interest
Avila's arguments were refuted by Anvisa’s Coordinator of Intellectual Property, Luiz Carlos Lima, who criticized
Bill 3709/08. "The bill is wrong in many points, it does not reflect the situation in the area of drugs and does not meet the public interest", he said.

He added that, if approved, the bill will mean the end of the prior licensing system (the need for authorization from the Agency for a drug to be marketed).

The coordinator noted that Anvisa considers that the proposal lacks legal foundation. He rejected the argument that the participation of Anvisa in patent surveillance is not provided for by law: "The author [of the bill] has based his ideas on the law that created the agency, but he has forgotten that a subsequent law has granted this right."

Lima said there would be a commitment on the part of Anvisa to release patents in 120 days. "In addition, our licensing department was set up in Rio de Janeiro just to be close to INPI", he said.

Also according to Lima, some of the analyses arrive at the organ up to ten years late, so he believes the period of four months of study by Anvisa makes little difference.

The Agency’s function
Speaking in favour of the bill, Deputy Moreira Mendes questioned the position of Anvisa. "I see an ideological Anvisa, as if we were discussing the extent of its power", he said. He emphasized that the agency may at any time withdraw a drug from the market. "That is its real function", he argued.

Deputy Guilherme Campos (DEM-SP) agreed with Mendes. For him, the impression is that the duplication of work (Anvisa and INPI) is not justified.

For his part, Deputy Luiz Carlos Hauly (PSDB-PR) argued that the United States has a body similar to Anvisa and that nothing in that country enters the market without the consent of that entity. "When we talk about patents, we must always bear in mind that the real interests must be those of the final consumer and domestic industry", he said.

Debureaucratization
Moreira Mendes said that he supports the bill as a measure against bureaucracy. He said that the coordinator of Anvisa could not justify why those redundant attributions should be maintained. Luiz Lima said that drugs are so important that the entity which is a national authority in public health should be added to the review process.

Although the rapporteur, Deputy Miguel Correa (PT-MG), had already presented his report recommending rejection of the proposal
in March, the bill is still under discussion in the Committee on Economic Development, Industry and Commerce.

Reporting - Juliano Pires
Edition - João Pitella Júnior
Translation – Adriana Resende