Initiative is reaction to final opinion Brazilian Attorney General restricting Anvisa?s power on patent examination process for medicines; one may fear that, in practice, restriction hampers authorization for generic medicines production
Lígia Formenti - O Estado de S.Paulo
ONG representatives submitted yesterday complaint against brazilian government to the Special Rapporteur on the right of everyone to the enjoyment of the highest attainable standard of physical and mental health, Anand Grover, regarding restrictions to the role performed by Anvisa (National Agency of Sanitarian Vigilance) on patent analysis. According to the text, this shift it's a retrocession that violates country's international commitments related to human right to health.
Signed by 15 organizations, the document must be analyzed by the Special Rapporteur, along with an eventual response coming Brazilian government. If he considers the arguments relevant, he may suggest the country to reconsider it's position.
The NGOs complaint to U.N is a reaction to the final opinion issued by AGU restricting Anvisa's powers on patent examination process for medicines, what was revealed by this Newspaper on 24.
Till AGU decision, ANVISA used to act like a "reviser" of patent process already approved by INPI (Intellectual property National Institute). With the new opinion, Anvisa must restrict its analysis to eventual health risks implied in the product applying for patent protection. Representatives of entities submitting the complaint fear that, with this shift, granting of undue patents will be facilitated, what, in practice, will prevent liberation for generics production.
As example, they cite statistics of Anvisa's performance. During the revision period, the 1,346 application passed to Anvisa, 119 were rejected. In other 90, Anvisa's participation made INPI change decisions, denying applications that otherwise would be approved.
"Even OMS defends health authorities-participation on the analysis of process involving medicines. It´s a guarantee society has to avoid undue patents", says Marcela Vieira, lawyer Working Group on Intellectual Property of the Brazilian Network for Integration of People?s (GTPI/Rebrip). Marcela remembers that other countries also adopt this double exam in strategic areas. "In the US, for example, the patent grant at the aviation sector is done after consulting the agency that is equivalent to our Anac".
The Ministry of Health, Alexandre Padilha, affirmed that AGU´s decision will not change Brazilian performance in relation to medicines policy or patent granting. "It just reinforces the synergy that must exist between Anvisa and INPI, and between all government Ministries".
According to him, with AGU's opinion, government may expand debates and spaces to understandings. "There is no regression" Gabriela Chaves, Médecins Sans Frontières NGO (MSF), fears the negative impact on access to medicines this decision may have. "Patented drugs are more expensive, what hampers purchases both to governments and population".
"The collaboration of an Health Agency on the analysis of patent for medicines makes it more qualified" - Gabriela Chaves