Brazil: Limitation of ANVISA’s Power over IP triggers lawsuit in the UN

Representatives from more than 15 non-governmental organisations (NGOs) have presented legal action against the Brazilian government in the United Nations (UN) special arbitrator. The initiative is a reaction to the final opinion of the Attorney-General of the Union (AGU) that limited the powers of the National Agency of Drugs and Medical Products (ANVISA) in assessing applications for patents for pharmaceutical products, returning the entire responsibility to the National Institute of Intellectual Property. The legal action was presented to the special rapporteur on health rights of the UN, Anand Grover, and according to the text, change is a retrograde step that violates the country’s international obligations regarding the human right to health.

Before the decision made by the AGU, Louis Adams, ANVISA participated in the process of examining applications of intellectual property rights, using technical criteria such as novelty, inventiveness and industrial application influencing the decision making in parallel with INPI. The decision came after a long dispute between ANVISA and INPI that started 10 years ago, when the law determined that ANVISA should provide feedback on processes for granting drug licences. The dispute centres on ANVISA’s jurisdiction on the issue of patent approval wherein its interventions were not welcomed by INPI. The agency has released figures to support this contention, noting that throughout these seven years, out of 1,596 applications approved, 145 were disapproved by ANVISA afterwards. After the new legislation, ANVISA will confine its analysis only within the scope of health risks on the product to be patented, without the capability to reject drugs or supervise the patent process.

Concerns in Generic Industry

From the point of view of the generic manufacturers, the decision is threatening the whole generic industry, because it might result in extension of patents that otherwise would become public domain and therefore delaying the entry of new generics into the Brazilian market. Indeed, in parallel with the legal action presented by NGOs, the president of the Brazilian Association of Manufacturers of Generic Drugs (PróGenéricos), Odnir Finotti, called the resolution a setback in the Brazilian generic development. He stated that the participation of ANVISA has given transparency to the patent-grant process and on the other hand prevented pharmaceutical companies adopting strategies in order to try to extend their patents and prevent drugs becoming public domain, allowing the production of generics. In addition, he pointed out that his Association is preparing legal action attempting to stop the process, as well as the NGOs and other groups. However, according to several experts on intellectual property issues in Brazil, the rationale in the decision made by the Attorney-General is based on the facts that the only role of ANVISA is to support the patent process from a health risk point of view rather than to be involved in industrial settings. Moreover, they believe that the generic industry will not be affected given the fact that the process is not easy to manipulate and it has a normal rate of rejection in the context of international benchmarking.

Outlook and Implications

The decision taken by AGU about restricting the powers of ANVISA confirms a decision that had already been adopted in November 2009, but was questioned by the agency. The new regulation is sparking concerns amongst the generic drugs industry and NGOs, because it might impede or delay the entry of generic versions of drugs into the Brazilian market, due to the hypothetical pro-branded drugs industry role of the INPI, instead of ANVISA, which is supposed to defend the interests of citizens and the government in terms of its pro-generics strategy. The Health Minister, Alexander Padilla, has said that the decision will not change the Brazilian performance in relation to drug policy or the process of granting patents and described the necessary synergy that must exist “between Anvisa and INPI and among all government ministries”. In the meantime, NGOs such as Doctors Without Borders (MSF) announced that they will carry on with the legal action present to the UN, using the argument that the WHO itself supports the involvement of health entities such as ANVISA in the analysis of cases involving patented drugs. Legal actions, from either NGOs or the Association of Generic Manufacturers in Brazil will determine the future course of action. However, it is highly likely that the jurisdiction of ANVISA over the patent grant process has definitely been reduced to just a minor role, which is assessing potential risk.