Por: O Estado de S.Paulo
Lígia Formenti and Felipe Recondo – O Estado de São Paulo
In a period of 19 months, Brazil has spent $ 123 million more to buy the patented version of only four drugs distributed in the public health system. The value refers to the money the government would save if the same drugs were bought in countries where they are sold in a generic version.
This is not possible because of a mechanism called pipeline – which recognized the patent granted in other countries before the Brazilian law on the subject comes into force in 1996. In practice, it prevents Brazil of breaking the patent of these drugs or buy them at lower prices abroad, in its generic version.
The end of the pipeline has become the cause of a movement that began two months ago by nongovernmental organizations (NGOs) in Brazil and 26 other countries aiming to speed up the trial in the Supreme Court (STF) of a direct action of unconstitutionality (Adin) on drug patents.
The Adin, proposed in May 2009, calls for the repeal of the pipeline. If the action is upheld by the Supreme Court, the patents granted automatically to at least 440 medicines in Brazil would be considered invalid – the first step to start the generic version of these drugs.
"We’re talking about a huge amount of money that could be saved and also about more people with access to treatment," says Gabriela Chaves, pharmaceutical from Medecins Sans Frontieres (MSF).
The four drugs mentioned at the beginning of the story are examples. The cost of R $ 123 million spent by the government between May 2009 and December 2010 was estimated by the Working Group on Intellectual Property (GTPI), responding to a request made by this Newspaper (GTPI’s study can be found in the end of this text). The medicines are olanzapine, used to treat schizophrenia, imatinib, indicated for treatment of a type of cancer; atorvastatin prescribed to reduce cholesterol levels, and lopinavir / ritonavir, an anti-Aids. The onlazapina lost its patent in April 2010. Therefore, the calculation done, we considered only the expenses until that time.
According to brazilian Patent law, from1996, interested companies could submit their patent applications through the pipeline mechanism until 1997. "We ran against the clock. Some of the patents have already expired. In theory, the last patents will expire in 2017, ", said the lawyer for the group Conectas, Marcela Cristina Vieira Fogaça. "The generic version of a drug may have an extremely significant impact on the accounts." The difference is noticeable with onlazapina. In 2010, Brazil paid 142.83 times more than it would have paid on the purchase of a generic version of the product.
Equality. The direct action of unconstitutionality (Adin) was proposed by then-Attorney General’s Prosecutor, Antonio Fernando de Souza Barros e Silva, following an submission made by the National Federation of Pharmacists(Fenafar). One of the arguments is that the pipeline violates the principle of equality: patents approved by that system did not have to be analyzed as the other medicines. The application was automatically accepted: it was enough proving the existence of the patent in other countries in the period before 1997. Furthermore, the thesis is that, as Brazil did not recognize patents on pharmaceuticals until 1996, any product by that date should be considered as prior of art. "The pipeline was an option of the Legislative power. Nothing forced the country to adopt this measure, " says Gabriela.
After the proposed action, several institutions asked to participate in the trial, including the National Health Surveillance Agency (Anvisa). Upon receiving the case at the Supreme Court, the minister Carmen Lucia decided not to consider the requests and adopted abbreviated trial procedure. She directed the action to the presidency and the Attorney-General’s Office, asking both to express their views on the subject. All information, including the General-prosecutor opinion, were sent to the Supreme Court until March last year. Since then, the process awaits the analysis of the minister. "I’m working on the process, "she said. She didn’t say, however, when the process will lead to trial.
Price difference
17.99 times more
This is how much the Brazilian government paid for the brand version of Imatinib in 2010, compared to the generic available in the international market.
10.84 times more
This is how much public coffers spent in 2010 to purchase the brand drug Lipitor, compared to the generic version of the same drug.
Find here the study by GTPI used on this story