Brazil Probes Pharmaceutical Industry For Building High-Cost Drug Demand

By Claudia Jurberg for Intellectual Property Watch
RIO DE JANEIRO – An investigation was conducted recently by the civil police in Sao Paulo State, Brazil, against multinational pharmaceutical companies, in which the prosecution affirmed that laboratories pay lawyers to get patients the right to obtain high-cost medicines through the Brazilian health ministry.

According to O Estado de São Paulo, one of the nation’s largest newspapers, the action is against the laboratories Abbott, Novartis, Serono (Merck), Wyeth, and the firm Benatti. The investigation began after two citizens, who identified themselves as former employees of Wyeth, last year sent a letter to the Ministry of Health. The case is being kept secret, with no public information available, sources said.

For the Sao Paulo government the bill from such practices is high. According to information from the State Health Secretary in an interview with Intellectual Property Watch, there are 300,000 patients in the system who receive the high-priced drugs. To distribute these drugs, the state of Sao Paulo needs to disburse US$530 million. Brazil has 26 states and one federal district.

The Brazilian Constitution, promulgated in 1988, affirms in Article 8 that “health is a right for all” and the National Health System (in Portuguese, Sistema Único de Saúde or SUS) provides that access to health is essential, including access to medicines. Under a health reform, Brazil established a health system based on decentralised universal access, with municipalities providing comprehensive and free health care to each individual in need financed by the states and federal government. This system includes access to drugs.

Lawyer Luiz Antonio Yunes, a specialist in this kind of action against the government, told Intellectual Property Watch that it is very common for patients to earn this right and afterwards receive the drug in a few days.

“When I promote an action to a patient to receive a drug with high cost and this drug is not covered by the health system, the process moves very quickly and in a week or 10 days, the maximum period, the patient will receive medicine necessary for the treatment. Up to now, I have never lost an action of this kind, because this right has been guaranteed by the Brazilian Constitution,” he said.

The majority of his actions were for patients with neurological diseases or cancer. He also has patients with diabetic disease, a group of patients that needs specific equipment to measure blood glucose in addition to the drugs. Yunes does not charge his customers because he had a similar experience when he applied and received from the government, for five years, an imported drug from Israel to treat his multiple sclerosis.

The SUS has been in existence for years, and is a network with a variety of services assisting 190 million people, 80 percent of whom depend exclusively on the system.

One of the guidelines of the SUS is the National Policy on Medicines. Implemented in 1998, this policy established free access to a number of essential drugs, which appear on the National Drug List (the acronym in Portuguese is Rename). The list comprises 330 drugs, eight correlates and 34 immunological therapies. The Health Ministry said that Rename follows parameters laid out by World Health Organization (WHO). The government analyses the primary diseases in the country. For each disease, the government chooses one or two drugs most appropriate to treat them, following the philosophy of the WHO.

The National Drug List is continuously reviewed to reflect modifications in data from epidemiological profiles with new diseases and other health disorders. Another factor that contributes to modifications is advances in the pharmaceutical industry with the launching of new drugs.

The current Rename was published in 2006 and, since that time, the list has been reviewed to update it and a new one will be published in October 2008. According to data from the Brazilian Health Ministry, the market for medicine in the country is around US$14 billion and in 2007 it was ninth compared with other countries in the world.

In terms of revenue, the official laboratories represent 5 percent of the market, the private laboratories with national capital 35 percent, and foreign capital laboratories have 60 percent. In 2007, among the 10 major laboratories in Brazil, four are Brazilian and operate on domestic capital. This situation is closely related to the growth of the market for generic drugs.

With regards to essential medicines, the Health Ministry invests every year around US$650 million and states and municipalities invest another US$530 million. The Health Ministry clarified that in all Brazilian municipalities there are medicines financed by public resources. The Health Ministry as well as states and municipalities invest resources toward pharmaceutical assistance. All three levels of government pay toward essential drugs for citizens, but some cases vary, such as higher cost drugs (only federal and state), or specific programmes, such as HIV/AIDS, malaria, tuberculosis, and leprosy (only the federal Health Ministry).

Press officers of the Abbott and Novartis laboratories did not answer email requests for comment.

Claudia Jurberg may be reached at info@ip-watch.ch.