Summary of the presentation of J.M. do Nascimento Júnior, Ministry of Health, Brazil
Access to Pharmaceuticals Rio meeting February 23, 2010
Transcript by Beatrice Stirner, University of Neuchatel
In 2007, the most used drug in antiretroviral (ARV) treatment in Brazil was “efavirenz”, provided by the company Merck under the brand name Stocrin. The year’s price for the medicine was US $ 580 per patient. Due to Brazil’s universal access to treatment program, about 75,000 people were eligible to receive efavirenz. In international comparison, the cost for the drug in Thailand was approximately US $ 245 per patient, and the eligible number of patients was about 17,000 people. Moreover, the prices for the supply of efavirenz by WHO prequalified laboratories, proposed to Brazil by UNICEF, ranged around US $ 163.
Article 196 of the Brazilian constitutional law declares health as a right of everybody and as an obligation of the State. Law No. 9,313, a special legal instrument for HIV/AIDS patients, guarantees the continuous treatment with essential medicines for everybody. Within Brazil’s National STD/AIDS Program HIV/AIDS medications are available free of charge to all citizens who need them through the country´s public health care system.
Efavirenz generic version by FarManguinhos, Brazil
In April 2007, the Brazilian Government declared “efavirenz” to be of public interest, preparing the way for the issue of a compulsory license for the patented product. Previous to the decree the Government held 16 meetings with the patent holder Merck, seeking to negotiate a price reduction for the 2007 supply of the drug. During the negotiations Merck proposed a technology transfer to the pharmaceutical manufacturer Farmanguinhos (an entity that is part of the Oswaldo Cruz Foundation of the Government of Brazil) after 2010, a date close to the expiry of the patent of the drug. Amongst others, the proposal also included a two percent price reduction; furthermore a provision, that for the time period prior to the technology transfer Farmanguinhos should purchase the drug supply from Merck, and should perform packaging and labeling activities. The Brazilian Government considered this proposal as insufficient to meet the national interests in the HIV/AIDS treatment policy. In order to ensure access to efavirenz for the 75,000 HIV/AIDS patients of the national HIV/AIDS program, as well as to meet the increasing demand for the drug, the Brazilian Ministry of Health asked for a significant price reduction comparable to that amount charged in Thailand. The proposal was refused by Merck. No satisfactory agreement could be concluded and the negotiations came to an end.
The Brazilian Government issued the compulsory license for efavirenz to ensure the supply of the drug for the National STD/AIDS Program, through local production.
The compulsory license included a validity period of five years and 1.5 percent royalties to Merck as remuneration. In addition, the Brazilian Government ordered Merck to transfer all technical documentation necessary for the production process. In response, the company provided the corresponding patent document only.
Due to lack of further technical information Farmanguinhos used the patent specification for the reproduction process. The disclosure of the patented invention was found to be insufficient and did not enable the generic company to replicate a generic form of the drug. Farmanguinhos had to perform own research activities in order to reproduce the medicine. In order to do so it imported small quantities of efavirenz from India. A preliminary injunction filed by Merck to stop the importation was refused by the Brazilian court. In order to ensure safety and quality of the product, the generic company had to follow all regulatory rules like private companies.
One of the main challenges for Brazil was the development of the local manufacturing processes of production for efavirenz. Thus, an advisory group for the manufacturing processes and related issues was created by the Government, and the Brazilian regulatory agency established a special group to accelerate the production.
In 2009, the generic product came to the market. It allowed an increased patient reach of 2.8 percent and a price reduction of efavirenz of 93 percent. Before the use of the generic product efavirenz represented approximately 12 percent of the costs of the ARV expenditures of the Brazilian Government. With the introduction of the generic version the costs dropped to 3.9 percent.
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