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Brazil Enters New Era of Co-Production of Anti-AIDS Drugs

RIO DE JANEIRO, Dec 6 2012 (IPS) - A new kind of public-private partnership will begin in 2013 in Brazil to produce an antiretroviral drug, through a technology transfer agreement that will be in effect until the patent expires in 2017.

The productive development partnership is based on an agreement with New York-based drug maker Bristol-Myers Squibb, to produce atazanavir sulphate.

The drug will be made by Farmanguinhos, a technical-scientific unit of the Oswaldo Cruz Foundation (Fiocruz) and the Health Ministry’s largest pharmaceutical laboratory.

It will be distributed in the public health network as part of the antiretroviral (ARV) cocktail therapy that is provided free of charge to everyone who needs it in this country of 194 million people.

“It’s an important symbolic process,” Dirceu Greco, the director of the Health Ministry’s Department of Sexually Transmitted Diseases, AIDS and Hepatitis (DDST), told IPS, referring to the five-year agreement with Bristol-Myers Squibb, which will represent some 200 million dollars in savings for Brazil.

“The Health Ministry programme is part of a national plan to reduce the deficit in the country’s trade balance in the area of medicines,” Gaetano Crupi, president of Bristol-Myers Squibb Brazil, said in an interview with IPS. “Today atazanavir is 100 percent imported.”

“The government of Dilma Rousseff wants, first, to cut the trade deficit, and second, to save money in the long term by producing the drug at a national level,” he said.

This is the first time Brazil is entering into a partnership with a private company to produce a drug that is still protected by a patent, and that is very important in the national response to AIDS treatment, he added.

“The important thing about this partnership is that it will give us a greater degree of sovereignty in the production of a medication, because the technology will be incorporated by our country, and there will be savings as well, since the medicine will be offered to the government at a reduced price,” Health Minister Alexandre Padilla said.

Since 1996, Brazil has provided universal free ARV treatment, which now benefits some 217,000 people. The Sistema Único de Saúde (SUS – Single Health System), the public health network, treats 97 percent of people diagnosed with HIV/AIDS in the country.

Pedro Chequer, United Nations Joint Programme on HIV/AIDS representative in Brazil, said it was a stride forward “that this country maintains its policy of (universal) access with its own funds and largely with its own production of medicine.”

The Health Ministry distributes 20 ARV drugs at a cost of around 425 million dollars a year. Eight of them are produced by Productive Development Partnerships.

“In the midst of an economic crisis, continuing this strategy was a political decision in favour of the public,” Greco said.

The agreement for the production of atazanavir sulphate provides for the transfer of technology to a national laboratory, as well as the manufacturing and distribution of the drug for five years.

Farmanguinhos has acquired equipment for the production and will receive training from Bristol-Myers Squibb.

Atazanavir sulphate, which is in the protease inhibitor class of ARVs, will start to be distributed in packaging with the Farmanguinhos logo in 2013. But it will only begin to be produced with national technology in early 2015.

A total of 99 million 300-mg tablets will be distributed between 2013 and 2017.

“This will be the 11th ARV medicine produced in Brazil,” Greco said. “The main advance was to ensure that we could manufacture and distribute essential anti-AIDS medicines with public funds.”

“In my view, the idea of having a small state structure has serious consequences in the area of health,” he added.

Brazil, through Farmanguinhos, has agreements to supply medication to other developing countries, in Latin America and Africa, through what it considers one of the main arms of its foreign policy: South-South cooperation.

Crupi added that “What to do when the patent expires is a strategic decision that the government will resolve.”

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