Por: Folha de S.Paulo

Contract with U.S. laboratory will allow countries to manufacture and buy cheaper antiretroviral

Brazil was excluded from the first agreement signed between a private pharmaceutical company and the Medicines Patent Pool. The contract authorizes the production and commercialization of generic AIDS drugs, which enables their prices reduction. The pool is an autonomous foundation financed by UNITAID, an organization created five years ago with the support of Brazil to facilitate the treatment against HIV, malaria and tuberculosis, especially in poor countries.

Each of the 29 donor countries contributes to the fund in different ways. In Brazil, a new law authorizes the government to donate $ 2 per passenger travelling outside Brazil to the UNITAID ($ 12 million per year). For legal impediment, the country will not charge the fee for travelers, as did France, for example.

The agreement between the pool and the US company Gilead allows Indian manufacturers to produce three generic anti-AIDS drugs and a combination of all three. The company will receive royalties of 3% to 5% from sales.

The number of countries with access to these generic goes from 99 to 111, depending on the substance. Besides Brazil, other countries were left out such as China, Mexico, North Africa and almost all South American countries, except Bolivia and Ecuador.

Most of the excluded countries are classified according to the World Bank as "upper middle income", with per capita income between U.S. $ 3,976 and U.S. $ 12,275 annually.
To have access to generics, they should negotiate prices with the company or to issue compulsory licensing, as allowed by the World Trade Organization.

CRITICISM

The exclusion has been criticized by groups fighting for access to health care. According to them, two principles have been thwarted in the pool: that all developing countries can be beneficiaries and that there is no technical restriction to manufacturing.

"Manufacturers in Thailand and Brazil, which have the capacity to produce, were left out. The agreement makes it difficult to reduce prices through competition by limiting production to a country, India," said Doctors Without Borders.

A manifesto of 70 Latin American entities, including Abia (Brazilian Interdisciplinary AIDS Association), called the agreement "disappointing".

The health professional Paulo Roberto Teixeira, member of the board of the pool, says he is "aware of the limitations of the agreement," but defends it: "It covers more than 80% of the epidemic," he says.

He recalls that the pool is only one of the mechanisms for campaigning access to medicines. "The agreement does not interfere the right of other nations to adopt safeguards for the production of generics."

Teixeira says that the contract leaves open the possibility that more countries or consortia of countries able to benefit from permission to make generic drugs from Gilead, along with India.

PHARMACEUTICAL COMPANY SAYS THEY ARE PRIVILEGING POOR COUNTRIES

Gilead said they are privileging “countries most in need and where most of people living with HIV are living” in the agreement for the generic production in which it owns the patents.
The pharmaceutical company says this is not the case of Brazil: “we have a pricing program that takes into account HIV prevalence and per capita income: We consider Brazil is a middle income country and we did not include it to be covered in our licensing agreement with the developing world”.

One of the ARV included in the agreement, tenofovir, is already produced in Brazil, as the company’s monopoly is not granted. The country spends R$ 846 millions per year with anti-HIV medicines. From the 20 medicines provided, 10 are imported.

PAID, BUT DID NOT TAKE IT

Brazil funded negotiations, but was out of the agreement to produce and import three anti-HIV generic

The Unitaid: 29 countries came together to create Unitaid, which aims to facilitate treatment against Aids, malaria and tuberculosis

The patent pool: is an autonomous foundation and funded by Unitaid that enables medicines for poorer countries

The terms: in the agreement with the pool, the pharmaceutical company Gilead just allows India to produce generic versions of the three medicines

Forbidden: Brazil did not get the authorization to produce or to import these medicines

The medicines:
Tenofovir blocks the replication of the HIV
Cobicistat enhances the efficacy of other ARVs
Elvitegravir blocks the replication of the HIV
Quad combination includes the three above mentioned ARVs plus emtrincitabina