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Brazil and US: A Deal on Generics


Brazil and US: A Deal on Generics

Under the terms of a new agreement, poor nations will have to go
through a two-step process in
order to obtain generic drugs.
First: prove they cannot manufacture these drugs. Second: get

authorization to import them. These requirements should
allow the US to exert pressure against such importation.

by:
AB

 

After weeks of intense negotiations, an agreement has been reached at the World Trade Organization, which will
make it possible for poor nations to acquire generic drugs. The agreement was possible because the United States decided to
accept an understanding it had rejected during the Doha negotiations, while Brazil and India accepted limitations on their
future exports of generic drugs.

At Doha it was agreed to permit compulsory licensing in the event of a health emergency. But there was a loophole
that remained to be resolved in the future: the problem of nations so poor they could not even afford to import generic drugs.

Thus, more negotiations took place and last December 144 member-nations at the WTO decided on a solution.
However, that solution was vetoed by one nation: the US.

Back at the negotiating table, now almost two years after Doha, on the eve of a ministerial meeting of the WTO in
Cancun, Mexico, the United States (representing pharmaceutical firms); Brazil and India (representing generic manufacturers);
and Kenya and South Africa (representing nations with health emergencies), have banged out a satisfactory solution.

Under the terms of the agreement, poor nations will have to go through a two-step process. First: prove they
cannot manufacture generic drugs themselves. Second: get authorization to import them. The two requirements are seen by
some as two opportunities for the US to exert pressure against the importation of generic drugs.

The agreement also guarantees that developed nation markets, or places without a health emergency, will not be
invaded by generic drugs from Brazil and India.

The agreement got a mixed reception from people who deal with the problem on the ground. Ellen `t Hoen, the
director of the Campaign for Access to Essential Medicine, which is part of Doctors Without Borders, says that it simply does
not guarantee that those who most need generic will be able to produce them or import them. "We need a highly
competitive market in order to keep prices down," she says.

Medical Patents

On August 21, representatives from various Latin American countries signed a declaration calling for an end to
the registration of medical patents across the globe. They expect to deliver the document to political leaders during the
meeting of the World Trade Organization (WTO), scheduled for September, in Cancun, Mexico. The Latin American
representatives fear that this meeting will result in a retrogression in terms of pharmaceutical assistance, due to the fact that developed
countries are cogitating new patent agreements.

"Intellectual property of medicines gets in the way of public health and universal access to remedies, due to the high
prices," stated the technical consultant to the Brazilian Consumer Protection Institute (Idec), Sezifredo Paz. On August 20-21,
the Idec sponsored the Latin American Seminar on Access to Essential Medicines and Intellectual Property.

Europe, the United States, and Japan own 85 percent of the world’s patents. All the other countries together possess
15 percent. In Brazil, 95 percent of the total of registered intellectual property belongs to foreigners, an Idec study reveals.

Breaking Patents

The government of Brazil ratified at the end of January its stance of full support for the Doha Declaration. This
document declares that countries can violate medical patents, to produce domestic equivalents and to import and export less
expensive generic drugs. This topic was discussed at the time between the Minister of Health, Humberto Costa, and the European
Union’s Foreign Trade Commissioner, Pascal Lamy.

The Minister said that the European representative presented a half-way proposal, to prepare a list of diseases for
which countries can produce or import generic drugs. According to Costa, the idea is for the World Health Organization to
prepare the list, or at least be consulted during the process of preparation.

The European measure, in the Minister’s view, would represent an inappropriate interference in each country’s
definition of health policy. "The spirit of the Doha Declaration is to assure the autonomy and sovereignty of each country to
determine which are its public health problems," Costa argued. (DAS)

Chamber for Medicines

As part of a new policy on prices for medicine, since the end of June, a Regulatory Chamber for Medicines (Câmara
de Regulação do Mercado de Medicamentos) (CMED) has been established in Brazil along with new criteria for adjusting prices.

The chamber will monitor and regulate the pharmaceutical sector, identifying price abuses, defining prices and
ruling on whether or not medicines can be sold. It will include an ombudsman for the pharmaceutical sector. The government
will also seek to stimulate the use of generic drugs.

According to technicians at the ministries of Health, Finance and Justice, which will have representatives in the
chamber, the idea is to boost competition, expand supply and the variety of medicines offered, as well as increase the bargaining
power of public buyers.

Under the new rules, laboratories will have to inform the chamber regarding substances used in medicines,
contraindications, their commercial presentation (packaging) and a technical analysis on their therapeutic advantages. The chamber will
check prices with those on domestic and international price lists. If there is price abuse, the medicine can have its price
controlled by the government.

 

The material for this article was supplied by Agência Brasil (AB), the official press agency of the Brazilian
government. Comments are welcome at lucas@radiobras.gov.br

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