Brazil's Congress Poised to Speed Process of Bioprospecting for New Drugs, Cosmetics

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By Michael Kepp

Feb. 18 — Brazil is poised to make it easier for companies to conduct bioprospecting and sign benefit-sharing contracts for extracting and commercializing products derived from genetic resources.

Perhaps the year's most important piece of environmental legislation in Brazil, the bill is aimed primarily at companies developing new pharmaceuticals or cosmetics made with genetic resources, materials from local plants, animals and micro-organisms.

“The bill will greatly reduce the red tape in bioprospecting and the commercialization of products derived from genetic resources,” Adriana Diaferia, vice president of Grupo FarmaBrasil, an association of local pharmaceutical companies, told Bloomberg BNA Feb. 11. “And it will provide greater juridical security than the confusing 2001 presidential measure that it replaces.”

The bill was approved by the lower house of Congress, the Chamber of Deputies, Feb. 10. The Senate is expected to approve the measure (PL 7,735/2014) in March, and then it is expected to be sanctioned by the president and become law.

Simplifying the Process 

Under the measure, companies and research institutes doing bioprospecting for research or product development would be required merely to electronically register such activities with the Genetic Assets Management Council (CGEN), an interministerial regulatory body.

Since 2001, researchers and companies have needed explicit approval from CGEN before they could undertake any search for new products from nature, a requirement that has slowed bioprospecting considerably.

Under the new bill, only when a company is ready to commercialize a product derived from that bioprospecting would it have to sign a CGEN-approved benefit sharing contract.

The bill would set a flat payment of 1 percent of the annual net revenues of the commercialized product, a fee that the company would deposit into a special fund. The government would distribute some of those proceeds to the local providers of the genetic resources.

In addition, the bill would allow agreements with the government for specific genetic assets that would reduce the percentage of annual net sales in any benefit-sharing agreement to a minimum of 0.1 percent.

Currently, companies and providers of genetic resources are free to negotiate the percentage of annual net sales that providers receive, although most receive less than 1 percent.

Environmental Criticism 

Some environmental groups object to the measure's language restricting benefit-sharing to genetic resources that are “the main value-added [biological] materials” in commercialized products.

“The bill benefits pharmaceutical and cosmetics companies by making it easier for them to bioprosect here and to commercialize products derived from genetic resources,” Maurício Guetta, a lawyer with nongovernmental organization Social Environmental Institute, told Bloomberg BNA Feb. 11. “But its benefit-sharing restrictions will reduce the amount of benefit-sharing money going into the government fund, part of which will be passed on to providers of those genetic resources, likely reducing their proceeds.”

Another provision would require companies that commercially develop genetically improved or genetically modified “native” seeds to sign benefit-sharing contracts with the government or with the traditional farmers who help develop and improve them.

To contact the reporter on this story: Michael Kepp in Rio de Janeiro at correspondents@bna.com

To contact the editor responsible for this story: Greg Henderson at ghenderson@bna.com

The Chamber of Deputies bill (No. 7,735/2014) is available, in Portuguese, at http://bit.ly/16Xw3bs.