SHU T T ERSTO CK
GOVERNMENT & POL ICY
col creates a framework ensuring them access to genetic resources. “It opens up the doors,” agrees Lila Feisee, vice president for global intellectual property policy at the Bio technology Industry Organization (BIO). Although the Nagoya protocol outlines a general system for access and benefit sharing, each country adopting the pact will tailor its own details for implement ing it. Thus, researchers seeking genetic materials abroad will need to conduct due diligence on the laws and regulations par ticular to each country they work in, Feisee tells C&EN. “Every country is not going to have the same type of system,” she explains. But having a single point of contact in every nation will benefit researchers and compa nies, she adds. “It’s always good for busi nesses to know that they’re dealing with the person in charge. That really reduces the uncertainty,” she says. Countries that participate in the Nagoya protocol are to establish a national point of access for genetic resources, she explains. This may be at a university, a government agency, or a specified contracting institu tion. The official handover of resources will take place within these organizations, she explains. Also at these national contact points, researchers or companies will ne gotiate legal agreements on access to the materials and on sharing the benefits that could result from the genetic material they wish to study and possibly develop. PRODUCT SOURCE
The Nagoya protocol establishes a new system for researchers gathering genetic materials from places like the Peruvian Amazon, shown, and elsewhere for R&D abroad.
OBTAINING GENETIC
RESOURCES ABROAD
TREATY GOVERNS ACCESS to materials and sharing of benefits CHERYL HOGUE, C&EN WASHINGTON
A NEW INTERNATIONAL treaty will
impact researchers who are on the quest for new products and drugs derived from plants, animals, fungi, and other living things. The pact could make it easier—or more complicated—for scientists to take biological material out of a country for research and development elsewhere in the world. And in exchange for access to the genetic resources within its borders, a country may cut deals for a percentage of royalties from products developed from these materials. The new accord has a long official name: The Nagoya Protocol on Access to Genetic Resources & the Fair & Equitable Sharing of Benefits Arising from Their Utilization. It is an extension of the 1992 United Na tions Framework Convention on Biological Diversity, which has the goal of protecting the diversity of life on Earth. Partners to the convention completed negotiation of the protocol in late October in Nagoya, Japan. The protocol covers genetic material, which contains functional units of heredi ty, as well as products of genetic expression or metabolism, such as proteins and small
molecules. Human genetic resources are exempt. However, materials from all other life forms are covered by the Nagoya pact. The accord is intended to help provide companies and researchers with access to genetic resources, such as plants used as tra ditional medicines. Countries or communi ties of indigenous people will get benefits in exchange, such as receiving a portion of the profits from products, like new pharmaceu ticals, developed from those resources. Conservation International, an envi ronmental group, describes the protocol as “ensuring that developing countries and their indigenous traditional peoples ben efit from the natural wealth harbored in their forests and oceans.” The accord creates new economic rela tionships between the industrialized and developing worlds and between companies and people, says Ahmed Djoghlaf, the UN’s top biodiversity official. “The poor in all the countries will have and will seek the value and will benefit from the commer cialization of their natural resources and their genetic resources,” he says. Researchers and businesses will also benefit, Djoghlaf says, because the protoWWW.C E N- ONLI NE .ORG
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BENEFITS DON’T necessarily mean direct
monetary payments, Feisee says. For ex ample, the provider of the material might ask for help in building and outfitting a laboratory to catalog its genetic resources. On the other hand, the provider may seek downstream benefits, such as a percent age of the royalties should R&D efforts on the material culminate in a successful commercial product, she says. Intellectual property issues will likely be addressed in those contracts, Feisee adds. “The protocol reaffirms the importance of legal certainty and transparency in whatever system countries adopt to regu late access to genetic resources and the equitable sharing of benefits,” says Rich-
ard Kjeldgaard, deputy vice president for the Pharmaceutical Research & Manufac turers of America (PhRMA), an industry group. The new accord “doesn’t interfere with existing regulatory systems,” includ ing those governing intellectual prop erty or drug-marketing approval, he tells C&EN. “It’s important that the protocol doesn’t apply retroactively,” Kjeldgaard continues. But the UN Environment Program, which administers the biodiversity conven tion, has a different view. “The protocol also says governments should begin con sidering ways of recompensing developing countries for genetic material that may have been collected years, decades, even centuries ago—if in [the] future they become used to produce say a new phar maceutical or crop variety,” UNEP says in a statement. It adds, “One option may be to put a proportion of any profits arising into a special fund to be used by developing countries in order, for example, to build conservation or scientific capacity.”
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EXACTLY WHAT the Nagoya protocol will
mean to U.S. industry remains to be seen. The U.S. is not a party to the biodiversity convention; it is the only member of the UN besides the European microstate of Andorra that isn’t. Until the U.S. joins as a partner to the convention, it can’t sign onto the Nagoya protocol. Nonetheless, researchers seeking genetic material from abroad to bring into the U.S. will have to deal with the new access systems other countries put in place. “U.S. companies will be affected by this protocol,” Djoghlaf told reporters at a re cent briefing. But he did not elaborate on the potential upshots of the pact on busi nesses besides fostering greater access to genetic resources. PhRMA’s Kjeldgaard says, “We’re not sure what the impact on our sector is going to be. Our industry isn’t usually in the field trying to access genetic resources.” “The devil is always going to be in the de tails,” BIO’s Feisee says about the possible effects of the new pact. She says countries need to adopt laws on access and benefit sharing that are transparent, clear, and not subject to change during or after a negotia tion of a deal with researchers or business es. If a country opts for onerous regulation, she adds, researchers or companies may bypass it as they seek out genetic resources in their search to discover and develop new commercial products. ■ WWW.C E N- ONLI NE .ORG
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