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 Nations 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 heredity, 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 traditional medicines. Countries or communities of indigenous people will get benefits in exchange, such as receiving a portion of the profits from products, like new pharmaceuticals, developed from those resources.
Conservation International, an environmental group, describes the protocol as “ensuring that developing countries and their indigenous traditional peoples benefit from the natural wealth harbored in their forests and oceans.”
The accord creates new economic relationships 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 commercialization of their natural resources and their genetic resources,” he says.
Researchers and businesses will also benefit, Djoghlaf says, because the protocol 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 Biotechnology 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 implementing it. Thus, researchers seeking genetic materials abroad will need to conduct due diligence on the laws and regulations particular 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 companies, she adds. “It’s always good for businesses 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 institution. The official handover of resources will take place within these organizations, she explains. Also at these national contact points, researchers or companies will negotiate 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.
Benefits don’t necessarily mean direct monetary payments, Feisee says. For example, 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 percentage 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 regulate access to genetic resources and the equitable sharing of benefits,” says Richard Kjeldgaard, deputy vice president for the Pharmaceutical Research & Manufacturers of America (PhRMA), an industry group. The new accord “doesn’t interfere with existing regulatory systems,” including those governing intellectual property 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 convention, has a different view. “The protocol also says governments should begin considering 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 pharmaceutical 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.”
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 recent briefing. But he did not elaborate on the potential upshots of the pact on businesses 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 details,” 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 negotiation of a deal with researchers or businesses. 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.