Plan to amend biopiracy rules would ‘smother research,’ biologists warn

European scientists are warning that a push to include “digital sequence information” in an international agreement against biopiracy could stifle research, hamper the fight against disease outbreaks, and even jeopardize food safety. Under proposed changes to the Nagoya Protocol, researchers might have to ask a country’s government for permission before using publicly available gene sequences obtained from plants or animals originating there. Just how that would work is unclear, but some biologists are alarmed.

“If this comes to pass the regulatory burden will be enormous,“ says Andreas Graner, head of the Leibniz Institute of Plant Genetics and Crop Plant Research in Gatersleben, Germany. “A lot of research could stop in its tracks.” The European Plant Science Organisation (EPSO) warned in a 26 June statement that the plan “would smother research activities worldwide.” The United States, however, has not ratified the 1992 Convention on Biological Diversity (CBD), to which the 2010 Nagoya Protocol is a supplementary agreement, and would not be bound by changes to the protocol.

Biopiracy—in which scientists or companies profit from the biological resources they find elsewhere in the world—has long been a concern of developing nations with a rich biodiversity. In one famous example, the U.S. company W. R. Grace in 1995 patented an oil extracted from the seeds of the Indian neem tree, long known for its medicinal properties, as a fungicide; the European Patent Office eventually revoked the patent because the concept wasn't new. Under the Nagoya Protocol, countries can ask foreign researchers what they plan to study during a visit, and require a plan to share the benefits of any useful organisms they find. (A 1962 United Nations resolution already enshrined countries' "sovereignty over natural resources” and some nations already had laws to regulate access and demand sharing of benefits, but the Nagoya Protocol created the legal framework to monitor compliance with these laws and triggered new legislation in many countries.) Many researchers say it has already added a huge burden of regulation to work.

But in recent decades, scientists have assembled massive amounts of genetic information from organisms collected around the world and stored them in publicly available databases for others to study or use. The fight now brewing is whether the protocol applies not just to actual biological samples, but also to this type of information.

Yesterday, a CBD advisory body began a 6-day meeting in Montreal, Canada, to try to come up with a recommendation. But any decisions can only be made at the next conference of the parties to the convention, in Egypt in November. Some insiders expect this week’s meeting to focus not so much on whether “digital sequence information” should be included in Nagoya, but on how exactly to define that term. Does it include only gene sequences, for instance, or also data on an organism’s gene transcription and its metabolites?

Either way, developed countries are likely to try to delay a decision, says Edward Hammond, who directs Prickly Research, a small consultancy in Austin, Texas; developing countries will likely push for treating digital information much the same way as biological materials. “It’s going to be a big collision. … It will be the biggest issue [at the meeting] in Egypt,” Hammond says.

Alice Jamieson, a policy officer at the Wellcome Trust, a London-based biomedical research charity, notes that rapid sequencing of the Ebola virus in the West African epidemic a few years ago helped stop its spread. Including sequence information in Nagoya would “do more harm than good,” the trust says in a statement submitted to the CBD panel. And taxonomist Chris Lyal of the Natural History Museum in London calls the idea of negotiating with dozens of countries to build a phylogenetic tree from sequence data “nightmarishly extreme.” EPSO says the plan would also “seriously impact the improvement of germplasm and thus put food safety in jeopardy.“

Hammond calls that “low-class scaremongering.” It’s not yet clear what the new system would look like, he says. “To claim, before efforts to define the system are earnestly underway, that it will jeopardize food safety is irresponsible and likely reflects attempt to cloak self-interest in more palatable clothing.”

Having a mechanism for benefit sharing is important, says Cassandra Quave, an ethnobotanist at Emory University in Atlanta who works with indigenous people to identify plants with medicinal properties. “On the other hand, overextension of the Nagoya Protocol to encompass sequence information on organisms could seriously compromise efforts aimed at the very conservation of the species in question,” Quave says, because genetic information also allows tracking of illicitly traded plants.

Manuel Ruiz, a lawyer with the Peruvian Society for Environmental Law in Lima, says the researchers’ concerns are valid, but predicts that the extension of Nagoya is inevitable because it’s genetic information that is ultimately important for biotechnology—not a physical sample. “Digital sequence information should not only be included in the Nagoya protocol,” Ruiz says, “it’s what it should all be about.” To avoid hampering research, Ruiz says the Nagoya Protocol system should be changed from its current form, based on bilateral contracts drawn up before research is done, to a multilateral system focused on sharing benefits later.

Despite worries about his own research, Lyal sympathizes with the developing countries. He says scientists have an obligation to “make this work so that everyone actually benefits. That’s the way we need to go.”