Accusations of biopiracy have led a French government institute to pledge that it will share any proceeds from a potential new malaria drug with local authorities in French Guiana. The Institute for Development Research (IRD) in Marseille, France, had come under fire for patenting the drug without acknowledging the indigenous and local communities that helped the institute isolate the drug from a traditional medicinal plant.
On Friday, IRD put out a statement saying it will work out a protocol with Guianan authorities to guarantee the fair sharing of the scientific and economic benefits if the drug makes it to the market and to ensure that people in Guiana can get it at an affordable price. The controversy comes just as France is passing a new biodiversity law that gives local communities more rights over the use of their traditional knowledge and regulates how researchers share benefits of their work.
At issue is a compound named Simalikalactone E (SkE), isolated by IRD researchers from Quassia amara, a small red-flowered tree native to Central and South America. The scientists focused on that species after they had interviewed members of the Kali’na, Palikur, and Creole communities, as well as local Brazilian and European people, about traditional remedies against malaria. In a paper published in 2009, they confirmed that SkE had antimalaria activity in test tubes and in animal studies. Without acknowledging the Guianan communities, they applied for a patent from the European Patent Agency, which was granted in March 2015.
The case is a textbook example of biopiracy, says Thomas Burelli, a legal scholar at the University of Ottawa. In a 25 January statement, Burelli and the human rights organization Fondation Danielle Mitterrand France Libertés condemned IRD for perpetuating former colonial practices and said its actions are “both immoral and in conflict with intellectual property regulations.” With IRD obtaining “a commercial monopoly” over SkE, “the populations who contributed to the development of the innovation could see themselves forbidden from exploiting their own ancestral remedies,” the statement said. Burelli and the foundation asked the European Patent Office to revoke the patent.
Rodolphe Alexandre, the president of the Regional Council of French Guiana, was furious as well, as was the Organization of the Autochthonous Nations of Guiana.
IRD initially mounted a vigorous defense. In a letter to France Libertés Director General Emmanuel Poilane, IRD President and Director General Jean-Paul Moatti deplored the “great violence” of the claims and said they “endanger a long-term research endeavor on a critical public health issue.” In a letter to Alexandre, Moatti defended the “good faith” of the researchers, and said that the survey was just intended to “offer recommendations on the use of local medicinal plants to authorities” at a time when resistance to malaria drugs is on the rise—not to find a new patentable drug. “Blaming these researchers retroactively for not obtaining consent from the persons they surveyed … reveals a certain incomprehension of the dynamics of the development of biomedical knowledge,” Moatti wrote.
Later, however, Moatti acknowledged in an interview that IRD “could have entered a more official dialog with the Guianan authorities” about the patent, and on Friday, after consultations with the French government, IRD announced the plans for benefit-sharing.
Although Burelli welcomes IRD's offer, he describes it is “hasty and not very well thought through.” By holding on to the patent itself, the agency keeps “the full power to decide what it wants to share,” he says. (He also doesn't believe that patents are necessary to develop new malaria drugs.) Burelli deplores what he describes as “paternalism” toward Guiana's communities.
French law doesn't provide clear guidance on the issue. In a 2011 report, the Paris-based Foundation for Research on Biodiversity said there was a “legal vacuum" that hampered trust between the stakeholders. What complicates matters is that technically speaking, many of the biological riches that interest French researchers are in France itself. French Guiana, a former colony, is now one of France's 101 departments, and is represented in the National Assembly, as are French Polynesia and French islands in the Caribbean and the Indian Ocean. Still, there's growing agreement that traditional knowledge in these overseas territories merits protection.
A new French biodiversity law that could see the light as early as this summer will help protect traditional knowledge while also facilitating access to it, says Tamatoa Bambridge, an anthropologist at the Center of Island Research and Environmental Observatory in Moorea, French Polynesia. The law will implement the 2010 Nagoya Protocol, which complements the international Convention on Biological Diversity and aims to guarantee a greater control of the states rich in biodiversity, and their indigenous populations, over how their biodiversity resources are used and an equitable sharing of the benefits.
However, the absence of a legal framework until now doesn't mean scientists can do whatever they want, Bambridge says. The failure by IRD researchers “to obtain the prior and free consent of their informants raises some ethical issues,” he says. A positive outcome of the controversy may be that it forces IRD and other institutions in France to really think about the issues, he adds. “In a postcolonial context, it is time for actors to respect each other.”