Waiting for Payday.

Drug research demands investment today over pie-in-the-sky royalties.

THE 20TH CENTURY WAS THE GOLDEN ERA FOR BIO-prospecting, at least for Northern Hemisphere drug companies. In the 1940s and 1950s, U.S. and European pharmaceutical firms routinely told working or vacationing employees to collect soil samples and plants from around the world and bring them back for analysis and drug discovery Chloromycetin, for example, still the standard treatment for typhus, was discovered in a Venezuelan compost heap in 1944. The antibiotic made hundreds of millions of dollars for drug maker Parke-Davis, but Venezuela never saw a dime.

Tough times have fallen on bio-prospecting in Latin America. Over the last decade, foreign scientists, drug companies, host countries and indigenous groups have struggled with their respective roles, sometimes clashing openly. The old carte blanche approach died in 1992, at the Earth Summit in Rio. There, 140 nations signed the Convention on Biological Diversity putting on paper the principle of fair compensation for countries hosting bioprospectors.

But how should host countries be compensated? Royalties from commercial product sales aren't enough. Because royalties might not flow for a decade or more, if at all, host countries can be left virtually empty handed. Unless bio-prospectors can offer tangible benefits, their projects risk political opposition, community unrest and outright rejection. But some successful models of cooperation are beginning to appear.

Panama is one such place. Scientists from the University of Utah and the Smithsonian Tropical Research Institute collaborate with a variety of Panamanian institutions on a rainforest drug discovery project. Six different Panamanian laboratories are up and running, testing and purifying hundreds of samples. "It's been working beyond my wildest dreams," says Utah-based investigator Phyllis Coley.

Local boon. Coley and her husband, fellow tropical ecologist Tom Kursar, dreamt up the project eight years ago. Alarmed by deforestation in Panama, they figured if bioprospecting employed enough Panamanians and offered immediate financial returns, it could offer an economic alternative to logging.

Royalties couldn't be the main incentive. "Waiting for royalties is kind of hopeless," says Coley. "We argued hard to try and shift the paradigm [to] more early milestones because that would be best for a developing nation." But pharmaceutical companies refused to pay out serious money just for meeting targets for sample collections and processing. They wanted drugs first.

So, instead of waiting for royalties, Coley and Kursar concentrated on building scientific infrastructure. A US$3 million government grant is being spent almost entirely in Panama, benefiting labs at the University of Panama and the Gorgas Memorial Institute for Health Research, among others. "We are trying to spread it around as many Panamanian institutions and Panamanian laboratories as possible," says Coley. The project employs forty Panamanian scientists and technicians.

Coley is optimistic, but finding an actual drug is still an extreme long shot. For every drug that makes it to market, according to the Pharmaceutical Research and Manufacturers of America, 5,000 compounds are synthesized and screened. It takes a decade or more to go from lab to clinic.

While Panama has so far been a cooperative success story, Mexico is a lesson in conflict and failure. Husband-and-wife anthropologists Brent and Elois Ann Berlin of the University of Georgia, who have long studied traditional medicine in the Highlands of Chiapas, in 1998 launched Maya ICBG, a joint Mexican-British-U.S. project to mine the area's bio-diversity for drug discovery and to catalogue the medicinal knowledge of Mayan healers. Their partners are El Colegio de la Frontera Sur in San Cristobal de las Casas, Mexico, and Molecular Nature Ltd., a privately held British drug company formed in 1999. As in the Panama project, much of the scientific work was to eventually be done in Chiapas, instead of being shipped back to Britain.

A nonprofit organization was created to distribute financial returns from the sale or licensing of products to indigenous communities. Unfortunately, the Mayans weren't organized to offer support, and the Mexican government refused to come on board because political opposition appeared almost immediately. It began with a local healer and midwives' organization claiming biopiracy, then snowballed. Maya ICBG is "a big business, while for our communities and doctors, the plants continue to be sacred plants," said Margarito Ruiz Hernandez, director of the Chiapas-based Centro de Capacitacion para el Desarrollo de Comunidades Indigenas, at an ethnobiology symposium last year. "We want to collaborate with science for the good of humanity, not to benefit a small group." All collecting activity is now on hold.

Projects like Maya ICBG face a dilemma. Many indigenous people fear that their traditional knowledge will financially benefit a few foreign companies and institutions at the community's expense. Yet patent protection and profits are necessary to justify the expensive and time-consuming drug development process.

Patents matter a lot to indigenous groups. In 1998 the World Intellectual Property Association, the body that sets international patent law, held a two-day roundtable in Geneva on the subject. Atencio Lopez, president of the Napguana Association in Panama, made a plea at that meeting for indigenous collective culture to be explicitly recognized in the intellectual property system. That included patent claims. This concept is now, in fact, pretty mainstream. The Suriname/Madagascar ICBG, for example, makes explicit allowance for native healers to be named in patents.

Biopiracy. For now, the Chiapas controversy has poisoned the climate for bioprospecting in Mexico. Another ICBG project, working in arid regions in several Northern Mexican states and in Oaxaca, has been affected, although work continues in Chile and Argentina.

Everyone is waiting to see what President Vicente Fox will do to conclude peace negotiations with the Zapatistas in Chiapas. Bioprospecting could help the region's economic development, so some expect the Mexican government will at least draft regulations to govern bioprospecting.

"One thing is certain, Mexico will have to establish clear and unambiguous procedures that allow for such research but that include all of the necessary safeguards to protect the country against biopiracy," notes Berlin, principal investigator for the Maya ICBG project.

Until the climate regarding research changes in Mexico, the future of bioprospecting in Latin America likely will depend on successes to the south of Chiapas.

                                  Biofund
            International Cooperative Biodiversity Group (ICBG)
       bioprospecting projects in Latin America. Each receives ICBG
           funding of approximately $3 million over five years.
Project name and site                       Collaborating institutions
Bioactive Agents          Argentina, Chile, University of Arizona,
from Dryland Biodiversity Mexico            Instituto Nacional deTecnologia
                                            Agropecuaria (Argentina),
                                            Pontifica Universidad Catolica
                                            (Chile), UNAM (Mexico)
Drug Discovery and        Mexico            University of Georgia,
Biodiversity among                          El Colegio de la Frontera Sur
the Maya of Mexico                          (ECOSUR) (Mexico)
Ecologically Guided       Panama            Smithsonian Tropical Research
Bioprospecting in                           Institute, University of Panama,
Panama                                      Gorgas Memorial Institute
Biodiversity Utilization  Suriname          Virginia Polytechnic Institute,
                          (and Madagascar)  Conservation International,
                                            Missouri Botanical Gardens,
                                            Bedrijf Geneesmiddelen
                                            Voorziening (Suriname)
Project name and site     Drug companies
Bioactive Agents          American Home
from Dryland Biodiversity Products
Drug Discovery and        Molecular Nature Ltd.
Biodiversity among
the Maya of Mexico
Ecologically Guided       Novartis (pending)
Bioprospecting in
Panama
Biodiversity Utilization  Bristol-Myers Squibb,
                          Dow Agrosciences
SOURCE: Pharmaceutical Biology.