Products derived from biological materials have benefited the pharmaceutical industry greatly, and indigenous knowledge of plants has played a significant role: “Globally, almost 121 prescription drugs are made from plants almost half come from the tropics and 74% were discovered pursuing claims from native fables”. The global market for plant based drugs has been estimated at $43 billion. In the past, companies from the more developed North have taken the knowledge of the indigenous peoples of the less developed, but biologically diverse South and converted medicinal herbs into pharmaceutical products without providing any payment to the providers of the knowledge, a practice dubbed “biopiracy”. One notorious example is the derivation of vinblastine and vincristine from the Madagascar rosy periwinkle; the drugs have earned Eli Lilly around $100 million per year, but neither the shamans that gave the knowledge to Lilly researchers nor the government of Madagascar have received any compensation for their contribution. , There has been a growing consensus that this kind of appropriation is morally unacceptable, and biopiracy should give way to (ideally) more equitable bioprospecting, especially in light of the North’s insistence that its own intellectual property laws be respected. ,,
Much debate exists about how much indigenous knowledge is intellectual property, and how to protect the knowledge that is potentially protectable. While some authors see no justification in the Lockean theory of mixed labor usually used to justify protection of intellectual property for “fencing of chunks of what we might call the ‘intellectual commons’”, at least when bioprospecting does not interfere with the ability of the indigenous peoples to continue to use the “commons”, other authors note the labor indigenous peoples have added by years of crop breeding and cultivation, and by identification of medicinal plants. There is little doubt that without the discovery performed by indigenous peoples, any attempts by companies from the North at finding potentially useful compounds will proceed at a glacial pace. The odds of finding a medicinally useful plant by purely random screening are estimated from 1 in 10,000 to 1 in 50,000.
In addition, there is an argument to be made that, until disclosed, information which is kept by shamans, or families of shamans within a tribe, may be protectable as trade secrets under the current TRIPS Art. 39.1 and the United States Uniform Trade Secrets Art. A. Further, it has been noted that any knowledge which is disclosed openly enough to be public domain would be unable to be patented in the United States but for the geographic limitation on prior art in 35 U.S.C. 102. There is no such limitation in European patent law. One impact the lack of a geographic limitation in Europe has had to date is the reversal of the patent of W.R. Grace’s neem-based insecticidal product; neem extract has been commonly used in India for centuries as an insecticide. , Protestors wrote both the U.S. and European offices to petition for rescinding the patents, noting “its novelty ‘exists mainly in the context of the ignorance of the West.’”
Even if one is (understandably) left puzzled by which intellectual property theory to apply, or does not sympathize with a moral call for a more equitable relationship between the developed and developing worlds, self-interest demands that bioprospecting is carried out in a way that takes the needs of the biodiversity-rich South into account. There is a serious practical problem that can arise with continuing to use indigenous knowledge without compensation—tribes and governments may simply refuse to cooperate with pharmaceutical companies. Their ability to do so has been given teeth by Article 16 the Convention on Biological Diversity (CBD). , After the CBD, the Andean nations of Colombia, Venezuela, Ecuador, Peru, and Bolivia have banded together to form the Cartegena Agreement on Access to Genetic Resources. The agreement gives guidance on what fair terms of access are, and creates serious sanctions for companies that violate the Agreement. , Brazil has also worked toward creation of legal sanctions for biopirates. Acre, a state in Brazil, imprisoned a researcher that appropriated indigenous knowledge without compensation and attempted to export raw plant materials in violation of a state law.
Several market-based agreements have arisen; while none of these has received universal praise in the literature, they do provide hope that Northern businesses are moving toward more equitable relationships with Southern countries, and are showing good faith in attempting to reject outright biopiracy.
One of the first and most famous of these is the Merck-INBio agreement. In 1991, Merck paid INBio an initial amount of $1 million and $135,000 in laboratory equipment, and to give (reportedly) one to three percent of any royalties from successful drugs to INBio. In addition, half of any royalties received must be earmarked for the Ministry of Natural Resources, which is supposed to use the funds for conservation of biological diversity. Merck will establish research facilities and train scientists in Costa Rica, furthering the goal of long-term self-sufficiency in Costa Rica. Merck does retain “all patent and intellectual property rights to any products developed”. Although some authors don’t think that INBio got a fair bargain from the agreement, and others have criticized INBio’s role as that of a mere “lab technician,” the agreement does provide benefits to both the environment and economy of Costa Rica.
As promising as the Merck-INBio agreement is, there are reasons to think that it may not be able to be replicated easily. Costa Rica is unique among less-developed countries: “[it] has an adult literacy rate of ninety eight percent, a well-developed business and scientific community, has been committed to environmental conservation, and has had a stable democratic government throughout the twentieth century.” In contrast, many less developed countries have corrupt governments that cannot be counted on to act in the best interests of their people. Additionally, channeling money through a government or academic institution has intrinsic problems if the goal is to get monies directly to holders of tribal knowledge. It is difficult, even when governments are not outright corrupt, to ensure that money is distributed fairly.
Novartis Pharmaceuticals entered into an agreement with the Brazilian Association for the Sustainable Use of the Biodiversity of Amazonia (BIOAMAZONIA) that is facially similar to the Merck-INBio agreement: Novartis agreed to pay $4 million up front for the ability to gather 10,000 samples a year for three years, and to give money to BIOAMAZONIA upon the clinical testing, patent registration, and launch date of any successful drug, and to give BIOAMAZONIA one percent of royalties during the ten years that Novartis retains exclusive rights. The key differences between this agreement and the Merck-INBio agreement that have drawn serious criticism are the lack of a requirement that any funds be used for biodiversity preservation and the lack of opportunity provided for Brazilian scientists in the Novartis-BIOAMAZONIA deal. The agreement is for raw materials, which Novartis will process, in contrast to Merck-INBio where INBio performs testing and sends Merck extracts. This creates the problem of violating the CBD’s goal of “promoting scientific and technological advancement” in the less-developed countries.
Shaman Pharmaceuticals is another company that has made efforts to utilize indigenous knowledge in an equitable way. Shaman negotiates directly with local communities and tribes, and compensates them directly, “based on the needs of [the] community”. In addition, they participate in the non-profit Healing Forest Conservancy, which has the goal of biodiversity conservation and spreads any profits contributed by Shaman throughout all the countries that Shaman negotiates with. , Shaman’s arrangements ensure that monies benefit the knowledge holders more directly, which has earned Shaman praise. , However, details of Shaman’s agreements have not been disclosed, so it is impossible to evaluate how equitable the deals are.
The National Cancer Institute (“NCI”) has also taken steps to insure that the materials that it gathers in its search for cancer and HIV drugs are harvested in an equitable way through its Letter of Collection (“LOC”) agreements. NCI utilizes U.S. contractors (primarily botanical gardens) to do its collections. Each contractor is obligated to collaborate with institutions (usually universities) in the countries in which it gathers. In return for allowing the U.S. contractors to harvest, the collaborating institute receives the screening results, training in NCI laboratories, and royalties from any successful patents. They also receive the first right to supply raw material for any successful drug. The plan is five years in duration, and cost $8 million. NCI retains the rights to drug patents and will license actual production of any successful drug to pharmaceutical corporations. NCI’s agreements have been criticized as insufficiently certain—NCI has promised to use its “best effort” to assure that the source country shares in the company’s profits.
There are problems that no one agreement, or set of agreements, will be able to settle. There are serious issues of unequal bargaining power that make it difficult to evaluate how equitable the agreements to date have been. , In addition, even if one assumes that all of the parties are acting in good faith, there are inherent difficulties in determining what a fair agreement for the uncertain commodity of potential drug material looks likes; even with the ability to use indigenous knowledge to narrow the field, the analogy to a lottery is nearly unavoidable. There may also be insoluble cultural problems that arise in some situations—the patenting of Ayahausca is offensive to the indigenous peoples of the Amazon Basin for religious rather than economic reasons. However, many of the agreements to date show serious effort at equity, and give some assurance that there will biopiracy will be less tolerated in the future.
Websites:
Merck: www.merck.com
INBio: www.inbio.ac.cr/en/default.html
Novartis: www.novartis.com
Brazilian Embassy: www.brasilemb.org/environment/environ3.shtml
Shaman: www.shamanbotanicals.com
National Cancer Institute: www.nci.nih.gov
