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February 2001
Cinchona seeds were pirated from Bolivia and planted in India. Illustration of Cinchona Calisaya Wedd from Köhler’s _Medizinal-Pflanzen in naturgetreuen Abbildungen mit kurz erläuterndem Texte_, 1887.
As recently as a decade ago, the legalities of obtaining samples of plants, microbes, and animals were straightforward. In many instances, a researcher could simply arrive at a field site, collect samples, and take them home. There was no applicable law. The researcher might obtain informal permission from a local community or landholder, as much for being on the land as for collecting. At most, the researcher might be required to obtain a permit to collect from national lands, like a fishing or hunting license.
“Take-and-run” describes the old approach to collecting, lately dubbed “biopiracy.”
- The recorded history of international plant collecting missions goes back at least 3500 years when Egyptian rulers began bringing plants home after military expeditions.1
In the last century, the British Empire instituted regular plant collections. During the Voyage of the Beagle, Charles Darwin simply took what interested him, from the Galapagos and elsewhere, and brought it home.
The Royal Botanical Gardens took rubber trees from Brazil, and planted them in Southeast Asia. They took cinchona seeds from Bolivia, in violation of national law, and planted them in India.
Commodore Perry’s naval mission to Japan collected a wide variety of plants to bring back to the United States.
More recently, the adventures of Richard Schultes during the mid-twentieth century have become a legend among ethnobotanists. He was able to befriend local shamans, who allowed him to collect thousands of voucher specimens of medicinal plants, hundreds of which had never previously been identified taxonomically.2
None of these famous collecting trips was challenged on legal grounds. If done today, how would they be challenged?
New rules for bioprospecting
The new rules for biodiversity prospecting and natural products research derive from three sources: international treaties, national laws, and professional self-regulation.
International treaties
The 1993 Convention on Biological Diversity (CBD) establishes sovereign national rights over biological resources and commits member countries to conserve them, develop them for sustainability, and share the benefits resulting from the use.3 Sustainable use of biological resources means finding new drugs, crops, and industrial products, while conserving the resources for future studies.
The basic bargain underlying passage of the CBD was that sovereign rights would be tempered by providing access to genetic resources, in exchange for a share of the benefits, including access to biotechnology. To satisfy the three goals of the CBD (conservation, development, and benefit sharing), the principle of sovereign rights is best applied through what have become known as Access and Benefit Sharing Agreements (ABAs).
Under the CBD, prior informed consent is the standard for ensuring a fair and equitable ABA. The source country providing access to genetic resources must know in advance what will be done with the resource, and what benefits will shared. Without such an understanding between the collector and the supplier, there could be no true meeting of the minds, and no fair agreement on benefit sharing. Benefits may include support for research and conservation, contributions of equipment and materials, assistance to indigenous and local communities, up front fees, milestone payments, and royalties.
National laws
Through national biodiversity-related laws and regulations, countries have begun to exercise their sovereign rights over biological resources as established in the CBD. In effect, many of these laws create a new category of poaching, in which biological materials are collected or exported without obtaining permission (informed consent) and satisfying certain conditions such as benefit sharing.
Professional self-regulation
Meanwhile, many institutions and professional organizations have decided to implement natural products research policies for their members, and these policies have quasi-legal or contractual status. Examples include botanical gardens (Kew, Missouri), biotechnology companies (Shaman, Monsanto), and professional groups (the Declaration of Belem of the International Society of Ethnobiology).
The consequences of breaking the new rules
There is a very simple reason for people who collect biological samples to follow the new rules on informed consent and benefit sharing. The consequences of following the old “take-and-run” approach — biopiracy — are extremely serious.
Cancelled patents on natural product inventions
Patents on natural product inventions are subject to attack unless all public knowledge about the species in question and its use are fully disclosed. Organizations in the bioresource-rich but economically poor countries of the developing world have demonstrated a willingness to attack natural product patents on the basis of traditional knowledge, motivated by principles of justice rather than the economic forces usually underlying patent disputes.
For example, a 1995 patent, “Use of Turmeric in Wound Healing,” was cancelled in 1998 after an investigation instituted by India’s Council of Scientific and Industrial Research. The new evidence established that use of turmeric to promote wound healing had been known for generations in India.
Likewise, the 1986 plant patent claimed an ostensibly new, distinct variety of Banisteriopsis caapi, known in the Amazon as ayahuasca. However, new evidence establishes that the claimed plant is actually the wild uncultivated type, and is neither new nor distinctive. COICA, an organization of indigenous people, and the Amazon Coalition have requested reexamination of the ayahuasca patent, seeking to eliminate what is perceived as an immoral expropriation of their traditional and biological heritage. More such challenges can be anticipated.
Where a plant sample is collected illegally and then a new drug compound or valuable gene is isolated from the sample, patented, and commercialized, the patent could be held unenforceable as the result of “tainted research.” The tainted research doctrine is illustrated in the case Regents of the University of California v. Eli Lilly & Co. In developing cDNA encoding human insulin, some researchers violated National Institute of Health (NIH) 1970s regulations that embargoed the use of uncertified plasmids in mammalian recombinant DNA research. They then lied in their patent application, stating that they had used a certified plasmid. The lower court held the patent unenforceable for fraud, the illegitimate fruit of a forbidden tree. The appeals court reversed, holding that it would not have affected examination of the patent if the truth had been told. In other words, recalling the recent impeachment proceedings, the misrepresentation in the patent was not “material.” This case teaches that if an invention is based on tainted research material, such as a plant sample smuggled out of a country in violation of its laws, and the inventor lies about it in a patent, a case of fraud might be made. However, the inventor must have gained some advantage by the misrepresentation, such as being the first to make the invention.
Loss of profits from illegal removal of biological material
If a researcher removes biological material illegally from a source country, and then profits from the material, the source country or affected person could recover all or some of the profits, in a United States court, based on a theory of misappropriation and related doctrines. Thus, there is a real legal risk for someone who fails to reach agreement on an Access and Benefit Sharing Agreement (ABA) before taking a sample home. The conditions a court might impose for a successful product could be much more onerous than one that could be negotiated at the outset, when success is still a highly unlikely outcome. This risk is highest in a country that requires an ABA.
Lack of clean title to biological material Clean title to biological material now means that it was obtained legitimately, and with prior informed consent from whoever had initial control over it. If there is no clean title, the value of the material is seriously reduced. The collector of an illegitimate sample will not be able to pass it on, in turn, to collaborators, partners, or third parties in the normal course of conduct for researchers. Absent assurances that the material was collected in compliance with all applicable laws and regulations including benefit sharing, a savvy recipient of biological material will not accept material. Moreover, if the supplier certifies that a sample was properly obtained, and it was not, then the recipient could assert a contractual claim for damages back against the collector.
Denial of access to samples
As a practical matter, if a collector does not agree to provide an equitable share of benefits, in advance, to the source of biological samples, the collector may well be denied access to the samples. Simply put, the possibilities for fieldwork will dry up.
Blacklisting a biopirate
Someone who is branded as a “biopirate” will suffer from a bad reputation. Someone who gains a reputation for evading access restrictions, or for being hard to deal with, may find it increasingly difficult to find doors open for further research. A company that is associated with biopiracy may end up with weak patents, be exposed to equitable claims for profit-sharing, lose sources of supply, face the prospect of consumer and government boycotts, barriers to importation of biotechnology products, and other loss of market share, and may face financial penalties.
Legal penalties
Finally, the ultimate legal sanction — criminal penalties, including jail — may apply. It is not uncommon for hunters to be jailed for poaching or trespassing. In the biodiversity prospecting context, there is at least one instance of a researcher who was temporarily detained in Australia for unauthorized collecting of plant materials. Collection of biological materials without a benefit- sharing agreement is likely to find its way into the list of criminal violations in some countries, so that biopiracy could result in a jail sentence.
Conclusion
Legal tools are being developed whereby developing countries and other biodiversity rich countries may exert greater leverage over the use of their resources. This leverage can be used to earn revenues, promote conservation, and train and educate biochemists. However, the required legal tools — legislation, agreements, and court action — are sophisticated and difficult to employ. It has been far easier to engage in political, economical, technological, and ethical debates than to find legal frameworks for action.
Nonetheless, given the growing legal and practical risks, many organizations have concluded that it is wise to enter into an access and benefit-sharing agreement for every collection. Corporations have recognized that adherence to principles of sustainable development, including the use of ABAs for natural product research, brings significant benefits to the company. Why are companies following the new rules? By doing so, they can:
- improve the reliability and quality of the material supplied to them
- benefit from access to traditional knowledge about plants and insects
- establish good will which can pay off in present or future markets for the company’s products
- distinguish themselves from less green competitors, thus obtaining a competitive advantage.
The true risk to natural product research is not that the greenhouse door will be shut, thus reducing supply, or that demand for natural products will cease. Rather, the risk is that supply will drop because species are disappearing faster than we can protect and study them. To quote E. O. Wilson, “useful products cannot be harvested from extinct species.”4 The most fundamental risk to natural products research is continued loss of biodiversity. If the new rules for biodiversity prospecting succeed in reducing biodiversity loss, while allowing research to continue, then any inconvenience they bring will be justified. Hopefully, the new system will work, and we can find effective ways to work within it.
© 1999, Michael A. Gollin, reprinted with permission. From “Legal consequences of biopiracy” published in Nature Biotechnology, Vol. 17, Sept. 1999 and previously presented to the American Society of Pharmacognosy in 1998. © February 2001, American Institute of Biological Sciences, article updated by the author for this web site. See reprint policy.
