Biodiversity
International Framework for Intellectual Property Rights in Biodiversity
Trade-Related Intellectual Properties in the GATT/WTO
The UN Food and Agriculture Organization
The Convention of Biological Diversity
Partnership of Benefit-Sharing
Merck and INBio
International Cooperative Biodiversity Groups Program
'Biodiversity' is a compound of the words "biology" and "diversity." Biodiversity is commonly used to describe the number and variety of living organisms on the planet, including genes, species and ecosystems that are the result of over three billion years of evolution. Attempts to quantify biodiversity are generally limited to species number. To date, an estimated 1.7 million plant and animal species have been identified, and although the exact number of the Earth's existing species is still unknown, conservative estimates have put the total number at close to 14 million species.
Species extinction is a natural part of the evolutionary process. Due to human activities, however, species and ecosystems are more threatened today than ever before in recorded history. The losses are taking place primarily on tropical forests where 50-90% of identified species live. The most recent estimates predict that we are losing 4,000 species a year in the tropics alone to extinction. I
see "What is biodiversity?" World Resource Institute homepage see vital sign of biodiversity images
directory of international biodiversity resources
The protection of intellectual property rights is a key element for assessing risks in bioprospecting investments, since products are heavily dependent on their "uniqueness" to recoup costs. Pharmaceuticals, in particular, involve significant capital investment to produce, but once on the market they are very easily duplicated. As a result, the pharmaceutical industry incurred worldwide losses of around $6 billion annually from the pirating of patented medicines in 1992 and this figure has increased ever since.
The biotechnology industry tends to be regulated in industrialized countries through national laws on laboratory practices and the release of living modified organisms outside the laboratory. For instance, intellectual property protection for organisms existed in the U.S. if they have been changed from their natural state, using traditional breeding techniques or recombinant DNA technology. By inducing new characteristics, unpatentable products of nature can be transformed into patentable products derived from nature. In the U.S. there are three major legislative acts, under which intellectual property protection for plants is available as long as such plants are original, novel, useful and nonobvious. However, there is no intellectual property protection for the plant/genetic/biodiversity resources discovered in nature. In the pharmaceutical arena, this lack of patent for naturally-occurring compounds is detrimental to corporate initiative since it allows competitors to copy these formulas and prevents the discoveries from recovering their development/discovery costs and yield a profit for investors.
see the U.S. governmental resources
about Intellectual Property Rights
To date, international frameworks for Intellectual Property Rights have existed in two primary regimes and a Convention;
The Uruguay Round of Multilateral Trade Negotiations under the General Agreement on Tariffs and Trade (GATT) has substantially expanded the normal purview of trade agreements to include trade in investment, services and intellectual property. As a result, an Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) has been in effect by majority of the developing and developed nations alike under the World Trade Organization (WTO). With the adoption of the agreement, signatory states are obligated to adopt a patent system for microorganisms and to establish either patents or some sui generis from intellectual property for plants.
However, extending intellectual property rights to genetic innovations is highly controversial. While governments in developed nations, particularly the U.S., defend intellectual porperty law as just and efficient, many developing nations view it as fundamentally unjust a means by which resources and wealth are transferred from them to developed countries with the imprimatur of legality.
see WTO Homepage
FAO grants extensive protection to plant breeders who improve plant varieties through crossbreeding wild and improved strains. In the 1996 FAO fourth International Technical Conference on Plant Genetic Resources, the countries reached consensus on specific wording which confirms the "needs and individual rights of farmers and, collectively where recognized by national law." And they also reaffirmed the FAO's resolution on Farmers' Rights. This wording does not necessarily protect farmers' rights, at least the term was retained despite the strong resistance of the U.S.
see FAO
Home page
Conservation of biological diversity and the sustainable use of plant and animal species was highlighted in the first global,
comprehensive agreement, namely the Convention on Biological Diversity signed in 1992 at the UN Earth Summit in Rio de Janiero.
Its objectives were stated as "the conservation of biological diversity, the sustainable use of its components and the fair and equitable
sharing of the benefits arising out of the utilization of genetic resources." Under this Convention, biodiversity and its economic benefits
were re-defined from the "common heritage of mankind" to "national goods" that nations could protect and trade as commodities. Even
though it stated that conservation was the "common concern" of all humanity, the Convention thus gave a great deal of emphasis to the
rights of developing countries to exploit, and reap benefits from, discoveries made in their own territory.
Since the early negotiation phases of the Convention on Biological Diversity (CBD) began, the harshest debates have occurred over issues related to the sovereign rights of countries within whose borders biological resources of global benefit lie. The main argument centered on the fact that even though biological resources from developing countries have created the basis for many pharmaceutical agricultural and biotechnological innovations in developed countries, little of the profits flow back to the source countries, usually poorer developing nations. It was, in essence, an unequal partnership between genetically-rich but technology-poor developing countries on one side and technology-rich but genetically-poor industrialized countries on the other.
By 1992, however, there were changes in legal and institutional treatment of indigenous genetic resources was changing. The CBD guaranteed states sovereignty over their genetic resources and forbade their appropriation without prior consent. This property right protection to genetic resources was exactly the kind of profit-sharing mechanism that the industrialized nations did not want. But since the CBD has already gone into effect even without U.S. support, corporations around the world (including the U.S.) are beginning to take into account these payments when they plan to engage in bioprospecting. In this convention, some government convinced that intellectual property is the main tool of a new technological colonialism, other viewed as proper and justifable means to protect industries and biodiversity.
An example of the growing level of cooperation between government and private sector entities in developed countries to share the fruits of bioprospecting with their counterparts and indigenous peoples of the regions which yield these discoveries can be found in recent two accords.
These contracts have drawn worldwide attention to an agreement that it ensures adequate compensation to the providers and protectors of genetic resource as well as solid, long-term commitment by local peoples to facilitate a pharmaceutical firm's research into drugs that may have global benefits. As a primary beneficiary of bioprospecting, industry ought to help in the funding of such biodiversity institutes.
The research organization Costa Rica's National Biodiversity Institute (INBio) is currently in the process of cataloging all plants and animals in Costa Rica. In exchange for the right to screen this catalogue for biological activities, Merck paid some $1.1 million up front, as well as an unspecified percentage of future royalties. Under this contract, Merck scientists can evaluate plant, insect and animal samples from protected Costa Rican government reserves to determine if they might have pharmaceutical or agricultural applications. Ten percent of the initial fee and 50% of the royalties will then be funneled back into conservation and biodiversity protection through an arrangement with the Costa Rican government. Considered a success so far by all parties involved, the agreement has been renewed twice, most recently in 1997.
see TED case of Merck
The U.S. government, for its part, has developed similar partnerships with developing countries to promote pharmaceutical prospecting and biodiversity conservation alike. The National Institute of Health (NIH), the National Science Foundation, and the USAID established the five-year International Cooperative Biodiversity Groups (ICBG) program in 1993. The program funded partnerships between academics, companies, government agencies and local peoples and local institutions in source countries to engage in bioprospecting efforts throughout Latin America and Africa. Its funding accounts for FY95 $2.35 million with capacity in 20 different institutions and training over 130 individuals. The ICBG program stresses three primary goals:
(1) drug discovery
(2) conservation of the environment and genetic resources of the source country
(3) development of sustainable economic activities for the people of the source country.
By adding economic value to biodiversity, therefore, this program aims to enhance the motivations surrounding environmental conservation to the economic, political and health care realms. In late February 1997, representatives from each group convened at NIH for the first evaluation of the program by an outside review panel.
Each of the five projects has developed its own intellectual right structure. For instance, in one of the project, the U.S. side entered into a contract with forest people in Peru, offering a "know-how" license to compensate them for assisting in American bioprospecting efforts. A know-how license covers the intangible resources such as in-depth knowledge that leads to the collection of certain plants. In exchange for annual payments, milestone payments and royalties, the forest people are giving the U.S. interests involved the right to use plant samples with their knowledge for a certain period of time.
This evolving framework which takes into account intangible, traditional knowledge about yet undiscovered species through fair compensation will further strengthen and validate the increasingly close relationship between pharmaceutical and biotech companies on one side and source countries and their indigenous peoples on the other.
see NIH homepage
see National Science Foundation homepage
Five Team :
(1) The Suriname ICBGworks with indigenous forest people who live in the interior of the country. Principal investigator is David G. I. Kingston, a chemistry professor at Virginia Polytechnic Institute & State University. The Suriname pharmaceutical company Bedrijf Geneesmiddelen Voorziening Suriname and Virginia Tech and BristolMyers Squibb Pharmaceutical Research Institute (NJ) have participated in extracting and analyzing plant materials.
(2) The Peruvian ICBG led by Walter H. Lewis, a biology professor at Washington University, works with three clans of the Agrarian people in northern Amazonian Peru. The Museum of Natural History of the University of Sam marcos in Lima provides additional information on potential useful species. A Peruvian University in Lima and Washington University and a pharmaceutical sector of Monsanto are jointly involved in extracting and analyzing species.
(3) The Costa Rica ICGB by Meinwald at Cornell University is looking at insects as sources of drugs. Bristol-Myers Squibb and Costa Rica's INBio and Guanacaste Conservation Area are joining in this program as partners.
(4) The Africa ICBG headed by Walter Reed's Schuster is looking primarily for drugs to treat parasitic diseases such as malaria, leishmaniasis, and trypanosomiasis. This team relies on the information from traditional healers. The University of Dschang in Cameroon and the Bioresouces Development & Conservation Program, an African NGO in Cameroon and Nigeria and Smithsonian Institute in Washington D.C. collaborate with Schuster's.
(5) The Latin American ICBG, led by Barbara Timmermann from the University of Arizona, is prospecting in the arid and semiarid regions in Argentina, Chile and Mexico. This group is looking for chemicals for agriculture and veterinary uses as well as drugs. This team is the largest in the ICBG program, collaborating on the Bioactive Agents from Dryland Plants of Latin America Project with several public and private groups from Buenos Aires, Patagonia, Argentina, Chile, Mexico and the U.S.
