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Sarah Houlton, PhD, is Pharmaceutical Executive’s international correspondent.
The number of pharmaceuticals derived from nature is staggering. Many medicine cabinet staples were first isolated from natural sources-penicillin from mold, quinine from the cinchona tree, digitalis (foxglove) for heart ailments, and the list goes on.
The number of pharmaceuticals derived from nature is staggering. Many medicine cabinet staples were first isolated from natural sources-penicillin from mold, quinine from the cinchona tree, digitalis (foxglove) for heart ailments, and the list goes on. But many modern miracle drugs also have their roots in nature. Cyclosporin, the immunosuppressant that revolutionized the prospects of organ transplant patients, was found in a fungus. And Taxol (paclitaxel), the potent anticancer agent, was discovered in the bark of the Pacific yew tree.
Many of the medicines nature provides have incredibly complex chemical structures, which would be almost impossible to discover in the laboratory. Microbes and plants have developed them over thousands of years in response to threats in their environments. And humans used plants as medicines many centuries before the industry came into existence. But pharma companies have managed to isolate the active molecules produced in medicinal herbs and use them to spark drug discovery programs.
Therein lies the problem. There is a growing disquiet among advocacy groups and the governments of developing countries about the rights to the intellectual property that such searches generate. Isolation of the active material may result from one company's efforts, but it's not clear who owns the rights to the plants from, say, a remote part of the Amazon jungle. Should it be the pharma company or the indigenous people who have used the plants as medicines for generations?
The World Intellectual Property Organization (WIPO) has formed an intergovernmental committtee to coordinate the development of guidelines for intellectual property and genetic resources, traditional knowledge, and folklore. The Convention on Biological Diversity, already ratified by 178 countries, encourages the equitable sharing of benefits arising from the use of local knowledge and practices. WIPO also encourages the establishment of regional databases of such traditional knowledge.
One such database is being set up in Venezuela. The BioZulua project is designed to record information about food crops and medicinal plants. Field researchers are collecting the data from 24 distinct ethnic groups in the Amazon jungle of Venezuela. The Foundation for the Development of Mathematics and Physical and Natural Sciences in Caracas is administering the project.
An essential part of the project is that ethnic groups retain the intellectual property rights associated with the plants' healing properties and that the Venezuelan government may eventually charge pharma companies for access to the information. The data include species, geographic location, and ailments that local people treat with the plants. Venezuelan authorities hope that the database will help prevent the "biopiracy" some groups, including Oxfam and Friends of the Earth, believe is going on.
Other countries, notably India and China, are also creating national "traditional knowledge" databases. WIPO is developing a portal, www.wipo.int/globalissues/tk/tkportal/index.html, that will improve patent examiners' access to details of such knowledge.
The databases also should prove advantageous to pharma. If all the information about the traditional uses of medicinal plants is collated in one database, it should make the task of pinpointing potentially useful plants much simpler. And if the databases become a tool to ensure that the indigenous people who have used the plants receive suitable payments for their knowledge, that will minimize the industry's vulnerability to charges of biopiracy.