Regulating Bioprospecting: Institutions for Drug Research, Access and Benefit-Sharing
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《新英格兰医药杂志》
Early European explorers sailed east and west in search of gold, silver, and rare spices, but some of the most extraordinary riches that they found were the medicinal plants of the New World. Throughout human history, cultures have identified medicinal properties in plants, and many of those plants remain in use today. Aspirin, chloroquine, the digitalis glycosides, morphine, curare, vincristine, and paclitaxel were all discovered in nature. Many of the plants from which these drugs were isolated had a history of use in traditional medicines. In addition to pharmaceuticals, botanical products (herbals) — including echinacea, ginkgo, saw palmetto, and St. John's wort — continue to play an important role in modern health care in both developed and developing nations. Historically, the natural environment has provided the best source for new drug leads, because the extensive chemical diversity found in nature is unmatched in synthetic chemical libraries. However, there is concern about the future of drug discovery based on natural products. Unique ecosystems are rapidly being lost worldwide, and access to natural resources for bioprospecting has become limited. This loss of access is due in part to the fact that source nations historically have not reaped significant benefits from their natural resources, and a few source nations hold the view that some early bioprospecting efforts constituted biopiracy.
Padmashree Gehl Sampath's book describes in detail the complex issues that govern bioprospecting today. The requirement to respect and adequately compensate source nations for their unique resources must be balanced with the need for new opportunities for pharmaceutical discovery. The issues are multifaceted. Source nations need to preserve their biodiversity, initiate sustainable development, and receive equitable compensation for their biologic and intellectual resources. The interests of the source nations must be reconciled with those of indigenous populations and private landowners to support national goals of resource protection. An economic reality is that pharmaceutical and biotechnology companies that are considering bioprospecting must be able to generate a reasonable return on their investments.
The Convention on Biological Diversity was drafted at the Earth Summit in 1992 to address conservation, sustainability, and benefit sharing of biologic assets. This document established a framework for reconciling the divergent issues involved in bioprospecting for the benefit of all. Unfortunately, the initial optimism about the effect of this treaty on encouraging bioprospecting and the sharing of benefits has diminished. As described by Sampath, "Drug companies, stuck between the choice of exploiting newer, more promising technologies, and using natural products for drug R&D amidst legal uncertainty and potentially unrealistic benefit-sharing expectations, are seemingly choosing the former option." For many interested in drug development, the decline in bioprospecting represents a missed opportunity.
The careful analyses presented in this book describe the economic and legal factors governing bioprospecting from all perspectives, including those of pharmaceutical research and development, the rights of nations and indigenous peoples to regulate access to their resources and intellectual property, and international policies. Sampath gives examples of contractual agreements for the collaborations that have been successful and those that have not been successful. After these extensive evaluations, she presents an approach to future bioprospecting agreements. The strength of this book is the comprehensive coverage of different viewpoints regarding how equitable bioprospecting can best be achieved and what its realistic goals should be.
(Figure)
Bark of the Pacific Yew Tree (Taxus brevifolia).
From K. Beebe/Custom Medical Stock Photo.
A few minor inaccuracies should be noted, including the misspelling of reserpine and the description of the original source of paclitaxel, the Pacific yew (Taxus brevifolia), as the Himalayan yew. Despite these minor issues, this book is a well-referenced, scholarly work that should be consulted by anyone wanting to understand the challenges of bioprospecting today, from source nations to those considering or conducting these efforts.
Susan L. Mooberry, Ph.D.
Southwest Foundation for Biomedical Research
San Antonio, TX 78245
smooberry@sfbr.org(By Padmashree Gehl Sampat)
Padmashree Gehl Sampath's book describes in detail the complex issues that govern bioprospecting today. The requirement to respect and adequately compensate source nations for their unique resources must be balanced with the need for new opportunities for pharmaceutical discovery. The issues are multifaceted. Source nations need to preserve their biodiversity, initiate sustainable development, and receive equitable compensation for their biologic and intellectual resources. The interests of the source nations must be reconciled with those of indigenous populations and private landowners to support national goals of resource protection. An economic reality is that pharmaceutical and biotechnology companies that are considering bioprospecting must be able to generate a reasonable return on their investments.
The Convention on Biological Diversity was drafted at the Earth Summit in 1992 to address conservation, sustainability, and benefit sharing of biologic assets. This document established a framework for reconciling the divergent issues involved in bioprospecting for the benefit of all. Unfortunately, the initial optimism about the effect of this treaty on encouraging bioprospecting and the sharing of benefits has diminished. As described by Sampath, "Drug companies, stuck between the choice of exploiting newer, more promising technologies, and using natural products for drug R&D amidst legal uncertainty and potentially unrealistic benefit-sharing expectations, are seemingly choosing the former option." For many interested in drug development, the decline in bioprospecting represents a missed opportunity.
The careful analyses presented in this book describe the economic and legal factors governing bioprospecting from all perspectives, including those of pharmaceutical research and development, the rights of nations and indigenous peoples to regulate access to their resources and intellectual property, and international policies. Sampath gives examples of contractual agreements for the collaborations that have been successful and those that have not been successful. After these extensive evaluations, she presents an approach to future bioprospecting agreements. The strength of this book is the comprehensive coverage of different viewpoints regarding how equitable bioprospecting can best be achieved and what its realistic goals should be.
(Figure)
Bark of the Pacific Yew Tree (Taxus brevifolia).
From K. Beebe/Custom Medical Stock Photo.
A few minor inaccuracies should be noted, including the misspelling of reserpine and the description of the original source of paclitaxel, the Pacific yew (Taxus brevifolia), as the Himalayan yew. Despite these minor issues, this book is a well-referenced, scholarly work that should be consulted by anyone wanting to understand the challenges of bioprospecting today, from source nations to those considering or conducting these efforts.
Susan L. Mooberry, Ph.D.
Southwest Foundation for Biomedical Research
San Antonio, TX 78245
smooberry@sfbr.org(By Padmashree Gehl Sampat)