Access to traditional knowledge resources key to pharma

[Aman, University of Houston law center member of the institute for intellectual property and information law, June 30 2019, Denver Law Review, “PATENTS, DISCLOSURE, AND BIOPIRACY”, https://papers.ssrn.com/sol3/papers.cfm?abstract_id=3188311, Accessed July 02 2024, AMH]

A. The Value & Loss of TK Resources92

The relationship between the requirement and the use of TK resources can be explained through the example of modern drug discovery and development. Although the example of TK use in the biopharmaceutical field is used as an example throughout this Article, one can imagine the multiple areas of modern research and development that could benefit from the use of TK.93

It is no secret that research and development takes considerable time and resources in the biotechnology and pharmaceutical (hereafter biopharmaceutical) industries. For instance, by one estimate, the out-of-pocket preapproval cost of the development of a drug to the point of marketing is around $802 million.94 And the average time from human testing to post-regulatory approval is estimated to be over nine years.95 One approach that biopharmaceutical firms have adopted to reduce this cost is “ethnopharmacology” or “ethnomedicine,” which is the use of TK in the search of resources with medicinal value.96 Empirical research has proved that ethnopharmacology has reduced the time and cost of developing biopharmaceutical products.97 One of the key benefits of using TK resources is in increasing the efficiency of initial screening of biodiversity candidates for further examination. For instance, in one study, the chances of getting a preliminary hit98 in plant screening increased from 6% without the use of TK to 25% with the use of TK.99 Additional research indicated that the use of TK increased the efficiency of screening plants in the development of a cure for HIV/AIDS.100 While some claims of traditional medicines have had questionable efficacy,101 the empirical evidence points to the significant potential that TK resources have as an input for modern industries. The trial and error from the centuries-old use of biodiversity resources by communities has been serving as a diverse pool upon which biopharmaceutical firms build to develop modern drugs.

Despite the value of biodiversity and TK resources, they increasingly face an alarming rate of loss.102 Conservationists have been warning of the high rate of biodiversity loss since the later decades of the twentieth century.103 Caused by human activity such as changes in land use, pollution, climate change, and invasion of invasive species, the loss of biodiversity has been estimated to be 100–1000 times the rate it would be without human interference.104 For example, the normal rate of biodiversity loss used to be in the range of “1–10 species per million per year,” but in recent years that number has risen to “hundreds or low thousands per million per year.”105 Researchers have calculated the annual loss from ecosystem services to be around $250 billion.106 To save this valuable resource from disappearing, world leaders worked towards the signing of the Convention on Biological Diversity in 1992.107 Two of the key contributions of the Convention to our current purposes were: (1) the recognition that source countries have sovereign rights in their biodiversity resources;108 and (2) the recognition that indigenous peoples and local communities should equitably benefit from the innovations arising out of TK resources.109

In addition to the inherent harm caused by the loss of biodiversity, this alarming rate of loss impacts the sustainability of innovation in the bioprospecting industry. Because only a small portion of the world’s biodiversity has been scientifically studied,110 the high rate of loss means inventors (and by implication, the public) miss out on the development of products with potential to enhance welfare.