[Book Review] The Protection of Traditional Knowledge at the Frontiers of Drug Discovery

This is a review of the book, The Protection of Traditional Knowledge at the Frontiers of Drug Discovery (Hart, 2024) by Peter S. Harrison. In this book, Harrison draws on his science background and experience as a lawyer in pharmaceutical and biotech patent litigation to explore the challenges of enforcing the rights of Indigenous peoples to control the use of their traditional knowledge.

The argument of the book

The book is currently available in hardback.

The book makes an important contribution to the scholarship on the protection of traditional knowledge under the Convention on Biological Diversity (CBD) and its Nagoya Protocol. These insights are especially helpful in the wake of the conclusion of the new WIPO Treaty on Intellectual Property, Genetic Resources and Associated Traditional Knowledge (covered by this Kat here). To avoid overuse of abbreviations, all references to "traditional knowledge" in this review refer to "traditional knowledge associated with genetic resources", which is abbreviated to TKAGR in the book.

The book is divided into six substantive chapters plus an introduction and conclusion. The introduction sets up the fundamental assumption underpinning the book's argument: that the Nagoya Protocol's requirement for free, prior informed consent (FPIC) - derived from language of the UN Declaration on the Rights of Indigenous Peoples (UNDRIP) - amounts to a "veto" over the use of traditional knowledge in the search for pharmaceutically active compounds. 

Setting up the argument

In Chapter 2, the first substantive chapter, Harrison outlines the different international legal instruments that have sought to protect Indigenous peoples' rights to their traditional knowledge. The book was finalised before the conclusion of the new WIPO Treaty, but this chapter still has relevant commentary on the proposed disclosure of origin requirement for patents that was subsequently adopted. 

In Chapter 3, Harrison then explains how the requirements for FPIC under the Nagoya Protocol creates a "positive right" over traditional knowledge that amounts to a veto. This is a common view of FPIC, but not a universal one. For example, a recent Federal Court ruling in Canada explicitly found that the concept of FPIC in UNDRIP "is not a veto or a right to a particular outcome". Instead, FPIC is "a process that places a heightened emphasis on the need for a deep level of consultation and negotiations geared toward a mutually accepted arrangement... tailored to consider [the impacted Indigenous Nation's] laws, knowledge, and practices": Kebaowek First Nation v Canadian Nuclear Laboratories [2025] FC 319. Regardless of these different views, the book thoroughly tackles the difficult legal and philosophical questions created by the Nagoya Protocol's requirement for FPIC, from the perspective of a veto. He notes that, without more guidance in the Nagoya Protocol, it is not clear how the need for fair protections for traditional knowledge are to be balanced with the need for legal certainty for third parties, as well as other policy concerns.

Chapter 4 examines the various philosophical justifications for these positive rights to traditional knowledge, by reference to the common justifications for intellectual property rights (such as utilitarian theories and natural rights theories). Harrison acknowledges that these are Western philosophical traditions, and the knowledge and cosmologies of Indigenous peoples are not usually founded upon these Western traditions. However, he argues that this analysis would still be helpful as a direct rebuttal to many critics of traditional knowledge protection, whose arguments tend to be rooted in these Western concepts. 

The issue of serendipity

Chapter 5 outlines the process of drug discovery and the flows of information through the process. It contextualises a key issue: serendipitous discoveries of new therapeutic uses of drugs that did not, in fact, derive from the use of traditional knowledge and were "truly unexpected in the light of the current understanding of the underlying biology when the discovery of the second use is made". The chapter uses four case studies of second uses of known chemicals to illustrate this point.

Chapter 6 assesses whether the philosophical justifications can support the positive rights over traditional knowledge in the context of serendipitous discoveries. Harrison shows that the results are varied and sometimes directly contradictory. Chapter 7 synthesises the results. The book uses additional theories and principles to weigh the different philosophical justifications and settle on a workable approach to the protection of traditional knowledge, especially one that would adequately support global health concerns.

Overall thoughts

The book is a timely and helpful resource that ultimately seeks to highlight the practical and workable approaches to traditional knowledge protection. Of course, given the subject matter, it contains a lot of technical language and details, but the book takes the necessary time to explain complex aspects of the drug discovery process and critically analyse various philosophical justifications for intellectual property. It will be of interest to any readers who follow the policy debates about intellectual property and the protection of traditional knowledge, especially in the pharmaceutical industry.

Details

Publisher: Hart, 2024

Extent: 352 pages

Format: Hardback

ISBN: 9781509937530