Service on Intellectual Property Issues (Jul20/03)
We are pleased to share with you a TWN Discussion Paper titled “Finding Traditional Knowledge’s Place in the Digital Sequence Information Debate” by Edward Hammond (https://twn.my/announcement/TWB_EHamm_Jul2020_D03.pdf)
In biodiversity, agriculture, and health, policy-makers are struggling with a difficult knot of considerations as they seek a solution to the access and benefit-sharing (ABS) issues posed by digital sequence information (DSI).
This discussion paper is intended to prompt thinking about one of the most important of those issues, how traditional knowledge (TK) and the rights of indigenous people and local communities (IPLCs) should be addressed in relation to DSI. In raising this discussion, which has not been given due attention by policy-makers to date, this paper primarily focuses on the Convention on Biological Diversity (CBD).
For over 25 years, CBD Parties have worked to develop ABS laws and regulations to facilitate the sharing and use of biodiversity for the Convention’s purposes. These systems typically rely on the material transfer agree-ments associated with shipments of physical samples. These documents, which are usually legally binding, show compliance by users of genetic resources with their obligations to obtain prior informed consent of resource providers (including of IPLCs) and to negotiate mutually agreed terms for benefit sharing.
since the CBD’s Nagoya Protocol on access and benefit sharing entered
into force in 2014, the legal systems for transfer of physical samples
of genetic resources between countries have become better established.
Yet, at the very same time, the technological realities of how genetic
resources are used have been shifting. To an increasing extent, use
of DNA sequences and other DSI – in lieu of and in addition to use
of physical samples – generates benefits from use of biodiversity.
That certainly includes valuable commercial products. But material
transfer agreements don’t typically cover transfer and use of DSI
like sequence information. As such, the rise of DSI as a means of
transferring and commercially exploiting biodiversity poses an existential
threat to the CBD through its potential to undermine the Convention’s
third objective (fair and equitable benefit sharing).
In late January 2020, Kate Broderick, a research director at Inovio, a US vaccine company, explained to the BBC that to design a COVID vaccine all Inovio needed was a SARS-CoV-2 virus sequence. Said Broderick, ‘We downloaded [the SARS-CoV-2 se-quence] and started working on it immediately. And essentially overnight, we designed the vaccine.’ Within days, the company synthesized that candidate vaccine and began clinical testing in mammals.
However, according to another Inovio research director named Trevor Smith, it didn’t take the company an entire night, it actually only took three hours. Said Smith to the US press a few days later, ‘We have an algorithm which we designed, and we put the DNA sequence into our algorithm and came up with the vaccine in that short amount of time.’
Not to be outdone, on the same day that Broderick’s BBC interview aired, US diagnostics maker IDbyDNA touted its DSI database diagnostic platform, claiming that it could now diagnose COVID-19 (as the disease caused by SARS-CoV-2 is called) by direct ‘next generation’ sequencing, a service the company offers to hospi-tals. The company’s tests rely on a proprietary database of DSI of 50,000 microorganisms, including more than 3,000 pathogens. On the same day, the company announced that it had received US$20 million in new venture capital investments.
within days of being posted on the Internet, SARS-CoV-2 DSI had been
converted into a physical product (candidate vaccine) and incorporated
into the proprietary DSI database of a company selling sequencing
and diagnostic services. And Inovio and IDbyDNA are only two examples
of the dozens, and perhaps hundreds, of companies doing so.
While a solution to benefit sharing for DSI cannot undo historical injustices to IPLCs, new international ap-proaches and agreements in biodiversity certainly should not repeat past mistakes. As surely as national inter-ests are threatened by the unregulated transfer and use of DSI undermining national laws on access to biological diversity, the same phenomena also threaten the rights of IPLCs over their knowledge and resources. What this means is that a prominent and secure place for IPLCs must be found in the access and benefit-sharing solution that is developed for DSI.
The tough negotiating road ahead has been delayed by the COVID-19 pandemic. This pause in the pace of negotiations offers the opportunity to reflect on how the CBD’s goals might best be supported by a benefit-sharing solution for DSI. For generations, scientific and commercial developments in agriculture, health, and other sectors have benefitted from the knowledge and insights of IPLCs, and the genetic resources that they have protected, cared for, and developed. But the process has not been a fair one, and DSI enables further alienation of IPLCs from their resources and knowledge.
As bioinformatics, the ‘-omics’ disciplines, and artificial intelligence come to dominate development of products based on biodiversity, it stands to reason – and is just – to preserve, fortify, and further develop the alternative biodiversity knowledge systems of indigenous peoples. Working in concert with IPLCs to dedicate DSI benefit sharing to the support of local knowledge, development of local biocultural information systems, and systems to govern them of the IPLCs themselves, benefit sharing from DSI can promote local innovation consistent with the cultures and values of IPLCs, and maintain biocultural diversity that ultimately benefits all of humanity.