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Implications of Digital DNA on the Nagoya Protocol

“Biopiracy” refers to the phenomena whereby plants and animals are physically removed from Indigenous communities, without their knowledge or consent, in order to extract and manipulate genetic material from those plants or animals. This is typically done to commercialize some characteristic of the plant or animal that has marketable properties. For example, the anti-freeze proteins in some species of Arctic fish are currently being used to develop more robust anti-freeze products for industrial uses.


With recent advances in digital and bio technologies, scientists are now able to take things one step further: rather than physically removing a plant or animal, the organism can be scanned and its genetic structure sequenced “on site” (in situ). This information can then be uploaded to the internet, and transferred to a DNA synthesizer to be copied or reconfigured elsewhere. The result? “Digital DNA.”


Prosecution of biopiracy based on patents requires a connection between the patented plant genetic resource or gene and the country or region from which it originated. With the use of digital DNA and synthetic biology, it is now almost impossible to track genes back to their true origin, since plants can now be genetically engineered in laboratories.


In an extensive report analyzing the implications of synthetic biology on the Nagoya Protocol, Intellectual Property law expert Margo Bagley raised concerns over “whether synthetic biology products and developers are subject to the Nagoya Protocol.” While Canada’s non-signatory status to the Nagoya Protocol on Access to Genetic Resources and Fair and Equitable Sharing of Benefits Arising from their Utilization has come under close scrutiny since 2014, it is questionable whether this international instrument will provide sufficient protection against biopiracy of Indigenous genetic resources in Canada and elsewhere, especially taking into consideration the fluidity of knowledge over genetic resources in the context of digital DNA.


In this blog, I will be discussing digital biopiracy in the Canadian context and its access and benefit sharing implications. I will first give a brief overview of Canada’s current stance on the Nagoya Protocol, and then discuss a potential solution to digital biopiracy that could address the access and benefit sharing obligations of states.


Tobacco could eliminate malaria in Aboriginal Communities in the absence of digital biopiracy


Scientists have developed a genetically engineered tobacco plant that is used to produce the chemical precursor to artemisinin – the best antimalarial drug. With the reduced cost of genetically engineered artemisinin, it is estimated that harvesting an area less than the size of Boston could provide sufficient supply to manufacture antimalarial drugs that would meet global demand.


In its 2014 inter-agency report on Indigenous Peoples’ Issues, the United Nations reported malaria as one of the most prevalent infectious diseases in Indigenous communities, in particular those settled in Southeast Asia and the Amazon Region of South America.


Tobacco is a sacred plant for many Aboriginal Peoples. It is still used for religious ceremonies alongside sweet grass, sage and red cedar in North and South America, as it has since before European contact. While there is no question about the availability of the plant in Aboriginal communities, access to scientific and technological resources to research or produce the drug is questionable. Under the Nagoya Protocol, the users (the researchers) who have accessed and used the genetic resource from the Indigenous community would be required to (a) seek permission to access the genetic resource or the traditional knowledge and (b) provide a share of the benefits derived from the genetic resource to the provider (Aboriginal peoples) if desired. By eliminating the link between the derivatives (pharmaceutical drug) and the place of origin (Aboriginal peoples), synthetic biology also eliminates any possibility of gaining access and benefit privileges, which could include technology transfer, research training, or free access to derivatives, in this case the much-needed antimalarial drugs – the very thing that the Nagoya Protocol is supposed to protect.


The Way Forward for Canada


In 2015, Environment Canada released a presentation on NP and ABS. At the time, it was noted that “Canada was actively involved in the negotiation of the Protocol but has not yet made a decision on whether to become a party.” More than two years since that presentation was published, and more than a year after the Trudeau government made an electoral promise to review, repeal and amend all existing laws that do not respect Indigenous rights or that were passed without proper consultation, Canada’s ongoing attempt to deliver on that promise has yet to broach the issue ABS and the NP specifically.


One of the underlying reasons that hinder progress on this front is the discussions held with stakeholders such as Intellectual Property Institute of Canada (IPIC). IPIC’s position indicates that “concerns related to pirating traditional knowledge and genetic resources can already be addressed through the existing frameworks for patentability, and that the proposed agreements could create uncertainty in a number of ways.”


On the one hand, it is true that the Nagoya Protocol remains insufficient to address problems of the new age – of synthetic biology. Once synthetic DNA is patented, it becomes ABS-free. In Association for Molecular Pathology v. Myriad Genetics, Inc., the United States Supreme Court held that the mere isolation and identification of a natural DNA gene sequence is not patentable, while creation of synthetic DNA is.


On the other hand, existing frameworks are also insufficient as isolated natural DNA can still be the subject of bioprospecting with the advent of technology in the absence of a multilateral intellectual property treaty that mandates countries to impose a genetic resource disclosure of origin requirement in patent applications.


Establishing a global digital database could be a solution to digital biopiracy


The key to establishing a digital biopiracy claim is to prove that traditional knowledge or genetic resources that are unique to a particular Aboriginal community have been stolen. The development of a global digital database that documents the origins of genetic resources could strengthen Indigenous data sovereignty claims while also facilitating free access to data. While many Indigenous and local communities are resistant to digitizing the traditional knowledge related to many of these genetic resources (for fear of exploitation, among other concerns) the fact remains that this is one of the best methods we know of to protect Indigenous rights over genetic resources housed on their traditional lands.


The International Treaty on Plant Genetic Resources for Food and Agriculture (IT-PGRFA) has been operating on a similar multilateral ABS solution since its adoption in 2001. Parties to the Treaty share genetic diversity and related information about the crops in their domestic gene banks through the Multilateral System. The System is freely accessible by all and provides monetary and non-monetary benefits in various forms, including through equitable share of financial profits, technology transfer and capacity building.


Germ Plasm Banks (GBs) constitute another example of biotechnological collaboration for data collection at the international level and are regulated under the Budapest Treaty by the World Intellectual Property Organization (WIPO). GBs store biological samples from around the world that can easily be examined in the event of a patenting dispute. In fact, Canada has a domestic gene bank, Plant Gene Resources of Canada, that preserves genetic resources for food and agriculture. PGRC also maintains a database for germplasm holdings that currently include 110,444 species.


Despite the existence of several other institutions and global initiatives that could provide the foundation for a solution to digital biopiracy that impact the intellectual property rights of Aboriginal peoples, there are currently no global initiatives to trace and preserve genetic resources of Aboriginal communities. Without such an initiative, there will neither be sufficient basis to establish a claim for intellectual property rights of Aboriginal peoples nor ABS.

Photo by Neil Palmer (CIAT). Plant samples in the gene bank at CIAT’s Genetic Resources Unit, at the institution’s headquarters in Colombia.

Ece Melisa Yilmaz is currently pursuing her JD at the University of Ottawa. She holds an M.A. from Carleton University in European, Russian and Eurasian Studies and a bilingual B.A. from Glendon College, York University in International Studies and Psychology. Ece has extensive research experience both in academia and the public sector. In 2015, she was awarded the Joseph Armand Bombardier Canada Graduate Scholarship for her master’s research. Most recently, she co-authored a publication in the Canadian Journal of Diabetes. Prior to law school, Ece was a Desk Officer at Global Affairs Canada responsible for foreign relations with Turkey, Georgia, Armenia and Azerbaijan. She also has international work experience interning in NGOs and law firms, including in Brussels and Istanbul.