Canada: Canadian Perspective On Legal Issues And Challenges Facing The Use Of Genetic Resources Under The Nagoya Protocol

Purpose of the Protocol

The Nagoya Protocol on Access and Benefit-sharing (the Protocol), adopted in 2010 by the parties to the Convention on Biological Diversity (the Convention), entered into force in October 2014. This Protocol is an international agreement meant to further advance the Convention's core objectives, namely to promote and safeguard "the fair and equitable sharing of benefits arising from the utilization of genetic resources," which "utilization" includes "the conduct of research and development on the genetic and/or biochemical composition of genetic resources."

Under the Protocol, the term "genetic resources" includes all types of genetic material that is "any material of plant, animal, microbial or other origin containing functional units of heredity" of actual or potential value. The Protocol also aims to secure the fair and equitable use of genetic resources by appropriate transfer of relevant technologies, and by proper funding, so as to contribute to the conservation of biological diversity and the sustainable use of its components.

Human genetic resources

Importantly, the apparently broad definition given to the term "genetic resources" does not encompass human genetic resources, which were intentionally left outside the Protocol's scope pursuant to Decision X/1 – Access to Genetic Resources and the Fair and Equitable Sharing of Benefits Arising from their Utilization. However, the exclusion was made without prejudice to the further consideration of this issue by the parties to the Protocol. Accordingly, the Protocol's scope may still be modified so as to apply to human genetic resources.

Canada slow to ratify Protocol

Although the Protocol has been studied for four years, the work toward Protocol ratification or accession by many parties to the Convention – including Canada – has still not been completed.

While agreements and policy statements exist in Canada, federal legislation has not been adopted to deal with the issues addressed by the Protocol. The same observation applies to the provinces.

Moreover, while the three Canadian territories have adopted legislation requiring the issuance of a license or permit prior to undertaking research on wildlife, these laws do not mirror the provisions contained in the Protocol; some of them even appear to contradict such provisions.

For instance, none of these laws differentiates between research and commercial purposes, thus defeating one of the Protocol's main purposes, which is to "create conditions to promote and encourage research which contributes to the conservation and sustainable use of biological diversity." Also, inconsistent with the Protocol, these laws do not require the state's prior consent (or even of the local communities) to use "genetic resources."

Despite its failure to ratify the Protocol or adhere to its principles, Canada has nonetheless taken measures to protect and preserve its biodiversity. For instance, Canada has developed strategies such as: (i) the "Canadian Biodiversity Strategy," which sets forth measures to meet its obligations under the Convention and to enhance coordination of national efforts for the conservation of biodiversity and the sustainable use of biological resources; and (ii) the "Invasive Alien Species Strategy," which intends to respond to invasive alien species affecting our environment, economy and society.

Furthermore, through acquisition, conservation covenants and similar agreements, Canada has protected some ecologically sensitive lands. Likewise, establishing large ocean management areas, as well as creating botanical gardens, zoos and other protected areas has allowed Canada to safeguard important living and non-living resources. Finally, governments have put in place a variety of policies, strategies, economic incentives and voluntary approaches to protect Canada's biodiversity.

However, the actions taken by the governments are mostly political, and in cases where there is political but not legal support for implementing specific measures, the respect of such measures may yet become a matter of executive discretion rather than legislative direction. And while some laws have been amended to offer a more comprehensive approach to biodiversity and sustainability, others have been weakened as part of governments' political platforms.

Finally, despite the growing interest in developing medical treatments and research based on genetic resources, the uses of such resources in cases of genetic modification, biosynthesis, breeding and selection, production of compounds or other purposes remain regulated by the laws already in place. Accordingly, significant legislative reform would be required. However, the federal and provincial division of powers renders the undertaking of such reform – as well as implementing the Protocol – quite challenging.

Protocol's impact on Canadian researchers and corporations

Although the Protocol does not currently apply to the use of human genetic resources, it could nonetheless have significant importance in many economic sectors, as a broad range of persons, including academic researchers and corporations, use genetic resources for research, investigation and development purposes.

Notwithstanding the fact that Canada has not yet ratified the Protocol, Canadian researchers and corporations wishing to use the genetic resources of foreign states may well have to comply with the Protocol's provisions. Indeed, once a signatory state ratifies the Protocol and adopts domestic laws, it then subjects persons – even those from non-signatory states – to a series of administrative and substantive obligations.

As a result, Canadian researchers and corporations will need to be issued a permit or certificate prior to accessing genetic resources and comply with all "appropriate domestic legislation" codified by the signatory states pursuant to the Protocol. Practically speaking, this could mean Canadian researchers and corporations may have to get acquainted and comply with various sets of legislative provisions that may be, in some cases, very onerous, as the laws adopted by each state under the Protocol may differ greatly from one another.

Moreover, Canadian researchers and corporations will have to consult local and indigenous communities prior to utilizing genetic resources found on their land. The form of the notice to be given, as well as the consultation to be undertaken, will be governed on a case-by-case basis by the legislation of each signatory state.

Furthermore, according to the Protocol, the right to access and utilize genetic resources is "subject to the prior informed consent of the Party [i.e. the signatory State] providing such resources." Accordingly, Canadian corporations and researchers will need to seek the express and informed consent from each state prior to undertaking their projects. Compliance with this requirement could create conceptual difficulties, as informed consent usually needs to be secured from each individual personally (and not from a group of persons).

Finally, as the Protocol provides that genetic resources shall be "shared in an equitable way with the [...] country of origin of such resources," Canadian researchers and corporations may have to make payments in order to be granted access to genetic resources and may even be required to share the benefits of their discoveries with local communities.

Conclusion

The Protocol reaffirms and further advances the fair and equitable sharing of benefits arising from the "utilization of genetic resources." However, recognizing, protecting and promoting genetic resources will depend upon the collaboration and full involvement of all states. Accordingly, we will report on developments in Canada (and other states) pertaining to genetic resources and how the research, access or other utilization of such resources will be regulated.  

Norton Rose Fulbright Canada LLP

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