Special Report: CBD Advisory Bodies Make Recommendations On Sequence Data, Global Mechanism, Implementation

The UN Convention on Biological Diversity advisory bodies met last month to consider issues in preparation of the high-level Conference of the Parties later this year in Egypt. Among the topics were how to deal with genetic resources DNA information under the CBD protocol on access and benefit-sharing (Nagoya Protocol). Another was problems met by countries implementing the protocol, in particular developing countries, and the need for capacity building.

The 22^nd meeting of the CBD Subsidiary Body on Scientific, Technical and Technological Advice (SBSTTA) took place from 2-7 July in Montreal, Canada. It was followed by the second meeting of the CBD Subsidiary Body on Implementation (SBI), which took place from 9-13 July.

The issue of digital sequence information on genetic resources was discussed and disagreement persisted on whether digital sequence information is a genetic resource and should be in or out of the scope of the Nagoya Protocol on Access to Genetic Resources and the Fair and Equitable Sharing of Benefits Arising from their Utilization, according to sources.

Developing countries are generally of the view that digital sequence information comes from physical samples and thus falls under the protocol’s rules of access and benefit-sharing (ABS).

The Nagoya Protocol now has 108 ratifications.

The SBSTTA gave a list of recommendations [pdf] on digital sequence information to be considered during the upcoming 14^th Conference of the Parties from 17-29 November in Sharm El-Sheikh, Egypt. The recommendations are bracketed, signalling the absence of agreement.

Digital sequence information “includes information on nucleic acids and protein sequences as well as information derived from biological and metabolic processes specific to the cells of the genetic resource,” according to the document.

One of the ongoing issues being discussed with digital sequence information is the fact that the need to access physical resources might be rendered obsolete, and thus ABS mechanisms could be circumvented. This is also discussed for example at the World Health Organization in the context of the Pandemic Influenza Preparedness (PIP) Framework.

Among the bracketed paragraphs, one notes that the creation of digital sequence information “requires initial access to a physical genetic resource, and that, therefore, a benefit arising from the utilization of digital sequence information should be shared fairly and equitably in accordance with the third objective of the Convention [CBD], the objective of the Nagoya Protocol and Article 5(1) of the Nagoya Protocol and in a way that directly benefits indigenous peoples and local communities conserving biological diversity so that it serves as an incentive for conservation and sustainable use.”

Also bracketed is a paragraph recognising that “digital sequence information on genetic resources can facilitate misappropriation if it is used to bypass national access legislation and no alternative benefit-sharing measure is put in place.”

Also bracketed is a request for the CBD to establish an open-ended working group to develop modalities for sharing benefits from digital sequence information, including possible multilateral approaches and approaches for publicly accessible databases.

Decisions on peer-reviewed studies on traceability and benefit-sharing associated with digital sequence information also need to be further discussed at the next COP.

Countries’ Views

A number of countries and stakeholders submitted their views [pdf] on the potential implications of the use of digital sequence information on genetic resources for the three objectives of the CBD.

In its submission [pdf], Brazil indicated that “even if genetic information obtained digitally is to be considered as excluded from the concept of genetic material, a systemic interpretation” of the CBD and the Nagoya Protocol “leaves no doubt that the use of this information is subject to benefit sharing.”

The European Union warned [pdf] against “disproportionate restrictions on sequencing of the genetic resources and the publication of DSI could result in a slowing down of research progress on a global scale due to decreased accessibility of information.”

“The EU and its Member States are of the view that access to information is not equivalent to access to genetic resources within the meaning of the CBD and the Nagoya Protocol,” according to the EU submission. The EU is taking the same approach at the World Intellectual Property Organization in the context of the Intergovernmental Committee on Intellectual Property and Genetic Resources, Traditional Knowledge and Folklore (IGC).

According to the United States (not a member of the CBD) submission [pdf], digital sequence information on genetic resources is neither genetic material nor a genetic resource.

Countries Struggling to Implement Nagoya Protocol

The 2^nd meeting of the CBD Subsidiary Body on Implementation (SBI) provided a number of recommendations, in particular in the context of assessment and review of the effectiveness of the Nagoya Protocol.

According to the SBI’s recommendations [pdf], further work is needed in several areas, such as developing ABS legislation or regulatory requirements, which provide for legal certainty, clarity and transparency.

The SBI also called for the enhancement of the protocol implementation by countries of the provisions on compliance with domestic legislation and regulatory requirements on ABS, including the designation of checkpoints, as well as the provisions related to indigenous peoples and local communities.

Full and effective participation of indigenous peoples and local communities should be supported in the implementation of the protocol, including by raising their awareness and capacity about ABS, the SBI said.

Support should also be given to those communities on protocols and procedures, and minimum requirements for mutually agreed terms and model contractual clauses for benefit-sharing arising from the utilization of traditional knowledge associated with genetic resources, taking into consideration their customary law, according to the recommendations.

The SBI also recommended capacity building for developing countries, in particular for least-developed countries to implement the Nagoya Protocol.

Key Findings on Protocol Assessment

According to key findings on the implementation of the Nagoya Protocol, many countries are still in the process of establishing ABS legislative, administrative and policy measures arrangements. For many countries this process is challenging, according to the document.

For example, the designation of checkpoints in countries, which is a new requirement created by the protocol, still needs to be addressed by many countries, it said.

Another requirement not yet fulfilled by many countries is the publication of mandatory information in the CBD ABS Clearing-House.

The ABS Clearing-House is designed to share information about ABS. According to the CBD, the clearinghouse is meant to enhance legal certainty and transparency on ABS procedures, and “for monitoring the utilization of genetic resources along the value chain, including through the internationally recognized certificate of compliance.”

The document also noted that parties have different approaches to prior informed consent, mutually agreed terms and the issuance of permits. “It is important for Parties to make clear information available on the ABS Clearing-House on the procedures to follow to access genetic resources and associated traditional knowledge,” it said.

Global Mechanism on Multilateral Benefit-Sharing

A set of recommendations on a global multilateral benefit-sharing mechanism, as envisioned by Article 10 of the protocol also bears a number of brackets. This mechanism would address resources that occur in transboundary situations or for which it is not possible to grand or obtain prior informed consent.

According to Article 10, the benefits shared through this mechanism would be used to support the conservation of biological diversity and the sustainable use of its components globally. Divergent views persist, according to sources, on the need and use of this mechanism, and its modalities.

The SBI suggested that the CBD “moderates open-ended online discussions to [identify and] discuss [the] specific cases for a global multilateral benefit-sharing mechanism [and the possible modalities for such a mechanism].”

The CBD is then to compile the outcomes of the online discussions, and update the information on developments in other relevant international processes for consideration by the SBI’s third meeting.

Potential Criteria for Specialised International Instruments

The SBI also considered [pdf] potential criteria for specialised international ABS instruments under the Nagoya Protocol. The potential criteria are set to be discussed again at the SBI’s fourth meeting.

According to the SBI recommendations, the CBD is to synthesise views submitted by countries and stakeholders, and information from developments in relevant international forums, and present the results to the SBI’s third meeting.

The WHO PIP Framework Review Group has suggested for some time that the framework becomes a specialised ABS instrument under the Nagoya Protocol, to avoid any potential complications in influenza virus sharing due to the implementation of the Nagoya Protocol (IPW, WHO, 29 January 2017).

According to several sources, there also have been suggestions that the WHO Global Influenza Surveillance and Response System (GISRS) could become a specialised international ABS instruments under the Nagoya Protocol.

On cooperation with other international organisations, the SBI asked the CBD to “continue liaising with the World Trade Organization, undertaking technical collaboration on issues of joint interest, and following up on pending requests for observer status in relevant committees of the World Trade Organization.”

The CBD’s request for observer status at the WTO Council for the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) has been deflected, mostly by the United States. The US also barred any request for the CBD coming to the TRIPS Council on an ad hoc basis to present the Nagoya Protocol to WTO delegates.

 

Image Credits: Flickr – Neil Palmer (CIAT)