Synthetic Biology: Is Scientific Progress Outrunning Normative Process? Case Of The CBD

A research group announced in March that it has designed the first minimal synthetic bacterial cell. Rapid advances in science seem to be leaving the international normative process lagging behind. Current international instruments are seeking to understand how this new technology will impact their regulatory efforts, while civil society raises high concerns.

This technology poses a number of questions around intellectual property, mainly on access and benefit sharing, which is included or discussed under several United Nations and other international organisations.

At the UN Convention on Biological Diversity (CBD), conversation is ongoing with member states and other stakeholders. A CBD-appointed expert group examined potential risks and benefits of synthetic biology. They found positive and negative possible impacts of synthetic biology on benefit-sharing, with a much larger list of negatives than positives.

Although a potential game changer, there seems to be no internationally agreed definition of synthetic biology. However, it can be understood as designing novel biological components, or/and re-designing of existing biological systems.

Through synthetic biology, it is possible to, for example, work from data such as genome sequencing, to reproduce living organisms without having actual access to the physical form of the resource.

The question of how synthetic biology relates to biological diversity has been addressed by the CBD for some time. Synthetic biology is on the agenda [pdf] of the upcoming meeting of the CBD Subsidiary Body on Scientific, Technical and Technological Advice, taking place in Montreal, Canada, from 25-30 April.

The CBD manages two protocols: the Cartagena Protocol on Biosafety, and the Nagoya Protocol on Access to Genetic Resources and the Fair and Equitable Sharing of Benefits Arising from their Utilization.

According to a CBD source, an October 2014 decision of the Conference of the Parties, established an Ad Hoc Technical Expert Group on synthetic biology (AHTEG).

Expert Group Delivers Recommendations

The expert group was tasked in particular to work on a definition of synthetic biology, and identify potential benefits and risks from products issued from synthetic biology on biodiversity, human health, and socio-economic impacts.

In September 2015, the Expert Group submitted its report with a set of recommendations. In particular, it proposed a definition for synthetic biology: “Synthetic biology is a further development and new dimension of modern biotechnology that combines science, technology and engineering to facilitate and accelerate the understanding, design, redesign, manufacture and/or modification of genetic materials, living organisms and biological systems.”

The AHTEG noted that benefit-sharing may be affected “both positively and negatively, by living organisms resulting from synthetic biology, as well as by non-living products or components.”

Technology Transfer Easier, Risk of Misappropriation

The AHTEG said: “The availability of synthetic biology may enable the fair and equitable sharing of benefits with relevant stakeholders in developing countries through greater access to the tools of synthetic biology, thereby facilitating the transfer of knowledge and technology.”

However, the AHTEG remarked that potential adverse effects of synthetic biology may include loss of market share and income by indigenous and local communities “due to the altered exploitation of genetic resources,” and inappropriate access without benefit-sharing due to the use of sequenced data without material transfer agreement under the Nagoya Protocol.

The Nagoya Protocol on Access to Genetic Resources and the Fair and Equitable Sharing of Benefits Arising from their Utilization to the Convention on Biological Diversity is a 2010 supplementary agreement to the 1992 Convention on Biological Diversity (CBD).

The AHTEG recommended that the Nagoya Protocol Conference of the Parties set up mechanisms to clarify the issue of digital genetic resource information as it relates to access and benefit-sharing.

The group also recommended that synergies be established with other United Nations and international organisations, such as the UN Food and Agriculture Organization (FAO), the World Intellectual Property Organization, the World Health Organization, the FAO’s Committee on World Food Security and Codex Alimentarius, and the Permanent Forum on Indigenous Issues.

Those recommendations were approved by the CBD’s Subsidiary Body on Scientific, Technical and Technological Advice, which recommended they be adopted as a decision at the 13th CBD Conference of the Parties, to be held from 4-17 December in Cancun, Mexico.

As shown on a tentative calendar of activities related to synthetic biology, in February 2015, an invitation to submit information on synthetic biology was launched by the CBD. A total of 27 submissions were received, 15 of which were from CBD members, one from a non-party country (United States), and 11 from organisations.

A number of submissions by countries related to the potential hazards of synthetic biology on biodiversity.

The US said “regulation and oversight of emerging technologies should avoid unjustifiably inhibiting innovation, stigmatizing new technologies, or creating trade barriers.” Belgium, Bolivia, Brazil, Colombia, India, Malaysia, and New Zealand also submitted information.

The European Association for Bioindustries in its submission said, “We believe it is impossible to define clear boundaries between genetic engineering and ‘synthetic biology’ in its broad definition today”.

“Synthetic biology represents a logical further development of existing molecular biology methods and is associated with a large innovation potential from which both basic research and industrial application can profit,” it added.

Civil Society: Concerns with Benefit-Sharing

In its submission, the Third World Network said, “synthetic biology may potentiate misappropriation of genetic resources.” According to the submission, “many access and benefit-sharing approaches are predicated on physical access to biodiversity,” and “digital transfer of synthesizable sequence data may evade rules as presently drafted or implemented.”

“[I]f yesterday’s biopirate hid seeds in his luggage, tomorrow’s biopirate may upload data at her hotel, or carry it onto her flight on a USB stick,” the TWN said.

An Open-ended Online Forum on Synthetic Biology was also open from March 2015. According to the CBD, some 235 experts were nominated to participate. Among these, 146 were from Parties, 9 from a non-Party, and 80 from organisations. The forum was active until July 2015.

Stakeholders were also invited to peer-review the outcome of the process, and in particular the AHTED report.

Countries Divided on Need to Act

One of the dividing issues is whether or not organisms generated through synthetic biology fall within the scope of the CBD and its protocols.

For example, Japan found that “It is impossible to determine only with current operational definition whether synthetic biology as a whole falls within the scope of the Convention and its three objectives or of its Protocols.”

Belgium said there is insufficient rationale to invite the Conference of the Parties “to set up mechanisms for clarifying the issue of digital genetic resource information as it relates to access and benefit-sharing.”

New Zealand found that it would be useful “to have more specific information about which aspects of the wide field of synthetic biology fall within the Convention’s framework.”

Friends of the Earth US remarked on the socio-economic impacts of synthetic biology and said, for example, the approval of vanillin and stevia derived from synthetic biology for commercial use, and the market label as “natural”, may have significant socio-economic impacts on agricultural communities that typically produce the “truly natural” form of these products.

According to CBD sources, synthetic biology in the context of the Nagoya Protocol raises more questions than answers. The question of knowing if genetic sequence information is outside the scope of the Nagoya Protocol is not necessarily clear, the sources told Intellectual Property Watch. There is not much information from the parties on their views on this point, the sources said.

If the protocol does apply, it would be difficult to enforce the provisions of the protocol on databases, one source said. There is no international decision on this, she added. For the moment, it is being left to national implementation.

 

Image Credits: Flickr – Pascal