Some 196 countries may decide to limit access to the benefits of pioneering new biotechnological applications at an upcoming international conference on biodiversity.
Though the prospect runs counter to the idea that science and innovation are essential to conserving the world’s biodiversity, it is expected to dominate discussions at the Nov. 17-29 United Nations Biodiversity Conference in Sharm El-Sheikh, Egypt.
If the countries adopt overly stringent new regulations for synthetic biology applications, genetic engineering techniques and digital sequence information on genetic resources, it could prevent these techniques from joining the biodiversity conversation and possibly result in a de-facto moratorium.
Background: Agreements now in place
The parties to the Convention on Biological Diversity (CBD) have convened periodically since it came into force on Dec. 29, 1993, holding 14 meetings to date. The goals of the CBD are a) conservation of biological diversity; b) the sustainable use of the natural world’s components, and c) the fair and equitable sharing of benefits arising from the use of genetic resources. The CBD recognizes that access to and transfer of technologies, and this includes biotechnology,[1] is essential to the fulfillment of these goals. Moreover, advances in biotech played a big part in the negotiation of subsequent agreements, such as: a) the Cartagena Protocol on Biosafety, which addresses the potential risks of Living Modified Organisms (LMOs); and b) the Nagoya Protocol on Access and Benefit Sharing of Genetic Resources[2]. The needed consensus for these agreements took years. Their full implementation is no easy task, and many countries still struggle to comply.
The CBD is implemented through each country’s National Biodiversity Strategies and Action Plans (NBSAPs), which 97 percent of parties have developed. Nevertheless, according to a recent UNEP report[3], mainstreaming biodiversity has been difficult to put into practice at the national level. Moreover, when it comes to the hard-to-reach agreements on biotech, some countries have yet to establish national laws for a biosafety system that regulates LMOs in accordance with the Cartagena Protocol. It calls for effectively balancing environmental protection, potential benefits and the needs of international trade. Despite this gap, parties at the November conference will be tasked with deciding whether and how to enact more regulations or guidelines for new technological applications.
This year’s multilateral fora will serve as a platform for countries to determine, among other objectives,how these agreements will apply to LMOs produced through genome editing, to those that contain engineered gene drives and to other synthetic biology applications. They may also determine a new definition and broaden the scope for “Digital Sequence Information of genetic resources” regarding Access and Benefit Sharing (ABS) within the Nagoya Protocol framework. These innovationshave great potential for human and environmental well-being but may be further regulated without clearly demonstrated need orconsensus, as is encouraged by the convention’s provisions and rules of procedures[4].
Egypt meeting: What’s at stake
The Subsidiary Body on Scientific, Technical and Technological Advice (SBSTTA) is established by the Convention on Biological Diversity with the mandate to provide fact-based advice on key issues to be addressed at the upcoming conference in Egypt. The 22nd meeting of the SBSTTA and the second meeting of the Subsidiary Body on Implementation (SBI) were held July 2-13 in Montreal, Canada. They effectually established the upcoming deliberations and provided a window into what the parties’ stances on the issues and priorities may be.
The scientific advice from these recent intercessional conversations will be especially relevant for new technologies since the environmental thrust of the biodiversity conference and the sheer amount of well-organized eco-friendly pressure groups can create a setting conducive to restricting scientific progress. The influence exerted by advocacy groups can undermine the access to and transfer of technology among parties and encourage hasty actions that lead to duplicated efforts and polarized views.
The sound science recommendations by SBSTTA help the parties agree on divisive issues. However, country representatives can enact chess-like interventions to further their delegation’s position and negotiate the final text of the draft resolutions that constitute the “advice” sent to Egypt. Consequently, there is no guarantee that all draft resolutions will be completely agreed upon. Debates can take place in the main plenary as well as in subsequent breakaway groups, and some of the proposed language may be sacrificed in order to arrive at a consensus.
This was the case for the debate on further guidance on risk assessment and management. It had such strong opposing opinions in the plenary that it had to be discussed in a breakaway group. Parties disagreed on the need to consider additional guidance materials for a) LMOs produced through genome editing b) living modified organism containing engineered gene drives and c) living modified fish. Some parties argued for the inclusion of the three, others for excluding the first. Ultimately, if no agreement is reached, brackets are placed around the contentious text, and the debate is tabled until the next meeting, with no clear final advice.Thus, “LMOs produced through genome editing” was bracketed in the final recommendation by SBSTTAA and the issue will be discussed further in Egypt[5].
Synthetic biology: Divided opinions
One example of divided opinions can be found in the recent SBSTTA discussions aroundsynthetic biology.Synthetic biology is a maturing scientific discipline that combines science and engineering in order to design and build novel biological functions and systems[6]. One of the most commonly cited definitions among the CBD work documents is “the design and construction of new biological parts, devices, and systems”[7]. However, an operational definition has yet to be agreed upon. Nor can parties agree on whether it should be considered a “new and emerging issue”[8]— a designation required to establish a new work program. Moreover, conclusions from the discussions to date have not presented a clear and strong need to create new regulations or further guidance. Regardless, the Secretariat independently produced a document that extracted elements from two existing reports and compared them to the criteria required to be considered as a “new and emerging issue”[9], despite the disagreement of some parties.
Views ran the gamut from carefully considering the decision process to slowing the advance of synthetic biology with more regulatory hurdles.In regard to the latter, Bolivia hastily called for the development of guidelines as a previous requirement for any synthetic biology applications. Others, such as Belgium, Norway and Moldova, called for including the use of tools like horizon scanning, monitoring and assessing developments in the field of synthetic biology. A more nuanced Canada supported the development of tools for risk assessment sharing among countries, but asserted that determining if synthetic biology meets the criteria for “new and emerging issues” is the first step and should be prioritized above all others.
As a result, SSBTTA delegates had to rely on the tactics of international diplomacy to find enough common ground to move forward. Ultimately, the SBSTTA concluded with many bracketed documents regarding Synthetic Biology[10]. The lack of consensus as to the scope and classification of synthetic biology applications resulted in guarded positions and recommendations requiring further information-gathering activities.
Moving forward with sound science
An excessive precautionary mind-set resulting in new restrictions on technological advances could impede the many potential contributions of these tools. In recent years, modern biotechnology has contributed to high yields that helped reduce pressure to use more land for farming. It also has the potential to restore deteriorating environments[11] and address climate change impacts[12] on agriculture. Moreover, new and more precise gene-editing techniques like CRISPR can protect or repair the environment from human harm[13].
LMOs produced through genome editing and those that contain engineered gene drives or other synthetic biology applications can similarly address many human and environmental problems that we must face. The high level negotiations that will take place at the Biodiversity Conference 2018 in Egypt must build on SBSTTA’s advice and make science-based decisions that will allow innovation to continue searching for solutions.
[8] COP 9 paragraph 12 of decision IX/29
[9] CBD/SBSTTA/22/INFO/17