Dear Synbio enthusiasts,
three weeks ago, we invited you to follow and contribute to our participation in the 13th Conference of the Parties to the UN Convention on Biological Diversity (COP13) and the parallel Meetings of the Parties to the Cartagena Protocol on Biosafety (CP-MOP8) and the Nagoya Protocol on Access and Benefit-sharing (NP-MOP2).
Following conclusion of this year's UN CBD events on December 17th, we would like to share with you the below draft outcomes which will have an impact on the future regulation of our discipline.
In case you do not have a particularly keen interest in science policy and governance (yet) or you simply lack the time to read through all of the below bullet points, here is a -considerably simplified- summary:
Synthetic biology may be subject to the same regulatory framework which already exists for classical biotechnology. However, a precautionary approach to synthetic biology has been encouraged, and methodologies for risk assessment of synthetic biology may be updated as new developments emerge.
More details are given below:
it has been reaffirmed that Parties and other Governments are urged and invited, respectively, to take a precautionary approach when addressing threats of significant reduction or loss of biological diversity posed by organisms, components, and products resulting from synthetic biology.
the draft operational definition "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" has been acknowledged, yet further refinement of this definition has been noted as neccessary.
it has been noted that living organisms developed or being developed through current applications of synthetic biology are similar to living modified organisms (LMOs) as defined in the Cartagena Protocol, and that general principles and methodologies for risk assessment under this Protocol and existing biosafety frameworks provide a good basis for risk assessment regarding such LMOs. However, it has also been noted that such methodologies may need to be updated and adapted for current and future developments and applications of synthetic biology.
it has been noted that it remains unclear whether or not some organisms created through synthetic biology would fall under the definition of LMOs under the Cartagena Protocol, and whether or not some results of a synthetic biology application are living.
Parties have been invited to take into account socio-economic, cultural, and ethical considerations when identifying the potential benefits and potential adverse effects of organisms, components, and products resulting from synthetic biology techniques.
Parties, other Governments, relevant organizations, and indigenous peoples have been invited to share experiences and fill knowledge gaps related to potential benefits and potential adverse effects of synthetic biology products as outlined above, to promote public and multi-stakeholder dialogue, and to cooperate in developing guidance and capacity.
it has been decided to extend the mandate of the Ad Hoc Technical Expert Group (AHTEG) on Synthetic Biology to make recommendations relevant to the above unresolved issues.
it has been decided that, at its next meeting, the Convention will consider any potential implications of the use of digital sequence information on genetic resources for (i) the conservation of biological diversity, (ii) the sustainable use of its components, and (iii) the fair and equitable sharing of the benefits arising out of the utilization of genetic resources. As with potential benefits and potential adverse effects of synthetic biology, relevant information and experiences have been invited from stakeholders, and establishment of a dedicated AHTEG has been decided.
In case you would like to dig deeper into the material, the official meeting documents can be found here.
We, the EUSynBioS Steering Committee, will make an effort to stay involved in this process, and to represent your opinion at future meetings of the UN Convention on Biological Diversity. It is for the sake of a future which allows us to freely and responsibly pursue our scientific careers in an appropriate regulatory environment.
All the best,