Rapid Synthetic Biology Developments Necessitate “Horizon Scanning”

 THIRD WORLD NETWORK BIOSAFETY INFORMATION SERVICE

7 December 2018
Published by Third World Network
www.twn.my

Rapid synthetic biology developments necessitate “horizon scanning”

Sharm el-Sheikh, 6 Dec (Lim Li Ching and Lim Li Lin) – The rapid and fast-paced developments in the field of synthetic biology and their potential adverse effects need to be anticipated, monitored and assessed.

This was a conclusion of Parties to the Convention on Biological Diversity (CBD), which held its Fourteenth meeting of the Conference of the Parties (COP 14) in Sharm el-Sheikh, Egypt from 17th to 29th November 2018.

COP 14 had before it text from the CBD’s Subsidiary Body on Scientific, Technical and Technological Advice (SBSTTA), which had met earlier in 2018. That meeting had reached agreement on most of its recommendations on synthetic biology, with the exception of square brackets on three issues, indicating disagreement.

Parties to the CBD therefore focused on the bracketed text at COP 14, in an effort to resolve the differences. These were discussed in a Contact Group, chaired by Horst Korn of Germany.

Language asking Parties and other Governments to “refrain from” the release, including experimental release, of organisms containing engineered gene drives was in square brackets. Some Parties wanted a moratorium on environmental releases of such organisms, but others were opposed.

At COP 14, after long negotiations, the Parties laid down strict and precautionary conditions for any introduction of organisms containing engineered gene drives into the environment.

These include any introduction into the environment for experimental releases and for research and development purposes. (See previous article, ‘No release of “gene drives” without precautionary conditions’.)

Two other paragraphs in the draft decision on synthetic biology were also undecided and contained square brackets.

SBSTTA had agreed that horizon scanning, monitoring and assessing of developments in the field of synthetic biology are needed for reviewing new information regarding the potential positive and negative impacts of synthetic biology vis-à-vis the objectives of the Convention and its Protocols. However, there was disagreement as to whether or not there should be specific text referring to “genome editing” in that paragraph.

Genome editing techniques are new techniques of modern biotechnology that are more powerful and flexible than those of classical genetic engineering, allowing for deeper interventions. At the same time, there is currently no way to guarantee that there would be no off-target effects.

Therefore, horizon scanning, understood as a means to scan the literature and existing research for future developments, would be very useful to identify and track new developments, both in synthetic biology and genome editing, as well as anticipate potential adverse effects.

Also at issue was whether or not to establish a process and modalities for regular horizon scanning, monitoring and assessment, and a mechanism for regularly reporting the outcomes to SBSTTA and the Parties to the CBD and the Cartagena Protocol on Biosafety.

Even as delegates to COP 14 in Sharm el-Sheikh deliberated on the necessary governance for gene drive organisms and genome editing, news headlines from a conference in Hong Kong on the birth of alleged gene-edited babies alarmed scientists and the public alike.

The scientist claiming responsibility for this was widely condemned for conducting the experiment without due regard for ethical or safety considerations, bringing attention to the fact that there are no international rules specifically governing this new field of genetic engineering technologies, and the urgent need for horizon scanning, monitoring and assessment.

During the discussions in Working Group 2 of COP 14, and in the subsequent Contact Group, there were sharp divergences between Parties who wanted to include genome editing and those who did not, although both sides agreed on the necessity of horizon scanning.

There were also differences in opinion on whether a regular and long-term process for horizon scanning should be set up by COP 14, or first tasked to the Ad Hoc Technical Expert Group (AHTEG) on Synthetic Biology, which provides technical expert advice on the issue.

When the draft decision on synthetic biology was discussed again in Working Group 2 before the final day of the meeting, the fault line still remained around genome editing and horizon scanning.

Bolivia, the European Union, Egypt, Uruguay, Cuba, Grenada, and Venezuela remained strongly in favour of retaining genome editing in the operative part of the decision on horizon scanning.

Argentina, Brazil, Colombia, Honduras, Ghana (speaking for the Africa Group but with Egypt holding the opposite position), New Zealand, Canada and Japan all supported its deletion.

In the final decision adopted by COP 14, the issue of genome editing no longer appears in the operative paragraph dealing with horizon scanning, monitoring and assessing of developments in the field of synthetic biology.

However, the terms of reference for the AHTEG on Synthetic Biology includes taking stock of new technological developments, “including the consideration, among other things, of concrete applications of genome editing if they relate to synthetic biology”.

This task supports “a broad and regular horizon scanning process”, a nod to the need to set up a regular and consistent procedure under the CBD, which the AHTEG is now also tasked with recommending options for. This could include the specific modalities and reporting back mechanism to the relevant CBD bodies.

Therefore as a compromise, Parties agreed to remove specific mention of genome editing in relation to horizon scanning, monitoring and assessment, and did not set up a process and modalities for this, nor a mechanism for regularly reporting on its outcomes.

Instead, this is delayed, and there will be a two-step process – first, asking the AHTEG to recommend options for regular horizon scanning, including of concrete applications of genome editing if they relate to synthetic biology, and then taking it back to SBSTTA and ultimately COP 15 in 2020 to make a decision. A decision on setting up a process for horizon scanning and reporting on its outcomes can also only be taken up in two years’ time at the next COP.

Additionally, the decision on risk assessment and risk management under the Cartagena Protocol on Biosafety includes living modified organisms (LMOs) developed through genome editing. It calls for broad international cooperation, knowledge sharing and capacity-building to support Parties in assessing potential adverse effects on the conservation and sustainable use of biodiversity, taking into account risks to human health, the value of biodiversity to indigenous peoples and local communities, and relevant experiences in performing risk assessment of such organisms.

This means that the issue of genome editing will very likely continue to be discussed under both the CBD and the Cartagena Protocol.

The COP 14 decision on synthetic biology also extends the AHTEG on Synthetic Biology with “renewed” membership, as well as the Open-ended Online Forum on Synthetic Biology, which is a moderated online discussion that feeds into the deliberations of the AHTEG. The work of the AHTEG will be submitted to SBSTTA, which will then make recommendations to COP 15, scheduled to be held in 2020 in China.

In summary, the terms of reference of the AHTEG are to:

(a) provide advice on the relationship between synthetic biology and the criteria for identifying new and emerging issues;

(b) take stock of new technological developments in synthetic biology, “including the consideration, among other things, of concrete applications of genome editing if they relate to synthetic biology”, in order to support a broad and regular horizon scanning process;

(c) undertake a review of the current state of knowledge by analysing information on the environmental impacts, taking into account human health, cultural and socioeconomic impacts, especially with regard to the value of biodiversity to indigenous peoples and local communities, of current and near-future applications of synthetic biology, including those applications that involve organisms containing engineered gene drives;

(d) consider whether any living organism developed thus far through new developments in synthetic biology fall outside the definition of living modified organisms as per the Cartagena Protocol;

(e) prepare a forward-looking report on synthetic biology applications that are in early stages of research and development, vis-à-vis the three objectives of the Convention;

(f) recommend options for carrying out the regular horizon scanning, monitoring and assessing of developments; and

(g) prepare a report on the outcomes of its work for consideration by the SBSTTA which will be held before COP 15. +

Rapid Synthetic Biology Developments Necessitate “Horizon Scanning”

 THIRD WORLD NETWORK BIOSAFETY INFORMATION SERVICE

7 December 2018
Published by Third World Network
www.twn.my

Rapid synthetic biology developments necessitate “horizon scanning”

Sharm el-Sheikh, 6 Dec (Lim Li Ching and Lim Li Lin) – The rapid and fast-paced developments in the field of synthetic biology and their potential adverse effects need to be anticipated, monitored and assessed.

This was a conclusion of Parties to the Convention on Biological Diversity (CBD), which held its Fourteenth meeting of the Conference of the Parties (COP 14) in Sharm el-Sheikh, Egypt from 17th to 29th November 2018.

COP 14 had before it text from the CBD’s Subsidiary Body on Scientific, Technical and Technological Advice (SBSTTA), which had met earlier in 2018. That meeting had reached agreement on most of its recommendations on synthetic biology, with the exception of square brackets on three issues, indicating disagreement.

Parties to the CBD therefore focused on the bracketed text at COP 14, in an effort to resolve the differences. These were discussed in a Contact Group, chaired by Horst Korn of Germany.

Language asking Parties and other Governments to “refrain from” the release, including experimental release, of organisms containing engineered gene drives was in square brackets. Some Parties wanted a moratorium on environmental releases of such organisms, but others were opposed.

At COP 14, after long negotiations, the Parties laid down strict and precautionary conditions for any introduction of organisms containing engineered gene drives into the environment.

These include any introduction into the environment for experimental releases and for research and development purposes. (See previous article, ‘No release of “gene drives” without precautionary conditions’.)

Two other paragraphs in the draft decision on synthetic biology were also undecided and contained square brackets.

SBSTTA had agreed that horizon scanning, monitoring and assessing of developments in the field of synthetic biology are needed for reviewing new information regarding the potential positive and negative impacts of synthetic biology vis-à-vis the objectives of the Convention and its Protocols. However, there was disagreement as to whether or not there should be specific text referring to “genome editing” in that paragraph.

Genome editing techniques are new techniques of modern biotechnology that are more powerful and flexible than those of classical genetic engineering, allowing for deeper interventions. At the same time, there is currently no way to guarantee that there would be no off-target effects.

Therefore, horizon scanning, understood as a means to scan the literature and existing research for future developments, would be very useful to identify and track new developments, both in synthetic biology and genome editing, as well as anticipate potential adverse effects.

Also at issue was whether or not to establish a process and modalities for regular horizon scanning, monitoring and assessment, and a mechanism for regularly reporting the outcomes to SBSTTA and the Parties to the CBD and the Cartagena Protocol on Biosafety.

Even as delegates to COP 14 in Sharm el-Sheikh deliberated on the necessary governance for gene drive organisms and genome editing, news headlines from a conference in Hong Kong on the birth of alleged gene-edited babies alarmed scientists and the public alike.

The scientist claiming responsibility for this was widely condemned for conducting the experiment without due regard for ethical or safety considerations, bringing attention to the fact that there are no international rules specifically governing this new field of genetic engineering technologies, and the urgent need for horizon scanning, monitoring and assessment.

During the discussions in Working Group 2 of COP 14, and in the subsequent Contact Group, there were sharp divergences between Parties who wanted to include genome editing and those who did not, although both sides agreed on the necessity of horizon scanning.

There were also differences in opinion on whether a regular and long-term process for horizon scanning should be set up by COP 14, or first tasked to the Ad Hoc Technical Expert Group (AHTEG) on Synthetic Biology, which provides technical expert advice on the issue.

When the draft decision on synthetic biology was discussed again in Working Group 2 before the final day of the meeting, the fault line still remained around genome editing and horizon scanning.

Bolivia, the European Union, Egypt, Uruguay, Cuba, Grenada, and Venezuela remained strongly in favour of retaining genome editing in the operative part of the decision on horizon scanning.

Argentina, Brazil, Colombia, Honduras, Ghana (speaking for the Africa Group but with Egypt holding the opposite position), New Zealand, Canada and Japan all supported its deletion.

In the final decision adopted by COP 14, the issue of genome editing no longer appears in the operative paragraph dealing with horizon scanning, monitoring and assessing of developments in the field of synthetic biology.

However, the terms of reference for the AHTEG on Synthetic Biology includes taking stock of new technological developments, “including the consideration, among other things, of concrete applications of genome editing if they relate to synthetic biology”.

This task supports “a broad and regular horizon scanning process”, a nod to the need to set up a regular and consistent procedure under the CBD, which the AHTEG is now also tasked with recommending options for. This could include the specific modalities and reporting back mechanism to the relevant CBD bodies.

Therefore as a compromise, Parties agreed to remove specific mention of genome editing in relation to horizon scanning, monitoring and assessment, and did not set up a process and modalities for this, nor a mechanism for regularly reporting on its outcomes.

Instead, this is delayed, and there will be a two-step process – first, asking the AHTEG to recommend options for regular horizon scanning, including of concrete applications of genome editing if they relate to synthetic biology, and then taking it back to SBSTTA and ultimately COP 15 in 2020 to make a decision. A decision on setting up a process for horizon scanning and reporting on its outcomes can also only be taken up in two years’ time at the next COP.

Additionally, the decision on risk assessment and risk management under the Cartagena Protocol on Biosafety includes living modified organisms (LMOs) developed through genome editing. It calls for broad international cooperation, knowledge sharing and capacity-building to support Parties in assessing potential adverse effects on the conservation and sustainable use of biodiversity, taking into account risks to human health, the value of biodiversity to indigenous peoples and local communities, and relevant experiences in performing risk assessment of such organisms.

This means that the issue of genome editing will very likely continue to be discussed under both the CBD and the Cartagena Protocol.

The COP 14 decision on synthetic biology also extends the AHTEG on Synthetic Biology with “renewed” membership, as well as the Open-ended Online Forum on Synthetic Biology, which is a moderated online discussion that feeds into the deliberations of the AHTEG. The work of the AHTEG will be submitted to SBSTTA, which will then make recommendations to COP 15, scheduled to be held in 2020 in China.

In summary, the terms of reference of the AHTEG are to:

(a) provide advice on the relationship between synthetic biology and the criteria for identifying new and emerging issues;

(b) take stock of new technological developments in synthetic biology, “including the consideration, among other things, of concrete applications of genome editing if they relate to synthetic biology”, in order to support a broad and regular horizon scanning process;

(c) undertake a review of the current state of knowledge by analysing information on the environmental impacts, taking into account human health, cultural and socioeconomic impacts, especially with regard to the value of biodiversity to indigenous peoples and local communities, of current and near-future applications of synthetic biology, including those applications that involve organisms containing engineered gene drives;

(d) consider whether any living organism developed thus far through new developments in synthetic biology fall outside the definition of living modified organisms as per the Cartagena Protocol;

(e) prepare a forward-looking report on synthetic biology applications that are in early stages of research and development, vis-à-vis the three objectives of the Convention;

(f) recommend options for carrying out the regular horizon scanning, monitoring and assessing of developments; and

(g) prepare a report on the outcomes of its work for consideration by the SBSTTA which will be held before COP 15. +

Rapid Synthetic Biology Developments Necessitate “Horizon Scanning”

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