No Release of “Gene Drives” Without Precautionary Conditions

THIRD WORLD NETWORK BIOSAFETY INFORMATION SERVICE

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

No release of “gene drives” without precautionary conditions

Sharm el-Sheikh, 6 Dec (Lim Li Ching and Lim Li Lin) — Parties to the Convention on Biological Diversity (CBD) have 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.

The Fourteenth Meeting of the Conference of the Parties (COP 14) to the CBD was held in Sharm el-Sheikh, Egypt from 17th to 29th November 2018. On its agenda was the topic of ‘synthetic biology’, which the CBD has been considering since 2010.

In recent years, the issue of organisms containing engineered gene drives has taken centre stage, due to the scientific uncertainties and potential for causing significant and irreversible adverse effects on biodiversity. Current research using gene drive systems include targeting the mosquitoes that are the vector for malaria, and some invasive species that are driving other species to extinction.

Gene drive systems are designed to deliberately spread transgenes and cannot be contained once released. They are very likely to cross national borders. The release of even a few organisms containing engineered gene drives can force the engineered trait to spread through sexual reproduction, resulting in the genetic engineering of whole populations, whether wild or domestic, and possible population or species extinction.

Civil society organisations have dubbed this new development of modern biotechnology, “Exterminator Technology”. Given the serious potential adverse effects, more than 160 such organisations had called for a moratorium on the technology in 2016.

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, including the need to apply a precautionary approach to organisms containing engineered gene drives.

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

[“Other Governments” refers to the United States that has signed but not ratified the CBD.]

Parties to the CBD therefore focused on the bracketed text at COP 14, in an effort to resolve the differences.

When the issue was first discussed in Working Group 2 of COP 14, the European Union proposed a compromise, saying it was willing to accept the phrase “refrain from” if conditions relating to risk assessment and risk management were put in place.

Malaysia was open to working with this approach, as was Argentina, provided that risk assessment was qualified by being on a case-by-case basis.  Costa Rica added that, in addition to the requisite scientific and technical assessment to ensure no negative impacts, liability and redress should be included.

Bolivia strongly supported the text calling for Parties and other Governments to “refrain from” environmental release of organisms containing engineered gene drives, citing the gaps in knowledge and uncertainties. This position was supported by El Salvador and Venezuela.

However, a slew of other Parties opposed the “refrain from” language, and merely wanted the precautionary approach to apply “with regard to” the release of organisms containing engineered gene drives. Although South Africa who spoke for the Africa Group for this issue also opposed this language, Egypt a member of the Group, supported Bolivia’s position with regard to “refrain from”.  

Observers noted that the Africa Group, which had previously been a strong defender of precaution for modern biotechnology and synthetic biology, may have been influenced by the well-funded Target Malaria project, which aims to release gene drive mosquitoes on the continent, purportedly to help with malaria control.

Given the sharp divergences, a Contact Group was set up, chaired by Horst Korn of Germany. Its mandate was to only address the bracketed text coming from SBSTTA.

At the Contact Group, a developing country Party which had supported the “refrain from” text stressed that it could only agree to the removal of “refrain from” if other important precautionary conditions such as a clear and transparent regulatory framework, strict risk assessment and obtaining the free, prior and informed consent of indigenous peoples and local communities were in place prior to any release of organisms containing engineered gene drives. This proposal was supported by two other developing country Parties.

This then became the basis for further discussions on the paragraph, encapsulating the idea that there should be strict and precautionary conditions to be met before any release of an organism containing engineered gene drives.

As the negotiations proceeded, discussion then turned on what phrase would be acceptable as a replacement for “refrain from”. The developing country Parties which supported “refrain from” favoured text that conveyed a similar sentiment, i.e. calling on Parties and other Governments to “avoid” introducing organisms containing engineered gene drives into the environment, “until” the conditions are met.

Surprisingly, there was support also for this from another African Group member, indicating that the purported Africa Group position in support of release of gene drive organisms into the environment did not have had the support of all the African Parties.

Other Parties preferred the text to call on Parties and other Governments to “consider” introducing organisms containing engineered gene drives into the environment, only when the conditions are met.

The other main sticking point was around the issue of obtaining the free, prior and informed consent of potentially affected indigenous peoples and local communities. A later paragraph, agreed at SBSTTA notes the conclusions of the Ad Hoc Technical Expert Group (AHTEG) on Synthetic Biology that such consent “might be warranted” when considering the possible release of organisms containing engineered gene drives that may impact traditional knowledge, innovation, practices, livelihood and use of land and water of indigenous peoples and local communities. An identical paragraph is also in the decision on risk assessment and risk management under the Cartagena Protocol on Biosafety (its Parties were meeting in parallel).

A few Parties insisted that the issue of obtaining the free, prior and informed consent of indigenous peoples and local communities was an important part of the whole package of conditions being discussed at that point. In addition to already being an international commitment under the UN Declaration on the Rights of Indigenous Peoples, this issue had already been raised at SBSTTA and had received strong support from the indigenous peoples and local communities, a critical constituency of the CBD.

After protracted negotiations especially on the need to obtain the free, prior and informed consent of indigenous peoples and local communities, a final compromise on the paragraph addressing organisms containing engineered gene drives was agreed, as follows:

“Calls upon Parties and other Governments, taking into account the current uncertainties regarding engineered gene drives, to apply a precautionary approach, in accordance with the objectives of the Convention, and also calls upon Parties and other Governments to only consider introducing organisms containing engineered gene drives into the environment, including for experimental releases and research and development purposes, when:

(a) Scientifically sound case-by-case risk assessments have been carried out;

(b) Risk management measures are in place to avoid or minimize potential adverse effects, as appropriate;

(c) Where appropriate, the “prior and informed consent”, the “free, prior and informed consent” or “approval and involvement” of potentially affected indigenous peoples and local communities is sought or obtained, where applicable in accordance with national circumstances and legislation.”

These conditions therefore have to be met when Parties and other Governments are considering the release of organisms containing engineered gene drives into the environment, including for field trial and research purposes.

Both the decision on synthetic biology and that on risk assessment and risk management under the Cartagena Protocol on Biosafety further stipulate that before organisms containing engineered gene drives are considered for release into the environment, specific guidance may be useful, to support case-by-case risk assessment. The Parties to the Cartagena Protocol will consider, in 2020, whether additional guidance materials on risk assessment is needed for such organisms.

Therefore, it would also be prudent and responsible for Parties and other Governments to wait until such international guidance specific to the obligations in the Cartagena Protocol is available, before considering any introduction of gene drive organisms into the environment.

An important footnote on precautionary approach

In addition, a footnote to the words “precautionary approach” recalls a series of inter-related decisions by the CBD Parties, which set out further important principles for addressing organisms containing engineered gene drives.

The footnote refers to a previous COP decision (XIII/17), which reaffirms decision XII/24, in which it urged Parties and invited other Governments to take a precautionary approach “in accordance with paragraph 4 of decision XI/11” and to do the following:

  1. establish effective risk assessment and management procedures and/or regulatory systems to regulate environmental release, consistent with Article 3 of the Convention (which reiterates the principle in international law that States have a responsibility to ensure that activities within their jurisdiction or control do not cause damage to the environment of other States; an issue of particular concern with gene drive organisms, given the high potential for spread and transboundary movement);
  2. approve field trials only after appropriate risk assessments have been carried out in accordance with national, regional and/or international frameworks;
  3. carry out scientific assessments with regard to potential effects on the conservation and sustainable use of biodiversity, taking into account risks to human health and addressing also other issues such as food security and socioeconomic considerations with the full participation of indigenous and local communities;
  4. encourage provision of funding for research into risk assessment methodologies and promotion of  interdisciplinary research that includes related socioeconomic considerations;
  5. cooperate in the development and/or strengthening of human resources and institutional capacities, including on methodologies for risk assessments, taking into account the needs of developing countries for financial resources, access to and transfer of technology, establishing or strengthening regulatory frameworks and for risk management.

Decision XIII/17 additionally noted that the above elements “can also apply to some living modified organisms containing gene drives”.

The precautionary approach “in accordance with paragraph 4 of decision XI/11”, is itself to be taken “in accordance with the preamble of the Convention and with Article 14”.

The preamble of the CBD notes that, “where there is a threat of significant reduction or loss of biological diversity, lack of full scientific certainty should not be used as a reason for postponing measures to avoid or minimize such a threat”. This provides Parties the right to take precautionary measures, including bans and moratoria, even in a situation where scientific knowledge is lacking.

Article 14 of the CBD meanwhile sets out the principles of impact assessment and for minimizing adverse effects, spelling out elements such as environmental impact assessment and allowing for public participation in such procedures; dealing with the consequences of extra-territorial impacts by promoting reciprocity, notification, exchange of information and consultation; immediate notification as well as action to prevent imminent or grave danger or damage beyond national jurisdiction; and emergency responses and international cooperation for joint contingency plans when there is a grave and imminent danger to biological diversity.

Furthermore, the issue of liability and redress, including restoration and compensation for damage to biodiversity, is to be examined.

All these elements are particularly pertinent to organisms containing engineered gene drives, and are now part of the package of precautionary conditions that should apply to such organisms, when their introduction into the environment, including for experimental releases and research and development purposes, is being considered. If these conditions are not met, there should not be releases of organisms containing engineered gene drives into the environment.

Footnote on “prior and informed consent”, the “free, prior and informed consent” or “approval and involvement”

An additional footnote in the COP 14 decision, on “prior and informed consent”, “free, prior and informed consent” or “approval and involvement” refers to Decision XIII/18.

That Decision adopted the Mo’otz Kuxtal Voluntary Guidelines for the development of mechanisms, legislation or other appropriate initiatives to ensure the “prior and informed consent”, “free, prior and informed consent” or “approval and involvement”, of indigenous peoples and local communities when accessing their knowledge, innovations and practices, for fair and equitable sharing of benefits arising from the use of their knowledge, innovations and practices, and for reporting and preventing unlawful appropriation of traditional knowledge. These guidelines, while voluntary, set out detailed standards for the international community on this issue.

No similar international guidelines exist yet for obtaining the “prior and informed consent”, “free, prior and informed consent” or “approval and involvement” of potentially affected indigenous peoples and local communities when considering the release of gene drive organisms. However, meeting a similar standard to the Mo’otz Kuxtal Voluntary Guidelines, would be the prudent and responsible thing to do when it comes to obtaining the “prior and informed consent”, “free, prior and informed consent” or “approval and involvement”, of indigenous peoples and local communities. +

(See next article, ‘Rapid synthetic biology developments necessitate “horizon scanning”’ for an analysis of the other synthetic biology issues discussed at COP 14.)

No Release of “Gene Drives” Without Precautionary Conditions

THIRD WORLD NETWORK BIOSAFETY INFORMATION SERVICE

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

No release of “gene drives” without precautionary conditions

Sharm el-Sheikh, 6 Dec (Lim Li Ching and Lim Li Lin) — Parties to the Convention on Biological Diversity (CBD) have 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.

The Fourteenth Meeting of the Conference of the Parties (COP 14) to the CBD was held in Sharm el-Sheikh, Egypt from 17th to 29th November 2018. On its agenda was the topic of ‘synthetic biology’, which the CBD has been considering since 2010.

In recent years, the issue of organisms containing engineered gene drives has taken centre stage, due to the scientific uncertainties and potential for causing significant and irreversible adverse effects on biodiversity. Current research using gene drive systems include targeting the mosquitoes that are the vector for malaria, and some invasive species that are driving other species to extinction.

Gene drive systems are designed to deliberately spread transgenes and cannot be contained once released. They are very likely to cross national borders. The release of even a few organisms containing engineered gene drives can force the engineered trait to spread through sexual reproduction, resulting in the genetic engineering of whole populations, whether wild or domestic, and possible population or species extinction.

Civil society organisations have dubbed this new development of modern biotechnology, “Exterminator Technology”. Given the serious potential adverse effects, more than 160 such organisations had called for a moratorium on the technology in 2016.

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, including the need to apply a precautionary approach to organisms containing engineered gene drives.

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

[“Other Governments” refers to the United States that has signed but not ratified the CBD.]

Parties to the CBD therefore focused on the bracketed text at COP 14, in an effort to resolve the differences.

When the issue was first discussed in Working Group 2 of COP 14, the European Union proposed a compromise, saying it was willing to accept the phrase “refrain from” if conditions relating to risk assessment and risk management were put in place.

Malaysia was open to working with this approach, as was Argentina, provided that risk assessment was qualified by being on a case-by-case basis.  Costa Rica added that, in addition to the requisite scientific and technical assessment to ensure no negative impacts, liability and redress should be included.

Bolivia strongly supported the text calling for Parties and other Governments to “refrain from” environmental release of organisms containing engineered gene drives, citing the gaps in knowledge and uncertainties. This position was supported by El Salvador and Venezuela.

However, a slew of other Parties opposed the “refrain from” language, and merely wanted the precautionary approach to apply “with regard to” the release of organisms containing engineered gene drives. Although South Africa who spoke for the Africa Group for this issue also opposed this language, Egypt a member of the Group, supported Bolivia’s position with regard to “refrain from”.  

Observers noted that the Africa Group, which had previously been a strong defender of precaution for modern biotechnology and synthetic biology, may have been influenced by the well-funded Target Malaria project, which aims to release gene drive mosquitoes on the continent, purportedly to help with malaria control.

Given the sharp divergences, a Contact Group was set up, chaired by Horst Korn of Germany. Its mandate was to only address the bracketed text coming from SBSTTA.

At the Contact Group, a developing country Party which had supported the “refrain from” text stressed that it could only agree to the removal of “refrain from” if other important precautionary conditions such as a clear and transparent regulatory framework, strict risk assessment and obtaining the free, prior and informed consent of indigenous peoples and local communities were in place prior to any release of organisms containing engineered gene drives. This proposal was supported by two other developing country Parties.

This then became the basis for further discussions on the paragraph, encapsulating the idea that there should be strict and precautionary conditions to be met before any release of an organism containing engineered gene drives.

As the negotiations proceeded, discussion then turned on what phrase would be acceptable as a replacement for “refrain from”. The developing country Parties which supported “refrain from” favoured text that conveyed a similar sentiment, i.e. calling on Parties and other Governments to “avoid” introducing organisms containing engineered gene drives into the environment, “until” the conditions are met.

Surprisingly, there was support also for this from another African Group member, indicating that the purported Africa Group position in support of release of gene drive organisms into the environment did not have had the support of all the African Parties.

Other Parties preferred the text to call on Parties and other Governments to “consider” introducing organisms containing engineered gene drives into the environment, only when the conditions are met.

The other main sticking point was around the issue of obtaining the free, prior and informed consent of potentially affected indigenous peoples and local communities. A later paragraph, agreed at SBSTTA notes the conclusions of the Ad Hoc Technical Expert Group (AHTEG) on Synthetic Biology that such consent “might be warranted” when considering the possible release of organisms containing engineered gene drives that may impact traditional knowledge, innovation, practices, livelihood and use of land and water of indigenous peoples and local communities. An identical paragraph is also in the decision on risk assessment and risk management under the Cartagena Protocol on Biosafety (its Parties were meeting in parallel).

A few Parties insisted that the issue of obtaining the free, prior and informed consent of indigenous peoples and local communities was an important part of the whole package of conditions being discussed at that point. In addition to already being an international commitment under the UN Declaration on the Rights of Indigenous Peoples, this issue had already been raised at SBSTTA and had received strong support from the indigenous peoples and local communities, a critical constituency of the CBD.

After protracted negotiations especially on the need to obtain the free, prior and informed consent of indigenous peoples and local communities, a final compromise on the paragraph addressing organisms containing engineered gene drives was agreed, as follows:

“Calls upon Parties and other Governments, taking into account the current uncertainties regarding engineered gene drives, to apply a precautionary approach, in accordance with the objectives of the Convention, and also calls upon Parties and other Governments to only consider introducing organisms containing engineered gene drives into the environment, including for experimental releases and research and development purposes, when:

(a) Scientifically sound case-by-case risk assessments have been carried out;

(b) Risk management measures are in place to avoid or minimize potential adverse effects, as appropriate;

(c) Where appropriate, the “prior and informed consent”, the “free, prior and informed consent” or “approval and involvement” of potentially affected indigenous peoples and local communities is sought or obtained, where applicable in accordance with national circumstances and legislation.”

These conditions therefore have to be met when Parties and other Governments are considering the release of organisms containing engineered gene drives into the environment, including for field trial and research purposes.

Both the decision on synthetic biology and that on risk assessment and risk management under the Cartagena Protocol on Biosafety further stipulate that before organisms containing engineered gene drives are considered for release into the environment, specific guidance may be useful, to support case-by-case risk assessment. The Parties to the Cartagena Protocol will consider, in 2020, whether additional guidance materials on risk assessment is needed for such organisms.

Therefore, it would also be prudent and responsible for Parties and other Governments to wait until such international guidance specific to the obligations in the Cartagena Protocol is available, before considering any introduction of gene drive organisms into the environment.

An important footnote on precautionary approach

In addition, a footnote to the words “precautionary approach” recalls a series of inter-related decisions by the CBD Parties, which set out further important principles for addressing organisms containing engineered gene drives.

The footnote refers to a previous COP decision (XIII/17), which reaffirms decision XII/24, in which it urged Parties and invited other Governments to take a precautionary approach “in accordance with paragraph 4 of decision XI/11” and to do the following:

  1. establish effective risk assessment and management procedures and/or regulatory systems to regulate environmental release, consistent with Article 3 of the Convention (which reiterates the principle in international law that States have a responsibility to ensure that activities within their jurisdiction or control do not cause damage to the environment of other States; an issue of particular concern with gene drive organisms, given the high potential for spread and transboundary movement);
  2. approve field trials only after appropriate risk assessments have been carried out in accordance with national, regional and/or international frameworks;
  3. carry out scientific assessments with regard to potential effects on the conservation and sustainable use of biodiversity, taking into account risks to human health and addressing also other issues such as food security and socioeconomic considerations with the full participation of indigenous and local communities;
  4. encourage provision of funding for research into risk assessment methodologies and promotion of  interdisciplinary research that includes related socioeconomic considerations;
  5. cooperate in the development and/or strengthening of human resources and institutional capacities, including on methodologies for risk assessments, taking into account the needs of developing countries for financial resources, access to and transfer of technology, establishing or strengthening regulatory frameworks and for risk management.

Decision XIII/17 additionally noted that the above elements “can also apply to some living modified organisms containing gene drives”.

The precautionary approach “in accordance with paragraph 4 of decision XI/11”, is itself to be taken “in accordance with the preamble of the Convention and with Article 14”.

The preamble of the CBD notes that, “where there is a threat of significant reduction or loss of biological diversity, lack of full scientific certainty should not be used as a reason for postponing measures to avoid or minimize such a threat”. This provides Parties the right to take precautionary measures, including bans and moratoria, even in a situation where scientific knowledge is lacking.

Article 14 of the CBD meanwhile sets out the principles of impact assessment and for minimizing adverse effects, spelling out elements such as environmental impact assessment and allowing for public participation in such procedures; dealing with the consequences of extra-territorial impacts by promoting reciprocity, notification, exchange of information and consultation; immediate notification as well as action to prevent imminent or grave danger or damage beyond national jurisdiction; and emergency responses and international cooperation for joint contingency plans when there is a grave and imminent danger to biological diversity.

Furthermore, the issue of liability and redress, including restoration and compensation for damage to biodiversity, is to be examined.

All these elements are particularly pertinent to organisms containing engineered gene drives, and are now part of the package of precautionary conditions that should apply to such organisms, when their introduction into the environment, including for experimental releases and research and development purposes, is being considered. If these conditions are not met, there should not be releases of organisms containing engineered gene drives into the environment.

Footnote on “prior and informed consent”, the “free, prior and informed consent” or “approval and involvement”

An additional footnote in the COP 14 decision, on “prior and informed consent”, “free, prior and informed consent” or “approval and involvement” refers to Decision XIII/18.

That Decision adopted the Mo’otz Kuxtal Voluntary Guidelines for the development of mechanisms, legislation or other appropriate initiatives to ensure the “prior and informed consent”, “free, prior and informed consent” or “approval and involvement”, of indigenous peoples and local communities when accessing their knowledge, innovations and practices, for fair and equitable sharing of benefits arising from the use of their knowledge, innovations and practices, and for reporting and preventing unlawful appropriation of traditional knowledge. These guidelines, while voluntary, set out detailed standards for the international community on this issue.

No similar international guidelines exist yet for obtaining the “prior and informed consent”, “free, prior and informed consent” or “approval and involvement” of potentially affected indigenous peoples and local communities when considering the release of gene drive organisms. However, meeting a similar standard to the Mo’otz Kuxtal Voluntary Guidelines, would be the prudent and responsible thing to do when it comes to obtaining the “prior and informed consent”, “free, prior and informed consent” or “approval and involvement”, of indigenous peoples and local communities. +

(See next article, ‘Rapid synthetic biology developments necessitate “horizon scanning”’ for an analysis of the other synthetic biology issues discussed at COP 14.)

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