Regulation of Gene Drive Organisms at the International Level

The topic of gene drives has been discussed within the framework of international agreements since the development of the first gene drive organisms in 2014/ 2015, and initial recommendations have been adopted within the framework of the UN Convention on Biological Diversity (CBD). However, from a legal point of view, such recommendations of the Conferences of the Parties to the Convention on Biological Diversity or even other international organizations are not binding for the Parties to the Convention or for other states. Guidance documents are also not legally binding. In this respect, there is currently neither a legally binding international agreement nor specific internationally binding provisions on the release of gene drive organisms into the environment.

Discussions about gene drive organisms in the CBD

Since 2015, gene drives have been discussed within the UN Convention on Biological Diversity as part of its work on synthetic biology and of the discussions on risk assessment of living modified organisms (LMOs) as part of the Cartagena Protocol on Biosafety. The convention treaty was concluded in 1992 and entered into force in 1993. Currently, 195 countries are parties to the Convention, with the notable exception of the United States. The EU became a party to the Convention in 1993.¹ All EU member states and the United Kingdom are also parties to the Convention. 

At the 14th Conference of the Parties to the UN Convention on Biological Diversity (CBD COP 14) in late 2018, delegates discussed a decision on synthetic biology , which should also include regulations on gene drive organisms.² Some Parties introduced a call for a moratorium on the release of gene drive organisms into the environment. In the run-up to the conference, more than 160 civil society organizations, mainly from the alternative agriculture movement and the global South, had called for this in an open letter.³ However, the proposal failed to gain the necessary consensus, as African countries in particular, led by Nigeria and South Africa, opposed a moratorium.

Research based on documents requested under U.S. Freedom of Information regulations concluded that this vote was due to the influence of Target Malaria, a project funded by the Bill & Melinda Gates Foundation. Internal correspondences and documents released as Gene Drive Files brought to light that Target Malaria had funded an agribusiness public affairs firm called Emerging AG. It recruited and coordinated about 65 scientists who became members of expert panels (Open-ended Online Forum on Synthetic Biology / Ad Hoc Technical Expert Group (AHTEG) of the CBD.⁴  

Decision 14/19 on synthetic biology, finally adopted at CBD COP 14 ⁵, argues that further research on gene drives is needed and that the development of specific guidelines for the risk assessment of gene drive organisms could be helpful. Further, the resolution stated that the "free, prior and informed consent" of indigenous peoples and local communities "may be warranted" when considering the release of gene drive organisms. As a compromise to the calls for a moratorium, the Parties were only able to agree on non-binding precautionary considerations related to the release of gene drive organisms into the environment.⁶  

This decision calls on Parties and other governments to apply a precautionary approach consistent with the objectives of the Convention, taking into account the current uncertainties regarding gene drives. Finally, it calls on Parties and other governments to consider the introduction of gene drive organisms into the environment, including for experimental,research and development purposes, only if the following conditions are met:

a)   scientifically sound risk assessments on a case-by-case basis

b)   existence of risk management measures to avoid or minimize potential adverse effects, if any

c)   where appropriate, "prior and informed consent," "free, prior and informed consent," or "approval and participation" of          potentially affected indigenous peoples and local communities is obtained, to the extent possible in accordance with            national circumstances and legislation.⁷ 

In addition, Decision 14/19 considers the recommendations of the CBDs Scientific Body on Scientific, Technical and Technological Advice (SBSTTA) on synthetic biology - including on gene drives - for discussion at the next COP.

Provisions on gene drive organisms under the Cartagena Protocol

 The Cartagena Protocol on Biosafety is a legally binding protocol under the CBD. It has been ratified by 170 countries, including all EU member states, as well as the EU. The USA, Australia, Canada and Argentina are not Parties to the Protocol. 

The Protocol aims to ensure the safe handling, transport and use of living modified organisms (broadly in line with the EU definition of GMOs) and to minimize adverse effects on biodiversity and risks to human health. Decisions of the Protocol must be implemented into national law by signatory countries. 

Currently, Article 17 of the Cartagena Protocol requires signatories to inform the Secretariat and all affected or potentially affected States (Parties and non-Parties) of any occurrence under their jurisdiction that results or may result in the unintended transboundary spread of living modified organisms (i.e., genetically modified organisms, and thus also gene drive organisms). This is also required by EU Regulation 1946/2003, which implements the Protocol.⁸ It stipulates that EU member states should prevent the unintended transboundary spread of GMOs.⁹ In this way, the EU goes further than the provisions of the Cartagena Protocol, which only suggest the start of mutual consultations in such a case.

At its ninth session, the Conference of the Parties to the Cartagena Protocol (COP-MOP9) recognized in its decision 9/13, paragraph 3, the potential adverse effects of gene drive organisms on the environment. This decision reiterated the need to consider, in advance of any release of such organisms into the environment, the need for research and (risk) assessment and whether specific guidance on this might be helpful in order to conduct a case-by-case risk assessment. International cooperation, knowledge exchange and capacity building should serve to better assess the potential adverse effects of gene drive organisms.¹⁰

At their tenth meeting (COP-MOP 10), the Protocol's member parties will discuss whether to develop guidance for the risk assessment of gene drive organisms. In the run-up to the meeting, a panel of experts called the Ad Hoc Technical Expert Group (AHTEG) had advocated for the development of such specific guidance materials. According to their report, they would have to assess the impacts of gene drive organisms on ecosystems as a whole, as irreversible impacts on biodiversity are identified as possible consequences of releasing gene drive organisms into the environment. Among others, the spatial and temporal controllability as well as unforeseen effects that occur only in following generations are highlighted as special challenges for the risk assessment of gene drive organisms.¹¹

Provisions on gene drive organisms under the Nagoya-Kuala Lumpur Supplementary Protocol on Liability and Redress to the Cartagena Protocol

 

The Nagoya-Kuala Lumpur Supplementary Protocol on Liability and Redress is a sub-protocol of the Cartagena Protocol on Biosafety. It entered into force in 2018 and has 46 signatories, including 21 EU Member States and the EU. The protocol provides liability rules for cases where the provisions of the Cartagena Protocol have not been followed. Like the Cartagena Protocol itself, this supplementatyl protocol applies to gene drive organisms. However, there are currently no provisions tailored specifically to gene drive organisms.

Under Article 3 of the Protocol, provisions on liability and redress apply when damage results from the transboundary movement of living modified organisms (LMOs), i.e. genetically modified organisms. No matter whether they were deliberately, unknowingly or illegally introduced into the environment.¹² According to Article 2, damage isdefined as negative effects on the conservation and sustainable use of biodiversity.

Article 2 also states that response actions can only be taken if the harm is measurable, observable and significant. The significance of the damage is measured by the following criteria¹³:

  • Whether they result in long-term or permanent changes that cannot be remedied by natural recovery within a reasonable period of time

  • The extent of qualitative or quantitative changes that adversely affect components of biodiversity.

  • Whether they reduce the ability of biodiversity to provide goods or services

  • What is the magnitude of the adverse effect on human health.¹⁴

Problematically, there are neither financial guarantees provided by the protocol nor enforcement mechanisms for the protocol. 

World Health Organisation (WHO) provisions

 

In 2014, an expert group established under the auspices of the World Health Organization (WHO) published a guidance framework for testing genetically modified mosquitoes.¹⁵ However, the guidance has never been approved or adopted in any form by the WHO itself. Because the first publications on gene drive technology did not appear until 2015, the specific problems of this technology were not discussed in this guide. A revised version is expected by spring2021, which should also include statements on gene drives. In October 2020 the WHO published a position statement, which clarifies the WHO’s stance on the use of genetically modified mosquitoes for the control of vector-borne diseases, including the use of gene drives.¹⁶ Along with this the WHO published guidance on ethics and vector-borne diseases, which includes a chapter on gene drive organisms.¹

Provisions of the UN Biological Weapons Convention

The Convention on the Prohibition of the Development, Production and Stockpiling of Bacteriological (Biological) and Toxin Weapons and on their Destruction prohibits the development, production and stockpiling of biological weapons for military use. The convention was adopted by United Nations member states in 1971 and entered into force in 1975. 183 state parties have signed the convention, committing themselves to destroy all stockpiles of biological weapons. However, there are no agreements on controls in this regard. Disclosure obligations and controls have not yet been integrated by an additional protocol. 

Gene drives are prohibited under Article 1 of the Biological Weapons Convention if they are used for hostile purposes. This would also be the case, for example, if they were used as a means of delivering poisons or pathogens.¹⁸ Likewise, any use of gene drives is also prohibited if there is no justification for their use for peaceful purposes or if they are otherwise inconsistent with the purposes and provisions of the UN Biological Weapons Convention.¹⁹ However, there are few convincing scenarios for gene drive weapons programs unless gene drives and their harmful effects can be spatially or temporally contained.²⁰

Sources:

 

[1] EUR-Lex Website (1993). Amt für Veröffentlichungen der Europäischen Union. Council Decision of 25 October 1993 concerning the conclusion of the Convention on Biological Diversity (93/626/EEC). Online: https://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=CELEX:31993D0626:EN:HTML [last accessed: 07.12.2020] 

 

 

[2] Convention on Biological Diversity (2018a). Decision adopted by the Conference of the Parties to the Convention on Biological Diversity. 14/19. Synthetic biology. 14th Meeting of the Conference of the Parties to the Convention on Biological Diversity; 2018 Nov 17-29, Sharm El-Sheikh, Ägypten. Online: https://www.cbd.int/doc/decisions/cop-14/cop-14-dec-19-en.pdf [last accessed: 07.12.2020]

 

 

[3] ETC Group Website (ohne Jahr). ETC Group. A Call to Protect Food Systems from Genetic Extinction Technology: The Global Food and Agriculture Movement Says NO to Release of Gene Drives. Online: https://www.etcgroup.org/sites/www.etcgroup.org/files/files/forcing_the_farm_sign_on_letter_english_web.pdf [last accessed: 07.12.2020]

 

[4] Gene Drive Files website (2017). Gene Drive Files. Online: http://genedrivefiles.synbiowatch.org/ [last accessed: 07.12.2020].

 

[5] Convention on Biological Diversity (2018a). Decision adopted by the Conference of the Parties to the Convention on Biological Diversity. 14/19. Synthetic biology. 14th Meeting Conference of the Parties to the Convention on Biological Diversity; 2018 Nov 17-29, Sharm El-Sheikh, Ägypten. p.2. Online: https://www.cbd.int/doc/decisions/cop-14/cop-14-dec-19-en.pdf [last accessed: 07.12.2020] 

 

[6] Convention on Biological Diversity (2018b). Biodiversity financing and safeguards: Lessons learned and proposed guidelines. 12th meeting of Conference of the Parties to the Convention on Biological Diversity; 2014 Oct 6-17, Pyeongchang, Republic of Korea. Online: https://www.cbd.int/doc/meetings/cop/cop-12/information/cop-12-inf-27-en.pdf [last accessed: 07.12.2020]

 

[7] Cf. ibid. CBD/COP/DEC/14/1930, Section 11.

 

 

[8] EUR-Lex Website (2003). Publications Office of the European Union. 32003R1946 - Regulation (EC) No 1946/2003 of the European Parliament and of the Council of 15 July 2003 on transboundary movements of genetically modified organisms (Text with EEA relevance). Official Journal L 287, 05/11/2003 P. 0001 - 0010. Online: https://eur-lex.europa.eu/legal-content/DE/TXT/HTML/?uri=CELEX:32003R1946&from=DE [last accessed 07/12/2020]. 

 

 

[9] Secretariat of the Convention on Biological Diversity (2000). Cartagena Protocol on Biosafety to the Convention on Biological Diversity: text and annexes. Article 14 (1) Online: https://www.cbd.int/doc/legal/cartagena-protocol-en.pdf [last accessed: 07.12.2020] 

 

 

[10]Convention on Biological Diversity (2018c). Decision adopted by the Parties to the Cartagena Protocol on Biosafety. 9/13.ca Risk assessment and risk management (Articles 15 and 16). 9th Meeting of the Conference of the Parties to the Convention on Biological Diversity serving as the Meeting of the parties to the Cartagena Protocol on Biosafety; 2018 Nov 17-29, Sharm El-Seikh, Ägypten.  Online: https://www.cbd.int/doc/decisions/cp-mop-09/cp-mop-09-dec-13-en.pdf [last accessed: 07.12.2020]

 

 

[11]Convention on Biological Diversity. Ad Hoc Technical Expert Group on Risk Assessment (2020). Report of the Ad Hoc Technical Expert Group on Risk Assessment. CBD/CP/RA/AHTEG/2020/1/5. 15. April 2020, Montreal, Canada. Online: https://www.cbd.int/doc/c/a763/e248/4fa326e03e3c126b9615e95d/cp-ra-ahteg-2020-01-05-en.pdf

 

 

[12]Convention on Biological Diversity Website (ohne Jahr a). Secretariat of the Convention on Biological Diversity (SCBD); c2001-2016. Text of the Nagoya-Kuala Lumpur Supplementary Protocol on Liability and Redress to the Cartagena Protocol on Biosafety - Article 3.1.c. Scope. Online: http://bch.cbd.int/protocol/nkl/article3/ [last accessed: 07.12.2020]

 

 

[13]Convention on Biological Diversity Website (ohne Jahr a). Secretariat of the Convention on Biological Diversity (SCBD); c2001-2016. Text of the Nagoya-Kuala Lumpur Supplementary Protocol on Liability and Redress to the Cartagena Protocol on Biosafety - Article 2. Scope. Online: http://bch.cbd.int/protocol/nkl/article3/ [last accessed: 07.12.2020] 

 

[14]Convention on Biological Diversity Website (ohne Jahr a). Secretariat of the Convention on Biological Diversity (SCBD); c2001-2016. Text of the Nagoya-Kuala Lumpur Supplementary Protocol on Liability and Redress to the Cartagena Protocol on Biosafety - Article 2. Scope. Online: http://bch.cbd.int/protocol/nkl/article3/ [last accessed: 07.12.2020] 

 

[15]World Health Organization on behalf of the Special Programme for Research and Training in Tropical Diseases 2014 (2014). Guidance Framework for Testing of Genetically Modified Mosquitoes. Online: https://www.who.int/tdr/publications/year/2014/Guidance_framework_mosquitoes.pdf [last accessed: 07.12.2020]

 

[16]World Health Organization (2020). Evaluation of genetically modified mosquitoes for the control of vector-borne diseases. Position statement. Online: https://www.who.int/publications/i/item/9789240013155 [last accessed: 14.03.2021]

 

[17]World Health Organization (2020). Ethics and vector-borne diseases. WHO guidance. Online: https://www.who.int/publications/i/item/978924001273-8 [last accessed: 14.03.2021]

 

[18]United Nations (2017). The Biological Weapons Convention - An Introduction. Genf: United Nations Publication. Online: https://www.unog.ch/80256EDD006B8954/(httpAssets)/6D16C7B1933F0937C125815D00349763/$file/BWS%20brochure.pdf [last accessed: 07.12.2020]

 

 

[19]United Nations (1996). Report of the Committee of the whole. BWC/CONF.IV/6. 4th Review Conference of the Parties to the Convention on the Prohibition, the Development, Production and Stockpiling of bacteriological (biological) and toxin Weapons and on their Destruction; 1996 Nov 25 - Dec 6; Genf, Schweiz. Online: https://www.unog.ch/bwcdocuments/1996-11-4RC/BWC_CONF.IV_06.pdf [last accessed:last accessed: 22.10.2020]

 

 

[20]Jeremias G (2019). Governing the Conflict Potential of Novel Environmental Biotechnologies (NEBs). BWC Meeting of State Parties; 2019 Dec 3. Online: https://www.unog.ch/80256EDD006B8954/(httpAssets)/FABC68A345728CFFC12584C7006218F4/$file/Conflict+potentials+from+Gene+Drives2.pdf [last accessed: 07.12.2020]

 

 

 

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