Report on ENSSER side events at 14th Conference of the Parties (COP14) to the Convention on Biological Diversity (CBD) and 9th Conference of the Parties serving as Meeting of the Parties (COPMOP9) to the Cartagena Protocol on Biosafety (CPB)


Side events at 14th Conference of the Parties (COP14) to the Convention on Biological Diversity (CBD) and 9th Conference of the Parties serving as Meeting of the Parties (COPMOP9) to the Cartagena Protocol on Biosafety (CPB)

18 – 21 November 2018, Sharm El-Sheikh, Egypt

Sponsored by Software AG and GLS Treuhand Zukunftsstifung Landwirtschaft

REPORT

Continuing its tradition of organising scientific side events at the biennial COP(MOP)s of the CBD and CPB, ENSSER co-organised four side events at COP14/COPMOP9 in Sharm El-Sheikh on topics which were on the agenda of the conferences. Co-organisers of the side events were the Federation of German Scientists (FGS), Critical Scientists Switzerland (CSS) and Third World Network (TWN). Our other tradition, holding a conference for NGOs and scientists of the host country in advance of the COP, could unfortunately not be carried out this time due to host country circumstances.

Side event 1

What is on the horizon? Biodiversity and gene drives: science, culture, ethics, socio-economics and governance
Sunday 18 November 2018, 18:15 – 19:45
Hosted by the Federation of German Scientists

Gene drive organisms are genetically modified organisms designed to rapidly spread a modified trait or a handicap through populations or entire species, by actively biasing their inheritance. The ability and willingness to modify or eradicate whole wild populations or entire species goes far beyond any previous capacities. Global gene drives carry a high risk of causing ecological imbalance and disruption, on top of the usual risks of genetic engineering. At the same time, the high potential for transboundary movement and unintentional spread of gene drive organisms poses challenges for the existing legal and regulatory regime.

A moratorium on gene drives was therefore proposed by 160 NGOs at COP13 in Mexico (2016) but was declined by the Parties (the countries that ratified the CBD). The subject was on the agenda of COP14 again as part of the topic of synthetic biology.

Christine von Weizsäcker (Ecoropa) chaired this side event and pointed out that a comprehensive assessment of gene drive technology should include not only the risks and benefits from a scientific point of view, but also the cultural, ethical, socio-economic and regulatory considerations. Ricarda Steinbrecher (Federation of German Scientists, board member of ENSSER) provided an update on the science, applications and risks of gene drives. Lim Li Ching (Third World Network) then explored their governance challenges, in particular pointing to the fact that while there are existing international instruments, including the CBD and its Protocols, that relate to various aspects of gene drive governance, there are gaps in relation to their coverage, as well as in addressing the specific challenges. She highlighted some of the elements for a comprehensive legally-binding international legal/regulatory regime for effective governance of gene drives.

The presentations reflected ongoing research into these critical aspects and aimed to promote informed input into the discussions at COP14 on gene drives. The side event was attended by 54 participants. Unfortunately it had to be finished a quarter of an hour early (due to an official meeting many were interested in), leaving no time for discussion. Yet, after the end of the side event, one of the participants, involved in the development of gene drives for mosquitoes, engaged in a lengthy conversation with Ricarda Steinbrecher.

Side event 2

Challenges to the risk assessment of LMOs derived from new genetic engineering techniques
Monday 19 November 2018, 18:15 – 19:45
Hosted by ENSSER

The development of ‘genome editing’ (which should rather be called genome engineering) and other new genetic engineering (GE) techniques requires that risk assessment techniques and methods equally develop to keep pace. In this side event, chaired by Diederick Sprangers (scientific co-ordinator of ENSSER), requirements to risk assessment techniques and methods were discussed and it was argued that work on risk assessment under the Cartagena Protocol must continue, facing the challenges arising from the new GE techniques.

Angelika Hilbeck (board member and co-founder of ENSSER) explained the limitations of current risk assessment concepts as implemented by most regulators and why a thorough risk assessment of these techniques and their products is urgently needed. She pointed out the discrepancy between the perception of the claimed benefits and the risks of living modified organisms (LMOs or GMOs). The benefits are taken as wide as possible (agronomic, environmental, socio-economic), but when the risks are considered, the LMO is split up in its chemical components, of which only a few are analysed in isolation of the whole. Obviously for risk assessment, just as for benefit assessment, the LMO should be assessed as a whole and in all its relevant contexts.

Georgina Catacora-Vargas (biosafety advisor of the Vice-Ministry of Environment of Bolivia) discussed the challenges and needs of the risk assessment and risk management of the new GE technologies from a regulatory perspective. This talk highlighted the gaps and social-ecological uncertainties around the new GE technologies, relevant for precautionary regulatory frameworks, having as background the Bolivian legislation. The insights she provided aimed to feed into the science-policy interface dialogue. The Bolivian constitution (renewed in 2009 after a very long consultation process with the population) forbids LMO cultivation, but Intacta GM soy and other LMOs are coming in illegally from Brazil. Bolivia therefore needs the instruments for risk assessment, including that of crops made with the new GE techniques. Ms. Catacora-Vargas pointed out that the precautionary approach is very proactive, very innovative and very creative.

Our third speaker had unfortunately had to cancel. There were ca. 40 participants, who asked very many questions and kept a lively discussion going right till the end of the side event.

Side event 3

Precautionary GMO assessment includes socio-economic considerations
Wednesday 21 November 2018, 13:15 – 14:45
Hosted by ENSSER

The responsible management of genetically modified crops and animals, particularly when made by genome editing and other novel GM techniques, requires a full technology assessment, not just a science-based risk assessment, and must be based on the precautionary principle. The work on socio-economic considerations under the Cartagena Protocol is vital to this and needs to be developed further. Diederick Sprangers chaired this side event.

Lim Li Ching (Third World Network) explained that, although the Ad Hoc Technical Expert Group (AHTEG) on socio-economic considerations of GMOs has developed guidance for assessing these aspects, this guidance still lacks concrete instructions and examples. She called on Parties to the Cartagena Protocol on Biosafety to extend the AHTEG to continue the work on socio-economic considerations under the Protocol and to supplement the guidance so that it can be used widely. Her presentation drew many questions from the audience. One of these was from a participant from Burkina Faso, who pointed out that the Target Malaria consortium wants to introduce mosquitoes containing gene drives into his country; however, after the failure of Bt cotton in Burkina Faso, which caused a collapse of the formerly high cotton export from the country and badly affected the livelihood of the farmers, this new GM effort may cause a social crisis.

Rosa Binimelis (board member of ENSSER) discussed the work of the AHTEG on socio-economic considerations as well as the actual implementation of these considerations across the world. Thirty-four countries have now included socio-economic considerations in their legislation, though only half of these actually do something about their implementation. The scope of these considerations varies and may include environmental, health, cultural and/or ethical aspects. The EU only introduced socio-economic considerations when it created the so-called opt-out Directive, stating that member states may opt out of a GMO authorised at EU level on the basis of various considerations, including socio-economic ones. However, the EU has not specified what these socio-economic considerations may be. There is a big lack of empirical and comprehensive research into the subject; especially social aspects of GM crops are hardly investigated. In the Cartagena Protocol framework, further work of the AHTEG, particularly in the light of the new GM techniques, is needed.

Angelika Hilbeck (board member of ENSSER) questioned the scientific foundations of genetic engineering – old and new techniques – which explains in part the failure to deliver on the promised products to date, countering the narrative of GM developer circles blaming regulations. It also explains why repeating the old promises for the new techniques will, inevitably, prove untenable once more. Precautionary GMO assessment highlights the first step of the risk assessment process, which is the framing of the question, i.e. the problem formulation and hazard identification. Socio-economic considerations are often totally ignored at this point, but should be the key issue in assessing the risks, just as they are the key issue for claiming the benefits.

This side event drew 25 participants from many countries, e.g. Uganda, Egypt and Ireland, who asked many very relevant questions.

Side event 4

Effectively addressing conflicts of interest at the CBD and its Protocols
Wednesday 21 November 2018, 18:15 – 19:45
Hosted by Third World Network

The issue of conflicts of interest has gained importance at several international processes because critical issues of international governance often see vested interests at play, with industry funding and participation sometimes not fully disclosed. The Subsidiary Body on Implementation (SBI) put forward a recommendation to Parties of the CBD and its Protocols to approve a procedure for avoiding or managing conflicts of interest and to ensure its implementation with respect to the work of technical expert groups. Parties were thus considering this issue in Sharm El-Sheikh, which will be important to ensure the transparency, integrity and effectiveness of all processes under the Convention and its Protocols. This side event discussed the need to avoid and manage conflicts of interest in discussions on modern biotechnology, with examples of how other processes have dealt with the issue and the lessons learnt, as well as proposals for the current discussions. Lim Li Ching (Third World Network) chaired the side event.

Lim Li Lin (Third World Network) first explained what is understood by conflicts of interest. Their definition is still evolving in academic literature. Conflicts of interest may be either intra-personal (competing interests in one person) or inter-personal (between more than one person with conflicting objectives). Conflicts of interest can be actual, potential or perceived, and direct or indirect. An important distinction is between private (financial and vested) and public interests.

Nina Holland (Corporate Europe Observatory) then spoke about the need to avoid conflicts of interest in discussions on modern biotechnology. Conflicts of interest are a tool for regulatory capture by industry, they are measurable and avoidable. The impact of research funding on outcomes has been evidenced on multiple occasions, not in the least through publication bias. Conflicts of interest in EFSA expert panels have influenced the questions asked in EU risk assessment. These conflicts of interest could persist because of flawed independence rules in that agency. She gave some examples on how other processes, such as the WHO, have dealt with the issue. In the CBD, the conflicts of interest were exposed by the so-called Gene Drive Files in 2017, documents obtained through a freedom of information request in the USA, showing that a concrete lobby coalition exists which attempts to influence discussions in the CBD and its Protocols, and that this lobby coalition is financed by the Bill and Melinda Gates Foundation with US$ 1.6 million.

Christine von Weizsäcker (Ecoropa) set out what is needed to ensure that the CBD processes are free of conflicts of interest, drawing on lessons from the IPBES process (IPBES = Intergovernmental Science-Policy Platform on Biodiversity and Ecosystem Services). In IPBES, the conflict of interest policy and implementation procedures were triggered in 2015 by a pending scandal in pollinator assessment. The policy contains definitions of conflicts of interest and of bias; the implementation procedures contain a conflict of interest form and a conflict of interest committee. Keywords are: legitimacy, integrity, credibility. One lesson from the IPBES experience for the CBD-COP is that conflict of interest policy should certainly apply to AHTEGs.

Lim Li Lin, finally, discussed the proposals for the current negotiations, stating e.g. that the proposed CBD text contained a big loophole, allowing for the CBD secretariat to appoint experts despite conflicts of interest. The often heard rationale that for certain subjects, experts with conflicts of interest are the only experts available, can be countered by proposals for distinguishing between hearings/written inputs and decision making processes: this allows ‘indispensable’ knowledge of experts with conflicts of interest to be received without the experts with conflicts of interest taking part in making recommendations that influence the decision.

Fifty participants attended the side event. The discussion provided many further interesting points, with Edward Hammond (Prickly Research, discoverer of the Gene Drive Files) e.g. pointing out that conflict of interest forms must be public; if they are kept confidential (as is the case in the draft gene drive study of IUCN), no one can verify if there are conflicts of interest or not. Another key issue that was highlighted is public research policy. Public research funding should be spent on public interest research, guaranteeing enough independent expertise for risk assessment work, for example.

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