Advisory and policy reports
After years of record-breaking numbers of publications, 2022 was a quieter year for COGEM. The Commission published 68 advisory and policy reports, marking an end to the period of intense activity and a return to the level in 2016 and the years before. COGEM provides both solicited and unsolicited advice. In 2022, 91% of our publications were prepared in response to requests by the ministry for advice on licence applications.
In contrast to the period just behind us, most publications (32) concerned topics under the responsibility of the Subcommittee on Agriculture (ScL): plants, crops and plant-associated microorganisms. The Subcommittee on Medical and Veterinary Aspects (ScMV) prepared 30 publications. Three advisory reports were prepared jointly by ScL and ScMV. Lastly, 3 publications were prepared by the Subcommittee on Ethics and Societal Aspects (ScEMA).
The fall in the number of advisory reports can be largely explained by the smaller number of applications for import licences for GM crops in the EU and a drop in the number of requests for advice on clinical trials. Earlier advisory reports containing generic risk assessments for gene therapy trials are beginning to bear fruit. COGEM no longer has to advise on the majority of clinical trials with genetically modified organisms (GMOs), while applicants benefit from the considerably simplified and speeded up the authorisation procedure brought about by the introduction of standard licensing conditions (vergunning onder vaste voorwaarden). Wherever possible, COGEM issues generic advice to support the streamlining of licensing procedures and reduce its own workload.
The fall in the number of requests for advice on applications to import GM crops in Europe has been offset by an increase in the number of requests for advice concerning plants and plant-associated microorganisms. As a result, the number of advisory reports prepared by the Subcommittee on Agriculture remained the same as in previous years.
At the request of the Ministry of Infrastructure and Water Management, the Subcommittee on Ethics and Societal Aspects has defined the criteria to be used when assessing the acceptability of environmental risks. Experiments involving GMOs may only be permitted if the risks are negligible. However, Dutch regulations on clinical studies with GMOs include the possibility of permitting slightly higher environmental risks as long as these are ‘acceptable’, although what this means in practice has never been specified or implemented in licensing procedures. In the policy report Risico’s voor mens en milieu bij gentherapieonderzoek: Wat is aanvaardbaar? [Risks to humans and the environment of gene therapy studies: What is acceptable?] COGEM describes the contours of an assessment framework that could provide structure, consistency and transparency. The report describes the principles and stages of the assessment and goes into the most important assessment criteria in more detail. The assessment criteria are also presented as a list of questions and the need for specific expertise to make properly informed assessments is discussed.
Five research reports commissioned by COGEM were published in 2022. COGEM commissions research by third parties to support its work. As can be seen from the reports published in 2022, the COGEM research programme covers the full range of topics within the Commission’s remit, such as developments in the deliberate release of GMOs, improving the environmental risk assessment, identifying and categorising ethical and societal issues relating to genetic modification, and identifying new scientific developments and trends.
Four of the research reports were published in English. The report On the nature of nature (CGM 2022-01) explores the different meanings associated with the concept of ‘naturalness’. Naturalness is a key concept in the public debate on genetic modification, but the different interpretations given to ‘naturalness’ means that the debate can become muddled and deadlocked. The report An exploration of the potential contribution of genetic modification and genome editing to the development of abiotic stress-tolerant crops as compared to conventional breeding (CGM 2022-04) investigated whether gene editing can meet the high expectations for developing stress tolerance. The remaining research reports are on developments concerning viral replicons and the possible presence of viable GM plant seeds in seed mixes for bird feed and other uses. COGEM made use of the information contained in the report Viral replicon systems and their biosafety aspects (CGM 2022-06) to advise the government on permitting working with replicons derived from alphaviruses and flaviviruses at a lower containment level. Bird feed sold to consumers in the Netherlands has been found to contain GM rapeseed, despite measures by retailers to prevent this (Bird feed and flower seed mixtures: potential for disseminating genetically modified seeds (CGM 2022-02)). The conclusion that can be drawn from this is that the possibility of GM crops spreading via bird feed should be included in the general monitoring plan for imported GM crops.
The fifth report, written in Dutch, concerns a study of the resilience of biotechnology policy. It examines the decision by the EU to derogate temporarily from the licensing procedure for research into Covid-19 vaccines and medicines, including the environmental risk assessment, to speed up the development of these vaccines. The authors of the report come to the conclusion that the legal basis for the decision is questionable, that it did not significantly accelerate the availability of the vaccines and that it may have adverse consequences for the confidence in government and the vaccines. Besides, the Netherlands had already instituted a fast-track licensing procedure for clinical trials.
The following members and associated members stood down in 2022: Dr Sander Herfst (Erasmus University Medical Centre), Dr Peter Bruinenberg (retired, AVEBE), Dr Tjeerd Kimman (retired, Wageningen Bioveterinary Research), Dr Ben Peeters (Wageningen Bioveterinary Research). COGEM extends its warm thanks for their efforts and all the valuable work they have done for the Commission. COGEM was pleased to welcome two new (associated) members in 2022: Dr Nancy Beerens (Wageningen Bioveterinary Research) and Dr Miranda de Graaf (Erasmus University Medical Centre).