Summary
Advisory reports
In 2023 COGEM published 77 advisory and policy reports, including the Biotechnology Trend Analysis 2023. Following a dip in 2021 and 2022, this brings the number of publications back to the level of 2017 and 2019. Most of the advisory reports concerned licence applications for experiments in laboratories, greenhouses and animal houses. As usual, most of the reports gave advice on medical and veterinary research.
In addition to advisory reports on licence applications, COGEM also published several more generic advisory reports, including two in response to the proposal by the European Commission (EC) for a new regulation on plants produced by new genomic techniques (NGTs), which would remove them from the scope of the current GMO legislation. Updating the GMO legislation has been a COGEM focus area since 2006. In its first advisory report, COGEM concluded that the EC proposal is in line with previous advice by COGEM. However, the Commission also pointed out that the criteria in the proposal (Annex 1) for distinguishing between plants that are equivalent to conventional breeding products (category 1 NGT plants) and plants that could not be obtained by conventional breeding (category 2 NGT plants) lack a sound scientific basis. At the end of 2023, following the publication by the EC of a Technical Paper on the rationale for the equivalence criteria in Annex 1, COGEM published a second advisory report containing concrete proposals for further amending and tightening up the criteria.
Biotechnology Trend Analysis
In 2023 the Fifth Biotechnology Trend Analysis was published. This Trend Analysis was prepared at the request of the Dutch Government. COGEM and the Health Council of the Netherlands were asked to prepare a new Biotechnology Trend Analysis ‘with the aim of providing Parliament and policymakers with an overview of the latest developments and applications in biotechnology, both within and outside the Netherlands and the EU, including any identifiable trends, as well as the social and economic opportunities and possibilities these present and the associated ethical questions.’
In the ‘Biotechnology Trend Analysis 2023: A call for vision, decision and direction’, COGEM and the Health Council of the Netherlands conclude, among other things, that the rampant growth of biotechnology presents social and economic opportunities, but that to exploit these opportunities a government-wide approach is needed. The Netherlands is ill-prepared for the rapid developments in biotechnology and is missing out on opportunities to make full use of its economic and social potentials. At the moment, Dutch government initiatives are piecemeal and lack clear objectives. To exploit the opportunities presented by biotechnology responsibly and accountably, a long-term vision and direction is urgently needed. COGEM and the Health Council of the Netherlands therefore call for a government-wide approach involving scientific institutions, social stakeholders and the business community.
In its response to the Trend Analysis, the Dutch Government recognises that while biotechnology presents major opportunities, it also raises dilemmas. Further to the recommendations in the Trend Analysis, a programme has been announced to develop a common vision with all relevant government departments. However, given the caretaker status of the Government, the final development of this vision will have to take place under the new, yet to be formed Government.
Research reports
Three research reports commissioned by COGEM were published in 2023. The report ‘Detection of replication-competent virus formation during production and use of lenti- and gammaretroviral vectors: An inventory and description of test methods and their characteristics’ presents an overview of the tests and methods that can be used to demonstrate the presence of replication-competent retro- and lentiviral vectors (RCV). The purpose of this report to facilitate the authorisation procedure for both laboratory research and clinical gene therapy trials by providing validated methods for detecting the presence of any replication-competent lenti- and retroviral vectors.
The second report, ‘Pathogens of nematodes’, gives an overview of the available information on nematode pathogens. One of COGEM’s tasks is to advise on classifying microorganisms in the appropriate pathogenicity class. The report discusses the suitability of methods to demonstrate pathogenicity for nematodes.
The last research report published in 2023 is an inventory of the characteristics that are important for the propagation (‘growth’), proliferation and survival of cyanobacteria. This overview supports the environmental risk assessment of work with GM cyanobacteria.
Symposia
In 2023 COGEM organised major events for the first time since the Covid-19 pandemic. On 9 March an international symposium on ‘Viruses, Replicons and Vaccines’ was held at the Koepelkerk Centre in Amsterdam. The symposium focused on the use of viruses as vaccines and to control tumours. International speakers discussed the latest scientific and technological possibilities, the potential risks and how legislation can permit ample opportunity for innovation while at the same time ensuring safety. The large turnout from the scientific, risk assessment, business and public sector communities was proof of the topicality of the subject.
The following day, 10 March, COGEM organised a closed meeting of European sister organisations. This was the 10th Meeting of the European Advisory Committees on Biosafety in the field of contained use and deliberate release of GMOs’ (MEACB) and was attended by representatives of 29 organisations from 19 countries. The MEACB offers advisory bodies the opportunity to share experiences, views and insights and to network and renew contacts.
The third meeting was the presentation of the Biotechnology Trend Analysis 2023 to Viviane Heijnen, Minister for the Environment, on 21 March in The Hague. During this mini-symposium, organised by the Health Council of the Netherlands and COGEM, the main findings of the Trend Analysis were explained by members of the project committee and the report was presented to the minister.