Summary

In 2019 COGEM published 71 advisory reports, 4 policy reports and 4 commissioned research reports. In addition, COGEM organised an international symposium.

COGEM published more reports in 2019 than in 2018 (71). Only in 2017 did COGEM publish more advisory and policy reports. On a number of occasions multiple requests for advice – particularly on the classification of organisms – were bundled together in a single report. If that had not been the case, the total number of advisory and policy reports would have been 86. As in previous years, the Subcommittee on Medical and Veterinary Aspects was involved in the preparation of more publications than the other subcommittees.

Advisory reports

Ninety per cent of these publications concerned licence applications and requests for pathogenicity classifications of microorganisms. Ten per cent of the publications were unsolicited advisory and policy reports on more generic topics. Several of these more generic advisory reports, such as the reports on changes in the legislation and the risk analysis for clinical studies with AVV vectors, have been translated into English and published on our website.

Yet again, last year saw an increase in the number of advisory reports on licence applications for clinical studies and on authorisations for placing on the market of GM medicines for humans and animals. The bulk of COGEM’s work continues to shift further towards medical and veterinary applications. The medical and veterinary sector is now not only the main focus of requests for advice on contained use, but also for advice on deliberate release and marketing authorisation. As a corollary, the share of advice on plant biotechnology continues to decline.

Publications by subcommittee and licence category
Publications by subcommittee and licence category

Policy reports

In addition to advisory reports on the risks to human health and the environment of activities involving GMOs, COGEM published four reports prepared for the purpose of informing the policymaking process. In October COGEM published ‘No rose without thorns: Implications of a product-based regulatory system for GM crops in the European Union. This policy report was prepared in response to the debate surrounding the regulation of new plant breeding techniques (NPBTs) and the recent decision by the European Court of Justice that crops obtained by site-directed mutagenesis fall under the GMO legislation. The report examined what the implications would be of changing the regulatory principle of the EU GMO legislation to turn it into a product-based regulatory system. This policy report is also available in English.

Research reports

Four research reports commissioned by COGEM were published in 2019. Two of these reports are in English. One concerns the transmission of antibiotic resistance genes by mobile genetic elements in bacteria in laboratory settings; the other is about the pathogenicity classification of insect-specific viruses. COGEM published an advisory report in response to a research report on the possible risks of transferring genetically modified T cells via donated human tissue and during pregnancy. This advisory report is also available in English.

Symposia

On 10 October 2019 COGEM held a symposium entitled ‘Gene Edited Crops: Global perspectives and regulation’ in the chamber of the Dutch Senate in The Hague. The symposium was opened by the minister of infrastructure and water management, and after her speech she was presented with the policy report ‘No rose without thorns’. A report of the meeting is available here. COGEM also helped to organise a side event at the international CRISPRCon event in Wageningen on 21 June 2019. The event was an initiative of the Council on Animal Affairs (Raad voor Dierenaangelegenheden RDA), which held a hearing on gene editing.

Changes in the membership of COGEM

The following members stood down in 2019:

  • Emeritus Professor John Degener (University of Groningen)
  • Drs. Vera Dalm (MilieuCentraal)
  • Dr. Raoul de Groot (Utrecht University)

COGEM thanks them heartily for their efforts and all the valuable work they have done for the Commission.

COGEM was pleased to welcome one new member in 2019:

  • Professor Jeroen Kortekaas (Wageningen Bioveterinary Research)