Publications in 2016

COGEM has had a busy year in which a record number of 73 advice requests and research reports were published, greatly exceeding the previous record of 66 publications. The vast majority (89%) of COGEM’s publications were issued in response to requests for advice on permit applications and notifications. The number of requests for advice by the GMO Office concerning proposed activities under ‘contained use’, in particular, strongly increased. Contained use refers to experiments involving genetically modified organisms (GMOs) carried out in laboratories, animal housing and plant greenhouses.

A striking aspect was the large number of requests to classify organisms and viruses in pathogenicity classes. On the one hand this would appear to suggest that experiments are now taking place with a wider variety of organisms. On the other hand, however, this could also be due to the revision of the Genetically Modified Organisms Decree and Regulations in the Netherlands in 2015 and the new permit procedures associated with this legislation.

Beyond this there was a slight increase in the number of requests for advice on permit applications for clinical studies (i.e. gene therapy; ‘introduction into the environment’). Following remarkable and hopeful results in combatting various types of cancer and other diseases, there has been a strong upward trend in the number of gene therapy studies worldwide. The same trend can be seen in the Netherlands.

The COGEM subcommittee Medical Veterinary Aspects (ScMV) prepared most of the advisory reports (47), followed by the subcommittee Agriculture (ScL; 22) and the subcommittee Ethics and Societal Aspects (ScEMA; 2).

Figure 1: Number of publications per subcommittee and category of permit applications.

Alongside the large number of advisory reports, COGEM, together with the Health Council of the Netherlands (Gezondheidsraad) and the Scientific Council for Government Policy (WRR), also published its Trend Analysis Biotechnology 2016 ‘A Regulatory Disconnect’. Furthermore the COGEM evaluation which takes place every four years was conducted, a volume with a collection of COGEM policy reports was published, and five more research reports commissioned by COGEM were issued.

Although the volume of work - and particularly that of the Medical Veterinary subcommittee - at times seemed to be increasing at an unprecedented rate, essentially all advisory reports were completed within the agreed time limits. It was only during the Christmas and summer holiday periods that it turned out to be impossible to issue all advisory reports concerning contained use permits within the set period of two weeks, also due to the reduced availability of COGEM experts.

COGEM research

COGEM has a modest budget which can be used to carry out external research to support its own tasks. COGEM’s broad task field means that these research reports also vary widely in topic and nature. All research reports are published on the COGEM website. In 2016 COGEM had five research reports prepared. Two of these research reports are in English. The first concerns the use of Single-Use Bioreactors (SUBs) for the large-scale cultivation of genetically-modified organisms (GMOs). SUBs - as their name suggests - are one-time use bioreactors comprising a plastic bioreactor bag fixed inside a stainless steel shell. COGEM’s report based on the study included an update of the requirements that applicants requesting permits for large-scale production in SUBs should be expected to meet.

The second study investigated the potential impact of using biological pest control in greenhouses where experiments with genetically modified (GM) plants are conducted. Based on this research COGEM provided advice on allowing biological pest control in greenhouses using GM plants under certain conditions and adviced on how to amend the GMO Regulation because this legislation insufficiently takes into account the use of biological pest control. The research showed, for example, that biological pest control is sometimes the most effective method of combatting pests but could also be a potential source for the spread of transgenic pollen.

The other three reports were published only in Dutch. In the context of its evaluation carried out every four years, COGEM considered the question of whether the advice that it gives on chimera viruses is consistent and sufficiently transparent. The evaluation report concluded that COGEM is consistent in the advice that it gives, but that transparency could be improved. In addition, based on a study of the pollination methods of a large number of plant species and the presence of compatible relatives, COGEM advised amending the list of plant species in the Genetically Modified Organisms Regulation and the measures required to prevent them from spreading from greenhouses. This particular research report looked closely at the background, purpose and scope of the European legislation on GMOs. This legislation is considered by many to be complex. Because COGEM believes that a clear understanding of the legislation is essential for an informed debate and useful dialogue, it carried out an analysis of the EU legislation.

COGEM evaluation

In Spring 2016 COGEM was evaluated by an external audit committee comprising Professor dr. Wiebe Bijker and Professor dr. Willem de Vos, chaired by Mr. drs. Jan Staman. The Environmental Management Act (WMO) lays down that COGEM will have its task, composition, organisation and methods reviewed every four years and that it makes proposals for desirable changes on the basis of this evaluation.

The audit committee noted that COGEM’s field of work is undergoing major change, but in the European context in particular, there also appears to be a degree of political stagnation and impasse in decision-making. The audit committee was of the view that as an authoritative advisory body, COGEM could take a more pro-active and incisive role in this context.

To conclude

2016 was a busy year for COGEM. The increased workload posed a major challenge to the Commission, but the commitment of the members of COGEM made it possible to respond to the requests for advice within the deadlines. It should be noted that the members do not receive remuneration for their work beyond a small reimbursement for expenses; they undertake their tasks out of a sense of public duty.

All COGEM publications can be downloaded from the website.