Summary

It is undeniable that public interest in genetic modification and biotechnology has waned considerably in the Netherlands. Research conducted on behalf of COGEM shows that most people know little or nothing about these subjects and few have an opinion on them. The present lack of interest among the general public is also reflected in the fact that the vast majority of people never actively seek out information on genetic modification on the internet, in the media or by attending meetings. Products and applications involving genetic modification are judged on a case-by-case basis in terms of their benefits (or drawbacks) to consumers or patients.

This lack of interest in the public arena stands in stark contrast to the developments taking place in this area of biotechnology itself. The possibilities technologically appear to be speeding up at an unprecedented rate and this will have a major impact on people's thinking, government policy and the legislation surrounding genetic modification. New and sometimes age-old ethical questions are being raised. The commercial benefits of biotechnology have greatly increased and it has become an integral part of numerous sectors, including healthcare and agriculture. Genetic modification as a tool plays a vital role in the production of biochemicals, enzymes, and antibiotics, as well as fragrances and flavourings. The pace of change in the field in which COGEM operates makes answering such questions, along with the reframing of legislation and policy, an urgent matter. Over the past year COGEM has attempted to contribute to the very necessary changes to policy and legislation with advice, reports and the organisation of an international symposium.

Symposium

One of the most striking developments in biotechnology, without doubt, is the increased ability to make selective changes in the human, animal or plant genome. The new gene editing technology of CRISPR/Cas9 has been widely acclaimed, also by COGEM, as a revolutionary breakthrough. During the course of 2015 it became increasingly clear what the consequences of these new gene editing possibilities might be. The removal of the technical barriers to germline modification – i.e. human genome editing – in particular, fell under the spotlight of both the media and scientists. The opportunities that this offers for tackling hereditary diseases, set against the fear of eugenics, led to a debate on the role and responsibilities of scientists, physicians and patients, and the question of whether everything which is possible should also be permissible. COGEM and The Health Council of the Netherlands therefore organised a joint international meeting 'Genome on Demand? Exploring the implications of human genome editing' at the end of 2015, to which both scientists and stakeholders were invited. The many different aspects touching on this loaded subject were examined from the different perspectives of stakeholders, technologists and social scientists. COGEM will continue to closely monitor this topic and will be publishing a report on the subject during the coming year.

Advice and reports in 2015

COGEM published 62 advisory and other reports in 2015. Since the dip seen in 2014, the number of publications has again risen to roughly the same as the ten-year production average (approx. 61 publications a year). The large number of reports and requests for advice received from the GMO Office and the Ministry of Infrastructure and the Environment (IenM) (81%) was most notable. Requests for advice related mainly to permit applications (authorisations) for activities involving the use of genetically modified organisms (GMOs).

The subcommittee Medical and Veterinary Aspects (ScMV) prepared most of these publications (35 in all); followed by the subcommittee Agriculture (ScL) with 23 publications. The subcommittee Ethics and Societal Aspects (ScEMA) drew up two reports, with two publications prepared by joint subcommittees.

The increase in the number of requests for advice compared with 2014 may be ascribed to the greater demand for advice related to permit applications in the areas of Introduction into the Environment and Market Authorisation. The number of requests for advice related to Contained Use, i.e. for experiments to be carried out in laboratories or greenhouses, etc., declined in 2015.

Introduction into the Environment (Deliberate release) covers both field trials with GM crops, as well as gene-therapy studies. Given that almost no field trials with GM crops take place in the Netherlands, the increase in the number of requests for advice can be attributed almost entirely to clinical gene therapy studies (see Figure 1).

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

Market Authorisations are permits for commercial activities using GMOs. Permits issued for the market authorisations of GMOs is not a national matter (unlike Introduction into the Environment or Contained Use), but are subject to centralized EU procedures. A permit issued for market authorisations will therefore apply to all EU member states. Both the number of requests for advice on the import of GM crops, as well as the authorisations of GMO medicines rose slightly in 2015.

This was the fourth year in succession in which there was an increase in the number of requests for advice concerning the authorisation of GM medicines (human and veterinary), such as gene therapies. In view of the trend over the past few years, the number of permit applications for gene therapy studies and GM medicines is likely to continue to rise in the future.

Permit applications for the cultivation of GM crops in the EU have ceased in recent years and in 2015 too, COGEM was not asked to publish any advisory reports on this. The market applications for GM crops all related to the import of products cultivated outside the EU. Whether further requests for the cultivation of GM crops will be submitted in the future will partly depend on the how the 'national cultivation competence' will be interpreted and applied across the EU. Since 2015 EU member states have been able to decide for themselves whether or not they will allow the cultivation of GM crops (in which the normal European market authorisation procedure must be followed and GM crops are therefore first assessed in terms of safety to humans and the environment).

Minority view in a report
Members can have a minority view included in a report. Minority views in relation to advisory reports are unusual, partly because COGEM adheres to the principle of caution when issuing its advice. Where there is scientifically substantiated doubt or insufficient evidence for the absence of risks to humans and the environment, the Commission will generally recommend extra safety measures (or containment measures) or, in the event that this is not possible, advise against.

In December 2015 an advisory report was published which included a minority view. It related to advice given in connection with the classification of Human papilloma viruses (CGM/151216-02).The majority of the COGEM panel held the view that all human papilloma viruses should be classified in pathogenicity class 2. A few members of the subcommittee Medical and Veterinary Aspects took the view that the papilloma viruses associated with cervical cancer should be classified in the higher class 3. As it appeared to be impossible to arrive at a consensus, the members concerned asked for a minority view to be included in the report. At present it is unknown how the authorising authority, the Ministry of Infrastructure and the Environment (I&M), has treated the advice given and the minority view in the context of its permit policy.

Other reports
The previously mentioned necessity to amend GMO policy also became clear from the report ‘Rode draden in de vergunningverlening’ [Common themes in permit applications]. The Ministry of Infrastructure and the Environment published a policy document providing an overview of the framework for the assessment of its various risk and safety policy areas. The issuing of GMO permits appeared to deviate from this framework in one vital area. GMO policy implementation, for example, provides no room for political consideration of the costs and benefits (benefits and risks) which takes place in other safety areas, simply because GMOs are only permitted if the risks are negligibly small. Apart from the fact that opportunities may well be lost and innovation inhibited as a result, the GMO policy is also not consistent with the public wish to be able to weigh up the merits and shortcomings of products.

In another report, 'GMOs on display: The use of genetically modified organisms in exhibitions’, at the request of the State Secretary of Infrastructure and the Environment, COGEM looked at the societal aspects of exhibitions involving GMOs and identified a number of policy options and important considerations. Bio-Art, as it is known, had come under the spotlight further to a number of permit applications for art projects using GMOs. The Netherlands' GMO legislation however has no provision for such exhibitions. Bio-Art using GMOs is an example of how genetic modification is increasingly appearing in other application areas and gradually becoming more widely accepted.

Research conducted at the request of COGEM

Seven research reports were published in 2015 at the request of COGEM. Some of these reports were in English or include an English summary. The reports were not only technical in nature, but also provide insight into the views of the Dutch public with regard to genetic modification and GMOs, or the economic position of the Dutch biotechnology sector. Other topics concerned the possible exposure of aquatic organisms to Bt toxins due to the cultivation of GM maize under Dutch growing conditions, establishing the criteria to be met when conducting laboratory experiments with non-target organisms, and the possible consequences of using biological pest control in greenhouses for the containment of activities involving GMOs. In addition, COGEM had a survey carried out of the pre-clinical gene therapy studies conducted worldwide, to gain an overview of the type of clinical studies that may be expected in the coming years and the direction that gene therapy is likely to take.

To conclude

2015 was a busy year for COGEM. Besides the many requests for advice that COGEM received, activities related to the fourth Trend Analysis Biotechnology were in full swing. This Trend Analysis is being prepared at the request of the House of Representatives. The Minister for the Environment has asked the Health Council and COGEM to draw up this Trend Analysis of developments in biotechnology, with the support of the Scientific Council for Government Policy (WRR). The Trend Analysis Biotechnology is expected to appear in Spring 2016.

All COGEM publications can be downloaded here

Publications and other activities in 2015

Advice on specific notifications

  • CGM/150106-01 Confidential advice on application for the market authorisation of a genetically modified medicinal product
  • CGM/150108-01 Classification of GM Penicillium brasilianum
  • CGM/150130-01 Experiments with chimeric GM noroviruses
  • CGM/150218-01 Confidential advice on application for the market authorisation of a genetically modified medicinal product
  • CGM/150303-02 Classification of Schwanniomyces occidentalis, Trichoderma aggressivum and Verticillium fungicola
  • CGM/150318-01 Classification of experiments with GM Cowpox virus
  • CGM/150327-01 Import of genetically modified soybean MON 87751 with two insect resistance traits http://bit.ly/1TFWFPj
  • CGM/150407-01 Survival and hybridisation of Gossypium herbaceum in the Netherlands
  • CGM/150416-01 Classification of Equid herpesvirus 1
  • CGM/150501-05 Safety measures for experiments with α-synuclein protein
  • CGM/150513-01 Explanatory advice on the classification of the fungi, Trichoderma aggressivum and Lecanicillium fungicola, pathogenic to other fungi
  • CGM/150518-01 Containment measures for working with GM Geranium robertianum and Geranium pyrenaicum
  • CGM/150518-02 Experiments with GM Rift Vally fever virus
  • CGM/150528-01 Import and processing of genetically modified maize 4114 http://bit.ly/1slZT3Y
  • CGM/150601-02 Advice on improving the general surveillance of GM crops
  • CGM/150611-01 Confidential advice on application for the market authorisation of a genetically modified medicinal product
  • CGM/150615-01 Classification of four primate adenoviruses
  • CGM/150617-01 A phase I/II clinical study to study the use of GM AAV to treat patients with severe to moderately severe haemophilia B (AMC, Amsterdam)
  • CGM/150617-02 A phase I/II clinical study to study the use of GM AAV to treat patients with severe to moderately severe haemophilia (UMC, Utrecht)
  • CGM/150617-03 A phase I/II clinical study to study the use of GM AAV to treat patients with severe to moderately severe haemophilia (UMCG, Groningen)
  • CGM/150617-04 A phase I/II clinical study to study the use of GM AAV to treat patients with severe to moderately severe hemophilia (Erasmus MC, Rotterdam)
  • CGM/150630-01 Containment measures for GM Camelina sativa
  • CGM/150707-01 Confidential advice on application for the market authorisation of a genetically modified medicinal product
  • CGM/150715-01 Replicons based on Venezuelan equine encephalis virus
  • CGM/150716-01 A ‘Salmonella Typhi’ based vaccin strain
  • CGM/150723-01 Experiments with GM seasonal human Influenza A viruses
  • CGM/150817-01 Import and processing of insect resistant and herbicide tolerant maize MON87427xMON89034xNK603 http://bit.ly/1qqk6EA
  • CGM/150821-01 Cyanobacterium Synechococcus sp. strain PCC7002
  • CGM/150824-01 Safety measures for experiments with GM AAV encoding α-synuclein
  • CGM/150825-02 Import and processing of insect resistant and herbicide tolerant maize MON87427xMON89034x1507xMON88017x59122 http://bit.ly/1TX7YVX
  • CGM/150831-01 Confidential advice on application for the market authorisation of a genetically modified medicinal product
  • CGM/150901-01 A phase I/II clinical study with an naked DNA vaccin tot treat Human papillomavirus induces (pre)malignancies
  • CGM/150902-01 Classification of Elephantid herpesvirus and Modoc virus
  • CGM/150907-01 Large-scale GM animal cell cultures in the ‘Single-Use Bioreactor Sartorius STR’
  • CGM/150907-02 Transmission experiments with GM Chikungunya virus and GM West Nile virus using mosquitos
  • CGM/150907-03 A clinical trial aimed at developing a malaria vaccine using a Plasmodium falciparum deletion mutant 
  • CGM/150907-04 A clinical trial with a Plasmodium falciparum deletion mutant administered by mosquitoes
  • CGM/150928-01 Renewal of the authorisation for import and processing of genetically modified maize line 1507 http://bit.ly/1sm0PFG
  • CGM/150930-01 Containment of GM Marchantia polymorpha (umbrella liverwort)
  • CGM/151008-01 Import and processing of genetically modified cotton GHB614xLLCotton25xMON15985 and LLCotton25xMON15985 http://bit.ly/1NwxAtu
  • CGM/151015-01 Experiments with GM Japanese Encephalitis virus
  • CGM/151019-01 Containment measures for working with GM α-synuclein animals
  • CGM/151029-01 Import and processing of genetically modified maize MON87411 http://bit.ly/1Tli7vD
  • CGM/151103-01 A field trial with GM apple with an increased anthocyanin content
  • CGM/151104-01 Import of genetically modified soybean FG72xA5547-127 with three herbicide tolerance traits http://bit.ly/1YymAMY
  • CGM/151123-01 Containment of GM Taraxacum kok-saghyz
  • CGM/151207-01 Confidential advice on application for the market authorisation of a genetically modified medicinal product
  • CGM/151210-01 Import and processing of genetically modified maize MON87403 with increased biomass http://bit.ly/1YymJjt

General advice (not linked to specific notifications)

  • CGM/150212-01Risk methodology and the potential exposure of aquatic organisms to plant material from Bt maize
  • CGM/150529-01 Classification of retroviruses
  • CGM/151013-01 Classification of Mouse mammary tumor virus and Murine stem cell virus
  • CGM/151014-01 Murid herpesvirus 1, and Spring viraemia of carp virus
  • CGM/151102-02 On the terminology of Influenza A virus variants
  • CGM/151214-01 Classification of eleven arteriviruses
  • CGM/151216-02 Classification of human papillomaviruses

Reports

  • CGM/150409-01 The authorisation of the GM vaccine Bovela
  • CGM/151209-01 Statistics in risk assessment of GM crops
  • CGM/151215-02 "Recurrent themes in GMO authorisation: The position of genetic modification in a departmental assessment framework for safety"

Letters

  • CGM/150305-02The Dutch biotech sector; an economic analysis
  • CGM/150601-02 Advice on improving the general surveillance of GM crops http://bit.ly/1VZNWha
  • CGM/150904-02 Preclinical gene therapy studies: future expectations
  • CGM/150929-01 The potential economic impact of using animal viruses against cancer
  • CGM/151103-05 The Dutch public and perceptions on genetic modifications: policy implications
  • CGM/151126-01 Revision of the COGEM lists of pathogenicity classifications
  • CGM/151203-01 Biological control of pests in GM plant experiments
  • CGM/151217-01 Risk assessment and methodology: Testing impacts of toxic compounds from GM crops on non-target arthropods

Research reports commissioned by COGEM

  • 2015-01"An economic analysis of the biotechnology sector in the Netherlands
    A. Van der Giessen, G. Gijsbers, O. Koops en F. Van der Zee (TNO)"
  • 2015-02The potential exposure of aquatic organisms to plant material from Bt corn. E. Dijkhuis, J.Loermans (FLORON), M. De Graaff en M. Wagelmans (Bioclear)
  • 2015-03"Assessment of preclinical gene therapy studies worldwide
    J. Verhagen, P. Buijs, B. van den Hoogen en, C.H.J. van Eijck (Erasmus MC) "
  • 2015-04"Biological control of pests in GM plant experiments: risks, benefits and consequences for containment
    K. Booij & G.Messelink (Wageningen UR) http://bit.ly/22eSjER "
  • 2015-05"Public perception of genetic modification in the Netherlands
    L. Hanssen (Deining Maatschappelijke Communicatie Nijmegen), A. Dijkstra (Universiteit Twente Enschede), J. Gutteling (European University Cyprus), S. Boekee (Newcom Research Amsterdam), S. Sleenhoff (Technische Universiteit Delft), W. Betten (Vrije Universiteit Amsterdam) en N. Van der Veer (Newcom Research Amsterdam) "
  • 2015-06"Screening of the COGEM lists of non-pathogenic bacteria and fungi for postharvest diseases and plant pathogens
    R.A.A. van der Vlugt, M. Verbeek, W. Molhoek and L. Stevens (Wageningen UR) http://bit.ly/1TljoTv "
  • 2015-08"Testing impacts of toxic compounds from transgenic crops on non-target arthropods in tier-1 studies: exposure and response
    K. Booij en Y.T. Qiu (Wageningen UR) http://bit.ly/27uWY9M "

Symposia

  • 5 & 6 november 2015International meeting ‘Genome on demand – Exploring the implications of human genome editing’, Amsterdam
    Organised by: Health Council and COGEM

Other publications

  • -Mampuys R & Brom FWA (2015). Governance strategies for responding to alarming studies on the safety of GM crops. Journal of Responsible Innovation 2: 201-219
  • -Mampuys R & Brom FWA (2015). Ethics of Dissent: A plea for restraint in the scientific debate about the safety of GM crops. Journal of Agricultural and Environmental Ethics 28: 903-924