In the Netherlands as well various companies and universities are busy with the search for and development of a cure. A number of researchers however are choosing not to have their relevant clinical trials carried out in the Netherlands due to the strict Dutch legislation which hinders the process on several points. An example of such an obstacle is the legislation on the use of 'genetically modified organisms' (GMOs).
For example, gene therapy and the development and application of some vaccines involve genetic modification and is thus subject to GMO legislation As such, a licence is required for the production and application in clinical trials. Clinical trials are necessary because new drugs may only be marketed after research has demonstrated their safety and effectiveness. In the Netherlands, clinical trials are regulated in the Medical Research Involving Human Subjects Act (Wet medisch-wetenschappelijk onderzoek met mensen, WMO). The purpose of the WMO is to protect subjects who are subject to a clinical study.
The GMO regulations
The aim of the GMO legislation is to ensure safety for human beings and for the environment. When identifying the environmental risks, the extent to which a GMO can spread is relevant. Firstly, it concerns the possible excretion of the GMO by the subject (e.g. via blood or urine). Secondly, it is relevant to what extent the GMO leads or may lead to potential adverse effects. This depends, among other things, on the genetic modifications that have been made.
The Dutch GMO legislation is based on the European directives, Directive 2009/41/EC on the contained use of genetically modified micro-organisms and on Directive 2001/18/EC on the deliberate release into the environment of genetically modified organisms.
If we are talking about European regulations, one may wonder how is it possible that the rules in the Netherlands are a lot stricter than in some other European countries? This has to do with the fact that clinical studies with GMOs are considered 'Introduction into the Environment' in the Netherlands, while in some other member states, these studies are qualified as 'Contained Use'. The Dutch legislator holds that the use of ggo in clinical studies qualifies as 'Introduction into the Environment' because treated patients are always free to leave the hospital in the Netherlands and when they do, they may excrete GMOs, for instance through urine. Thus when patients go home, it is possible that the GMOs with which they have been treated are spread in the environment. Based on this reasoning the Dutch legislator holds that the environmental risk assessment must be based on the assumption that GMOs can end up in the environment.1
The deliberate release of GMOs into the environment requires a permit from the Minister of Infrastructure and Water Management in accordance with the Environmental Management Act and with the underlying Genetically Modified Organisms Decree (GMO Decree) for the environmental safety assessment, based on an environmental risk assessment. Under the current regulations, the permit is granted via the Uniform Public Preparation Procedure (Section 3.4 General Administrative Law Act (Algemene wet bestuursrecht, Awb)). The processing of the application for a permit under the GMO Decree can take up to 120 days. A permit is not always required for 'Contained Use' of GMO as for certain categories of GMO, the submission of a notification prior to its use may be sufficient.
Temporary emergency regulation
In light of the current circumstances, time is of the essence. The House of Representatives (Tweede Kamer) has also acknowledged this. Following a motion on 26 March 2020 by the member of Parliament Veldman, Minister Van Nieuwenhuizen (Infrastructure and Water Management) informed the House of Representatives on 30 March 2020 about the Temporary Regulation on the Exceptional Treatment of Gene Therapy Applications in connection with combating COVID-19. This temporary regulation was published in the Dutch Government Gazette on 30 March 2020 and came into effect on 31 March 2020.
The temporary arrangement contains an emergency regulation which aims to allow the processing of permit applications for GMO applications in connection with COVID 19 to take place via the regular procedure of the General Administrative Law Act (Awb), instead of via the usual Uniform Preparation Procedure of the Awb. The emergency regulation also aims to shorten the decision period from 120 days to 28 days.
In addition to the GMO license, the WMO requires permission from the Central Committee for Medical Research (CCMO) in order to carry out clinical trials that involve GMO. On 27 March, the CCMO already published its statement that it will use a ‘fast-track’ procedure for assessments that concern COVID-19. According to this statement, the total duration of the assessment will take a maximum of 25 days (instead of 60 or 90 days depending on the study).
A window of opportunity?
Although the regulation applies for a limited period of time (1 year), and only applies to GMO applications that aim to combat COVID-19, it can in a broader sense be concluded that the Dutch environmental legislation on the use of GMOs requires to be updated . The current legislation (unnecessarily) limits the possibilities for rapid development of, for example, certain vaccines and gene therapies. Compared to other European countries, Dutch legislation causes clinical trials to commence with a delay in addition to unnecessary hurdles throughout the process. After all, the problem that we are currently facing is not 'new'. Researchers and the industry have been facing the same problems when it comes to research into, for example, new cancer treatments that involve GMOs.
1. Explanatory memorandum, Decree on Genetically modified organisms, page 34.