Life Sciences Horizons Brochure 2025 - Flipbook - Page 89
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2025 Horizons Life Sciences and Health Care
Complex patchwork of rules govern GMO medicine trials in the EU (continued)
The Netherlands
Clinical trials involving investigational medicinal
products containing or consisting of GMOs in the
Netherlands are mainly regulated by the Genetically
Modified Organisms (Environmental Management)
Decree 2013: (Besluit genetisch gemodificeerde
organismen milieubeheer 2013, the Decree) and
the Medical Research with Humans Act: (Wet
medisch-wetenschappeijk onderzoek met mensen)
and subordinate legislation.
These clinical trials must be assessed by various authorities:
The Central Committee on Human Research (as competent
review committee: Centrale commissie mensgebonden
onderzoek or CCMO), in the context of clinical trials in
general, and
by the Ministry of Infrastructure and Water Management:
(Ministerie van Infrastructuur en Waterstaat or Ministry
of I&W) and its GMO Bureau, which is responsible for
processing permit applications) in the context of risks to
humans and the environment.10
In the Decree, a distinction is made between "contained use" or
"deliberate release." Contained use in the context of the Decree is
understood to mean any activity such as production, application
or which contains the possessing of GMOs, if containment
measures are used in that activity. Deliberate release means
the intentional introduction into the environment of a GMO
or a combination of GMOs in any way whatsoever without
containment measures being present or applied. In any case,
deliberate release also includes activities such as the
manufacture and use of a GMO or a combination of GMOs.
10
Therefore, the permit of the I&W for deliberate use is likely
required for most clinical trials involving investigational
medicinal products containing or consisting of GMOs. However,
it is possible that in the context of the manufacturing of the
investigational medicinal products, the notification/license
requirements for contained use may also be applicable.
The minister will decide on the application for the license of the
Ministry of I&W within 120 days of receiving the application. The
entity that actually performs the clinical trial (not the sponsor) is
required to request the permit, such as the board of directors of
the hospital involved. In addition, there is a simplified and
shortened procedure for specific categories of GMOs of a
maximum of 56 days. If a number of additional conditions
are met, a period of a maximum of 28 days applies.
The assessments of medical ethical aspects by the CCMO and the
biosafety aspects by the GMO Bureau both have their own legal
basis with associated terms and requirements. In terms of content,
it is possible to request the Ministry of I&W permit separately from
the other permission because the research protocol is not part of
the Ministry of I&W application.
A positive opinion from an Ethics Committee is required for all
clinical trials and is a procedure independent of the procedures as
described above.
Julia Mischie
Associate
Amsterdam
Please note that for changes or relevant information from ongoing WMO medicine research (under old pre-CTR legislation) the Minister of Health, Welfare and Sport is the competent
authority, which tasks are delegated to the agency of the Medicines Evaluation Board. Submissions for new medicine research files however fall under the CTR and do not have an additional
assessment by the competent authority. In practice, therefore assessment by the agency of the Dutch Medicines Evaluation Board may occur less and less.
