Gene Therapy Legislation in The Netherlands
The GMO aspects of clinical trials with medicinal products for human use containing or consisting of GMOs are regulated under the deliberate release framework- Part B of Directive 2001/18. The applications to seek authorization under clinical trials and under GMO frameworks are not linked. The applications to seek authorization under clinical trials and under GMO frameworks can be submitted in parallel (i.e. the sponsor may apply for GMO authorization but does not need to wait for the GMO authorization before submitting the clinical trial application).
In the Netherlands different legal regimes apply to the different aspects of clinical trials, which are often based on European legislation and regulations. Three different regulatory organizations are involved in the assessment of clinical gene therapy trials in the Netherlands:
- Medical, ethical and scientific aspects are evaluated by the Central Committee on Research Involving Human Subjects (Centrale Commissie Mensgebonden Onderzoek, CCMO).
- The Ministry of Health, Welfare and Sport (VWS) approval is issued when no additional adverse effects are found in the EudraVigilance Clinical Trial database of the EMA that pose unacceptable risk to the human subjects.
- The Ministry of Infrastructure and Water Management (IenW) is the competent authority for the environmental risk assessment. The Bureau for Genetically Modified Organisms (Bureau GGO, BGGO), which is responsible for processing permit requests, with additional advice regarding environmental aspects is being provided by the Netherlands Commission on Genetic Modification (COGEM).
Additional information can be found at:
- https://www.loketgentherapie.nl/en
- https://english.ccmo.nl/
- https://www.ggo-vergunningverlening.nl
- Netherlands Commission on Genetic Modification (COGEM)
- Gene therapy legislation in The Netherlands. J. Gene Med. 2007; 9(10): 904-9. This review summarizes the gene therapy legislation in The Netherlands and in particular The Netherlands rationale to follow Directive 2001/18/EC for the environmental risk assessment.
Application forms to seek authorisation for the GMO aspects
Application forms can be found at: https://www.loketgentherapie.nl/en/Application_form/Application_forms
Public consultation
A draft decision together with the public part of the research file is made available for comments for a period of six weeks. Third parties can raise objections to the proposed permit. The final decision takes effect as soon as the perusal deadline of another six weeks, in which appeal to Council of State is possible, has passed. If any objections to the permit are lodged, the Council of State informs the investigator and the Ministry of IenW. In case an injunctive relief is granted by the Council of State, all activities have to be stopped.
National authorities involved
Authorization of clinical trials:
Medicines Evaluation Board: MEB has been tasked (by the Ministry of Health, Welfare and Sport) with the evaluation and statement of no-objection on clinical trials.
PO Box 8275, 3503 RG Utrecht
e-mail:
Central committee on research involving human subjects (CCMO) is a medical research ethics committee that performs an integrated review of scientitic, medical and ethical aspects of clinical trials.
PO Box 16302, 2500 BH The Hague
e-mail:
Authorisation of GMO aspects:
Ministry of Infrastructure, Environment and Water Management (lenW) makes decisions on permit applications.
PO Box 1, Intern Postvak 1, 3720 BA Bilthoven
e-mail:
The Gene therapy office serves as a central point of contact between investigators and the GMO and clinical trial assessment bodies. It was set up as a service to professionals in the field of gene therapy. The Office has no role in the assessment process.
PO Box 1, Intern Postvak 1, 3720 BA Bilthoven
e-mail:
(Last reviewed by the Competent Authority: June 2019)