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Gene Therapy Legislation in The Netherlands

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 Environment (IenM) 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).

In 2004, the Gene Therapy Office (Loket Gentherapie) was established in order to streamline the different assessment procedures of clinical gene therapy applications,  to provide more insight into the procedures for the researchers and to coordinate the procedures more efficiently with the different assessments organizations. The tasks of are to receive and distribute the (combined) applications, changes, notifications and reports to the public organizations involved, and to streamline the processing where possible.
Depending on the type of trial several applications need to be submitted to comply with the different legislations. They are combined in one application form to reduce the overlap in requested data. The applicant may also decide to split the form and send in the different parts on different points in time. The Gene Therapy office directs the application to the authorities involved. An option for the applicant is to request for an informal consultation between the applicant and the organizations that decide or advise on the application. The preliminary consultation is unofficial and takes place before the application is officially submitted.
The aim is to exchange information so that, when submitting the application, the researcher submits the correct information and has insight into which aspects the different organizations focus on during the assessment.

See also:
- Application form: Assessment of clinical research involving gene therapeutics in the Netherlands
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.

(Last reviewed by the Competent Authority: 2 January 2015)