Positive outcomes of third evaluation of Dutch Act on Medical Research involving Human Subjects

Anna-Maria Withagen

On 9 January 2019, the Dutch Minister of Health, Welfare and Sports published its report evaluating, for the third time, the Dutch Act on Medical Research involving Human Subjects (WMO). According to the report, the overall functioning of the WMO is satisfactory. As per the evaluation, the goal of the WMO, which is to protect human subjects from the risks of medical research without unnecessary burden on the progress of the research, has been achieved.

Apart from this general conclusion, the evaluation mentions several areas of concern. The main difficulties are the unclear scope of protection of the WMO and the functioning of the review committees concerned with the assessment on whether research that is undertaken meets the requirements regarding the protection of human subjects, as set out by the WMO. In his letter to the Dutch Parliament analysing the evaluation, the Minister indicates that in 2019, he will conduct research to provide more clarity in these areas, emphasising that the protection of human subjects will be decisive and take precedence. In addition, he will notably support the review committees by optimising the review process with respect to their workload, the recruitment of members for medical-ethical review committees (METCs), the internal quality control and the support for researchers.

In the short term, several EU regulations (such as the Medical Device Regulation ((EU) 745/2015), the In-Vitro Diagnostic Regulation ((EU) 746/2015) and the Clinical Trial Regulation ((EU 536/2014) will enter into force. These regulations might have an impact on the WMO’s overall functioning. It is expected that more studies will be examined by METCs, which will result in a further increase of their workload. In addition, the Clinical Trial Regulation will impose a stricter assessment period for pharmaceutical research and several initiatives will ensure a flexible implementation in the Netherlands. The new regulations are expected to encourage more multinational research, and the Minister aims to benefit from the strong competitive position of the Netherlands and will take steps to ensure that many of the studies are conducted in the Netherlands.

This post has been co-authored by Sophie van Asten. 

A prior version of this post was originally published by the same author in Practical Law – Life Sciences, January 2018 Issue (Thomson Reuters).

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