At the end of January 2025, a team of experts from the WHO and ECDC conducted an external evaluation to identify critical gaps in the Dutch healthcare system. As part of this evaluation, biosafety and biosecurity were assessed, followed by recommendations for further improvements.

The International Health Regulations (IHR 2005) of the WHO outline agreements between 196 WHO member states on what each country must have in place to safeguard public health. One of the obligations under the IHR is an annual self-assessment. However, countries can also opt for a voluntary external evaluation, known as the Joint External Evaluation (JEE). The JEE is conducted by the WHO and provides an overview of a country's capacity to prevent, detect, and respond to public health risks or incidents, while also identifying any gaps or shortcomings. Based on these findings, the JEE team provides recommendations to strengthen the country’s preparedness and response capacity.

Following the COVID-19 pandemic, the European Commission also sought greater insight into how EU member states ensure public health security. In December 2022, the new EU Regulation on Serious Cross-Border Threats to Health (EU Regulation 2022/2371()) came into force. This regulation mandates that EU countries undergo an evaluation of their preparedness and response plans every three years. These evaluations are conducted by the ECDC under the framework of the Public Health Emergency Preparedness Assessment (PHEPA). The PHEPA process has many similarities with the WHO’s JEE.

The Netherlands became the first EU member state to combine the JEE and PHEPA evaluations into a joint assessment by the ECDC and WHO, which took place from January 27 to 31, 2025. Biosafety and biosecurity were among the key capacities evaluated during this process. In the PHEPA framework, biosafety and biosecurity are part of Capacity 3 (Laboratories), whereas in the JEE they are assessed as a standalone capacity (P7). Consequently, biosafety and biosecurity were assessed using the JEE methodology. Capacity P7 covers both the policies and oversight for biosafety and biosecurity (P7.1), as well as education and training (P7.2). The scope of these assessments is broad, addressing biosafety and biosecurity for human, animal, and plant pathogens, as well as genetically modified organisms (GMOs).

Indicator Capaciteit P7: Biosafety and Biosecurity
P7.1 Whole-of-government biosafety and biosecurity system in place for all sectors (including human, animal and agriculture facilities)
P7.2 Biosafety and biosecurity training and practices in all relevant sectors (including human, animal and agriculture)

The WHO JEE tool provides a methodology for self-assessment, consisting of substantive questions for each capacity, a scoring table, descriptions of strengths and challenges, and concludes with recommendations. For the self-assessment of P7 Biosafety and Biosecurity, a working group of stakeholders was assembled, with expertise covering the various components of P7. To verify whether the self-assessment carried out by the working group was representative of organizations across the Netherlands, it was tested during one of the workshop sessions at the annual Knowledge Day organized by the Biosecurity Office. The perspective outlined by the working group aligned with that of the workshop participants, who also agreed with the proposed scores.

Following approval from the Minister of Health, Welfare, and Sport (VWS), the self-assessment, along with supporting documents, was submitted to the WHO and ECDC. The WHO and ECDC evaluation team reviewed the self-assessment in preparation for their visit. During their visit at the end of January, a summary of the self-assessment was presented, and questions from the JEE/PHEPA team were addressed. The team agreed with the scores and recommendations for Capacity P7 as proposed by the working group. Most of the recommendations are aimed at strengthening biosecurity, as it was identified as the weakest link within the whole-of-government system. Recommendations focus on biosecurity legislation and its implementation, the integration of biosecurity and dual-use concepts in academic programs, and the introduction of the role of a Biorisk Management Advisor with a mandate addressing biosafety, biosecurity, and dual-use concerns. The JEE/PHEPA report will soon be published on the WHO’s JEE webpage.