National Authority for Containment: Monitoring of facilities containing poliovirus

Polio is a viral disease that has almost been eradicated worldwide. Nevertheless, the virus is still present in places where people produce vaccines and in laboratories where people do blood tests. Facilities that work with the poliovirus must meet strict requirements. The Health and Youth Care Inspectorate (Inspectie Gezondheidszorg en Jeugd, or IGJ), and more specifically the National Authority for Containment (NAC), makes sure that these facilities meet these requirements to prevent the poliovirus from being reintroduced into society.

Minimizing the risks of poliovirus outbreaks

Global vaccinations have almost eradicated the poliovirus. However, some laboratories and other facilities still work with poliovirus to do blood tests or produce vaccines. The presence of this virus means that there is still a risk that it could be reintroduced into society.

That is why the Netherlands and other countries have made agreements with the World Health Organization (WHO) to lower this risk. Countries must ensure that the poliovirus is present in as few locations as possible. Only facilities that meet the WHO’s requirements are allowed to work with the poliovirus. The IGJ supervises facilities that work with the poliovirus in the Netherlands. It does this as the National Authority for Containment (NAC).

Requirements for working safely with poliovirus

The WHO recognizes 5 locations in the Netherlands where the poliovirus is still present. These are called Poliovirus Essential Facilities (PEFs). A PEF must meet strict WHO requirements to work with and store the poliovirus. The NAC audits these locations to make sure they meet these requirements. For example, the facility must:

Have a quality system that allows it to monitor compliance with the requirements and make timely adjustments where necessary;
Have identified the risks of accidental or intentional release of the poliovirus;
Have taken measures to minimize these risks;
Have screened and vaccinated personnel trained to work safely with the poliovirus.
Have good security and data security in place.

All of these location requirements are described in the Global Action Plan for poliovirus Containment (GAPIV). If a PEF facility meets all of these requirements, the NAC applies for a WHO certificate for the facility.

From 2025: mandatory notifications and permits for PEFs

On 1 February 2025 (target date), a change to the Public Health Act (Wet publieke gezondheid, Wpg) will come into effect. From then on, Poliovirus Essential Facilities (PEFs) must apply for a permit to work with or store the poliovirus. They will also be required to report incidents and calamities with the poliovirus to the National Authority for Containment (NAC) and ask the NAC for prior permission for the transport of poliovirus material. These requirements will be laid down in a general administrative measure (algemene maatregel van bestuur, AMvB) and a ministerial regulation supplementing the Wpg. See also: Mandatory notifications and applications for PEFs.

Monitoring of poliovirus sites

Every year, the NAC visits all PEFs where the poliovirus is being worked with or where it is being stored. During these visits, the NAC assesses whether the PEF in question meets the requirements of the fourth Global Action Plan for Poliovirus Containment (GAPIV). This is called an audit. In addition, the NAC has the power to visit locations unannounced in the event of incidents or a suspected contravention of the Wpg. If a PEF contravenes the Wpg, the NAC can take enforcement action.

The NAC audits PEFs in accordance with the methodology of the World Health Organization (WHO). In the WHO cycle, a full audit that covers all 14 GAPIV elements is conducted every 3 years. This audit lasts around one to two weeks. In addition, a periodic audit is conducted annually. These periodic audits last from around two days to one week. After three years, the cycle starts again with a full audit.

Start of the audit

Each audit starts with a request for documents from the PEF. On the basis of these documents, the NAC decides when the audit will be conducted on location. The PEF is notified of this at least two months in advance by way of a letter with practical information on the audit and how to prepare for it.

The audit team

The auditors are independent GAP professionals. The composition of the audit team may differ per PEF, depending on the expertise required.

The audit

Each audit starts with a kick-off meeting, so that the PEF is clear about the scope of the audit. The auditors assess compliance with the GAP requirements by conducting interviews, reviewing documents and visiting rooms in which the poliovirus is present, as well as other areas. The PEF must give the audit team access to all rooms and information at the NAC’s request. Depending on the scope, the audit lasts from a number of days to two weeks. At the end of the audit, the audit team presents its findings to the PEF.

After the audit

The NAC records the audit outcomes in the WHO-prescribed format and sends them to the PEF within two weeks. If the PEF meets the requirements, the NAC will share the outcomes with the WHO and apply for a WHO certificate (or an extension). For safety reasons, audit outcomes are not made public.

If the NAC identifies shortcomings during an audit, the PEF must investigate how these can be remedied and prepare an action plan to this effect. The PEF must send this plan to the NAC within 40 working days, counting from the presentation at the end of the audit. If the NAC approves the plan, it will send it to the WHO together with the audit outcomes and apply for an interim WHO certificate. In the meantime, the NAC will actively monitor whether the PEF carries out the action plan to meet the requirements.

WHO certificate

If the WHO agrees, a certificate will be issued by the NAC. If necessary, the WHO may ask the NAC for supplementary information. In this case, the NAC will notify the PEF of this in writing.

NAC enforcement action

In the event of a contravention of the Wpg, for example if a PEF fails to report an incident with the poliovirus, the NAC may take enforcement action. Among other things, it may issue a written warning to the PEF or impose a fine.

Role of the NAC with regard to permits and certificates

The NAC assesses all Dutch PEFs on the basis of equality. If they meet the GAP requirements, the NAC will issue the necessary certificate, subject to WHO approval.
Once the Wpg has come into effect (target date: 1 February 2025), the NAC will also use a PEF’s GAP audit outcomes to advise the Minister of Health, Welfare and Sport on the granting of a permit to a new PEF or an existing relocating PEF.

Contact

The NAC serves as the point of contact for PEFs that have questions about certification and permit requirements. Please contact the NAC..