13 May 2020 - Authored by:Iradj Nazaryar
In March and April 2020, the Dutch Health and Youth Care Inspectorate (IGJ) announced various measures to mitigate the consequences of the Covid-19 coronavirus pandemic on the Dutch healthcare sector:
- Permission to supply medical devices that are not CE marked . Manufacturers and suppliers may temporarily supply medical devices without CE markings provided there are no CE-marked alternatives available. However, the healthcare provider must explicitly request the alternative devices and bears responsibility for their use. Prior notification is required only for the use of Class IIa/b and III medical devices. Medical devices (such as breathing apparatus) and in vitro diagnostics (tests) purchased via a central national working group set up by the Ministry of Health, Welfare and Sport must follow a separate procedure.
- Mutual exchange of pharmaceuticals by pharmacists . If necessary to resolve shortfalls due to supply problems, pharmacists may exchange pharmaceuticals temporarily. The IGJ requires the requesting pharmacist to request the pharmaceuticals in writing and to be able to demonstrate receipt and dispensation afterwards. The supplying pharmacist must also keep comprehensive records. Lastly, the pharmacists must organise the transport of the pharmaceuticals to preserve the quality of the product.
- Acceleration of the implementation of e-health applications. Healthcare providers may accelerate the implementation of e-health applications if this does not pose a threat to patient safety or to the availability and integrity of existing critical information systems. Healthcare providers must carefully record their considerations and decisions. The use of software without CE marking for diagnosis or treatment is only temporarily permitted if: (i) no alternatives are available; (ii) the healthcare provider can demonstrate that the application is safe; and (iii) necessary care cannot be provided without the use of the application. Prior notification is required only for the use of Class IIa/b and III software.
- Prescriptions following online video consultations Doctors may write a patient a prescription after an online video consultation, except if the doctor does not know the patient, has never seen the patient, or does not have the patient’s current medication overview available at his disposal. If a patient’s safety is at stake, the doctor may write a prescription nevertheless. Doctors must record their considerations.
- Standard extension of statutory deadlines. For legally required notifications and responses to IGJ requests, a standard extension of statutory deadlines will be granted, except in cases involving significant healthcare risks.
A prior version of this post was originally published by the same author in Practical Law – Life Sciences, May 2020 Issue (Thomson Reuters)