On 1 July 2007, the new Medicines Act (“Geneesmiddelenwet”) entered into force in The Netherlands. The new Medicines Act implements European Directives and deregulates and simplifies the pharmaceutical provision in The Netherlands. It replaces the old Medicines Act of 1963 and its accompanying delegated legislation. Some important changes are highlighted below.
The new Act enables the Public Health Inspectorate to impose considerable administrative fines for violating certain provisions of the Act. Under the old Medicines Act, only criminal penalties were possible and these were often considered to be inappropriate. The level of the administrative fines has been set out in policy guidelines with the maximum amount being €450,000 for each violation. The administrative fines can be imposed upon both pharmaceutical companies and practitioners, for example, in the case of practitioners accepting gifts or hospitality.
The Medicines Act no longer makes an exception for advertising which is exclusively intended as a reminder of the name of the medicinal product. This kind of advertising (for example, pens bearing the name of a medicinal product) has to be regarded as written advertising and must therefore set out the summary of product characteristics.
Prescription through the internet
The new Act includes more stringent rules for prescription of medication through the internet. An internet prescription is prohibited where the practitioner does not know the patient, has never met the patient and does not have the medication history of the patient available.
Obliged to report adverse reactions
Under the new Act, practitioners are obliged to report severe adverse drug reactions to the Netherlands Pharmacovigilance Centre.
Changes to definitions
The definition of ‘practitioner’ now includes certain nurses under the new Medicines Act. The Ministry of Health may appoint categories of nurses with the power to prescribe medicines. Until now, the Ministry has not done so.
The definition of ‘medicinal product’ in the new Medicines Act is now consistent with the Medicines Directive 2001/83/EC.
A major change for homeopathic medicinal products in the new Act is the obligation to demonstrate the effectiveness of homeopathic medicines with an indication. This obligation also applies to homeopathic products which are already registered, in which case the effectiveness has to be demonstrated by means of clinical data within 18 months.
The practicalities of some of these amendments have already raised questions and the Ministry of Health, Public Health Inspectorate and self-regulatory bodies are currently discussing how best to tackle these recent changes. It remains to be seen how these new changes may be carried out in practice.