Amendment of policy for usage patents and publication

The Medicines Evaluation Board (MEB) wants to continue publishing the complete SmPC and package leaflet of generic medicinal products on the MEB website, even if a patent still rests on an indication. A new proposal is to mark the patented indication, so that it is clear that this is a patented indication.

This proposed policy change is published on the MEB website for public consultation.

The MEB is proposing this change to the policy following the judge’s ruling in the preliminary injunction proceedings surrounding the usage patent for pregabalin, filed by the company WLC/Pfizer. According to the MEB, this makes it possible to combine the interests of good patient information and the disclosure of patents.

Patients' interests

The MEB policy since 2009 has been to publish the complete product information for medicinal products on its website, regardless of any usage patents. After all, the MEB assesses and registers generic medicinal products for all indications. In addition, this comprehensiveness is in the interests of the patients who are prescribed a generic medicinal product for an illness or a symptom that they cannot find in the package leaflet in the box. Therefore, the complete package leaflets are available on the MEB website: