The Netherlands

The Medicines Evaluation Board (MEB) will no longer publish full product information about the active substance of generic medicines on its website if there is still a patent on one of the indications.

A generic drug may not be sold for indications that the brand drug manufacturer still has a patent on. That is why the patented indication is not included in the package leaflet for the generic medicine. The paper package leaflet for the generic substance therefore referred to the full package leaflet on the MEB website. In the importance of providing good patient information, the MEB published the complete product information of certain generic medicines on its website, whereby indications for which patents still existed were also stated.

This policy was legally challenged in 2016 by manufacturer Warner-Lambert, who found that this publication policy meant that more often generic drugs were prescribed for conditions for which the branded drug should have been prescribed.

The European Court of Justice issued a judgment on this matter on 14 February 2019. As a result, the information on patented indications, that the manufacturer of the generic medicinal product is not allowed to promote, will no longer be published in the information on the generic product on the MEB website. In the package leaflet for generic medicines, the reference to the Medicines Information Bank will be deleted. From now on, it will be indicated that the patient can contact his doctor or pharmacist if he has any questions about the use of the product in the case of conditions that are not mentioned in the package leaflet.

More information can be found here.

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