Change in policy on patient information due to judgement by the European Court of Justice

The Medicines Evaluation Board (MEB) will no longer publish the full product information about the active substance of generic medicinal products on its website if an indication is still subject to a patent. The European Court of Justice issued a judgement in legal proceedings on this matter on 14 February 2019. The MEB is amending its policy on the basis of that verdict.

In the interest of good patient information the MEB used to publish all the information on medicinal products on its website whereby, in the case of generic medicinal products, indications which were subject to a patent were also listed. A generic medicinal product is a kind of 'copy' of a branded medicinal product with the same active substance and the same strength. However, a generic medicinal product cannot be sold for indications on which the manufacturer of the branded medicinal product still has a patent. That is also the reason why the patented indication was not listed in the package leaflet of the generic medicinal products. Nevertheless, in practice patients sometimes still received a generic medicinal product for an illness or a symptom with regard to which they were unable to find any information in the packaging leaflet due to the indication in question being subject to a patent. The MEB decided it was important that those patients should then receive full information about the medicinal product. For that reason the paper package leaflet of the generic product therefore referred to the full package leaflet on the Medicines Information Bank on the MEB website. This policy was legally contested in 2016. Manufacturer Warner-Lambert believed that this publication policy meant that generic products were being prescribed more frequently for ailments for which the branded medicinal product should have been prescribed.

As a consequence of the judgement by the European Court of Justice, the information about patented indications which the manufacturer of the generic medicinal product is not allowed to trade will, in principle, no longer be published in the information about the generic product. The generic medicinal products package leaflet will no longer contain a reference to the Medicines Information Bank. In the future it will be stated that the patient should contact his doctor or pharmacist in the event of questions about using the product for ailments which are not referred to in the package leaflet.

The changes are to be implemented in consultation with the authorisation holders of the generic medicinal products. The authorisation holders in question will be sent a letter asking them to change the package leaflet on this point. The MEB will amend the product information of the generic medicinal products in question on the MEB website. The new MEB policy links up with the policy of the other European Member States, as coordinated in the CMDh.