The Federal Supreme Court recently decided that prescribing information is subject to competition law and, under certain circumstances, can be assumed to be misleading.
The plaintiff was the authorised rights holder of BOTOX pharmaceuticals. The defendants were the authorised rights holder and distributor of the competing pharmaceutical Xeomin 50 LD50-Einheiten. The plaintiff believed that the specifications regarding the equipotency of the two drugs as laid out in the prescribing information were misleading and sought injunctive relief.
In the previous instance, the Hamburg High Regional Court found that the prescribing information should not be assessed under competition law, as it had been subject to review in the admission process. Therefore, it was deemed approved and could not be challenged by competitors or reviewed by courts.
The Federal Supreme Court did not share this view. Respective specifications in prescribing information are generally misleading if based on studies which do not agree with the statements. The legitimising effect of the authorisation decision did not extend to individual content in the prescribing information and therefore specifications in the prescribing information can be assessed by civil courts under competition law. However, in doing so, it can be assumed that specifications in the prescribing information comply with established science at the time of authorisation. The indicative meaning of authorisation is based on the fact that specifications are subject to official examination in the authorisation procedure. However, an advertiser can refute the scientific substantiation of prescribing information by providing newer scientific insights which have come to light after the licensing date or which were not accessible to the licensing authority at the time of the decision and are contrary to the statements.
However, the court clearly indicated that a confutation would not have been possible had the plaintiff only challenged the licensing authority’s studies and conclusions on which its authorisation is based. A drug manufacturer has a legitimate interest in gaining legal certainty for advertising information taken from prescribing information previously reviewed by the licensing authority during the licensing process. In this case, the plaintiff was unsuccessful because it did not provide any new or newly accessible insights.
Prescribing information is subject to competition law and can be assumed to be misleading. Competitors may raise objections to the prescribing information based only on new insights or insights which were not accessible at the time of authorisation. It is impossible to object based on an incorrect assessment of the documents submitted in the authorisation process.
In future, pharmaceutical companies will have to check which specifications and documents they submit for authorisation and product licence holders will have to regularly examine whether specifications remain in accordance with current science.