Federal Administrative Court, Decision C-6896/2019 from 29 October 2021
12 novembre 2021 – In the present case, the court had to decide whether in addition to an APV a TQV had to be carried out in the context of a price reduction in order to assess the economical character of a medicinal product. Contrary to appellant’s arguments, the Court held that the lower instance had rightfully not included a medicinal product from another range (gammenübergreifend). With regards to the question whether a patent-protected product should have been included in the TQV, the Court stated that if, as in the present case, no patent-expired comparator medicinal product is available for the TQV, the patent-protected medicinal product had to be included in the TQV if it represented an available therapeutic alternative. As it was established that this was the case, but the lower instance had refrained from including the medicinal product in the TQV, the Court held that the reduction of the price in the case at hand was illegal and that the matter was to be referred back to the lower instance.
For more information, see here.