Discourse about ending the existing market call
13.02.2014 14:48
What was already evident in the numerous written statements that were submitted on the occasion of the extremely well-attended public hearing of the Committee for Health on the draft bill of the CDU/CSU and SPD factions on the draft of a Fourteenth Act amending SGB V as well as six amendment proposals: Before Above all, the abandonment of the benefit assessment of the existing market is more than controversial among experts heard. The main reasons given were legal, but also methodological reasons.
The question round began after introductory words from the new chairman of the health committee, Dr. Edgar Franke, MdB (CDU/CSU) introduced his parliamentary group colleague Jens Spahn, Prof. Dr. Eberhard Wille, the deputy chairman of the Advisory Council, the G-BA and the vfa for a statement on the legal and practical problems of the existing market call as well as the “substitute measure”. “If it were possible,” Wille tried to use a subjunctive at the beginning, that the G-BA “could evaluate all patent-protected original preparations on the existing market within a reasonable period of six months to a year,” he would be in favor of it. But since the G-BA - as convincingly explained in the draft law - is unable to complete this task with the required quality and time, a prioritization criterion is required that is of central importance for the companies' sales. Wille: “The pharmaceutical companies whose products are evaluated first by the G-BA and which still have a long patent term must fear high losses, while companies whose products are only evaluated after a certain period of time will have significantly lower sales losses.” Here Considerable legal certainty is required, also because the G-BA originally envisaged a procedure based on the sales expected over the patent term. In Wille's opinion, this criterion shows the right direction conceptually, but it would also result in controversial decisions that would open up a wide field for legal uncertainty and corresponding legal disputes. For this reason, Wille considers it not to be an ideal solution, but justifiable, for the legislature to forego an assessment of the existing market. With one exception, as he emphasizes: the competition call.
You can read full details in the upcoming issue of “Market Access & Health Policy”.