Because of bureaucracy, it can take up to two years for generic medicines and biosimilars to be included in the List of subsidized medicines, much to the detriment of patients and the public budget, the drug manufacturers said on Wednesday.
„This is happening although these drugs cover the treatment of over 70% of patients, and 90% of them cost less than RON 50. The blockage is caused by legislation and cost-volume contracts that remain in force even after the patent of the innovative medicine expires. Instead of generics and biosimilars being automatically included in the List, manufacturers are compelled to go through an extremely long and arduous bureaucratic process that takes up to 2 years. (…) Meanwhile, the patients are deprived of access to treatment, and generic medicines end up being destroyed,” the Association of Romanian Generic Medicines Manufacturers (AMPGR) said in a release on Wednesday.
Moreover, the Association said, in the coming years patents will expire for molecules that address the issues of a very large number of patients and that take up impressive amounts of the health budget.
According to a calculation made by AMPGR for just one drug molecule, delaying the generic’s entry into the List of subsidized medicines by 2 years could generate a potential cumulated loss of RON 27 million to the health budget.
Statistics show that generic and biosimilar medicines cover the treatment of over 70% of Romanian patients, at a cost of only EUR 1.43 billion out of a total of EUR 7.63 billion, i.e. under 20% of total costs, and the price of 90% of reimbursable generic medicines is under RON 50.
In this context, APMGR proposes: revising the reference price mechanism and the annual indexation of prices under RON 50 according to inflation; reducing the clawback rate for generic and biosimilar medicines by 5%, respectively from 15% to 10%; amending the legislation to include generic medicines equivalent to innovators subject to cost-volume contracts in the list of reimbursable drugs within a maximum of two months.
