The clawback tax mechanism will be changed in two steps, with the Medicines Health House’s budget first being indexed to the inflation rate and, in the second stage, revising the formula for calculating the contribution, announced , Augustus Costache, spokesman for the National Health Insurance House (CNAS). Bringing the budget up to date by updating the inflation rate is considered beneficial by the farm industry as it would leave a lower amount (the difference between medication consumption and the CNAS budget) to be collected from producers through the clawback tax, while producers generic drugs, cheaper, insistent demand, and the change in the levy mechanism to mitigate the disproportionate burden it is incurring.
The public health system only covers part of the cost of drug use in one year, a sum unchanged in 2012.
“We are currently working at an accelerated pace with representatives of the Health and Finance Ministries as well as with the pharmaceutical industry (APMGR, ARPIM, PRIMER) to finalize several clawback mechanism variants that will be presented to the Government. the first step is to correct the reference budget, the amount from which the calculation of the contribution starts, by indexing it with the inflation rate and bringing it to the level of 2018 , and there will be a way to automatically update this budget in the future, and in a second step, the mechanism itself, the formula for calculating the contribution, will be revised, “Augustus Costache announced. The clawback tax was introduced in 2009 as a temporary measure, in the context of the financial crisis, and only affected drug producers. They have to pay the difference between how much CNAS has a settlement budget in a year and how much it actually discounts for medicines. So far, however, this fee has not been waived despite the temporary nature with which it was introduced and the CNAS budget has not been increased for many years. The drug makers paid 1,22 billion lei in the first six months of the year for the clawback tax, with 90 million lei (8%) more than in the same period last year. Despite this increase, the total is 250 million lei under what the Government estimated for the first semester. For the whole year, the Government anticipates in the middle of the year the collection of 2.81 billion lei from the clawback tax.
Representatives of the Ministry of Health said last month that they proposed to the drug producers, in the discussions about the quarterly contribution (clawback tax), that CNAS’s budget could increase with the cumulative inflation rate from 2012 to the present.
The Association of Generic Medicines Manufacturers in Romania (APMGR) has repeatedly appealed to the Ministries of Health and Finance to introduce differentiated clawback tax on price, showing that the current calculation method puts undue pressure on cheap medicines, the producers being put in the situation of removing them from the market in order not to make them at a loss. APMGR representatives claim that in the coming years more than 2,300 generic drugs used by more than 8.5 million patients will disappear due to the fact that manufacturers will no longer be able to pay for production costs. APMGR points out that 60% of these are drugs under 25 MDL, used by more than 8.5 million patients and, most of the time, manufactured in Romania.
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