• THE CLAWBACK TAX ON Q1 2014 CONTINUES TO BE UNREASONABLY HIGH, AS THE PERCENTAGE “P” IN THE CALCULATION OF THE CLAWBACK IS OVER 20% OF THE SALE OF REIMBURSED MEDICINES
  • APMGR REQUIRES THE NATIONAL HEALTH INSURANCE HOUSE (NHIH) TO BE MORE TRANSPARENT IN THE WAY THE CLAWBACK TAX IS CALCULATED BY TRANSMITTING THE NUMBER OF REIMBURSED MEDICINE UNITS

BUCHAREST, MAY 7 2014– The Association of Generic Medicine Producers from Romania (APMGR) calls for more transparency in the calculation of the clawback tax contribution, given that the level of the contribution was maintained at a very high level, unsustainable for generic manufacturers.

APMGR asked the leadership of the National Health Insurance House (NHIH) to provide pharmaceutical companies data regarding the volumes of reimbursed drugs (number of units) used for determining the tax base for each company. “If the reporting of the NHIH to companies would be based on the number of units settled, they could more accurately calculate the consumption of medicines in relation to their sales and the artificial increase of the clawback tax could be stopped”, said Dragos Damian, President of APMGR. The request comes in the context of the maintenance of an unreasonably high level of the clawback tax in Q4 2013 and Q1 2014, which is not reflected in sale of medicines registered by companies producing generic medicines. The above 20% level of the percentage “p” in the calculation of the clawback tax is burdensome for manufacturers of generic medicines, while the reference budget for the calculation of the clawback tax still at the level of medicine consumption from 2011.

APMGR salutes the openness of the NHIH leadership to work with generic medicine manufacturers in order to increase the transparency on the calculation of the clawback tax, but signals that so far there were no ??sufficient measures to correct the discrepancy between the clawback contribution reported by NHIH and the data on the sales of medicines that APMGR member companies have.

At the same time, APMGR supports the need to implement a clawback tax with a differentiated calculation for generic medicines, based on the introduction of a maximum proportion of 65% in calculation of the percentage ‘p’ in the clawback formula. The proposal is based on the current pricing mechanism for generic medicines (up to 65% of the originator medicine’s price) and has already been agreed with the NHIH and accepted by the Ministry of Finance as budget-neutral. “We hope that NHIH will respond positively to our call for transparency and will support a more rapid implementation of a differentiated calculation of the clawback tax, so as to avoid the bankruptcy of the pharmaceutical industry with local production capacities and the limitation of the patient’s access to affordable medicines, following their disappearance from the market, ” also said Damian.