APMGR asks for more transparency in the calculation of the clawback tax

The Romanian Generic Drug Manufacturers Association (APMGR) asks for more transparency in the calculation process of the clawback tax, by the reporting of the number of discounted units by the National Health Insurance Fund (CNAS), in the context of keeping the contribution at a very high level, considered by APMGR as unsustainable for the generic drug manufacturers, according to a press release sent today to the editorial office.

APMGR asked the CNAS management to put at the disposal of the pharmaceutical companies data related to the volume of discounted drugs (the number of units) used for the set of the tax base for each company.

Dragoş Damian, the APMGR chairman, stated: "If CNAS reporting towards companies was done based on the number of units discounted, they could calculate more accurately the drug consumption, in relation to their own sales, and the artificial rise of the clawback tax could be stopped".

The request comes in the context of maintaining the unjustified high level of the clawback tax from T4 2013 and in T1 2014, that is not reflected in the drug sales recorded by the generic drug manufacturer companies. The level of over 20% of the "p" percentage from the clawback tax calculation is considered by APMGR as "cumbersome" for the generic drug manufacturers, in the circumstances that the reference budget for the calculation of the clawback tax is at the level of the drug consumption from 2011.

"APMGR welcomes the willingness of CNAS management to collaborate with the generic drug manufacturers in order to make transparent the calculation method of the clawback tax, but announces that for the moment sufficient approaches haven't been done in order to correct these inadvertences between the level of the clawback contribution reported by CNAS and the data related to the drug sales owned by the APMGR member companies", it is shown in the press release.

Therewith, APMGR supports the necessity for the implementation of a differentiated calculation of the clawback tax of the generic drugs, based on the introduction of a maximum proportion of 65% in the calculation of "p" percentage from the clawback formula. The proposal is based on the current system for the calculation of the price for generic drugs (maximum 65% of the innovative drug price) and was already agreed by CNAS and accepted by the Ministry of Finance as neutral from the budgetary point of view.

"We hope that CNAS will answer positively to our request for transparency and will support the implementation of the differentiated calculation of clawback tax in order to avoid the pharmaceutical industry bankruptcy with local production capacities and the limitation of the patients' access to more accessible drugs, after their disappearance from the market", stated Damian.

APMGR represents the main generic drug companies in Romania: Actavis, AC Helcor, B. Braun Pharmaceuticals, Biofarm, Dr. Reddy's, Egis, Fresenius Kabi, Gedeon Richter, Glenmark Pharmaceuticals, Infomed Fluids, Krka, Labormed, Magistra CC, Medochemie, Sandoz, Terapia-Ranbaxy, Teva, Zentiva. APMGR is affiliated to EGA - the European Generic Medicines Association, the representative organisation of the generic drug manufacturing industry and biosimilar in Europe.