The Association of Generic Medicines Producers from Romania together with the Romanian Association of International Medicines Producers demand the regulatory authorities an urgent review on how the increasing deficit of the health system is financed.
They claim that the clawback tax reached an unsustainable level, subsequent to an increase in Q4 in 2013 of approximately 30 percent compared with the first nine months of the year, so that the respective tax accounted for a fifth of the total sales of subsidized drugs. According to these associations, such increase is not corroborated by a growth of the market, estimating that it will be followed by further increases which will speed up within the next period since the referencing budget on the basis of which the clawback tax was calculated has not been updated and concerns the consumption of medicines recorded in 2011.
Based on these, Dragos Damian, APMGR’s President warns that investments in the pharmaceutical sector will be braked: ‘By keeping this tax in its current form may have serious economic and social consequences, firstly for people, by a complete disappearance of some drugs from the market and by the impossibility to introduce new ones, and then for producers who will have to delay or annul investments in domestic production capacities.’
Calin Galaseanu, ARPIM’s President supports his point of view, stressing out that ‘the clawback tax turned from a budget control measure to a fiscal burden which created a business environment lacking transparency and predictability. The burden is even greater as the list of subsidized medicines has not been updated for six years now, which means a severe negative impact both economically and socially.’
Therefore, a review of the quarterly referencing amount is considered compulsory (the association estimates that the said amount should be around 434.3 million euro (1.95 billion lei), VAT included), as well as a differentiated calculation of the clawback tax as from January 1, 2014, a measure which the medicines producers have consistently requested lately, as Govnet also informed.