It is an unprecedented situation in the EU! Drug charges have reached absurd and unsustainable rates
The Association of Generic Medicines Manufacturers of Romania (APMGR) again sounds the alarm signal regarding the clawback tax.
The clawback tax reached 26.49%, a total unsustainable level for generic drugs!
Generic drug manufacturers pay not only an unfair tax for consumption they did not generate, but also an increased clawback tax, which reaches over 37% for affordable drugs. It is an unprecedented situation in the European Union, for generic drugs to be penalized with such a high tax.
As can be seen from the graph below, from 2015 the clawback tax has doubled, these years being lost to Romania, because the tax has affected the investment capabilities of the producers and the availability of cheap medicines for Romanian patients.
From 2015 and until now, about 3,000 drugs have been withdrawn from the market, of which over 2,500 are generic drugs, most of them under 30 RON. If the issue of clawback is not resolved, we will witness an unprecedented situation regarding the availability of generic drugs, as well as closing production lines.
The generic drug manufacturers in Romania can no longer claim the clawback tax.
In addition to the socio-economic consequences, the clawback tax, together with the lowest price policy, increase Romania's dependence on drug imports, usually with much higher prices than the drugs that disappeared from the market.
There is no greater proof of the lack of fiscal predictability, than the fact that CNAS does not seem to be able to give details, let alone prove, the correctness / reality of the data transmitted regarding the clawback.
'' The clawback tax, first introduced in 2009 as a temporary fiscal measure in the context of the economic crisis, is still in effect after 10 years. This tax, which has become unsustainable, results in negative effects for patients, such as the disappearance of thousands of important drugs on the market, thus deepening the drug crisis in Romania. Adjusting the drug budget with inflation, at the level of 2018, ie 4.63% according to the NIS, is an immediate and minimal measure. There is an urgent need to stay at the table of dialogue with the competent authorities and we are confident that the Government will identify and implement the necessary solutions for differentiating the clawback tax and its cap for generic drugs, which should not pay this tax for a consumption that they do not have. generated. The recent statements of Prime Minister Ludovic Orban, regarding the clawback tax, have made us trust that there is a political will to solve the tax problem so that patients can enjoy access to generic drugs. Generic medicines should not be penalized, along with biosimilar medicines are viable solutions for budget optimization, solutions found in almost all EU Member States, except in Romania, said Valentina Băicuianu, Executive Director, APMGR.