The clawback mechanism currently implemented by Romania is not sustainable and lacks predictability, AmCham said in a press release.
Moreover, through this tax system, the difference between real medicine consumption and the budget allotted for medicines is covered entirely by the pharmaceutical industry. In other European countries, such a contribution is aimed at reining in exaggerate drug market increases, not to cover a systemic deficit of the state budget, reads the press release.
According to AmCham, the value of the clawback tax for the first quarter of the year stands at about 30% of producers’ discounted medicine sales (in absolute terms, more than EUR100 million).
Estimations show the clawback tax will generate EUR400 million in 2012. Such a high contribution is unsustainable and unjustified both because drug producers must cover the significant difference between medicine consumption and the sum allotted from the budget and because the clawback tax applies to the retail price, not to producers’ price, AmCham said.
The current mechanism will make producers withdraw medicines from the Romanian market and will discourage the launch of new products.
AmCham said it proposed a series of solutions to improve the mechanism, such as setting a fair maximum threshold considering the real medicine consumption in the previous year and directing the funds collected exclusively to the medicine budget.
Romania’s Government said in its latest letter of intent to the International Monetary Fund (IMF) it will continue to apply the clawback tax in the pharmaceutical industry to avoid amassing new arrears in the sector.
Romanian Health Minister Vasile Cepoi said Tuesday a decision regarding the clawback tax will be taken following an impact study to be completed by June 15.
The clawback system was implemented at the end of 2009 and stated all medicine producers must contribute 5% to 11% of drug sales to finance the public healthcare system.
Pharmaceutical companies complained about the consequences of the tax and the Government admitted the system proved inefficient, as it collected only 5% of the sum expected to be raised.
Later, authorities decided drug producers would pay a quarterly tax computed based on a formula that considers the value of medicine consumption.
Players in the pharmaceutical industry said the new system is still precarious as the clawback tax also applies to the value added tax on drug sales, which breaches the Tax Code.