1. New deadline and related facility

On September 26, 2012, the Romanian Government enacted EGO 53. Under this law, pharmaceutical companies owing clawback tax from Q4 2009 to Q3 2011 may benefit from certain fiscal facilities, if they pay in full such tax and related interests to the state budget by October 29, 2012.

As per GO 17/2012, such fiscal facilities include cancellation of all delay penalties (“penalitati de intarziere”) and cancellation of 50% of delay gross-up fees (“majorari de intarziere”) related to the above tax.

2. History of Romanian clawback tax

Clawback tax is a common practice in EU countries such as Austria, Belgium, Hungary, Italy, Netherlands, Poland, Spain and the United Kingdom. In essence, clawback tax requires pharmaceutical companies that are selling medicines to the public health system, in exchange for reimbursement from the state budget, to contribute an additional amount (so-called „clawback tax”) determined on the basis of their quarterly sales. Clawback tax was designed not only as a measure to refinance public health systems, but also to contain an increase in consumption costs, which would affect states’ budgets.

In October 2009, Romanian authorities decided to adopt such a measure, and enacted EGO 104/2009, providing for a clawback tax. As both EGO 104/2009 and its implementing norms enacted in June 2010 were unclear as to the tax calculation, authorities were reluctant to enforce it.

In September 2011, a new clawback tax calculation formula was adopted under EGO 77/2011, applicable as of Q4 2011, while the old clawback tax formula provided under EGO 104/2009 was repealed. The EGO 77/2011 calculation formula was further amended by EGO 110/2011, applicable as of Q1 2012.

However, to facilitate payment of clawback tax due from Q4 2009 to Q3 2011, when EGO 104/2009 was into force, GO 17/2012 was enacted, outlining such fiscal facilities. Whether retroactive payment of such tax, based on a repealed legislation, is constitutional, may be subject of further debates. As per EGO 53/2012, to claim such facilities, October 29, 2012 was set as new tax payment deadline. Ministry of Finance (MoF) Order 1151/2012 details the procedure to claim such fiscal facilities.

3. Which entities must pay the new clawback tax

Based on EGO 77/2011, holders of an authorization for placing medicines on the Romanian market (APM) must pay such clawback tax to the state budget.

As per  Law 95/2006 on health reform, and the preamble of EGO 53/2012, producers or distributors of medicines may hold an APM. Moreover, under a September 2012 MoF letter to the Producers of Medicines Association (ARPIM) , a clawback tax payer was deemed as any legal entity obtaining income as a result of a right of commercialization of medicines, granted directly or indirectly for Romania, by such medicines APM holder. Further, such MoF letter deems object of the clawback tax the medicines reimbursed from state budget, excluding medicines commercialized outside such reimbursement system, or medicines that are sold outside Romania.