ERNST & YOUNG SRL

  |  2014-11-20

Amendments brought to clawback tax

Emergency Ordinance no. 69/2014 published in the Official Gazette no. 807 of 5 November 2014

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The Emergency Ordinance introduces a series of changes, especially regarding the terminology used in the context of clawback tax, but the main change is represented by the introduction of the cost-volume / cost-volume-result contracts and the computation of the related clawback tax. 


Cost-volume / cost-volume-result contracts
The contracts can be concluded for medicines which are conditionally included on the “List” (the List containing the common international terms corresponding to the medicines for the benefit of insured persons, with or without personal contributions, based on medical prescription, in the social health insurance system, as well as the common international terms corresponding to the medicines prescribed within the national health programs, approved by Government Decision no. 720/2008, as subsequently amended) further to the evaluation made by National Agency for Medicine and Medical Devices. 


Based on the cost-volume / cost-volume- result contracts, the holders of the authorizations to release medicines on the market commit to supply the medicines included the List at a certain price, for a certain category of patients and for a certain period of time.


The holders of the authorizations to release medicines on the market, which are not Romanian legal entities, have the duty that, in a 15 days term from the issuance of the decision for conditional inclusion in the List, to designate a legal representative, a Romanian legal entity, in order to negotiate and conclude the cost-volume / cost-volume-result contracts, to declare and pay the clawback contribution.


Furthermore, they have the obligation that, in 30 days term from the conclusion of the cost-volume / cost-volume-result contracts, to register with the National Agency of Fiscal Administration (’NAFA’) as clawback taxpayer.


In the case of medicines which are conditionally included in the List, the holders of the authorizations to release medicines on the market have the duty to pay a quarterly contribution on the basis of the contracts concluded. The quarterly contribution is computed by applying the percentage (as mentioned in the cost-volume / cost-volume-result contracts) to the value of the quarterly consumption of medicines, determined by multiplying the retail sale price before VAT / wholesale price with the volume of medicines consumption, in the volume limit as established through these contracts.


If the volume of the cumulated medicines consumption exceeds the volume mentioned in the contract, the contribution is due for the entire value of consumption exceeding this limit without VAT.

 

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