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.
The contribution is paid on a quarterly basis, by 25th of the second month following the end of the quarter for which the contribution is due. To this end, the National Health Insurance House (’NHIH’) has the obligation to communicate by the end of the month following the quarter the data based on which the quarterly contribution is computed. This data can be appealed against in a 10 calendar days period from its communication date. We note that the appeal can only refer to the data communicated for the quarter to which it relates.
We also note that in a 15 days period from the contribution payment deadline, NAFA communicates to NHIH, based on the protocol for exchange of information, the status of the amounts cashed in for each taxpayer subject to this contribution.
Amendments brought to previous regulations in force for clawback tax
With regard to the contribution due for medicines already included in the national health programs and subsidized from the National Unique Health Insurance Fund (’NUHIF’), the following main amendments were brought:
- It is mentioned that the legal representative of the holders of the authorizations to release medicines on the market, which is not a Romanian legal entity, is the person empowered to fulfill the legal duties with regards to the due contribution (not only the obligations regarding the reporting and payment of the contribution).
- It is specified that NHIH communicates, to the persons obliged to pay the tax for the medicines included in the national health programs, the value of the centralized consumption of medicines including VAT, as per information included on the social health insurance informatics platform. Additionally, it is specified that the contribution is computed by firstly deducting VAT from the value of the quarterly medicines consumption.
- Furthermore, the duty to acknowledge under electronic signature is introduced, by the open circuit pharmacies, the sanitary units with beds and dialysis centers, of the data reported to the health insurance houses with regard to the total consumption of medicines, including VAT, subsidized from NUHIF.
- It is mentioned that for the legal entities that do not submit, within the deadline, the lists of medicines for which they hold authorization to release medicine on the market, the competent authorities will exclude them from the list of medicines, with or without personal contribution, used in the ambulatory treatment based on medical prescription […], as well as from the list of commercial international terms and settlement price for the medicines prescribed within the national health programs […]. The subsequent inclusion of these medicine on the lists shall be made if all the conditions stipulated by the Ordinance provisions are met.
Moreover, the following aspects are mentioned:
- the holders of the authorizations to release medicines on the market which are not Romanian legal entities and have not declared to NHIH their legal representatives, have the obligations to do so in a 30 days period from the date this Ordinance enters into force.
- the holders of the authorizations to release medicines on the market which are not registered with NAFA as taxpayers for this contribution, have the obligation to do so in a 30 days period from the date this Ordinance enters into force. This timeframe is also applicable for new medicine to be included in the List, which triggers the payment duty for the clawback tax contribution.
