Health Care

20/ 03/ 2019

The 10% surcharge for medical devices is canceled

We welcome the decision of the Cabinet of Ministers of Ukraine (CMU) to cancel the 10% surcharge for medical devices procured with funds allocated from the state and local budgets, which was taken on March 6, 2019. Cancellation of the 10% surcharge is intended to exert a positive impact on the increase of competition in the medical devices market. The EBA Health Care Committee made a substantial contribution to ensure legislative implementation of this decision.

On January 25, 2017 CMU took a decision to cancel the declaration of the wholesale prices for medical devices, to be in line with the EU law. At the same time, the 10% surcharge for medical devices fully or partially procured with public funds remained in the legislation.

The surcharge, in fact, almost deprived the official entities of the opportunity to participate in public procurement. In return, the manufacturing companies had to look for other ways to cover their costs in full or to refuse from participation in procurement. No surcharges exist in the EU legislation. Unfortunately, the surcharge has led to the second-hand goods’ concentration in the market. Most of devices remained in clinics with no further certificated technical support that obviously reduced the quality of medical and diagnostic services provided for the population.

The 10% surcharge for medical devices in Ukraine created pressure precisely on fair enterprises that underwent all regulatory procedures for medical devices in accordance with the current legislation and paid official salaries to their employees making regular tax allocations to the state budget.

The Association is grateful to the Cabinet of Ministers of Ukraine, the Administration of the President of Ukraine, the Ministry of Health of Ukraine, the Ministry of Economic Development and Trade of Ukraine, the Ministry of Finance of Ukraine, the State Regulatory Service of Ukraine, the State Fiscal Service of Ukraine, the State Service of Ukraine for Food Safety and Consumer Protection and the Ministry of Agrarian Policy and Food of Ukraine for the support of the CMU Resolution cancelling 10% surcharge for medical devices.

The Association also hopes that the state authorities will make sure of the correctness of the new regulation. Simultaneously with the cancellation of 10% surcharge for medical devices, the CMU obliged the Ministry of Health of Ukraine to submit proposals for improving of the state regulation of prices for medical devices by March 1, 2020. This provision attests that the final decisive end in the absence of any price regulation for medical devices in Ukraine has not yet been made. Thereby, in the year 2020 international business should also make sure of the stability of the decision cancelling the surcharge, which is in line with the EU legislation. If the regulation does not change Ukraine is supposed to get a full positive effect from direct participation of international medical devices manufacturers in public procurement.

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