13:08 24.04.2015

Pharmaceutical industry hope fiscal service will inform customs agencies of rules clearing drugs for clinical studies - EBA

2 min read
Pharmaceutical industry hope fiscal service will inform customs agencies of rules clearing drugs for clinical studies - EBA

The pharmaceutical industry expects that the State Fiscal Service will finally inform regional customs services of the rules on clearing drugs imported for clinical studies and imposing 7% value added tax (VAT) on them, reads a press release issued by the European Business Association (EBA).

The EBA said that all the preparatory work has been conducted to resolve the problem of applying 7% VAT on drugs imported for clinical studies: amendments to two orders of the Health Ministry were made, and the regulations on cooperation between the Health Ministry and the State Expert Center of the ministry were agreed and signed. On April 9, 2015, an explanation letter from Health Ministry confirming the possibility of applying 7% VAT was issued.

"The last step is to inform regional customs services that there are all legal grounds for imposing 7% VAT and start applying it. The central office of the State Fiscal Service is to do this, as the explanation letter was received from Health Ministry," reads the press release.

The EBA said that on April 19, a year had passed when the requirements stipulated in Ukrainian law was impossible to realize in practice.

"Until now companies conducting clinical studies cannot apply the 7% rate, as the content of bylaws was not regulated and the mechanism for applying it was not approved," the association said.

EBA said that during clinical studies all drugs, jointly with treatment, diagnostics and therapy, are provided to patients free of charge. In many countries these drugs are not only imported at beneficial rates, but they are fully exempted from imports duties. The full exemption from extra tax burden of this category of socially important goods/drugs is declared in the International Convention on the Simplification and Harmonization of Customs procedures, which Ukraine joined in 2006.

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