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Business welcomes the first step to the final settlement of the compassionate drug use

17/ 08/ 2022
  The European Business Association welcomes the adoption on August 15 of Draft Law No. 5737 On Amendments to the Tax Code of Ukraine Regarding Regulation of the Compassionate Drug Use as a basis in the first reading by the Verkhovna Rada of Ukraine. The draft law was developed with the participation of the Clinical Trials Subcommittee and the Health Care Committee of the European Business Association. The draft law is aimed at regulating the taxation of operations by business entities that will participate in programs for providing patients with compassionate medicines. This will enable sponsors to further develop relevant programs for Ukraine. Thus, the changes concern the exemption from taxation of the importation into the customs territory of Ukraine and the supply in the territory of Ukraine of unregistered and/or registered medicinal products, medical devices, related health materials, and/or services needed for the programs of extended patient access to unregistered medicinal products and programs for patient access to a studied medicinal product after completion of a clinical trial. It is also expected to reduce the tax burden on the patients participating in such programs and receiving innovative medicinal products free of charge. Namely, the cost of drugs, medical products, services, etc. provided within the framework of the programs will not be included in the calculation of the patients total taxable income. The adoption of Draft Law No. 5737 is an integral part of the functioning of compassion programs in Ukraine, the first step in the regulation of which was the adoption of Draft Law No. 5736 on the regulation of requirements and rules for conducting such programs. These programs will improve the access to innovative medicines for seriously ill patients, as well as reduce the cost of treatment of seriously ill patients for the state. The adoption of the Draft Law in the first reading demonstrated the states awareness of the importance of such programs and the support they need. Therefore, the EBA is waiting for a quick decision from Parliament regarding the adoption of Draft Law No. 5737 in the second reading. After all, even in such difficult times for our country, the legislative process in the field of clinical trials should not stop. On the contrary, it is necessary to solve such urgent issues for part of the Ukrainian people and ensure the improvement of patients access to innovative treatment tools.

The European Business Association welcomes the adoption on August 15 of Draft Law No. 5737 “On Amendments to the Tax Code of Ukraine Regarding Regulation of the Compassionate Drug Use” as a basis in the first reading by the Verkhovna Rada of Ukraine. The draft law was developed with the participation of the Clinical Trials Subcommittee and the Health Care Committee of the European Business Association.

The draft law is aimed at regulating the taxation of operations by business entities that will participate in programs for providing patients with compassionate medicines. This will enable sponsors to further develop relevant programs for Ukraine. Thus, the changes concern the exemption from taxation of the importation into the customs territory of Ukraine and the supply in the territory of Ukraine of unregistered and/or registered medicinal products, medical devices, related health materials, and/or services needed for the programs of extended patient access to unregistered medicinal products and programs for patient access to a studied medicinal product after completion of a clinical trial.

It is also expected to reduce the tax burden on the patients participating in such programs and receiving innovative medicinal products free of charge. Namely, the cost of drugs, medical products, services, etc. provided within the framework of the programs will not be included in the calculation of the patient’s total taxable income.

The adoption of Draft Law No. 5737 is an integral part of the functioning of compassion programs in Ukraine, the first step in the regulation of which was the adoption of Draft Law No. 5736 on the regulation of requirements and rules for conducting such programs.

These programs will improve the access to innovative medicines for seriously ill patients, as well as reduce the cost of treatment of seriously ill patients for the state.

The adoption of the Draft Law in the first reading demonstrated the state’s awareness of the importance of such programs and the support they need.

Therefore, the EBA is waiting for a quick decision from Parliament regarding the adoption of Draft Law No. 5737 in the second reading. After all, even in such difficult times for our country, the legislative process in the field of clinical trials should not stop. On the contrary, it is necessary to solve such urgent issues for part of the Ukrainian people and ensure the improvement of patients’ access to innovative treatment tools.

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