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Clinical Trials, Health Care

21/ 02/ 2022
  Compassionate medicines use allowed in Ukraine On February 15, the VRU adopted in the second reading the Draft Law of Ukraine “On Amendments to Certain Legislative Acts of Ukraine Concerning the Regulation of Compassionate Medicines Use.” It was initiated by the EBA Clinical Trials Subcommittee that also took active participation in the development of the document. The enactment of the Draft Law will expand access to unregistered medicines by providing them in compassionate use programs, specifically: Program of extended access of patients to unregistered innovative medicines; Program of access of patients to the investigational medicinal product after completion of the clinical trial. It should be recalled that compassionate use programs are widely used in developed countries and for a long time have been recognized as an effective tool for expanding access to treatment. From now on, Ukraine will be able to use the same mechanisms. In Ukraine, before the adoption of the Law, patients access to unregistered medicines was significantly complicated and required the use of special legal grounds in each case. We would like to thank the People’s Deputies of Ukraine Mr. Zub V. and Mr. Radustskyi M., as well as the members of the VRU Committee on Public Health, Medical Assistance, and Medical Insurance for supporting the initiative of the EBA Clinical Trials Subcommittee, and EBA Health Care Committee legal advisor Arzinger law firm, for support in the development of the Draft Law text.

Compassionate medicines use allowed in Ukraine

On February 15, the VRU adopted in the second reading the Draft Law of Ukraine “On Amendments to Certain Legislative Acts of Ukraine Concerning the Regulation of Compassionate Medicines Use.” It was initiated by the EBA Clinical Trials Subcommittee that also took active participation in the development of the document. The enactment of the Draft Law will expand access to unregistered medicines by providing them in compassionate use programs, specifically:

  • Program of extended access of patients to unregistered innovative medicines;
  • Program of access of patients to the investigational medicinal product after completion of the clinical trial.

It should be recalled that compassionate use programs are widely used in developed countries and for a long time have been recognized as an effective tool for expanding access to treatment. From now on, Ukraine will be able to use the same mechanisms. In Ukraine, before the adoption of the Law, patients’ access to unregistered medicines was significantly complicated and required the use of special legal grounds in each case.

We would like to thank the People’s Deputies of Ukraine Mr. Zub V. and Mr. Radustskyi M., as well as the members of the VRU Committee on Public Health, Medical Assistance, and Medical Insurance for supporting the initiative of the EBA Clinical Trials Subcommittee, and EBA Health Care Committee legal advisor Arzinger law firm, for support in the development of the Draft Law text.

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