Clinical Trials, Health Care

17/ 11/ 2021

The first step was taken to regulate the compassionate use of medicines On November 17, the Verkhovna Rada of Ukraine adopted as a basis in the first reading draft Law №5736 on compassionate drug use, developed on the initiative of the People’s Deputy of Ukraine – Mr. Zub V.O. with the participation of the EBA Health Care Committee. Thus, the document contains definitions of the programs under which seriously ill patients can gain gratis access to drugs unregistered in Ukraine for treatment (so-called compassionate use programs). It also provides the procedure and conditions of the implementation of such programs. There are two types of such programs, namely: · program of extended access of patients to unregistered innovative medicines · program that provides patients with access to the drug in research upon their complete participation in the clinical trial. Many countries have regulated the use of new compassionate drugs before they undergo the complete registration process. According to business representatives, early access programs operate in the United States, Canada, the United Kingdom, most EU countries, Australia, and Japan. For example, in 2019 the United States approved about 1,100 requests for early access programs that make unregistered drugs available to patients, and in France, the program of Temporary Authorization for use in 2018 alone was used by about 22,000 patients. These examples demonstrate how broad and effective such programs are. At the same time, the adopted draft law proposes to establish rules for the importation into Ukraine and the use of unregistered medicines intended for compassionate treatment. Shortly, we also expect the adoption of the draft Law “On Amendments to the Tax Code of Ukraine to regulate the compassionate drug use ” №5737 of July 6, 2021, which will reduce the tax burden on imports of such free medicines that will enable sponsors to further develop the compassionate use programs in Ukraine. The European Business Association hopes for the prompt adoption of draft law №3636 in the second reading and for the support of the Parliament of such important draft laws as the steps towards improving the quality of the national legislation so that patients have full access to innovative medicines. We truly thank Arzinger, the legal advisor to the EBA Health Care Committee, for its support in developing the proposals to the document.

The first step was taken to regulate the compassionate use of medicines

On November 17, the Verkhovna Rada of Ukraine adopted as a basis in the first reading draft Law №5736 on compassionate drug use, developed on the initiative of the People’s Deputy of Ukraine – Mr. Zub V.O. with the participation of the EBA Health Care Committee.

Thus, the document contains definitions of the programs under which seriously ill patients can gain gratis access to drugs unregistered in Ukraine for treatment (so-called compassionate use programs). It also provides the procedure and conditions of the implementation of such programs.

There are two types of such programs, namely:

· program of extended access of patients to unregistered innovative medicines

· program that provides patients with access to the drug in research upon their complete participation in the clinical trial.

Many countries have regulated the use of new compassionate drugs before they undergo the complete registration process. According to business representatives, early access programs operate in the United States, Canada, the United Kingdom, most EU countries, Australia, and Japan. For example, in 2019 the United States approved about 1,100 requests for early access programs that make unregistered drugs available to patients, and in France, the program of Temporary Authorization for use in 2018 alone was used by about 22,000 patients. These examples demonstrate how broad and effective such programs are.

At the same time, the adopted draft law proposes to establish rules for the importation into Ukraine and the use of unregistered medicines intended for compassionate treatment.

Shortly, we also expect the adoption of the draft Law “On Amendments to the Tax Code of Ukraine to regulate the compassionate drug use ” №5737 of July 6, 2021, which will reduce the tax burden on imports of such free medicines that will enable sponsors to further develop the compassionate use programs in Ukraine.

The European Business Association hopes for the prompt adoption of draft law №3636 in the second reading and for the support of the Parliament of such important draft laws as the steps towards improving the quality of the national legislation so that patients have full access to innovative medicines.

We truly thank Arzinger, the legal advisor to the EBA Health Care Committee, for its support in developing the proposals to the document.

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