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Сompassionate drug use needs to be regulated by law

20/ 07/ 2021
  Ensuring the availability and proper funding of new medicines is a major challenge for governments around the world. According to EBA experts, it takes a tedious amount of time in Ukraine to conduct clinical trials and register innovative medicines. Meanwhile, patients can access innovative treatment before the completion of the drug registration only through participation in clinical trials. However, many problems arise in the situation when a patient is seriously ill. For example, a patient cannot be included in clinical trials for various reasons and may not wait for the completed registration of a drug that has already undergone phase I-III clinical trials. For cases when without such treatment the disease can reach a serious and irreversible stage or even lead to the death of the patient, there are Compassionate Use Programs under which patients are given early access to unregistered drugs. According to business representatives, such programs provide expanded access of patients to unregistered medicines free of charge for ethical and humane reasons. In Ukraine, the legislation does not provide for the possibility of compassionate treatment of seriously ill patients, for whom only such experimental medicine can improve their health condition. Meanwhile, many countries have regulated the use of new compassionate drugs before the completion of their registration process is completed. Thus, early access programs are available in the United States, Canada, the United Kingdom, most EU countries, Australia, and Japan. In the United States, there were about 1,100 requests for participation in Compassionate Use Programs in 2019. At the EU level, the provision of compassionate medicines is governed by Article 83 of Regulation №726/2004. For example, in France, the Provisional Authorization Program benefited about 22,000 patients in 2018 alone. This proves that such programs are efficient and in high demand. The EBA experts consider that legislative regulation of compassionate medicines in Ukraine will enable pharmaceutical manufacturers to implement such programs in the country, as well as import and provide free medicines to critically ill patients, improve the situation with the treatment of such patients with new drugs and reduce the burden on the health care system. For this, the EBA Clinical Trials Subcommittee developed five proposals together with representatives of the Subcommittee member companies, EBA legal partner Arzinger, and the Subcommittee on Cancer Prevention and Control of the VRU Committee on Nation Health, Medical Care and Health Insurance. The first is to define a program for extended access of patients to unregistered drugs. The definition should specify categories of patients for an unregistered medicinal product that is approved for use in one of the following countries – the United States, the European Economic Area, Australia, Canada, Japan, the United Kingdom, or the Swiss Confederation, or that has undergone or is undergoing clinical trials in the United States, countries of the European Economic Area, Australia, Canada, Japan, the United Kingdom or the Swiss Confederation, and for which safety and efficacy information is sufficient to assess the risk/benefit balance. The second is to determine the right of a doctor to prescribe and use in medical practice the medicines that have not passed the procedure of state registration in Ukraine in accordance with current legislation and which are not included in health care industry standards. The third is to determine the grounds for the import of unregistered medicines that will be used in compassionate drug programs, as the existing grounds (import for individual use and for conducting clinical trials) do not cover such a need; The fourth is to exempt from value-added tax operations for the import into the customs territory of Ukraine and/or operations for the supply in the customs territory of Ukraine of unregistered drugs for compassionate drugs provided free of charge. Currently, the value-added tax rate of 20% will be applied to them as such drugs are not registered and not intended for clinical trials. The fifth is to exclude the cost of medicines, medical devices, related materials, and health care services, received free of charge by individuals/patients within the specified compassionate programs based on the total monthly (annual) taxable income of individuals/patients, etc. Draft Law №5736 on Amendments to Certain Legislative Acts of Ukraine on Settlement of Issues Regarding Compassionate Drug Use and Draft Law №5737 on Amendments to the Tax Code of Ukraine on Settlement of Issues Regarding Compassionate Drug Use were registered in the Verkhovna Rada on July 6, 2021. For that, we thank the Peoples Deputy of Ukraine – Mr. Valery Zub for the authorship, as well the Peoples Deputies of Ukraine who are co-authors, and the profile Committee of the Verkhovna Rada for supporting the proposals. Therefore, the community hopes for the support of the Parliament of such important draft laws so that Ukraine can have effective national legislation enabling full access of patients to innovative medicines.  

Ensuring the availability and proper funding of new medicines is a major challenge for governments around the world. According to EBA experts, it takes a tedious amount of time in Ukraine to conduct clinical trials and register innovative medicines. Meanwhile, patients can access innovative treatment before the completion of the drug registration only through participation in clinical trials. However, many problems arise in the situation when a patient is seriously ill. For example, a patient cannot be included in clinical trials for various reasons and may not wait for the completed registration of a drug that has already undergone phase I-III clinical trials.

For cases when without such treatment the disease can reach a serious and irreversible stage or even lead to the death of the patient, there are Compassionate Use Programs under which patients are given early access to unregistered drugs.

According to business representatives, such programs provide expanded access of patients to unregistered medicines free of charge for ethical and humane reasons.

In Ukraine, the legislation does not provide for the possibility of compassionate treatment of seriously ill patients, for whom only such experimental medicine can improve their health condition. Meanwhile, many countries have regulated the use of new compassionate drugs before the completion of their registration process is completed. Thus, early access programs are available in the United States, Canada, the United Kingdom, most EU countries, Australia, and Japan. In the United States, there were about 1,100 requests for participation in Compassionate Use Programs in 2019.

At the EU level, the provision of compassionate medicines is governed by Article 83 of Regulation №726/2004. For example, in France, the Provisional Authorization Program benefited about 22,000 patients in 2018 alone. This proves that such programs are efficient and in high demand.

The EBA experts consider that legislative regulation of compassionate medicines in Ukraine will enable pharmaceutical manufacturers to implement such programs in the country, as well as import and provide free medicines to critically ill patients, improve the situation with the treatment of such patients with new drugs and reduce the burden on the health care system. For this, the EBA Clinical Trials Subcommittee developed five proposals together with representatives of the Subcommittee member companies, EBA legal partner Arzinger, and the Subcommittee on Cancer Prevention and Control of the VRU Committee on Nation Health, Medical Care and Health Insurance.

The first is to define a program for extended access of patients to unregistered drugs. The definition should specify categories of patients for an unregistered medicinal product that is approved for use in one of the following countries – the United States, the European Economic Area, Australia, Canada, Japan, the United Kingdom, or the Swiss Confederation, or that has undergone or is undergoing clinical trials in the United States, countries of the European Economic Area, Australia, Canada, Japan, the United Kingdom or the Swiss Confederation, and for which safety and efficacy information is sufficient to assess the risk/benefit balance.

The second is to determine the right of a doctor to prescribe and use in medical practice the medicines that have not passed the procedure of state registration in Ukraine in accordance with current legislation and which are not included in health care industry standards.

The third is to determine the grounds for the import of unregistered medicines that will be used in compassionate drug programs, as the existing grounds (import for individual use and for conducting clinical trials) do not cover such a need;

The fourth is to exempt from value-added tax operations for the import into the customs territory of Ukraine and/or operations for the supply in the customs territory of Ukraine of unregistered drugs for compassionate drugs provided free of charge. Currently, the value-added tax rate of 20% will be applied to them as such drugs are not registered and not intended for clinical trials.

The fifth is to exclude the cost of medicines, medical devices, related materials, and health care services, received free of charge by individuals/patients within the specified compassionate programs based on the total monthly (annual) taxable income of individuals/patients, etc.

Draft Law №5736 on Amendments to Certain Legislative Acts of Ukraine on Settlement of Issues Regarding Compassionate Drug Use and Draft Law №5737 on Amendments to the Tax Code of Ukraine on Settlement of Issues Regarding Compassionate Drug Use were registered in the Verkhovna Rada on July 6, 2021. For that, we thank the People’s Deputy of Ukraine – Mr. Valery Zub for the authorship, as well the People’s Deputies of Ukraine who are co-authors, and the profile Committee of the Verkhovna Rada for supporting the proposals.

Therefore, the community hopes for the support of the Parliament of such important draft laws so that Ukraine can have effective national legislation enabling full access of patients to innovative medicines.

 

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