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Information about the failure of holders of medicine registration certificates to fulfill their obligations is false

28/ 04/ 2021
  The European Business Association does not support the draft law amending the system of holders of medicine registration certificates, as its adoption may lead to a deterioration in the pharmaceutical sector, higher prices for medicinal products, and the disappearance of certain categories of medicines from the Ukrainian market. According to business, the content of this draft law lacks substantiation and will not lead to a positive impact on the availability of medicines for patients in Ukraine, nor on the state economy. Meanwhile, in fact, these criteria should be considered in rule-making and shaping public policy. Particular attention should be paid to changes that require serious adaptation and restructuring of the business in times of crisis because there can be hidden risks such as the loss of staff, extra expenditures, and more. The key proposal of the draft law is to change the organizational and legal form of activity of pharmaceutical companies operating in Ukraine. First of all, such a proposal should include substantiation of the grounds, analysis of the expected impact on the provision of the population with all necessary medicines after the final implementation of the new requirement, and clear economic calculations on the expected positive impact on the budget of Ukraine. At the same time, there are no facts available in the open access and in the Explanatory Note to the draft law that indicate that the holders of medicine registration certificates do not fulfill their obligations under the current legislation of Ukraine. There is also no information on improper communication on quality control of the business with the State Medical Service, or on post-registration supervision or pharmacovigilance with the State Expert Center of the Ministry of Health of Ukraine, etc. The current legislation of Ukraine contains an effective list of conditions, rules, and requirements for ensuring the safety, quality, and efficacy of medicines, including the existence of a system of pharmacovigilance and compliance with GMP requirements, and provides effective mechanisms for control, prevention and prosecution in case violations are detected. Therefore, EBA experts believe that there is a lack of justification in the Explanatory Note to the draft law, which states in particular that “there are no provisions on the requirements for the holder of a registration certificate in terms of quality, safety and efficacy of a medicinal product registered in Ukraine; pharmacovigilance; fulfillment of responsibilities related to the requirements of good manufacturing practice (GMP) . Meanwhile, it should be borne in mind that currently, other factors play great importance to business, namely, the restructuring of the state approaches to public funding for medicines in Ukraine, which has and will have a significant impact on companies. Pharmaceutical companies are already changing their business plans and activities in Ukraine taking into account the future introduction in the country of such strategic approaches as health technology assessment (HTA), managed entry agreements (MEAs), extended reimbursement program, transition to a positive list and other important and time-consuming changes in favor of the effective drug supply by the state. Imposing an additional change factor on current processes will risk increasing uncertainty for business and, as a result, the destabilization of the market. Therefore, the EBA calls on the VRU Public Health Committee, the Ministry of Health of Ukraine, and other public authorities to take a comprehensive approach and focus their efforts on completing the work that has already started to obtain the first tangible results from HTA and MEAs in 2022 and continuing to develop HTA. According to the EBA experts, any initiative to change the legal regulation of certain relations should be based on objective factors and evidence. For example, regulators can analyze and present to both the authorities and the professional pharmaceutical community the identified and proven violations by business representatives or improper performance of their duties. In this way, we can make a conclusion on the systemic nature of violations. However, such facts are currently lacking or there was no proper analysis done. Therefore, this draft law is considered by the experts of the EBA Health Committee as an attempt to complicate the business activities, which is unacceptable and will not benefit the population of Ukraine, the industry, or the state. Business insists on a balanced, gradual, and comprehensive approach. Therefore, the European Business Association calls on the Ministry of Health of Ukraine to intensify joint work to address the real pressing issues of current legislation, namely, harmonization of its provisions with the EU. For example, we are talking about problematic aspects of the legal regulation of the GMP confirmation procedure, the actual duplication of state control systems and licensing of activities, further implementation of the mechanism of managed entry agreements. Among further plans are the establishment of an independent health technology assessment agency, the digitalization of registration procedures, and the modernization of legislation in the field of clinical trials.   Be the first to learn about the latest EBA news with our Telegram-channel – EBAUkraine.

The European Business Association does not support the draft law amending the system of holders of medicine registration certificates, as its adoption may lead to a deterioration in the pharmaceutical sector, higher prices for medicinal products, and the disappearance of certain categories of medicines from the Ukrainian market.

According to business, the content of this draft law lacks substantiation and will not lead to a positive impact on the availability of medicines for patients in Ukraine, nor on the state economy. Meanwhile, in fact, these criteria should be considered in rule-making and shaping public policy. Particular attention should be paid to changes that require serious adaptation and restructuring of the business in times of crisis because there can be hidden risks such as the loss of staff, extra expenditures, and more.

The key proposal of the draft law is to change the organizational and legal form of activity of pharmaceutical companies operating in Ukraine. First of all, such a proposal should include substantiation of the grounds, analysis of the expected impact on the provision of the population with all necessary medicines after the final implementation of the new requirement, and clear economic calculations on the expected positive impact on the budget of Ukraine.

At the same time, there are no facts available in the open access and in the Explanatory Note to the draft law that indicate that the holders of medicine registration certificates do not fulfill their obligations under the current legislation of Ukraine. There is also no information on improper communication on quality control of the business with the State Medical Service, or on post-registration supervision or pharmacovigilance with the State Expert Center of the Ministry of Health of Ukraine, etc.

The current legislation of Ukraine contains an effective list of conditions, rules, and requirements for ensuring the safety, quality, and efficacy of medicines, including the existence of a system of pharmacovigilance and compliance with GMP requirements, and provides effective mechanisms for control, prevention and prosecution in case violations are detected. Therefore, EBA experts believe that there is a lack of justification in the Explanatory Note to the draft law, which states in particular that “there are no provisions on the requirements for the holder of a registration certificate in terms of quality, safety and efficacy of a medicinal product registered in Ukraine; pharmacovigilance; fulfillment of responsibilities related to the requirements of good manufacturing practice (GMP) “.

Meanwhile, it should be borne in mind that currently, other factors play great importance to business, namely, the restructuring of the state approaches to public funding for medicines in Ukraine, which has and will have a significant impact on companies. Pharmaceutical companies are already changing their business plans and activities in Ukraine taking into account the future introduction in the country of such strategic approaches as health technology assessment (HTA), managed entry agreements (MEAs), extended reimbursement program, transition to a “positive list” and other important and time-consuming changes in favor of the effective drug supply by the state. Imposing an additional change factor on current processes will risk increasing uncertainty for business and, as a result, the destabilization of the market. Therefore, the EBA calls on the VRU Public Health Committee, the Ministry of Health of Ukraine, and other public authorities to take a comprehensive approach and focus their efforts on completing the work that has already started to obtain the first tangible results from HTA and MEAs in 2022 and continuing to develop HTA.

According to the EBA experts, any initiative to change the legal regulation of certain relations should be based on objective factors and evidence. For example, regulators can analyze and present to both the authorities and the professional pharmaceutical community the identified and proven violations by business representatives or improper performance of their duties. In this way, we can make a conclusion on the systemic nature of violations. However, such facts are currently lacking or there was no proper analysis done.

Therefore, this draft law is considered by the experts of the EBA Health Committee as an attempt to complicate the business activities, which is unacceptable and will not benefit the population of Ukraine, the industry, or the state. Business insists on a balanced, gradual, and comprehensive approach.

Therefore, the European Business Association calls on the Ministry of Health of Ukraine to intensify joint work to address the real pressing issues of current legislation, namely, harmonization of its provisions with the EU. For example, we are talking about problematic aspects of the legal regulation of the GMP confirmation procedure, the actual duplication of state control systems and licensing of activities, further implementation of the mechanism of managed entry agreements. Among further plans are the establishment of an independent health technology assessment agency, the digitalization of registration procedures, and the modernization of legislation in the field of clinical trials.

 

Be the first to learn about the latest EBA news with our Telegram-channel EBAUkraine.

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