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The EBA calls on the Government to start reforming the system of falsification of medicinal products prevention

27/ 06/ 2023
  The Health Committee of the European Business Association calls on the Government of Ukraine to strategically decide to initiate the reform of the system aimed at preventing the counterfeiting of medicines and quality control of drugs in Ukraine. The reform should be based on EU regulations and practices and aimed at achieving the primary goal of ensuring patient safety and the effectiveness of their treatment. In support of this decision, the Committee of the Association, in partnership with the law firm Legal Alliance, has developed comprehensive proposals for reforming the system to prevent falsification and ensure quality control of medicines in Ukraine. These proposals were sent for consideration to the relevant government authorities on June 12, 2023. Among other things, these proposals include: In a specific shift of focus and authority, the State Service of Ukraine on Medicines and Drug Control (SMDC) will transition from targeting legal players to addressing the black market; Changes to criminal and administrative legislation to implement appropriate mechanisms for accountability and enforcement; Cancellation of existing duplication between state quality control and licensing of import activities for medicinal products;  Change in approaches to the original GMP certificates confirmation - implementation of EU approaches; Digitization of procedures of the SMDC;  Appealing to the EU requesting full authorized access for the SMDC to the EU electronic database EudraGMDP;  Preparation for the establishment of a new state control body envisaged by the new Law on Medicinal Products. According to experts from the Associations Committee, these proposals reflect priority issues that are most problematic in the current legal regulation and its enforcement. As it is well known, the activities of the SMDC are currently legislatively and practically limited to the control of legal participants in the pharmaceutical market. This hinders the effective prevention and counteraction of the entry and circulation of counterfeit medicines in Ukraine, including the black and gray imports of drugs. The transportation of medicines in suitcases and their sale in illegal online pharmacies, social networks, and messaging apps, which operate without any permits, are clearly the central means of distributing counterfeit products and are carried out by illicit market entities. Moreover, the fight against the market of illegal medicine is primarily conducted by law enforcement agencies, which often lack the necessary specialization and sufficient resources. The existing control system is highly burdensome for businesses and the state since it involves numerous bureaucratic processes, conducting specific laboratory tests (which only concern the legal part of the market), and so on. Therefore, according to business representatives, such a system is incapable of improving the situation regarding the prevention of counterfeiting and poses direct risks to the lives and health of Ukrainian citizens. Specifically, the available statistics from the SMDC for 2022 confirm the absence of any detected cases of counterfeiting. However, as it is known, there have been recent widespread reports by law enforcement agencies and the media about significant cases of drug falsification. The anticipated implementation of a drug verification system in Ukraine can only partially solve the problem. It is not an exhaustive answer to the issue of drug counterfeiting as a whole. Firstly, the system will not be applied to all medicinal products in circulation. Secondly, the system does not address the mechanisms to counter illegal retail channels. Comprehensive and effective results can only be achieved through the simultaneous reform of the anti-counterfeiting system. Therefore, it is necessary to establish an efficient functioning mechanism to control the circulation of medicinal products.  In addition, Associations Committee experts state that the draft resolution of the Cabinet of Ministers of Ukraine, which was put up for public discussion on May 24, 2023, titled On Amending the Procedure for State Quality Control of Imported Medicinal Products in Ukraine, will not contribute to a comprehensive solution to the problem and will not expedite the negotiations on expanding the Agreement on Conformity Assessment and Acceptance of Industrial Products (ACAA) between Ukraine and the EU regarding the field of medicines. Particularly the mutual recognition of GMP certificates. Furthermore, changes in the resolution may exacerbate the practical issues with the supply of drugs by legal manufacturers from EU member states, the United Kingdom, and other countries with stringent regulatory systems. Therefore, the draft resolution is highly undesirable and would signify a deepening crisis.  The EBAs Committee is open to continuing the dialogue on these and other priority issues in the pharmaceutical and healthcare sectors. It expresses readiness to continue providing expert support in aligning Ukraines legislation and practices with the EU. The Health Care Committee also expresses gratitude to the experts from member companies and the law partner, Legal Alliance, for their professional assistance in developing draft amendments to relevant legislative acts, including the Criminal Code of Ukraine, the Code of Ukraine on Administrative Offenses, the Procedure for State Quality Control of Imported Medicinal Products in Ukraine approved by Resolution of the Cabinet of Ministers of Ukraine No. 902 dated September 14, 2005, the Licensing Conditions for Pharmaceutical Manufacturing, Wholesale and Retail Trade of Medicinal Products, Import of Medicinal Products (excluding active pharmaceutical ingredients) approved by Cabinet of Ministers Resolution No. 929 dated November 30, 2016, the Procedure for State Registration (Re-registration) of Medicinal Products approved by Cabinet of Ministers Resolution No. 376 dated May 26, 2005, the Procedure for Establishing Prohibition (Temporary Prohibition) and Resumption of Circulation of Medicinal Products on the Territory of Ukraine, approved by the Order of the Ministry of Health of Ukraine No. 809 dated November 22, 2011, the Procedure for Monitoring Compliance of Immunobiological Products Used in Medical Practice with the Requirements of State and International Standards, approved by the Order of the Ministry of Health of Ukraine No. 698 dated October 1, 2014, and the Procedure for Confirmation of Compliance of Medicinal Product Manufacturing Conditions with Good Manufacturing Practice Requirements, approved by the Order of the Ministry of Health of Ukraine No. 1130 dated December 27, 2012.

The Health Committee of the European Business Association calls on the Government of Ukraine to strategically decide to initiate the reform of the system aimed at preventing the counterfeiting of medicines and quality control of drugs in Ukraine. The reform should be based on EU regulations and practices and aimed at achieving the primary goal of ensuring patient safety and the effectiveness of their treatment.

In support of this decision, the Committee of the Association, in partnership with the law firm “Legal Alliance,” has developed comprehensive proposals for reforming the system to prevent falsification and ensure quality control of medicines in Ukraine. These proposals were sent for consideration to the relevant government authorities on June 12, 2023. Among other things, these proposals include:

  • In a specific shift of focus and authority, the State Service of Ukraine on Medicines and Drug Control (SMDC) will transition from targeting legal players to addressing the “black” market;
  • Changes to criminal and administrative legislation to implement appropriate mechanisms for accountability and enforcement;
  • Cancellation of existing duplication between state quality control and licensing of import activities for medicinal products; 
  • Change in approaches to the original GMP certificates confirmation – implementation of EU approaches;
  • Digitization of procedures of the SMDC; 
  • Appealing to the EU requesting full authorized access for the SMDC to the EU electronic database EudraGMDP; 
  • Preparation for the establishment of a new state control body envisaged by the new Law on Medicinal Products.

According to experts from the Association’s Committee, these proposals reflect priority issues that are most problematic in the current legal regulation and its enforcement. As it is well known, the activities of the SMDC are currently legislatively and practically limited to the control of legal participants in the pharmaceutical market. This hinders the effective prevention and counteraction of the entry and circulation of counterfeit medicines in Ukraine, including the “black” and “gray” imports of drugs. The transportation of medicines in suitcases and their sale in illegal online pharmacies, social networks, and messaging apps, which operate without any permits, are clearly the central means of distributing counterfeit products and are carried out by illicit market entities. Moreover, the fight against the market of illegal medicine is primarily conducted by law enforcement agencies, which often lack the necessary specialization and sufficient resources. The existing control system is highly burdensome for businesses and the state since it involves numerous bureaucratic processes, conducting specific laboratory tests (which only concern the legal part of the market), and so on. Therefore, according to business representatives, such a system is incapable of improving the situation regarding the prevention of counterfeiting and poses direct risks to the lives and health of Ukrainian citizens.

Specifically, the available statistics from the SMDC for 2022 confirm the absence of any detected cases of counterfeiting. However, as it is known, there have been recent widespread reports by law enforcement agencies and the media about significant cases of drug falsification.

The anticipated implementation of a drug verification system in Ukraine can only partially solve the problem. It is not an exhaustive answer to the issue of drug counterfeiting as a whole. Firstly, the system will not be applied to all medicinal products in circulation. Secondly, the system does not address the mechanisms to counter illegal retail channels. Comprehensive and effective results can only be achieved through the simultaneous reform of the anti-counterfeiting system. Therefore, it is necessary to establish an efficient functioning mechanism to control the circulation of medicinal products. 

In addition, Association’s Committee experts state that the draft resolution of the Cabinet of Ministers of Ukraine, which was put up for public discussion on May 24, 2023, titled “On Amending the Procedure for State Quality Control of Imported Medicinal Products in Ukraine,” will not contribute to a comprehensive solution to the problem and will not expedite the negotiations on expanding the Agreement on Conformity Assessment and Acceptance of Industrial Products (ACAA) between Ukraine and the EU regarding the field of medicines. Particularly the mutual recognition of GMP certificates. Furthermore, changes in the resolution may exacerbate the practical issues with the supply of drugs by legal manufacturers from EU member states, the United Kingdom, and other countries with stringent regulatory systems. Therefore, the draft resolution is highly undesirable and would signify a deepening crisis. 

The EBA’s Committee is open to continuing the dialogue on these and other priority issues in the pharmaceutical and healthcare sectors. It expresses readiness to continue providing expert support in aligning Ukraine’s legislation and practices with the EU.

The Health Care Committee also expresses gratitude to the experts from member companies and the law partner, “Legal Alliance,” for their professional assistance in developing draft amendments to relevant legislative acts, including the Criminal Code of Ukraine, the Code of Ukraine on Administrative Offenses, the Procedure for State Quality Control of Imported Medicinal Products in Ukraine approved by Resolution of the Cabinet of Ministers of Ukraine No. 902 dated September 14, 2005, the Licensing Conditions for Pharmaceutical Manufacturing, Wholesale and Retail Trade of Medicinal Products, Import of Medicinal Products (excluding active pharmaceutical ingredients) approved by Cabinet of Ministers Resolution No. 929 dated November 30, 2016, the Procedure for State Registration (Re-registration) of Medicinal Products approved by Cabinet of Ministers Resolution No. 376 dated May 26, 2005, the Procedure for Establishing Prohibition (Temporary Prohibition) and Resumption of Circulation of Medicinal Products on the Territory of Ukraine, approved by the Order of the Ministry of Health of Ukraine No. 809 dated November 22, 2011, the Procedure for Monitoring Compliance of Immunobiological Products Used in Medical Practice with the Requirements of State and International Standards, approved by the Order of the Ministry of Health of Ukraine No. 698 dated October 1, 2014, and the Procedure for Confirmation of Compliance of Medicinal Product Manufacturing Conditions with Good Manufacturing Practice Requirements, approved by the Order of the Ministry of Health of Ukraine No. 1130 dated December 27, 2012.

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