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Healthсare in wartime: current changes and further strategic development

19/ 05/ 2022
  The armed aggression of the russian federation against Ukraine required prompt and sometimes non-trivial measures by the state and business. On the first day of the russian attack on our country, the EBA Health Care Committee identified 8 priority steps to support the state with pharmaceutical products, most of which were successfully implemented! The European Business Association and the Health Care Committee member companies are grateful to the Ministry of Health of Ukraine, the State Expert Center of the Ministry of Health of Ukraine, the State Service of Ukraine for Medicines and Drug Control for hard work under the martial law and the constructive cooperation with the EBA representatives in providing Ukrainians with the necessary treatment. We would also like to thank the respective authorities for the implementation of operational changes in sectoral legislation. Thus, the EBA experts are grateful for the opportunity to be involved in the development of one of the crucial regulatory documents. Our joint efforts resulted in the adoption of CMU Resolution  №471 on Some issues of emergency state registration of drugs, medical immunobiological drugs, blood products produced or supplied to Ukraine during the period of martial law, under the obligation dated April 15, 2022. The resolution introduces: Emergency registration of medicines from any country in the world (except the aggressor country); E-submission of registration documents for medicines, including with the use of cloud storage, which is significant progress; Automatic renewal of term registration certificates; Removal of restrictions on the minimum shelf life of medicines for supply to Ukraine if their use is justified prior to the expiration of this period; Access to the market of medicines in foreign packaging, etc. It should be noted that a number of components of this resolution have also been implemented by separate operational decisions of state regulators since the first days of the war against Ukraine. This helped to avoid the risks of a humanitarian catastrophe. Business, for its part, focused all its efforts on charity, prevention of the complete destruction of logistics chains (due to the refusal of some operators to supply drugs to the border with Ukraine), creation of new supply chains for medicines and medical devices, including for patients involved in clinical trials. Particular attention was paid to meeting the urgent needs of the Armed Forces of Ukraine, medical institutions, and pharmacies. In total, the EBA pharmaceutical community has provided humanitarian aid for more than UAH 5.87 billion and does not stop its efforts in humanitarian work. Meanwhile, business suggests not stopping at the current successes and starting active preparations for further development of Ukrainian healthcare. According to the EBA Health Care Committee representatives, the basic components of such reconstruction should include: Comprehensive eurointegration in healthcare by: Approving modern standards (building codes & sanitary-epidemiological rules) of construction and technical support of hospitals to replace the Soviet norms promptly; Defining the European model of access to medical and pharmaceutical specialties, professional self-governance; Active cooperation with EU institutions, namely with the European Medicines Agency and the European Organization for the Verification of Medicinal Products, namely in the launch of an internal evaluation mission on legislative and institutional regulation of the Ukrainian pharmaceutical industry for membership to the EU pharmaceutical ecosystem, the potential inclusion of Ukraine in centralized and decentralized procedures for registration of medicines in the EU, reassessment of GMP validation approaches in Ukraine, the extension of the ACAA agreement with the EU on medicines and GMPs to medicines. Restoration of the network of medical institutions based on capacity, efficiency, and accessibility for patients of Ukraine, with the application of modern standards of construction, equipment, and the need to optimize hospital infrastructure. Redesign and final identification of the approach to the role and relationship of state and business participation in the medical field, the transition to equal market conditions in the health business, and modern models of public-private partnership in healthcare. Further development of access to innovation in Ukraine, namely in the field of clinical trials and evaluation of medical technologies. Full digitalization that includes affordable telemedicine, e-medical card for patients and doctors, e-prescriptions, eSubmission, and eCTD format for all registration procedures for drugs and other necessary components. Assessment of Ukraines role in the world pharmaceutical market. Development of a comprehensive vision for stimulating domestic production of medicines, finding global markets, localizing and transferring technologies that would meet competition and market principles (state insurance of export risks, lending for re-equipment of enterprises, determination of stable long-term state order contracts, accelerated depreciation of fixed assets, tax rebates and/or reimbursement of costs related to the implementation of innovations, etc.) with the consideration of Ukraines obligations under the WTO and the EU Association Agreement. Expansion of state programs & instruments for co-payment by the state and citizens of the cost of medical services and medicines, and medical devices, including through reimbursement. The EBA Health Care Committee invites the Ministry of Health and the National Council for the Recovery of Ukraine to consider these proposals in further work. The Committee is ready to become a platform for joint elaboration of relevant decisions, which should ensure a new level of quality, and accessibility to modern medical care for the citizens of Ukraine. Glory to Ukraine!

The armed aggression of the russian federation against Ukraine required prompt and sometimes non-trivial measures by the state and business. On the first day of the russian attack on our country, the EBA Health Care Committee identified 8 priority steps to support the state with pharmaceutical products, most of which were successfully implemented!

The European Business Association and the Health Care Committee member companies are grateful to the Ministry of Health of Ukraine, the State Expert Center of the Ministry of Health of Ukraine, the State Service of Ukraine for Medicines and Drug Control for hard work under the martial law and the constructive cooperation with the EBA representatives in providing Ukrainians with the necessary treatment. We would also like to thank the respective authorities for the implementation of operational changes in sectoral legislation.

Thus, the EBA experts are grateful for the opportunity to be involved in the development of one of the crucial regulatory documents. Our joint efforts resulted in the adoption of CMU Resolution  №471 on “Some issues of emergency state registration of drugs, medical immunobiological drugs, blood products produced or supplied to Ukraine during the period of martial law, under the obligation “dated April 15, 2022. The resolution introduces:

  • Emergency registration of medicines from any country in the world (except the aggressor country);
  • E-submission of registration documents for medicines, including with the use of cloud storage, which is significant progress;
  • Automatic renewal of term registration certificates;
  • Removal of restrictions on the minimum shelf life of medicines for supply to Ukraine if their use is justified prior to the expiration of this period;
  • Access to the market of medicines in foreign packaging, etc.

It should be noted that a number of components of this resolution have also been implemented by separate operational decisions of state regulators since the first days of the war against Ukraine. This helped to avoid the risks of a humanitarian catastrophe.

Business, for its part, focused all its efforts on charity, prevention of the complete destruction of logistics chains (due to the refusal of some operators to supply drugs to the border with Ukraine), creation of new supply chains for medicines and medical devices, including for patients involved in clinical trials. Particular attention was paid to meeting the urgent needs of the Armed Forces of Ukraine, medical institutions, and pharmacies. In total, the EBA pharmaceutical community has provided humanitarian aid for more than UAH 5.87 billion and does not stop its efforts in humanitarian work.

Meanwhile, business suggests not stopping at the current successes and starting active preparations for further development of Ukrainian healthcare. According to the EBA Health Care Committee representatives, the basic components of such reconstruction should include:

  1. Comprehensive eurointegration in healthcare by:
  • Approving modern standards (building codes & sanitary-epidemiological rules) of construction and technical support of hospitals to replace the Soviet norms promptly;
  • Defining the European model of access to medical and pharmaceutical specialties, professional self-governance;
  • Active cooperation with EU institutions, namely with the European Medicines Agency and the European Organization for the Verification of Medicinal Products, namely in the launch of an internal evaluation mission on legislative and institutional regulation of the Ukrainian pharmaceutical industry for membership to the EU pharmaceutical ecosystem, the potential inclusion of Ukraine in centralized and decentralized procedures for registration of medicines in the EU, reassessment of GMP validation approaches in Ukraine, the extension of the ACAA agreement with the EU on medicines and GMPs to medicines.
  1. Restoration of the network of medical institutions based on capacity, efficiency, and accessibility for patients of Ukraine, with the application of modern standards of construction, equipment, and the need to optimize hospital infrastructure.
  2. Redesign and final identification of the approach to the role and relationship of state and business participation in the medical field, the transition to equal market conditions in the health business, and modern models of public-private partnership in healthcare.
  3. Further development of access to innovation in Ukraine, namely in the field of clinical trials and evaluation of medical technologies.
  4. Full digitalization that includes affordable telemedicine, e-medical card for patients and doctors, e-prescriptions, eSubmission, and eCTD format for all registration procedures for drugs and other necessary components.
  5. Assessment of Ukraine’s role in the world pharmaceutical market. Development of a comprehensive vision for stimulating domestic production of medicines, finding global markets, localizing and transferring technologies that would meet competition and market principles (state insurance of export risks, lending for re-equipment of enterprises, determination of stable long-term state order contracts, accelerated depreciation of fixed assets, tax rebates and/or reimbursement of costs related to the implementation of innovations, etc.) with the consideration of Ukraine’s obligations under the WTO and the EU Association Agreement.
  6. Expansion of state programs & instruments for co-payment by the state and citizens of the cost of medical services and medicines, and medical devices, including through reimbursement.

The EBA Health Care Committee invites the Ministry of Health and the National Council for the Recovery of Ukraine to consider these proposals in further work. The Committee is ready to become a platform for joint elaboration of relevant decisions, which should ensure a new level of quality, and accessibility to modern medical care for the citizens of Ukraine.

Glory to Ukraine!

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