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Business has proposed its vision for the National Health Strategy 2030

09/ 11/ 2021
  Following the decision of the National Security and Defense Council of Ukraine, the Ministry of Health has begun work on the formation of the Strategy for Health Care Development 2030. The European Business Association calls on the Ministry of Health to develop a strategic vision in a thorough, professional, and cohesive manner. Such a document should identify ways for the development of healthcare, including the pharmaceutical sector, for the next decade. Moreover, the document should be implemented upon its adoption. Meanwhile, the Strategy is not the only document, it is followed by the adoption of relevant regulatory acts and management decisions. Therefore, it is necessary to involve a wide range of representatives of the professional community - so that the decisions come out practical and not detached from reality. Besides, work on the Strategy cannot be rushed but requires sufficient time for full expert and public discussion, as well as careful drafting of the final text, which is unlikely to be done by December 1, 2021, as currently defined. At the same time, it is crucial to adhere to the principles of publicity, efficiency, balance, and consider the views of patients, manufacturers, doctors, experienced managers, and experts from relevant associations. Unfortunately, previous attempts to create a strategic document have not been successful. The previous National Strategy for Health Care Reform in Ukraine 2015-2020 remained an unapproved project. Subsequently, the State Strategy 2025 for the implementation of the state policy of the medicine provision for the public was approved in 2018. However, it works in isolation - as it has a reference to the Action Plan developed by the previous Government that ceased to exist. Unfortunately, the analysis and public information on the implementation of the action plan has not been carried out. Given this “legacy”, the business decided to prepare its own strategic vision. On March 11, 2021, the European Business Association presented the EBA Guide to Reforms 2030 - a comprehensive strategic document in which business envisions the necessary reforms for the next 10 years. There was a separate block covering the medical and pharmaceutical industries. Besides, the EBA representatives were actively involved in the development of the National Economic Strategy 2030, approved by the Cabinet of Ministers of Ukraine, which also contains detailed measures of the state in the medical and pharmaceutical spheres. Based on these documents, the EBA proposes to take into account the following conceptual provisions for the future Strategy: 1. Full and gradual integration of the medical and pharmaceutical spheres into the EU market in terms of regulation. In this sense, we propose to consider Ukraine as an integral part of the EU ecosystem, which is formed within the framework of the Pharmaceutical Strategy for Europe. 2. Final confirmation of a single model for the state financing of the health care system, public explanation of the content and basic components of the chosen model, and its purposeful implementation without attempts from various government agencies to deviate. Those separate opinions from authorities only hinder the development of the spheres. Also, it is necessary to create incentives for private insurance as an additional tool, for example, with tax rebates. 3. Strategic prioritization of medical innovations by the state, introduction of new mechanisms of access to innovations that already exist in developed countries. Development of an action plan to stimulate clinical trials in Ukraine in terms of the R&D field and direct access of patients to the latest developments. Development of the biopharmaceutical industry (including the provision of vaccines). 4. Expansion of the state programs and instruments of co-payment (including reimbursement) of the cost of medical services, medicines, medical devices by the state and citizens. 5. Introduction of mechanisms to stimulate domestic production of medicines, localization, and transfer of technologies that would meet market competitiveness principles (state insurance of export risks, loans for re-equipment of companies, determination of stable long-term state order, accelerated depreciation of fixed assets, etc.), taking into account Ukraine’s obligations to the WTO and the Association with the EU. 6. Digitalization of the industry with the world’s standard tools (eHealth, eCTD, ePrescription, electronic registers) and the latest technologies (telesurgery, the use of artificial intelligence in disease prevention, diagnosis, and treatment, etc); 7. Establishment of a system of control over the effectiveness and quality of health care in Ukraine. 8. Conclusion with the EU of the Agreement on Conformity Assessment and Acceptance of Industrial Products (ACAA Agreement) for medical devices and GMP certification for medicines. 9. Guarantee of the legal protection of all objects of intellectual property that are novel, involve an inventive step, and are industrially applicable. 10. Approximation of Ukraines membership in the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). 11. Reorientation of the state control function on fight against falsification, illegal or uncontrolled circulation of medical products, gray imports in the pharmaceutical sphere. The EBA Health Care Committee is ready to become a platform for a broad professional discussion of the draft Strategy. Therefore, we hope for constructive cooperation with the Ministry of Health of Ukraine for us to achieve a common goal – to develop a quality Health Development Strategy 2030, as well as its further practical implementation, which should significantly improve access to modern and effective health care for Ukrainian citizens.

Following the decision of the National Security and Defense Council of Ukraine, the Ministry of Health has begun work on the formation of the Strategy for Health Care Development 2030. The European Business Association calls on the Ministry of Health to develop a strategic vision in a thorough, professional, and cohesive manner. Such a document should identify ways for the development of healthcare, including the pharmaceutical sector, for the next decade. Moreover, the document should be implemented upon its adoption.

Meanwhile, the Strategy is not the only document, it is followed by the adoption of relevant regulatory acts and management decisions. Therefore, it is necessary to involve a wide range of representatives of the professional community – so that the decisions come out practical and not detached from reality. Besides, work on the Strategy cannot be rushed but requires sufficient time for full expert and public discussion, as well as careful drafting of the final text, which is unlikely to be done by December 1, 2021, as currently defined. At the same time, it is crucial to adhere to the principles of publicity, efficiency, balance, and consider the views of patients, manufacturers, doctors, experienced managers, and experts from relevant associations.

Unfortunately, previous attempts to create a “strategic” document have not been successful. The previous National Strategy for Health Care Reform in Ukraine 2015-2020 remained an unapproved project. Subsequently, the State Strategy 2025 for the implementation of the state policy of the medicine provision for the public was approved in 2018. However, it works in isolation – as it has a reference to the Action Plan developed by the previous Government that ceased to exist. Unfortunately, the analysis and public information on the implementation of the action plan has not been carried out.

Given this “legacy”, the business decided to prepare its own strategic vision. On March 11, 2021, the European Business Association presented the EBA Guide to Reforms 2030 – a comprehensive strategic document in which business envisions the necessary reforms for the next 10 years. There was a separate block covering the medical and pharmaceutical industries. Besides, the EBA representatives were actively involved in the development of the National Economic Strategy 2030, approved by the Cabinet of Ministers of Ukraine, which also contains detailed measures of the state in the medical and pharmaceutical spheres.

Based on these documents, the EBA proposes to take into account the following conceptual provisions for the future Strategy:

1. Full and gradual integration of the medical and pharmaceutical spheres into the EU market in terms of regulation. In this sense, we propose to consider Ukraine as an integral part of the “EU ecosystem”, which is formed within the framework of the Pharmaceutical Strategy for Europe.

2. Final confirmation of a single model for the state financing of the health care system, public explanation of the content and basic components of the chosen model, and its purposeful implementation without attempts from various government agencies to deviate. Those “separate opinions” from authorities only hinder the development of the spheres. Also, it is necessary to create incentives for private insurance as an additional tool, for example, with tax rebates.

3. Strategic prioritization of medical innovations by the state, introduction of new mechanisms of access to innovations that already exist in developed countries. Development of an action plan to stimulate clinical trials in Ukraine in terms of the R&D field and direct access of patients to the latest developments. Development of the biopharmaceutical industry (including the provision of vaccines).

4. Expansion of the state programs and instruments of co-payment (including reimbursement) of the cost of medical services, medicines, medical devices by the state and citizens.

5. Introduction of mechanisms to stimulate domestic production of medicines, localization, and transfer of technologies that would meet market competitiveness principles (state insurance of export risks, loans for re-equipment of companies, determination of stable long-term state order, accelerated depreciation of fixed assets, etc.), taking into account Ukraine’s obligations to the WTO and the Association with the EU.

6. Digitalization of the industry with the world’s standard tools (eHealth, eCTD, ePrescription, electronic registers) and the latest technologies (telesurgery, the use of artificial intelligence in disease prevention, diagnosis, and treatment, etc);

7. Establishment of a system of control over the effectiveness and quality of health care in Ukraine.

8. Conclusion with the EU of the Agreement on Conformity Assessment and Acceptance of Industrial Products (ACAA Agreement) for medical devices and GMP certification for medicines.

9. Guarantee of the legal protection of all objects of intellectual property that are novel, involve an inventive step, and are industrially applicable.

10. Approximation of Ukraine’s membership in the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH).

11. Reorientation of the state control function on fight against falsification, illegal or uncontrolled circulation of medical products, “gray” imports in the pharmaceutical sphere.

The EBA Health Care Committee is ready to become a platform for a broad professional discussion of the draft Strategy. Therefore, we hope for constructive cooperation with the Ministry of Health of Ukraine for us to achieve a common goal – to develop a quality Health Development Strategy 2030, as well as its further practical implementation, which should significantly improve access to modern and effective health care for Ukrainian citizens.

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