Business proposes steps to support Ukraine with the necessary pharmaceutical products
Dear President of Ukraine Volodymyr Zelensky, Prime Minister of Ukraine Denys Shmyhal, Chairman of the Verkhovna Rada Committee on Public Health, Medical Care and Health Insurance Mykhailo Radutsky, Minister of Health of Ukraine Viktor Lyashko, Chairman of the State Medical Service Roman Isaenko, Director of the State Enterprise State Expert Center of the MoH Mykhailo Babenko and Acting Head of the State Customs Service of Ukraine Vyacheslav Demchenko.
The European Business Association and its member companies support the measures implemented by You, the Government of Ukraine, and other state officials in the context of armed aggression against Ukraine, ensuring the reliable functioning of critical life support facilities of the country. At the same time, we ask you to pay attention to a range of problematic issues and proposals formulated by the EBA Health Care Committee experts, which are extremely urgent in this situation in terms of the functioning of the pharmaceutical industry of Ukraine and interrupted provision of the citizens of Ukraine with the necessary treatment.
The important thing is to ensure the priority regime of customs clearance and certification of medicines, medical devices, and other pharmaceutical products, regardless of their purpose (including for clinical trials).
1. Given the possibility of panic among the population and the craze of the medicines purchase, pharma manufacturers, and importers, in the current situation, will try to make every effort to meet all demand for these drugs. At the same time, it is necessary to ensure uninterrupted import of medicines and raw materials for their production in Ukraine, which includes the need to avoid queues at customs checkpoints.
Therefore, we ask you to ensure the priority customs clearance of medicines, active pharmaceutical ingredients, medical devices, and other pharmaceutical products by introducing an official “Green Corridor” for these categories of goods.
Besides, we ask you to establish working cooperation on this issue with the customs authorities of neighboring countries, such as Poland, in order to ensure a similar priority of customs clearance of medicines by their customs posts to ensure imports into Ukraine.
2. Given the possible restrictions during martial law, including on the work of state bodies, for the smooth functioning of the pharmaceutical market, as well as the safety of workers in all pharmaceutical industries, including the production, import, distribution, and retail of medicinal products, funds, it is urgent to ensure the work of the State Medical Service on the issuance of relevant permits, conclusions, certificates of other permits in the remote mode. This applies not only to the issuance of such documents but also to the acceptance by the State Medical Service of documents and applications for processing.
To do this, we propose to temporarily introduce the submission of all documents in electronic form (including scanned) through the official e-mail of the State Medical Service. It should be noted that the submission of documents through the “Electronic Cabinet” of the State Medical Service currently works for only a few procedures and is not sufficient in the current situation.
3. A similar proposal to submit scanned documents to official e-mails and ensure full-fledged work remotely applies to all procedures carried out by the State Enterprise “State Expert Center of the Ministry of Health of Ukraine” and directly to the Ministry of Health of Ukraine. Please indicate the e-mail addresses of the relevant departments on the official websites of these bodies and ensure the processing of incoming correspondence from these addresses.
Such proposals are necessary to avoid delays in operational processes, initial and specialized examinations for registration, re-registration of medicinal products and amendments to approved registration materials, approval of clinical trials, and significant amendments to clinical trial materials. Besides, we ask you to speed up the process of reviewing all applications submitted to these bodies for the issuance of permits for the release of products with deviations that do not affect quality, which will also meet the demand for quality and effective drugs and applications for approval of clinical trials/significant amendments.
4. We ask you to temporarily simplify the implementation of regulatory procedures in the pharmaceutical field for medicines, medical devices, and other pharmaceutical products. In particular, to ensure simplified recognition of documents on the conformity of the production of medicinal products with the requirements of Good Manufacturing Practice (GMP) issued by the authorized body of EU member states, Great Britain or countries with mutual recognition agreements with the EU or Ukraine, limited where possible, solely by using information from EudraGMP or the US FDA electronic registry.
5. We propose to automatically extend the validity of all permits/regulatory documents that expire during the period of martial law.
6. We propose to suspend for the duration of the martial law the provision of clause 185 of the Licensing conditions to produce medicinal products, wholesale, and retail trade in medicinal products, import of medicinal products (except for active pharmaceutical ingredients) approved by Cabinet of Ministers Decree No. 929 of 30 November 2016, under which the shelf life of medicinal products imported into Ukraine must be at least half of the period specified by the manufacturer.
Such a restriction is quite critical and results in an unnecessary burden on business activities for the EBA Committee member companies, as part of the necessary range of goods in this situation may be available from a foreign producer or in the country, but due to such restrictions must be withdrawn from circulation. At the same time, the current situation particularly needs the ability to meet critical needs.
7. We propose to improve the financial affordability of medicines for all citizens of Ukraine by abolishing VAT on all medicines and medical devices, including investigational medicines and related materials for clinical trials, which are permitted to be conducted by the Ministry of Health of Ukraine.
8. Please provide recommendations to applicants, sponsors on conducting clinical tests in Ukraine to ensure patient safety.
The EBA asks you to consider the above proposals, which should guarantee the provision of citizens of Ukraine with effective and high-quality medicines, medical devices, and other pharmaceutical products. At the same time, we emphasize that the EBA member companies take all possible measures to support the proper functioning of the pharmaceutical industry of Ukraine and all parts of the circulation of pharmaceutical products for the health and safety of citizens of Ukraine.