Medicines procurement under the medical guarantee program may be suspended in 2021

04/ 12/ 2020

The existence of a legislative conflict and the lack of timely amendments to the legislation may lead to the unavailability in 2021 of certain drugs that should be guaranteed by the state in terms of medical care under the program of medical guarantees (PMG). On December 3, 2020, the European Business Association appealed to the heads of the Ministry of Health of Ukraine, the National Health Insurance Fund, and the Verkhovna Rada Committee on Public Health, Medical Assistance, and Medical Insurance to prevent the problem. Unfortunately, today there is no clear understanding of the procedure for purchasing drugs outside the National List of Health Care Institutions. However, such drugs are needed within the PMG for both 2020 and 2021 and due to the unclarity of some legislative changes for 2021, there are doubts about the possibility of timely provision of medicines to the population. This situation is also the cause of some uncertainty among pharmaceutical companies, as it is more difficult to plan the supply of drugs for PMG as 2021 approaches. Several factors contribute to the overall risk situation. First, on January 1, 2021, the previously postponed provision of the Law on PMG, which provides for the possibility of centralized procurement of drugs outside the National List, is terminated. Certain drugs have been used within PMG, so to make those drugs more available, the relevant provision of the Law (Article 10, Part 10) was postponed. Will the postponement still last after January 1, 2021? This issue has not yet been discussed publicly and has not been implemented in legislation. Secondly, the draft Nomenclature-2021, submitted to the Ministry of Health of Ukraine for public discussion, did not contain certain drugs that were previously purchased centrally (including in 2020). Also, these drugs are currently absent from the National List. Thus, if the Nomenclature-2021 will not include certain drugs that are needed within the PMG - their purchase will be possible only by the health care facilities themselves or through regional programs. However, there is a collision regarding the purchase of medicines by health care facilities. This leads to the third reason - the lack of a provision in the legislation that would regulate the possibility of purchasing drugs by health care facilities outside the National List to provide services under PMG. Thus, the current situation does not allow manufacturers to effectively plan their activities in Ukraine for 2021 in various therapeutic areas, nor help health facilities to proactively prepare for the provision of medical care under various PMG service packages. If we add a fourth factor to the unresolved legislative issues, namely uncertainty about the budget, which will be finally approved in 2021 for PMG, then the situation looks even more unpredictable for all parties. Given this situation, the EBA Health Care Committee has proposed a comprehensive solution to these problems - by January 1, 2021, to initiate and make the following two changes in the legislation of Ukraine. First is to extend the entry into force of Part 10 of Article 10 of the Law of Ukraine On State Financial Guarantees of Medical Care for the period until the development and implementation of a new positive list of drugs to replace the current National List (so that all necessary drugs were included in the list). The second is to supplement the CMU Resolution №333 of March 25, 2009, with an additional case not covered by this Resolution, namely for drugs purchased under PMG (so that procurement can be done not only within the National List before its update). The European Business Association calls on the Verkhovna Rada Committee, the Ministry of Health of Ukraine, and the National Health Service of Ukraine to consider this situation as soon as possible. It is necessary to prevent problems with the provision of medical care in 2021, which will be guaranteed by the state following the program of medical guarantees.

On December 3, 2020, the European Business Association appealed to the heads of the Ministry of Health of Ukraine, the National Health Insurance Fund, and the Verkhovna Rada Committee on Public Health, Medical Assistance, and Medical Insurance to prevent the problem.

Unfortunately, today there is no clear understanding of the procedure for purchasing drugs outside the National List of Health Care Institutions. However, such drugs are needed within the PMG for both 2020 and 2021 and due to the unclarity of some legislative changes for 2021, there are doubts about the possibility of timely provision of medicines to the population. This situation is also the cause of some uncertainty among pharmaceutical companies, as it is more difficult to plan the supply of drugs for PMG as 2021 approaches. Several factors contribute to the overall risk situation.

First, on January 1, 2021, the previously postponed provision of the Law on PMG, which provides for the possibility of centralized procurement of drugs outside the National List, is terminated. Certain drugs have been used within PMG, so to make those drugs more available, the relevant provision of the Law (Article 10, Part 10) was postponed. Will the postponement still last after January 1, 2021? This issue has not yet been discussed publicly and has not been implemented in legislation.

Secondly, the draft Nomenclature-2021, submitted to the Ministry of Health of Ukraine for public discussion, did not contain certain drugs that were previously purchased centrally (including in 2020). Also, these drugs are currently absent from the National List. Thus, if the Nomenclature-2021 will not include certain drugs that are needed within the PMG – their purchase will be possible only by the health care facilities themselves or through regional programs.

However, there is a collision regarding the purchase of medicines by health care facilities. This leads to the third reason – the lack of a provision in the legislation that would regulate the possibility of purchasing drugs by health care facilities outside the National List to provide services under PMG.

Thus, the current situation does not allow manufacturers to effectively plan their activities in Ukraine for 2021 in various therapeutic areas, nor help health facilities to proactively prepare for the provision of medical care under various PMG service packages. If we add a fourth factor to the unresolved legislative issues, namely uncertainty about the budget, which will be finally approved in 2021 for PMG, then the situation looks even more unpredictable for all parties.

Given this situation, the EBA Health Care Committee has proposed a comprehensive solution to these problems – by January 1, 2021, to initiate and make the following two changes in the legislation of Ukraine. First is to extend the entry into force of Part 10 of Article 10 of the Law of Ukraine “On State Financial Guarantees of Medical Care” for the period until the development and implementation of a new positive list of drugs to replace the current National List (so that all necessary drugs were included in the list). The second is to supplement the CMU Resolution №333 of March 25, 2009, with an additional case not covered by this Resolution, namely for drugs purchased under PMG (so that procurement can be done not only within the National List before its update).

The European Business Association calls on the Verkhovna Rada Committee, the Ministry of Health of Ukraine, and the National Health Service of Ukraine to consider this situation as soon as possible. It is necessary to prevent problems with the provision of medical care in 2021, which will be guaranteed by the state following the program of medical guarantees.