Apteka.ua, 23.08.2021
The Presidential Decree "On the National Security and Defense Council of Ukraine Decision on the state of the national health system and urgent measures to provide citizens of Ukraine with medical care," dated July 30, 2021, concerns the range of problems in the current health system.
Dmytro Aleshko, Managing Partner at Legal Alliance law firm
The problems set forth in the Decree include the lack of a systematic approach to the reform of the existing system, the lack of a unified medical space, the discrepancy between medical treatment rates and the actual expenses of medical facilities, as well as the lack of a coherent strategy to provide the necessary highly trained professionals to the sector.
Instructions to the Cabinet of Ministers of Ukraine and a number of ministries have been given as possible tools for solving problems. However, it should be noted that a number of tasks fall outside the competence of the Cabinet of Ministers and therefore, amendments to laws will be required.
The Cabinet of Ministers has been instructed, until December 1, 2021, to ensure the elaboration and approval of the Strategic development plan for the public health system until 2030. I believe that this is a real challenge for the government, as in 3 months it is necessary to develop, agree with other ministries and departments, and submit a rather significant document to the Cabinet of Ministers' meeting.
The Decree also envisages the phased inclusion of the cost of centrally procured medicines and medical products in medical treatment rates. In my opinion, this refers to just a part of the medicines that are now being procured under centralized programs, since there are high-priced items for orphan patients that make no sense to give for purchase to medical facilities. One facility, purchasing a small quantity of such medicines, will never receive a price as with centralized procurement through State-owned enterprise "Medical Procurement of Ukraine."
A separate instruction is to define mechanisms for monitoring compliance with national clinical guidelines and standards of medical care, as well as to introduce a vertically integrated system on quality assurance of medical care. I believe that the establishment of a real quality assurance function as a separate agency or within an existing structure is long overdue. In terms of national clinical guidelines, it is difficult to deny the fact that many types of medical care simply do not exist. Perhaps the first instruction should have been to complete the elaboration and approval of such guidelines, and then to monitor their implementation.
The introduction of key performance indicators for public and communal health facilities' heads is well received. In the light of the current conditions, the facility's head shall be, foremost, the competent manager and then the chief physician.
The Decree further addresses issues that relate to establishing a unified medical space. Reading between the lines it is clear that until April 1, 2022, all medical facilities must pay for medical treatment under the medical guarantees program by entering into an agreement with the National Health Service of Ukraine (NHSU). There are no exceptions for the institutes of the Academy of Medical Sciences, departmental institutions of the Ministry of Internal Affairs, the State Security Service of Ukraine, the Ministry of Defense, the Ministry of Transport, and others.
This task will require amendments to relevant codes and laws. In contrast to communal nonprofit enterprises, state-owned enterprises, to which the aforementioned medical facilities will be reorganized, are not exempt from income tax and do not have land tax benefits. Under such conditions, such enterprises would not be able to provide medical care at the NHSU existing rates.
It is necessary to dwell on the instruction to draft regulations aimed at excluding from the powers of central and local executive authorities non-core functions with regard to centralized procurement of medicines and medical products. In fact, this involves the transfer of the procurement of medicines and medical products from ministries and regional health departments to centralized purchasing organizations. It is expected that one such organization could become SOE "Medical Procurement of Ukraine." The Decree makes no mention of the medicine procurement by medical facilities. In addition, the government is mandated to expand the reimbursement program for patients.
The Decree will also apply to graduates of medical universities studying at the expense of budget funds. Those who are sent to rural areas will actually have to work there for three years. It is doubtful that the enforcement mechanism will be effective without creating appropriate working and living conditions in rural areas.
For the first time in recent years, the issue of eliminating informal payments in the health sector has been raised. Meanwhile, for several years in a row, the norm on financing the health system at the level of at least 5% of the gross domestic product, as stipulated by the Law of Ukraine "On state financial guarantees of medical services to the population," is not fulfilled. This norm fulfillment would guarantee a decent salary for health professionals.
In fact, an instruction was given to provide support for bill No. 5547, which proposes to adopt a new version of the Law of Ukraine "On Medicines." Accordingly, a vote in favor of the bill could be expected in the coming months. This also means that at the end of spring, a new single regulatory agency will appear in Ukraine as part of the State Expert Center and the State Service of Ukraine on Medicines and Drugs Control.
The Cabinet of Ministers of Ukraine is expected to submit the bill of Ukraine "On Medical products" until December 15, 2021. As far as known, there is not yet even a crude version of such a bill. Thus, it is unlikely that this instruction will be implemented in such a timeframe.
Special attention should be paid to the introduction of a moratorium until January 1, 2024 on the provision of advertising information on medicines, medical products and methods of prevention in television, radio broadcast and the media. It should be noted that the execution of such instruction will require amendments to the Law of Ukraine "On Advertising." A total ban on advertising, albeit for a certain period, contravenes Directive 2001/83/EC, referred to in another clause of the Decree. Bill No.5547, which is instructed to support this year, contains a complete ban on medicine advertising. It is unclear whether such a ban will be imposed immediately in the future, or whether there will be a certain transitional period.
The Health Ministry of Ukraine has been instructed within one month to ensure that regulations are amended to make it impossible to purchase over-the-counter antibacterial, antiviral and hormonal medicines, immunomodulators in retail. It is likely that such an assignment will require amendments in legislation to lift the moratorium on unscheduled inspections of the State Service of Ukraine on Medicines and Drugs Control. Otherwise, it will be almost impossible to complete such an assignment, given that some 88% of medicines are purchased at patients' out-of-pocket expenses in our country.
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