Alexander Yanev, Associate with Legal Alliance Company
The current legislation of Ukraine sets forth that the Ministry of Health of Ukraine (hereinafter referred to as the MOH of Ukraine) may approve the decision on permanent or temporary prohibition of use (part 17 of Article 9 of the Law of Ukraine “On Medicines”).
Moreover, clause 8 of the Procedure for State Registration (Re-Registration) of Medicines approved by Resolution No 376 of the Cabinet of Ministers of Ukraine, dated May 26, 2005 (hereinafter referred to as the Registration Procedure) sets forth that the MOH of Ukraine may approve such a decision under the approved procedure.
Noticeably, there is no such procedure as of today under which the MOH of Ukraine would prohibit the use of medicines through termination of their registration certificates. Thus, if the MOH of Ukraine does approve such decisions on prohibition of use of medicines, there are solid grounds to challenge such decisions due to them being illegitimate.
Thus, the aforementioned Procedure for permanent or temporary prohibition of use of medicines, including medical immunobiological drugs through termination of registration certificate (hereinafter referred to as the Draft Procedure) is being passed in pursuance of the above provisions of the legislation and to ensure systematic and efficient control over the production, import, wholesale and retail trade of medicines.
Let us be reminded, that the currently effective in Ukraine Procedure for Prohibition (Temporary Suspension) and Renewal of Circulation of Medicines on the Territory of Ukraine (hereinafter referred to as the Circulation Prohibition Procedure) was approved by Order No 809 of the Ministry of Health of Ukraine, dated 22.11.2011 and defines the authorities of the State Service of Ukraine for Medicinal Products (hereinafter referred to as the SSMP of Ukraine) related to prohibition of circulation of medicines.
Thus, the key provisions envisaged by the Draft Procedure include:
1. Approval of the Draft Procedure does not envisage termination of the Circulation Prohibition Procedure. That is, two procedures shall be effective simultaneously: one to prohibit circulation of medicines, and the other to prohibit the use of medicines.
Considering the above mentioned, it shall be crucial to clearly distinguish between the authorities of the SSMP of Ukraine and the authorities of the MOH of Ukraine.
Namely, clause 3.2.3 of the Circulation Prohibition Procedure sets forth that one of the reasons to prohibit circulation of a medicine is the evidence of insufficient guaranteed quality of such medicine due to production and / or quality control failures. At the same time, according to clause 2.5 of the Draft Procedure the use of a medicine shall be prohibited, among other reasons, if the Applicant throughout the effectiveness of the registration certificate for the medicine has not taken the measures to guarantee efficacy, safety, and quality of the registered medicine, to improve the scientific and technological level of production and quality assurance through implementation of scientific methods available in Ukraine in its technology and quality control with respect to the registered medicine.
The similarity of the above provisions may potentially result in both the SSMP of Ukraine and the MOH of Ukraine exercising their respective authorities.
2. The Draft Procedure provides for the sustainable conclusion and recommendations on behalf of the State Expert Center of the MOH of Ukraine (hereinafter referred to as the Center) to serve as basis for permanent or temporary prohibition of use of medicines, including MID through termination of their respective registration certificates.
Such a sustainable conclusion of the Center shall refer to cause-and-effect relation between the identified violations or potential previously unknown characteristics of the medicine.
In this context it is important to establish the criteria based on which the Centre shall execute its conclusion related to temporary or permanent prohibition of use. Lack of such criteria may lead to arbitrary decisions on permanent prohibition of use of medicines through termination of registration certificates.
3. The Procedure to a certain extent details the instances for initiation of the prohibition procedure with respect to the use of medicines, including MID through termination of registration certificates and listed in clause 8 of the Procedure for Registration of Medicines. Such a detalization is aimed to reduce the incidents of too broad of interpretation of the respective provisions.
4. According to the Draft Procedure, if the MOH of Ukraine approves the decision on temporary or permanent prohibition of use of a medicine, the respective entry shall be made in the State Register of Medicines of Ukraine (hereinafter referred to as the Register). However, currently the Register lacks the column for such entries, thus, respectively, requires respective amendments to be made thereto.
At the same time it ought to be noted that the Draft Procedure overall requires significant improvements and, in particular, with respect to the following:
The aforementioned comments at the very least would provide for clear, decisive, and transparent application of prohibition of use of medicines, including MID. However, without the pro-active stand on behalf of the pharmaceutical sector operators and the engagement of the community these issues shall not be resolved.
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