In response to the official appeal of the State Medical Service to the members of the Public Council under the State Medical Service to submit proposals to the draft resolution of the CMU “On Amendments to the Procedure for State Registration (Re-registration) of Medicinal Products”, which stipulates that the procedure of state registration/re-registration of drugs jointly with the State Enterprise be brought under the competence of the State Medical Service of Ukraine “State Expert Center of the Ministry of Health of Ukraine”, the Association expresses its position on this issue.

The issue of the admission of medicinal products to the market of Ukraine, in particular the state registration of medicinal products, is currently regulated by a number of legal acts. These regulatory documents were developed in accordance with European legislation, and based on the main principles, they repeat the fundamental document regulating the mentioned issues in the European Union – Directive of the European Parliament and the Council of the EU No. 2001/83 EU of November 6, 2001, as amended.

It is worth noting that the product approval system developed over the years in Ukraine is approaching EU standards and is currently the most advanced among the CIS countries. This system is built on the principle of balance and equilibrium, when a number of parties take part in the decision-making process regarding the granting of a permit for the admission of products to the market of Ukraine. The current legislation of Ukraine clearly delimits the powers of regulatory bodies regarding medicinal products:

• The Ministry of Health of Ukraine is the central body of the executive power, which forms the state policy in the field of health care and makes decisions on registration or refusal to register a medicinal product; approves indicators of quality and safety of medicinal products, requirements and conditions of production quality control, preclinical studies of medicinal products and clinical trial programs of medicinal products.
• The State Medical Service of Ukraine ensures the implementation of the state policy in the areas of quality control and safety of medicinal products (it assesses the level of production when making a decision on the registration of medicinal products and ensures the quality control of medicinal products during their admission and circulation on the market of Ukraine).
• The State Expert Center at the Ministry of Health of Ukraine provides independent examination of pharmaceutical products for their admission to the market.

Such a structure allows avoiding monopolization and, as a result, the creation of corruption schemes in this area.

The existing form of the drug registration system is transparent and understandable, as it enables market participants and the public to exercise independent control and monitoring of the authorization process. This is facilitated by the existing mechanisms for the publication of draft orders on the registration of medicinal products, the openness of state registers regarding registered medicinal products and, although often not updated, information on the issuance of certificates of compliance of medicinal products with the requirements of good manufacturing practice in Ukraine.

The role of post-market surveillance and the pharmacosafety system, which is an integral part of the drug registration system, deserves special attention. In accordance with the Order of the Ministry of Health No. 898 “On approval of the Procedure for the supervision of adverse reactions of medicinal products” of December 27, 2006, a system of interaction with medical institutions in Ukraine and the international center in the city of Uppsala (Sweden) was created, which is necessary a condition for compliance with the requirements for the safe consumption of medicines in Europe. Structural changes in this part may have negative consequences on an international scale.

The association considers it reasonable and expedient that, according to the current legislation, the Ministry of Health, which is an executive body that ensures the formation and implementation of state policy in the field of health care, makes a decision on the admission of products to the market of Ukraine. The Ministry of Health is the determining institution responsible for the medical process in the state. Medicines and other products of the pharmaceutical market are, in fact, the main means that practically allow health care workers to perform their functions. That is why medicines approved for use in Ukraine must meet 3 main criteria: quality, safety and effectiveness. These criteria can be ensured by the currently existing balanced system of registration of medicinal products through:

• procedures of independent examination of pharmaceutical products at the stage of admission to the market;
• assessment of production level;
• further monitoring of the circulation of drugs on the market, including the appropriate exchange of information between independent institutions in the system of the Ministry of Health.

Therefore, the separation of the drug registration system from the Ministry of Health and the transfer of relevant competences to another structure carries a number of threats and risks for both market participants and patients:

Threat 1: the concentration of authorization and control functions in one regulatory body creates the basis for the development of corruption schemes;

Threat 2: incompetence of the regulatory body in matters of provision and implementation of the medical process may lead to violations in the system of providing the population with medicines;

Threat 3: violation of the existing structure of the drug registration system can lead to destabilization of the already unstable and extremely sensitive drug market, which, against the background of rising prices and limiting the physical and economic availability of drugs for the population, can lead to a social explosion.

Summarizing the above, we would like to once again draw attention to the fact that the proposed text of changes to the Resolution of the Cabinet of Ministers of Ukraine dated 05/26/2005 No. 376 contradicts the state policy of Ukraine in the field of health care. In view of the arguments listed above, the Association considers it unacceptable to transfer the powers regarding the registration of medicinal products from the Ministry of Health to another regulatory body and considers it expedient in the conditions of political and economic instability to ensure the preservation of the system in its existing form and structure, which, in accordance with European practice, allows to guarantee safe and efficient consumption of medicines in Ukraine.