On May 28, 2024, to discuss one of the most controversial draft amendments to the Licensing conditions on conducting economic activity in medicinal products manufacturing, wholesale and retail trade of medicinal products, import of medicinal products, the State Service on Medicines and Drugs Control invited representatives of the domestic pharmaceutical business and other government agencies to a dialogue.
One of the main issues of pharmaceutical business representatives was the risk of closure of well-known price aggregators (marketplaces) such as tabletki.ua and liki24.com, through which domestic consumers can monitor the availability of medicines in pharmacies and make "reservations" for their subsequent purchase.
In the opinion of some pharmaceutical community representatives, the adoption of the relevant amendments to the License conditions published by the State Service of Ukraine on Medicines and Drugs Control, which should regulate electronic retail trade in medicines, in particular Article 1591, may lead to the closure or significant restriction of the work of well-known price aggregators, which in turn will cause information barriers for pharmaceutical market participants and final consumers and, as a result, will negatively affect the work of many licensees for wholesale and retail trade in medicines.
Roman Isaienko, Head of the SMDC/Ukraine, noted that the development and adoption of the relevant amendments to the License conditions is not intended to impair or restrict the work of any pharmaceutical market operator, including price aggregator companies, for most of which such risks do not exist in general if they provide only information services and do not sell medicines.
The purpose of this project is to prevent unlicensed electronic retail of medicines and relevant violations as it relates to human safety and health, and to streamline the relevant processes in accordance with current legislation and European practices.
At the same time, if some draft amendments raise questions, the State Service of Ukraine on Medicines and Drugs Control is ready to work constructively with stakeholders to resolve controversial issues, clarify terminology and content, and prevent misinterpretation of certain provisions of the License conditions. This is the reason why the procedure for public discussion of draft regulations exists. Therefore, it is advisable to hold an expanded meeting on controversial issues in the near term, to which wholesale and retail licensees representatives will be invited. The jointly developed constructive changes will be included in the draft resolution of the Cabinet of Ministers of Ukraine. If necessary, the issues of determining the timing of the implementation of the draft amendments to the License conditions will be discussed.
During the discussion, it was decided at this stage to focus on jointly solving the following issues:
- to define certain definitions in the draft amendments to the License conditions, in particular, the definition and features of medicines e-retail;
- to define more clearly the mechanism of medicines e-retail by pharmacies that do not have their own websites through the Internet resources of other licensees;
- to clarify which types of activities will be covered by the future regulation and whether information services should be separately specified as an exception to the regulatory impact.
The State Service of Ukraine on Medicines and Drugs Control is open for further joint discussions and consultations.