On June 23, 2021 in the Committee of the Verkhovna Rada of Ukraine on the health of the nation, medical care and medical insurance, a round table was held to discuss problematic issues of the draft law "On Medicinal Products", registered in the Verkhovna Rada of 21.05.2021, No. 5547.
The event was attended by People's Deputies, Chairman of the Subcommittee on Pharmacy and Pharmaceutical Activities of the Committee S. Kuzminykh, Chairman of the Committee M. Radutsky, Deputy Chairman of the State Service of Ukraine for Medicinal funds and drug control V. Korolenko, adviser to the head of the Office of the President of Ukraine M. Pasechnik, representatives of specialized public organizations, industry experts.
Within the framework of the round table, problematic issues of the draft law were discussed, such as:
1. Introduction of a new institution of "brokering in the field of drug circulation". It is assumed that such persons will carry out actions for the sale or purchase of medicines, with the exception of wholesale, subject to the rules of good distribution practice (GDP) of medicines, which is mandatory for wholesalers. In this regard, it is necessary to finalize the provisions on brokering in the field of circulation of medicines, supplementing them with the grounds on which they will carry out their activities (agreement or brokerage deal), and to prescribe in detail the delineation of powers between the concepts of "broker" and "agent".
2. Introduction of Good Pharmacy Practice (GPP). In this matter, the problem lies in the fact that the bill provides for mandatory compliance by pharmacies with the GPP requirements, but in the countries of the European Union, the GPP is a recommendation document. In addition, now this document has not been developed by the Ministry of Health of Ukraine, which makes it impossible to implement it after the entry into force of the law, especially without fail.
3. The need to finalize the conceptual apparatus, in particular, the provision of definitions "manufacturer of medicinal products" and "obligations of the manufacturer to sell medicinal products."
4. The event separately discussed the issue of manufacturing medicines in a pharmacy and creating conditions for such activities, since some provisions of the law simply will not allow the production of medicines in a pharmacy. Specialized public organizations have provided proposals on some exemptions for such medicines, regarding their labeling, accompanying information materials, and the availability of a certificate.
5. Proposals regarding the specifics of licensing of business entities were submitted. In particular, the issue of the right of the state control body to fully or partially suspend or revoke the enterprise's license was very important.
6. The issue of the term for issuing licenses was also discussed. The draft stipulates that the license will be issued within a period not exceeding 90 calendar days from the date the state control body receives an application for a license. However, for now, the term is not spelled out in the law, but in the current Licensing Conditions, where the issuance period is not later than 10 working days. Previously, the deputies noted that it is planned to keep the term for issuing a license exactly in the law, but to reduce it to 30 calendar days for licensees of retail and wholesale trade in medicines, and for manufacturers - to leave up to 90 calendar days.
7. The issues of requirements for distance selling of medicines were also discussed in detail. In particular, the draft law does not refer to the Standard Form of the Agreement between the Licensee and the Postal Operator, which must be approved by a resolution of the Cabinet of Ministers of Ukraine. The absence of this provision will create corruption risks and chaos in the drug delivery market.
According to the results of the round table, the proposals of the participants were taken into account by the people's deputies, the deputies are ready to take into account many proposals when finalizing the law for the second reading if it is adopted in the first reading.