Business, with support from the Ministry of Health, requests changes to avoid shortages of medicines

14/ 11/ 2024

On 6 November, representatives from the European Business Associations Health Сare Committee met with the Ministry of Health of Ukraine, the State Expert Centre, and the State Service of Ukraine on Medicines and Drugs Control. The participants discussed new labelling rules for the secondary packaging of medicines, which will come into effect in mid-January 2025 under Law No. 3910-IX. This law, passed by the Verkhovna Rada of Ukraine, prohibits any advertising information or details about entities other than the manufacturer or the holder of the medicine’s registration on the packaging. While business supports the changes introduced by the Law, it requests a sufficient transition period to allow medicine packaging to comply with the new requirements. Although the law has been in effect since 18 September, its requirements will become mandatory on 18 January 2025, giving manufacturers only four months to update packaging. Otherwise, medicines with non-compliant labelling will be subject to disposal. Since production continued up to the law’s adoption, and considering that large volumes of medicines are already in circulation or storage, this could lead to the destruction of quality medicines, ultimately affecting Ukrainian patients. According to Committee member companies, more than 300 medicines may face circulation bans, potentially causing shortages in pharmacies. Given that around 100 of these medicines are part of the “Affordable Medicines” programme, this could primarily impact the most vulnerable populations. Therefore, the business community finds it essential to bring this issue to the Governments attention to prevent adverse effects on patients access to medicines. Committee Manager Olena Sytenok also highlighted the need for information on the manufacturer and applicant to be included on the packaging when they are operating under a licensed contract, as well as the possibility of including product information fully aligned with the medicinal product’s instructions. Ensuring continuous medicine supply also requires a clear understanding of the terminology defined in the Law, specifically the interpretation of “advertising information,” an issue the Committee has already raised with the Ministry of Health and the State Medicines Service. During the meeting, Deputy Minister Edem Adamanov announced that clarification on this matter would be provided as soon as possible. The Committee expresses sincere gratitude to Mr. Adamanov for his willingness to meet patients’ needs and his constructive dialogue. The European Business Association looks forward to continued cooperation and the Ministry of Health’s support in resolving this issue, recognising its significance and urgency for the industry.

On 6 November, representatives from the European Business Association’s Health Сare Committee met with the Ministry of Health of Ukraine, the State Expert Centre, and the State Service of Ukraine on Medicines and Drugs Control. The participants discussed new labelling rules for the secondary packaging of medicines, which will come into effect in mid-January 2025 under Law No. 3910-IX. This law, passed by the Verkhovna Rada of Ukraine, prohibits any advertising information or details about entities other than the manufacturer or the holder of the medicine’s registration on the packaging.

While business supports the changes introduced by the Law, it requests a sufficient transition period to allow medicine packaging to comply with the new requirements. Although the law has been in effect since 18 September, its requirements will become mandatory on 18 January 2025, giving manufacturers only four months to update packaging. Otherwise, medicines with non-compliant labelling will be subject to disposal. Since production continued up to the law’s adoption, and considering that large volumes of medicines are already in circulation or storage, this could lead to the destruction of quality medicines, ultimately affecting Ukrainian patients.

According to Committee member companies, more than 300 medicines may face circulation bans, potentially causing shortages in pharmacies. Given that around 100 of these medicines are part of the “Affordable Medicines” programme, this could primarily impact the most vulnerable populations. Therefore, the business community finds it essential to bring this issue to the Government’s attention to prevent adverse effects on patients’ access to medicines.

Committee Manager Olena Sytenok also highlighted the need for information on the manufacturer and applicant to be included on the packaging when they are operating under a licensed contract, as well as the possibility of including product information fully aligned with the medicinal product’s instructions.

Ensuring continuous medicine supply also requires a clear understanding of the terminology defined in the Law, specifically the interpretation of “advertising information,” an issue the Committee has already raised with the Ministry of Health and the State Medicines Service. During the meeting, Deputy Minister Edem Adamanov announced that clarification on this matter would be provided as soon as possible.

The Committee expresses sincere gratitude to Mr. Adamanov for his willingness to meet patients’ needs and his constructive dialogue. The European Business Association looks forward to continued cooperation and the Ministry of Health’s support in resolving this issue, recognising its significance and urgency for the industry.