Establishment of the Ukrainian Pharmaceutical Agency continues: Ministry of Health discusses funding model for the new regulator

Deputy Minister of Health of Ukraine for European Integration Maryna Slobodnichenko held a working meeting with representatives of the pharmaceutical industry, sectoral associations and civil society to discuss the establishment of a new state regulator for the pharmaceutical sector – the Ukrainian Pharmaceutical Agency.

The discussion was also attended by Edem Adamanov, Director of the State Expert Centre of the Ministry of Health of Ukraine, along with other representatives of the Centre.

Participants reviewed proposals submitted during the public consultation on the procedure for paying the fees and charges provided for under the Law of Ukraine “On Medicinal Products”. Particular attention was paid to ensuring that the future rules are clear for market participants while providing adequate funding for the work of the new regulator.

Following the meeting, the Ministry of Health agreed to take into account a number of proposals put forward by the industry. In particular, together with the State Expert Centre, it will clarify that pharmacovigilance fees and electronic account usage fees will not apply to active pharmaceutical ingredients (the active substances used to manufacture medicines) or to products in bulk (medicinal products that have not yet undergone final packaging). These fees will apply only to finished medicinal products entered in the State Register of Medicinal Products of Ukraine.

The Ministry also plans to introduce a transitional mechanism for responding to breaches of payment procedures or deadlines. The Ukrainian Pharmaceutical Agency will initially issue a warning and give the payer an opportunity to remedy the breach. Sanctions will be imposed only if the relevant requirements are not met. In addition, the new arrangements will allow payments to be made through an authorised representative.

The Ministry of Health emphasised that consultations with representatives of the pharmaceutical sector will continue in order to resolve a number of outstanding issues. In particular, a separate discussion is planned on the payment of fees by companies operating as a single manufacturing complex but across several locations.

The Ministry will also hold additional consultations with representatives of the pharmacy sector on the future supervisory framework and fee payment arrangements.

Overall, work on refining the future operating model of the Ukrainian Pharmaceutical Agency continues. The process is being carried out in close dialogue with representatives of the pharmaceutical market to ensure that practical proposals from the industry are taken into account and that the new regulator operates under clear and balanced rules.