New State Regulatory Body in Pharmaceuticals to Be Financed Through Public-Private Partnership: What Ukrainians Need to Know
A new state regulatory authority in the healthcare and pharmaceutical sectors is on the horizon, aiming to align Ukraine’s standards with those of the European Union and to ensure a transparent and stable framework for the drug market.
According to Deputy Minister of Health Marina Slobodnichenko, the funding for this body will be a mixed model: approximately 30% of its expenses will come from the national budget, while the remaining 70% will be covered by fees and contributions from industry representatives engaged in the pharmaceutical sector.
This practice has already been successfully implemented in European countries such as Sweden, Denmark, and the Baltic states, demonstrating its effectiveness in providing accountability and financial stability.
The deputy minister highlighted that market participants will be required to pay annual fees to cover activities related to state oversight, including manufacturers, wholesale distributors, importers, pharmacies, and registration authorities.
Additionally, there will be obligatory yearly contributions for pharmacovigilance activities and for using personal accounts in a dedicated database.
Registrants will also incur fees for the state registration of medicines.
These diversified funding sources are expected to make the new regulatory body more flexible and ensure its operational stability and independence.
In addition to establishing the new regulatory framework, Ukraine is working on legislative amendments to meet EU standards—specifically, revisions to the law “On Medicinal Products.” This will facilitate greater compliance with European practices and accelerate Ukraine’s integration into the EU’s regulatory space.
Results of the Twinning project competition organized by the European Commission are anticipated in September, with the winner country’s experts assisting Ukraine in developing institutional capacities for the regulatory authority over the next one and a half years.
They will support drafting regulations, creating organizational models, and training personnel.
The deputy minister also mentioned ongoing plans to finalize the fee structures for the market participants, which is crucial for the system’s sustainability.
Furthermore, the government intends to expand the “Affordable Medicines” program by including new medications for oncology patients and pregnant women.
From August 2025, drugs for treating anemia in pregnant women—such as iron supplements and folic acid—will become available under the program.
Creating an effective, transparent, and EU-aligned regulatory body will be a significant step forward in modernizing Ukraine’s pharmaceutical industry, improving drug quality, and ensuring objective control over compliance with international standards.