Unified Pharmaceutical Regulatory Authority: Reform for a Transparent and Safe Medicines Market in Ukraine

The pharmaceutical market in Ukraine has long remained one of the most competitive yet problematic sectors of the economy. On the one hand, it provides millions of citizens with vital medicines, generates significant tax revenues, and integrates into international standards; on the other hand, it is characterized by corruption risks, uneven access to quality drugs, shadow imports, and constant scandals over government procurement. In these circumstances, the idea of creating a unified state regulatory authority in pharmaceuticals, which can ensure market transparency, the control of medical products quality, and consumer rights protection, is becoming increasingly relevant.

Why is a new authority needed?
Today in Ukraine, pharmaceutical market control is exercised by several institutions with partially overlapping powers. In particular, the Ministry of Health shapes policy and issues regulatory documents, the State Service for Medicines and Drug Control inspects the circulation of drugs, while the State Tax Service and customs bodies oversee the financial and customs segment. This fragmentation leads to duplicated functions, blurred accountability, and decision-making delays.

According to civil society organizations, hundreds of cases of counterfeit medicines occur in Ukraine every year. There are also issues with registering new drugs, which often takes years due to bureaucratic barriers and frequent cases of undue benefit requests. EU experience shows: the most effective model is the presence of a dedicated authority responsible for quality control, licensing, market monitoring, and cooperation with international institutions.

Possible functional structure of the new authority
The state pharmaceutical control authority should be granted comprehensive powers for centralized management. Its functions can be divided into several blocks:

• Regulatory block: licensing the activities of pharmacies, distributors, and drug manufacturers; supervision of pharmaceutical companies’ compliance with production standards; approval of drug circulation rules.
• Inspection block: checking the quality of medicinal products at all stages, from import to retail; performing laboratory analyses; monitoring storage and transportation conditions.
• Monitoring block: creating a national database of medicines with information on original and generic drugs; cooperation with customs and law enforcement to detect counterfeits.
• Sanctions block: applying fines, temporary suspension of market actors, revocation of licenses, informing law enforcement about serious violations.
• International coordination: integration into EU systems, cooperation with the European Medicines Agency, adoption of European GMP, GCP and pharmacovigilance standards.

Legislative framework
Launching the new authority requires significant amendments to current legislation. First, a new law “On State Control in Pharmaceuticals” must be adopted to clearly define the authority’s remit, its accountability mechanism to the Cabinet of Ministers, and interaction with other state bodies. Additionally, Ukraine’s “Medicines Act” should be amended to introduce European-style procedures for drug registration, clinical trial oversight, and pharmacovigilance.

A key issue is the accountability and independence of such an authority. If it is merely a Ministry of Health division, there may be risks of political influence and administrative pressure. Therefore, an option is to create a central executive authority with a special status that is guaranteed independence in making regulatory decisions.

Benefits for the state and society
Creating a specialized authority will allow the achievement of several strategic goals:

• Protecting public health: regular oversight will reduce the risk of dangerous or counterfeit drugs entering the market.
• Public trust in healthcare: citizens will be confident that medicines purchased are safe and high-quality.
• Market transparency: eliminating duplication of functions and implementing uniform standards will facilitate business and reduce administrative pressure.
• Harmonization with the EU: implementation of European practices will open opportunities for investment and help Ukrainian manufacturers enter international markets.
• Fighting corruption: standardized procedures and digitalization will reduce opportunities for administrative abuse.

Potential risks
At the same time, establishing such an authority is associated with several challenges. First, there is a risk of bureaucratization; the new structure may duplicate current agencies’ functions if powers are not clearly delineated. Second, creating a modern laboratory base will require significant budgetary spending, and lack of funding may result in the authority’s formal existence only. Third, initial resistance may occur from pharmaceutical companies and certain officials losing control over lucrative flows.

Staffing is also critical – effective operation requires highly qualified specialists in pharmacy, international law, and standardization, who may be lacking in the public sector due to low salaries.

European experience
In the European Union, drug control is exercised by the European Medicines Agency (EMA), which serves as a model for many national systems. It is responsible for the scientific assessment of medicines, post-marketing surveillance, and cooperation with national authorities of member states. Such structures operate in Germany, France, Poland, Italy, providing a full range of oversight functions: from inspections to adverse drug reaction systems.

Ukraine can draw on Poland’s experience, which established the Chief Pharmaceutical Inspectorate – an independent body with wide powers, separate from the Ministry of Health. Centralization enabled Poland to quickly introduce European rules and integrate into the EU’s pharmacovigilance system.

Prospects for Ukraine
Given society’s demand for safe medicines and a transparent pharmaceutical market, establishing a unified control authority appears to be a logical reform step for the healthcare system. This requires political will, dedicated legislation, financial guarantees, and staffing strategy. If these are met, Ukraine will gain a modern state regulatory system capable of reducing corruption, improving citizens’ quality of life, and gradually integrating into European pharma infrastructure.

Ultimately, the new authority may not only become a control tool but also a catalyst for industry development, ensuring a balance between the interests of the state, business, and society.

Author: Ihor Yas’ko, Managing Partner, Law Firm “WINNER”, PhD in Law.