Ukrainian pharmaceutical companies and specialized associations sharply criticized the proposed changes to the Licensing Conditions for Manufacturers, Importers and Distributors of Medicines. The draft resolution of the Cabinet of Ministers, published by the State Service of Ukraine for Medicines, has caused serious concern in the business environment, which warns of risks to market stability and patient access to treatment.

The key concern was caused by the proposed paragraph 31-3, which, according to experts from the European Business Association (EBA), actually changes the principles of regulating contractual and commercial relations between market entities. In particular, the document provides for restrictions on sales of medicines: companies that have already purchased 20% of the annual volume of a certain drug will not be able to purchase it anymore without fulfilling additional conditions — even if other buyers do not show interest.

The innovations also oblige companies to publish internal rules for interacting with customers, which actually requires the disclosure of confidential commercial information. It is proposed to entrust the State Medical Service with monitoring compliance with such rules, although previously its powers were limited to technical supervision - product quality, storage conditions and personnel qualifications.

Experts warn of the risk of double regulation. In the event of the implementation of new norms, pharmaceutical companies will find themselves between two fires: on the one hand, the risk of sanctions from the Antimonopoly Committee for violating competition legislation, and on the other - punishment from the State Medical Service for failure to comply with licensing requirements. The worst-case scenario could be the cancellation of the license, which would jeopardize the activities of even large and stable market players.

The business community emphasizes that the implementation of such changes could lead to destabilization of the drug supply system, restriction of competition and deterioration of patients' access to necessary therapy. This may also reduce the investment attractiveness of the industry and cause foreign and Ukrainian manufacturers to withdraw from the Ukrainian market.

The European Business Association, together with a number of leading industry organizations representing over 95% of Ukrainian and international pharmaceutical companies, has already sent an official letter of objections. They also expressed a critical position during specialized meetings. However, according to representatives of the association, these arguments were not taken into account during the public discussion of the project.

Market participants are calling on the government to review the initiative, in particular, to remove paragraph 31-3 from the final version of the document. Business insists that the reform should be based on the principles of transparency, dialogue and balance of interests of the state, industry and consumers.