The EBA Committee warns against insufficiently thought-out steps in the pharmaceutical sector, the stable operation of which affects the health  and quality of life of people, and appeals to the President of Ukraine to veto this draft law and prevent a negative impact on the health of Ukrainian patients,

The EBA notes that the draft law on the regulation of the pharmaceutical market goes against the launched course of implementing European practices and poses a significant threat to the stable functioning of the industry. 

In particular, the adopted draft law, according to the EBA experts, jeopardizes the stable supply of medicines for Ukrainian patients, which was ensured by consolidating the efforts of the state and business during the first months of the full-scale invasion. This, in turn, poses great risks to the ability to provide the necessary treatment to patients.

Unfortunately, the changes directly affect the circulation of medicines and lead to a decrease in their availability for Ukrainian patients. For a number of medicines, manufacturers, importers and distributors will not be able to objectively comply with the proposed requirements, and therefore certain medicines will be gradually withdrawn from circulation. The draft law contains a number of insufficiently developed provisions, the negative impact of which on the supply and, as a result, the availability of medicines for patients is not in doubt among experts.The EBA Healthcare Committee considers it necessary to warn about the destabilization of the pharmaceutical market associated with the adoption of this draft law,

The EBA Health Committee  emphasized that the proposed legislative changes do not bring the current regulation closer to the best standards and will not contribute to lowering the prices of medicines. 

The affordability of medicines is a complex issue that cannot be solved by instruments that artificially restrict the supply of medicines. The changes currently proposed by the draft Law No. 11493, unfortunately, may lead to the effect of physical inaccessibility of medicines for patients rather than improving their affordability,

The European Business Association emphasized that the updated regulation of the pharmaceutical market will have a negative impact on international manufacturers, the main investors in the healthcare sector of Ukraine.

In particular, the EBA explained that the introduction of a “national catalog” of medicines implies the exclusion from sale of those drugs that do not meet price restrictions, creating risks of reducing the availability of international medicines. At the same time, the catalog applies even to drugs that are not funded by the state, which is contrary to European practices. The use of reimbursement mechanisms for medicines could improve their affordability, as it has been the case in the past. 

The introduction of a distribution quota creates risks for international producers that operate under strict quality and safety standards. And limiting the supply and sales margin to 8% may become a barrier for international companies to operate in the Ukrainian market.

In this regard, the EBA called on the President of Ukraine Volodymyr Zelenskyy to veto the law passed by the Rada.

Add

Health Minister Viktor Lyashko does not rule out a possible reduction in the range of medicines in pharmacies after the law comes into force, which may affect the availability of medicines for Ukrainians. 

Recall

President Volodymyr Zelenskyy previously stated that it was necessary to make a decision to reduce drug prices. The pharmacy business supported the President’s statement. He also announced a meeting of the National Security and Defense Council on Wednesday, which will consider the issue of reducing drug prices. 

The Pharmacy Professional Association of Ukraine NGO sent the Ministry of Health of Ukraine a Declaration of Cooperation on Reducing the Cost of Medicines, which has already been signed by a number of large pharmacy chains.

It sets out the following obligations of all market participants:

• National manufacturers of medicinal products reduce the selling prices for their products by a certain percentage compared to the prices as of January 1, 2025. 

• Distributors reduce wholesale prices in proportion to the manufacturer, which will affect the entire logistics network. 

• Pharmacies, for their part, reduce retail prices for medicines, providing the end user with a real reduction in the cost of medicines, i.e., they apply a discount on their margin proportional to the manufacturer. 

The memorandum is expected to be signed by leading Ukrainian manufacturers and distributors.