Pharmaceutical market participants oppose controversial amendments to the bill that could increase medication prices, raising alarms within the industry.

Participants in the pharmaceutical market have actively opposed the controversial amendments to Bill No. 11493 regarding the quota system for drug supplies and the elimination of discounts for pharmacies. They warn of significant negative impacts on the pharmaceutical sector and society at large, including reduced accessibility to medications and substantial price increases. What led to this situation and how catastrophic the consequences could be was explored by UNN.

At the end of November, the Verkhovna Rada adopted Bill No. 11493 on amendments to the Law of Ukraine "On Medicines" in its first reading. Its primary goal is to simplify the registration of medicines for centralized procurement. However, the changes proposed for the second reading have raised serious concerns among pharmacists and relevant associations.

What exactly is being proposed for change:

-         set limits on the volume of drug purchases by a single distributor to no more than 15% of the total volume;

-         create a unified state electronic catalog to manage trade markups, mandating the inclusion of all drugs;

-         establish quotas for the supply of medicines under special conditions;

-         prohibit retail entities from receiving discounts from manufacturers or suppliers of medicines, meaning pharmacies will no longer be able to offer discounts on medications, including to socially vulnerable groups.

Relevant associations have actively protested these innovations and are urging against decisions that could affect the physical availability of medicines, potentially leading to shortages.

Industry experts emphasize that applying the e-catalog to the relationships between manufacturers/importers and pharmacy networks will create additional bureaucracy and may cause delays in drug supplies.

"The electronic catalog is a non-market mechanism for relationships among private business entities. Based on practical experience, the current operation of the e-catalog for drug procurement with budget funds, where changes are made over weeks, raises questions about its efficiency and flexibility for the operational work with over 85% of pharmaceutical products sold in retail without state involvement and budgetary funds," noted the Association of Pharmaceutical Manufacturers of Ukraine.

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The proposal to limit sales of products to a single business entity to 15% raises concerns that pharmacies will not be able to maintain adequate stock of medications, resulting in customers facing artificial shortages. Consequently, chronically ill patients may be forced to seek necessary drugs in other towns, complicating access to essential medicines, especially in frontline areas.

Quota restrictions on the supply of critical medications without considering the specifics of the existing distribution system will also lead to supply chain disruptions and limited access to medical products.

"As we learned, the draft includes a number of specific restrictions that do not take into account the real conditions of business operations in the field of drug circulation, which may negatively impact all participants in the pharmaceutical market. We also consider it unacceptable to allow the import and sale of medicines without proper registration, which could result in the entry of counterfeit and substandard products into the domestic market, potentially harming the end consumer," stated the Union of Employers of the Medical and Microbiological Industries of Ukraine in their appeal to the committee.

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At the same time, the public organization "All-Ukrainian Pharmaceutical Chamber" stated that the process of preparing these changes may exhibit signs of corruption aimed at lobbying the interests of certain pharmaceutical players. They believe that the amendments to the bill will lead to a loss of tax revenues and a significant shadowing of drug supplies.

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At the meeting on December 9, the Committee on Health Issues planned to consider the controversial amendments to Bill No. 11493; however, thanks to the active position of market participants, this issue was postponed. Nonetheless, participants in the pharmaceutical market fear that the postponement was intentional, aiming to "push through" the amendments when the outrage from the professional community subsides and there is little time for comprehensive discussion. According to agency sources, the consideration has been rescheduled for December 19, and the committee meeting might take place in the morning, after which the amendments will be sent directly to the Verkhovna Rada for a vote on the same day.

At this stage, it is crucial for deputies to listen to industry representatives and consider their expert opinions. Ill-conceived changes risk being costly not only for businesses but also for society as a whole. If constructive dialogue between the parties is not established, the consequences could affect every Ukrainian, resulting in job losses, increased drug prices, and a widespread circulation of counterfeit products that are dangerous to life and health.