New regulatory changes may restrict access to medicines in Ukraine - American Chamber of Commerce

The law No. 11493 on the regulation of the pharmaceutical market adopted by the Verkhovna Rada restricts competition and access to medicines, reduces the investment attractiveness of the Ukrainian pharmaceutical sector and creates risks to the stability of the health care system. This is the warning of the American Chamber of Commerce in Ukraine, UNN reports.

The member companies of the American Chamber of Commerce in Ukraine welcome the initiatives aimed at ensuring the affordability of medicines for the population. At the same time, companies believethat the adopted changes will have the following negative consequences:

• Undermining the transparency and predictability of regulatory policy, which contradicts international standards and creates significant risks for the sustainable functioning of the pharmaceutical market.
• Violation of the legislative procedure, as the amendments do not correspond to the subject matter of the original draft law, which is a gross violation of the Rules of Procedure of the Verkhovna Rada of Ukraine.
• Negative impact on competition and the possibility of uninterrupted supply of medicines from international manufacturers to Ukraine, which may lead to artificial restrictions on access to medicines necessary for the treatment of patients.
• Decrease in investment attractiveness of Ukraine in the pharmaceutical sector due to unpredictable regulatory changes, which may lead to a reduction in tax revenues and a decrease in the range of available medicines.
• Increased risks to the stability of the healthcare system due to the lack of proper assessment of the consequences of the proposed changes and their impact on the availability of medicines for patients.

In this regard, the Chamber recommends that in case of changes in the pharmaceutical market regulation, a transition period of at least one year should be introduced to allow the pharmaceutical market to adapt to the new requirements. This will help avoid potential disruptions in the supply of medicines and negative impact on patients.

The American Chamber of Commerce calls for an open dialog between the government, business and the expert community. The companies emphasize that only joint work will help find balanced solutions to regulate the pharmaceutical market and protect the interests of patients.

Recall

The Verkhovna Rada passed in the second reading the draft law No. 11493 on the regulation of the pharmaceutical market. In particular, one of the provisions is the establishment of a margin limit of 8% for distributors and representative offices of foreign pharmaceutical companies.

The European Business Association urged the President of Ukraine to veto the draft law passed by the parliament due to concerns that the innovations could negatively affect the health of patients.

Add

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