Chaos and uncertainty: how foreign pharmaceutical companies are reacting to regulatory changes in Ukraine

Some representative offices of foreign pharmaceutical companies are considering scenarios for reducing activity or even withdrawing from the Ukrainian market after the introduction of new regulations, in particular due to restrictions on markups and changes in distribution. This is evidenced by the comments of market participants, which were collected by UNN.

Details

Earlier, in a comment to UNN, anesthesiologist Ivan Chernenko noted that due to unclear and unfavorable conditions created as a result of the regulation of the pharmaceutical market, some international pharmaceutical companies are already preparing to reduce their presence in Ukraine. He expressed concern that this could jeopardize the provision of hospitals with quality medicines.

UNN contacted representatives of foreign pharmaceutical companies to find out if some of them are really considering curtailing business or reducing activity in Ukraine.

Oleksandr Shalunov, head of Unipharm-Ukraine LLC, noted that the pharmaceutical market in Ukraine began to be regulated from four sides - the introduction of a national price catalog, a ban on marketing bonuses, regulation of distribution (to reduce the influence of large distributors) and restrictions on trade margins.

Today, all these four points put a lot of pressure on the entire market, on all participants. And there are no final decisions on any of these points - only draft resolutions that change every day. There are no final bylaws. Uncertainty on these points creates chaos. I cannot say how the situation will develop further. But one of the scenarios that the company's representative office is considering is reducing activities and presence in the market. This is not said openly, but these scenarios are being considered

At the same time, some foreign players maintain a restrained position. Haleon Ukraine LLC indicated that they are currently operating as usual, but are monitoring developments.

We do not know what the plans of other companies are. Regulation is really changing now, new rules are being introduced, but not all details are known yet. We are monitoring the situation and working as usual

Roche Ukraine stated that they do not plan to reduce or curtail their activities in Ukraine, but expressed concern about the introduction of certain aspects of regulation.

New regulatory changes are an important step towards expanding patients' access to modern treatment and harmonizing national legislation with European approaches. At the same time, it is important to avoid interruptions in the supply of medicines, as patients should receive therapy continuously. Some concern is caused by the short time frame for the implementation of certain provisions, in particular the mandatory submission of price declarations within 10 days for more than 1,000 items. Due to technical limitations and the declaration process has not yet been established, there is a risk of delays and, accordingly, limited access of patients to medicines

Let us remind you

Resolution of the Cabinet of Ministers of Ukraine No. 168 of February 14, 2025 provides new rules for regulating the pharmaceutical market. In particular, restrictions were introduced on markups on supply and marketing and retail allowances for all medicines, and not only for certain categories. In addition, the resolution prohibits retailers from entering into marketing agreements with pharmaceutical manufacturers, which allowed pharmacies to provide discounts to patients, implement social projects and train pharmacists.

The purpose of the resolution was to reduce prices for medicines and increase their availability to the population. At the same time, patient organizations warned that excessive regulation could lead to a shortage of medicines, the closure of pharmacies in small towns and villages, as well as the termination of social programs to support patients.

As UNN reported, despite the fact that this resolution of the Cabinet of Ministers is regulatory, it did not undergo their expertise. They emphasized that this is a violation of the Law on Regulatory Policy. The Ministry of Justice and the Verkhovna Rada Commissioner for Human Rights also did not provide their conclusions to the draft resolution. In particular, Ombudsman Dmytro Lubinets appealed to the Ministry of Health and the regulatory service due to the risks of closing pharmacies in villages and small towns.