08
Fri, Nov
64 New Articles

Ukraine: From Challenges to Change – Key Healthcare and Life Sciences Developments

Issue 11.7
Tools
Typography
  • Smaller Small Medium Big Bigger
  • Default Helvetica Segoe Georgia Times

Despite the ongoing full-scale invasion by the Russian Federation, the life sciences and healthcare sector in Ukraine is actively evolving to support the well-being of its population.

Under martial law, certain regulatory measures have been simplified to maintain the steady supply of essential goods within the Ukrainian market. These regulatory changes can sometimes affect the business interests of market players, as in the case of the extension of patents until the end of martial law (i.e., without a specific time limit), potentially putting competitors at a disadvantage. Nonetheless, Ukraine remains on a promising path toward advancing its healthcare system, demonstrating resilience and commitment to public health in the face of challenging circumstances.

Healthcare reform in Ukraine is underway, with the objective of establishing an effective and universally accessible healthcare system. Efforts are being directed toward creating a robust network of medical institutions, with substantial investments being made in their modernization and re-profiling. Over the past few years, the state program of medical guarantees (PMG) and the reimbursement system were introduced, and these initiatives are expanding, enabling the population to save significantly on healthcare costs. Areas that were not previously in the spotlight, such as rehabilitation, transplantation, mental health, infertility treatment, blood donation and transfusion, are now receiving significant attention and development. Relevant legislative acts are being adopted to improve the regulation and access to respective treatment and services. Reforming the blood system has become a priority, and efforts are underway to align it with European standards by replacing outdated equipment and strengthening control over blood quality, ensuring that these services meet the highest levels of safety and efficacy.

Looking ahead, there are plans to implement a system of compulsory health insurance. However, given the ongoing full-scale war, determining the exact timeline for this implementation remains challenging.

Another emerging trend is driven by the fact that during Russia’s full-scale invasion of Ukraine, more than 1,500 medical facilities were damaged, and about 200 more were destroyed and cannot be restored. In response, there has been a significant increase in public-private partnership projects aimed at rebuilding Ukraine’s infrastructure and restoring the capacity of the hospital network.

To ensure the population has access to medicines, new supply mechanisms have been introduced. In 2022, Ukraine introduced compassionate use and expanded access mechanisms, significantly expanding patients’ access to unregistered medicines. These mechanisms, widely used in developed countries, are acknowledged as effective tools for expanding treatment options for patients with life-threatening, long-lasting, or seriously debilitating illnesses. Additionally, a procedure for procuring innovative medicines through managed entry agreements was introduced. This allows the Ministry of Health of Ukraine to directly negotiate with manufacturers and obtain them at significantly reduced prices under the condition of price confidentiality. As a result, seriously ill patients gain access to expensive treatments free of charge.

Moreover, to facilitate the treatment of thousands of patients, Ukraine has become the 57th country in the world to legalize medical cannabis.

It is also worth noting that even the clinical trials sector, which is quite vulnerable to military operations, is gradually recovering in Ukraine, and new clinical trials are being launched.

Furthermore, Ukraine is undergoing significant changes in its public procurement system, with one of the notable achievements being the introduction of electronic catalogs for the procurement of medicines and medical devices. According to recent data, this tool has proven to be highly effective, enabling hospitals to achieve savings of more than 20% on procurement costs.

Another development involves licensed entities being allowed to sell medicines online, except for certain categories such as those containing narcotic or potent substances.

As part of Ukraine’s digitalization efforts, the comprehensive electronic healthcare system e-Health was introduced to automate the management of medical information in an electronic format. To this end, Ukraine is gradually transitioning to electronic prescriptions for all prescription medicines (although paper prescriptions remain an option during martial law).

Telemedicine is also rapidly advancing in Ukraine: 328 healthcare facilities have already been connected to telemedicine services, virtual operating rooms have already been installed in two hospitals, and 31 out of 41 healthcare packages within the PMG include telemedicine services.

The area of medical devices is also advancing, with ongoing efforts to develop and adopt the draft law On Medical Devices and updated versions of relevant technical regulations aligned with EU standards.

In summary, despite the challenges of martial law, Ukraine is vigorously striving to restore and enhance its healthcare system, as the well-being of the population is definitely the driving force behind all transformations.

By Lana Sinichkina, Partner, Arzinger

This article was originally published in Issue 11.7 of the CEE Legal Matters Magazine. If you would like to receive a hard copy of the magazine, you can subscribe here.