Legal reforms toward greater patient access to essential medicines. SAFEMed Technical Brief

May 2025

Source: https://msh.org/wp-content/uploads/2025/06/Technic...

About SAFEMed

Improving access to safe and affordable medicines for the Ukrainian population is one of the Government of Ukraine's top priorities, with ambitious health reforms underway to ensure that access. The United States Agency for International Development (USAID) Safe, Affordable, and effective medicines for Ukrainians (SAFEMed) Activity (2017-2025) is supporting this effort by appIying health system strengthening best practices and evidence-based interventions that institutionalize rational medicine selection; systematize public procurement of pharmaceuticals and commodities; support sustainable

public-sector pharmaceutical financing; and strengthen the pharmaceutical supply chain in collaboration with the government, civil society, and the private sector. SAFEMed is managed by Management Sciences for Health. LA Law Company (LA Law Firm) a Ukrainian firm, serves as the technical lead for legal support.

BACKGROUND

Over the last decade, the Government of Ukraine (GOU) has been on a journey of reforming its health sector, with critical advances achieved in making health services and medicines more affordable and accessible. Well-elaborated laws, policies, and regulations based on sound evidence and broad-based consultation serve as the foundation of these reforms. For these reasons, as the key GOU technical support project in the pharmaceutical sector, SAFEMed and its partners focus on advancing Ukraine's legal and regulatory reforms, through analyzing policy options, drafting legal acts, facilitating stakeholder dialogue and broad-based review of policies, and supporting their implementation.

Health reforms in Ukraine face several obstacles. Stakeholders often have differing perspectives on priorities and limited awareness and information regarding policy options and successful examples from other countries with similar objectives to increase access and affordability. Political instability, leading to frequent changes in the leadership of the Ministry of Health of Ukraine (MOH) and its subordinated technical agencies, slow regulatory reforms.

Further, the COVID- 19 pandemic and then the February 2022 Russian invasion of Ukraine and the necessary institution of martial law hindered some reform processes while also serving as catalyst to other reform efforts that had previously been stalled.

UKRAINIAN LEGAL CONTEXT

Over time, Ukraine has made progress in aligning its pharmaceutical legislation with international best practice. The work in legal reforms continues. Updated laws and regulations are needed to address gaps, further clarify inconsistencies, and address evolving challenges. The following key milestones achieved in the last five years lay the foundation for addressing these gaps and further advancing health sector reforms:

• The successful adoption on July 28, 2022 by the Verkhovna Rada (the Ukrainian Parliamentary body), of the new law on medicinal products, set to take effect 30 months after the end of martial law', outlines an ambitious agenda of reforms, many of which SAFEMed advocated for over the previous five years as well as those currently underway and further described below.
• The granting of Ukraine candidate status by the European Union* in June 2022 cleared the way to start formal negotiations as a member state. Gaining this status renewed the push to advance health sector regulatory reforms. As a result, many stakeholders, including Parliament, the Cabinet of Ministers of Ukraine (CMU), MOH, pharmaceutical industry, patient organizations, and others, committed to aligning Ukrainian institutions and regulations with the rest of Europe and beyond.
• Continuous GOU-approved increases in the national state budget for health and associated reforms as well as improving efficient use of available funds. The budget for health nearly doubled from 2017 ( 112 B UAH/equivalent 4.8 M USD) to 2022 (200 B UAH/equivalent 6.66 M USD).The exchange rate of the hryvnia against the dollar has changed over time, increasing by I .5 times due to the war processes. At the beginning of the project in 2017, the rate was 27.8 UAH/USD due to the economic impacts of the war. By 2025, it had already risen to 4 I .7 UAH/USD. This explains the more modest increase in the budget in dollar terms compared to the more significant growth reflected in UAH. Further, the impacts of the war resulted in a drop in the amount of the overall state budget dedicated to health from 2024 to 2025, although investments in flagship medicine programs such as the Affordable Medicines Program (AMP) and the state procurement body, Medical Procurement of Ukraine (MPU) grew in 2023 and 2025.

***

The full Technical Brief is available in the attached files in both English and Ukrainian.

The legal team from LA Law Firm provided legal support for the project implementation, working under the guidance of managing partner Dmytro Aleshko.

***

More about the project results:

https://msh.org/projects/safe-affordable-and-effective-medicines-for-ukrainians/