Ukraine expands funding for MEAs to enhance patient access to innovative therapies

On 18 June, the Ukrainian parliament adopted Draft Law # 13135, which includes amendments that empower the Medical Procurement of Ukraine (MPU) with diversified funding sources for Managed Entry Agreements (MEAs). These changes secure broader patient access to innovative medicines by pooling state, regional, municipal and public-hospital budgets while formally embedding the Health Technology Assessment (HTA) into primary law.

Additionally, after rigorous parliamentary debates, the Tax Code amendments (Draft Law # 13134) introducing corporate and personal tax exemptions for in-kind transfers of innovative medicines under MEAs were also adopted on 18 June, unlocking immediate fiscal support for public procurement of innovative therapies.

The key takeaways from the newly adopted legislation include the following:  

New funding streams for MEAs

• Multi-level budget pooling: MPU may now combine central, regional, municipal and public-hospital budgets, and partner with state- or commune-owned healthcare entities to finance MEAs.
• Why it matters: By unlocking regional and local funding sources, this approach mitigates pressure on the state budget, already stretched by defence and reconstruction, and provides for the procurement of high-cost innovative therapies.
• Systemic impact:
  • Increased buying power: Larger volumes can be guaranteed when multiple budgets are pooled together and committed.
  • Risk sharing: Regional and local authorities can co-finance therapies that address regional / local health priorities.
  • Price confidentiality: While key MEA contract details (e.g. product names, dosages, durations) are published on the MPU website, public accountability will be ensured, and sensitive pricing and commercial terms will remain confidential.

HTA elevated to primary law

The HTA has long underpinned MEA selections under secondary regulations. The recent amendments codify this prerequisite in the Basic Principles of Health care Law mandating that every MEA decision rests on a formal HTA conclusion aligned with national health care priorities.

Better patient access to innovation

• Broader coverage: Regional and local budget co-funding enables the MPU to extend MEAs to more therapies.
• Regional vs. national funding: The MPU is now authorised to collect funding commitments from interested regional and local governments and sign MEAs for the defined regions.
• Faster roll out: Funding of therapies at the regional and local levels can be secured without waiting for annual state budget allocations.

Tax exemptions

The Tax Code amendments contained in the law provide:

• Corporate profit tax relief: In-kind supplies under MPU-facilitated MEAs are excluded from taxable profits for all recipients (e.g. regional and local governments, public hospitals).
• Personal income tax exemption: The value of free-of-charge medicines provided via MEAs is not included in taxable income for patients.

These exemptions remove tax obstacles and reduce the administrative burden, ensuring that sourced therapies reach public health care institutions intact.

Next steps for innovative pharmaceutical companies

• Engage local partners: Identify regional and local health authorities and public hospitals with budgetary capacity. Propose joint-MEA frameworks that leverage pooled funding and address local treatment gaps.
• Consider collaboration based on pooled-budget proposals: Work closely with the Ministry of Health (MOH), MPU and local stakeholders to structure funding shares, volumes and delivery schedules maximising the impact of a combined budget.
• Consider further HTA submissions: Align your HTA proposals with the new funding opportunities and anticipate updates to the Cabinet Resolution No. 1300 (2020) on HTA procedures.
• Design competitive pricing & supply plans: Consider price-volume agreements that optimise pooled budgets and support both national and regional-local health priorities.
• Monitor subordinate legislation updates: Track expected amendments to Cabinet Resolutions No. 1300 (2020) and No. 61 (2021), which will refine HTA and MEA negotiation procedures.

If you have questions on possible structuring for pooled-budget and regional MEAs or on how to align market-access strategies, contact you CMS client partner or CMS expert: Borys Danevych.