Ukraine adopts MEAs for funding innovative medicines, biologicals and, vaccines and introduces HTA procedures

Following the Ukrainian parliament's adoption of legislation for the introduction of managed entry agreements (MEAs) early last year, the Cabinet of Ministers of Ukraine (CMU) adopted regulations in December and January enabling the full application in practice of both MEAs and health technology assessments (HTAs).

The HTA regulation (Resolution of the CMU No. 1300, 2020) does the following:

• establishes the independent HTA agency while authorising the regulatory body under the Ministry of Health (MOH) to temporary perform HTA function;
• sets down detailed HTA procedures for medicines (including fast-track and regular assessments);
• Mandates the launch of HTAs for medical devices in 2022.

The MEA regulation (Resolution of the CMU No. 61, 2021) sets down detailed requirements on negotiating, concluding, executing, prolonging, amending and terminating MEAs, and includes a template MEA. Below is the summary of the new Resolution:

Scope, MEA types, possible MEA parties

• MEA applicability is limited to the centralised procurement of innovative medicines, biologicals, and vaccines.
• The legislation allows finance-based (i.e. cost-sharing), outcome-based (i.e. risk-sharing) and mixed types of MEAs. Parties to a MEA can include the MOH or the Central Procurement Agency that is subordinated to MOH on one side, and the market authorisation holder (MAH) for the medicine in Ukraine or the MAH's representative on the other side.

Term of validity

• A MEA may be initially concluded for one calendar year and extended annually for up to three calendar years in total.
• Authorisation of a generic/biosimilar in Ukraine will trigger MEA termination on the last day of the calendar year.

HTA and negotiations

• A positive HTA decision is a prerequisite for a MEA.
• The MOH, MAH or the MAH representative can initiate a MEA negotiation where a designated negotiation group represents the MOH. All group members must accept non-disclosure obligations and declare the absence of conflict of interest.

MEA template

The regulation includes a template MEA for use by the parties. In addition to general terms and conditions, this template includes shipment conditions, rules for acceptance and payment for goods, quality requirements, the responsibility of parties, and other conditions.

Adoption of regulations for the legislative framework concerning HTAs and MEAs is a positive development. While a number of open questions remain, companies are now able to allocate time and resources for the preparation of future negotiations.

At the moment, some provisions of the MEA regulation are in direct conflict with Ukrainian public procurement legislation. In order to eliminate this conflict, a draft law aimed at resolving this issue has already been submitted to parliament. Its adoption is expected shortly.

For more information on these amendments and regulations governing the application of MEAs in Ukraine, contact your regular CMS client partner or local CMS experts: Borys Danevych, Anna Pogrebna.