On 21 September 2021, Parliament passed a law to cover the missing elements in the previously enacted regulation of managed entry agreements ("MEA"). MEA instrument grants flexibility to Ukrainian public payers in negotiating the individual terms of market access to original medicinal products with pharmaceutical companies and managing financial impact of such access. Please refer to our previous legal alert regarding MEA.
Public procurement exemption
MEAs entered into between the Ministry of Health of Ukraine (or State Enterprise "Medical Procurement of Ukraine") and the marketing authorization holder ("MAH") (or its authorized representative) will now enjoy an exemption from the general requirements of Ukrainian public procurement laws.
One of the reasons behind this change is the high level of public disclosure applicable to public procurements, including in relation to their financial terms, which conflicts with the special confidentiality regime provided for MEA.
Irrespective of the above exemption, the new law establishes a limited set of information on MEA that will still be made public in Ukrainian e-procurement system within 3 business days from MEA execution, including: INN (if available), trade name, pharmaceutical form and strength of the medicinal product, MAH and its authorized representative (if available) and MEA validity period.
In addition, the law requires that an annual report summarizing the results of MEA monitoring is also made publicly available within 3 business days from the monitoring date. We note that this provision lacks details on protection of confidential information that may be contained in the report and expect that this may be further dealt with in subordinate regulations.
The law grants the public procurement exemption until 31 December 2023 only, which creates an uncertainty as to the longer-term sustainability of MEA instrument. Presumably, such limitation was established by the Parliament as a period for MEA piloting, following which the pilot results will be evaluated and further regulatory decisions made.
The feasibility of MEA for a medicinal product will need to be confirmed by the state health technology assessment ("HTA"), which is in line with the approach already reflected in MEA subordinate regulations. An important development is that the termination of MEA in case a generic product or biosimilar with the same INN (if available) and therapeutic indications is authorized for marketing in Ukraine shall now also be conditional on the results of the fast-track state HTA.
Finally, according to the new law, the list of products subject to MEA shall be approved by Ukrainian Government. The procedure for developing such list is not yet established.
The new law is another step towards completion of regulatory framework for implementation of MEA in Ukraine. It still needs to be signed by the President and officially promulgated to become effective, following which mirroring changes would need to be introduced to subordinate regulations.
In the meanwhile, some of the medicinal products that could potentially be further considered for MEA purposes are already undergoing the state HTA, being a pre-requisite for the launch of MEA procedures.
For further information, please contact Asters' Counsel Viktoriya Podvorchanska.