On 27 January 2021, Ukrainian Government approved a set of regulations for managed entry agreements ("MEA") aiming to ensure that patients have timely and affordable access to innovative therapies. Regulations open a new dimension of business opportunities for innovative pharmaceutical companies.
MEA instrument grants flexibility to Ukrainian public payers in negotiating individual terms of market access to original medicinal products with pharmaceutical companies and managing financial impact of such access. Both financial-based and outcome-based MEAs, as well as a combination thereof, will now be possible. The Ministry of Health of Ukraine (the "MOH") has preliminary declared its intention to pilot MEAs on a more straightforward financial basis.
Importantly, MEAs will benefit from confidentiality regime protecting their sensitive commercial terms from public disclosure.
Condition precedent for MEA
Feasibility of MEA in respect of an original medicinal product has to be confirmed by state health technology assessment ("HTA"). The HTA process may be launched by the marketing authorization holder ("MAH") at its own initiative or, in limited circumstances, at the proposal of the MOH. Please refer to our recent legal alert regarding HTA procedures.
Decision-making on MEA is vested to the MOH. MEA shall be entered into following a negotiation between MAH (or its authorized affiliate) and the MOH negotiation group. The entire process (excluding HTA) up to conclusion of MEA may take over 1 year, however, there are statutory time limits for each of its stages.
MEA validity period
Up to 1 year, with a possibility of annual extension of up to 3 years in total. Extension is subject to positive conclusion of state HTA.
MEA may be terminated early in case a generic product or biosimilar with the same INN, dosage form and/or therapeutic indications is authorized for marketing in Ukraine.
Expected further developments
New regulations permit implementing MEA from 15 February 2021. However, for the instrument to be fully effective additional changes to Ukrainian laws are still required. In particular, MEAs have to exempted from Ukrainian public procurement procedures. Relevant draft law is now pending approval by Ukrainian Parliament.
Key takeaway for business
Bearing in mind the strategic importance of MEAs for innovative pharmaceutical companies, as well as complexity and timeline of HTA and MEA processes, we recommend companies to start / proceed with their preparations to these procedures for products that could potentially be subject to MEA.
Among other things, we note that the new regulations approved a rather detailed template of MEA that should be analyzed in advance to fully understand the contractual landscape of MEA in Ukraine and potential commercial benefits / exposures.
For further information, please contact Asters' Counsel Viktoriya Podvorchanska