On 1 February 2017, the Cabinet of Ministers of Ukraine (the "CMU") adopted Regulation No. 38 (the "Amending Regulation") aimed at postponing the implementation of the CMU Regulation "On the State Regulation of Prices for Pharmaceuticals" No. 862 (the "Pricing Regulation") until 1 April 2017. By way of reminder, the reimbursement of prices for pharmaceuticals under CMU Regulation No. 863 is also due to launch on 1 April 2017. In particular, the Amending Regulation provides for the following changes to the Pricing Regulation:
- the state regulation of prices for pharmaceuticals, enforced through a reference pricing mechanism, will be launched on 1 April 2017 instead of 1 January 2017;
- the period during which pharmacies can sell pharmaceuticals at prices exceeding the maximum wholesale prices has been extended from 1 February 2017 until 1 April 2017.
The actual implementation of the Pricing Regulation is also subject to the approval of certain orders by the Ministry of Health of Ukraine (the "MOH"). Some of the required MOH orders have been adopted, while approval of the remaining order establishing the procedure for calculating maximum mark-ups for pharmaceuticals is pending. The draft procedure for calculating maximum mark-ups was published for public discussion on 29 December 2016. Please refer to our Newsletter for detailed information on available and pending regulations on reference pricing, as well as on reimbursement mechanism.
The implementation of the Pricing Regulation has been postponed. Thus, the reference pricing and reimbursement mechanisms should be launched simultaneously on 1 April 2017. The actual introduction of the reference pricing mechanism is also conditional upon adoption of the MOH order on calculating maximum mark-ups (which has not yet been adopted as of the date hereof).