Recently, the President of Ukraine signed the new law aimed at facilitating investments to Ukraine (the “Law”). The Law introduces the long-awaited concept of a nominee holder to Ukrainian regulatory framework.
On 21 June 2018 Ukrainian Parliament adopted the new Law of Ukraine “On Foreign Currency and Foreign Exchange Transactions” (the “New FX Law”) introducing a major and long-awaited reform of current FX regulatory framework.
Effective as of 28 December 2017, new rules and requirements for obtaining by non-bank financial companies (“Financial companies”) of a general license for carrying out of operations in foreign currencies (the “General License”) were introduced by the National Bank of Ukraine (the “NBU”).
Starting September 2017, the EU-Ukraine Association Agreement (the “Agreement”) entered into force. According to the Agreement, Ukraine, among other things, has taken certain obligations for IP, though it was not clear whether they should apply with an immediate effect or after conflicting Ukrainian laws are changed. Recently, the Patent office finally explained that the Agreement will be applied in full and prevail over the national legislation, including the most relevant changes as follows.
On 9 October 2017, the governments of Ukraine and the United Kingdom of Great Britain and Northern Ireland signed a new Protocol to Double Tax Treaty (DTT) of 1993. The Protocol, among other things, increases withholding tax (WHT) on all passive income by additional 5%, thereby potentially affecting existing and future cross-border financing structures involving UK lenders.
On 17 August 2017, the National Bank of Ukraine (the “NBU”) adopted resolution No. 80 (the “Resolution”) whereby the rules and procedures for issuance to non-bank financial companies (“Financial Companies”) of licenses for making money transfers in national currency without opening of accounts (“License”) have been significantly amended. The Resolution is effective as of 22 August 2017.
In March 2017, Ukrainian Government approved the new National Essential Medicines List for Ukraine (the “NEML”), which is to become a single basis for the procurement and reimbursement of medicines in the public sector, as well as price controls.
The National Agency for Prevention of Corruption (the “NAPC”) introduced new minimum standard for compliance and anticorruption efforts mandatory for large state-owned enterprise and participants of major public procurement.
Over March 2017, Ukrainian Government and Ministry of Health (“MOH”) approved a number of regulations to finalize the framework for reimbursement of several groups of medicinal products. “Available Medicines” pharmacy reimbursement program (the “Program”) is scheduled to be launched from 1 April 2017.
With effect from 30 December 2016, the Ministry of Health of Ukraine (the “MOH”) by its Order No. 1245 enacted a procedural by-law (the “Procedure”) which should finally open the way for a fast-track registration (marketing authorization (“MA”)) in Ukraine of medicinal products that have already been approved by drug regulatory authorities of (i) the U.S., Switzerland, Japan, Australia, Canada and (ii) the EU under centralized authorization procedure, in each case for use in relevant countries.
Ukraine is launching reference pricing and reimbursement for medicinal products. Regulatory progress or a legal pitfall?
In November 2016 Ukrainian Government passed resolutions to introduce reference pricing and reimbursement for medicinal products starting from 1 January and 1 April 2017, respectively (“November Resolutions”).