LEGAL UPDATES

New minimum benchmark for compliance in Ukraine

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.

Ukraine is rolling out its drug reimbursement program

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.

Update - Fast track Ukrainian authorization for drugs approved in stringent foreign jurisdictions

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.

Tax reform 2017: excise tax and other changes (in Ukrainian)

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”).

Law of Ukraine on financial restructuring

On 19 October, the new Law of Ukraine “On Financial Restructuring” (the “Law”) came into force.

Ukrainian competition authority rules on drug pricing practices

In September 2016, the Antimonopoly Committee of Ukraine (the “AMC”) handed down a significant decision holding a major global pharmaceutical company and its four Ukrainian distributors liable for uncompetitive conduct that resulted in overcharging for drugs in Ukrainian public tenders.

Updated Proposal for Introduction of Reference Pricing in Ukraine

Ukrainian Government is continuing to develop a new reference pricing system for Ukrainian pharmaceutical market. Initially expected by 1 August 2016, relevant decisions are now being delayed but still proposed to be approved in the near future.

Ukraine is changing the regulatory landscape for pharmaceutical business

On 31 May 2016, Ukrainian Parliament passed a law to significantly simplify the market access for certain categories of medicinal products. In particular, the law introduces a streamlined registration (marketing authorization) process for any drugs already authorized by competent 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. Such registration is to be performed within 17 business days and involve a limited documentation check, without a full-scale local review of the registration dossier. The law entered into effect on 19 June 2016. However, bringing it to life still requires approval of a number of by-laws that are being developed by the Ministry of Health of Ukraine. When implemented, simplified registration procedures are expected to reduce the market entry barriers for international pharmaceutical business.

Payment of Dividends and Liberalization of Certain other Currency Control Restrictions

On 7 June 2016, the National Bank of Ukraine (“NBU”) adopted new resolution No. 342 (the “Resolution”) aimed at stabilization of the situation on the Ukrainian FX market. The Resolution reinstated many of the temporary currency control restrictions existing to date, including restrictions on payments under individual licenses, restrictions on early prepayment of loans to foreign lender, etc. At the same time, the Resolution provided for liberalization of certain limitations.

Ukraine signed the Hague Convention on Choice of Court Agreements

On 21 March 2016, Ukraine signed the Hague Convention of 30 June 2005 on Choice of Court Agreements (“Convention”). This is a major step towards integration of Ukraine into European and global trade and investment environment. Availability of choice of court agreements in Ukraine will ensure yet another instrument of legal protection for businesses engaging in trade with Ukrainian parties or investing into the country.

Cross-Border Loans: Assignment Ban Lifted, New Hurdles Imposed

Effective as of 1 January 2016, the National Bank of Ukraine (the “NBU”) adopted Resolution dated 30 December 2015 No. 996 (“Resolution 996”) introducing certain amendments to the procedure of registration of cross-border loans raised by Ukrainian borrowers.

Ukraine facilitates property and other registrations

On December 13, 2015, new legislation introducing a number of substantial novelties in the property registration system in Ukraine (the “New Law”) entered into force. Although already modernized in the past years, property registrations have been often seen as the area of typical bureaucracy and transparency issues. As briefly summarized below, the changes proposed in the New Law are generally aimed at facilitation of property registrations by ensuring higher accessibility of registrations.

The NBU Reinforces FX Restrictions

The National Bank of Ukraine (the “NBU”) has adopted resolution No.863 dated 4 December 2015 (“Resolution 863”) aimed at stabilisation of the situation on Ukrainian FX market. The Resolution 863 shall be effective as of 5 December 2015 until 4 March 2016. According to the Resolution 863, the NBU has generally extended all of temporary restrictions introduced (or prolonged) under similar resolution of the NBU No.581 dated 3 September 2015 (as amended). At the same time, the NBU has slightly modified some of its previously introduced restrictions.

Ukrainian Ministry of Healthcare changes authorization process for medicinal products

With effect from 30 October 2015, a new order of the Ministry of Healthcare of Ukraine (the “Order”) introduced a number of significant changes to Ukrainian drug review and authorization process.