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.
Federal Law No.259-FZ dated July 29, 2017 (the “Law”) introduced significant amendments to the Civil Code of the Russian Federation (“the Civil Code”) in regard to the regulation of inheritance-related matters. One of the key novelties was the emergence of a new tool – estate funds. The Law provides for procedures to set up an estate fund, determines the legal status of its beneficiaries and sets forth procedures for managing the fund. The Law will take effect on September 1, 2018.
On July 1, 2017 entered into force the Federal Law dated July 1, 2017 No. 155-FZ “On amendments to Article 5 of the Federal Law “On the Privatization of State and Municipal Property” and the Federal Law “On the Procedure for Making Foreign Investments in Companies which are of Strategic Importance for Ensuring the National Defense and State Security” (hereinafter – “Law No. 155-FZ” and “Strategic Investments Law” respectfully).
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 its cornerstones being as follows:
The Tagansky District Court has published its exceptional decision in the case of Roskomnadzor (the Russian supervisory authority for telecommunications, information technology, and the media) vs the LinkedIn Corporation. The court ruled that the company’s activity in Russia was in breach of Russian legislation on personal data. The Moscow City Court in its resolution as per November 10, 2016 did not overturn the decision: LinkedIn.com has been blocked in Russia.
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.
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.
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.
In late February 2016 a draft law (No. 1004188-6) setting out to regulate the operations of so-called news aggregators was submitted to the State Duma. The reaction from the business community has been mixed, and public authorities are taking different views too. For example, German Klimenko, the Presidential Adviser on Internet Development, supported the initiative, while Deputy Minister Alexey Volin says the Ministry of Communications and Media does not support the draft law, which equates news aggregators and media.