Danevych.Law team (represented by of Borys Danevych and Anastasiia Filipiuk) acted as a counsel on Ukraine in a multi-jurisdictional project advising one of the leading global suppliers of dental, medical and animal health technologies on legal and compliance aspects of interactions with and transfers of value to healthcare professionals. The advice covered anti-corruption and advertising legislation, practice of its application and its implications on the company's activities.
Advising on clinical trials compliance
November 20, 2018
Borys Danevych and Anastasiia Filipiuk advised a top-10 global pharmaceutical company on compliance matters in clinical trials area. Danevych.Law revised clinical study agreements templates in line with effective regulatory framework and with consideration for the recent focus on the clinical trials sphere from the law enforcement, as well as advised the Client on responding to requests for clinical trials-related information from law enforcement.
Implementing Compliance Framework for Client
October 10, 2018
Borys Danevych and Anastasiia Filipiuk advised a european consultancy focused on pharma industry on business ethics and compliance matters in the course of setting up the Ukrainian subsidiary. Danevych.Law assisted the Client with implementation of local Compliance framework, as well as trained its local team on business conduct expected by international big pharma.
Complex regulatory/IP advice
August 21, 2018
Danevych.Law team advised and represented a global top 10 pharmaceutical company on a complex matter concerning registration in Ukraine of life-saving innovative and generic medicines during the period of marketing exclusivity of innovative medicine, including IP, regulatory and compliance aspects of the registration.
Procurement Through International Organization
August 15, 2018
Borys Danevych and Anastasiia Filipiuk advised a global top 10 biopharmaceutical company on various matters related to procurement of innovative medicines through an international organization contracted by the Ministry of Health of Ukraine. The advice covered jurisdictional, contractual, regulatory and customs matters. Introduction of medicines and medical devices procurement through specialized international organizations back in 2015 significantly increased transparency and efficiency of public spendings in the area.
Investigations Concerning Clinical Trials
August 13, 2018
Borys Danevych, Anastasiia Filipiuk and Artem Grudinin advised a number of global sponsors of clinical trials and a leading CRO on criminal investigations concerning clinical studies in Ukraine, including procedural, regulatory and compliance matters.
Advising Shire on US$2.4 billion oncology business sale to Servier
August 10, 2018
In 2018 Danevych.Law team led by partner Borys Danevych along with associates Artem Grudinin and Yuliya Cherniavska advised Shire on Ukrainian components of US$2.4 billion oncology business sale to Servier S.A.S. The work mainly concerned transfer of rights for pegaspargase - a treatment for acute lymphoblastic leukemia being marketed in Ukraine and procured through international organization contracted by the Ministry of Health of Ukraine.
Advice on Early Access to Medicines
August 10, 2018
Borys Danevych,Artem Grudinin and Yuliya Cherniavska advised a global top 5 biopharmaceutical company on implementation of early access programs in Ukraine. Although Ukraine still lacks clear regulation of compassionate use, post-trials access, post-authorization access and many other early access mechanisms, it is practically possible to provide access to Ukrainian patients using the existing legal instruments.
Advertising and promotion advice
August 1, 2018
Borys Danevych and Anastasiia Filipiuk advised a top 10 global biopharmaceutical company on legal aspects of advertising, sponsorship and promotion with the use of logo of the company with Rx products portfolio in light of Ukrainian regulatory framework on advertising and promotion of Rx medicines, as well as industry codes.
MAH status transfer
August 1, 2018
Borys Danevych and Anastasiia Filipiuk advised a top 20 global pharmaceutical company on a complex regulatory matter concerning transfer of MAH status for a medicinal product in Ukraine, as well as on fast track registration procedure available for medicines approved by US FDA, EMA, Swiss, Canadian, Australian and Japanese regulatory authorities.