Our Projects

Advising Lilly on market access strategy



Fast-track regulatory procedures introduced in Ukraine allow applicants of medicines registered by strong regulatory authorities, as well as procured by international specialized organizations contracted by MoH (Crown Agents, UNDP and UNICEF), to promptly obtain registration. In some complex regulatory cases, the fast-track regulatory procedures remain the only viable option for putting/keeping products on the market.

 
 

Training course for Teva



The ongoing healthcare funding reform in Ukraine brings numerous novelties to pharma sector at many levels: market access and pricing, funding allocation, procurement and reimbursement of medicines.

Advising on market access



Fast-track regulatory procedures introduced in Ukraine in the recent years allow applicants of medicines registered by strong regulatory authorities, as well as procured by international specialized organizations contracted by MoH (UNDP, UNICEF and Crown Agents), to promptly obtain registration. In some complex regulatory cases, the fast-track regulatory procedures remain the only viable option for putting/keeping products on the market.

Advising Bayer on pricing & reimbursement



Pricing for publicly procured and reimbursed medicines remains increasingly important. In the recent years, the Government introduced a number of new rules in the area and together with public payers continued pushing the medicines prices down. Ukraine still lacks managed entry agreements, direct pricing negotiations and confidential pricing mechanisms for innovative medicines, which makes pricing for such products traceable from international reference pricing perspective.

Supporting a health tech startup

March 27, 2019

Danevych.Law team (Artem Grudinin and Borys Danevych) supported pro-bono a local health and lifestyle start-up focused on social impact in settling an IP dispute. The Client’s IP rights were defended vis-a-vis a product developed by company commercializing health and lifestyle apps worldwide through Apple App Store. With the initial claim submitted to the Apple legal department, followed by good faith negotiations, which ended up in the settlement, within just one month 100% of disputable content was removed from the app. Terms of the settlement also covered compensation to the Client.

Advising on healthcare reform

March 26, 2019

Danevych.Law team advised a global top-10 pharma company on key developments of the healthcare funding reform, focusing on:

  • New roles of MoH, NHS and local healthcare authorities within governance and funding related decision-making;
  • Changing rules of public funds allocation for healthcare services, medicines and devices;
  • Outcomes of de-centralized decision-making;
  • Transformed public and private hospitals: new role in the healthcare funding system, challenges and restrictions;
  • National essential medicines list as a restrictive measure.

Advising on transfers of value to HCPs

December 26, 2018
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.
 
 

© 2018-2019. All rights reserved