On December 13th-14th, 2017 Kyiv hosted conference “Healthcare and Pharmaceuticals-2018. Anticipations and Expectations”. The event was held with the support of key industry associations – AIPM Ukraine, European Business Association, APRAD, APAU and AMOMD.
The event was organized by Legal Alliance Company, which unites experts in the field of pharmaceutical law.
Conference “Health and Pharmaceuticals-2018. Anticipations and Expectations” in the opinion of numerous market participants has become one of the most large-scale events of 2017. More than 250 representatives of the healthcare and pharmaceutical industries took part in it. It was attended by heads of leading pharmaceutical companies, representatives of the regulatory authority, public healthcare institutions, the public, and the professional press.
The event was focused on forecasts of development and functioning of the healthcare and pharmaceutical industries, which the actors of the relevant markets should understand in order to enter the new business season confidently. The main agenda issues were medical reform in Ukraine, procurement of medicines, the National List of Essential Medicines, as well as ensuring competition in the pharmaceutical market.
The first session of the conference was devoted to the medical reform. The session was attended by representatives of various ranks of the national healthcare system. Iryna Sysoenko, Deputy Head of the Committee of the Verkhovna Rada of Ukraine on Public Health, Tetiana Dumenko, Director of the State Expert Center of the Ministry of Health of Ukraine, Oleksandr Zhyhinas, Project Manager of Health Care Reform Office of the Cabinet of Ministers of Ukraine, Yaroslava Avgustinovich, Chief Physician, Communal Establishment of Vasilkivskyi District Council “Vasylkivsky District Center for Primary Health Care”, Alexey Babich, CEO, Chief Physician of medical laboratories “DILA”, Olga Lyos, Head of Glevakha Outpatient Clinic of General Practice of Family Medicine, General Practitioner. Dmytro Aleshko, Partner at Legal Alliance, and Maryna Buchma, Government Affair Director, Teva Ukraine, acted as moderators of the event.
As expected, the health system reform has become the most discussed topic of the event. The participants of the conference voted to support the need to change the model for financing the healthcare industry and spoke about the existing problems of the modern system. Dmytro Aleshko, commenting on his expectations from the conference and the results achieved during the fruitful discussion, said, “In my opinion, one of the most important messages received from representatives of state bodies present at this event is an understanding of the need and, importantly, the willingness to work to strengthen public-private partnership. Improved investment attractiveness of Ukraine will provide patients with access to better the quality of medical services. Medical reform is another impetus to the actualization of this issue.”
The session “International Procurement: The Way to 2018” brought together representatives of manufacturing companies, distributors and the pharmaceutical community, as well as Crown Agents, UNDP and UNICEF, international organizations that procure medicines and medical products for Ukraine. The session was moderated by Vitaliy Gordienko, Chairman of the Board of Directors of the Association of Manufacturers of Innovative Medicines “APRAD”, and Helena Studzinskaya, Specialty Care Business Unit Head, Delta Medical. Oleg Gudym, Head of the Legal Department, Delta Medical, Volodymyr Redko, Executive Director of the Association of Pharmaceutical Research and Development APRaD, Tetiana Korotchenko, Crown Agents Representative Ukraine, Zafar Yuldashev, Programme Specialist, United Nations Development Programme, Anatolii Trukhanov, Tender Manager, Teva Ukraine participated in the discussion as well.
During the session the results of the work of international organizations in Ukraine with regard to the procurement of medicines and medical products were discussed. Also the questions about changing approaches to the formation of the nomenclature for procurement, optimizing the delivery of drugs and medical products for patients in Ukraine, as well as other aspects that could make international procurement more effective, including the possibility of introducing international experience in Ukraine on long-term contracts were raised.
At the session the reforming of public procurement was discussed, in particular, the prospects and terms of establishing a centralized procurement agency based on the experience of foreign countries and of specialized international organizations that have been procuring medicines and medical products under contracts with the Ministry of Health of Ukraine since 2016. Participants noted some delay in reforming this area and discussed the readiness of international organizations to extend cooperation with the Ministry of Health after March 31st, 2019 in the event that by that time the centralized procurement organization will not become fully operational.
In addition, the conference participants agreed that one of the tasks for 2018 is the introduction of a procedure for negotiations between customers and bidders, which, as experience of other countries shows, will allow reducing prices for drugs, and, accordingly, procuring more drugs needed for patients.
Transition of Ukraine to the model of the National List of Essential Medicines, which has been a topical issue for the whole 2017, is closely related to the issue of providing the population with drugs for budgetary funds. These issues were discussed at the third session of the conference moderated by Volodymyr Ihnatov, Executive Director of the Association of Representatives of International Pharmaceutical Manufacturers AIPM Ukraine, Head of the Representative Office of IPSEN Pharma in Ukraine and Moldova, and Nataliia Serhiienko, Executive Director of the Healthcare Committee, European Business Association. Roman Ilyk, Deputy Minister of Health of Ukraine, Taras Lyaskovskyy, Head of Department of Pharmaceutical Activity and Pharmaceutical Products Quality, Elena Matveeva, Director of Pharmacovigilance Department of State Expert Center of the Ministry of Health of Ukraine, Deputy Head of the Expert Committee on the selection and use of Essential Medicines, Dmytro Aleshko, Partner of Legal Alliance Company, Juanita Folmsbee, Chief of Party, USAID/SAFEMED, Oksana Lebega, Senior Technical Adviser on Governance and Health Police, USAID/SAFEMED, acted as experts at the event.
In addition, within the framework of the session, a conference call with Hector Castro, Senior Technical Director, USAID/SAFEMED, was held, during which Mr. Castro spoke about the world experience in applying the Health Technology Assessment, approaches to price regulation and reimbursement. Experts who spoke at the event agreed that there is already an understanding of the need for change in the professional environment, and this enables a further constructive dialogue between the state and the business environment.
At the conference, the session “Ensuring Competition in the Pharmaceutical Market: on the Verge of Change” was held. The session was attended by Svitlana Panaiotidi, State Commissioner of the Antimonopoly Committee of Ukraine, and Olena Shevchuk, the Head of the Committee’s Sixth Directorate for Research and Investigations. It was devoted to the latest Committee’s practice in the pharmaceutical sector, as well as to discussion of challenges faced by drug manufacturers and pharmacy chains. Natalia Olbert-Sinko, Director of Be—it Health&Social Impact, and Andrii Gorbatenko, Associated Partner and Head of the Competition Law Practice at Legal Alliance Company, AIPM Ukraine representative in the public council at the Committee moderated the session. “The decisions made by the Antimonopoly Committee regarding pharmaceutical companies demonstrate the urgent need for more precise criteria and methods for assessing the market participants’ behavior for compliance with the requirements of competition law. In the absence of such, the most effective way to minimize risks is to obtain the Committee’s recommendations in each case” – commented Andrii Gorbatenko.
Traditionally, the last session of the first plenary day of the conference was devoted to the forecasts of the healthcare and pharmaceutical industry development in Ukraine from the top managers of the pharmaceutical business. Ilya Kostin, Attorney-at-Law and Partner at Legal Alliance Company, and Krzysztof Siedlecki, Patent Attorney and well-known expert of the pharmaceutical market, moderated the session. Sergey Ishchenko, Director of Proxima Research, Artem Matveev, Director of Sales and Marketing, ALKALOID, Georgiy Viktorov, General Manager, Abbott Laboratories GmbH, Head of the Health Committee, European Business Association, Tatiana Pechayeva, Director General, Group of pharmaceutical companies “Lekhim”, Pavlo Kharchyk, President, AMOMD.
According to Ilya Kostin, representatives of the pharmaceutical market representing various segments of it – domestic producers, foreign manufacturers-originators, foreign generic companies, as well as representatives of operators of the medical products market were invited to participate in this session. “While the companies are different, the problems that concern them were very similar,” comments Ilya Kostin. “The main risks for business development, according to experts of the session, lie in the activities of the state and the enlargement of pharmacy chains, which are already beginning to play a dangerous anticompetitive role.” Sergii Ishchenko, who provided an overview of the main market indicators, noted the positive dynamics of financial resources for 2018, which will give an opportunity to increase sales to 20%. The operators of the medical products market also spoke very optimistically about the prospects for the coming year. In particular, Pavlo Harchik noted an increase in medical products sales and a tendency for production localization.
The second day of the conference, December 14th, was devoted to workshops from the leading legal experts of the pharmaceutical industry. Some of the most important practical topics that were discussed were the following: competition in the pharmaceutical market, business protection, procurement in PROZORRO electronic system, the practice of appealing to the Antimonopoly Committee, filling an application for the National List, as well as Digital Promotion of medicines and management of intellectual property objects. Commenting on the workshop on procurement in PROZORRO electronic system, Olexander Bondar, Senior Associate at Legal Alliance Company, noted, “Appealing the procurement to the Antimonopoly Committee of Ukraine is a legal mechanism for the timely protection of violated rights and legitimate interests of the procurement participant. Such a protection mechanism has a number of advantages over appeal to the court, including shorter terms of appeal to the Committee. However, given that there are no clear legislative conditions or explanations of authorized bodies on a number of issues, the success of the appeal procedure largely depends on the participants’ knowledge of Committee’s practices and approaches.”
At the workshop “The National List. Filling in the Application” Oksana Lebega, Senior Technical Adviser of the USAID-SAFEmed Project, spoke about the nuances in preparing the application for inclusion of a drug in the National List of Essential Medicines. According to the expert, all the applicants prepare their applications for the first time and, of course, a lot of questions arise. The USAID-SAFEmed project will continue its series of seminars on this topic. One of the final workshops of the second day was one by Oleksii Bezhevets, Partner at Legal Alliance Company, and Lydia Sanzgarovskaya, Senior Associate, dedicated to the issues of Digital Promotion of medicines. “The Internet gives us tremendous opportunities for drug promotion and business development. Internet applications are more flexible and provide an opportunity to reach target audiences, – Oleksii Bezhevets commented. The scope of this activity, if correctly defined from the legal point of view, gives a qualitative result. We shared our knowledge and experience with colleagues from pharma, there was an active discussion and everyone liked it.”