Pharmaceutical Business Summarized the Sector Regulation in 2015

Summary conference «PHARMBUSINESS: 2015 CONCLUSIONS – 2016 ANTICIPATIONS» was held on January 29. Being an annual event for the pharmaceutical sector representatives, the Conference focuses on the regulatory aspects of the pharmbusiness and other legal tendencies of the pharmaceutical market. The event was hosted by Legal Alliance Company, which is famous for its profound expertize in the pharmaceutical law.

This year the event attended 130 representatives of the pharmaceutical sector, specialized media, non-governmental organizations, professional associations, and state regulatory authorities. 35% of the attendees were represented by the top-managers of the pharmaceutical business. For these specialists the Summery Conference constitutes a great opportunity to gain in just one day a comprehensive understanding of the regulatory processes, as well as a platform for a dialog with their market colleagues, public members and state officials.

The Conference started with the plenary session «Perspectives of the pharmaceutical regulation in 2016», held by Tatiana Dumenko, Director of rational pharmacotherapy and support of state formulary system at State Expert Center, Ministry of Health of Ukraine, Dr. Krzysztof Siedlecki, European Business Association President, Astellas Pharma Europe BV Country Manager Ukraine, Dr. Volodymyr Redko, Executive Director of Association of Pharmaceutical Research and Development (APRaD), and Oksana Lebega, Senior Technical Advisor on pharmacovigilance and rational administration of medicinal devices USAID/ SIAPS. Co-moderators of the session were Dmytro Aleshko, «Legal Alliance» Partner, and Vladimir Ignatov, Executive Director of Association of International Pharmaceutical Manufacturers (AIPM Ukraine), Head of IPSEN Pharma representation in Ukraine, Belarus and Moldova.

In the beginning of the session Dmytro Aleshko presented a report on the regulation of the medicinal products and medical devices market. The Conference delegates held a comprehensive discussion over the outcomes of the report. Thus, one of the major worries discussed by market representatives were the National Policy for Medicinal Products Supply, new version of the Law of Ukraine «On Medicinal Products», the concept of National Essential Medicines List, changes in registration/reregistration of medicinal products, import licensing issues, changes is state regulation of prices, circulation of medical devices, and the perspectives of the medicines advertising restriction.

Taking into consideration the composition of the event members many of whom represented the medical devices market, the regulation of the medical devices circulation in 2016 was discussed during a separate interactive session involving Pavel Harchyk, President of the Association of market operators of medical devices, Natalia Serhienko, Health Care Committee Executive Director, European Business Association, and Darya Bondarenko, CEO of Association of market operators of medical devices. The session participants discussed the technical regulations for medical devices in the semi-annual retrospective, the medical devices’ regulation as an inseparable part of medicinal products, and brought an actual conversation over the draft laws in the sphere of technical regulation of medical devices.

Session devoted to public procurement of medicinal products and medical devices was led by Andra Brige, administrative development advisor, UNDP, Тetiana Korotchenko,Representative of Crown Agents in Ukraine and Mikhail Ulyanov, Consultant at the U.N Development Programme (U.N in Ukraine), who shared the peculiarities of the first practice of public procurements with the involvement of specialized international organizations. The discussion was held around the current status, potential problems and roadmaps in this sphere. In the end of the session the Legal Alliance senior associateAlexander Bondar presented a report on the new public procurements law, which practically implements the electronic procurements (electronic auction), electronic system of appeal, and the exchange of information, documents, submission of explanations in the electronic procurements system.

The next session of the conference touched the most current issues of the organization of corporative ethics and anticorruption compliance system in the pharmaceutical business. The session was opened by Legal Alliance Partner Oleksii Bezhevets, who informed the participants on the main changes in anticorruption requirements. In the course of his report the delegated had an opportunity to discuss the plans and implementations of 2015 and to share their expectations and forecasts for the coming year. Another important topic – disclosure of information on HCPs payments/benefits – was revealed in a mutual report made by Lidiya Sangarovskaya-Gurlach, «Legal Alliance» senior associate, and Dr. Volodymyr Redko, Executive Director of Association of Pharmaceutical Research and Development APRaD. In the framework of this session the participants discussed the adjustments in the personal data protection, as well as promotional activities and programs of the pharmaceutical companies.

Following the traditions of the summery conferences the session on taxation of pharmbusiness was held. In the framework of this session Legal Alliance PartnerAnatoliy Menshikov presented the perspectives and expectations of the pharmaceutical market in 2016. After he passed the floor to the special guests of the conference - Aliona Kushnova, Judge at the regional Kiev administrative court, and Jonas Triggvason,Managing Partner, UPharma Consulting. Mrs. Kushnova informed the audience on the court practice in tax disputes, and Mr. Triggvason highlighted the pharmaceutical market taxation issues in nine European countries comparing the VAT rates for medicinal products, general tax rates, the volume of pharmaceutical markets in these countries, and their reimbursement systems.

As always the participants were expecting with a great excitement the session devoted to «Competition: Tendencies, Preferences, Sanctions…». Legal Alliance Associate Partner Andrii Gorbatenko, who leads the antimonopoly and competition law practice, acted as a moderator of this session. The session was traditionally opened with an analytical report on the status of the pharmaceutical market in 2015 presented by Irina Gorlova, General Director, SMD. In addition to a lot of interesting facts the reporter highlighted that the total volume of the medicinal products market in Ukraine amounted to 2.1 billion USD in 2015. However, 85% of all medicines procurements are funded by patients. In 2015 the retail market demonstrated negative dynamics in money and packages. The slight improvements were noticed only in the last quarter of 2015. The best retail figures are shown by dietary supplements, patients care items and medicinal products, the worst figures – personal care products and cosmetics. Session speakers -Zoya Zamikhovska, Junior associate, Lidiya Sangarovskaya-Gulach, Senior associate, and Andrii Gorbatenko, Associate partner, who presented to the audience their reports on medicinal products advertising, marketing agreements in the pharmacy sector, and distribution contracts. Andrii Gorbatenko emphasized the types of law infringements foreseen by the competition law, and paid the attendees attention to the provisions of distribution contracts, which are attracting a close attention of the Antimonopoly Committee of Ukraine, in particular the provisions regulating the reports, discounts and bonus payments. Moreover, Andrii Gorbatenko recommended to deliberate the provisions of the contracts with the distributers that in any way limit the further distributers operations with medicinal products, in particular limit the distribution territory, dictate the pricing terms, etc.

The final session of the Summary Conference «PHARMBUSINESS: CONCLUSIONS 2015 – ANTISIPATIONS 2016», led by the moderator Illya Kostin, Attorney-at-law, Legal Alliance Partner, Patent & Trademark attorney. Legal consultants of leading pharmaceutical companies were invited to the discussion. Vitalii Savchuk, Senior Associate, Legal Alliance, presented a report on the most high-profile cases, investigations and court practices regarding the pharmaceutical industry. Irina Holovkova, Director of the Legal Department in Ukraine and the CIS, Authorized person for the prevention of corruption, Pharma Start | Acino Group, Oleg Gudym, Head of Legal Department, Delta Medical, Aleksander Kozyrev, Legal Consultant, Bayer HealthCare Pharmaceuticals, and Pavel Bespalov, Head of Legal and Corporate Ethics Department, Dr. Reddy's Laboratories shared their thought and conclusions on the regulatory issues.

The highly topical conference programme did not let the participants to relax and loose focus, just as the regulatory and law-enforcement authorities does not let the sector representatives to relax in the course of the year. Nevertheless, all the attendees remained satisfied with a quantity and quality of the information received at the event and expressed a desire to meet in such a format at least twice a year.

Summarizing the event we would like to express a special gratitude to the companies, organizations and media who extended their informational support to the conference: Association of International Pharmaceutical Manufacturers AIPM Ukraine, Association «Market Operators of Medical Devices», European Business Association, Board of Pharmaceutical Research and Development APRaD, UPharma Consulting, SMD, Brandberg, PharmaGate, Health Media, Ukrmedsert, Annual Competition of Pharmaceutical Industry Professional of Ukraine «Panacea», Magazines “Pharmacist Practice”, “Pharmacy Audit”, “Modern Pharmacia”.