Pharma Business after Revolution. To keep buoyant or be on the bench

July 17, 2014 the Summer Conference called "Pharma Business after Revolution" was held by the Legal Alliance Company in Kyiv.

More than sixty representatives of leading companies, among which were manufacturers of pharmaceuticals and medical devices, medical cosmetics, distributors, representatives of pharmacy chains, gathered together to discuss current industry issues and identify trends of the second half of 2014.

According to estimations of the participants the program of the event appeared to be intense and especially timely. The conference participants spoke about the current state of the Ukrainian pharmaceutical market, reforms in the health care and the ways they reflected on the pharmaceutical companies. Such issues as the public procurement of medicinal products and medical devices, competition law risks, new amendments to advertising law were covered separately. A special conference session addressed restructuring of business processes in the Crimea peninsula.

The conference was opened by the partner with the Legal Alliance Company Dmytro Aleshko, who discussed with the participants regulatory changes that had occurred in the pharmaceutical market since the beginning of this year. Among them was the resonant draft law "On Medicinal Products", aimed at the simplification of procedures for registration of certain medicinal products, abolition of re-registration of medicinal products, introduction of mandatory certification for compliance with GDP and GPP, and much more.

The executive director of the Association "Operators of Medical Devices Market" Daria Doroshchuk together with the associates of the Legal Alliance Company Natalia Spivak and Alexander Yanev shared their opinion on the introduction of VAT on medicinal products and medical devices, raised the questions of technical regulation of medical devices, reviewed initiatives in the state registration of medicinal products and prospects for amendments to the legislation on the wholesale and retail trade, quality control of medicinal products upon their import. Speakers also addressed issues of import licensing. "Despite the common understanding of public authorities with regard to the need to harmonize our legislation with the European Union, the analysis of draft legal acts pointed to the lack of a unified and coherent approach to rulemaking" – contended Mr. Yanev.

The audience focused its exceptional attention to the report of the counsel with the Legal Alliance Company Natalya Lavrenova dedicated to price regulation. As it is well-known, the Cabinet of Ministers of Ukraine adopted a resolution "On the Stabilization of Prices for Medicinal Products and Medical Devices" on July 2, 2014. The adopted resolution reverses the approach to the formation of prices for medicinal products, medical devices and procedure of their declaration. The new procedure provides for reference pricing, the need for approval of declared price with the competent authority, as well as expands the list of submitted documents. It is expected that the new procedure should come into force on August 1, 2014. Given the fact that the decision of the CMU has not been published as of today, it can be expected a difficult period for the members of the pharmaceutical market in the near future.

The senior associate Alexander Bondar told about what had really changed with the entry into force of the Law of Ukraine "On public procurement" in April this year. Mr. Bondar explained in detail such issues as whether the new law effectively solved the existing problems in the procurement of pharmaceutical products, including writing technical specifications of the subject matter of the procurement, a significant fluctuation in exchange rates. At the conclusion of his speech, the senior associate commented on the possibility of providing parts of goods free of charge within the framework of public procurement in accordance with applicable legislation.

In the conference session devoted to the competition and advertising in the pharmaceutical market held their speeches the partner Alexei Bezhevets and the senior associate Lidia Sanzharovskaya-Gurlach. Speakers talked about the issues in the regulation of pharmaceutical activities on which the attention of the Antimonopoly Committee of Ukraine had been drawn, provided examples of investigations of the Committee, as well as said a few words about the misleading advertising and some aspects of the competitive wars in pharmaceutics. "The general decline of the economy leads to a reduction of the "pie" and forms of a struggle for their own pieces become more acute for each company. Compliance with the norms and rules of fair competition becomes a great importance in this context. Herewith, using the right approach, there still remain effective means to win over the competitors"- contended Alexei Bezhevets.

The associate partner Andriy Gorbatenko presented to the audience a report on the new regulation of television broadcasts sponsorship by the manufacturers and distributors of medicinal products and medical devices. Relevance of the report was prompted by the fact that the President of Ukraine signed the Law amending the Law of Ukraine "On Advertising" on June 26. The noted amendments relate to the sponsorship of television and radio broadcasts and programs by the manufacturers and distributors of medicinal products. Furthermore, the new Law regulates telesales. The law will have the force of law three months after promulgation.

Speakers did as well not overlook a pressing topic of business reorganization in the Crimea. The partner with the Crimean office of the Legal Alliance Company Anatoly Menshikov outlined the opportunities of the business to adapt to the current difficult political and socio-economic situation on the peninsula. The matters of economic activities, labor relations and relations with financial institutions were discussed within the framework of the session. The senior associate Alexander Maznov reported about transactions in respect of the Crimean estate made by the Ukrainian residents. In his turn, the senior associate Vitaliy Savchuk drew attention of the listeners on the specifics of the economic activity in the temporarily occupied territory of Ukraine, as well as innovations in the tax and customs control, which was set out by the draft law on free economic zone on the territory of Crimea.

"Despite the goals that were declared in the draft law, it bears few signs of the free economic zone. Quite the contrary - there is a reason to fear that, if adopted, it would be simply unprofitable for the Ukrainian business to work with the Crimean counterparties". - Vitaliy Savchuk.

"The conference aroused lively interest among the participants, as the managers of business entities, heads of pharmaceutical Representative offices, were able to get the compressed information about the situation in the regulation of the pharmaceutical sector. In addition, the speakers made references to innovations of the regulators, expected in 2014. Particular interest was devoted to the session that was moderated by Anatoly Menshikov, a partner with the Crimean office of Legal Alliance Company, who shared the experience of the first months work on the occupied territory". - summed Dmytro Aleshko.

Legal Alliance Company expresses its sincere gratitude to all participants, speakers, moderators, partners and media partners of the event, for your attention to our activities and assistance in its holding.
Source of information:http://www.l-a.com.ua/eng/news/1849/