Summary Conference «Pharma-business: Conclusions 2012 — Expectations 2013» was held In Kyiv
According to the press service of the Legal Alliance Company
The summary Conference of the Legal Alliance Company «Pharmaceutical business: Conclusions 2012 - Expectations 2013» was held in Kyiv on the 7th of December this year, which has become a traditional venue for the discussion of the actual issues of pharmaceutical law of the year by the market participants and their legal counsels.
More than 120 representatives of the pharmaceutical industry, professional associations and the mass media participated in the conference this year.
The event was held with the support of Smart Solutions, the Association of International Pharmaceutical Manufacturers (AIPM Ukraine), Infoscreen, SMD, Business Credit, journals «Pharmaceutical Practitioner», «Pharmacy Audit», «Pharmaceutical Courier», «Mister Blister», «Medical Practice», The legal newspaper, the newspaper «Law and Business», portals Pharma.net.ua, Pravotoday, Medpharmconnect and Bizreliz.
The conference was conducted in the format of the parallel sessions, in the course of which twelve leading experts of the Legal Alliance Company summed up the legislative regulations in the key areas affecting the pharmaceutical business: regulatory aspects, customs, public procurement, advertising and promotion, competition and intellectual property.
Traditionally, the first sessions of the conference focused on the broadest issues - regulatory mechanisms and advertising. The pharmaceutical business felt the most dynamic changes in these areas within this past year.
The regulatory session was moderated by Dmytro Aleshko, partner with the Legal Alliance Company, together with Vladimir Ignatov, Executive Director of AIPM Ukraine, Head of the representative office of IPSEN Pharma in Ukraine. The speakers in the session were Olga Baula, adviser to Vice Prime Minister of Ukraine - Minister of Healthcare of Ukraine, Natalia Lavrenova, senior associate with the Legal Alliance Company, Karina Babanly, associate with the Legal Alliance Company, and Pavel Harchik, President of the Association "Association of market operators of medical devices" (AMOMD), Director of Kalina BDC. The speakers profoundly elaborated on the issues of registration of medicines and medical immunobiological products, GMP-certification and quality control, medicines counterfeiting, declaration of prices for medicines and medical devices, import licensing. In addition, a separate block of the session was devoted to the regulation of the market of medical devices, which has drawn much attention in 2012.
In a parallel session Oleksiy Bezhevets, partner with the Legal Alliance Company, and counsel Andriy Gorbatenko covered the issues of advertising and promotion of medicines, including the Internet advertising issues, and spoke about the limitations for the pharmaceutical and health care specialists. The Conference guest from Minsk Tatiana Ignatovskaya, partner with the Stepanovskiy Papakul and Partners law firm, told about the advertising and promotion of medicines in the market of Belarus in the view of the ban on the use of images of doctors in advertising, the main requirements for the harmonization of advertising, but also highlighted the examples of measures of responsibility for violations of the law on advertising medicines.
"There was a well-organized event, interesting speakers, great presentations. For us, expertise of our colleagues is very interesting, because the Ukrainian pharmaceutical market is much more developed. And, of course, it is very pleasant to chat with the colleagues in the practice. Unfortunately, there are not so many experts in this area. I was the only non-Ukrainian representative of the legal practice at the conference "- noted Tatiana.
In the next block Yana Kartseva, associate with the Legal Alliance Company and senior associate Eugen Scheglov shared their experience on customs regulation. The speakers spoke on the customs clearance of medicines and medical products, the results of the new Customs Code after six months of its execution, as well as told about the practice of customs disputes resolution in court. The speakers were analyzing peculiarities of formation and evaluation of evidence in court in the administrative disputes and disputes related to bringing the leaders of pharmaceutical companies to liability, some statistics on decisions with regard to the pharmaceutical market, trends and prospects of development of the practice in the future. In addition, the speakers shared their expectations in the sphere of customs regulations for 2013, in particular, pointed out the Customs Service plans for the next year to implement the strategy of "pure business - fair taxes", introduce the institution of authorized senders (recipients), cancel the value added tax on unregistered medicines which are imported to Ukraine for conducting clinical trials.
In the parallel session the issues of competition in the pharmaceutical market were discussed. The associate with the Legal Alliance Company Lidya Sangarovska-Gurlach presented to the audience the results of a study of the pharmaceutical market by the Antimonopoly Committee of Ukraine, and the partner with the Legal Alliance Company Victoria Ptashnyk reminded pharmacists about the key rules of protection in cases of antimonopoly legislation violations.
The final block of the event included sessions on public procurement and intellectual property.
In the first session Dmytro Aleshko, partner with the Legal Alliance Compnay, Alexander Bondar, associate, and the expert in the field of public procurement Mikhail Ulyanov spoke of the key developments and trends in the field of public procurement, as well as issues of concern related to the procurement of medicines and medical devices.
Dmytro Aleshko, in particular, drew the audience's attention to the problematic issues related to formation of medical and technical requirements of the bidding documentation. For example, the speaker told about different positions of the experts of the regional and national level on choosing medicines needed for patients with respective diseases, difficulty in justifying the amount of medicines and the cost of medical equipment to be purchased, etc. The speaker also pointed out possible solutions.
Alexander Bondar spoke about legislative initiatives in the area of public procurement, and set out its position on the possible problematic issues associated with adoption of the regulations.
Mikhail Ulyanov noted the typical errors with respect to preparation of tender proposals, emphasized the important aspects that contribute to the victory in the tender.
Leading experts of the intellectual property practice of the Legal Alliance Company - partner Illya Kostin, senior associate Natalya Lavrenova and patent attorney Oleksandr Bragarnyk told the audience about that how intellectual property can be used in marketing strategies taking into account the limits related to advertising. Special attention was focused on the need for regular monitoring of medicine registration in order to prevent violations of rights for the trademarks, trade names, industrial designs, utility models and inventions. Also, the audience's attention was drawn to the major trends in the field of intellectual property, for example, the issues of compulsory licensing intellectual property in the pharmaceutical field.
The Session part of the event ended with the report of Eugeniy Zhivodernikov, SMD Deputy Director, on the topic «The pharmaceutical market of Ukraine. The structure, the participants, the trends». As part of his report, Mr. Zhivodernikov spoke about the features of the business environment in which pharmaceutical market operates, the development of its segments and the results of the participants of the distribution chains.
As Dmytro Aleshko, partner with the Legal Alliance Company, noted: "At the final conference we had the issues discussed which concern all the pharmaceutical market of Ukraine. The presence of the representatives from the Ministry of Health among the speakers provided the participants with an excellent opportunity to address some problematic issues in the field of regulation of the medicines market directly, as well as emphasize some possible consequences in the event of failure to make changes to the legislation of Ukraine. The depth of expertise in the presentations of the lawyers with the Legal Alliance Company once again confirmed that the company was deservedly recognized in 2011 as a leader in the sphere of pharmaceutical regulatory mechanisms in Ukraine".
At the end of the conference, the participants were invited to the banquet where partners with Legal Alliance Company traditionally thanked those who were present in the conference for their commitment to the company and permanent interest in its activities, and presented client cards to customers for 2013, providing a range of privileges, including free access of the client companies managers to the mini-trainings of the Legal Alliance Company. In addition, it was announced that those, who for whatever reason were not able to attend the summary event, would be able to listen to the reports of lawyers participating in a series of short mini-seminars. Such seminars will begin in the second half of January, 2013.
The summary Conference of the Legal Alliance Company «Pharmaceutical business: Conclusions 2012 - Expectations 2013» was held in Kyiv on the 7th of December this year, which has become a traditional venue for the discussion of the actual issues of pharmaceutical law of the year by the market participants and their legal counsels.
More than 120 representatives of the pharmaceutical industry, professional associations and the mass media participated in the conference this year.
The event was held with the support of Smart Solutions, the Association of International Pharmaceutical Manufacturers (AIPM Ukraine), Infoscreen, SMD, Business Credit, journals «Pharmaceutical Practitioner», «Pharmacy Audit», «Pharmaceutical Courier», «Mister Blister», «Medical Practice», The legal newspaper, the newspaper «Law and Business», portals Pharma.net.ua, Pravotoday, Medpharmconnect and Bizreliz.
The conference was conducted in the format of the parallel sessions, in the course of which twelve leading experts of the Legal Alliance Company summed up the legislative regulations in the key areas affecting the pharmaceutical business: regulatory aspects, customs, public procurement, advertising and promotion, competition and intellectual property.
Traditionally, the first sessions of the conference focused on the broadest issues - regulatory mechanisms and advertising. The pharmaceutical business felt the most dynamic changes in these areas within this past year.
The regulatory session was moderated by Dmytro Aleshko, partner with the Legal Alliance Company, together with Vladimir Ignatov, Executive Director of AIPM Ukraine, Head of the representative office of IPSEN Pharma in Ukraine. The speakers in the session were Olga Baula, adviser to Vice Prime Minister of Ukraine - Minister of Healthcare of Ukraine, Natalia Lavrenova, senior associate with the Legal Alliance Company, Karina Babanly, associate with the Legal Alliance Company, and Pavel Harchik, President of the Association "Association of market operators of medical devices" (AMOMD), Director of Kalina BDC. The speakers profoundly elaborated on the issues of registration of medicines and medical immunobiological products, GMP-certification and quality control, medicines counterfeiting, declaration of prices for medicines and medical devices, import licensing. In addition, a separate block of the session was devoted to the regulation of the market of medical devices, which has drawn much attention in 2012. In a parallel session Oleksiy Bezhevets, partner with the Legal Alliance Company, and counsel Andriy Gorbatenko covered the issues of advertising and promotion of medicines, including the Internet advertising issues, and spoke about the limitations for the pharmaceutical and health care specialists. The Conference guest from Minsk Tatiana Ignatovskaya, partner with the Stepanovskiy Papakul and Partners law firm, told about the advertising and promotion of medicines in the market of Belarus in the view of the ban on the use of images of doctors in advertising, the main requirements for the harmonization of advertising, but also highlighted the examples of measures of responsibility for violations of the law on advertising medicines."There was a well-organized event, interesting speakers, great presentations. For us, expertise of our colleagues is very interesting, because the Ukrainian pharmaceutical market is much more developed. And, of course, it is very pleasant to chat with the colleagues in the practice. Unfortunately, there are not so many experts in this area. I was the only non-Ukrainian representative of the legal practice at the conference "- noted Tatiana.
In the next block Yana Kartseva, associate with the Legal Alliance Company and senior associate Eugen Scheglov shared their experience on customs regulation. The speakers spoke on the customs clearance of medicines and medical products, the results of the new Customs Code after six months of its execution, as well as told about the practice of customs disputes resolution in court. The speakers were analyzing peculiarities of formation and evaluation of evidence in court in the administrative disputes and disputes related to bringing the leaders of pharmaceutical companies to liability, some statistics on decisions with regard to the pharmaceutical market, trends and prospects of development of the practice in the future. In addition, the speakers shared their expectations in the sphere of customs regulations for 2013, in particular, pointed out the Customs Service plans for the next year to implement the strategy of "pure business - fair taxes", introduce the institution of authorized senders (recipients), cancel the value added tax on unregistered medicines which are imported to Ukraine for conducting clinical trials.
In the parallel session the issues of competition in the pharmaceutical market were discussed. The associate with the Legal Alliance Company Lidya Sangarovska-Gurlach presented to the audience the results of a study of the pharmaceutical market by the Antimonopoly Committee of Ukraine, and the partner with the Legal Alliance Company Victoria Ptashnyk reminded pharmacists about the key rules of protection in cases of antimonopoly legislation violations.The final block of the event included sessions on public procurement and intellectual property.
In the first session Dmytro Aleshko, partner with the Legal Alliance Compnay, Alexander Bondar, associate, and the expert in the field of public procurement Mikhail Ulyanov spoke of the key developments and trends in the field of public procurement, as well as issues of concern related to the procurement of medicines and medical devices.
Dmytro Aleshko, in particular, drew the audience's attention to the problematic issues related to formation of medical and technical requirements of the bidding documentation. For example, the speaker told about different positions of the experts of the regional and national level on choosing medicines needed for patients with respective diseases, difficulty in justifying the amount of medicines and the cost of medical equipment to be purchased, etc. The speaker also pointed out possible solutions. Alexander Bondar spoke about legislative initiatives in the area of public procurement, and set out its position on the possible problematic issues associated with adoption of the regulations.
Mikhail Ulyanov noted the typical errors with respect to preparation of tender proposals, emphasized the important aspects that contribute to the victory in the tender.
Leading experts of the intellectual property practice of the Legal Alliance Company - partner Illya Kostin, senior associate Natalya Lavrenova and patent attorney Oleksandr Bragarnyk told the audience about that how intellectual property can be used in marketing strategies taking into account the limits related to advertising. Special attention was focused on the need for regular monitoring of medicine registration in order to prevent violations of rights for the trademarks, trade names, industrial designs, utility models and inventions. Also, the audience's attention was drawn to the major trends in the field of intellectual property, for example, the issues of compulsory licensing intellectual property in the pharmaceutical field.The Session part of the event ended with the report of Eugeniy Zhivodernikov, SMD Deputy Director, on the topic «The pharmaceutical market of Ukraine. The structure, the participants, the trends». As part of his report, Mr. Zhivodernikov spoke about the features of the business environment in which pharmaceutical market operates, the development of its segments and the results of the participants of the distribution chains.
As Dmytro Aleshko, partner with the Legal Alliance Company, noted: "At the final conference we had the issues discussed which concern all the pharmaceutical market of Ukraine. The presence of the representatives from the Ministry of Health among the speakers provided the participants with an excellent opportunity to address some problematic issues in the field of regulation of the medicines market directly, as well as emphasize some possible consequences in the event of failure to make changes to the legislation of Ukraine. The depth of expertise in the presentations of the lawyers with the Legal Alliance Company once again confirmed that the company was deservedly recognized in 2011 as a leader in the sphere of pharmaceutical regulatory mechanisms in Ukraine".
At the end of the conference, the participants were invited to the banquet where partners with Legal Alliance Company traditionally thanked those who were present in the conference for their commitment to the company and permanent interest in its activities, and presented client cards to customers for 2013, providing a range of privileges, including free access of the client companies managers to the mini-trainings of the Legal Alliance Company. In addition, it was announced that those, who for whatever reason were not able to attend the summary event, would be able to listen to the reports of lawyers participating in a series of short mini-seminars. Such seminars will begin in the second half of January, 2013.
