On January 25th, 2019 the Committee of Pharmaceutical Law of the Ukrainian Bar Association devoted to topical subjects of the industry in 2018 and development forecasts for 2019 took place. Matters of adaptation of internal documents to GDRP, public procurement of medicines and medical devices, as well as legal regulation of the medical reform in 2019, AMCU activities on the pharmaceutical market – results of 2018 and forecasts for 2019 were considered at the meeting.
Representatives of Legal Alliance Company actively participated in the discussion and presented their vision of different aspects of the pharmaceutical industry to the participants.
The following experts from Legal Alliance Company spoke at the event:
Illya Kostin, partner at Legal Alliance Company, Deputy Head of the UBA Pharmaceutical Law Committee, moderated the event.
Nataliia Abramovych, associate at Legal Alliance Company, devoted her speech to the matter of adaptation of internal documents to GDPR. The EU has introduced the General Data Protection Regulation introducing new rules and requirements to personal data processing, strengthening personal data protection and establishing liability for offenders. Underlining the importance of this matter, Ms Abramovych stressed that “Failure to fulfil the new requirements to personal data processing results in fines in the amount from EUR 20 thousand to EUR 50 million, as it happened to Google in France”. In her report, the lawyer spoke in detail on how to mitigate risks, prevent violation of personal data processing and avoid fines.
Aleksander Bondar, senior associate, in his speech considered main aspects of legal regulation of public procurement of medicines in Ukraine. First of all, Aleksander focused on public procurement cases, analysis of regulatory acts governing this mechanism and prospects for its functioning in 2019. The next subject of the report was analysis of the centralized procurement organization operation, whose function was entrusted to Professional Procurement State Enterprise. Finally, Mr Bondar announced development of the new version of the law of Ukraine “On Public Procurement”, the draft of which is being prepared by the Ministry of Economic Development, and briefly spoke on its main novelties and changes.
Natalia Spivak, senior associate, presented main focuses of the pharmaceutical regulation reform in Ukraine. In particular, her speech concerned the main idea, objective and tasks of the state formulated in the State Strategy for Implementation of State Policy of Providing the Population with Medicines till 2025.
Khrystyna Sushkevych, associate, devoted her report to analysis of the AMCU activity on the pharmaceutical market in 2018 and made interesting forecasts for 2019. Ms Sushkevych based her key arguments and conclusions on the last news of the AMCU activity and bright cases.
The event focused on the transformation of Ukraine's intellectual property sector on its path toward European integration.
Improving access to safe and affordable medicines for the Ukrainian population is one of the Government of Ukraine's top priorities. SAFEMed Activity (2017-2025) has supported this effort by appIying health system strengthening best practices.
The Ministry of Health website has posted a notice about the release of a revised draft order of the Ministry of Health ‘On Approval of Amendments to Certain Re
On 25 September, a webinar was held on the topic: ‘180 days of new drug price regulation. Results, prospects and practical advice.’ The event was organized by LA Law Firm in partnership with Proxima Research International.
