The meeting will be devoted to the discussion of implementation of provisions regarding medical devices of the Council of Europe Convention on the counterfeiting of medical products and similar crimes involving threats to public health (Medicrime Convention) to Ukrainian legislation
The meeting will be devoted to the current situation with State Enterprise “Ukrvaccine” and discussion of potential demonopolization of the market of logistics services provided in healthcare sphere for governmental procurement of medicinal products
The meeting will be devoted to discussion of vision of development of the National Health Service of Ukraine, particularly in terms of monitoring and estimating the need in healthcare services and medicinal products, reimbursement of the medicinal products under the guaranteed package, peculiarities of including private clinics to the reform and of signing contracts on medical care for population
Mykola Romaniok, Head of the Working Group on Healthcare Hardware & Medical Devices Manufacturers, and Ruslan Sovershennyi, Head of the Working Group on Health & Medical Services Providers, disclosed one of the most demanded services to date on the markets, namely - the creation of an effective system of protection against illegal import for business, discussed with participant’s methods of combating illegal import, and shared the results achieved in this area
During the meeting Deputy Minister of Health of Ukraine Oleksandr Linchevskyy presented MoH proposals regarding the improvement of treatment of patients by hemodialysis
The meeting was devoted to discussion of the following Draft Orders of the Ministry of Health of Ukraine and shaping the Chamber position thereon
The SAFEMed project supported Ministry of Health of Ukraine in implementing the pharmaceutical policy that will provide methodological guidance and support during the transition period, as well as in harmonization the pharmaceutical policy and scientifically grounded decision making, applying an enhanced system approach to obtaining positive and sustainable results in healthcare system for Ukrainians
The meeting was devoted to discussion of the bioequivalency, as an important criterion for forming the list of reimbursed medicinal products by the national program “Affordable Medicines”
During the meeting procurement optimization of medicinal products in 2018, pilot project’s results of establishing and implementation of the central procurement organization, possible ways for procurement of drugs within procurement and medical reform and the Impact of IP on a Price of Medicines were discussed
Meeting was devoted to discussion of EU experience in GDPR and how it will work for Ukrainian legal and business environment in terms of legal and technical aspects
The meeting was devoted to the importance of control on the healthcare facilities’ procurement of medicinal products via Prozorro and the practical aspects of such control by public and patient organizations
The meeting was devoted to the transferring the government procurement of the medicinal products to the National Health Service, as well as improvement of the medicinal products’ procurement system as a whole
The meeting was devoted to the problematic issues in confirming compliance of the conditions of medicinal products production with the requirements of Good Manufacturing Practice, which may have a negative impact on competition in the markets of medicinal products
On March 5, the Ministry of Health of Ukraine published its Draft Order “On Amending the Standard “Guidelines. Medicines. Good Pharmacovigilance Practices”
The meeting was devoted to discussion of the recent requests of the General Prosecutor's Office regarding the provision of information and documents for conducting clinical trials
The Meeting with Deputy Minister of Health of Ukraine was exclusively devoted to discussion of private clinics participation in healthcare reform
The meeting was devoted to discussion of the Licensing conditions for conducting economic activity on import of medicines with representatives of the Chamber Member Companies operating via distributers for import their medicinal products, and those, who import medicinal products from several pharmaceutical companies
The Meeting was devoted to the discussion of further cooperation with Ministry of Health in the sphere of quick and transparent delivery of effective and quality medicines to Ukraine
The meeting was devoted to discussion of the Draft Procedure on Confirming Compliance of the Сonditions of Medicinal Products Production with the Requirements of Good Manufacturing Practice
Participants shaped new working group priorities and took part in the appointment of Head
On February 5, eHealth system was transferred to the Ministry of Health. In the future, the Ministry of Health and the newly established eHealth state-owned enterprise will proceed with the eHealth development and implementation
During the meeting was presented the new Working Group as well as discussed its objective
The meeting was devoted to discussion of next steps of the Ministry of Health in implementation of the Healthcare Reform, plans of the Ministry’s Team and ways of cooperation with the business community as well as priorities of the state healthcare policy for 2018
The joint meeting of pharmaceutical and logistics directions of the Chamber Healthcare Committee was devoted to discussion of the Licensing conditions for conducting economic activity on import of medicines
The Meeting was devoted to discussion of the next steps of the Ministry of Health of Ukraine in implementation of the recently adopted Healthcare Reform
The Meeting was devoted to the discussion of decisions of the Antimonopoly Committee of Ukraine in the recent pharma cases
On December 7, the Verkhovna Rada of Ukraine introduced amendments to the Tax Code of Ukraine, according to which the rate of value added tax (VAT) in the amount of 7% applies to the supply of goods in and the importation into the customs territory of Ukraine of all medical products included in the State Register of Medical Devices and Medicinal Products or meet the requirements of the relevant technical regulations, confirmed by the compliance document, and are allowed for entering the market and/or putting into operation and use in Ukraine
The Meeting was devoted to discussion of healthcare reform implementation in Ukraine and patients’ perspective to Ukrainian Health Technology Assessment
The Meeting was devoted to the discussion of Draft Law #7182 “On Amendments to the Law of Ukraine “On Licensing of Economic Activity””, initiated by MPs Igor Lapin, Yuriy Tymoshenko and others
The Meeting was devoted to discussion of next steps of the Ministry of Health in implementation of the recently adopted Healthcare Reform
Ministry of Health of Ukraine amended the Procedure for Consideration of Registration Materials of Medicinal Products for State Registration (Re-Registration) and Materials for Amending the Registration Materials during the Validity of the Registration Certificate of Medicinal Products Registered with the Competent Authorities of the United States of America, Switzerland, Japan, Australia, Canada, Medicines Registered via the Centralized Procedure by the Competent Authority of the European Union
The Meeting was devoted to the discussion of Draft Law #2162-d “On Medicinal Products”, initiated by MPs Olga Bogomolets, Oleg Musiy and others
The meeting was devoted to the current status of government policies and support to Ukraine
The meeting was devoted to the discussion of the cooperation of SAFEMed Project with Ministry of Health of Ukraine
The meeting was devoted to the discussion of the modules of the Guidelines on Pharmacovigilance and respective next steps
The meeting was devoted to the discussion of response of the State Fiscal Service of Ukraine to the Chamber Position Paper regarding VAT rate on medical devices
The Meeting was devoted to the discussion of current legislative initiatives on Intellectual Property Rights issues in Ukraine
On October 30, the Chamber participated in a meeting devoted to the preliminary recommendations of Wilbert Bannenberg, UNDP Ukraine consultant, on the ongoing public procurement reform in the healthcare sector of Ukraine
The meeting was devoted to the discussion of healthcare system in Ukraine, realization of the reform and issue of increasing the patients’ access to quality medicinal products
During the meeting were discussed global trends in Consumer Health and latest trends on consumer behavior
The Meeting was devoted to the discussion of the Chamber Draft Position Paper to Acting Minister of Health of Ukraine regarding application procedure to the National Essential Medicines List
Meeting participants had an excellent opportunity to discuss vision of the Ministry of Health of Ukraine regarding forming the e-Health system as well as current state of the Project directly with Yuriy Bugay, Head of the eHealth Project Office and Svitlana Kotliarevska, Head of Promotion and Support of the eHealth Project Office
On October 19, Verkhovna Rada of Ukraine voted for Draft Law #6327 "On Governmental Financial Guarantees for the Medical Services' Provision" in the second reading, Draft Law #6604 “On Amendments to the Budget Code of Ukraine on Provision of State Financial Guarantees for the Provision of Medical Services and Medicines”, and Draft Law #7117 “On Increasing the Availability and Quality of Medical Services in Rural Areas” in the first reading
During the Workshop participants learned about list of the documents required for recognition procedure as well as advantages and disadvantages of recognition conformity assessment procedure
Cabinet of Ministers of Ukraine published its Resolution #718 "On Some Issues of Procurement of Medicinal Products" dated September 27, 2017 that foresees that the requirement for procurement to meet the 100% need in medicinal products from National Essential Medicines List will come into force on January 1, 2018
Andy Hunder, President, and Maxim Proskurov, Policy Officer (Healthcare Issues), at the American Chamber of Commerce (AmCham Ukraine), provide insights into the Chamber’s main activities and strategic priorities as well as an analysis of the ever-changing business ecosystem of Ukraine, more specifically healthcare, and the role of the AmCham Ukraine in stimulating investment opportunities
The meeting was devoted to the healthcare reform in general as well as its various particular aspects, such as National Essential Medicines List, reimbursement and procurement of medicinal products and medical services
The Meeting has been devoted to the discussion of the joint Chamber-APRaD Draft Answer to the letter of the Antimonopoly Committee of Ukraine on the conformity assessment procedure conditions for the production of medicinal products with GMP requirements along with a request for information
On August 23, the Cabinet of Ministers of Ukraine adopted the Concept of Reforming the Mechanisms of Public Procurement of Medicinal Products and Medical Devices, which provides the basis for forming the Central Procurement Organization. According to the Concept, public procurement of medicinal products and medical devices will be performed on international, national and regional levels on the principles of efficiency, transparency and anticorruption
The Ministry of Health of Ukraine (MoH) published Draft CMU Resolution "On Amendments to CMU Resolutions #333 dated March 25, 2009 and #1303 dated August 17, 1998". According to the suggested amendments, National Essential Medicines List (NEML) comes into force on January 1, 2018 within the requirement for healthcare facilities to procure medicinal products firstly to meet 100% need in medicines from NEML
The Meeting has been devoted to discussion of the role of MoH Public Health Center in the course of implementation of MoH policy
On July 24, Ministry of Health of Ukraine published Draft (MoH) Order "On Amendments to MoH Order #1245 dated November 17, 2016" for public discussion. This Draft Order foresees amendments to the Simplified Procedure of Medicinal Products' Registration contributing to its effective functioning. Also, medicinal products' manufacturers would have a possibility to register new medicines within shorter timeframe
President of the American Chamber of Commerce in Ukraine Andy Hunder on Healthcare reform.
The meeting was devoted to antimonopoly aspects of doing business in pharmaceutical industry.
On July 4, the Cabinet of Ministers of Ukraine adopted Resolution, that provides the transition period for the completion of the process of procurement of medicinal products
The meeting has been devoted to efficiency in pharmaceutical spending and establishment of the Purchasing Agency for procurement of medicinal products
During the meeting has been discussed harmonization of the national legislation on the technical regulation of labelling due to EU legislation
The meeting has been exclusively devoted to technical issues of inclusion of the medicinal products to the National Essential Medicines List
On June 14 the Chamber Healthcare Committee launched Healthcare Marketing HUB
As a result, technical meeting with SEC regarding steps for resolving the issue of ineffective implementation of simplified procedure for registration of medicines will be held till the next MoH meeting
Healthcare Committee representatives highlighted problems in current regulatory data protection, data exclusivity, patent protection, counterfeit and grey import etc.
On June 8, the Verkhovna Rada of Ukraine passed Draft Law #6327 "On Governmental Financial Guarantees for the Medical Services' Provision" in the first reading as advocated by the Chamber
Co-Chair of the Chamber Healthcare Committee, Partner at Marchenko Danevych Borys Danevych shared his view on healthcare reform in Ukraine
Healthcare Committee representatives held a discussion regarding existing problems in IPR sphere for pharmaceutical companies
On June 6, Parliament of Ukraine voted for including Draft Law #6327 "On Governmental Financial Guarantees for the Medical Services' Provision" and Draft Law #6329 "On Amendments to the Budget Code of Ukraine" to the agenda. Draft Laws are expected to be put to first vote later this wee
On May 31 the Chamber Healthcare and IT Committees held a meeting with e-Health Project Office, devoted to discussion of the Ministry of Health vision of forming the e-Health system, current state of the project and potential cooperation with the Chamber experts
On May 23, the Chamber Healthcare Committee held a meeting with International Charitable Organization “East Europe and Central Asia Union of People Living with HIV” (ECUO) representatives
The meeting has been devoted to discussion of implementation of international clinical protocols in Ukraine, their advantages and importance of their application in medical practice
The event has been devoted to discussion of the agenda for the meeting with the profile Deputy Minister of Economic Development and Trade of Ukraine
In the light of launch of the Chamber Healthcare Marketing HUB, this meeting has been an excellent opportunity to review key market trends in EU and Eastern Europe, trends and challenges on the Ukrainian pharmaceutical market, and impact of the EU trends on the Ukraine
The Chamber welcomes entering into force of Order #122 “On Approving the Procedure of Maintaining the Register of Persons Responsible for the Introduction of Medical Devices, Active Implanted Medical Devices, and Medical Devices for in vitro Diagnostics in Turnover, Forms of Communication and List of Data Stored therein and Access to Them” adopted by the Ministry of Health of Ukraine
During the meeting has been discussed Implementation of the National Essential Medicines List
The meeting has been devoted to discussion of the WHO vision of reforming healthcare sector in Ukraine
Agenda of the meeting included discussion of the last working version of Draft Law “On Information for Consumers regarding Food Products” with participation of representatives of the Ministry of Health of Ukraine, State Service of Ukraine on Food Safety and Consumer Protection and EU Project "Improvement of Food Products Safety Control System in Ukraine"
On April 6, Chamber Healthcare Committee held its regular meeting with participation of representatives of Association of Pharmaceutical Research and Development (APRaD) and healthcare professionals moderated by Committee Co-Chair Vitaliy Gordienko, AbbVie Biopharmaceuticals GmbH
On March 29, the Chamber Healthcare Committee held a meeting with Pavlo Kovtonyuk, Deputy Minister of Health of Ukraine, devoted to discussion of implementation of healthcare insurance system in Ukraine as well as MoH vision of the necessary legislation to be adopted by the Parliament this year
Read the article on Ukrainian language version of the website
Participants discussed the mechanism for future cooperation on the issues related to competence of the National Police of Ukraine that Chamber Members face and reached a number of agreements. In particular, issue of access of attorneys during searches was discussed
On March 16, the Chamber participated in a meeting devoted to the National Essential Medicines List which will enter into force on April 1, 2017
On March 16, the Cabinet of Ministers of Ukraine approved reimbursement of medicinal products that introduces a mechanism of refunding during outpatient treatment of patients suffering from cardiovascular disease, type II diabetes, asthma by setting wholesale prices for these medicines which are calculated as median reference prices for the same medicinal products in approved reference countries list
On March 9, the Chamber participated in a meeting devoted to the Draft Regulation on introduction of reference pricing and reimbursement since April 1, 2017 which was held in the Ministry of Health of Ukraine (MoH). The meeting gathered representatives of the MoH, Cabinet of Ministers of Ukraine (CMU), Ministry of Economic Development and Trade of Ukraine (MEDT) and pharma market operators
On February 24, the Chamber participated in a meeting devoted to the Draft Regulation on introduction of reference pricing and reimbursement since April 1, 2017 which was held in the Ministry of Health of Ukraine (MoH). The meeting gathered representatives of the MoH, Cabinet of Ministers of Ukraine (CMU), Ministry of Economic Development and Trade of Ukraine (MEDT) and pharma market operators
The agenda of the meeting has been devoted to the discussion and analysis of the recent presentation of the Expert Committee on selection and application of medicinal products regarding National List of Essential Medicinal Products formation
The agenda of the meeting has been devoted to discussion of the State Expert Center’s vision regarding facilitation of registration of medicinal products procedure
On February 1, the Cabinet of Ministers of Ukraine approved a compromise to amend Order #862 "On State Regulation of Prices for Medicinal Products" and postponed the start of its implementation to April 1, 2017
On January 13, Chamber Healthcare Committee held its regular meeting with participation of representatives of U.S.-Ukraine Business Council (USUBC) and Association of Pharmaceutical Research and Development (APRaD) moderated by Committee Co-Chairs: Vitaliy Gordienko, AbbVie Biopharmaceuticals GmbH, Guilhem Granier, Sanofi-Aventis Ukraine LLC and Borys Danevych, Marchenko Danevych
Meeting has been devoted to reconciliation of positions among the Working Group on the possible ways of avoiding the double regulation
On December 1, Steering Committee of the Chamber Healthcare Committee met with Oleksandr Saienko, Minister of the Cabinet of Ministers of Ukraine and Ulana Suprun, Acting Minister of Health of Ukraine
On November 24, Vaccines Summit dedicated to the issues of establishing a long-term strategy for protecting the population against vaccine preventable diseases was held in Kyiv
The agenda of the meeting has been devoted to discussion of possible ways of cooperation between business and government in solving urgent problems in the healthcare sector
The agenda of the meeting has been devoted to the discussion, with representatives of APRaD and other associations, of the most recent Government decisions in the healthcare sector
The agenda of the meeting has been devoted to the discussion of the current situation in the healthcare sector
Participants with Chamber Healthcare Committee experts explored the practical aspects of conformity assessment of medical devices
The agenda of the meeting has been devoted to the discussion of the development of the regulation of the registry of medical devices, as well as illegal imports of medicinal products
The agenda of the meeting was devoted to the election of the Head and defining main priorities for newly established Working Group
Participants met with the newly appointed Acting Minister of Health of Ukraine Ulyana Suprun, who shared her vision on the healthcare system reform and plans to be accomplished in her role within the Ministry of Health of Ukraine
The agenda of the meeting has been devoted to discuss the concept of import substitution recently announced by the Ministry of Health of Ukraine
On July 8, the Chamber participated in the meeting devoted to clarifications of procedures of Conclusions of the State Sanitary-Epidemiological Expertise (hereinafter – Conclusions) issuance and signing held by the State Regulatory Service of Ukraine
Specific discussion regarding reimbursement of insulins in terms of launching a specific pilot project in Kyiv, implementation of medical insurance mechanisms and electronic healthcare system
Participants had an opportunity to contribute to the establishment of a new Working Group on Healthcare Hardware Manufacturing
On June 23, Steering Committee of the Chamber Healthcare Committee met with Viktor Shafransky, Acting Minister of Health of Ukraine
Order #359 of the Ministry of Health of Ukraine on Adoption of the Regulation on the Register of Reference Prices for Insulins and the Rules of Reference Prices Calculation for Insulins was published in the Official Bulletin of Ukraine
We aimed to define major pain points faced by investors in the sphere of IPR and raised awareness among the general public of Ukraine
Verkhovna Rada of Ukraine adopted Draft Law #4484 “On Amendments to Article 9 of the Law of Ukraine "On Medicinal Products" on Simplification of State Registration of Medicinal Products”
Join us to find the possible ways cooperation within the Project and get the update on the SIAPS activities in Ukraine.
Presentation of United Nations Development Programme approach to anti-corruption in healthcare sphere.
The agenda of the meeting has been devoted to presentation of the State Expert Center’s vision of working process of specialized expertise on quality of medicinal products for 2016
It was a discussion on current issues in illegal imports, improvement of legal framework of procurements, and advertising of medicinal products
It was an ad-hoc expert Meeting on Draft CMU Resolution “On Approval of License Conditions of Production...
Please read the news on Ukrainian version of the website.
Mr. Rachman, CEO, Immix Biopharma, Inc a Los Angeles, CA shared his experience on...
Chamber welcomes the signing of Laws in the sphere of Public Procurements of Medicinal Products via International Organizations.
Please read the news on Ukrainian version of the website.
Chamber welcomes CMU Resolution #125 “On Amendments to the Procedure of State Registration (Re-Registration) of Medicinal Products”.
Business community appreciates yesterday’s adoption of amendments to the CMU Resolution #376 which repeal reregistration of medicines for the treatment of tuberculosis, HIV/AIDS, viral hepatitis, cancer and rare diseases registered in the United States, Switzerland, Japan, Australia, Canada and the EU countries.
Healthcare Business Forum will be focused on Ukraine – Tuscany partnership.
