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Upon the consideration of the provided materials the Antimonopoly Committee has come to the conclusion that given marketing agreement does not contain any signs of the abuse of monopoly and anticompetitive concerted actions conducted by GlaxoSmithKline Ukraine. Moreover, the project team put major efforts into the materials preparation aimed at the justification of Competition Law non-infringement by the drafted marketing agreement concluded with the pharmacies and pharmacy chains.
The document proposes to extend the list of medicinal products liable for simplified state registration, in particular to simplify the procedure for those medicinal products that have already been registered by the competent authorities of the USA, Switzerland, Japan, Australia, Canada or the European Union. The Parliament Health Care Committee did not support this Draft Law and submitted it for further improvement.
The Regulation proposes to establish the selection procedures (development of the first draft Essential Medicines List by the Expert Committee) and yearly revision of the National Essential Medicines List. Further, upon the approval of the first Draft National Essential Medicines List the Expert Committee shall revise the existing taking into account the abovementioned factors and sources. The Draft Regulation also established the schedule of revision of the National Essential Medicines List. Please note that the Order of the Ministry of Health of Ukraine as of February 11, 2016, a„– 84 approved the Regulation on the National Essential Medicines List and the Regulation on the Expert Committee on the selection and usage of essential medicinal products. For 28 years, The Legal 500 has been analyzing the capabilities of law firms across the world, with a comprehensive research programme revised and updated every year to bring the most up-to-date vision of the global legal market. The Concept suggests the implementation of activities aimed at solving the issues of timely patients support with qualitative, safe and efficient medicinal products, immunobiological products and medical evices, and activities aimed at the prevention of corruption and limited competition that lead to medicinal products and medical devices procurement at an over-inflated price. The document authors note that the Concept designates the directions, mechanisms and terms for public procurements system transformation in healthcare sector of Ukraine through the development of modern convenient system aimed at the establishment of competitive environment and further development of fair competition in this sector.
The Concept shall be implemented with the assistance of international organizations and donors in three stages during 2016—2018. Stage 1 (2016) – establishment of institutional and legal basis for the reformation of public procurements in healthcare sector.
CPO shall fulfill the procurements at local and foreign levels, and if required shall maintain the procurement from international suppliers — import of medicinal products, immunobiological products and medical devices, involve other organizations into customs clearance, storage and distribution, conduct other business activities based on long-term plan principles.
The procedure for insulin products reimbursement foresees that the pharmacy warehouse should file monthly report on the medicinal products sold. Moreover, the document amends the CMU Resolution as of March 5, 2014, a„– 73 "On the Implementation of Pilot Project on State Regulation of Insulin Products Prices" regarding the definition of the unified mechanism of the state regulation of insulin products prices. These medical devices are allowed for market distribution before their expiry date and not later than 5 years from the date of their sales start without the compliance assessment and national quality standard mark. Based on the abovementioned, the compliance assessment procedures shall become obligatory starting from July 1, 2017 for registered medical devices with the unlimited state registration certificate or with the certificate expiring after this date. Another significant change introduces the opportunities to conduct the compliance assessment procedures during the period of validity of medical devices registration certificate.
Moreover, certain changes have been introduced into the registration of the officials responsible for putting medical devices into operation. In case such entity is not a resident of Ukraine, the authorized representative should be assigned with the responsibility to introduce such medical devices into Ukrainian market. State Administration of Ukraine on Medicinal Products should maintain a Register of entities responsible for the introduction of medical devices into the market. The legal support of the development and adoption of the abovementioned Order of Cabinet of Ministers, as well as the above-mentioned order of the Ministry of Health of Ukraine was provided by the Legal Alliance Company in cooperation with the SIAPS project. The said provision establishes that the drugs will be included in the National List of Essential Medicines (hereinafter - the National List), taking into account population incidence rates, prevalence of disease and mortality, evidence of the comparative effectiveness (performance), safety and cost-effectiveness of medicines, as well as industry standards  in terms of health and level of funding for health care. The Expert Committee will consist of 12-18 people, it will be composed of specialists with higher medical, pharmaceutical and economic education. Once an expert committee under the Ministry of Health of Ukraine is established, work concerning the selection of drugs to be included in the National List will be conducted by them. Interested individuals and legal entities can apply with a package of necessary documents  for inclusion of drugs in the National List of Medicines. Notice of tax assessment is developed for each separate tax due together with the penalties, as well as for each penalty and poena for the violation of other legislation being under supervision of regulatory authorities. Notice of tax assessment is considered to be submitted to the taxpayer – legal entity if such assessment notice is delivered by hand to the official employee of such taxpayer against acknowledgement or forwarded in a letter with notification of the delivery.
Notice of tax assessment is considered to be submitted to the taxpayer – individual if such assessment notice is delivered by hand to such individual or his authorized representative or forwarded in a letter with notification of the delivery to the address of residence or of the latest known location of such individual. The new Law provides for the implementation of public procurement with the use of two competitive regulatory procedures: open tendering and competitive dialogue, as well as a non-competitive procedure - negotiating the purchase procedure.
An important innovation of the Law is the introduction of electronic procurement (e-auction), the electronic review system, as well as the implementation of the exchange of information, documents, to provide clarifications in the e-procurement system. Moreover, for the conduct of unauthorized concentration, which did not lead to monopolization and significant impediment of competition on Ukrainian market , the AMCU recommends to calculate the basic penalty in accordance with the total revenue (income) received from the sales of products (goods, services) at all commodity markets of Ukraine.
The AMCU made the greatest specification regarding the calculation of the basic penalties in the cases of the infringements of informational character. Moreover, the AMCU believes that if the incorrect information has been provided several times during the consideration of the case regarding the violation of informational character, the total penalty charges shall amount to the penalty for one relevant violation. It is worth to mention that the AMCU established the reduced penalty, which may be imposed on the respondent during the investigation of the case of informational character and on the applicant in the case regarding the concentration and the concurrent actions if they provided incomplete case information.
Correction of previously determined penalty taking into consideration the aggravating and mitigating circumstances. Declarations with violation of the deadlines for submission for the reporting period in case the application is submitted within its contents.
The registers are published at the official State Fiscal Service’s web-site on a daily basis. In case the Main Directorates of the State Fiscal Service in regions, or in the city of Kyiv send to the appellant the decision on final or partial denial of the appeal, the appellant has a right to file the subsequent appeal within 10 calendar days upon the receipt of such decision. The document in its new edition, updated and improved in line with the requirements of the Law of Ukraine "On Prevention of Corruption", was recently approved by the  Management Board of AIPM Ukraine. The project was conducted by Oleksii Bezhevets, partner with Legal Alliance Company and senior associate Lidiya Sangarovskaya-Gurlach.
The most important among the suggested amendments is the one concerning the Procedure of monitoring of adverse reactions to medicinal products permitted for medical use as approved by decree a„– 898 of the Ministry of Health of Ukraine, dating December 27, 2006 (hereinafter - the current procedure), in the new edition, changing its name to "The Procedure for the Conduct of Pharmacovigilance" (hereinafter - the new procedure). Thus, the new procedure determines that the applicant may have more than one system of pharmacovigilance, for example, specific systems for different types of medicines (vaccines, OTC drugs, etc.). With regards to the authorized person, the new order establishes that in the case of the applicant, who is located in Ukraine, the authorized person must be part of the applicant's personnel. The new procedure defines the document with a detailed description of the pharmacovigilance system as a Pharmacovigilance System Master File (PSMF).
An important achievement of the new procedure is to establish the requirements for the system of risk management in pharmacovigilance. In contrast to the existing rules, the new procedure provides for the obligation of creating a risk management plan. In concern with medicinal products that do not require the creation of risk management plans, the applicant must support the specification file of important identified risks and important potential risks with the aim of preparing regular reports. In terms of other amendments foreseen by the new procedure, emphasis should be given to the advanced categorical apparatus and a new player in the field of pharmacovigilance - rapid response groups of relevant departments of Health, which are responsible for investigating all serious adverse events after immunization and some others. Therefore, the adoption of the new order will contribute to the harmonization of national legislation with the European legislation.in the field of pharmacovigilance. It is to be recalled that  in their time some of the provisions were "the bone of contention" between the regulator and the subjects of the pharmaceutical market. Therefore a situation may arise where the abovementioned provisions will be in force before the relevant decision of the Cabinet of Ministers' of Ukraine albeit with the edition of order a„– 143. The abovementioned draft legislation proposes the disclosure of information contained in the materials of the pre clinical studies and the clinical trials that are attached to the application for the registration of the medicinal product. In the opinion of the legislation draft's initiators, the closed nature of such data results in the circulation of drugs, whose effectiveness and safety have not been proved. The Project aims to supporting of Ukrainian government in issue of improvement of effectiveness and transparence in public purchasing system for medicinal products, in particular, by complying of National list of main medicinal products and medical devices with international standards. This year the event attended 130 representatives of the pharmaceutical sector, specialized media, non-governmental organizations, professional associations, and state regulatory authorities. In the beginning of the session Dmytro Aleshko presented a report on the regulation of the medicinal products and medical devices market. 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 next session of the conference touched the most current issues of the organization of corporative ethics and anticorruption compliance system in the pharmaceutical business.
Following the traditions of the summery conferences the session on taxation of pharmbusiness was held.
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. Hygiene requirements  exclusively concern dietary suppements and do not apply to medicinal products, functional foods and special dietary foods. Hygienic requirements set requirements for the content of dietary supplements, in particular, the latter indicate that for the production of dietary supplements  vitamins and minerals listed in Annex 1 of the hygiene requirements may be used, in the form specified in Annex 2 to the hygienic requirements.
Therefore  amendments are provided to the Law of Ukraine "On Insurance" , namely by defining sponsor liability insurance a mandatory type of insurance . The document designates the mechanism for taxpayers’ appeals against tax assessment notices or any other decisions made by the regulatory authorities in the course of administrative procedure.
This Procedure shall not be applied to the appeals against the regulatory authorities’ decisions, actions or inactions of their officers or other employees if the special law establishes other procedures for appeals.
Complaints about the decisions of state tax inspection offices are filed to regulatory authorities in Kyiv and regions, to inter-regional territorial agencies.
Complaints about the decisions of regulatory authorities of Kyiv and regions, of inter-regional territorial agencies, and of customs offices are submitted to the State Fiscal Service of Ukraine.
The decisions of State Fiscal Service of Ukraine made upon the consideration of taxpayers’ complaints are final and without any further administrative appeal, however may be appealed to court. The complaint should be submitted in writing to the higher regulatory authority within 10 calendar days following the taxpayer’s receipt of the respective decision made by the regulatory authority.
The complaints for the regulatory authorities’ decisions and actions should be cited and submitted separately. The taxpayers may attach to their complaints all calculations and evidence, which they deem appropriate.
Certified copies of quality certificates (certificates of analysis, test reports, etc.) issued by the manufacturer for the series of medicinal products to be imported. The Ministry of Health shall within five working days from documents delivery shall issue for the importer a certificate of import confirmation or send a written refusal notice indicating the reasons for refusal. The Ministry of Health shall issue within five working days from documents delivery the certificate of confirmation for the medicines payment under the agreements or send a written refusal notice indicating the reasons for refusal. The supplier shall submit the confirmation certificate to the revenues and duties authority, where it is registered as a tax payer, not later than 10 working days after the deadline for submission of VAT declaration for the relevant reporting (tax) period. The intended use of the medicinal products and medical devices exempt from VAT shall be fulfilled in accordance with corresponding legislation. Nevertheless, the tax payers are still obliged to pay advanced corporate profit tax payments for the first three quarters of 2016. The failure to make this payment shall result in imposing on such tax payer the penalty in the amount provided in Article 123 of the Tax Code of Ukraine. In such a way, the National List of Essential Medicinal Products and Medical Devices has been renamed into the National Essential Medicines List.
Since CMU Resolution a„– 333 as of March 25, 2009 adoption, the list has not been amended with any medical device.
National Essential Medicines List should be formed with due consideration of world-wide practices of rational pharmacotherapy and pharmacotherapeutic approach to primary health care of patients with priority pathologic conditions taking into consideration disease burden and mortality rate, and health care sector standards. In the majority of countries this function is fulfilled by the WOH Model List of Essential Medicines, which has been elaborated as a core document for ensuring public health care at government expense. The designated authority, on the basis of a document of compliance issued by a foreign authority, shall apply the conformity assessment procedure or part of it and issue the relevant document under this procedure under its responsibility.
This Regulation shall enter into force six months after the date of publication and will be valid until 31st March 2019. It is to be noted that these legislative changes are due to the implementation of public procurement procedures of medical devices involving specialized international organizations that provide states and other entities with related services. Dmytro Aleshko, Legal Alliances' Partner, became a member of the working group on essential medicines selection within the implementation of the project for National Medicinal Products Policy development. Pfizer, the makers of Viagra , will now also sell this medicine in New Zealand men to access treatment for a healthier sex life.
In particular, the team made a comprehensive research on medicinal product markets, which may be affected by the concluded marketing agreement, conducted social and marketing studies, analyzed the experience of GlaxoSmithKline group of companies regarding the relevant agreements in other countries, developed internal standard operating procedures for the Client with regard to pharmacies and pharmacy chains cooperation.
We would also like to express our gratitude to the project team members representing GlaxoSmithKline Ukraine for the fruitful collaboration. The Draft Law was initiated by the Cabinet of Ministers of Ukraine and presented the same say at the Government session. This Regulation belongs to the package of documents drafted in order to implement the new model of Essential Medicines List. The difference lies in the fact that all individuals intending to include a particular medicinal product into the List shall have an opportunity to submit a corresponding application including the documents confirming the comparative efficiency, safety and cost-effectiveness of the product. The Regulation Annexes formalize the application execution Instruction for amending the National Essential Medicines List. The adoption of the Draft Resolution shall promote the establishment of professional centralized procurement organizations (hereinafter - CPO) in Ukraine, which requires some time and incremental actions. CPOs shall be established under the Health Ministry decision and shall operate under its supervision. During this period all medical devices shall be introduces to the market and put into operation on the basis of acting certificate of state registration.
Registered medical devices with the certificate expiring after July 1, 2017, should undergo the compliance assessment procedures after the expiration of such certificate in order to stay on the market.
The structure and contents of national lists will be based on the latest edition of the Basic List of Essential Medicines recommended by WHO. An important step forward is the need to study whether or not such persons present a conflict of interest, as well as the possibility of participation of foreign specialists with the necessary knowledge and experience in the selection process in the national list,"- said Dmytro Aleshko, who heads the team of experts developing a normative - regulatory package  on this matter.
Such persons shall not present a real conflict of interest, in particular,  they should not be in an employment or any other contractual relationships with producers and holders of certificates of registration of drugs or associated persons. At the same time, the Law provides a number of cases to which the provisions of the latter do not apply. In addition, the AMCU has specified the meaning of such aggravating circumstances as the obstruction of case investigation.
This method is recommended in case the respondent did not provide any information on the total revenue at the market where the concentration took place and at adjacent markets.
Thus, previously the basic penalty equaled up to 5% of the revenue from the sales of the products (goods, works, services) of economic entity in the last reporting year prior to the year the penalty was charged, and if there was no revenue or the respondent did not provide any information on the total revenue – the penalty equaled to 10 000 of non-taxable incomes of the residents. The written appeal should contain all data outlined in the Procedure, it should be signed by the appellant-physical entity or by the authorized person, for other appellants – the appeal should be signed by the director or a legally authorized representative and sealed (if available).
Thus, the new procedure provides a number of new features, the most interesting of which relate to the applicant. At the same time, each applicant's pharmacovigilance system can have only one authorized person responsible for the pharmacovigilance (hereinafter – authorized person). Should the applicant not be located in Ukraine, then a contact person for pharmacovigilance in Ukraine, who is a subordinate of the applicant's authorized person, must be assigned on the territory of Ukraine. In comparison with the current procedure, the new procedure establishes simultaneously a clear framework for such PSMFs with the requirements for information that must be contained in it. It should be noted that the current procedure contains a provision, according to which the applicant creates a pharmacovigilance risk management plan, i.e. The draft resolution prepared by the Ministry of Health of Ukraine , does not contain any significant differences , except for some editorial amendments. The matter concerns a three-way contract, the requirement for the conclusion of which seems by importers to not be feasible. Therefore the draft legislation at hand is aimed at initiating access to such information, which will enable all interested citizens, their associations and professionals to decide on the selection  for the appointment and the medical use of the medicinal products on the basis of objective data concerning the level of proof on their safety and effectiveness. 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.
Krzysztof Siedlecki, European Business Association President, Astellas Pharma Europe BV Country Manager Ukraine, Dr.
The discussion was held around the current status, potential problems and roadmaps in this sphere.
The session was opened by Legal Alliance Partner Oleksii Bezhevets, who informed the participants on the main changes in anticorruption requirements.
Legal Alliance Associate Partner Andrii Gorbatenko, who leads the antimonopoly and competition law practice, acted as a moderator of this session. 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. Quality criteria for nutrients used for the production of dietary supplements must comply with the requirements of Ukrainian legislation and in their absence - standards established by the Codex Alimentarius Commission. The opportunity to track  dietary supplements and any substance intended to be administered in dietary supplements should be ensured at all stages of production and circulation.
According to the proposed changes , the relevant contract may be concluded not only by the sponsor of the clinical trial , but also by their  authorized representative.


In addition the mentioned procedures shall not be applied to the appeals against decisions made in the course of administrative violations proceedings.
Prior to this Resolution adoption the list approved by the CMU Resolution a„– 400 March 29, 2006 was in force containing 783 products among which only 1 product was a medical device – test system. The essential medicines are selected with regard to the morbidity rate, comparative effectiveness and safety evidence, economic efficiency.
In addition, we would like to mention a substantial expertise and due attention to this issue expressed by Antimonopoly Committee specialists.
The reimbursement of insulin products costs shall be fulfilled at the rate of reference price for the medicinal product approved by the Ministry of Health of Ukraine. The patients shall receive their medication for a lowered price or for free in accordance with these categories.
Business entity should submit the relevant report not later than the 5th day of the month following the reporting month, and in December — not later than the 24th day of the reporting month. An important selection criterion is the presence of experience of the evaluation of the comparative efficacy (effectiveness), safety and cost-effectiveness of drugs. This Order updates the mailing procedures for tax assessment notices to be sent to taxpayers by regulatory authorities. Today the AMCU increased the penalty up to 30% of the revenue from the sales of the products (goods, works, services) that violated the legislation on the protection against unfair competition. In the end of the session the Legal Alliance senior associate Alexander 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.
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. 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. 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. Vitalii Savchuk, Senior Associate, Legal Alliance, presented a report on the most high-profile cases, investigations and court practices regarding the pharmaceutical industry. Before 2006 the list approved by the CMU Resolution a„– 1482 as of November 16, 2001 was acting. Our joint efforts led us to the implementation of the project that only yesterday seemed to be almost impossible”.
The reports should be submitted to local budgets holders who have been legitimately assigned for the execution of operating expenses of local budgets for preferential provision of insulin products to diabetic patients defined by the decisions on such expenditures in accordance with the legislation for the reimbursement to business entity of the amount stated in the register within 15 days upon the report receipt.
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. Ieteicama deva ir 50 mg, registracijas apliecibas pieskirsanu un ieteikumus par Viagra lietosanu. 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. Therefore, the National Essential Medicines List did not function properly from the very beginning of its development.
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