Chamber Healthcare Committee Meeting took place on October 24^th, 2011. The agenda of the Meeting was devoted to the discussion of price registration issues, possible changes to IPR legislation concerning medicinal products and new Good Manufacturing Practice (GMP) compliance requirements, and possible changes to imported medicines control.

The participants of the Meeting had an opportunity to put practical questions to Mr. Valeriy Stetsiv, Director of the Department of Pharmaceutical Sector Development in the Healthcare Sphere, Ministry of Health of Ukraine, and Ms. Yanina Tolkacheva, Head of the Section on Medical Technologies, Standardization and Certification of the Department for Regulatory Policy in the Sphere of Circulation of Medicines and Products in the Healthcare System, Ministry of Health of Ukraine. The main focus of the discussion was the CMU Resolution #932 “On Improvement of Government Regulation of Prices for Medicines and Medicinal Products Procured from the State and Local Budgets” that was adopted on August 8th, 2011. Its adoption became a logical step towards implementation of the state registration of medicine prices. Many procedural questions regarding price declaration and registration were explained by the state officials.

The presentation titled “Price Registration of Medicinal Products: Perspectives and Consequences” was also delivered by Mr. Oleksiy Bezhevets, Attorney-at-Law, Partner.

Please click here to view the Presentation (UKR).

During this presentation the speaker covered the issues concerning price registration procedure of medicinal products, ideology and methodology of this process and answered the questions on application documents.

Update  regarding possible changes to IPR legislation concerning medicines and new GMP compliance requirements as stipulated in the Draft Law #7412 “On the Amendments to the Article 9 of the Law of Ukraine “On Medicinal Products” regarding Bringing Registration Procedure of Medicinal Products into Correspondence with International Standards” Draft Law #7412 was provided by Mr. Borys Danevych, Partner, Attorney-at-Law, PARITET Law Firm.

The discussion that followed was devoted to the new provision (amendment #8) that had been added to the Draft Law #7412 and which required, in addition to a standard set of documents, filing a document issued by the State Service on Medicinal Products confirming compliance by the applicant (for state registration of medicine) with GMP.

Mr. Borys Danevych has also updated the participants regarding establishment of the Working Group on Drafting Amendments to the CMU Resolution #902 “Certain Issues of Medicinal Products Turnover” under the auspices of the State Service of Medicines of Ukraine and encouraged the Members of the Healthcare Committee to get involved into active participation of improvement of quality control procedures.

The agenda of the Meeting was devoted to the discussion of issues of quality control and licensing of medicines.

Ms. Inna Demchenko, Deputy Head, State Service of Ukraine on Medicines and Mr. Sergiy Dubovytskyy, Director, Department of State Control Organization, State Service of Ukraine on Medicines, attended the Meeting and informed the participants of the functioning of medicines quality control system.

Ms. Inna Demchenko shared the plans of the State Service concerning medicines registration, development of controlling procedures, in particular regarding additional requirements to marking the packaging of medicinal products, etc.

Among other discussion items were coordination improvement of the State Service and the State Expert Center in the field of pharmacovigilance as well as the State Service’s vision on GMP compliance expertise and inspections at the stage of the medicines (being manufactured outside PIC/S countries) state registration. Also the possibility to avoid audit if the site situated in non-PIC/s territories inspected by PIC/s member GMP authority was discussed. The principal position of State Service about need of mandatory GMP status confirmation before Registration in Ukraine was supported by the Committee Members.

Continuing the discussion, Ms. Anna Pogodaeva, Delta Medical, noted that Members of the Healthcare Committee got access to newly proposed draft of changes to Cabinet of Ministers of Ukraine (CMU) Resolution # 376 “On Approving State Registration Procedure (Re-Registration) of Medicines and Amounts of State Registration Fee (Re-Registration)”  were performed for expertise of CMU expert board and discovered that conception of GMP compliance review by the State Service mentioned in this legislation draft to be improved as there is no need to add additional procedure of receiving Ukrainian GMP certificate in case of sites are situated on PIC/s territories.

Ms. Inna Demchenko confirmed the State Service’s vision that applicants need to make this step only for their database. But in newly created draft the procedure of getting Ukrainian GMP certificate would take additional efforts and time and could become critical due to the lack of resources in the State Service. So the proposition of Committee was to regulate it like “notification only” possibly via MoH Order to avoid next bureaucratic procedure.

Also Ms. Inna Demchenko emphasized that in the view of the planned reorganisation in responsibilities of authorities for medicines registration procedure Chamber Healthcare Committee Members should pay attention to changes of procedure mentioned in the above mentioned draft changes to (CMU) Resolution # 376with regard to application submission to the Ministry of Healthcare instead of the State Expert Center. The Healthcare Committee Members believe it is critical taking into consideration administrative reform steps reflected in recent changes in the staff of Ministry of Healthcare due to the administrative reform. So the Members believe in a pragmatic approach on behalf o the State Service management that would influence Ministry of Healthcare opinion in order to avoid some illogical steps which can block registration procedures already on the stage of application.

As a result of the Meeting, the participants agreed to provide the Ministry of Healthcare of Ukraine with the Chamber Healthcare Committee’s view that there are no grounds to introduce additional changes in the procedure of registration in the part of provision of a set of documents for registration.

The Members decided to send a Chamber Letter to the Ministry of Healthcare of Ukraine with a request to join pilot project regarding reimbursement of medicines costs in certain regions of Ukraine in the framework of reform of medical services process.

Upon Ms. Inna Demchenko’s suggestion to hold a joint meeting between the leadership of the Ministry of Healthcare of Ukraine and professional associations, the Members of the Healthcare Committee decided to approach APRAD (Association of Pharmaceutical Research and Development) in order to jointly host such meeting in September.

If you or one of your colleagues would like to participate in the Chamber Healthcare Committee Meetings and receive informational updates, please feel free to contact Yaroslava Marusyk, Chamber Committee Coordinator.

Chamber Joint Healthcare and IPR Committees Meeting took place on June 21^st. 

The agenda of the Meeting was devoted to the discussion of practical aspects of import substitution policy implementation, protection of economic competition and perspectives of pharmaceutical sector reforms in general. 

Mr. Sergiy Kalashnyk, Country Manager of Ukraine, Belarus and Moldova, Eli Lilly Vostok S.A., Chamber Healthcare Committee Co-chair, presented practical aspects of cooperation in development of new medicinal products between local and foreign pharma producers. 

A presentation titled “Import Substitution Concept: Are Emergency Rules to Be Applied?” was delivered by Ms. Iryna Kirichenko, Patent Attorney of Ukraine, Ilyashev & Partners Law Firm. 

Please click here to view the Presentation (RUS). 

The participants discussed the ways of addressing perspectives of implementation of import substitution policy and agreed to address the newly appointed Mr. Oleksandr Anishchenko, Minister of Healthcare of Ukraine, with a Chamber letter in which Healthcare Committee’s  position on import substitution policy is stated. Ms. Svitlana Ivasenko, Arzinger will prepare the Draft Letter. 

In addition, Members of the Healthcare and IPR Committees – representatives of Ukrainian Legal Group and Vasil Kisil&Partners agreed to prepare a Chamber position, addressing Members’ concerns regarding new edition of Law “On Medicinal Products” to the Ministry of Healthcare. In particular, Article 9 on data exclusivity protection and Article 17th that proposes a procedure of importing the production "in bulk" without state registration (Draft Law #8175) are of major concern to the Members. It was also decided to invite Ms. Raisa Moiseyenko, Deputy Minister of Healthcare, to one of the next Healthcare Committee Meetings in order to discuss import substitution policy. 

The Members of the Healthcare and IPR Committees supported suggestion of the Healthcare Committee leadership to invite Mr. Oleksiy Solovyov, Head of the State Service of Ukraine on Medicines and Ms. Inna Demchenko, Deputy Head of the State Service in order to discuss issues of quality control and licensing of medicines. 

If you or one of your colleagues would like to participate in the Chamber Healthcare or IPR Committees Meetings and receive informational updates, please feel free to contact Yaroslava Marusyk, Chamber Healthcare Committee Coordinator or Oleksandr Chumak, Chamber Policy Officer.

Agenda was devoted to the following issues:

-Focus on goals, tasks and priorities of the Healthcare Committee in crisis time and under the increasing regulatory pressure

-Discussion of ideas for the Healthcare Committee’s work optimization, including more active co-operation with the US Embassy and Authorities to the benefit of the Healthcare Committee membership

-Elaboration of the approaches to the Healthcare Committee’s advocacy actions

-Discussion on improvement of communication within Committee and delegation of senior representative on behalf of the pharmaceutical company for consolidation of industry’s position

-Elaboration of better reaction mechanisms to crisis situations on the pharmaceutical market

Please click here to view the Minutes.

The agenda of the Meeting was devoted to the discussion of medicines' import substitution policy.

During the Meeting Mr. Sergiy Kalashnyk, Country Manager of Ukraine, Belarus and Moldova, Eli Lilly Vostok S.A., co-chair of the Healthcare Committee, initiated a discussion on the risks of implementation of medicines' import substitution policy for foreign pharmaceutical companies specializing in R&D based on the Draft Concept of the State Target Program “Development of Import Substitution Production in Ukraine and Substitution of Imported Medicinal Products by National, Including Biotechnological, Products and Vaccines” for years 2011-2021. He emphasized that it was important that this document provided protection of intellectual property rights of foreign pharmaceutical companies and ensured improvement of patients’ health by guaranteeing their access to quality and safe medicines. He underlined that the Draft Concept should exclude any possibilities for corruption schemes at the state procurement tenders.

Ms. Elena Petraneva, Medical Affairs Director, Sanofi-Aventis Ukraine LLC, noted that it was important to pay attention to the criteria that were to be applied in the governmental import substitution program. Their company was ready to provide price discounts at the state procurement tenders; however, this document did not provide transparency in realization of import substitution policy.

Mr. Arkadiy Lytvak, Corporate Affairs Manager, Pfizer, Healthcare Committee Secretary, mentioned that the Draft Law #7412 “On the Amendments to the Article 9 of the Law of Ukraine “On the Medicinal Products” regarding Bringing Registration Procedure of the Medicinal Products into Correspondence with the International Standards”  (passed in the first reading on April 19^th) proved further heightened governmental pressure on medicinal products’ import market.

Ms. Svitlana Postrygan, Associate, Arzinger, underlined that it was important to ensure inclusion of such terms as “data exclusivity” and “patients’ rights” into the State Concept.

In addition, such issues as IPR risks of import substitution policy, plans on advertising of medicines, plans of preferences for national producers of medicines, violations of GATT/WTO rules were covered at the Meeting.

The Members consolidated their position by agreeing that in general they supported the Draft Concept but in the current version the document did not protect the interests of foreign and Ukrainian pharmaceuticals’ producers, since it was important to establish favorable climate for development of the pharmaceutical market first which was only possible after adoption of the corresponding Law “On Medicinal Products”.

Therefore, it was agreed to prepare a Healthcare Committee position and address the President of Ukraine and the Minister of Healthcare of Ukraine in order to obtain the support of the Draft Concept from all market participants through its further development.

Additionally, Healthcare Committee Leadership discussed ways of improving communication among Members and efficiency of the Committee’s work.

In his presentation titled Discussion of Main Positions of the Law “On Personal Data Protection” Mr. Olexiy Mervinskyy, Head of the State Service of Ukraine on Personal Data Protection, outlined the most significant myths that exist regarding this Law from the point of view of the State Service. He also described key plans and objectives of the State Service of Ukraine on Personal Data Protection for 2011. 

During the discussion participants have expressed their interest in regulations in the sphere of personal data protection which are being developed now by the State Service, and terms of submitting for public consideration of the Draft Procedure of personal data processing in personal data bases. They were also interested in plans, prospects and expected terms of creation of the Databases State Register and the procedure for registration of personal data bases. 

Mr. Olexiy Mervinskyy stated willingness of the State Service to cooperate with business representatives while drafting regulations to encourage establishment of balance between personal data protection of individuals and interests of business. He expressed an idea to introduce classification of personal data bases. Presumably, the goal of such classification is to identify data bases which fall within the scope of the Law and those falling outside of the scope, and possibly to differentiate the registration procedures for different types of data bases.

According to Mr. Mervinskyy the Statute of the State Service is being drafted now and is planned to be adopted in the nearest future. 

It should be noted that some of the issues over which the Members had stated their concerns were not covered by Mr. Mervinskyy, since the official position of the State Service has not been formulated yet. 

Summarizing the results of the discussion, Mr. Borys Danevych, Partner, PARITET law firm, Co-Chair of Chamber Healthcare Committee, expressed readiness of the Committees to further develop cooperation with the State Service of Ukraine on Personal Data Protection in order to clarify some unresolved issues concerning the implementation of the Law of Ukraine "On Protection of Personal Data". The Chamber Committees will continue to actively monitor the information on legislation development in this area.

At the Meeting participants discussed upcoming changes due to the administrative reform in the regulatory authorities in the field of pharmaceuticals and medical devices as well as possible problems related to such restructuring in the authorities. Members shared their thoughts on anticorruption legislation initiatives of the Parliamentary Committee on issues of organized crime and corruption. 

As a result of the discussion of the Draft Order of the Ministry of Healthcare of Ukraine “On Amendments to the Procedure of Import of Non-registered Medicinal Products on  the Territory of Ukraine” placed on the official website on January 24, 2011 and the Draft Order of the Ministry of Healthcare of Ukraine “On Confirmation of Import/Export Procedure of Registered and Non-Registered Medicinal Products, Biological Samples for Laboratory Analysis and Accompanying Materials  for Conduction of Clinical and Pre-Clinical Trials on the Territory of Ukraine”, it was decided to receive the comments from the Members in order to provide the Ministry of Healthcare with suggestions regarding improvement of quality control issues of above-mentioned documents. 

Following the discussion of the Draft Law # 7007 "On the Amendments to Certain Healthcare Legislation" (as regards strengthening control of the turnover of medical products, food products for special dietary consumption, functional food products and dietary additives), it was decided to organize a meeting with representatives of All-Ukrainian Advertising Coalition in order to consolidate efforts against  the ban of advertising of pharmaceuticals and provide a solid argumentation to the Members of Parliament. It is the Chamber Healthcare Committee’s position that the issue of advertising of OTC medicines should be regulated but there should be no ban on advertising as such practice is absent in Western countries.

If you or one of your colleagues would like to participate in the Chamber Healthcare Committee Meetings and receive informational updates, please feel free to contact Yaroslava Marusyk, Chamber Committee Coordinator.

On Thursday, December 16^th the Chamber Healthcare Committee held its regular Meeting. 

Mr. Borys Danevych, Co-Chair of the Chamber Healthcare Committee, PARITET Law Firm, started Committee Meeting with discussion of response from the State Customs Service regarding usage of warning marking. 

Please click here to view the letter (UKR). 

According to the letter, the usage of warning marking is the right, not obligation of the trademark owner. 

Further, attendees had a vivid consideration of new anti-corruption legislation coming into force on January 1, 2011 and decided to work on the Draft Law which amends this legislation upon the text availability at the official Government website. The decision was also made to invite Head of the Academy of Medical Sciences to join efforts in this regard. 

Among other issues reviewed were the following: 

• New Personal Data Protection legislation – participants decided to prepare the letter asking to clarify certain provisions of the Law;
• Draft Law #7054 “On Amendments to Certain Legislative Acts of Ukraine on Clinical Trials of Medicinal Products” and Methodological Recommendations of the Central Ethics Committee on Insurance of Clinical Trials - participants deemed such developments as successful ones. 

Committee Leaders and Members of the Committee summed up the activities of the Chamber Healthcare Committee and defined the key priorities for 2011: 

• setting up the reimbursement of medicinal products in Ukraine;
• the new Law “On Medicinal Products”;
• IPR protection of medicinal products;
• quality control of medicinal products;
• registration of medicinal products;
• fighting the trafficking of medicinal products;
• consequences of administrative reform for healthcare sphere;
• clinical trials perspectives in Ukraine. 

Moreover attendees discussed their active involvement into preparation of 2011 Chamber analytical project “Partnership for Successfully Competing in the Global Economy” (Partnership)”. 

If you or one of your colleagues would like to participate in the Chamber Healthcare Committee Meetings and receive informational updates, please feel free to contact Yaroslava Marusyk, Chamber Committee Coordinator.

In support of the discussion among healthcare experts, Mr. Yuriy Gaidayev, Member of Parliament, suggested to establish a Working Group within the Parliamentary Healthcare Committee. The Chamber Healthcare Committee Leadership will join the Working Group and continue to work on the development of principles of reformation of the supply system of medicines, i.e. establishment of reimbursement system which is one of the top priorities for the Healthcare Committee.

The following questions were raised during the presentation:

• Why 20% VAT? Place of services supply rule
• Nature of clinical trials services
• Options to consider
• Court practice and opinion of the tax authorities
• Current legislation and the Tax Code

In particular, Mr. Oleg Shmal mentioned that clinical trials services are not directly mentioned in the VAT Law. Arrangement of clinical trials is a complex service comprising of various activities and may be treated as “consulting” or “data processing and supply of information”, which are VAT exempt.

The speaker informed the participants of the tax authorities’ position regarding clinical trials services. If treating services as consulting or data processing / supply of information, there is a risk of disputes with tax authorities as they use to narrow these concepts.

Please click here to view the Presentation (ENG).

During the discussion, the participants raised concerns that customs services in Ukraine take arbitrary decisions regarding importation of investigational products and expressed the necessity of valuation methods to be conducted according WTO regulations and world best practices.

The Members of the Healthcare Committee agreed on the need to raise awareness that Ukraine ought to hold its position as a participant of clinical trials that can provide social and economic benefits to the country.

As a result of the meeting, the participants agreed to develop Healthcare Committee’s position on taxation of clinical trials in the part of VAT on import of investigational products and send a letter to the Parliamentary Tax and Customs Policy Committee in which argumentation will be provided regarding the importance of competitiveness of Ukraine in terms of being the market for clinical trials, and therefore regarding the necessity to exclude import of investigational products from VATable transactions. It was also decided to present Committee’s experts opinion in the media in order to improve the situation and publicize advantages of clinical trials.

The Meeting titled Reforming the Ukrainian Healthcare System: First Steps to Be Taken provided a platform for discussion regarding priority steps to be taken in reforming the national healthcare system. It was aimed at sharing the best international practices based on British and Canadian experience.

Agenda included the following presentations by noted speakers:

Presentation “Healthcare Challenges for Ukraine” by Dr. Richard Styles, M.D. Family Physician, American Medical Centers.

Please click here to view the presentation (ENGL)

Presentation “Canadian and Ukrainian Healthcare Systems. Impressions, Comparisons, and Reflections” (based on MIM-Kyiv MBA Program in Healthcare Management internship in Canada) by Ms. Nataliya Dankovych, Director, “Neomed” Reproductive Medicine Center and Ms. Marianna Azarskova, Laboratory Director, ”Eurolab” Clinic

Please click here to view the presentation (ENGL)

 Presentation “Healthcare System Reform: Challenge, Path, Steps” by Mr. Myroslaw Kohut, Visiting Professor, MBA Program in Healthcare Management, International Management Institute (MIM-Kyiv).

Please follow the links to view the presentation (ENGL/UKR)

 The participants discussed a necessity of development of primary healthcare and the institution of family doctors in Ukraine as well as expressed their views on the challenges of electronic health information technologies introduction.

The Meeting was devoted to discussion of business climate in Ukraine, in particular IPR issues in pharmaceutical sector, with a participation of a distinguished guest Mrs. Christine Lucyk, a Senior Policy Advisor at the U.S. Department of Commerce Ukraine desk.

The vision of the Further Development of Pharma-Business in Ukraine was jointly developed and presented by APRAD and Chamber Healthcare Committee Leadership. 

Mr. Sergiy Kalashnyk, Country Manager of Ukraine, Belarus and Moldova, Eli Lilly Vostok S.A., Mr. Borys Danevych, Partner, Paritet Law Firm, and Mr. Yuriy Savko, Executive Director, APRAD, focused on the following issues: a need of a new Laws on Medicines, on State Medical Insurance and on Products of Medical Purpose; a necessity of re-shaping of IPR protection system and a specialized training for judges aiming to improve their knowledge of IPR cases; introduction of a state medical insurance system and implementation of a workable reimbursement model.

Especially, the speakers have emphasized that VAT for medicines should be introduced only after the establishment of a state medical insurance/reimbursement, but not before it.

As a result of the Meeting, Mrs. Christine Lucyk, a Senior Policy Advisor at the U.S. Department of Commerce Ukraine desk, has expressed a readiness for further cooperation, in particular on the regional level, and unveiled plans of further technical assistance to Ukraine in terms of IPR protection issues in pharmaceutical and other sectors of economy.

Please click here to view the Minutes.

1) Mr. Mykhaylo Yunko, LL.M., Noerr LLP, a guest speaker from Germany, made a presentation titled “Reimbursement of Medicines in Germany”. It was the first presentation of this kind made in Ukraine because the speaker has conducted a unique research by analysing legislative framework of functioning of reimbursement system in Germany and translated his findings into Ukrainian to share with the Chamber Members.

In his presentation, Mr. Yunko described the system of the state medical insurance, pointed out its main subjects and characterized relations between them. He also named a main legislation framework that regulates provision of medicines in Germany. Main principles of reimbursement and subjects of reimbursement have been also mentioned in the presentation, central place among which is occupied by the Joint Federal Commission (JFC). This body provides a detailed list of medicinal products that are subject to reimbursement on behalf of hospital funds and defines conditions of reimbursement according to the Fifth Book of the Social Code of Germany. In the process of decision-making, the JFC is guided by the Institute of Quality and Economic Efficiency in the Healthcare System (IQWIG). Mr. Yunko conducted a general legal analysis of the reimbursement conditions of different groups of medicinal products in Germany. Following the report, the participants engaged into an active discussion regarding the possibility of introduction of the certain elements of the German reimbursement system in Ukraine.

For comparative analysis, please view the presentation on the healthcare costs in Poland kindly provided by the Swedish Trade Council (ENG).

2)     As a result of the discussion of perspectives of VAT introduction for medical drugs and products, medical equipment and medical services starting from January 1st, 2011, the Chamber Healthcare Committee Co-chair Borys Danevych, Paritet Law Firm, has prepared a letter addressing the Cabinet of Ministers of Ukraine in regards to VAT introduction  in order to develop a consolidated position on this issue.

Please click here to view the Minutes.