1. Insurance / Reimbursement / Insulin
2. Investment conferences
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First annual conference – 2006
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Second annual conference – 2007
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Third annual conference – 2008
3. Code of Conduct – Rules of Promotion
4. Farmsodruzhestvo and IGC CIS (Intergovernmental Commission of the Commonwealth of Independent States)
5. Anti-counterfeit activities
6. Normalization on the market of generics
Insurance / Reimbursement / Insulin
- Support of the Obligatory Medical Insurance System implementation.
Round table. The implementation of the obligatory medical insurance in Ukraine was defined as one of the most urgent problems and the lead of the highest priority in the activity of the Committee in 2007. In order to contribute to health care reforms the Committee initiated a project “Medical insurance and reformation of Ukraine’s health care system” with the main objectives to elaborate and implement the obligatory medical insurance system, develop the reimbursement system and improve the private medical insurance sector. The Committee set up a working group supervised by a highly professional expert. In order to enforce the realization of the project, an external expert was invited to take part in the process. During this period the Committee provided the analysis of the legislature in force as well as the analysis of the Draft Laws, which are on consideration of the Verkhovna Rada. The existing world insurance systems have been examined.
In June 2007 a round table was held. It comprised the representatives of the insurance companies, which provide the services of private medical insurance. The results helped to receive a number of strategic steps, the realization of which make the implementation and development of the healthcare system possible.
Conference. Regarding the Heath Care Committee priorities for 2008, on 15 April 2008 the Conference took place and completed this phase of the EBA HCC project on developing and implementing the obligatory medical insurance in Ukraine.
The event gathered officials from National Insurance Company of Moldova, representatives from Ministry of Health of Poland and a health care expert from Finland, as well as Head of the Health Care Parliamentary Committee Mrs Bakhteeva, Deputy Minister of Health Mr Rybchuk and other representatives from the governmental authorities and pharmaceutical companies. Following up the Conference, the EBA Health Care Committee laboured and put forward its view on this issue.
The Conference was broadcast on TV, printed and Internet media.
- Development of the Reimbursement system in Ukraine
Working group. In the beginning of 2007 the Committee applied to state organs and to the Verkhovna Rada with the initiative of creation and development of the reimbursement system. This initiative was met with great concern and readiness for cooperation.
An appropriate analysis of the Ukrainian legislature has been conducted. All existing models of reimbursement in Europe have been worked up. As a result – all the materials were submitted to the appropriate state organs. The process is continuing up to date.
There was created a working group under the Ministry of Health, which was aimed at the development and of the state reimbursement system of medical drugs (insulin) for patients diseased with diabetes (approved by the Order of the Ministry of Health No 188 dated of 08.04.08).
This year the EBA HCC was also a partner of the forum Conference APTEKA 2008 (27-28 May 2008) in order to maintain the cooperation. The Committee attended the session centring on the reimbursement issues. The Committee commented on the role pharmacies tend to play in the reimbursement practice as well as considered Lithuania’s scheme of drugstores dealing with reimbursement. Health Care Committee is an active participant of the group.
Investment conferences
Code of Conduct – Rules of Promotion
The Committee Marketing Practice Code - rules of pharmaceutical products promotion to the Ukrainian market have been worked out and approved by the participants of the Committee in 2004.
In 2006 EBA publicized an initiative to produce the document, which will influence not only the EBA HCC member-companies, but also all the pharmaceutical market players.
In December 2006 according to the Order of the Ministry of Health of Ukraine a working group has been created. The representatives of the state organs, NGOs and of the EBA Healthcare Committee became the members of this group.
Improving a system of permission and circulation of medical products in the Ukrainian market and enhancing the legislation in the sector, the Committee considered: Rules of Promotion. The EBA Marketing Practice Code was taken as a pattern.
Press-conference 31 January 2008. On 31 January 2008 the State Service of Medical Drugs and Medical Devices of Ukraine initiated the Press-conference “Presentation of Rules of promotion of medical drugs by pharmaceutical companies and health care professionals” at LIGABusinessInform.
During the press-conference the Rules of Promotion of Medical Drugs by Pharmaceutical Companies and Health Care Professionals were officially presented to the wide audience and mass-media. The main goal of these Rules is the establishment of ethic of promotion of medical drugs and medical devices to the pharmaceutical market of Ukraine. Deputy Minister of Health Care, Mr Mytnyk stressed on the important role, played by the ethical regulations in the day to day activity of health care professionals.
Presented Rules had been worked out by the working group founded in the State service of medical drugs and medical devices with an initiative of NGOs. During their elaboration the experience of the existing in Europe regulation system had been taken into consideration. Those companies, which supported this initiative, are to sign the Memorandum of accession. There was decided that the regulative organ on the implementation of rules will be a Social Council under the direction of State Service of medical drugs and medical devices.
These Rules will have the voluntary character. This is the beginning of the work on the Ethical Code of the pharmacist. Rules will become the integral part of it.
Press-conference 24 June 2008. On 24 June 20008 State Service of Medical Drugs and Medical Devices of Ukraine in conjunction with the European Business Association initiated the Press-conference to mark an official ceremony of signing the Rules on promoting medical drugs performed by pharmaceutical companies and health care professionals at LIGABusinessInform.
The press-conference members presented the list of companies that have already signed the Memorandum to the wide audience and mass-media. Also the key participants of the press-conference outlined the next steps to be made to start implementing the Rules. Moreover they noted that these Rules constitute a prerequisite for regulating and adjusting Ukraine’s pharmaceutical market.
Deputy Minister of Health Viktor Rybchuk marked that it is essential for health care professionals to stick to an ethical code in their day-to-day activities.
European companies combined their efforts with the members of the Ukrainian Association of Pharmaceutical Manufacturers and Association of the Pharmaceutical Research & Development to design, elaborate and implement the Rules.
The Ministry of Health representatives stressed that the Rules, when brought to effect, will signify another step forward in adapting and adjusting the Ukrainian legislation to the European standards.
The working group set up and run by the State service of medical drugs and medical devices jointly with the NGOs initiative worked out the Rules complying with the current European regulation system. Social Council under the State Service of medical drugs and medical devices was elected a body supervising and running the implementation procedure.
The Rules originate from a voluntary basis. According to Deputy Chief of the State Service on Medical Drugs, the signing of the Memorandum is a first step in designing and developing the Pharmacist’s Ethical Code whereas the Rules are to be the integral part of the Code.
List of companies, which signed adhered the Rules of promotion by means of signing the Memorandum:
- Actavis
- Alcon Pharmaceuticals Ltd
- Arterium Corporation
- AstraZeneca UK Limited
- Beaufour Ipsen Pharma
- Berlin-Chemie / Menarini
- BHFZ
- Bionorica
- Boehringer Ingelheim GmbH
- Brupharmexport
- Delta Medical
- Dr. Falk Pharma, Gmbh
- Egis Nyrt
- FIC Medical
- GlaxoSmithKline
- Hoffmann-La-Roche
- IVAX
- Laboratoire Innotech International
- Les Laboratoires Servier
- Novo Nordisk
- Nycomed
- Orion Corporation
- Pharmonyx Limited
- Polpharma
- Ratiopharm
- Santen Oy
- Schering-Plough Central East AG
- Solvay Pharma
- Sona-Pharm
- TEVA Pharmaceuticals LTD
- Vitamed d.o.o.
- Woerwag Pharma GmbH & Co. KG
- Zentiva
Farmsodruzhestvo and IGC CIS (Intergovernmental Commission of the Commonwealth of Independent States)
Farmsodruzhestvo. In 2006 the Committee started its cooperation with of Farmsodruzhestvo (PharmCommonwealth) project. Main purpose of such collaboration refers to joint actions against counterfeit products, pharmacovigilance and implementation of ethics standards in promotion of pharmaceuticals.
On 08 September 2006 the Committee together with the Association of Pharmaceutical Manufacturers of Ukraine and Information Agency "Remedium" hosted the First International Forum “PharmaCommonwealth – Common Space for Professionals”. The Forum was held with support of the Ministry of Health of Ukraine, State Services for Drugs and Medical Devices of the Ministry, State Pharmacological Centre of the Ministry of Health of Ukraine. The Forum welcomed representatives of different associations of pharmaceutical manufacturers and distributors from Kazakhstan, Belarus, Russian Federation and Ukraine. Officials from the Ministry of Health of Ukraine and relevant Ukrainian regulatory bodies are invited as well.
There Forum included following sections: harmonization of the regulatory requirements to circulation of the pharmaceutical products; issues of the pharmaceutical quality, prevention of the counterfeited products distribution; the professional Association role in the pharma industry development and etc.
On 25-26 April 2007 the Second International Forum PharmCommonwealth “PharmCommonwealth – united space for professionals” was held in Almaty. More than 150 people – representatives of state organs, pharmaceutical industry and associations, producers and distributors from all over the CIS - participated in this event. During this Forum there was stressed on the need to consolidate the efforts and effective actions coordination for those companies, which plan to continue their business leeding.
On 27-28 March 2008 the representatives of the EBA Health Care Committee participated in the Third International Forum PharmCommonwealth “Healthcare: State, Society and Business” held in Moscow (Russian Federation). The Forum was opened by the Head of the Council of the Federation Committee on Social Policy and Healthcare Issues.
Two-days-Forum gathered representatives of the pharmaceutical associations from the CIS countries, government representatives from Russia, Kazakhstan, Georgia, Byelorussia, as well as the representatives of the EU Institutions. The leaders of the State Service of Medical Drugs and Medical Devises and State Pharmacological Centre of Ukraine represented the Ukrainian health care authorities.
During the Forum the following important issues were discussed: priorities and perspectives of the industry developments, legal and ethical issues of the pharmaceutical business, the issues of the intellectual property rights protection in pharma sector, medical drugs quality and effectiveness, the role of the industrial associations in the pharmaceutical market.
It was stressed that the Ukrainian legislation was one of the most harmonised with the EU one and world standards especially on the issues of the access to the Ukrainian market and ethical promotion. And the EBA Health Care Committee presented its view on the role of the industrial associations in the pharmaceutical market development.
Meeting of the CIS Industrial Pharmaceutical Associations. On 19.07.07 the working meeting of the representatives of the Industrial Pharmaceutical Associations, integrated into the PharmCommonwealth Project, was held in Minsk (Belarus). The leaders of the EBA Health Care Committee, the Association of International Pharmaceutical Manufacturers (Belarus), the Association of Foreign Pharmaceutical Companies' Representatives in Kazakhstan and the Association of International Pharmaceutical Manufacturers in Russia took part at the meeting. The Councilor of the Department for Humanitarian Cooperation, General Political and Social Issues of the CIS Executive Committee, Mr Georgiy Narushevich was also present.
During the meeting participants discussed issues dealing with evaluation of technology in the health care sector, intellectual property rights protection and ethical aspects of the pharmaceutical products promotion rules.
Regarding evaluation of medical technologies, it was noticed that it was essential to create and develop general components of medical technologies guaranteeing the high technological level of medical aid to each patient. Such general components are national treatment standards, the List of Essential Pharmaceutical Products and selection criteria of products financed from state social and insurance funds.
It was agreed to address the Pharmaceutical Products CIS Standards Committee and national health care regulatory bodies with the recommendations to use as a base relevant EC Directives, Codes of Promotion developed by Associations as well as impellent Pharmaceutical Products Promotion Rules on national levels.
The EBA Health Care Committee proposals on harmonisation on CIS level. On 28 May 2008 the next meeting of the Intergovernmental Commission on Standard, Registration and Quality Control of the Medical Drugs, Medical Devices of the CIS member-states was held in Issyk Kul (Kyrgyzstan).
Rules for Promoting of Medical Drugs by Pharmaceutical Companies to Health Care Professionals developed and adopted in Ukraine was presented there as a case on behalf if Industrial Associations of EBA Health Care Committee, Byelorussia Association of International Pharmaceutical Manufacturers and Association of Representatives of International Pharmaceuticals Manufacturers. Such presentation was the result of the previous Intergovernmental Commission meeting was held on 19.10.07 (Moscow, Russian Federation).
Ukraine is the only country in CIS that adopted such ethical standard on governmental level, although on voluntary base. As a result of the Intergovernmental Commission meeting the Rules would send to the member-states for comments. Afterwards it is plan to proposed to develop the framework Rules of the Pharmaceutical Products Promotion for their further recommendation for implementation in the CIS member-states at the level of Intergovernmental Commission.
Anti-counterfeit activities
Draft on amendments to the Criminal Code of Ukraine was approved under the cooperation with the State Inspection of Medical Drugs Quality Control. The Committee proposed to change some statements based on the WHO and EC documents, namely Public Consultation in Preparation of Legal Proposal to Combat Counterfeit Medicines for Human Use (Key Ideas for Better Protection of Patients Against the Risk of Counterfeit Medicines) (EC, Brussels, 11 March 2008) and Principles and Elements for National Legislation against Counterfeit Medical Products (text endorsed by IMPACT General Meeting Lisbon, 12 December 2007). The Committee proposed to use the general policy envisaged in the documents. Ministry of Health helped to develop the Draft Law and submitted it to the relevant state authorities.
Normalization on the market of generics
In 2008 the dialogue with PIC/S (Pharmaceutical Inspections Cooperation Scheme) was brought to the new level. Health Care Committee of the European Business Association in conjunction with the State Service for Medical Drugs and Medical Devices worked out mutual action plan, according to which the meeting with the PIC/S authorities was organized and held. Within the frameworks of the meeting, which took place at Krakow (Poland) on 29 May 2008 the Head of the State Service for Medical Drugs and Medical Devices met the Chairman and the representatives of the Secretariat. The main purpose of the meeting was to define the final list of requirements and terms for Ukraine to receive the membership status. Following the results of the meeting, parties accorded the mutual action plan and terms of fulfilment.
Up to date the parties keep on working on this issue in response to the terms and actions as agreed.
The adherence of Ukraine to the PIC/S will launch the limitation and throw the manufacturers of the doubtfully qualified production back. It means that we can expect the normalization on the market of generics by means of unfair competition reduction. |
