Transcript Document

ACTIVITY of
ASSOCIATION of INTERNATIONAL
PHARMACEUTICAL MANUFACTURERS
In the period 2008-2011years
Goal of Association’s activity –
Assistance to Association’s members in economical and legal
activity aiming at development of an organized and open modern
ethical market of pharmaceutical products and medical equipment
on the territory of the Republic of Belarus;
Assistance in development of ethical standards of activity on
the pharmaceutical market of the Republic of Belarus.
Statutes of AIPM, section 2, p. 2.1
DEVELOPED AND APPROVED:
 Cooperation Agreement with Association of ethical pharmaceutical
manufacturers (EFA) Republic of Lithuania.
 At the stage of approval Cooperation Agreement with the Ministry of
Trade of the Republic of Belarus.
 Cooperation Agreement with Association of international pharmaceutical
manufacturers in Ukraine.
(During the period of 2005-2008 the Cooperation Agreement with the Ministry of
Healthcare of the Republic of Belarus , the Cooperation Agreement with RUE
“ Center of Expertise and Trials in healthcare”, “Pharmabel”, the Protocol on
cooperation with the Standing Committee on healthcare, physical culture, family
and youth services of the House of Representatives of the National Assembly were
approved).
There are working groups in Association:
On working up the current questions for discussion with the representatives
of the regulatory bodies and for development of the proposals on additions
and amendments to the Laws of the Republic of Belarus and to the
Resolutions of theSoviet of the Ministers of the Republic of Belarus and the
Ministry of Healthcare on the questions of the medicines’ circulation and the
medicine registration and quality control system’s improvement .
On working up the current questions to discuss with the representatives of
the regulatory bodies and to develop e the proposals on additions and
amendments to the Laws of the Republic of Belarus and to the Resolutions of
theSoviet of the Ministers of the Republic of Belarus and the Ministry of
Healthcare on protection the rights of intellectual property on medicines.
On questions of ethical promotion of medicines and cooperation of
companies’ medical representatives with the representatives of regulatory and
legislative bodies of the Republic of Belarus.
Activity of working groups is aiming the realization
of main goals of Association.
Main directions and annual plan of activities
were determined for realization AIPM’s goals (on
the results of AIPM members’ opinions)
 Assistance in the establishment of ethical market in the Republic of
Belarus.
 Assistance in the development of the efficient structure of drug usage
(assessment of healthcare technologies).
 Assistance in the establishment of legal system of protection of the
intellectual property in the field of pharmacy.
 Development of Association’s image as an expert (analyzing of legal
and legislative acts in pharmaceutical sphere, international cooperation
and partnership with the regulatory bodies on improvement of the
system of drug circulation and elaboration of the recommendations).
The work of the Supervisory Board, Secretariat and
working groups was to dissolve these problems.
For this period of time 37 meetings of Supervisory Board, 15 meetings of
Association’s members were hold.
Organized and hold working meetings:
•With the deputies of the House of Representatives of the National
Assembly of the Republic of Belarus - 5;
•With the authorities of the Ministry of Healthcare of the Republic of Belarus
- 3;
•With the authorities and specialists of RUE “Center of Expertise and Trials
in healthcare” of the Ministry of Healthcare of the Republic of Belarus - 5. (an
arrangement with the authorities of RUE “Center of Expertise and Trials in healthcare” about
meetings, as needed ,and conducting of educational seminars on the relevant issues for the
AIPM companies’ staff )
Assistance in the establishment of ethical market
in the Republic of Belarus.
In October 2010 the educational seminar for pharmaceutical companies
“Ethical drug promotion in the context of modern market” was organized
and hold together with the Ministry of Healthcare and the Ministry of Trade
of the Republic of Belarus.
The testing program on the knowledge of the “Code of Marketing
Practice” for the staff of the companies was brought in.
The questions on ethical drug promotion in the market of the Republic of
Belarus received wide coverage in the speeches of the members of the
Supervisory Board and the Secretariat at conferences and meetings.
Assistance in the establishment of ethical market
in the Republic of Belarus.
Draft Regulations “About public council on control of ethical drug
promotion in the Republic of Belarus” and “Practices of reasonable drug
promotion by pharmaceutical companies to healthcare professionals”
were completed with account of the remarks and directed to the Ministry
of Healthcare of the Republic of Belarus.
The situation on informing of healthcare by medical representatives was
constantly within sight of Supervisory board and Secretariat of the
Association (personal contact and correspondence with the authorities of
the Ministry of Healthcare).
IFPMA Council Meeting viewed the work of AIPM Belarus on
development of Code of marketing practice favorably (25-th IFPMA
Assembly 9-10.11.2010)
Assistance in development of qualitative structure
of drug consumption (assessment of healthcare
technologies)
Association is constant and active participant of the working meetings on
improvement of the system of registration and drug quality control in CIScountries with participation of the regulatory bodies.
Association’s made a motion to Inter-State Commission of CIS-countries on
elaborating recommendations on composition and renewal of national
catalogues «Essential Drug List»
Association has become an initiator of implementation into practical
healthcare pharmacoeconomical ways to assessment of drug use.
Association is successfully confirms its membership in International
Federation of Pharmaceutical Manufacturers and Associations and
represented in Directors’ Council.
Assistance in establishment of legal system of
protection of intellectual property in the field of
pharmacy.
The questions of protection of intellectual property for medicines were
discussed at the meeting of the working group, Supervisory Board’s
Assembly, at the meetings with the representatives of regulatory and
legislative bodies of republican and international levels.
In cooperation with ARS “LeksPatent” the analysis of condition of
protection of intellectual property was carried out and made forward
proposals during the working-out of the amendments and additions into the
relevant Laws of the Republic of Belarus.
In cooperation with the department of management and healthcare
organization of the humanitarian faculty of the Belorussian State University,
ARS “LexPatent” the preparation of the brochure «Innovative drugs and
intellectual property. The problems of security».
Development of the Association’s image on the
basis of international cooperation and partnership
with the regulatory bodies
Organization and carrying out the joint meetings, seminars, conferences,
symposiums, international forums, and also participating in International
forums, in international commissions on the problems of harmonization of
legislation in the sphere of drug circulation.
Under the Associations the Belorussian department of International
Society for Pharmacoeconomics and Outcomes Research (ISPOR Belarus)
was established.
The Association was an initiator of establishment of the Committee on the
problems of drug circulation in CIS-countries under “Business Centre of
economic development of CIS” (Chairman of the Committee–executive
Director of AIPM Belarus Sychev A.N.)
Development of AIPM image on the basis of
cooperation with the regulatory bodies
Development of the Association’s image on
the basis of international cooperation
The international forums were organized and
carried out:
2011 – Scientific practical symposium «Harmonization of the requirements
to pharmacovigilance in CIS-countries» together with educational seminar
2010 – Scientific practical symposium «Medicine for the human goods»
together with educational seminar
2009 –Scientific practical symposium “Pharmaceutical markets of the postSoviet countries. Global problems – global resolutions"
Development of AIPM image on the basis of
cooperation with the regulatory bodies
The educational seminars were organized and carried out for the staff of
the companies-AIPM members:
 «General rules of collection and provision of the information about the
detected facts of drug side effect in the Republic of Belarus»
 «Ethical drug promotion on the modern market»
 «Foundations of restrictive drug lists in the Republic of Belarus. Clinical –
economical expertise»
 «Realization of clinical trials in the Republic of Belarus»
 AIPM and Ministry of Healthcare in the Republic of Belarus «Expertise of
the results of clinical and pharmacoeconomical studies of the
assessment of the effectiveness of medical technologies».
Development of AIPM image on the basis of
international cooperation and partnership
with the regulatory bodies
AIPM’s representatives actively participated (presentations,
speeches)in the work of 40 international forums (assemblies,
conferences, meetings).
The Association actively cooperated with Scientific
Research Institute of clinical economic expertise and
pharmaeconomics of Russian State Medical University on
implementation of the ABC/VEN method and DDD analysis, program
medical systems, based on the healthcare technologies assessment,
into the practice of healthcare.
AIPM organized the next studies:
Scientific research “Study of particularities of drug consumption by the
population in the Republic of Belarus”;
(Е. Е Kuchko, I. V. Levitskaya, L.V.Solovieva. BSU, State Institute of management and social
technologies, «Public opinion»)
Forecasting analysis of social and economic development of the Republic
of Belarus and pharmaceutical sector for 2011- 2012 years.
(D.Kruk, Belorussian economic research-educational center (BEREC); D.Petrovich “Intellyx-М")
In 2010 modernization of the web-site and organization of mail-out were
carried out
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RESUME
For the period to date to compare with the previous one the number and
quality of meetings on discussion of main problems with the
representatives of the regulatory bodies were substantially increased.
To improve the effectiveness of realization of the goals the committees
were reorganized into the working groups according to main directions
of AIPM activities.
Cooperation with RUE “Center Expertise and Trials in healthcare” has
become dynamic and practical.
AIPM participation in international events on the questions of drug
circulation (at the WHO, IFPMA, CIS, Associations level) as an expert
was increased profoundly.
CONCLUSIONS
ACTIVITIES
2008-2011
Common meetings
15
Supervisory Board’s meetings
37
Meetings with:
Deputies of House of Representatives4
Authorities of Ministry of Healthcare 3
Authorities of “Centre of Expertise
and Trials”
5
Belbiopharm
1
Pharmatsia
0
Educational seminars
5
Studies
2
Participation in international
forums (assemblies, congresses,
conferences, meetings)
30
2005-2008
12
22
4
0
3
0
2
1
0
12
Collective publications
3
0
Web-site modernization
Organization of mail-out
+
+
-
PROSPECTS
 Accomplishment of work on realization of AIPM’s proposals to include them into
normative and legislative acts on protection of intellectual property on medicine in
the Republic of Belarus.
 Generalization of international experience and development of proposals for
normative documents about individual visits of medical representatives to
specialists of healthcare to get the information on facts of the detected drug sideeffects.
 Setting strategy of preferences of original medicine and branded generics into
practice of national healthcare.
 Signing of partnership and cooperation agreement with the Department of
pharmaceutical industry.
 Activization of work on foundation and participation of AIPM members in the
Council on development of the national pharmaceutical industry.
 Signing of partnership and cooperation agreement with Belorussian Association of
Doctors (foundation of public council, working groups).