Upload
julius-gilmore
View
216
Download
0
Tags:
Embed Size (px)
Citation preview
Association of Pharmaceutical Companies Representatives in
Georgia
APCRG, WASHINGTON DC, February 2011
www.apcrg.org.ge
APCRG Foundation
APCRG was founded In July 2007 by:
Actavis Berlin-Chemie/MENARINI
Hoffman - La RocheGlaxoSmithKlaine
Ipsen PharmaLes Laboratoires Servier
Lek PharmaceuticalsNycomed Osteuropa marketing Service
Novartis -Pharma service Pfizer Luxembourg Sarl
Sanofi Aventis group
APCRG, WASHINGTON DC, February 2011
Association of Pharmaceutical
Companies Representatives Member Companies
APCRG, WASHINGTON DC, February 2011
International recognition of Association ( APCRG)
November 25, 2009 - APCRG became an official Member of IFPMA ( International Federation of Pharmaceutical Manufacturers and Associations) IFPMA –Geneva, Switzerland
APCRG, WASHINGTON DC, February 2011
Development of Pharmaceutical Market in Georgia (commercial import value in USD)
APCRG, WASHINGTON DC, February 2011
020 000 00040 000 00060 000 00080 000 000
100 000 000120 000 000140 000 000160 000 000180 000 000200 000 000
1996 1998 2000 2002 2004 2007 2009 2010* 11m
source: MLHSA, www.moh.gov.ge source: National Statistics office of Georgia
Pharmaceutical Market in Georgia
APCRG, WASHINGTON DC, February 2011
More than 7 000 registered medicines (including different dosages and forms)
More than 140 importers of medicines
More than 3 000 pharmacies
source: MLHSA, www.moh.gov.ge source: National Statistics office of Georgia
Development of Pharmaceuticals Import Structure in Georgia (top 7 countries)
APCRG, WASHINGTON DC, February 2011
RUSSIA 21 %
FRANCE 17 %
HUNGARY 17%
GERMANY 14%
UKRAINE 13%
SLOVENJA 9 %
CZECH REP 9%
GERMANY 15%
FRANCE 13%
SWITZERLAND 12%
UKRAINE 10%
HUNGARY 10%
USA 9%
TURKEY 31%
1998 2010
source: MLHSA, www.moh.gov.ge
Pharmaceuticals Regulations Development Steps in Georgia
• Decentralization of state drug supply 1989• Privatization of pharmaceutical bodies 1990• Implementation of first drug law 1992
(Georgia was the first former Soviet Union country adopted new drug law prepared following WHO recommendations )
• Creation of “Essential Drug” list and “National Formulary” 1993• Certification of pharmaceutical activities 1994 • Liberalization of drug import and turnover 1996 (VAT=0% )• Revising of Drug law 1997• Simplification of Drug import certification 2000• Revising of “Essential Drug” list 2005• Cancelation of drug import license system 2006• Revising of Drug law 2009
APCRG, WASHINGTON DC, February 2011
GEORGIA : CHANGES AND IMPROVEMENT OF THE
REGULATORY ENVIRONEMENT:
Since September of 2009 new law of Pharmaceutical Products brought as a result drastic simplification of the medicines registration (approval) procedures in Georgia :
-implementation of different approval (registration) modes
-minimum list of elements required
-low cost (350-1800 USD per product)
- minimum time period required (from 14 days to 3 months)
Participation of the private sector in law modification procedures
APCRG, WASHINGTON DC, February 2011
GEORGIA : CHANGES AND IMPROVEMENT OF THE
REGULATORY ENVIRONEMENT:
In the end of 2010 were adopted modification of two basic laws regulating business relationship and communication between healthcare authorities, healthcare workers and industry representatives
Goal of the modifications are: more protection of patients rights and creation of friendly and ethical environment for healthcare workers and industry representatives.
Participation of private sector in law modification procedures
APCRG, WASHINGTON DC, February 2011
GEORGIA : CHANGES AND IMPROVEMENT OF THE
BUSINESS ENVIRONEMENT:
Active participation and close cooperation between officials and private sector
Involvement of the industry representatives (APCRG) on the tax law and regulation modification procedures on the different stages Simplification of import and export procedures and minimization of
Import-export expenses (customs clearance of medicines = 0 )
APCRG, WASHINGTON DC, February 2011
EXISTING PROBLEMS
Weakness of the IP protection regulations (patent rights)
Lack of the statistical data
Weakness of the pharmaceutical products quality control state system
Absence of the treatment guidelines and prescription system
APCRG, WASHINGTON DC, February 2011
SOLUTION OF PROBLEMS: ON PROCESS
Complete reconstruction of the state statistics service an close cooperation with the private sector (signature of the MoU between State Statistics Department and APCRG)
Reconstruction of the National Intellectual Property Center Agency (SAKPATENTI) and involvement of the private sector on the existing regulations modification procedures (signature of the MoU between SAKPATENTI and Business Association of Georgia (BAG))
Close cooperation between Industry and Health Officials on the quality control system improvement issue
Ministry of Health works on treatment guidelines and prescription issues in cooperation with healthcare specialists and NGOs
APCRG, WASHINGTON DC, February 2011
SUMMARY
Georgia is a very attractive, perspective and safe country for the international pharmaceutical industry development .
From the geographical and political point of view it is a regional center for business development and business management in neighbor countries (Azerbaijan, Armenia ) as well
APCRG, WASHINGTON DC, February 2011
SUMMARY
Permanent improvement of the regulatory and business environment and intensive involvement of the private sector (industry representatives) in modification procedures, underlines willingness of the Government of Georgia to develop pharmaceutical market according to the modern and civil international standards.
All above mentioned points give very good background and even sign for international pharmaceutical companies not only to import, promote & distribute its products in Georgia, but also think about set up of the manufacturing facilities in Free Economic Zones created recently in Georgia.
APCRG, WASHINGTON DC, February 2011
Association of Pharmaceutical Companies Representatives
in Georgia
Welcome to Georgian Pharmaceutical Market!
Thank You!
APCRG, WASHINGTON DC, February 2011