Association of Pharmaceutical Companies Representatives in Georgia www

Association of Pharmaceutical Companies Representatives in Georgia www. apcrg. org. ge APCRG, WASHINGTON DC, February 2011

APCRG Foundation APCRG was founded In July 2007 by: Actavis Berlin-Chemie/MENARINI Hoffman - La Roche Glaxo. Smith. Klaine Ipsen Pharma Les Laboratoires Servier Lek Pharmaceuticals Nycomed 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) 2010* 11 m source: MLHSA, www. moh. gov. ge source: National Statistics office of Georgia APCRG, WASHINGTON DC, February 2011

Pharmaceutical Market in Georgia More than 7 000 registered medicines (including different dosages and forms) More than 140 importers of medicines More than 3 000 pharmacies APCRG, WASHINGTON DC, February 2011 source: MLHSA, www. moh. gov. ge source: National Statistics office of Georgia

Development of Pharmaceuticals Import Structure in Georgia (top 7 countries) 1998 2010 TURKEY 31% source: MLHSA, www. moh. gov. ge APCRG, WASHINGTON DC, February 2011

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 = APCRG, WASHINGTON DC, February 2011 0)

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 statistics service an close cooperation with the private sector (signature of the Mo. U 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 Mo. U 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