Association of Pharmaceutical Companies Representatives in Georgia

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

2. APCRG Foundation APCRGwas founded In July 2007 by: Actavis Berlin-Chemie/MENARINI Hoffman - La Roche GlaxoSmithKlaine 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

3. Association of Pharmaceutical Companies RepresentativesMember Companies APCRG, WASHINGTON DC, February 2011

4. November 25, 2009 - APCRG became an official Member of IFPMA ( International Federation of Pharmaceutical Manufacturers and Associations)IFPMA –Geneva, Switzerland International recognition of Association( APCRG) APCRG, WASHINGTON DC, February 2011

5. Development of Pharmaceutical Market in Georgia (commercial import value in USD) 2010* 11m source: MLHSA, www.moh.gov.ge source: National Statistics office of Georgia APCRG, WASHINGTON DC, February 2011

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

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

8. 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 Pharmaceuticals Regulations Development Steps in Georgia APCRG, WASHINGTON DC, February 2011

9. 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 GEORGIA : CHANGES AND IMPROVEMENT OF THE REGULATORY ENVIRONEMENT: APCRG, WASHINGTON DC, February 2011

10. 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 GEORGIA : CHANGES AND IMPROVEMENT OF THE REGULATORY ENVIRONEMENT: APCRG, WASHINGTON DC, February 2011

11. 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 ) GEORGIA : CHANGES AND IMPROVEMENT OF THE BUSINESS ENVIRONEMENT: APCRG, WASHINGTON DC, February 2011

12. 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 EXISTING PROBLEMS APCRG, WASHINGTON DC, February 2011

13. 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 SOLUTION OF PROBLEMS: ON PROCESS APCRG, WASHINGTON DC, February 2011

14. 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 SUMMARY APCRG, WASHINGTON DC, February 2011

15. 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. SUMMARY APCRG, WASHINGTON DC, February 2011

16. Association of Pharmaceutical Companies Representatives in Georgia Welcome to Georgian Pharmaceutical Market! Thank You! APCRG, WASHINGTON DC, February 2011