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