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Lnur Armenian Pharmaceutica Idsty 2008 Armenian Pharmaceutical I ndust yr Investme tn Ha dn book MPI Union of Medicine UNION Producers & Importers Armenian Development Agency Acknowledgements: Thanks are given to the Ministry of Health, the National Statistical Service, the Scientific Center of Drug and Medical Technology Expertise, and the USAID-funded Financial Sector Deepening Project for their contributions in preparing this handbook. Disclaimer: The contents of this Handbook are derived from a variety of sources, have been researched with the utmost care and are believed to be accurate as of the beginning of August 2008. The purpose of the Handbook is to provide brief guidance to potential investors. It must not be used in place of professional advice. The Competitive Armenian Private Sector Project, the Armenian Development Agency and the Union of Medicine Producers & Importers cannot be held liable for the accuracy or implications of use of the information contained within. Photographs: Provided by: Esculap, Liqvor & Vitamax-E companies Preface With a tradition of fine chemical production, Armenia’s pharmaceutical industry has blossomed over the past decade into one of the country’s most dynamic sec- tors of the economy. Exports of pharmaceutical prod- ucts, for instance, have grown at an impressive com- pound annual growth rate of 50% during the past five years. Such growth has been largely founded on several critical factors: the skilled and highly educated work- force, an open and cooperative cluster comprised of enthusiastic entrepreneurs, significant domestic and foreign direct investment, and an appreciation and willingness to adopt international standards. Current producers focus largely on the production of generic drugs, although there are those producing branded products as well, which are gaining in popu- larity among both domestic and foreign markets. Quality assurance is a high priority and the industry has demonstrated a strong commitment to adopt inter- nationally accepted standards. Three producers are currently audited to good manufacturing practice (GMP) standards and others are at various stages in the process to implement GMP in the near future. The industry also benefits from a modern testing and inspection laboratory, which is ISO 9001-2000 certi- fied and approved by the World Health Organization and International Pharma- ceutical Federation. Although current production volumes are relatively small, opportunities exist for potential investors in: penetrating the large and growing markets of the CIS through existing free trade agreements, and utilizing small to moderate scale production facilities – ideal for low volume, high value production. We believe Armenia’s pharmaceutical industry will continue to expand and grow, and we welcome your participation in this emerging and vibrant sector. Nerses Yeritsyan Minister of Economy 1 Introduction This Pharmaceuticals Investment Handbook has been prepared for foreign investors considering entry into the Armenian pharmaceuticals market and is designed to provide enough information to make a decision on whether invest- ment is a potential option for you. It is intended to highlight industry potential and recent performance, backed up by quantitative and qualitative data. The handbook also suggests investment competitive advantages & opportunities and provides details of investment incentives. Given the country’s prominent history in the fine chemicals industry, the suc- cess of existing pharmaceutical manufacturers and the high skill levels of the workforce, Armenia is worth your consideration for investment; particularly in the areas of equity investment and contract manufacturing for local distribution and export. Armenia’s domestic market may be small but it neighbors the large and fast- growing market of the CIS. Additionally, only 10% of the local market is current- ly served by domestic production. Opportunities also exist for manufacturing low-volume specialized drugs that larger producers find uneconomical to pro- duce. Whilst it is appreciated that investors will need to carefully consider a wide variety of factors, this guide should give the reader enough background information to assess investment potential, and enable them to move forward quickly with further research. Contact details of useful organizations are pro- vided to assist with gathering further industry insights. A general analysis of the economic environment and investment incentives is followed by a detailed review of pharmaceutical industry performance, the regu- latory environment, recent investments and investment opportunities. The third part of the handbook focuses on general information on the business environ- ment. 2 Table of Contents PART ONE – ECONOMIC PERFORMANCE & INVESTMENT INCENTIVES 1. Armenia’s Economic Performance ................................................................. 4 2. Investment Incentives ................................................................................... 14 3. Investor Assistance ...................................................................................... 17 PART TWO – PHARMACEUTICAL INDUSTRY PERFORMANCE, BACKGROUND & OPPORTUNITIES 4. Pharmaceutical Industry at a Glance ............................................................ 18 5. Key Competitive Advantages ....................................................................... 19 6. Armenian Pharmaceutical Industry ............................................................... 20 7. Export Markets & Opportunities .................................................................... 23 8. Pharmaceuticals FDI .................................................................................... 26 9. Legal Framework & Regulations .................................................................. 27 10. Quality Control & Assurance ...................................................................... 30 11. Workforce and Education ........................................................................... 30 12. Business Opportunities ............................................................................... 33 13. Pharmaceutical Industry Organizations ...................................................... 33 14. Sources of Pharmaceutical Industry Information ........................................ 35 PART THREE – ARMENIA'S BUSINESS ENVIRONMENT 15. Forms of Business Organization ................................................................ 36 16. Corporate Taxation ..................................................................................... 37 17. Individual Taxation...................................................................................... 39 18. Labor Relations .......................................................................................... 40 19. Intellectual Property .................................................................................... 41 20. Insurance .................................................................................................... 42 21. Business Financing .................................................................................... 43 22. Zoning, Land Use & Building Permits ......................................................... 44 23. Business Costs ........................................................................................... 44 24. Country Information .................................................................................... 45 3 1. Armenia’s Economic Performance International Rankings Armenia’s Standing in International Rankings Index of Economic Freedom (Heritage Founda- 28 (Rank among 157 countries), Mostly tion), 2008 free Ease of Doing Business (The World Bank), 39 (Rank among 178 countries) 2008 Best Countries for Doing Business (Forbes), 63 (Rank among 121 countries) 2008 Human Development Index (UNDP), 2007/2008 83 (Rank among 177 countries) Global Competitiveness Index (World Econom- 93 (Rank among 131 countries) ic Forum), 2007/2008 According to the Heritage Foundation’s 2008 Index of Economic Freedom, Ar- menia is classified as ‘Mostly Free’ and ranks 28th place (out of 157 coun- tries) ahead of Austria, Spain, Georgia, Norway, the Slovak Republic, the Czech Republic, Hungary, Israel & France. Such an impressive ranking results from the following: 1) Short period of time in starting a business – 18 days versus the average of 43 days 2) Quick turnaround on issuing a business license – only 19 proce- dures and expected time for completion is half the world aver- age of 234 days 3) Low average trade tariff of 2.5% 4) Low taxation – overall tax revenue as percentage of GDP is 17.3% 5) Low government spending – only 21.3% of GDP 6) Low inflation – averaging 2.3% between 2003 and 2005 (3.7% between 2001-2007) 7) Equal rights for Armenian and foreign investors 8) Liberal trade regime 9) Flexible labor market 4 In fact for eight out of the ten indicators used by the Heritage Foundation, Armenia scores higher than the world average and CIS average. Economic Freedoms – Average Rankings for Armenia, the CIS and World Labor Freedom Freedom from Corruption Property Rights Financial Freedom Investment Freedom World Monetary Freedom CIS Government Size Armenia Fiscal Freedom Trade Freedom Business Freedom 0 20406080100 Source: Heritage Foundation, 2008 Armenia’s position in the Index of Economic Freedom increased by 2 places compared to 2007. Five years ago it was ranked in 37th place. Ten years ago it was in 117th position – remarkable progress in a relatively short period of time. Armenia’s
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