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Business Studies & Analysis Center (BSAC) The Egyptian Pharmaceutical Industry February 2001 To purchase a copy of this study please contact the Business Studies & Analysis Center Address: 33 Soliman Abaza
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Business Studies & Analysis Center (BSAC) The Egyptian Pharmaceutical Industry February 2001 To purchase a copy of this study please contact the Business Studies & Analysis Center Address: 33 Soliman Abaza St., Dokki, Cairo, Egypt 5 th Floor Tel: (+202) Fax: (+202) Business Studies & Analysis Center. All rights reserved. Neither this publication or any part of it may be reproduced, stored in a retrieval system, or transmitted in any form or by any means without the prior permission of the Business Studies & Analysis Center. All information in this report is verified to the best of the Author s and the publisher s ability. However, the center does not accept responsibility from any loss resulting from reliance on it. The Egyptian Pharmaceutical Industry is considered one of the oldest strategic industries in the country. It was founded in 1939 with the establishment of Misr Company for Pharmaceutical Industries. The industry developed slowly between the 1960s and 1980s, following nationalization schemes, which brought the industry under full government control. With the launching of reform programs in 1991, pharmaceutical companies gained greater autonomy and an increasing number of private sector companies entered the market. At present there are 30 pharmaceutical producing companies of which 8 are public and 22 are private. The Egyptian Pharmaceutical market was valued at L.E. 4.1 billion in 1999; 94% of which is covered by locally produced products. Egypt is the largest producer and consumer of pharmaceuticals in the MENA region contributing to 30% of supply in the MENA market. The MENA region also absorbs most of Egypt s pharmaceutical exports, which represent approximately 6% of total production. The U.S. plays an active role in the industry through its contribution to foreign direct investment and pharmaceutical imports. Internal challenges facing the pharmaceutical industry involve the regulatory framework; quality assurance tests, research & development, market fragmentation, limited health insurance coverage, and the presence of production contracts. External challenges involve the implementation of GATT & TRIPS as well as global competition. Despite these challenges, the Egyptian pharmaceutical market is expected to grow at an accelerated rate to reach L.E. 5 billion in Strong investment opportunities exist in therapeutic groups and application of e- commerce is starting to develop. Nonetheless removing challenges faced by the industry will, no doubt, accelerate performance and improve the overall outlook. This study provides a general overview of the Egyptian Pharmaceutical Industry in terms of its structure, market profile, the current challenges, future outlook and investment opportunities. It serves as an indicator to the current and expected performance of the industry for potential investors. Moreover, the study recommends certain guidelines to face internal and external challenges and boost industry performance. Sector Highlights! The private sector dominates over three-quarters of the local market.! The five largest pharmaceutical companies dominate approximately one third of the market.! There are eight multinational corporations operating in the industry and accounting for over one third of total private sector sales.! Egypt is the largest producer and consumer of pharmaceuticals in the MENA region, capturing one third of the MENA market.! The U.S. plays an active role in the industry through its contribution to investment and imports.! Local production covers approximately 94% of the domestic market.! Europe supplies the lion s share of Egypt s pharmaceutical imports.! Exports comprise approximately 6% of pharmaceutical production Table of Contents LIST OF TABLES AND FIGURES LIST OF ACRONYMS v vi INTRODUCTION 1 Global Outlook 1 Egyptian Pharmaceutical Industry: Historical Background 2 INDUSTRY FRAMEWORK 4 Ownership Structure 4 Public Sector Companies 4 Private Sector Companies 6 The Arab Company for Drug Industries and Medical Appliances (ACDIMA) 6 Local Private Sector 7 Multinationals 7 Privatization 8 Regulatory Environment 9 Pricing Policy 9 Registration System 9 Registration & Pricing Procedures 11 Import Regulation 11 Intellectual Property Rights (IPR) 12 MARKET PROFILE 13 Local Production 14 Trade 15 Investment 17 U.S. Participation in the Pharmaceutical Market 18 CHALLENGES FACING THE PHARMACEUTICAL INDUSTRY 20 Internal Challenges 20 Regulatory Framework 20 Quality Assurance Tests 20 Research & Development 20 Market Development 21 Backward Linkage 21 Health Insurance Coverage 21 Production Contracts 21 External Challenges 21 Application of the GATT & TRIPS 21 Global Competition 23 FUTURE OUTLOOK & RECOMMENDATIONS 24 Future Outlook 24 Industry Growth 24 Investment Opportunities 25 Electronic Commerce 26 Recommendations 27 Enhancing the Regulatory Framework 27 Strengthening Research & Development 27 Improving Quality Standards 27 Encouraging Foreign Direct Investment (FDI) 27 Enhancing Health Insurance Coverage 28 SELECTED REFERENCES 29 APPENDICES 30 Appendix 1: The Egyptian Pharmaceutical Industry (Organization Chart) 31 Appendix 2: Registration & Pricing Procedures (Flow Chart) 32 Appendix 3: Registration Application Form 33 Appendix 4: Egypt's Draft Law On Issuing Patents, Exploitation Models, Projection Designs For Integrated Circuits, Confidential Information, And Geographical Indicators: Patents 37 Appendix 5: Agreement On Trade Related Aspects Of Intellectual Property Rights (Trips): Patents 39 Appendix 6: SWOT Analysis 42
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