BANU OGAWA SENIOR PROJECT DIRECTOR “HEALTH SECTOR OF TURKEY”
OUTLINE ØCOUNTRY PROFILE ØPHARMACEUTICAL MARKET; -MILESTONES -PRODUCTION -INTERNATIONAL SUCCESS -TOP 10 COMPANIES OF THE SECTOR -INTERNATIONAL RATING & TENDENCIES -REGULATION -ESTABLISHING A LOCAL OFFICE -REIMBURSEMENT, PRICING & DISTRIBUTION ØTURKISH HOSPITAL STRUCTURE ØR&D ØCOMMERCIAL INSURANCE ENVIRONMENT
COUNTRY INFORMATION 2007 2008 2009 70. 60 71. 5 NA GDP Growht, % 4. 70 0. 90 - 7. 00 Inflation (CPI), % 8. 39 10. 06 5. 08 Unemployment 9. 90 11. 00 12. 80 (as of 2009 July) Population (million) Source: TUIK, 2009
- PRESCRIBED PHARMACEUTICAL MARKET OF TURKEY - 2008 MARKET VOLUME (in bln. €) 6. 35 MARKET VOLUME (in bln. units) 1. 38 NUMBER OF PHARMACEUTICAL PRODUCTs IN THE MARKET 7 155 NUMBER OF PRESCRIBED PHARMACEUTICAL PRODUCTs IN THE MARKET 4 971 - HIGH LEVEL OF TECHNOLOGY & AUTOMATION -25 000 EMPLOYEES IN THE PHARMACEUTICAL SECTOR -RAPID GROWTH IN 5 YEARS Source: IEIS
- TURKISH PHARMACEUTICAL INDUSTRY: MILESTONES 2008 1952 -1972 q BEGINNING OF THE “INDUSTRIAL PERIOD” q FORMATING OF THE MODERN MANUFACTURING FACILITIES q RAW MATERIAL MANUFACTURING STARTS q 95% OF ALL PRODUCTS LOCALLY PRODUCED 1972 -1990 q STAGNATION PERIOD UNTIL 1984 q MULTINATIONAL COMPANIES LEAVING q INTRODUCTION OF GOOD MANUFACTURING PRACTICES 1990 -2003 q MARKET GROWING BY 10% PER YEAR q INSTABLE PRICING AND REIMBURSEMENT POLICIES SINCE 2004 q NEW PRICING REGULATION BASED ON REFERENCES PRICES q VAT RATE REDUCED TO 8% q NEW REGISTRATION REGULATION INTRODUCED q DATA EXCLUSIVITY FOR ORIGINAL PRODUCTS Source: IEIS
- TURKISH PHARMACEUTICAL SECTOR: PRODUCTION - § GOOD MANUFACTURING PRACTICES (GMS) APPLICATION § ALMOST EU-COUNTRIES COMPARABLE TECHNOLOGICAL LEVEL (EXCEPT BIOTECHNOLOGY AND A FEW NEW PHARMACEUTICAL BRANDS) § APPR. 300 ENTITIES OPERATING § 43 MANUFACTURING FACILITIES (INCL. 14 MULTINATIONAL FIRMS) Source: IEIS § MAJOR DISTRIBUTION REGION - MARMARA REGION, ESPECIALLY: - ISTANBUL - KOCAELI - TEKIRDAG § MAJOR TURKISH MANUFACTURERs: - EIS-ECZACIBASI - TEKIRDAG - ABDI IBRAHIM - FAKO - ILSAN-ILTAS - MUSTAFA NEVZAT - IBRAHIM ETHEM - BILIM
- TURKISH PHARMACEUTICAL INDUSTRY: INTERNATIONAL SUCCESS - § ILSAN-ILTAS IS WELL-KNOWN FOR ITS KNOW-HOW IN PELLET-DEVELOPMENT § MUSTAFA-NEVZAT PLANTS GOT INTERNATIONAL ACCREDITATION. IT IS A FIRST TURKISH PHARMACEUTICAL COMPANY. THE COMPANY SIGNED SEVERAL STRATEGIC PARTNERSHIP AGREEMENTS WITH LEADING US GENERIC COMPANIES FOR MARKETING AND SALES OF ITS PRODUTCS Source: IGEME § - EXPORT TO 140 COUNTRIES, INCL. : GERMANY USA UK SWITZERLAND THE NETHERLANDS
- TURKISH PHARMACEUTICAL INDUSTRY: TOP 10 COMPANIES ABDI IBRAHIM NOVARTIS SANOFI-AVENTIS BILIM GSK PFIZER BAYER ASTRA ZENECA EASTPHARMA SANOVEL Source: AIFD MAY 2009 1 018 957 693 642 640 626 530 496 475 456 GROWTH MARKET SHARE 21% 20% 7% 13% 21% 12% 11% 0% 12% 7. 1% 6. 6% 4. 8% 4. 4% 4. 3% 3. 7% 3. 4% 3. 3% 3. 2%
- TURKISH PHARMACEUTICAL INDUSTRY: INTERNATIONAL RATING 2000 1 2 3 4 5 6 7 8 9 10 11 12 13 14 USA JAPAN FRANCE GERMANY ITALY UK SPAIN CANADA BRAZIL CHINA MEXICO S. KOREA AUSTRALIA INDIA 2007 USA JAPAN FRANCE GERMANY ITALY UK SPAIN CANADA CHINA BRAZIL MEXICO S. KOREA TURKEY INDIA . . . 28 TURKEY Source: IMS Health 2012 USA JAPAN FRANCE GERMANY CHINA ITALY UK BRAZIL SPAIN CANADA TURKEY INDIA S. KOREA MEXICO SHARE OF GLOBAL SALES (2013) JAPAN 10 % ALL OTHERS 23 % EU 5 17 % USA 33 % PHARMER GING 17 %
- TURKISH PHARMACEUTICAL INDUSTRY: REGULATIONS ü PATENT PROTECTION ü DATA EXCLUSIVITY ü PRICING & REGISTRATION ü GOOD MANUFACTURING PRACTICES (GMP) ü GOOD LABORATORY PRACTICES (GLP) - THE PRODUCTION AND MARKETING OF ALL PHARMACEUTICALS MUST BE AUTHORIZED BY THE MINISTER OF HEALTH ü GOOD CLINICAL PRACTICES (GCP) ü BIO-AVAILABILITY / BIO-EQUIVALENCY ü PACKAGING LABELLING üPROMOTION / ADVERTISING üDRUG RESEARCH & MEDICINAL PRODUCT REGISTRATION üSTABILITY REQUIREMENTS üREGULATION ON GOOD DISTRIBUTION & STORAGE PRACTICES ü PHARMA-COVIGILANCE Source: IEIS - PHARMACEUTICAL PRODUCTS AND FIRMS MUST BE REGISTERED IN THE MINISTRY
- TURKISH PHARMACEUTICAL INDUSTRY: ESTABLISHING A LOCAL OFFICE 1. CONTROL OF COMPANY NAME AND TITLE 2. PREPARATION OF COMPANY MAIN CONTRACT 3. COMPANY ESTABLISHMENT (ADDITION TO LETTER OF APPLICATION & DOCUMENTS REQUESTED BY CHAMBER OF COMMERCE) 4. PAYMENT OF CHAMBER OF COMMERCE SHARE (4/10000 OF CAPITAL) 5. REGISTRATION OF COMPANY 6. PUBLICATION OF COMPANY IN TRADE REGISTRY GAZETTE 7. SIGNATURE SPECIMEN OF GENERAL MANAGER 8. APPLICATION FOR TAX ACCOUNT NUMBER 9. RECEIVING AND APPROVAL OF THE BOOKS 10. COMPOSITION OF EXAMINATION RECORD 11. RECEIVING TAX ACCOUNT NUMBER 12. PRINTING INVOICE, SHIPPING BILL AND EXPENSE BILL 13. REGISTRATION TO RELATED CHAMBERS 14. GETTING THE WORK PERMISSION CERTIFICATE, WEEKLY HOLIDAY CERTIFICATE Source: MINISTRY OF HEALTH
- TURKISH PHARMACEUTICAL INDUSTRY: REIMBURSEMENT, PRICING & DISTRIBUTION ü FDA DOSSIER NEEDS TO BE CONVERTED TO EU-CTD FORMAT ü PRE-FILLING: 3 MONTHS, INCLUDING TRANSLATION ü OFFICIAL TARGET: 240 DAYS ü REALITY: 18 -24 MONTHS FOR GENERICS, 24 -30 MONTHS FOR ORIGINALS ü GMP INSPECTION ! ü PRICE CONTROL BY MINISTRY OF HEALTH (REFERENCE PRICING SYSYTEM) ü MOSTLY REIMBURSED ü PHARMACY SALES ONLY ü DETAILING ONLY TO PROFESSIONALS & AD`S ONLY IN MEDICAL MAGAZINES Source: MINSITRY OF HEALTH Rx STATUS (18 -30 months) § EYE DROPS § PANSIRON BRAND MEDICINE § COLD REMEDIES § DERMAL MEDICINE § HAY FEVER
- TURKISH PHARMACEUTICAL INDUSTRY: REIMBURSEMENT, PRICING & DISTRIBUTION - DOSSIER SHOULD INCLUDE; ü FORMULA NON-Rx STATUS ü CONTROL OF STARTING MATERIALS (18 -24 months) ü MANUFACTURING METHOD ü FINISHED PRODUCT CONTROLS § EYE WASHES ü PIL § CONTCT LENS CARE ü INNER & OUTER PACKAGE NAMED AS “INTERMEDIATE PRODUCTS” PRICE CONTROL; o BY MINISTRY OF HEALTH Source: MINISTRY OF HEALTH
- TURKISH PHARMACEUTICAL INDUSTRY: REIMBURSEMENT, PRICING & DISTRIBUTION - FOOD SUPPLEMENTs DERMO-COSTMETICS (Ministry of Agriculture, 2 -4 months) (Ministry of Health, 2 -4 months) ü VITAMINS, MINERALS, HERBAL PRODUCTS ü LIP CARE ü REGULATORY PROCESS IS RELATIVELY SHORT ü PARFUMES ü NO PRICE CONTROL ü NO REIMBURSEMENT Source: MINISTRY OF HEALTH ü HAND / BODY / SUN CARE
- TURKISH PHARMACEUTICAL INDUSTRY: REIMBURSEMENT & PRICING (AS OF 18 TH OF MAY, 2009) SEGMENT DIFFERENCES ü REFERRED TO CHEAPEST EX-FACT PRICE AMONG ITALY, PORTUGAL, GREECE, SPAIN, FRANCE OR THE SOURCE (MANUFACTURING & SUPPLY) COUNTRY PRICE ü PLANTS TO EXPAND TO 10 COUNTRIES (POLAND & HUNGARY!) ü GREECE ALREADY REFERS TO HUNGARY; SO TURKEY REFERS INDIRECTLY TO HUNGARY Source: AIFD ü ORIGINALS WITH GENERICS - 60% OF REFERENCE PRICE ü ORIGINALS WITHOUT GENERICS – 100% OF REFERENCE PRICE ü ANY DECREASE IN REFERENCE COUNTRY PRICE SHOULD BE IMPLEMENTED IN 3 MONTHS ü €/TRY CONVERSION IS FIXED
- TURKISH PHARMACEUTICAL INDUSTRY: REIMBURSEMENT After registration, the product is be submitted to Social Security Institution (SGK) REIMBURSEMENT ü Rx Products are reimbursed as 80% ü Non-Rx category (food supplement and dermo-cosmetics) are not reimbursed ü Approval may take 3 -9 months ü Approval may be based on various restrictions ü SGK announces annual reimbursement rules (RUT) changing twice a year ü The reimbursement is 15% of original product price, if there is a generics as of 1 st of August 2009. The remaining sum is be paid by the patient MANDATORY DISCOUNTs (18 TH of September, 2009) ü 24% for Originals without Generics ü 11% for Originals with Generics ü 24% for Drugs categorized as 20 years old with an equivalent group and a retail selling price higher than TRY 10, - until a reference price is assigned Source: MINISTRY OF HEALTH
- TURKISH PHARMACEUTICAL INDUSTRY: DISTRIBUTION THERE ARE NO CHAIN PHARMACIES. A PHARMACIST CAN ONLY OWN ONE PHARMACY ALL DRUGS ARE TO BE SOLD IN PHARMACIES THE PHARMACIST SHOULD ALWAYS BE IN THE PHARMACY MANUFACTURER OR IMPORTER Source: MINISTRY OF HEALTH PHARMACEUTICAL WHOLESALER ONLY SOME VITAMINS ARE SOLD IN GROCERY STORES LICENSED BY MINISTRY OF AGRICULTURE INSTEAD OF MINISTRY OF HEALTH PHARMACIES
- TURKISH PHARMACEUTICAL INDUSTRY: HOSPITALs - - TURKISH HOSPITAL STRUCTURE (2008) - PUBLIC PRIVATE NUMBER OF HOSPITALS 894 400 NUMBER OF BEDS 138 217 20 938 SHARE 87% 13% - NUMBER OF DOCTORS IN TURKEY (2006) Mo. H 2000 2006 1 205 HOSPITALS WITH 192 685 BED CAPACITY (2006) MEDICAL SCHOOLS PRIVATE TOTAL 17 655 23 808 7 204 10 447 4 226 6 786 290 852 41 041 AN IMPORTANT NEW TREND: ATTRACTING PATIENTS FROM EUROPE (MAINLY, UK) OR MIDDLE EAST FOR A TREATMENT IN TURKISH PRIVATE HOSPITALS Source: MINISTRY OF HEALTH AVERAGE CAPACITY UTILIZATION – 60% (2006)
- TURKISH PHARMACEUTICAL INDUSTRY: R&D and INNOVATION PERFORMANCE - SINCE 2002 INVESTMENT TO CLINICAL RESEARCH IN TURKEY ü Share of R&D expenditures in GDP has increased from 0. 53% to 0. 71% ü The number of R&D personnel increased from 29 000 to 83 000 ü 20 Pharma-Companies (250 employees in total) ü The number of scientific publications increased from 10 000 to 22 000 ü 2 Associations playing a key role ü The number of patent application increased from 85 to 357 ü Total Investment: $ 40 -60 mln. Source: AIFD ü 12 CRO’s
- TURKISH PHARMACEUTICAL INDUSTRY: COMMERCIAL INSURANCE q THE INSURANCE SECTOR IN TURKEY IS STILL SMALL, BUT IT IS RAPIDLY GROWING q TOTAL PREMIUM AMOUNT GENERATED BY THE SECTOR WAS $ 6. 7 BLN. WITH A GROWTH OF 16% q THERE ARE 54 INSURANCE AND 2 RE-INSURANCE COMPANIES OPERATING IN TURKEY q 21 INSURANCE COMPANIES WORK IN THE LIFE-INSURANCE SECTOR q 33 INSURANCE COMPANIES WORK IN THE NON-LIFE SECTOR Source: IGEME
THANK YOU VERY MUCH FOR YOUR ATTENTION
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