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BANU OGAWASENIOR PROJECT DIRECTOR
“HEALTH SECTOR OF TURKEY”
OUTLINE
COUNTRY PROFILE
PHARMACEUTICAL MARKET;
-MILESTONES-PRODUCTION-INTERNATIONAL SUCCESS-TOP 10 COMPANIES OF THE SECTOR-INTERNATIONAL RATING & TENDENCIES-REGULATION-ESTABLISHING A LOCAL OFFICE-REIMBURSEMENT, PRICING & DISTRIBUTION
TURKISH HOSPITAL STRUCTURE
R&D
COMMERCIAL INSURANCE ENVIRONMENT
COUNTRYINFORMATION
2007 2008 2009
Population(million)
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)
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
-RAPID GROWTH IN 5 YEARS-RAPID GROWTH IN 5 YEARS
-25 000 EMPLOYEES IN THE PHARMACEUTICAL SECTOR-25 000 EMPLOYEES IN THE PHARMACEUTICAL SECTOR
- HIGH LEVEL OF TECHNOLOGY & AUTOMATION
- HIGH LEVEL OF TECHNOLOGY & AUTOMATION
Source:IEIS
- TURKISH PHARMACEUTICAL INDUSTRY:MILESTONES -
2008
1952-1972
BEGINNING OF THE “INDUSTRIAL PERIOD” FORMATING OF THE MODERN MANUFACTURING FACILITIES RAW MATERIAL MANUFACTURING STARTS 95% OF ALL PRODUCTS LOCALLY PRODUCED
1972-1990
STAGNATION PERIOD UNTIL 1984 MULTINATIONAL COMPANIES LEAVING INTRODUCTION OF GOOD MANUFACTURING PRACTICES
1990-2003 MARKET GROWING BY 10% PER YEAR INSTABLE PRICING AND REIMBURSEMENT POLICIES
SINCE 2004
NEW PRICING REGULATION BASED ON REFERENCES PRICES VAT RATE REDUCED TO 8% NEW REGISTRATION REGULATION INTRODUCED 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)
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)
MAJOR DISTRIBUTION REGION - MARMARA REGION, ESPECIALLY:
- ISTANBUL - KOCAELI - TEKIRDAG
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
MAJOR TURKISH MANUFACTURERs:
- EIS-ECZACIBASI- TEKIRDAG- ABDI IBRAHIM- FAKO- ILSAN-ILTAS- MUSTAFA NEVZAT- IBRAHIM ETHEM- BILIM
Source:IEIS
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
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
EXPORT TO 140 COUNTRIES,INCL.:- GERMANY- USA- UK- SWITZERLAND- THE NETHERLANDS
EXPORT TO 140 COUNTRIES,INCL.:- GERMANY- USA- UK- SWITZERLAND- THE NETHERLANDS
- TURKISH PHARMACEUTICAL INDUSTRY:INTERNATIONAL SUCCESS -
Source:IGEME
MAY 2009 GROWTH MARKET SHARE
ABDI IBRAHIM 1 018 21% 7.1%NOVARTIS 957 20% 6.6%
SANOFI-AVENTIS 693 7% 4.8%BILIM 642 13% 4.4%GSK 640 21% 4.4%
PFIZER 626 12% 4.3%BAYER 530 12% 3.7%
ASTRA ZENECA 496 11% 3.4%EASTPHARMA 475 0% 3.3%
SANOVEL 456 12% 3.2%
Source:AIFD
- TURKISH PHARMACEUTICAL INDUSTRY:TOP 10 COMPANIES -
SHARE OF GLOBAL SALES (2013)
SHARE OF GLOBAL SALES (2013)
2000 2007 20121 USA USA USA2 JAPAN JAPAN JAPAN3 FRANCE FRANCE FRANCE4 GERMANY GERMANY GERMANY5 ITALY ITALY CHINA6 UK UK ITALY7 SPAIN SPAIN UK8 CANADA CANADA BRAZIL9 BRAZIL CHINA SPAIN
10 CHINA BRAZIL CANADA11 MEXICO MEXICO TURKEY12 S.KOREA S.KOREA INDIA13 AUSTRALIA TURKEY S. KOREA14 INDIA INDIA MEXICO
...
28 TURKEY
Source: IMS Health
- TURKISH PHARMACEUTICAL INDUSTRY:INTERNATIONAL RATING -
- TURKISH PHARMACEUTICAL INDUSTRY: REGULATIONS -
PATENT PROTECTION
DATA EXCLUSIVITY
PRICING & REGISTRATION
GOOD MANUFACTURING PRACTICES (GMP)
GOOD LABORATORY PRACTICES (GLP)
GOOD CLINICAL PRACTICES (GCP)
BIO-AVAILABILITY / BIO-EQUIVALENCY
PACKAGING LABELLING
PROMOTION / ADVERTISING
DRUG RESEARCH & MEDICINAL PRODUCT REGISTRATION
STABILITY REQUIREMENTS
REGULATION ON GOOD DISTRIBUTION & STORAGE PRACTICES
PHARMA-COVIGILANCE
PATENT PROTECTION
DATA EXCLUSIVITY
PRICING & REGISTRATION
GOOD MANUFACTURING PRACTICES (GMP)
GOOD LABORATORY PRACTICES (GLP)
GOOD CLINICAL PRACTICES (GCP)
BIO-AVAILABILITY / BIO-EQUIVALENCY
PACKAGING LABELLING
PROMOTION / ADVERTISING
DRUG RESEARCH & MEDICINAL PRODUCT REGISTRATION
STABILITY REQUIREMENTS
REGULATION ON GOOD DISTRIBUTION & STORAGE PRACTICES
PHARMA-COVIGILANCE
- THE PRODUCTION AND MARKETING OF ALL
PHARMACEUTICALS MUST BE AUTHORIZED BY THE MINISTER OF HEALTH
- THE PRODUCTION AND MARKETING OF ALL
PHARMACEUTICALS MUST BE AUTHORIZED BY THE MINISTER OF HEALTH
- PHARMACEUTICAL PRODUCTS AND FIRMS MUST
BE REGISTERED IN THE MINISTRY
- PHARMACEUTICAL PRODUCTS AND FIRMS MUST
BE REGISTERED IN THE MINISTRY
Source:IEIS
- 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
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 -
EYE DROPS
PANSIRON BRAND MEDICINE
COLD REMEDIES
DERMAL MEDICINE
HAY FEVER
EYE DROPS
PANSIRON BRAND MEDICINE
COLD REMEDIES
DERMAL MEDICINE
HAY FEVER
PRICE CONTROL BY MINISTRY OF HEALTH (REFERENCE PRICING SYSYTEM)
MOSTLY REIMBURSED
PHARMACY SALES ONLY
DETAILING ONLY TO PROFESSIONALS & AD`S ONLY IN MEDICAL MAGAZINES
PRICE CONTROL BY MINISTRY OF HEALTH (REFERENCE PRICING SYSYTEM)
MOSTLY REIMBURSED
PHARMACY SALES ONLY
DETAILING ONLY TO PROFESSIONALS & AD`S ONLY IN MEDICAL MAGAZINES
FDA DOSSIER NEEDS TO BE CONVERTED TO EU-CTD FORMAT
PRE-FILLING: 3 MONTHS, INCLUDING TRANSLATION
OFFICIAL TARGET: 240 DAYS
REALITY: 18-24 MONTHS FOR GENERICS, 24-30 MONTHS FOR ORIGINALS
GMP INSPECTION !
FDA DOSSIER NEEDS TO BE CONVERTED TO EU-CTD FORMAT
PRE-FILLING: 3 MONTHS, INCLUDING TRANSLATION
OFFICIAL TARGET: 240 DAYS
REALITY: 18-24 MONTHS FOR GENERICS, 24-30 MONTHS FOR ORIGINALS
GMP INSPECTION !
Rx STATUS
(18-30 months)
Rx STATUS
(18-30 months)
Source:MINSITRY OF HEALTH
- TURKISH PHARMACEUTICAL INDUSTRY: REIMBURSEMENT, PRICING & DISTRIBUTION -
EYE WASHES
CONTCT LENS CARE
NAMED AS “INTERMEDIATE PRODUCTS”
EYE WASHES
CONTCT LENS CARE
NAMED AS “INTERMEDIATE PRODUCTS”
PRICE CONTROL;
o BY MINISTRY OF HEALTH
PRICE CONTROL;
o BY MINISTRY OF HEALTH
DOSSIER SHOULD INCLUDE;
FORMULA
CONTROL OF STARTING MATERIALS
MANUFACTURING METHOD
FINISHED PRODUCT CONTROLS
PIL
INNER & OUTER PACKAGE
DOSSIER SHOULD INCLUDE;
FORMULA
CONTROL OF STARTING MATERIALS
MANUFACTURING METHOD
FINISHED PRODUCT CONTROLS
PIL
INNER & OUTER PACKAGE
NON-Rx STATUS
(18-24 months)
NON-Rx STATUS
(18-24 months)
Source:MINISTRY OF HEALTH
- TURKISH PHARMACEUTICAL INDUSTRY: REIMBURSEMENT, PRICING & DISTRIBUTION -
VITAMINS, MINERALS, HERBAL PRODUCTS
REGULATORY PROCESS IS RELATIVELY SHORT
NO PRICE CONTROL
NO REIMBURSEMENT
VITAMINS, MINERALS, HERBAL PRODUCTS
REGULATORY PROCESS IS RELATIVELY SHORT
NO PRICE CONTROL
NO REIMBURSEMENT
FOOD SUPPLEMENTs
(Ministry of Agriculture,2-4 months)
FOOD SUPPLEMENTs
(Ministry of Agriculture,2-4 months)
LIP CARE
HAND / BODY / SUN CARE
PARFUMES
LIP CARE
HAND / BODY / SUN CARE
PARFUMES
DERMO-COSTMETICS
(Ministry of Health,2-4 months)
DERMO-COSTMETICS
(Ministry of Health,2-4 months)
Source:MINISTRY OF HEALTH
- TURKISH PHARMACEUTICAL INDUSTRY: REIMBURSEMENT & PRICING(AS OF 18TH OF MAY, 2009) -
REFERRED TO CHEAPEST EX-FACT PRICE AMONG ITALY, PORTUGAL, GREECE, SPAIN, FRANCE OR THE SOURCE (MANUFACTURING & SUPPLY) COUNTRY PRICE
PLANTS TO EXPAND TO 10 COUNTRIES (POLAND & HUNGARY!)
GREECE ALREADY REFERS TO HUNGARY; SO TURKEY REFERS INDIRECTLY TO HUNGARY
REFERRED TO CHEAPEST EX-FACT PRICE AMONG ITALY, PORTUGAL, GREECE, SPAIN, FRANCE OR THE SOURCE (MANUFACTURING & SUPPLY) COUNTRY PRICE
PLANTS TO EXPAND TO 10 COUNTRIES (POLAND & HUNGARY!)
GREECE ALREADY REFERS TO HUNGARY; SO TURKEY REFERS INDIRECTLY TO HUNGARY
ORIGINALS WITH GENERICS - 60% OF REFERENCE PRICE
ORIGINALS WITHOUT GENERICS – 100% OF REFERENCE PRICE
ANY DECREASE IN REFERENCE COUNTRY PRICE SHOULD BE IMPLEMENTED IN 3 MONTHS
€/TRY CONVERSION IS FIXED
ORIGINALS WITH GENERICS - 60% OF REFERENCE PRICE
ORIGINALS WITHOUT GENERICS – 100% OF REFERENCE PRICE
ANY DECREASE IN REFERENCE COUNTRY PRICE SHOULD BE IMPLEMENTED IN 3 MONTHS
€/TRY CONVERSION IS FIXED
SEGMENTDIFFERENCES
SEGMENTDIFFERENCES
Source:AIFD
- TURKISH PHARMACEUTICAL INDUSTRY: REIMBURSEMENT -
Approval may take 3-9 months
Approval may be based on various restrictions
SGK announces annual reimbursement rules (RUT) changing twice a year
Approval may take 3-9 months
Approval may be based on various restrictions
SGK announces annual reimbursement rules (RUT) changing twice a year
After registration, the product is be submitted to Social Security Institution
(SGK)
After registration, the product is be submitted to Social Security Institution
(SGK)
REIMBURSEMENTREIMBURSEMENT
Rx Products are reimbursed as 80%
Non-Rx category (food supplement and dermo-cosmetics) are not reimbursed
The reimbursement is 15% of original product price, if there is a generics as of 1st of August 2009. The remaining sum is be paid by the patient
Rx Products are reimbursed as 80%
Non-Rx category (food supplement and dermo-cosmetics) are not reimbursed
The reimbursement is 15% of original product price, if there is a generics as of 1st of August 2009. The remaining sum is be paid by the patient
MANDATORY DISCOUNTs(18TH of September, 2009)MANDATORY DISCOUNTs(18TH of September, 2009)
24% for Originals without Generics
11% for Originals with Generics
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
24% for Originals without Generics
11% for Originals with Generics
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 -
ALL DRUGS ARE TO BE SOLD IN PHARMACIES
ALL DRUGS ARE TO BE SOLD IN PHARMACIES
MANUFACTURER OR IMPORTER
MANUFACTURER OR IMPORTER
PHARMACEUTICAL WHOLESALER
PHARMACEUTICAL WHOLESALER PHARMACIES PHARMACIES
THE PHARMACIST SHOULD ALWAYS BE IN THE PHARMACY
THE PHARMACIST SHOULD ALWAYS BE IN THE PHARMACY
THERE ARE NO CHAIN PHARMACIES. A PHARMACIST
CAN ONLY OWN ONE PHARMACY
THERE ARE NO CHAIN PHARMACIES. A PHARMACIST
CAN ONLY OWN ONE PHARMACY
ONLY SOME VITAMINS ARE SOLD IN GROCERY STORES LICENSED BY MINISTRY OF AGRICULTURE INSTEAD OF
MINISTRY OF HEALTH
ONLY SOME VITAMINS ARE SOLD IN GROCERY STORES LICENSED BY MINISTRY OF AGRICULTURE INSTEAD OF
MINISTRY OF HEALTH
Source:MINISTRY OF HEALTH
- TURKISH PHARMACEUTICAL INDUSTRY: HOSPITALs -
1 205 HOSPITALS WITH 192 685 BED CAPACITY (2006)
1 205 HOSPITALS WITH 192 685 BED CAPACITY (2006)
AN IMPORTANT NEW TREND:ATTRACTING PATIENTS FROM
EUROPE (MAINLY, UK) OR MIDDLE EAST FOR A
TREATMENT IN TURKISH PRIVATE HOSPITALS
AN IMPORTANT NEW TREND:ATTRACTING PATIENTS FROM
EUROPE (MAINLY, UK) OR MIDDLE EAST FOR A
TREATMENT IN TURKISH PRIVATE HOSPITALS
AVERAGE CAPACITY UTILIZATION – 60% (2006)
AVERAGE CAPACITY UTILIZATION – 60% (2006)
- TURKISH HOSPITAL STRUCTURE (2008) -
NUMBER OF HOSPITALS
NUMBER OF BEDS
SHARE
PUBLIC 894 138 217 87%PRIVATE 400 20 938 13%
MoHMEDICAL SCHOOLS PRIVATE TOTAL
2000 17 655 7 204 4 226 290 8522006 23 808 10 447 6 786 41 041
- NUMBER OF DOCTORS IN TURKEY (2006) -
Source:MINISTRY OF HEALTH
- TURKISH PHARMACEUTICAL INDUSTRY: R&D and INNOVATION PERFORMANCE -
SINCE 2002SINCE 2002
Share of R&D expenditures in GDP has increased from 0.53% to 0.71%
The number of R&D personnel increased from 29 000 to 83 000
The number of scientific publications increased from 10 000 to 22 000
The number of patent application increased from 85 to 357
Share of R&D expenditures in GDP has increased from 0.53% to 0.71%
The number of R&D personnel increased from 29 000 to 83 000
The number of scientific publications increased from 10 000 to 22 000
The number of patent application increased from 85 to 357
INVESTMENT TO CLINICAL RESEARCH IN TURKEY
INVESTMENT TO CLINICAL RESEARCH IN TURKEY
20 Pharma-Companies (250 employees in total)
2 Associations playing a key role
12 CRO’s
Total Investment: $ 40-60 mln.
20 Pharma-Companies (250 employees in total)
2 Associations playing a key role
12 CRO’s
Total Investment: $ 40-60 mln.
Source:AIFD
- TURKISH PHARMACEUTICAL INDUSTRY: COMMERCIAL INSURANCE -
THE INSURANCE SECTOR IN TURKEY IS STILL SMALL, BUT IT IS RAPIDLY GROWING
TOTAL PREMIUM AMOUNT GENERATED BY THE SECTOR WAS $ 6.7 BLN. WITH A GROWTH OF 16%
THERE ARE 54 INSURANCE AND 2 RE-INSURANCE COMPANIES OPERATING IN TURKEY
21 INSURANCE COMPANIES WORK IN THE LIFE-INSURANCE SECTOR
33 INSURANCE COMPANIES WORK IN THE NON-LIFE SECTOR
THE INSURANCE SECTOR IN TURKEY IS STILL SMALL, BUT IT IS RAPIDLY GROWING
TOTAL PREMIUM AMOUNT GENERATED BY THE SECTOR WAS $ 6.7 BLN. WITH A GROWTH OF 16%
THERE ARE 54 INSURANCE AND 2 RE-INSURANCE COMPANIES OPERATING IN TURKEY
21 INSURANCE COMPANIES WORK IN THE LIFE-INSURANCE SECTOR
33 INSURANCE COMPANIES WORK IN THE NON-LIFE SECTOR
Source:IGEME
THANK YOU VERY MUCHFOR YOUR ATTENTION