1. The Pharmaceutical Industry in Turkey
Murat Salihoğlu
Deputy Secretary General
Pharmaceutical Manufacturers Association of Turkey
2 May 2010

2. Pharmaceutical Manufacturers Association of Turkey (IEIS)
It was founded in 1964 in Istanbul with the purpose of sustaining development of the local pharmaceutical industry.
It plays an important role in healthcare policy-making and promotes the use of generics.
Head office is in Istanbul and a liaison office in Ankara.
It currently has 43 members.

3. Facts & Figures of The Industry
No. of pharmaceutical companies
Multinationals
>300 56
No. of manufacturing facilities 42 14
Employment in the pharmaceutical industry
~ 25,000
No. of pharmaceuticals in the market
~ 5,000
Number of pharmacies
~ 23,500
Source: IEIS, TEB

4. Per Capita Consumption on Medicines (2009, $)
Source :
United Nations, IMS Health, IEIS

5. Pharmaceutical Market
Volume (mn units)
Source: IMS, IEIS

6. Pharmaceutical Market
Value (mn €)
Source: IMS, IEIS

7. Breakdown of Market: Originator - Generic
Volume
Value
Source: IMS, IEIS

8. Breakdown of Market: Imports – Local
Volume
Value
Source: IMS, IEIS

9. Foreign Trade Export, € mn Export/Import Ratio
Source: IEIS, Turkish Statistical Institute

10. Therapeutic Classes Market Share
(Value Basis)
Source: IMS, IEIS

11. Regulatory Environment

12. Pricing Reference Price system is in force since 2004.
The reference price is the lowest ex-factory price among 5 EU members. Currently the reference countries are France, Greece, Italy, Portugal and Spain.
An original product which is in reimbursement list, can be priced up to 100% of the reference until its first generic enters into the market. Then they are both priced at 66% of the reference price. This rule is applied to the products with an ex-factory price over 3.56 TL.
The system takes also into account the Euro/TL exchange rate. A 90-day moving average is followed and more than 5% change is reflected to the prices.

13. Track and Trace system
The pharmaceuticals track and trace system which enforces the companies, wholesalers, pharmacists to take technical measures (2D barcode), to control the products purchased by social security institutions have been on the agenda since 2007.
This system was firstly described in the Regulation Regarding the Packaging and Labeling of Medicinal Products for Human Use in February However, due to the complex issues and a structure not tested anywhere, the commencement of the system has been postponed although the pharmaceutical companies have been faced with considerable financial implications arising from their investments made in accordance with this regulation.
Currently, the problems of the system have not been solved yet and different approaches from the IEGM as well as SGK and the Pharmacists’ Associations are hindering the correct functioning of the system which results uncertainty of the payments made from the SGK.
Though all those facts above the system will be operational
starting from 1st of June

14. Social Security System
Social security system covers approximately 90% of the population.
The government is the largest buyer accounting for around 90% of the sales.
Since 2004, the Ministry of Labour and Social Security has been working on a new structure for the social security and the general health insurance system covering the whole population.
Three public social security institutions were united under a new single body in 2006.

15. Reimbursement Reimbursement status after the marketing authorisation
Positive list
Discounts for state drug purchases;
producer discounts;
4% for those with retail price equal and/or smaller to 3.56TL
23 % for original products having no generic competition with ex-factory price greater than 3.56TL
(except the first year from launch of products with new molecules)
11% for the rest
pharmacy discounts; 0% - 2.5% according their revenue
Ongoing process of removing the OTC products from the
list since
Price band (cheapest +15%) on 407 active substances

16. Licensing
In January 2005, the licensing regulation was published in line with EU principles and was amended in April 2009.
Accordingly, the applications must be made in CTD format and the appraisal period is limited to 210 days. Under the old regime, this period could be as long as 2 years.
The regulation grants data exclusivity to reference products licensed in the EU starting from January 1st, The exclusivity is limited with the patent term of the concerned molecule.

17. Licensing In accordance with the new amendments in April 2009;
Licenses will be renewed once after five years.
In order to reduce healthcare expenditures and to ensure rapid public access to the drug, the licensing procedure shall be completed within no more than 180 days.
The application for certain co-marketed products (where the reference product is authorised in Turkey) shall be concluded within 90 days.
Although, the obligation of the market access permission is revoked with this amendment, the Council of State granted a stay of execution on December 15th, The final decision has not been taken yet.

18. Intellectual Property Rights
Patent
20 years patent protection was introduced in 1995
Data exclusivity
6 years for products licensed in the EU starting from 01/01/2005 as well as for molecules registered in the EU from 01/01/2001 to 31/12/2004 if no generic product application exists for these molecules
Bolar Provision
It was introduced in 2004

19. THANK YOU