presentazione dei settori Farmaceutico, Biotecnologie e Apparecchiature elettromedicali in Serbia

1. PHARMACEUTICAL SECTOR OF SERBIA
Vekoslav Šošević, Secretary of Association of Chemical and
Pharmaceutical Industry, Rubber and Non-Metal Industry
25 th October 2012, Rome

2. PHARMACEUTICAL INDUSTRY - ECONOMIC OVERVIEW
 Share of pharmaceutical sector in GDP - 0,7%
 Gross production of the industry - over 450 mil. Euro (2011)
 Total consumption of medicines in Serbia - 740 mil. Euro
 Annual production rate ~10%
 Number of employees - 7000
 Export oriented (155 mil Euro of goods were exported in 2011)
 Direct contribution to the budget of the Republic of Serbia (2011) ~40 mil. Euro (taxes,
contribution, customs)

3. TRADE FLOW OF DOMESTIC PRODUCERS FROM SERBIA IN 2011
 For years, domestic pharmaceutical industry has been a carrier of stable supply of the market with
medicines of all forms and dosages
 Total consumption of medicines in Serbia for 2011 is estimated to around 740 mil. Euros. Share of
imported medicines is 370 mil. Euros
 According to number of boxes of medicines sold: domestic producers supply the market with
around 75% of medicines, reaching around 45% of the cash flow (this difference is caused by the
difference in price of domestic medicines which is significantly lower than the price of imported
medicines)

4. TRADE FLOW OF MEDICINES IN SERBIA IN 2011
Hemofarm A.D.
Galenika A.D
Zdravlje A.D.
F.Hoffmann-La Roche LTD.
Glaxosmithkline SPA
Pfizer H.C.P. Corporation
21% 26% Sanofi-Aventis S.P.A.
1% Novo Nordisk A/S
1% 1% SERBIAN Alkaloid A.D.
1% Jugoremedija A.D.
Krka Tovarna Zdravil D.D.
1% 1% Bristol-Myers Squibb
Pharmaswiss D.O.O.
2% Novartis Pharma AG
2% 13%
2% 6% Ferring international center SA
2% 2% 3% 3% 3% 4% Schering AG
Janssen-Cilag International N.V.
2% 2% Astra Zeneca UK Limited
Merck Sharp & Dohme BV
Habit Pharm A.D.
Ostalo

5. TRADE BALANCE
 Export of medicines in 2011 was 208,3 mil. dollars (index for 2011 / 2010 was109)
 The highest export was in Russian Federation (50 mil.), Germany (40 mil.), Montenegro, Bosnia
and Herzegovina, Bulgaria, Macedonia
 Export in Italy was 2,2 mil. dollars in 2011
 We believe that opportunities are a lot bigger
 Import of medicines was (mostly from EU): it is growing on yearly basis - export in 2011 reached
525,9 mil USD (index for 2011 / 2010 was 101)
 The highest import was from Germany (99 mil.), France (76 mil.), Italy 47 mil. USD, Great Britain 30
mil. Denmark, etc.

6. TRENDS IN IMPORT AND EXPORT OF MEDICINES IN SERBIA (CARTAR 3003, 3004)
SERBIAN

7. SERBIAN

8. OWNERSHIP STRUCTURE
Privatized companies Non-privatized companies
 Hemofarm - Stada Nemačka  Galenika Zemun - 2400 employees
 Zdravlje - Actavis Island  Institute for Immunology and Virology Torlak -
 Pharmaswiss Švajcarska 400 employees
 Alkaloid Makedonija  Jugoremedija - 450 employees
SERBIAN
 Pharmanova
 Slaviamed
 Ivančić i sinovi
Participation of Italian companies is expected in process of privatization of not privatized companies
(Galenika, Torlak, Jugoremedija)

9. PRESENCE OF FOREIGN COMPANIES
 The Highest number of multinational companies are present today in Serbian market through
import and licensed products or through market agreements with domestic companies
 Around 70 foreign pharmaceutical companies have its representative offices in Serbia
Table 1 Table 2
ТОР10 foreign manufactures in Serbia pharmaceutical ТОР10 foreign manufactures in Serbia pharmaceutical market ( by
market ( by share in value terms), Q3SERBIAN
2011 share in real terms), Q3 2011

10. ITALIAN COMPANIES PRESENT IN SERBIA
 ABBOT S.R.L.  MERCK SHARP & DOHME S.P.A.
 ACTAVIS ITALY S.P.A.  NOVARTIS FARMA S.P.A.
 BAYER HEALTHCARE  PFIZER ITALIA S.R.L.
MANUFACTURING S.R.L.  PHARMATEX ITALIA SRL.
 CATALENT ITALY S.P.A.  ROTTAPHARM S.P.A.
 DOMPE PHARMA S.P.A. SERBIAN
 SIGMAR ITALIA S.P.A.
 ELI LILLY ITALIA S.P.A.  ZAMBON S.P.A.
 FRESENIUS KABI ITALIA S.R.L.
 GLAXOSMITHKLINE SP
 HAUPT PHARMA LATINA
 ISTITUTO DE ANGELI S.R.L
 LABORATORI BALDACCI S.P.A.
 MERCK SERONO S.P.A.

11. DISTRIBUTION OF MEDICINES
 Distribution of medicines in Serbia is done through wholesalers
 75 % medicines and medical devices are done through 17 wholesales gathered in
group of wholesalers with around 2500 employees
 All wholesalers meet the requirements specified in the Book of rules on conditions for
wholesale of medicines and medical devices, and the majority of its members conduct
SERBIAN
their business with implemented ISO quality standards
 Following link in supply chain of medicines in Serbia are pharmacies (state and
privately owned)

12. AGENCY FOR MEDICINES AND MEDICAL DEVICES OF SERBIA
 Issues permits for medicines
 Registers medical devices in the Register of Medical Devices
 Conducts a registration of traditional herbal medicines
 Issues permits for clinical testing of medicines and medical devices
 Performs control of clinical testing
 Issues certificates for export of medicines and medical devices
SERBIAN
 Approves import of medical devices for patient’s needs
 Approves import of medicines for scientific testing
 Controls the quality of medicines and medical devices
 Participates in development of regulations and national policy in the field of medicines and medical
devices

13. PROCEDURE FOR MEDICINES REGISTRATION
Agency for medicines and medical devices
In Serbia, a permit for medicine can be given to:
 A producer that has a permit to produce medicines in the Republic of Serbia
 Representative of foreign producer that has headquarters in the Republic of Serbia
 Representative of foreign legal entity that is not a producer of that medicine but has a permit for
SERBIAN
that medicine in the countries of the EU or in countries that proscribe same requirements for
permits issuance as that of the Republic of Serbia
 Legal entity with headquarters in the Republic of Serbia that received a permit for the medicine
from a producer in Serbia, that is that provided him with conditions to become a receiver of the
medicine permit from their own production program
Medicine permit is being renewed every five years, and after risk and benefits evaluations have
been made

14. ACCESSIBILITY VS AVAILABILITY
Who is responsible for access and availability of medicines?
Accessibility AVAILABILITY
Government
SERBIAN Producers
Health Insurance Fund Wholesalers
Regulatory bodies (AMMD, Ministry of Health institutions (pharmaceutical
Health and Ministry of Trade) institutions, pharmacies, hospitals)

15. REGULATIONS
 Law on Medicines and Medical Devices (Official Gazette of RS no. 30, May 7th, 2010)
 Subact
 Regulation on conditions for trade with medicines and medical devices (Official Gazette of RS no. 27
March 17th , 2008)
 Guidelines for Good practice in Distribution of Medicines (Official Gazette of RS no. 28, March 18th
2008)
SERBIAN
 Regulation on conditions for import of medicines and medical devices which do not have a permit to
be distributed (Official Gazette if RS no. 37, April 11, 2008)
 Book of rules on amendments and remarks, Book of rules on content and inner and outer labeling of
medicine packaging and on patient’s /user’s instructions (Official Gazette RS 104, December 16 th
2009)
 Regulation on Medical Waste Management (Official Gazette of RS no 78, October 25th 2010)

16. CONCLUSION
Advantages
 Serbia has a status of potential candidate for EU membership
 Economy of the country needs significant investments in domestic pharmaceutical sector
 A lot more stable conditions for FDI and domestic development
 Good economic and political cooperation with Russia provide access to this big market
SERBIAN
Opportunities
 Gradual integration in EU and future membership should provide quicker reforms
 Privatization and modernization of domestic pharmaceutical producers provide higher chances for
export
 Investments and improvements of healthcare program will be promoted by the Government
 Shortened procedures for registration of generics for both foreign and domestic producers

17. THANK YOU FOR YOUR
ATTENTION!
phone: + 381 63 3233 671
cell: + 381 63 336 743
e-mail: vekoslav.sosevic@pks.rs
www.pks.rs