PHARMACEUTICAL SECTOR OF SERBIA Vekoslav Šošević, Secretary of Association of Chemical and Pharmaceutical Industry, Rubber and Non-Metal Industry 25 th October 2012, Rome
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)
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)
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
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.
TRENDS IN IMPORT AND EXPORT OF MEDICINES IN SERBIA (CARTAR 3003, 3004) SERBIAN
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 sinoviParticipation of Italian companies is expected in process of privatization of not privatized companies(Galenika, Torlak, Jugoremedija)
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
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.
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)
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
PROCEDURE FOR MEDICINES REGISTRATIONAgency for medicines and medical devicesIn 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 programMedicine permit is being renewed every five years, and after risk and benefits evaluations have been made
ACCESSIBILITY VS AVAILABILITYWho 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)
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)
CONCLUSIONAdvantages 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 SERBIANOpportunities 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
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