Serbia - Farmaceutico, biotecnologie

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presentazione dei settori Farmaceutico, Biotecnologie e Apparecchiature elettromedicali in Serbia

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  • 1.PHARMACEUTICAL SECTOR OF SERBIAVekoslav oevi, Secretary of Association of Chemical and Pharmaceutical Industry, Rubber and Non-Metal Industry25 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 withmedicines of all forms and dosages Total consumption of medicines in Serbia for 2011 is estimated to around 740 mil. Euros. Share ofimported medicines is 370 mil. Euros According to number of boxes of medicines sold: domestic producers supply the market witharound 75% of medicines, reaching around 45% of the cash flow (this difference is caused by thedifference in price of domestic medicines which is significantly lower than the price of importedmedicines) 4. TRADE FLOW OF MEDICINES IN SERBIA IN 2011Hemofarm A.D.Galenika A.DZdravlje A.D.F.Hoffmann-La Roche LTD.Glaxosmithkline SPAPfizer H.C.P. Corporation21%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 SquibbPharmaswiss D.O.O.2%Novartis Pharma AG 2% 13% 2% 6%Ferring international center SA2%2% 3% 3% 3% 4%Schering AGJanssen-Cilag International N.V. 2% 2%Astra Zeneca UK LimitedMerck Sharp & Dohme BVHabit 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, Bosniaand 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 reached525,9 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 30mil. 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 Nemaka Galenika Zemun - 2400 employees Zdravlje - Actavis Island Institute for Immunology and Virology Torlak - Pharmaswiss vajcarska 400 employees Alkaloid Makedonija Jugoremedija - 450 employees SERBIAN Pharmanova Slaviamed Ivani i sinoviParticipation 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 throughimport 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 10 foreign manufactures in Serbia pharmaceutical 10 foreign manufactures in Serbia pharmaceutical market ( by market ( by share in value terms), Q3SERBIAN2011 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 ingroup of wholesalers with around 2500 employees All wholesalers meet the requirements specified in the Book of rules on conditions forwholesale of medicines and medical devices, and the majority of its members conduct SERBIANtheir business with implemented ISO quality standards Following link in supply chain of medicines in Serbia are pharmacies (state andprivately 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 patients 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 medicaldevices 13. 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 forSERBIANthat medicine in the countries of the EU or in countries that proscribe same requirements forpermits issuance as that of the Republic of Serbia Legal entity with headquarters in the Republic of Serbia that received a permit for the medicinefrom a producer in Serbia, that is that provided him with conditions to become a receiver of themedicine permit from their own production programMedicine permit is being renewed every five years, and after risk and benefits evaluations have been made 14. ACCESSIBILITY VS AVAILABILITYWho is responsible for access and availability of medicines? Accessibility AVAILABILITYGovernment SERBIAN Producers Health Insurance FundWholesalers Regulatory bodies (AMMD, Ministry ofHealth institutions (pharmaceuticalHealth 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. 27March 17th , 2008) Guidelines for Good practice in Distribution of Medicines (Official Gazette of RS no. 28, March 18th2008)SERBIAN Regulation on conditions for import of medicines and medical devices which do not have a permit tobe 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 ofmedicine packaging and on patients /users instructions (Official Gazette RS 104, December 16 th2009) Regulation on Medical Waste Management (Official Gazette of RS no 78, October 25th 2010) 16. 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 17. THANK YOU FOR YOURATTENTION! phone: + 381 63 3233 671 cell: + 381 63 336 743e-mail: vekoslav.sosevic@pks.rswww.pks.rs