Bulgaria: Medical & Pharma Sector InvestBulgaria Agency

Transcription

1 YOUR MOVE Bulgaria: Medical & Pharma Sector 2006 InvestBulgaria Agency

2 WHY Bulgaria? 1. Opportunities for production of low-priced generics in the country due to low manufacturing costs 2. Expensive surgical operations can be successfully and costly carried out in Bulgaria 3. High growth potential of the pharmaceutical and medical equipment markets (15-20% per year) 4. Opportunities for carrying out dental tourism, already successfully explored in Central Europe, due to existing high quality and price competitiveness of dental services in the country 5. Though the major local pharma companies have already been acquired by foreign players, there are consolidation opportunities for strategic investors to gain a foothold or bolster existing presence in the region 6. Opportunities for carrying out repackaging and re-labeling of pharmaceuticals/medical devices LATEST deals Vendor Investor Target Size (EUR m) Greenfield Tokushukai Medical Corp. (Japan) Construction of a multi-functional high-tech hospital 90 Intervet Biovet Buyout of feed additives business of the animal healthcare firm Intervet, part of Akzo 22.5 Nobel Greenfield Chaikapharma Pharmaceuticals repackaging plant 7.7 NIHFI Sopharma Sopharma integrated its chemical and pharmaceutical research institute into the parent 5.1 company Greenfield Sopharma Pharmaceuticals plant 3.0 Greenfield GlaxoSmithKline (UK) Multi-Market Warehouse (distribution center with repackaging facility) 2.5 Greenfield Doverie Obedinen Holding Hospital construction and medical equipment supply 1.4 Brownfield Doverie Obedinen Holding 5-year non-collateralized Euro bond issuance to finance the construction and medical equipment supply for the hospital in Sofia (annual coupon % paid semi-annually) 1.4 Acquisition of minority stakes Sopharma Stakes in 3 pharma distribution companies - Global Medical (9% stake), Kaliman RT and Ceiba (9.99% in each) Undisclosed Actavis Biovet Acquisition of the veterinary drug production plant in Razgrad Undisclosed Libra Phoenix (Germany) Acquisition of the Bulgarian drug wholesaler Libra Undisclosed Higia Actavis Conditional acquisition of Higia, Bulgaria s largest pharmaceutical distributor Undisclosed 1

3 MEDICAL/PHARMA Fact Sheet Healthcare About healthcare in Bulgaria One of the first countries in Europe and the world to institutionalize drug regulation and control; More than 33,600 doctors in Bulgaria; Approximately 7,000 certified dentists; About 4,000 dental offices and 500 dental labs throughout the country; 1,140 patients per dentist; Estimated growth rate of the dentistry market in Bulgaria for the period is approximately 20% per annum Pharmaceuticals, medical and dental equipment and devices 10% 8% 6% 4% 2% 0% State budget spending on healthcare, % 6.2% 4.3% Bulgaria CEE average EU Pharmaceutical market volume, EUR m European producers 77% Medical equipment market (Total USD 165 m) US producers 20% Local producers 3% Sources: Bulgarian Drug Agency, CEEBIC End-user market of dental equipment and devices Medical Universities 10% Dental clinics in regional hospitals 1% Private dental clinics 89% Case studies GlaxoSmithKline (UK) Multi-Market Warehouse (MMW) in Sofia MMW is a distribution center with production facility for repackaging Investment value: EUR 2.5 million Officially opened on November 2, 2004 Innovative technology production facility for customizing the secondary package, providing the served markets with consignments of products with local language packs Serves 12 markets and 55 distributors in the region Eastern Europe, Caucasus and Central Asia Manages stock and negotiates production programs with 25 production sites in Europe, America, and Australia Modern and high-technologically equipped - flexible warehouse management system based on SAP ERP and Radio Data Network Dispatches 150 to 200 orders per week and stores almost 1000 palettes Operates under the control of GSK Quality Management System, based on GMP Tokushukai Medical Corp. (Japan) Tokuda multi-functional high-tech hospital in Sofia Project value: USD 110 million Planned to be operational in mid 2006 Tokushukai s first hospital outside Japan Planned to be operational in mid 2006 Will employ 1,225 medical professionals 1000 beds, 16 clinical departments, 11 surgery rooms Ultra-modern diagnostic center, state-of-the-art equipment Connection to long-distance consultation and therapy network systems in Japan ERGO Hospital (Greece) ERGO Hospital (Greece) is one of the main producers and suppliers of medical equipment and devices for haemodialysis and manages six medical centers The Bulgarian entity of ERGO Hospital is Biocheck Ltd Medical Center Biocheck was established in It is 100% Greek investment of more than USD 1.4 million The amount of reinvestment is USD 150,000 Biocheck is the first private medical institution in Bulgaria in the field of diagnostic medicine More than 67 high qualified specialists work at Biocheck Biocheck has hi-tech equipment in the fields of radiological diagnostics, functional gastroenterology, functional cardiology, laboratory diagnostic, dentist and laser procedures ERGO Hospital was attracted to Bulgaria by the high professional qualification of Bulgarian specialists although there is not enough high technology equipment Actavis (Iceland) Actavis Group (former Pharmaco) operates in 29 countries and employs over 7,000 people Actavis AD (Bulgaria) is one of the largest companies within Actavis Group Actavis AD is headquartered in Sofia and operates three manufacturing plants in Dupnitza, Troyan and Razgrad The Bulgarian subsidiary produces over 200 pharmaceutical products covering most significant therapeutic classes for human use Actavis AD is one of the biggest employers in Bulgaria, with about 2,700 employees Actavis AD is one of the major suppliers of finished pharmaceuticals to the former Soviet Union and a significant exporter of active pharmaceutical ingredients (APIs) for veterinary use to more than 50 countries 2

4 Legal 4.1. Pharmaceuticals manufacturing authorization Bulgarian Drug Agency Starting production of pharmaceuticals Required documents: 1. Application form; 2. Name and address of firm s management; 3. Location of premises for production, control and preservation of pharmaceuticals; 4. List of pharmaceuticals and forms to be produced; 5. Documents certifying the competence of the managers responsible for production and quality control; 6. Certificate for firm s court registration; 7. Environmental impact assessment of production according to the Environment Protection Law; 8. Permit for use of premises for production, control and preservation, issued according to the Spatial Planning Law. If the application refers to manufacturing of radiopharmaceuticals, a permit by the competent state authority for safe use of atomic energy for peace is required. If the application refers to manufacturing of narcotic substances and medical devices containing such substances the requirements of the Control over the Narcotic Substances and Precursors Law have to be observed. 3 months Cost (Fees) BGN 10,000 BGN 800 for producers executing different steps of the manufacturing process BGN 450 for license variations Pharmaceuticals and Pharmacies for the Human Medicine Law Ordinance No.12/2001 on the Good Practices in Production of Pharmaceuticals, issued by the Minister of Health 4.2. Accreditation of medical establishments Cost (Fees) The Minister of Health upon a proposal by the Accreditation Council Ad-hoc Expert Commission for Valuation Conditions and procedure for implementation of accreditation of medical establishments Medical establishments have the obligation to start a procedure for accreditation not later than 6 months after registration. The director of the medical establishment upon the approval by the Board of Directors creates a medical board for self-valuation. The director files the approved report to the medical board to the Minister of Health to start procedure for accreditation. Accreditation assessment of activities are made for the period of one to five years. Requirements: 1. Report by the medical board for self -valuation 2. Decision for implementation of the procedure for accreditation 3. Program for management and development of medical establishment 4. List of experts involved in valuation 5. List of experts working at the medical establishment 3 months The amount of costs for accreditation is defined by a contract between the Minister of Health and the applying medical establishment. The amount should be paid at least 7days before the start of the procedure. Medical Establishments Law Ordinance for the criteria, indicators and methods for accreditation of medical establishments 4.3. Medical establishments for hospital care Minister of Health Foundation and registration of medical establishments for hospital care Prior registration as a trade partnership or cooperation is required. The applying entity must perform hospital care activities only and files an application to the Minister of Health to start procedure for issuance of permit for carrying out activities. Requirements: 1. Court decision for registration; Certificate for current court registration; Unified identification code; 2. Constituting act of the applying entity and regulations for structure, activity and internal order of the medical establishment; 3. Certificate of registration in the District College of the Bulgarian Physician s Union or the Union of the Dentists in Bulgaria for the doctors or dentists who will manage the establishment; 4. Permit for use of premises as medical establishment; 5. Diploma for higher education of the person who will manage the establishment; 6. List of the members of the executive and controlling bodies; 7. Certificate by the District Center of Health Care where the medical establishment is located. All medical establishments are subject to accreditation which is not a necessity for carrying out medical activities. Cost (Fees) 3 months BGN 5,000 50,000 depending on the type of trade partnership registered Law for the medical establishments Ordinance for the basic requirements to which the structure, activity and internal order of the hospital establishments, dispensaries and social welfare homes should correspond 3

5 4.4. Medical establishments for non-stationary care and hospices The respective regional center of health care on whose territory is located the medical establishment Registration of medical establishments for non-stationary care and hospices Prior registration as a trade partnership or cooperation required according to Bulgarian legislation. To start the procedure the legal entity files an application to the respective regional centre of health care on whose territory is located the medical establishment. Requirements: 1. Court decision for registration; certificate for current court registration; Unified identification code. 2. Management by a master-physician; diploma for proper education of the people involved in health care giving. 3. Certificate for entry in the register of the district college of the Bulgarian Physician s Union or the Union of the dentists in Bulgaria for the doctors and dentists who will manage, respectively work in the establishment 4. The permit for using the premises as medical establishment or a conclusion of the Regional Inspection for Protection and Control of the Public Health. Not defined Cost (Fees) BGN depending on the type of trade partnership registered Law for the Medical Establishments Ordinance for Keeping a Register of the Medical Establishments for Non-Stationary Care and Hospices 4.5. Sales Permit Bulgarian Drug Agency (BDA) Prerequisite for sale in the country Sale permit is not required for pharmaceuticals produced in Bulgaria. It is necessary in the following cases: 1. Import of pharmaceuticals; 2. Vaccines, toxins, sera, biotechnology products and human plasma products manufactured in Bulgaria; 3. The first three batches of medicinal products which have received marketing authorization; 4. The first three batches following identification of nonconformities with the quality requirements. Remark: Before obtaining a sale permit marketing authorization is required. The pharmaceuticals producer/importer or his/her representative can apply. Required documents: 1. Application form; 2. Batch certificate of quality for each batch, issued by the producer; 3. Certificate for release of the batch issued by the competent authority of the country of the producer (in case of import of vaccines and human plasma products) 4. Copy of the permit for import of narcotic substances or medicinal products containing such substances issued by The National Drug Control Council under The Ministry of Health. On its discretion BDA may conduct analyses before issuing sale permits for vaccines, toxins, sera, biotechnology products and human plasma products. 30 days 60 days for vaccines, toxins, sera, biotechnology products and human plasma products Cost (Fees) BGN 15 for each batch Law for the Pharmaceuticals and Pharmacies for the Human Medicine Regulation No.29/2000 on The Conditions and Order of Issuance of Sale Permits for Pharmaceuticals, issued by the Minister of Health 4.6. Marketing Authorisation Bulgarian Drug Agency Max 7 months Cost (Fees) BGN Prerequisite for production, import, export and trade of pharmaceuticals in the country Only the pharmaceuticals producer or his/her representative can apply. A foreign producer can apply if he has permanent representative on the territory of the Republic of Bulgaria. Required documents: 1. Application form; 2. Registration dossier containing administrative, pharmaceutical, pharmacological toxicological and clinical data, specified in regulation, issued by the Minister of Health (Regulation No 17/2001). The registration file should be presented in Bulgarian, English or Russian language. 3. For non-local producers have to be presented also: a) A certificate for the medicine product issued by the specialized state body for control over the medicines in the country of production certifying the compliance of the of production, control and preservation with the requirements of the Good pharmaceuticals production practice; b) Marketing authorisations issued by the country of production; c) Information about other marketing authorisations. Law for the Pharmaceuticals and Pharmacies for the Human Medicine Ordinance No.17/2001 on the Requirements to the Documentation for Permitting Use of Pharmaceuticals, Issued by the Minister of Health 4

6 COMPETITION AND partners 5.1. Top pharmaceutical manufacturing companies Company Activity Net sales (EUR 000) Number of employees Year 1 Actavis AD (Sofia) Pharmaceuticals 58,700 2,700 ( 05) Sopharma (Sofia) Pharmaceuticals and biotech 57,372 1, Biovet (Peshtera) Pharmaceuticals and food biotech 25,467 1,200 ( 05) Eurostock (Sofia) Instant drinks and vitamins 8, Unipharm (Sofia) Solid and liquid drugs 6, Bul Bio NCZPB (Sofia) Human medicines and in-vitro diagnostic medicine products 7 Vetprom (Radomir) Veterinary and human medicinal products, synthetic substances, cosmetic goods 8 Inbiotech (Sofia) Pharmaceuticals and chemical pharmaceutical preparations 4, , , Tomil Herb (Sofia) Herbal pills 1, Biopharm Engineering (Sliven) Veterinary medicinal products 1,010 n.a Manufacturers of medical and dental equipment and devices Company Activity Net sales (EUR 000) Number of employees Year 1 Medica (Sofia) Medical dressing materials 5, Salvamed (Sandanski) Medical dressings 4, Momina Krepost (Veliko Tarnovo) Medical devices for single use 3, Etropal (Etropole) Medical devices for single use 2, Berchtold Bulgaria (Sofia) Manufacture of medical electronics, lathed and cut parts for surgical lamps and tables and autonomous gas installations 1, Art Colenta Bulgaria (Sofia) Medical equipment 1, Medical Equipment (Sofia) Medical, pharmaceutical, dental and physiotherapeutic equipment, hospital furniture Centillion (Sofia) Medical equipment Optela - Optic Technologies (Plovdiv) Industrial CO 2 lasers systems and laser optics Dimson (Sofia) Lens and rims for spectacles Gama Proekt JSC (Gabrovo) Manufactures surgery and reanimation equipment, dental equipment, instruments Intergalenika (Plovdiv) Medical devices (Concentrates for hemodialysis) Optica Laser (Sofia) Manufacture of laser systems for surgery, dentistry and physiotherapy Ochna Optika i Korektsiya (Sofia) Optics and eye correction Source: Bulgarian Industrial Association 5

7 WORTH knowing 6.1. Educated workforce U1 U2 U3 U4 U5 C1 C2 C3 University / College Location Majors Medical University Sofia Medical University - Plovdiv Medical University Medical University - Varna Trakia University Medical College of Sofia Medical College of Plovdiv Medical College of Pleven Sofia Health care Health management Medical rehabilitation and ergo therapy Plovdiv Medicine Dentistry Pleven Medicine Health care Varna Medicine Health care Health management Stara Zagora Veterinary medicine Medicine Sofia Assistant pharmacist Dental mechanics Masseur Medical laboratory technician Midwife Plovdiv Nurse Midwife Medical laboratory assistant Assistant pharmacist Pleven Nurses Laboratory Assistants C4 Medical College of Varna Varna Nurse Midwife Medical laboratory assistant Assistant pharmacist C5 Medical College of Shumen Shumen Nurse Midwife Medicine Pharmacy Dentistry Pharmacy Public healthcare Nurses Dentistry Nurse Rehabilitation therapist Sanitary inspector Social assistant X-ray technician X-ray laboratory assistant Dental mechanic Sanitary inspector Obstetrician Remedial gymnast Sanitary inspector X-ray laboratory assistant Dental mechanic Social worker C6 Medical College of Dobrich Dobrich Nurse Rehabilitation therapist 6.2. Sector-related exhibitions in Bulgaria Exhibition name Location (City) Dates Frequency For more info OPTO, PHOTO & VIDEO SALON (Optics, photography and video equipment) BULDENTAL International Specialized Exhibition for Medical Techniques, Intensive Care, Diagnostics, Surgery, Hospital Equipment, etc. BULMEDICA / BULDENTAL International Healthcare Exhibition - Dentistry ORTHOPAEDY & REHA EXPO (Orthopedics & Rehabilitation Expo) MEDICUS, DENTO, GALIENA (International Exhibition of Medicine, Dentistry and Pharmaceuticals) Inter Expo Center (Sofia) 7 10 Apr 2005 Annually Bulgarreklama International Exhibition Centre (Sofia) Bulgarreklama International Exhibition Centre (Sofia) Bulgarreklama International Exhibition Centre (Sofia) May 2005 Annually May 2005 Annually May 2005 Annually International Fair Plovdiv (Plovdiv) Oct 2005 Annually 6

8 USEFUL contacts Organization Phone Web site Ministry of Health ; Parliamentary Health Commission (Bulgarian only) Bulgarian Drug Agency National Health Insurance Fund ; National Center for Health Information ; Bulgarian Red Cross ; National Center of Infectious and Parasitic Diseases Executive Agency for Transplantation (Bulgarian only) National Council for Narcotics (Bulgarian only) National Center of Public Health Protection National Committee of AIDS and STIs Prevention at the Council of Ministers ; (Bulgarian only) National Centre of Radiobiology and Radiation Protection (NCRRP) ; National Oncology Center (Bulgarian only) National Center for Addictions ; (Bulgarian only) Children Medical Treatment Fund Center (Bulgarian only) Bulgarian Medical Association ; Union of the Dentists in Bulgaria Association of Bulgarian Pharmaceutical Manufacturers ; USEFUL sites Organization/Source Bulgarian medical web portal Bulgarian Medical Journal Bulgarian Mountain Rescue Service BGMEDICINE Medical database for patients Specialized Hospitals for Rehabilitation National complex EAD The International Federation of Red Cross and Red Crescent Societies Bulgarian health web-portal - The International Healthcare and Health Insurance Institute Multiprofile Hospital for Active Treatment and Emergency Medicine N.I.Pirogov University Hospital Queen Giovanna Alexandrovska Hospital Multi-profile hospital for active treatment St. Joan Rilski Fifth Multifunctional Hospital for Active Treatment Sofia Hospital Lozenets USAID Bulgaria Health Reform Project Specialized Hospitals for Rehabilitation National complex EAD Bulgarian web portal in drug addiction European Monitoring Centre for Drugs and Drug Addiction Initiative for Health Foundation Web site (Bulgarian only) (Bulgarian only) (Bulgarian only) (Bulgarian only) 7