REPUBLIC OF TURKEY PRIME MINISTRY Investment Support and Promotion Agency of Turkey ISPAT “Pharmaceutical Sector and PPP Projects in Turkey” Derun ÜLGEN Direttore di Progetto Senior
The Turkish pharmaceutical sector is the 6 th largest in Europe in terms of sales Top 20 Countries According to Pharmaceutical Sales in 2012 Source: EIU Ø Great progress has been made in the sector during the last decade and thanks to a series of reforms, the quality and efficiency of the public and private healthcare system have been increased. Ø Turkey was the 6 th largest pharmaceutical market in Europe and 16 th largest in the world in 2012 with USD 12. 5 billion sales, which means a growth of nearly 10% between 2003 and 2012 and it is expected to grow by 7%-10% each year
Global and Turkish pharmaceutical sector will grow According to EIU forecasts, global healthcare and pharmaceutical spending is expected to increase in 2013 compared to the previous year by 2. 4% and 4. 0%, respectively, whereas in Turkey, forecasts indicate higher growth rates than global ones. Within this context, the healthcare sector is expected to grow by 5. 8% and pharmaceutical sector by 8. 9%, in 2013. Healthcare and Pharmaceutical Spending Growth by Region, 2013 Forecasts Turkey’s pharmaceutical sales grew 9. 7% from 2003 to 2012. This is expected to increase of 8. 8% from 2012 to 2017 surpassing USD 19 billion.
Pharmaceutical exports Exports of Pharmaceuticals Sector in Turkey Ø Turkey’s pharmaceutical exports increased 10% from 2007 to 2012, surpassing USD 720 million. Ø For the export values, top ten countries had over 55% of the total export share. Germany is a prominent partner of Turkey with 10% in 2012, followed by Iraq with 8%, South Korea, which is the largest export market in Asia, for Turkey, with 7%. Ø With the help of 2023 Vision Targets, Turkish pharma sector can deliver over USD 13 billion worth of exports by 2023.
M&A market with USD 1. 7 billion worth of transactions since 2006 Acquirer Target Date Deal Value USD Millions Stake Citibank Venture Capital Ltd; Partners in Biofarma Pharmaceuticals Co. Ltd. Life Sciences (Pi. LS) 2006 200 100% White Swan Corporation B. V. Taymed Saglik Urunleri Ticaret Ltd Sti 2006 N/A 100% Partners in Life Sciences (Pi. LS) Munir Sahin llac Sanayi ve Ticaret A. S. 2006 22 100% International Pharma Ltd. Deva Holding AS 2006 50. 2 18% Actavis Group hf (formerly. Pharmaco hf ) Fako Ilaclari As 2006 20. 4 10% Eastpharma Holding Saba Ilac Sanayii ve Ticaret A. S. Eczacıbaşı-Zentiva Kim. Ur. San. ve Tic. A. S. EczacıbaşıZentiva Sag. Urun. San. ve Tic. A. S. 2007 10 96% 2007 602 75%-75% Sandoz International Gmb. H Roche Holding AG (Gebze production plant) 2007 N/A 100% Eczacıbaşı Ilaç Monrol Nükleer Ürünler 2008 43. 1 50% İş Girişim Sermayesi Dr. F. Frik Ilaç Sanayi 2008 13. 4 17% Partners in Life Sciences Betasan Pharmaceuticals 2008 N/A 100% Recordati Sp. A Yeni Ilac 2008 60 100% Ebewe Pharma 2008 N/A 100% 2009 N/A 25%-25% Alliance Boots EBV Limited Eczacıbaşı-Zentiva Kim. Ur. San. ve Tic. A. S. EczacıbaşıZentiva Sag. Urun. San. ve Tic. A. S. Hedef Alliance Holding 2010 N/A 10% Polpharma Cenovapharma 2011 N/A 77% NBK Dem Ilaç 2012 N/A Amgen Mustafa Nevzat Ilaç 2012 669 96% Zentiva NV
Top 10 Pharmaceutical Manufacturing Companies in Turkey # Company 1 Abdi Ibrahim 2 Novartis 3 Sanofi 4 Bilim 5 Pfizer 6 Bayer 7 Eastpharma 8 Glaxo 9 Roche 10 Astra. Zeneca Top Ten Total Market Share (2012) 7. 5% 7. 0% 5. 8% 4. 9% 4. 3% 3. 8% 3. 7% 3. 4% 3. 0% 47. 6% Industrial employment includes approx. 25. 000 people v Turkey has the necessary knowledge base, skilled workforce, infrastructure and geostrategic location to attract global pharmaceutical R&D and could become a global player in the pharma industry. v Strong production facility infrastructure; 76% of drugs consumed in Turkey on a box basis and 49% on a value basis are locally produced. v Under current budget framework, Turkey’s local pharma production will reach 23. 3 billion USD by 2023 through the production of innovative and technologically advanced products (as compared to local production of USD 5 billion USD in 2011).
Foreign companies play an important role in manufacturing phase Multinationals with manufacturing facilities that operate in Turkey include Sanofi, Baxter, Bayer, GSK, Novartis, Pfizer and Roche, with the most recent foreign entrant on the market being East. Pharma. Leading multinationals such as Pfizer, Novartis, Bayer and Roche command market shares of 4 -6% each. Baxter runs a 50: 50 JV with Eczacıbaşı. International companies are represented by the Pharmaceutical Manufacturers Association of Turkey (IEIS)has 60 members, which also includes domestic firms.
Regulation v Turkish Drug and Medical Device Institution, a part of the Mo. H, is in charge of the regulation and control of pharmaceutical prices. v The data protection liability generated by TRIPS entered Turkey’s regulations in March of 1995. In this context all of the confidentiality of information submitted for the purpose of obtaining a license is protected. With this development, laws that are related to data protection in Turkey got closer to standards in Europe.
Clinical research • Turkish Drug and Medical Device Institution is the regulatory authority in drug discovery and R&D and monitors clinical research and R&D activities in Turkey. The institution has prepared a legislation related on Clinical Research in August 2011, which is compatible with European Union directives. • Turkey is ranked as the 35 th country in number of clinical research conducted in the world and 19 th in Europe. Turkey conducted over 1, 200 clinical researches in 2013 and took a share of 0. 6% in total clinical research conducted in the world. • Companies who want to conduct research in following areas must take permission from Ministry of Health: • Pharmaceuticals, medical products, herbal medical products that will be tested on human subjects; observational pharmaceutical studies; bioavailability and bioequivalence studies; observational medical device studies and medical device clinical research; stem cell transplantation research; organ and tissue transplantation etc • One of the goals of the government is to increase R&D spending in the sector to 3% og GDP, thus, in turn it aims to increase the total number of clinical research conducted.
Technology Development Zones also contribute significantly to research and development of manufacturing industry ü Entrepreneurs are exempt from income tax until 2023 over income made from R&D operations and software. Taxes over wages of R&D personnel are exempt until 2023. One TDZ More than one TDZ Underconstruction ü 50% of the social security premium support for 5 years for R&D personnel will be supported under the law no. 5746 named R&D Operations Support. • TDZs are organized research centers where universities, research institutions and industrial foundations work together for innovation and technology transfer; increasing product quality and standards; product development; commercializing know-how; supporting technological investments and entrepreneurships. • Every year, 4 new TDZs are opened in Turkey and the goals for 2023 are 5. 500 companies, 65. 000 employment, and 10 billion dollars of exports. • 55% of the firms in TDZs are engaged in Software and Informatics business. Other areas of focus are electronics and defense industries. • Number of projects reached 5, 717 in April 2013 and total export reached USD 893 million at the end of 2012. • A total of 322 patents were applied by the firms in TDZs. • Employment in the TDZs consists of 15, 960 R&D and 3, 536 support personnel, with a total of 19, 496.
Turkish Investment Incentives Programme General Inv. Regional Inv. Large Scale Inv. Strategic Inv. Vat Exception x x Customs Duty Exemption x x Tax Deduction - x x x Land Allocation - x x x Interest Support - x Vat Refund - - - x Employer's Social Security Premium Support - x x x Support Measures Only For Region 6 Income Tax Withholding Support x x x Employee’s Social Security Premium Support Ø The investment incentive program of 2012 comprises 4 different schemes: general, regional, large scale and strategic. Moreover, specific priority investment subjects are supported by measures of Region 5 even they are made in Regions 1, 2, 3 and 4. Ø All investment types, except the ones that are specifically excluded from investment incentives program, will be supported by General Investment Incentives Program. In this scope, the minimum fixed investment amount is TL 1 million in Region 1 and 2 and TL 500 thousand in Regions 3, 4, 5 and 6. x - x x x REGIONAL INVESTMENTS INCENTIVE SCHEME MEASURES Region OIZ 1 2 3 4 5 6 Out of OIZ 15 20 25 30 40 50 Within OIZ 20 25 30 40 50 55 Out of OIZ 2 3 5 6 7 10 Within OIZ 3 5 6 7 10 12 Tax Reduction (%) Employer's Social Security Premium Support Period (years)
Pharmaceuticals and medical equipment are incentivized Ø Investments with a minimum amount of 50 million TL are considered as Large Scale Investments. Ø Strategic investment incentives are given to the production of intermediate and final products with high import dependence with a view to reduce current account deficit. The criteria to gain this support would be: to be made for production of intermediate and final goods with high import dependence of which more than 50% of these goods are supplied by imports, to have a minimum investment amount of TL 50 million, to create minimum 40% value added and to have an import amount of at least USD 50 million for goods to be produced in the last one year period (not applicable to goods with no domestic production). Ø More specifically, investments in the fields of biotechnological and oncological drugs, and blood products are considered as strategic investments benefiting from the incentives implemented in the fifth region provided that the fixed investment amount is above TL 20 million.
Strategic Plans ØThe Ministry of Health in its Strategic Plan for period of 2013 -2017 is aiming to improve, monitor and evaluate quality standards for pharmaceuticals, biological products and medical devices; to develop, monitor and evaluate standards for medical devices used for treatment purposes; to increase the number of inspections for GMPs; to improve the evaluation of applications and licensing processes and to ensure the rational use of drugs and medical devices. ØThe Ministry of Science, Industry and Technology has identified strategic goals on its Strategy Paper which are the improvement of regulations to meet the demands of public health and improve investments; the investment on qualified human resource; the improvement of the cooperation among public sector, private sector and universities; effective planning of R&D operations to produce high value added products. Source: Ministry of Health Strategic Plan 2013 -2017
2023 Goals Selected Key Performance Indicators from Action Plan Key Performance Indicators Innovation Capacity Current Status 71. The quality of scientific research centers 89. Vision 2023 Top 20 Top 30 Retaining scientists and engineers 35. Top 20 Global Innovation 74. Top 30 Number of new local molecules 0 At least 1 Pharmaceutical R&D expenditures/GDP (2011)* 0. 02% 0. 1% Pharmaceutical R&D expenditures/total R&D expenditures (2011)* 0. 04% 3. 6% 1, 267 ≈3600 10% 107% 3 20 Global Competitiveness 59 Top 25 Ease of doing business (2013) 71 Top 35 350 days ‹ 210 days Number of clinical trials conducted throughout a year (2013) Pharmaceutical exports as a percentage of pharmaceutical imports (2010) Number of multinational pharmaceutical companies, that have established regional management centers in Turkey (2011) Duration of GMP certification (2011) Source: AIFD, Vision 2023 Report; Ministry of Scince, Industry and Technology, Turkstat, Deloitte Analysis *: Includes manufacture of basic pharmaceutical products and pharmaceutical preparations Note: Status is out of 142 counties
HEALTH CAMPUSES
Turkish PPP Program • Turkey has undertaken an ambitious Healthcare PPP Program through which a total of 35 health campuses and city hospitals are intended to be built using the buildlease-transfer model. • Each campus will house 2, 000 to 4, 000 beds divided among general and specialized hospitals and laboratories • The health campuses and city hospitals will add between 40, 000 - 50, 000 beds to Turkey’s existing healthcare infrastructure. • It is estimated that the lease payments for the planned health campuses and city hospitals will be between TL 80, 000 and 85, 000 per year per bed, amounting to a total of TL 3. 2 to 4 billion per year. Added Bed Capacity 50, 000 Average Lease Period 25 Years Lease Payments per year TL 3. 2 -4 billion Planned PPP Projects 35 Current PPP Projects 20 Total Lease Payments TL 80 – 100 billion • Assuming the Mo. H will lease the facilities for 25 years, the total amount of lease payments for healthcare campuses • International tenders are being opened for the and city hospitals will reach TL 80 to 100 billion. contracting of each of these hospitals to consortiums (composed of construction companies, architectural designers, operators, and medical technologies companies). The winning consortium of each project will finance the construction and will operate the campus for 25 years against guaranteed annual lease payments to be made by the Mo. H.
Turkish PPP Program Policy Framework Legal Framework Institutional Framework • 2003 -2013 Health Transformation Program • Vision 2023 • Mo. H 2013 -2017 Strategic Plan • 10 th National Development Plan • Supreme Planning Board • Mo. H, Department of Public Private Partnership • Under Secretariat of the Treasury • Law no. 6428 published in the Official Gazette on 9 March 2013 decreases the burden and risk undertaken by companies involved in PPP projects. It brings legal certainty and introduces a mechanism through which lease payments can be adjusted according to changes in foreign exchange rate. • The Supreme Planning Board is involved in a limited number of decisions with fundamental importance, while the Mo. H assumes bulk of the work to be done for the initiation and realization of Healthcare PPP Projects. The Mo. H selects relevant PPP projects, prepares feasibility reports and tender documentation. The Under Secretariat of the Treasury, in most cases, procures the land for the PPP project provided that it is determined the land will be treasury-owned land. Healthcare PPP Project, buildlease-transfer
Healthcare PPPs in Turkey use the Build-Lease-Transfer (BLT) Model Under the BLT model, the project company contracts or renews healthcare facilities, and subsequently leases it to the government for a set amount of time. During the contract period, in addition to getting regular lease payments from the government, the project company also has the right to develop and operate non-healthcare facilities. If the company is renewing the facility it receives the right to provide non-healthcare services and a service fee in return for its investment. If new facilities are built the following procedure is followed: Projects are awarded through one of the following procedures: Tender Phase Build - Open Bid Procedure (preferred) - Open Bid Procedure among bidders selected through a pre-qualification process - Negotiated procedure (only allowed in a limited set of circumstances) - Lease - Transfer - The project company secures the financing required for the completion of the project. If the land on which the facility will be built is treasury-owned, Mo. H arranges for the land to be used by the project company, free of charge, for the project period. During the investment period, the transactions between Mo. H and the company are exempt from stamp tax. Once the health facility is built according to the contracted standard, Mo. H will lease the facility for a maximum period of 30 years. Mo. H will pay the project company a yearly lease adjusted annually on the basis of the Turkish Producer Price Index and the Turkish Consumer Price Index. During this period, the project company also has the right to operate non-healthcare facilities. At the end of the contract term, the project company returns the healthcare facilities built to the Mo. H in good working condition and without any encumbrances. If the land on which the facility is developed is not treasury-owned, the Mo. H takes necessary steps to adequately compensate related parties.
Projects in the Pipeline… Istanbul Bakırköy Integrated Health Campus 1, 043 beds Istanbul Üsküdar Public Hospital 425 beds Pre qualification phase PPP Projects in Healthcare as of December 2013 Pre qualification tender announcement phase Eskişehir City Hospital 1, 060 beds Kocaeli Integrated Health Campus 1, 180 beds TPHA + TPMDA Campus N/A Bursa Integrated Health Campus 1, 355 beds Isparta City Hospital 755 beds Izmir Bayraklı Integrated Health Campus 2, 000 beds Adana Integrated Health Campus 1, 539 beds Elazığ Integrated Health Campus 1, 038 beds Gaziantep Integrated Health Campus 1, 867 beds Konya Karatay Integrated Health Campus 838 beds Manisa Education and Research Hospital 558 beds Mersin Integrated Health Campus 1, 253 beds PTR, Psychiatry and High Security Forensic Psychiatry Hospitals 2, 400 beds Yozgat Education and Research Hospital 475 beds Istanbul İkitelli Integrated Health Campus 2, 682 beds Ankara Bilkent Integrated Health Campus 3, 660 beds Ankara Etlik Integrated Health Campus 3, 566 beds Kayseri Integrated Health Campus 1, 583 beds Bid phase Final Bid phase Contract phase Construction phase
THANK YOU
Скачать презентацию REPUBLIC OF TURKEY PRIME MINISTRY Investment Support and
47d6cdd759ab69650995a59a5e8732ce.ppt