6. No distributor in China has nationwide access and suppliers must work with many distributors to get broad yet effective coverage.
7.
8. Reimbursement list of medical insurance; if treatment or exam is not listed the demand for specific product will drop significantly.Risks
9. Medical Devices Primed for Growth Preface: Market Size and Forecasted Growth Rate Life Science Industry Segments (2009 – 2012 growth forecast) USD (billions) Source: CLSA Asia Pacific Markets
10. Recent Medical Devices M&A / Joint Venture Activity Preface: Trends in Medical Devices M&A / Joint-Venture Activity 2008 Medtronic acquired a 15% equity interest in Weigao Group Medical Polymer to market therapies in the spine and orthopedics sector. The agreement Gave Medtronic a 51% interest and Weigao a 49% interest. 2009 The Shanghai based Sym-Bio life science company, a supplier of diagnostic instruments was acquired by PerkinElmer for approximately USD 63.6 million. 2010 Chindex recently formed an alliance with Shanghai’s Fosun Pharmaceutical. The Joint Venture agreement will form Chindex Medical Limited and focus on manufacturing and distributing medical devices in China. . Source: Public Websites
11. Recent Medical Devices M&A / Joint Venture Activity Preface: Trends in Medical Devices M&A / Joint-Venture Activity 2004 Neusoft and Philips formed a manufacturing and R&D Joint Venture for medical systems. The Agreement formed Philips-Neusoft Medical Systems to develop CT and x-ray equipment. 2008 Philips acquires Shenzhen Goldway to help strengthen its high-end patient monitoring business segment in China. 2008 GE Healthcare established a Joint Venture agreement with China’s Shinva Medical Instrument Co. and will focused on the manufacturing of x-ray equipment. Source: Public Websites
12. Preface: Trends in Medical Devices PRC Research & Development Activity Foreign & Domestic Medical Devices R&D Operations Research & Development Centers Heilongjiang Jilin Liaoning Xinjiang Inner Mongolia Beijing Gansu Tianjin Hebei Shanxi Ningxia Shandong Qinghai Henan Jiangsu Shaanxi Tibet Shanghai Hubei Anhui Sichuan Zhejiang Chongqing Jiangxi Hunan Fujian Guizhou Yunnan Guangdong Guangxi Source: Company and Public Websites
24. Gradually provide equal public health services in both rural and urban areas
25. Public Hospital Reform Pilot Projects
26. Reform public hospital administration, operations and supervision to improve service qualitySource: Ministry of Health, National Development and Reform Commission
27. Construction and Renovation of 50,000+ Medical Institutions Preface: Large-Scale Construction of New Healthcare Institutions Construction of Healthcare Institutions ren* = renovations Source: Ministry of Health, National Development and Reform Commission
28. 2014 Market Value Forecasted @ USD 25 BILLION Preface: Market Size Forecasted to 2014 Medical Devices Market Value (2005 – 2014f) USD (billion) Source: CAMDI, SFDA, China Customs BMI
29. Medical Devices Primed for Growth across Major Sub-Segments Preface: Market Size of Medical Devices Industry Sub-Segments Medical Devices Industry Sub-segments (Dental Implants) (Implants, Supports) (Syringes, Catheters) (X-ray Machines, MRI) (ECG, Incubators, Ventilators, Heart-Lung Machines) Source: Epsicom Business Intelligence, DeviceLink.com
45. Nearly all of China’s 1.3 billion population covered by some form of insurance by 2012. Source: Ministry of Health, KPMG
46. 1.1 Income Growth: World Bank Projects China as #1 Economy 2020 GDP* GDP* PPP-adjusted France France EU-27 UK UK EU-27 US US Germany Germany China India Japan $30.0 tr $13.4 tr $28.8 tr $6.8 tr $29.6 tr GDP* PPP-adjusted 2009 GDP* China 6,4 trillionsde $ 3,6 trillionsde $ Japan India Japan $4.1 tr $3.8 tr $9.1 tr $14.2 tr $14.1 tr Source: World Bank
47. 900 800 99 700 90 600 500 53 170 355 400 461 525 239 300 255 200 157 106 100 73 35 0 2005 2010F 2015F 2020F 2025F 1.1 Income Growth: Forward Trend in Exploding Middle Class China’s Middle Class: 400 million (2010) … 500 million (2015) Upper Middle Class Middle Class Income Bands for Urban Population Lower Middle Class Urban Household Income (US$ – PPP-Adjusted) 822 822 756 756 Global > US$107,800 684 684 Affluent US$3,800 - 107,800 607 607 531 531 Urban Population (millions) Upper Middle US$21,501 – 53,900 Lower Middle US$13,500 – 21,500 Poor < US$13,500 Sources: Urbanization Rates, Population based on UN, World Urbanization Prospects 2007; MGI Consumer Demand 2008
48. 1.1 Income Growth: Significant Income Stratification across China Coastal Wealth Spreading Across the Country Per Capita Annual Income (USD, PPP-Adjusted) China Per Capita Annual Income (USD, PPP-Adjusted) Heilongjiang Jilin Xinjiang Liaoning Inner Mongolia Beijing Gansu Hebei Tianjin Shanxi Ningxia Shandong Qinghai Henan Jiangsu Shaanxi Tibet Anhui Shanghai Hubei Sichuan Zhejiang Chongqing Jiangxi Hunan Guizhou Fujian Yunnan Guangdong Guangxi
49. 1.1 Income Growth: Healthcare Expenditure Per Capita Trend Healthcare Expenditure Per Capita Continues to Grow Healthcare Expenditure Per Capita (2005 – 2020f) 249% Increase USD per Capita Source: PWC, Prof. Wen Tiejun, Renmin University of China
50. 1.2 Aging Population:Aging Population … One-Child Policy 87 MM 65+Yeal Old in 2000 … 112 MM in 2010 … 340 MM in 2050 Population under 14 Years Old (% of Total Population) Population over 65 Years Old(% of Total Population) Source: Dr. Jean-Paul Rodrigue; Exolus
51. 1.3 Lifestyle Changes:Wealth tied to Disease Accelerating Activities Disease Acceleration Lifestyle Changes 1/3 of world’s smokers are Chinese Lifestyle-related disease accelerating -- e.g., obesity, diabetes, cardiovascular, chronic respiratory diseases China will have 38 million diabetic patients by 2025, almost double projections of diabetes for the US No established culture of health consciousness and fitness Source: Dr. Jean-Paul Rodrigue
52.
53. Focus on establishing 2,000 provincial level hospitals and complete 29,000 township clinics and 5,000 clinics in remote villages
62. Reform public hospital administration, operations and supervision to improve service qualitySource: Ministry of Health, National Development and Reform Commission
63. 1.5 Insurance Reform:Programming to Universal Coverage by 2012 8-Fold Increase in Insurance Coverage in 10 Years … Coverage for Nearly All by 2012 China Insurance Reform Source: CCCPC, Xinhua, Public Websites
64. 2. Costs:First-World Infrastructure with Third-World Wages Exist? Asia Labor Costs: 10 – 20 Times Cheaper than in West Labor Costs (USD per month) Utility Costs Note: Units for Electricity $/kWh; Water in USD/m3; Waste Water in USD/m3 Source: Wage Data from the International Labor Organization; Utilities Rates from Public Utilities (non-negotiated rates)
66. 3. Innovation:Where are Key Nodes for Structuring R&D Platforms? “R” of R&D Seeks MD Clusters … “D” Seeks Hospitals & Production R&D Centers (# Operations) Research & Development Centers (Number of Operations in Select Cities) > 10 > 50 Deserts Heilongjiang Steppe > 150 Jilin Wage Bands Mega-Cluster Liaoning Xinjiang Mega-Corridors 1 Inner Mongolia Beijing Gansu Tianjin Hebei Mountains Shanxi Ningxia Shandong Qinghai 0.65 - 0.75 Henan Jiangsu Shaanxi 1 Tibet Anhui Shanghai Hubei Sichuan 0.8 - 0.9 0.7 - 0.8 Zhejiang Chongqing Jiangxi Hunan Fujian Guizhou Yunnan 1 Guangdong Guangxi Source: UNCTAD, WIR
67. 3. Innovation:Existing Medical Devices R&D Operations in China Foreign Medical Devices R&D Operational Largely in YRD and Bohai Rim R&D Centers (# Operations) R&D Centers (# Operations) Foreign MD R&D Centers in the PRC > 10 > 50 Heilongjiang > 150 Jilin Wage Bands Mega-Cluster Liaoning Xinjiang Mega-Corridors Inner Mongolia Beijing Gansu Tianjin Hebei Shanxi Ningxia Shandong Qinghai Henan Jiangsu Shaanxi Tibet Anhui Shanghai Hubei Sichuan Zhejiang Chongqing Jiangxi Hunan Fujian Guizhou Yunnan Guangdong Guangxi Source: UNCTAD, WIR
68. 3. Innovation:Big Pharma also Migrating R&D Functions to China Foreign Life Sciences R&D Operational Largely in YRD and Bohai Rim R&D Centers (# Operations) Foreign Life Sciences R&D Centers in the PRC > 10 > 50 Heilongjiang > 150 Jilin Wage Bands Mega-Cluster Liaoning Xinjiang Mega-Corridors Inner Mongolia Beijing Gansu Tianjin Hebei Shanxi Illustrative Innovation Trend Based on Big Pharma R&D Investment Ningxia Shandong Qinghai Henan Jiangsu Shaanxi Tibet Anhui Shanghai Hubei Sichuan Zhejiang Chongqing Jiangxi Hunan Fujian Guizhou Yunnan Guangdong Guangxi Source: UNCTAD, WIR
69. 3. Innovation:Driving Creation of a National Innovation System 19% YoY Increase in Research Spend for past Decade … RMB460 billion Total China National Innovation System 1. Institutions that Drive Innovation CAS MOST CAE NSFC NDRC MOE MOC MOF 2. Programs, Initiatives, Processes for Innovation 4. Intermediaries / Aggregators of Innovation Government Programs 863 Program 973 Program 211 Program 985 Program NSFC Funding National Key Technology R&D Hi-Tech Development Zone (HTDZ) Science Parks Incubators Natural Clusters 3. Academia, Firms, People that Drive Innovation Academia Private Firms Source: CCCPC
70. Ministry of Science and Technology (MOST) Programs for R&D 3. Innovation:Programs Created to Undergird National Innovation System Core Programs Supporting R&D in China Source: MOST, NDRC
71. Ministry of Education (MOE) Programs for R&D 3. Innovation:Programs Created to Undergird National Innovation System Core Programs Supporting R&D in China Source: MOST, NDRC
73. Senior Executives Select China as Most Attractive in World Investor Confidence in China #1 in World Top 14 Most Attractive Destinations for Future Investment (2009 – 2011) % Percent of Responses Source: World Investment Prospects 2009 - 2011
74. Foreign Investment Continues to Soar – Strong Vote of Confidence Record FDI of USD106 billion in 2010 Foreign Direct Investment Inflows (1990 – 2010) USD Source: China Statistical Yearbook
75.
76. China banks cleaned up in 1990s: Non-performing loans in 1997 averaged 40 – 50%; only 6% in 2007.
77. Financial institutions extended approximately USD1.4 tr in new loans in 2009; almost double that of 2008; and USD1.2 tr in 2010, slightly down from 2009.
82. State Owned Enterprise net profits as share of GDP has grown from (-1%) in 1997 to (+4.3%) in 2007.
83. Record corporate profit growth over past 5 years (industrial profits rose 38 ppa); liability ratios declined.
84. Urban incomes have nearly doubled in past 10 years.Source: Deutsche Bank; Standard Chartered; UBS; IMF; Other
85. Global Expansion Strategy & Cross-Border Investment Execution (Greenfield, M&A, Joint Ventures, Outsourcing) About Exolus: Exolus is a hybrid management consulting and transaction advisory firm. We work with management teams in the development of their global expansion strategies, across the range of investment formats: Greenfield, M&A, Joint Ventures and Outsourcing. As well, we deploy against global strategies by providing program management across all phases of cross-border investment projects, from candidate searches and evaluation, through investment structuring and negotiations. The founders of Exolushave spent the past two decades in the global service space and have direct experience operating in nearly all of the major investment destinations in the world (40+ countries). The team has served clients of all sizes, both public and private, on projects that ranged in investment size from USD10 million to greater than USD1 billion. We have served clients across all of the following industry segments: Life Sciences, Manufacturing, Automotive, Technology, Retail, Consumer Business, Real Estate, Public Sector. Follow Exolus at: www.exolus.com Need Further Information: info@exolus.com Want Copies of our Reports: www.exolus.com/en/knowledge/research.html
86. Disclaimer In writing we benefit from standing on the shoulders of others and, in the process, we strive to make our own contributions to the market of ideas. As well, we are always tremendously grateful for the many, often selfless, contributions that are availed in the process. The opinions represented herein were prepared for information purposes only, at the time of publication. The information represented herein is believed to be reliable, at the time of publication, and was obtained by various public sources also believed to be reliable. The opinions were considered to be accurate at the point of creation, and further, any views, forecasts, or estimates contained herein may be subject to change at anytime without notice. The opinions expressed or implied herein may not be the opinions of the author, also Exolus, or any associated affiliates. This report and the information contained herein collectively, is not offered as, and should not be regarded as, used or relied upon as advice on any matter. It shall not constitute or be construed as a recommendation or solicitation on behalf of the author, and no legal commitment or obligation shall arise by reason of this document. Thus, the reader shall make an independent assessment of opinion’s stated herein that shall not be considered a substitute for obtaining advise from the readers’ advisors. The author shall not accept responsibility, express or implied, with regards to the accuracy and completeness of the information herein, and the author shall not be liable whatsoever and howsoever arising in connection to this publication. The author shall not accept, and hereby disclaim, all responsibility and liability to all persons, entities, or organizations for all consequences arising out of any use or reliance on the whole or any part of this publication. This publication should not be reproduced or distributed without the author’s consent and is not intended for distribution in any jurisdiction in which this would be prohibited.
In state-owned hospitals, CEO is the key responsible person. So they are also the key decision-maker of the decision-making team in medical equipment purchase, instead of the expert who use the equipment as key person in western hospitals.Because CEO is not professional in techniques of the equipment to purchase, so in Chinese market, technical advantages are not as powerful as in western market. CEOs only recognize key parameter differences. So setting up industry standard and right positioning are the most important works to do in medical equipment marketing.The decision making team in China’s state-owned hospitals have a very complicated and even uncertain structure. Team members within hospital include CEO, vice CEOs, party secretary, equipment officer, user department director, related department directors, etc. Team members outside hospital include reference experts, healthcare bureau, government leader, related university dean, etc. To conquer such a big team, a sales dream-team is a must need
On April 6, 2009, the Central Committee of the Communist Party of China (“CCCPC”) and the State Council jointly endorsed and issued the Guidelines on Deepening the Reform of the Healthcare System (”Guidelines”)1, followed by the Implementation Plan on Focuses for Deepening the Reform of the Healthcare System 2009-2011 issued on April 7, 2009 (“Implementation Plan”)2. The Guidelines focus on directions, objectives and policy structure to reform the healthcare system in the long term, while the Implementation Plan details objectives in the coming three years. Priorities of China’s health reforms include:Expansion of health insurance programs, especially rural healthcare cooperatives• Building hospitals and clinics• Reducing government expenditures for drug costs• This memorandum addresses some of the efforts to control drug costs through the national essential drug system.Regulatory Frame work is improving: Guangdong Provincial FDA’s decision to revoke the licenses of 67 medical device manufactures and nearly three hundred distributors for producing and selling sub-standard goods. Meanwhile, the SFDA – China’s premier food, drug and medical device watchdog – recently completed the draft version of the revised regulations for the supervision and administration of medical devices. These two developments give a clear signal that quality is becoming increasing important, which is good news for the multinationals and also enlightened indigenous playersNational Essential Drug System – Program ChangesOne of the major reforms in the healthcare system in 2009-2011 will be the establishment of the National Essential Drug System, which covers three primary areas:1) Establishing the administrative system to adjust the National Essential Drug List. The National Essential Drug List will be renewed periodically. Ma Xiaowei, Vice Minister of Health, said in early April 2009 that the formulation of the National Essential Drug List is the first task to establish the National Essential Drug System, and it was intended to be issued in April3. As of early May, however, the List has not yet been published. 2) Establishing a bidding process for essential drugs. Both the producer and the supplier of essential drugs used by government affiliated medical institutions may be required to participate in public bidding held by institutions designated by the provincial-level government. Enterprises in various regions and in various ownerships shall be treated equal in the bidding. Purchase/pricing of essential drugs with small dosage, and certain designated production/suppliers will be structured through bidding. The central government will set guiding retail prices for essential drugs, while provincial-level governments may set unified prices of essential drugs in the corresponding regions within the price scope set by the central government. Government affiliated basic medical institutions shall sell drugs to patients at the purchase price without markup.3) Establishing a system that encourages the use of essential drugs. All government affiliated retail drug stores and medical institutions shall have and sell national essential drugs for patients’ needs. Urban and rural basic medical institutions shall all use national essential drugs, while other medical institutions shall give priority to the use of essential drugs and follow the requirement on utilization percentage of essential drugs which will be set by the health administrations later. All the essential drugs will be covered by the basic medical insurance system, and may see higher reimbursement rates than non-essential drugs in the insurance system. 2New drugs and patented drugs will be subject to an economic evaluation to help determine pricing. The economic evaluation is intended to provide an objective analysis of quality, curative effect, cost, safety, and other clinical and economic features. These evaluations will contribute not only to drug pricing, but also to the formulation of a drug reimbursement catalogue, formulation of national essential drug list, and prescription plans at medical institutions for patients. Further, in order to control costs, new generic drugs will be required to be sold at the current lowest market price. The markup percentage in the drug distribution will also be strictly regulated. Drug pricing in China currently is under the primary supervision of the National Development and Reform Commission (NDRC) and the State Food and Drug Administration (SFDA). Hospital Purchase/Sale of DrugsAnother major reform involves restrictions on public hospitals’ purchase and sale of drugs. More specifically, hospitals will no longer be able to markup the price on drugs in sales to patients. The percentage markups of drug prices will be gradually eliminated. To protect hospitals from significantly reduced revenues, patients’ payment to hospitals for medical services will be increased, and the government will also increase subsidies to public hospitals on infrastructure construction, purchase of capital equipment, public sanitary missions, etc.. Basic medical services of non-profit medical institutions shall follow the guiding price set by the government, and medical institutions are independent to price other medical services. The central government will work out the pricing policies and measures on medical services, and the provincial-level or the municipal-level pricing authorities will set the guiding prices jointly with the administration of health, human resources and social security. Observations and Implications:The Guidelines and the Implementation Plan are another step for the Chinese government to lower drug prices. Provincial-level governments will have the power to set drug prices of essential drugs in the corresponding jurisdictions through public bidding. Essential drugs will be sold in government affiliated basic medical institutions at the purchase price without markup, while in the future, both essential drugs and non-essential drugs will be sold without markup in more medical institutions including public hospitals. Official figures suggest that currently, about half the income of China’s general hospitals may come from price markups of the drugs sold to maintain operations. The government will reinforce the financial support to those institutions to maintain their daily operations. The unified procurement of essential drugs is intended to be fair to both domestic and foreign invested drug companies, as pursuant to the Implementation Plan, “enterprises in various regions and various ownerships are equal in taking part in the fair competition” in the bidding.To promote the reform, the State Council has established the Steering Team on Deepening the Reform of the Healthcare System, which is under the leadership of Vice Premier Li Keqiang and composed of officials from 16 ministries of the State Council including the National Development and Reform Commission, the Ministry of Health, the Ministry of Finance, the Ministry of Human Resources and Social Security, etc. The Steering Team will be responsible for formulating pilot program policies and principles. More affiliated documents and regulations on operations are expected to emerge soon.dk
Medical Device Industry:projects cutting edge medical equipment will experience the greatest demand, while low-end goods will keep the sector highly buoyant. By 2014, the value of the md industry will reach rmb 164 bn (usd25bn) posting a cagr of 12.9 % in usd. Total md market accounts for 6.6% of total healthcare market.
In state-owned hospitals, CEO is the key responsible person. So they are also the key decision-maker of the decision-making team in medical equipment purchase, instead of the expert who use the equipment as key person in western hospitals.Because CEO is not professional in techniques of the equipment to purchase, so in Chinese market, technical advantages are not as powerful as in western market. CEOs only recognize key parameter differences. So setting up industry standard and right positioning are the most important works to do in medical equipment marketing.The decision making team in China’s state-owned hospitals have a very complicated and even uncertain structure. Team members within hospital include CEO, vice CEOs, party secretary, equipment officer, user department director, related department directors, etc. Team members outside hospital include reference experts, healthcare bureau, government leader, related university dean, etc. To conquer such a big team, a sales dream-team is a must need
On April 6, 2009, the Central Committee of the Communist Party of China (“CCCPC”) and the State Council jointly endorsed and issued the Guidelines on Deepening the Reform of the Healthcare System (”Guidelines”)1, followed by the Implementation Plan on Focuses for Deepening the Reform of the Healthcare System 2009-2011 issued on April 7, 2009 (“Implementation Plan”)2. The Guidelines focus on directions, objectives and policy structure to reform the healthcare system in the long term, while the Implementation Plan details objectives in the coming three years. Priorities of China’s health reforms include:Expansion of health insurance programs, especially rural healthcare cooperatives• Building hospitals and clinics• Reducing government expenditures for drug costs• This memorandum addresses some of the efforts to control drug costs through the national essential drug system.Regulatory Frame work is improving: Guangdong Provincial FDA’s decision to revoke the licenses of 67 medical device manufactures and nearly three hundred distributors for producing and selling sub-standard goods. Meanwhile, the SFDA – China’s premier food, drug and medical device watchdog – recently completed the draft version of the revised regulations for the supervision and administration of medical devices. These two developments give a clear signal that quality is becoming increasing important, which is good news for the multinationals and also enlightened indigenous playersNational Essential Drug System – Program ChangesOne of the major reforms in the healthcare system in 2009-2011 will be the establishment of the National Essential Drug System, which covers three primary areas:1) Establishing the administrative system to adjust the National Essential Drug List. The National Essential Drug List will be renewed periodically. Ma Xiaowei, Vice Minister of Health, said in early April 2009 that the formulation of the National Essential Drug List is the first task to establish the National Essential Drug System, and it was intended to be issued in April3. As of early May, however, the List has not yet been published. 2) Establishing a bidding process for essential drugs. Both the producer and the supplier of essential drugs used by government affiliated medical institutions may be required to participate in public bidding held by institutions designated by the provincial-level government. Enterprises in various regions and in various ownerships shall be treated equal in the bidding. Purchase/pricing of essential drugs with small dosage, and certain designated production/suppliers will be structured through bidding. The central government will set guiding retail prices for essential drugs, while provincial-level governments may set unified prices of essential drugs in the corresponding regions within the price scope set by the central government. Government affiliated basic medical institutions shall sell drugs to patients at the purchase price without markup.3) Establishing a system that encourages the use of essential drugs. All government affiliated retail drug stores and medical institutions shall have and sell national essential drugs for patients’ needs. Urban and rural basic medical institutions shall all use national essential drugs, while other medical institutions shall give priority to the use of essential drugs and follow the requirement on utilization percentage of essential drugs which will be set by the health administrations later. All the essential drugs will be covered by the basic medical insurance system, and may see higher reimbursement rates than non-essential drugs in the insurance system. 2New drugs and patented drugs will be subject to an economic evaluation to help determine pricing. The economic evaluation is intended to provide an objective analysis of quality, curative effect, cost, safety, and other clinical and economic features. These evaluations will contribute not only to drug pricing, but also to the formulation of a drug reimbursement catalogue, formulation of national essential drug list, and prescription plans at medical institutions for patients. Further, in order to control costs, new generic drugs will be required to be sold at the current lowest market price. The markup percentage in the drug distribution will also be strictly regulated. Drug pricing in China currently is under the primary supervision of the National Development and Reform Commission (NDRC) and the State Food and Drug Administration (SFDA). Hospital Purchase/Sale of DrugsAnother major reform involves restrictions on public hospitals’ purchase and sale of drugs. More specifically, hospitals will no longer be able to markup the price on drugs in sales to patients. The percentage markups of drug prices will be gradually eliminated. To protect hospitals from significantly reduced revenues, patients’ payment to hospitals for medical services will be increased, and the government will also increase subsidies to public hospitals on infrastructure construction, purchase of capital equipment, public sanitary missions, etc.. Basic medical services of non-profit medical institutions shall follow the guiding price set by the government, and medical institutions are independent to price other medical services. The central government will work out the pricing policies and measures on medical services, and the provincial-level or the municipal-level pricing authorities will set the guiding prices jointly with the administration of health, human resources and social security. Observations and Implications:The Guidelines and the Implementation Plan are another step for the Chinese government to lower drug prices. Provincial-level governments will have the power to set drug prices of essential drugs in the corresponding jurisdictions through public bidding. Essential drugs will be sold in government affiliated basic medical institutions at the purchase price without markup, while in the future, both essential drugs and non-essential drugs will be sold without markup in more medical institutions including public hospitals. Official figures suggest that currently, about half the income of China’s general hospitals may come from price markups of the drugs sold to maintain operations. The government will reinforce the financial support to those institutions to maintain their daily operations. The unified procurement of essential drugs is intended to be fair to both domestic and foreign invested drug companies, as pursuant to the Implementation Plan, “enterprises in various regions and various ownerships are equal in taking part in the fair competition” in the bidding.To promote the reform, the State Council has established the Steering Team on Deepening the Reform of the Healthcare System, which is under the leadership of Vice Premier Li Keqiang and composed of officials from 16 ministries of the State Council including the National Development and Reform Commission, the Ministry of Health, the Ministry of Finance, the Ministry of Human Resources and Social Security, etc. The Steering Team will be responsible for formulating pilot program policies and principles. More affiliated documents and regulations on operations are expected to emerge soon.dk
On April 6, 2009, the Central Committee of the Communist Party of China (“CCCPC”) and the State Council jointly endorsed and issued the Guidelines on Deepening the Reform of the Healthcare System (”Guidelines”)1, followed by the Implementation Plan on Focuses for Deepening the Reform of the Healthcare System 2009-2011 issued on April 7, 2009 (“Implementation Plan”)2. The Guidelines focus on directions, objectives and policy structure to reform the healthcare system in the long term, while the Implementation Plan details objectives in the coming three years. Priorities of China’s health reforms include:Expansion of health insurance programs, especially rural healthcare cooperatives• Building hospitals and clinics• Reducing government expenditures for drug costs• This memorandum addresses some of the efforts to control drug costs through the national essential drug system.Regulatory Frame work is improving: Guangdong Provincial FDA’s decision to revoke the licenses of 67 medical device manufactures and nearly three hundred distributors for producing and selling sub-standard goods. Meanwhile, the SFDA – China’s premier food, drug and medical device watchdog – recently completed the draft version of the revised regulations for the supervision and administration of medical devices. These two developments give a clear signal that quality is becoming increasing important, which is good news for the multinationals and also enlightened indigenous playersNational Essential Drug System – Program ChangesOne of the major reforms in the healthcare system in 2009-2011 will be the establishment of the National Essential Drug System, which covers three primary areas:1) Establishing the administrative system to adjust the National Essential Drug List. The National Essential Drug List will be renewed periodically. Ma Xiaowei, Vice Minister of Health, said in early April 2009 that the formulation of the National Essential Drug List is the first task to establish the National Essential Drug System, and it was intended to be issued in April3. As of early May, however, the List has not yet been published. 2) Establishing a bidding process for essential drugs. Both the producer and the supplier of essential drugs used by government affiliated medical institutions may be required to participate in public bidding held by institutions designated by the provincial-level government. Enterprises in various regions and in various ownerships shall be treated equal in the bidding. Purchase/pricing of essential drugs with small dosage, and certain designated production/suppliers will be structured through bidding. The central government will set guiding retail prices for essential drugs, while provincial-level governments may set unified prices of essential drugs in the corresponding regions within the price scope set by the central government. Government affiliated basic medical institutions shall sell drugs to patients at the purchase price without markup.3) Establishing a system that encourages the use of essential drugs. All government affiliated retail drug stores and medical institutions shall have and sell national essential drugs for patients’ needs. Urban and rural basic medical institutions shall all use national essential drugs, while other medical institutions shall give priority to the use of essential drugs and follow the requirement on utilization percentage of essential drugs which will be set by the health administrations later. All the essential drugs will be covered by the basic medical insurance system, and may see higher reimbursement rates than non-essential drugs in the insurance system. 2New drugs and patented drugs will be subject to an economic evaluation to help determine pricing. The economic evaluation is intended to provide an objective analysis of quality, curative effect, cost, safety, and other clinical and economic features. These evaluations will contribute not only to drug pricing, but also to the formulation of a drug reimbursement catalogue, formulation of national essential drug list, and prescription plans at medical institutions for patients. Further, in order to control costs, new generic drugs will be required to be sold at the current lowest market price. The markup percentage in the drug distribution will also be strictly regulated. Drug pricing in China currently is under the primary supervision of the National Development and Reform Commission (NDRC) and the State Food and Drug Administration (SFDA). Hospital Purchase/Sale of DrugsAnother major reform involves restrictions on public hospitals’ purchase and sale of drugs. More specifically, hospitals will no longer be able to markup the price on drugs in sales to patients. The percentage markups of drug prices will be gradually eliminated. To protect hospitals from significantly reduced revenues, patients’ payment to hospitals for medical services will be increased, and the government will also increase subsidies to public hospitals on infrastructure construction, purchase of capital equipment, public sanitary missions, etc.. Basic medical services of non-profit medical institutions shall follow the guiding price set by the government, and medical institutions are independent to price other medical services. The central government will work out the pricing policies and measures on medical services, and the provincial-level or the municipal-level pricing authorities will set the guiding prices jointly with the administration of health, human resources and social security. Observations and Implications:The Guidelines and the Implementation Plan are another step for the Chinese government to lower drug prices. Provincial-level governments will have the power to set drug prices of essential drugs in the corresponding jurisdictions through public bidding. Essential drugs will be sold in government affiliated basic medical institutions at the purchase price without markup, while in the future, both essential drugs and non-essential drugs will be sold without markup in more medical institutions including public hospitals. Official figures suggest that currently, about half the income of China’s general hospitals may come from price markups of the drugs sold to maintain operations. The government will reinforce the financial support to those institutions to maintain their daily operations. The unified procurement of essential drugs is intended to be fair to both domestic and foreign invested drug companies, as pursuant to the Implementation Plan, “enterprises in various regions and various ownerships are equal in taking part in the fair competition” in the bidding.To promote the reform, the State Council has established the Steering Team on Deepening the Reform of the Healthcare System, which is under the leadership of Vice Premier Li Keqiang and composed of officials from 16 ministries of the State Council including the National Development and Reform Commission, the Ministry of Health, the Ministry of Finance, the Ministry of Human Resources and Social Security, etc. The Steering Team will be responsible for formulating pilot program policies and principles. More affiliated documents and regulations on operations are expected to emerge soon.dk
In state-owned hospitals, CEO is the key responsible person. So they are also the key decision-maker of the decision-making team in medical equipment purchase, instead of the expert who use the equipment as key person in western hospitals.Because CEO is not professional in techniques of the equipment to purchase, so in Chinese market, technical advantages are not as powerful as in western market. CEOs only recognize key parameter differences. So setting up industry standard and right positioning are the most important works to do in medical equipment marketing.The decision making team in China’s state-owned hospitals have a very complicated and even uncertain structure. Team members within hospital include CEO, vice CEOs, party secretary, equipment officer, user department director, related department directors, etc. Team members outside hospital include reference experts, healthcare bureau, government leader, related university dean, etc. To conquer such a big team, a sales dream-team is a must need
In state-owned hospitals, CEO is the key responsible person. So they are also the key decision-maker of the decision-making team in medical equipment purchase, instead of the expert who use the equipment as key person in western hospitals.Because CEO is not professional in techniques of the equipment to purchase, so in Chinese market, technical advantages are not as powerful as in western market. CEOs only recognize key parameter differences. So setting up industry standard and right positioning are the most important works to do in medical equipment marketing.The decision making team in China’s state-owned hospitals have a very complicated and even uncertain structure. Team members within hospital include CEO, vice CEOs, party secretary, equipment officer, user department director, related department directors, etc. Team members outside hospital include reference experts, healthcare bureau, government leader, related university dean, etc. To conquer such a big team, a sales dream-team is a must need