Constructing Healthy China: Sharing, Innovation & Sustainable Development

Transcription

1 Constructing Healthy China: Sharing, Innovation & Sustainable Development 3 / 1/2017

2 Table of Contents Chapter One: Healthy China Healthy China 2030 is the first long-term national strategy in the health field Pharmaceutical industry development guarantees Healthy China 2030 s realization Pharmaceutical MNCs bring valuable experience to Health China Chapter Two: China Medical and Health Reform... 7 Chapter Three: Sanofi in China... 8 Chapter Four: Policy Recommendations to Health China 2030 from Sanofi China perspective Enhancing the total health investment, and bettering the expenditure structure Encouraging Innovation in the Pharmaceutical Industry ) Transformation from imitation to innovation ) Reinforce clinical research to eliminate innovation bottlenecks ) Scientific supervision with international standards ) Ensure the financial return of innovation Improving the quality and safety for medicinal products ) Strengthen the supervision depth ) Promote industry structure reform ) Enhance international cooperation to better health awareness ) Manage the procurement and MI reimbursement system during transition while carrying out GQCE Accelerating accessibility to innovative medicines ) Learn from foreign mature drug market approval experience, and

3 improve the threshold of new drug registration ) Set up special channel to encourage effective new drug production ) Speed up the talent development...18 Chapter Five: Closing... 18

4 Executive Summary With Chinese economic development, the medical & health reform has finally stepped into a crucial period. CPC published "Healthy China 2030" strategic plan in order to build an innovational, harmonize, green, opened, and shared environment for next 14 year s healthy China construction. Sanofi, as a leader of pharmaceutical industry and advocate of social responsibility, has been involved in Chinese public health development and supporting the medical & health reform for many years. Sanofi is committed to improve the accessibility of medical products and services and meet the high quality medical and health needs of patients. Adhering to the principles of friendly exchange and mutual development, Sanofi is glad to take the opportunity to express recommendations about enhancing health investment, rewarding innovation, improving drug quality and safety and Accelerating accessibility to innovative medicines on behalf of pharmaceutical enterprises to the Chinese government. Sanofi is determined to serve as the most reliable medical and health partner of China and to contribute to the sustainable development of both economy and society and to create a healthier future. Chapter One: Healthy China 2030

5 1.Healthy China 2030 is the first long-term national strategy in the health field Health is a necessary prerequisite for the overall development of the people, as well as the foundation for the sustainable development of the society. Since China started its reform and open up, people s wellbeing has improved remarkably. However, new changes, such as the industrialization, urbanization, aging population, have taken place; environmental pollution, changing lifestyles and disease spectrums all pose new challenges. Healthcare reform has entered a deep water zone. Health China 2030 Plan stipulates that treatment should be people-oriented. It also integrates measurable health indicators into all policies so that the goals are qualifiable, measurable and reviewable. There are three step goals to achieve the over-arching goal of building a healthy China, so that short term goals are connected with long-term strategy. 2.Pharmaceutical industry development guarantees Healthy China 2030 s realization Health China 2030 is the first general guideline document in the pharmaceutical and healthcare industry.

6 At present, the total shortage of medical resources, uneven distribution, and shortage in high quality resource are key issues in our country. At the heart of building a healthy China is the determination to solve the health problems of key groups such as women and children, the elderly, the disabled and the low - income groups. Pharmaceutical industry, as a special industry that is at the intersection of the first, second and tertiary industry, is closely related to disease prevention, treatment and rehabilitation and improvement of overall wellbeing of its people. The development of pharmaceutical industry, and better drug supply are the cornerstone for building a healthy China. Homogenization among low-quality drugs is commonplace. Low industry concentration, money laundering, commercial bribery occurred repeatedly. Currently, patients still tend to go to the class III hospitals for common diseases, and frequently occurring diseases, causing waste of a large amount of good medical resources and a big burden of high medical expenses. To achieve the structural adjustment of pharmaceutical industry and implement the medical supply-side structural reform is the key to solve those problems and guarantee the achievement of first stage goal.

7 3.Pharmaceutical MNCs bring valuable experience to Health China 2030 As modern pharmaceutical industry develops vigorously in China, the medical service industry is the most active in international cooperation and exchanges. Pharmaceutical MNCs are the pioneers of social responsibility and practices. The philosophy of being responsible for patients and providing valuable products for doctors, thus contributing to the society and improving lift quality of all mankind is integrated into their business, visions and strategic management. Now, those MNCs introduce these philosophies to China to help enhance health awareness, knowledge about disease management, in an attempt enhance the wellbeing of the Chinese people. At current stage, MNCs are adjusting their strategies in China. Many companies are seeking opportunities to collaborate with local R&D institutions and medical associations. Series of international monitoring standards of production and quality control were brought to China, promoting the development of China's drug safety and quality control system. MNCs in China are here for business opportunities and sustainable development, but they have also brought advanced management experience. The successful cases provide good examples and references for Chinese

8 pharmaceutical industry. Chapter Two: China Medical and Health Reform China started its medical and health reform in 2009, in an attempt to explore a reform model that suits China s unique characteristics. The attempts have borne fruit and received good reviews from all over the world. A basic national health insurance system has been completed; with coverage over 95%.There is more equality in the access to public health services. The national essential drug system has been implemented. While the wellbeing level of the Chinese lacks behind that of the Americans and the Japanese, it is better than that of the people from average mid-income countries. In early February 2017, the State Council announced No.13 document - <Opinions on Further Improvement of the Production, Circulation and Use of Drugs>. This landmark document opened a new chapter in the healthcare reform. The implementation of this document will enhance the drug R&D and innovation capabilities, drug efficacy, make the production and circulation process more orderly, as well as ensuring drug supply. This way, people will be able to use more reasonably-priced drugs that are of better quality. This is undoubtedly a big step in building a healthy China.

9 Chapter Three: Sanofi in China Sanofi has a strong commitment to China. In 1982, Sanofi became one of the first foreign pharmaceutical companies to open offices in China. Its business covers a broad portfolio of prescription drugs, rare diseases, vaccines and consumer healthcare products. Today, Sanofi has five manufacturing facilities in Beijing (pharmaceutical), Hangzhou (one pharmaceutical, one consumer healthcare), Shenzhen (vaccine) and Tangshan (consumer healthcare) respectively. Integrated and Collaborative R&D Sanofi China R&D s capabilities span the entire R&D value chain, from drug target identification to late stage clinical trials. With a commitment to bringing innovative drugs to China faster and more effectively, we focus on discovery research on Asia s most prevalent diseases, such as liver disease and diabetes, and leverage the growing biomedical ecosystem to develop new approaches such as translational medicine to fulfill Chinese patients needs. Improvement in Disease Prevention and Education As a leading healthcare company, Sanofi actively participates in and promotes Chinese public health service, providing innovative and high-quality vaccines for

10 disease prevention, actively promoting vaccine inoculation and delivering vaccines to those who are in urgent need of immunization. Promote Disease Management The Chinese government has attached great importance to cardiovascular disease, diabetes and cancer. As the leader in diabetes and cardiovascular disease, and with a deep understanding and vast expertise worldwide, Sanofi has cooperated with disease control institutions at all levels to conduct disease prevention programs and help control and improve the health of the Chinese people. Primary Care As the first multinational healthcare company to focus resources on the primary level medical treatment market, Sanofi is committed to the health and well-being of people in China. In the past years, Sanofi launched and supported numerous educational programs covering cardiovascular disease and diabetes across the country. As such, Sanofi played an active role in bringing benefits to patients at the county level. Actively Contributing to Corporate Social Responsibility As a corporate citizen of China, Sanofi take public service as one of the direct ways to contribute to social responsibility. As the date of entering China, Sanofi

11 had worked with professional social service organizations to participate in care for vulnerable groups, disaster relief, public health education, and spread the health concept in public healthcare. Chapter Four: Policy Recommendations to Health China 2030 from Sanofi China perspective 1.Enhancing the total health investment, and bettering the expenditure structure There is a big gap in health investment in China Financial spending is one of the important safeguard measures to promote medical and health reform. Since reform started in 2009, the government health investment in China has leapfrogged, but the proportion of health expenditure in total fiscal spending has been hovering at a low level, around 4% to 6%. Moreover, the spending in the pharmaceutical industry has never exceeded 40% of the total health expenditure, lagging much behind the world average level.

12 of The lack of government expenditure would directly lead to the shortage medical resources, and ultimately decrease the supply of medical services, finally, negatively impacting the wellbeing of our people. The expenditure structure needs to be changed With the economic improvement, Chinese people s life quality has improved and the average life expectancy has increased too. Faced with an aging population, China will tackle issue such as how to attend to the physical and psychological needs of the elderly and how to meet their needs through specific industry services. We have also witnessed significant changes in the major disease spectrum. Chronic diseases are causing higher mortality rate than infectious diseases. In response, the traditional treatment-based approach need to be changed accordingly to a prevention-focused approach. The removal of the one child policy has stimulated new demands, while maternal and child healthcare resources are still in short supply. There will be no well-off society if its people are not healthy. People s health awareness is just as important, so the government needs to invest more in health researches as well as awareness campaigns. \ In order to fulfill the great China dream, health expenditure needs to be increased, and the expenditure structure

13 needs to be bettered, to lay a solid foundation for the economic and social development. 2.Encouraging Innovation in the Pharmaceutical Industry The necessity of innovation At present, corporate R & D investment and innovation capacity are limited in China. If this were to continue, the development of the pharmaceutical industry in the next decade may be lack of endurance. As a promising sunrise industry, innovation of the pharmaceutical industry is an important engine for the sustainable development of China s economy. Encouraging innovation is the requirement of realizing the leap-forward development of the industry and the driving force of China's economic growth. China has a population of 1.3 billion. To meet the huge demand for medical needs is beneficial to the people s livelihood. The current main health challenge of mankind is the non-communicable diseases, such as cardiovascular and cerebrovascular diseases, tumors, diabetes, immune disorder and so on. It is very difficult to find effective treatment for these diseases. To encourage innovation is an inevitable choice to protect lives and health.

14 of Thirdly, to encourage pharmaceutical innovation is the requirement strengthening international competitiveness of the local market. There is a huge potential for pharmaceutical market development in the country, and China ranks as one of the top countries in terms of growth in the pharmaceutical field. Big but not strong enough is the current state of Chinese pharmaceutical industry. Only by strengthening the innovation capacity of the industry can China transform from a big medicine country to a strong medical country. Recommendations for Pharmaceutical Innovations 1)Transformation from imitation to innovation For a long time, many government departments and bureaus have to be involved in the communication and coordination of work in this industry. Structural changes are needed so that one clear strategic goal is set in order to facilitate the transformation from generics manufacturing to innovation. 2)Reinforce clinical research to eliminate innovation bottlenecks. The clinical science development in China is still backward. A few measures could be adopted to eliminate innovation bottlenecks by promoting clinical trial concept revolution. For example, to in clinical trial institutions and establish a multi-level clinical trial testing system; to set up central ethics committee system

15 pilot, to better the approval process for clinical trial applications, or to motivate key researches by clarifying the responsibility and duty of the project leader. 3)Scientific supervision with international standards In the past two years, the policy environment of pharmaceutical industry has changed significantly, especially in the supervision and approvals stages. The government issued a lot of incentive policies to mobilize innovation. Take Quality Consistent Evaluation of Generics (GQCE) as an example, there are 41 documents published for evaluation guidance and related operation. More and more advanced philosophies and supervision standards were adopted during the process of policy making. 4)Ensure the financial return of innovation The financial return of new drug launched in China is negative. It will against the innovation development in the coming years. It is very important that to improve the procurement and MI reimbursement system in China to ensure the valuable new drugs used in hospitals and the continuous development.

16 of 3.Improving the quality and safety for medicinal products Drug s quality and safety is not only related to the development pharmaceutical enterprises, but also related to the whole social security. Comprehensively strengthening the drug supervision is urgent without hesitation. Recommendations for drugs quality and safety 1)Strengthen the supervision depth In China, there is one-time evaluation for quality supervision. In order to ensure the drug quality and safety comprehensively, should strengthen the monitoring depth, and change the short-term static supervision model into a longterm dynamic one. 2)Promote industry structure reform At the very beginning, Chinese pharmaceutical industry was built for solving the problem of medicine shortage. With China's accession to the WTO in 2001, China's traditional pharmaceutical industry is facing big challenge while joining the global market. Structural contradictions become one of the root causes of China's drug quality and safety risks. The reform is benefit for the resources reallocation. To discard the dross and select the essential, so that it could satisfy

17 the needs of opened market by quality products and smooth distribution. 3)Enhance international cooperation to better health awareness. Drug quality and safety accidents occurred repeatedly. People s health awareness is relatively weak. Enhance the international cooperation, and learn from MNCs for the advanced management experience, such as the drug safety control program, rational drug use and so on, would be benefited for people to build up health lifestyles and better the healthy cognitive management. 4)Manage the procurement and MI reimbursement system during transition while carrying out GQCE. With the progress of the GQCE, China will stay in different transition periods for mass quality classification coexistence. Dynamically manage the procurement and MI reimbursement system with fully consideration takes great significance in promoting the industrial structural adjustment, and guarantee the drug quality, and supply. 4.Accelerating accessibility to innovative medicines

18 of New drug registration takes time and weak in accessibility after launch It takes a long time for the new drug registration in China. Take the imported sub-packaged drugs as an example; it will take at least 4 years for

19 registration approval, and spending more time in material test, production equipment debugging and other preparatory works before the production. Moreover, there is a huge time gap for new drugs to get reimbursement qualification after registration. The new version of National Reimbursement Drug List was published after 8 years waiting since Furthermore, the provincial procurement process is very slow due to the uneven political and economic levels. Pharmacy level is far behind the economic developing level in China. Recommendations for accelerating accessibility 1)Learn from foreign mature drug market approval experience, and improve the threshold of new drug registration. With lots of foreign patents expired in recent years, low quality imitation blossoms in domestic market. Improving the registration standard is not only good to speed up the approval process, but also conducive to eliminate low-level declaration. 2)Set up special channel to encourage effective new drug production Take Child medication as an example. The lack of child-specific drugs has become a worldwide problem. Compared with the increasing medical demand, clinical valuable children's drugs are short of supply in China. Incentive policy to

20 mobilize the innovation enthusiasm of enterprises for shortage drugs is one of the effective solutions to speed up the R& D development and enrich the drug varieties. 3)Speed up the talent development According to the yearly report of the Drug Review Center of SFDA in 2015, the average assessment number per official is up to 21.3 and it is about 8 times than the US reviewers. Opposite of the increasing application number, professional field staffs are far behind the requirement. Heavy workload is difficult to attract high-level talent and keep the team stable. Chapter Five: Closing It very honors to have such opportunity to present our recommendations as a pharmaceutical industrial representative in China Development Foundation Conference Since its inception in 2000, the CDF has contributed actively to development policy exchanges and international cooperation. Sanofi believes that the Chinese government is fully capable and courageous to seize every opportunity to realize inclusive economic globalization by deepening supply-side structural reform with the goal of Engaging the World for Common Prosperity.