Health Care Legal Newsletter
New Laws and Regulations on Health Care Field
The Standards on the Administration of Electronic Registration for Medical Institutions, Physicians and Nurses (for Trial Implementation)
Enacted details
Promulgated authority: The National Health and Family Planning Commission
Promulgation date：May 11,2017
Effective date：May 11, 2017
Related content
On May 11,2017,the General Office of the National Health and Family Planning Commission, together with another authority, have issued the Standards on the Administration of Electronic Registration for Medical Institutions, Physicians, and Nurses (for Trial Implementation) (the "Standards"), effective from the date of promulgation.
The Standards clearly state that the administrative department of health and family planning under the State Council will develop an electronic registration system and carry out a unified administration of electronic registration. An applicant that intends to go through the registration formalities shall fill out and submit all forms with real information, and make a commitment regarding the authenticity of such information. Any medical institution, institution for disease prevention and control, or health care institution shall verify and confirm the personal registration information of all physicians and nurses who are practicing or plan to practice medicine within the institution.
The Standards set out that any social organization or individual that intends to apply for the practice registration for medical institutions or update its registration may log into the electronic registration system to submit its application to the competent authority.
The Relevant Policies on Encouraging the Innovation of Drugs and Medical Devices and Protecting the Rights and Interests of Innovators (Draft for Comment)
Enacted details
Promulgated authority：The China Food and Drug Administration
Promulgation date：May 12,2017
Expiration date：Jun 10,2017
Related content
On May 12,2017, the China Food and Drug Administration ("CFDA") has issued Relevant Policies on Encouraging the Innovation of Drugs and Medical Devices as well as Protecting the Rights and Interests of Innovators (Draft for Comment) (the "Draft for Comment") for public comments before June 10, 2017.
The Draft for Comment lays out arrangements from four perspectives, including "establishing the drug patent linkage mechanism", "improving the system of protecting data on drug trials", "implementing state functionaries' responsibilities in maintaining the confidentiality", and "producing the catalog of drugs launched into the market".
According to the Draft for Comment, an applicant for drug registration, if the applicant knows or is aware of certain rights that are related to, he/she shall provide a statement on such rights, while submitting the registration application.
Where the applicant challenges a relevant drug patent, he/she needs to make a statement that registration application does not constitute an infringement of the relevant drug patent, and inform the drug patent owner within 20 days after the submission of the registration application; If such drug patent owner resolves that its patent right is infringed upon, he/she should institute an action for infringement of patent to a judicial organ within 20 days upon receipt of the notification delivered by said applicant, and notify the institution of drug evaluation of the action.
The Relevant Policies on Encouraging the Innovation of Drugs, Medical Devices and Accelerating the Evaluation and Approval of New Drugs to be Launched into the Market (Draft for Comment)\Relevant Policies on Encouraging the Innovation of Drugs and Medical Devices and Reforming the Administration of Clinical Trials (Draft for Comment)\Encouraging the Innovation of Drugs and Medical Devices and Implementing Full Lifecycle Administration of Drugs and Medical Devices (Draft for Comment)
Enacted details
Promulgated authority: The General Office of the China Food and Drug Administration
Promulgation date：May 11,2017
Expiration date：Jun 10,2017
Related content
On May 11,2017, the China Food and Drug Administration ("CFDA") has formulated and issued the Relevant Policies on Encouraging the Innovation of Drugs and Medical Devices and Accelerating the Evaluation and Approval of New Drugs and Medical Devices to be Launched into the Market (Draft for Comment) (the "Draft for Comment"). Relevant Policies on Encouraging the Innovation of Drugs and Medical Devices and Reforming the Administration of Clinical Trials (Draft for Comment), Encouraging the Innovation of Drugs and Medical Devices and Implementing Full Lifecycle Administration of Drugs and Medical Devices (Draft for Comment) for public comments before June 10, 2017.
The Draft for Comment States that for drugs and medical devices used to cure badly life-threating diseases, which could not be treated effectively by existing methods and other drugs and medical devices that are of great importance to meet clinic demands, could be approved to be launched into the market on the condition that indictors, obtained in the early and middle stages of clinic trials, demonstrated their curative effects and foreseeable clinical values.
The Draft for Comment sets forth requirements in eight aspects, including "accelerating the evaluation and approval of drugs and medical devices urgently needed in clinic treatment".
The revised version of the Regulations on the Supervision and Management Medical Equipment
Enacted details
Promulgated authority：The State Council
Promulgation date：May 19,2017
Effective day：May 19, 2017
Related content
On May 19,2017,Premier Li Keqiang signed an order to promulgate and implement the revised version of the Regulations on the Supervision and Management of Medical Equipment (Hereinafter referred to as the "Decision"). The updated regulations strengthen after-approval scrutiny, management, and clarify legal responsibilities.
According to the modified regulations, health authorities should oversee and evaluate the use of large medical equipment.
The Decision Emphasized takes appropriate steps to rectify and punish the irregular or excessive use of large medical equipment.
The Decision added a new definition of large medical equipment, which is the use of complex technology, capital investment, high operating costs, large impact on medical expenses, and be adopted to the directory management of large medical equipment.
The Guidance on the promotion of healthy tourism development
Enacted details
Promulgated authority：Five Departments
Promulgation date：May 12,2017
Effective day：May 12 , 2017
Related content
On May 12,2017,with the consent of the State Council, the State Health Commission, Development and Reform Commission, Ministry of Finance, Tourism Bureau, Chinese Medicine Bureau and other five departments jointly issued "The Guidance on the promotion of healthy tourism development" (hereinafter referred to as "The guidance "), Aimed at promoting the deep integration of health services and tourism, and fully mobilize the enthusiasm and creativity of social forces.
The Guidance stresses the need to establish a departmental collaboration mechanism, co-ordination of health tourism development involved in health care, tourism and other aspects of the policy. These factors give full authority to the local government to guide and promote the role.
The basic principle of Guidance is "government guidance, market allocation; according to local conditions, innovation-driven; foreign exchange, open win-win situation; pilot first, steady progress."
The Guidance from the supply capacity, cultivate the consumer market, optimize the policy environment, three aspects of the deployment of 13 key tasks.
Interpretation of Key Policy
A Brief Interpretation of the Key Tasks of Deepening the Reform of Medical and Health System in 2017
On May 5,2017,The General Office of the State Council has recently issued the Key Tasks in Deepening the Medical and Health System Reform in 2017 (the "Tasks").
The Task stressed that 2017 is an important year for a comprehensive implementation of National Health and Health Conference as well as the implementation of the "thirteen five" health care reform plan, which is the formation of a more systematic basis for the basic medical and health system. 2017 as a "work to implement the year” does a good job and has introduced major reform initiatives for implementation, inspection, and evaluation. To improve the policy system: Innovation and institutional mechanisms, the basic establishment of graded clinics, modern hospital management, universal health insurance, drug supply protection, comprehensive supervision and other five basic medical and health system frameworks, as well as constantly promote the medical reform to the depth of development.
The Task proposed that 2017 is to deepen the medical reform. Its task is divided into the need to develop policy documents, and promote the implementation of focus for the two parts. Policy documents need to be developed mainly to strengthen the comprehensive supervision of the health care industry, the establishment of modern hospital management system, strengthen the medical union construction, reform and improve the shortage of drug supply protection mechanism and other aspects of the 14 guidance documents.
The Task also identifies the responsible departments of the reform tasks and sets out the time and schedule requirements for the policy documents that need to be developed.
A Brief Interpretation of the Opinions on Encouraging Social Forces to Provide Multi-layered and Diverse Healthcare Services
On May 16,2017,the General Office of the State Council has distributed the Opinions on Encouraging Social Forces to Provide Multi-layered and Diverse Healthcare Services (the "Opinions"). The Opinions on Encouraging Development of Diverse Private Healthcare Services is a move to expand public participation in the regulation of the private medical market.
The Opinions point out that great efforts will be made in the future, aimed at significantly enhancing social forces' capacity for providing healthcare services, remarkably improving their healthcare technologies, quality of services, and brand reputation, and further consolidating the support of professional talents, health insurances and medical technologies by 2020.
A number of private healthcare institutions with strong competence in services will be set up, and several influential healthcare industry clusters with certain characteristics will be formed, in order to enable services supplied to meet basic domestic demands and form a new landscape of multi-layered and diverse healthcare services step by step.
To this end, the Opinions propose several tasks, including "expanding services in a multi-layered and diversified manner", and "further opening the market to a wider extent".
According to the Opinions, all places are required to take into account multi-layered healthcare demands in an overall manner, and shall not set any restriction for any reason over such private healthcare institutions that meet the planning conditions and market access qualifications. Setting up a private clinic can not be subject to the planning layout, and major attention will focus on the qualifications of relevant personnel and capacities of technical services, an application for setting up a specialized hospital or a medical institution of any other type will need to be examined and approved.
The General Office of the State Council issued today The opinions stated that eligible private healthcare institutions will be equally treated and enjoy the same benefits as government-backed public hospitals in such areas as patient referral, charges & payments and performance assessment and incentives. To boost the social healthcare market, local governments will lower the entry threshold and open the market to any applicant that acquires qualification.
According to the opinions, local governments must strengthen crackdowns against illegal practicing, medical fraud, lease of professional certificates or medical resources as well as fake & illegitimate medical ads.
Brief Report to Medical Law Professional Activities
Dentons Shanghai office lawyer Shen successfully held "Talking about Health care legal services" lecture
On May 23, 2017, as one of the series of lectures on "outstanding lawyer practice", Dentons Shanghai office partner Shen Tao held a lecture on "Talking about Health Care Legal Service".
At the beginning of the lecture, Lawyer Shen waived his physician to the lawyer's work experience, summed up his own business experience, and clearly pointed out that he focused on the medical institutions of professional legal services at first, and then continue to spread to the other health care industry areas.
The main contents of the lecture primarily contained the four plates. The first section is the legal services of medical institutions, for the contents of this plate, lawyers Shen Tao explained in detail six aspects of legal service on the establishment of medical institutions, medical institutions Internal risk prevention and control, medical damage liability dispute handling, medical behavior quality control, medical institutions of administrative responsibility, medical Institutional insurance legal services.
The second section is the legal service of medical device enterprise. For the contents of this section, Lawyer Shen Tao focuses on sharing the registration and production of medical device products, and medical device production, operation, bidding, use, post-marketing supervision, tort liability, intellectual property protection and so on, combined with the latest changes in the highlights of Medical Device Supervision and Management Regulations.
The third plate is the legal services of pharmaceutical enterprises, lawyers Shen Tao mainly from the pharmaceutical business compliance, mergers and acquisitions business, listed licensing system, two-Piao system, drug donation, adverse drug reactions, intellectual property rights, pharmaceutical companies daily services as the entry point to solve the legal problems arising from the establishment, research, development, production, operation and use of pharmaceutical enterprises. In view of the recent enforcement of the regulatory authorities, the relevant issues, such as the compliance of pharmaceutical enterprises, two-piao system and listing license system have been carried out and further explored.
The fourth sector is other health care industry areas, including the recent popular pension industry, the Internet medical industry, health management industry, cross-border medical industry, which detailed analysis of legal risk control of the Internet medical industry and cross-border medical industry, and pointed out the development direction and legal service prospect of Chinese medicine and doctor group.
At the end of the lecture, lawyer Shen Tao actively interacted with the audience, answered questions and described relevant legal issues in detail. In the end, he won the audience's praise and warm applause.
Pharmaceutical Industry Updates
Yangtze River Pharmaceutical raised funds 203 million Yuan, part of which for the production of Chinese medicine
Recently announced that the Yangtze River Pharmaceutical on June 1 will be officially in the new three-board public offering of shares 750 million shares, all for unrestricted shares, to raise funds 203 million Yuan. The proceeds are mainly used for proprietary Chinese medicines, high-grade refined Chinese medicine Pieces and granules production.
The legal background of the transaction: on Feb 29,2016,the State Council has issued the Outline of the Strategic Plan on the Development of Traditional Chinese Medicine (2016-2030) (the "Outline"), defining the development direction and priorities of traditional Chinese medicine (TCM) in China for the next 15 years.
The Outline puts forward that 2030 will witness full coverage of TCM service sector, significant enhancement of the health service ability of TCM, and greater contributions by TCM to economic and social development.
The legal background of the transaction: The Traditional Chinese Medicine Law of the People's Republic of China had adopted at the 25th Session of the Standing Committee of the 12th National People's Congress on 25 December 2016,effective as of 1 July 2017.
This Law is enacted to inherit and develop the science of traditional Chinese medicine, ensure and promote the development of traditional Chinese medicine, and protect people's health.
CITIC Capital, Humanwell Healthcare to be the world's second biggest condom maker by acquiring Jissbon
CITIC Capital Holdings Ltd. and Hubei province-based Humanwell Healthcare Group Co., Ltd. has agreed to acquire Australia stock exchange-listed Ansell Ltd's condom division, the world's second biggest condom maker, for US$600 million.
Ansell expects to receive net proceeds after-tax of US$529 million from the all-cash deal. The transaction is subject to regulatory approval and expected to be completed by the end of September.
Ansell was founded in 1905.Before being acquired by Dunlop in 1969 to form the Ansell Rubber Company, Ansell had expanded its business into rubber products including surgical and industrial gloves.
The company currently develops a number of products including industrial gloves and sleeves, medical gloves, condoms and personal products. Its brand Jissbon is the second biggest condom maker in China after Reckitt Benckiser Group Plc's Durex.
Legal Statement：Healthcare legal newsletter all the contents are reproduced or taken from newspapers or news websites, which purposes are only for reference and not intended to provide any legal advice or solutions.We do not assume any form of legal liability for any consequences arising from any action taken or not taken by any of the contents of this Legal Newsletter. Please consult our legal service team at any time in case of any query.
Healthcare legal Newsletter Editor-in-chief：Richard Lee Stone Shen
Editorial board：（Ranked in no particular order）Jianfeng Wang Andy Wang Yong Deng Bailey Xu Daniel Wei Ken Dai Lu Wang George Zheng Mingzhen Zhu Kingston Wang Shane Luo Jiacai Tan Bruce Lee Lu Zhou Feng Sheng Chunfeng He David Chen Zhongcheng Ma Vic Li Lihua Tan Nancy Ji Tina Liu
Editors of this issue：Stnoe Shen