Research On Medical Device Regulation Based On Public-private Partnershi

In recent years,with the rapid growth of social economy and the improvement of people’s yearning for a better life,China’s medical device regulation has developed vigorously,and a medical device regulation system with regulations and technical specifications as the main content has been preliminarily formed.At the same time,public-private partnership governance has attracted the attention of scholars and has been widely practiced in many fields including the medical device industry.Inspecting the internal problems and external opportunities faced by medical device regulation,how to realize the transformation and development of medical device regulation under the background of cooperative administration and active administration has become an urgent research topic.This paper intends to reveal the main problems in the regulation of medical devices from the perspective of public-private partnership governance and put forward suggestions for improvement.Chapter Ⅰ focus on the current situation of medical device regulation and publicprivate partnership governance in China,which mainly includes two parts:firstly,it summarizes and introduces the theoretical basis of public-private-partnership,including the definition of administrative subject of "completing administrative tasks",the theory of administrative legal relationship of "multiple consultation and participation",the theory of administrative behavior form of "cooperation agreement as the center",and the theory of right and responsibility distribution of "sharing and responsibility".This will lay a theoretical foundation for the following analysis of the practice of publicprivate-partnership in the field of medical devices.Secondly,analyze the practical status of public-private partnership governance in the field of medical devices,and summarize the common situations of public-private joint formulation and implementation of medical device regulations,mainly including the joint formulation of medical device market access regulations and quality safety regulations by both parties,and the practical activities of enterprises,experts and institutions participating in the implementation of these regulations.This paper takes the pilot work of the medical device registrant system in Shanghai as an example so as to analyze the new characteristics of regulatory legislation in cooperation and negotiation between the public sector and private subjects compared with traditional administrative legislation.Including:(1)equality status of both parties;(2)whole process of private participation;(3)professionalism of cooperation and negotiation;(4)public-private cooperation protects public interests and promotes private interests.Chapter Ⅱ focus on the problems of medical device regulation from the perspective of public-private cooperation,which focuses on revealing the problems of current medical device regulation in terms of cooperation concept,regulation subject,regulation behavior,regulation procedure and regulation responsibility from the perspective of public-private cooperation.Firstly,although the current medical device regulation has established the principle of social co-governance,the concept of public-private cooperation is still in the bud.Secondly,the multiple participation mechanism of regulatory subjects is not smooth,and there are problems such as the failure of subject coordination,role conflict,and the "multi-center" subject structure has not yet formed and so on.Thirdly,the type of regulatory action is insufficient,a large number of untyped medical device administrative actions need to be standardized,the value compatibility and subject participation of regulatory procedures need to be strengthened,and the space for cooperation needs to be expanded.Fourthly,the regulatory responsibilities of both public and private parties need to be consolidated.The decline in the efficiency of traditional regulatory means has led to the reduction of the public welfare.The rapid development of new technologies has contributed to the ability and motivation of private subjects to evade their responsibilities.Chapter Ⅲ analyzes the causes of the lack of public-private cooperation of medical devices,focusing on the causes of the problems in the current public-private cooperation of medical devices from several aspects,such as the concept,principles,relationship,behavior system,and responsibility mechanism of medical device regulation.Firstly,the traditional administrative law has a deep impact on the concept of medical device regulation and the principle of medical device regulation lacks proper supplement and expansion.The former is mainly reflected in:(1)Under the influence of "control theory",medical device regulation takes administrative law as the standard,and takes control of the exercise of administrative power in the field of medical devices as the primary goal.(2)Under the influence of the "management theory",the thinking inertia of the government’s single supervision has prevailed for a long time,causing the concept of multiple participation to sprout too late.(3)The "administrative process theory" that emphasizes the administrative process has failed to support the idea of public-private cooperation to play a dominant and leading role in the field of medical devices.The latter is mainly manifested in:(1)the absence of auxiliary principle.Because of the lack of this principle,the formulation of medical device regulation has almost become an official one-way expression from top to bottom,which makes the public-private cooperation of medical devices lose the support of the principle.(2)The principle of cooperation has not been established.When the principle of cooperation did not rise to the general administrative principle,the concept of public-private cooperation could not be expressed and consolidated.Public-private cooperation activities are more random and arbitrary than institutional arrangements,which not only narrow the scope of public-private cooperation practice,but also difficult to produce formal procedures suitable for cooperation.Secondly,in the relationship of medical device regulation subject,the scope of regulation subject is difficult to expand,the form of regulation subject is solidified,and the partnership of regulation subject is weakened.The main performance is as follows:(1)China has neglected the cultivation of medical device industry organizations and third-party institutions for a long time.When the scope of regulation subject needs to be expanded,there is no object to cooperate or rely on.(2)The disordered allocation of governance resources leads to the solidification of the main body.For a long time,the irrational allocation of governance resources has made it difficult for the private sector to transform from the subject form of "administrative order submitter" to the subject form of "administrative power executor".(3)Difficult convergence of interest demands weakens the partnership of the main body.The main reason for the public sector of medical device supervision to seek cooperation is not to make up for the lack of funds,but to obtain more invisible professional knowledge,information and experience.Their criteria for selecting cooperation objects are not wealth but talent.Thirdly,in the medical device regulatory behavior system,the existing publicprivate cooperation of medical devices has not become the mainstream behavior type,and the perspective of observing the effectiveness of regulatory behavior is narrow,and the positioning of designing regulatory behavior procedures is biased.Due to the failure of formalization to effectively promote the development of public-private cooperation of medical devices,and the fact that the current untyped administrative behavior of medical devices has not been institutionalized in terms of content,procedures,relief channels and other aspects,its application scenarios are greatly limited,which jointly restrict the development of public-private cooperation of medical devices.Also,the narrow perspective affects the definition of the effectiveness of public-private cooperation of medical devices.It is mainly manifested in the lack of consideration of legitimacy from the traditional perspective of public determination,the lack of supplement to consensus from the traditional perspective of certainty,and the lack of expansion of cooperation from the traditional perspective of executive power.Finally,the positioning bias affects the operation of the public-private cooperation procedure of medical devices.This is mainly due to the difficulties in implanting diversified procedural values,forming a reticulated procedural structure,highlighting the consultative procedural style,and the unclear procedural characteristics.Fourthly,the responsibility mechanism of medical device regulation has not clarified the responsibility mode,opened up diversified relief channels and prepared preventive relief means,which has affected the smooth development of public-private cooperation.Under the background of public-private cooperation,the current medical device regulation is faced with the choice of "purpose mode" or "function mode" for the accountability mode,but due to the limitation of conditions,its responsibility mode has not been clarified.At the same time,the current regulation of medical devices is still dominated by public law relief,and the administrative and civil relief channels have not yet achieved convergence,and a complete cooperative relief mechanism has not been constructed.In addition,the current medical device regulation relies excessively on the existing relief means and fails to provide more preventive means in advance,further weakening the supporting role of the medical device regulation responsibility mechanism for the development of public-private cooperation.Chapter Ⅳ focuses on the mature experience and effective practices of the United States,Japan,the European Union,the IMDRF and other countries,regions and international medical device regulation that can be used for reference.The third party review in the 510(K)procedure for medical devices in the United States,the third party review by the EU medical device notification body,the Accreditation Requirements of the Regulatory Body for Medical Device Conformity Assessment Institutions issued by the IMDRF on the accreditation of medical device conformity assessment institutions and the single review scheme for medical devices,have given beneficial inspiration to the public-private cooperation in the regulation of medical devices in China.Firstly,strengthen the cultivation of medical device industry organizations and third-party institutions to create a good institutional environment for their healthy development;Secondly,the government should effectively perform its supervision responsibility to the third party institutions to prevent public interests from being damaged and private responsibilities from escaping;Thirdly,establish different forms of public-private cooperation paths according to the difficulty and risk of completing the administrative tasks of medical devices;Fourthly,encourage medical device industry organizations,enterprises and third-party institutions to develop self-regulation.Chapter Ⅴ explores the way to improve the regulation of medical devices from the perspective of public-private cooperation,puts forward the basic suggestion that the regulation of medical devices in the future should move towards the development direction of cooperative regulation,and re-establishes the empowerment of regulatory subjects and the construction of regulatory behavior from the perspective of publicprivate cooperation,and tamps the regulatory responsibility.The specific suggestions are as follows: Firstly,correct the development direction of medical device regulation by resetting the task of medical device regulation,reshaping the concept of medical device regulation and reconstructing the framework of medical device regulation.To this end,the subject of administrative tasks should include both public and private parties,the content of tasks should be aimed at promoting common interests,and the way of tasks should be guided by "task fulfillment".Establish the concept of subject equality,negotiation and cooperation,multiple participation and responsibility guarantee in the regulation of medical device cooperation.The regulatory framework for medical device cooperation is established by promoting the introduction of the Medical Device Management Law,improving the status of technical norms,and enriching the regulatory connotation according to the development law of risk regulation.Secondly,enrich the rights and obligations of the third party review institutions,public service contractors,experts,social cooperation control subjects,public-private partnership companies and other subjects,and build a multi-agent participation mechanism through the determination of participation matters,the selection of cooperation objects,and the optimization of participation methods,so as to do a good job in the subject empowerment of medical device cooperation regulation.Thirdly,develop "selfregulation" into "cooperative regulation" and regulate the development of untyped medical device administrative behavior.Select the form of administrative behavior reasonably according to the "task attribute" constructed by the three major factors of legitimacy,uncertainty and resource dependence.At the same time,pay attention to the design of cooperative medical device regulatory procedures to do a good job in the behavior construction of medical device cooperative regulation.Fourthly,we should reasonably define the responsibilities of the public sector and the private subject in the regulation of medical device cooperation,and strengthen the responsibility of the private subject in the regulation of medical device cooperation while preventing the loss of the public nature of the regulation of medical device cooperation,so as to implement the governance responsibility of the regulation of medical device cooperation.