COSROMA

COSROMA

A Panoramic Interpretation of the Drug Licensing Permit Holder System

Medical Network April 19th, in November 2015, the 17th meeting of the 12th National People's Congress Standing Committee passed the "National People's Congress Standing Committee on the authorization of the State Council to carry out pilot drug licensing system in some places and related The decision on the issue marks the beginning of the establishment of the system of drug listing license holders (hereinafter referred to as the holder system). The holder system is a drug management system commonly used by the international community. As the core of the reform of the drug management system, the holder system will have a fundamental, overall and strategic impact on the innovation of China's drug management system.

Path Selection

To study the holder system, we need to grasp the basic positioning of this system. Is the core word of this system a marketing license or a holder?

Medicines are health products with high risks and are related to the health and safety of the public. In order to better protect the public's health rights and interests, the international community generally implements strict supervision over the life cycle of drugs.

Judging from the relationship between drug registration applicants and production enterprises, there are currently two main systems in the international community: one is the separation system. The drug registration applicant and the production enterprise may be different subjects. After the registered applicant obtains the marketing authorization, it becomes the holder of the drug listing license. The holder may engage in the production and sale of the drug, or entrust other enterprises to carry out the drug production. Sales, the holder is responsible for the full life cycle of the quality of the drug. The second is the binding system. Applicants for drug registration must be pharmaceutical manufacturers. If the applicant is a research and development unit, it must be jointly declared with the manufacturer as a co-applicant, or separately by the manufacturer, and the R&D unit becomes the anonymous holder of the drug listing permit. The system established by China's Drug Administration Law is this "bundled" system. Under this kind of institutional arrangement, the R&D unit as the applicant and the production enterprise jointly hold the approval document number or the research and development unit implicitly holds the approval document number, which has prominent problems of ambiguous property rights and unclear responsibilities.

From the perspective of the main body of each link involved in the drug marketing authorization, the international society is also divided into two systems: First, the unified system, that is, a responsible entity conducts a unified closed-loop management of the whole life cycle of drug quality. People system. The second is the decentralization system, in which several entities conduct segmented management of the development, production, and sales of drugs. Each subject is responsible for the risk prevention and control of related links. The system established by China's Drug Administration Law is a decentralized system.

In the study of the holder system, people are accustomed to understand the holder system as a drug marketing licensing system, so the main focus is on the drug marketing permission part. This understanding is not comprehensive. The holder system covers the whole process of pre-marketing and post-marketing management of drugs, and has the legal status of “basic system” in the drug management system. To study the holder system, we need to grasp the basic positioning of this system. Is the core word of this system a marketing license or a holder?

Generally speaking, the listing licensing system is a link management system, which belongs to the category of “procedural law”. It involves the applicant body, application conditions, application procedures, application documents, evaluation agencies, evaluation criteria, review procedures, time limits for review, The conclusions of the review, the licensing authority, the licensing process, the licensing period, the licensing documents, the licensing effectiveness, etc., are mainly based on the basic procedures of application, review and approval. The holder system, as a factor management system, belongs to the category of "subject law" and involves status, qualifications, conditions, relationships, rights, obligations, responsibilities, and so on. The core word of the holder system is the “holder”. Only the “holder” system can cover the full life cycle of drug quality. This is just like the drug inspection and appraisal system. The inspection agencies and appraisal agencies issue inspection conclusions and appraisal opinions. Therefore, people often attribute the inspection system and appraisal system to the "documentary card" system. In fact, the test conclusions and appraisal opinions are the recognition and judgment activities of the inspectors and appraisers. From the perspective of management factors, the inspection system and the identification system mainly regulate the qualifications of institutions, personnel qualifications, competence, professional ethics and practice discipline. Therefore, in essence, the inspection system and the identification system belong to the category of “personal card” system.

Regarding what is meant by “marketing licenses”, Chinese and foreign regulatory practices have different understandings. The holder system originated in the West. Since Western countries implement product license management without enterprise license management, product licenses are essentially listing licenses. China implements a dual licensing system for product licensing and corporate licensing, which is very different from Western countries. Therefore, some people think that it is not accurate enough to define product registration as a marketing license in China. In fact, after the implementation of the holder system, the holder entrusts other enterprises to produce and operate. This is also a kind of market activity. Therefore, in China, the registration of products is called a marketing license, and there is no confusion or cognitive impairment.

Why is it called "holder" rather than "owner"? Under the holder system, the holder holds a “right” or “qualification” granted by the administrative organ. This “right” or “qualification” has certain property rights and personal rights, but it is pure Property rights or personal rights are different. The concept of “all” is generally the concept of the tangible property rights system, that is, the concept of property rights, and its powers include possession, use, disposal and income. Intangible property rights, such as the concept of “all”, are generally not used in the field of intellectual property. There is no uniform, normative and authoritative expression of the power of intangible property rights. It is generally considered to include holding, using, disposing and income, and the forms of punishment are more diverse, such as transfer and transfer. In fact, the term “holding” more accurately reflects the property rights of the listing license that can be transferred.

The design of any legal system has its profound social and cultural background, and the holder system is derived from the market economic system. Under the market economy system, any civil subject can engage in drug development activities equally, and whether each civil subject can become a license holder does not depend on its identity and status, but on whether it has a corresponding ability. With the advancement of science and technology, among the various elements of productivity, the value of science and technology continues to increase, and the design of the holder system further demonstrates the value of science and technology. At the same time, the implementation of the holder system means that the commanding heights of drug quality management are transferred from the production link to the development process. The concept of product quality from design is further highlighted, and drug quality management has entered a new stage. Therefore, the holder system is a drug management system under market economy conditions.

The system for the listing of drugs established by China's Drug Administration Law is held by the production enterprises and originated in the era of planned economy. At that time, due to the limitation of productivity level, the ability of drug research and development innovation was insufficient. The drugs produced by enterprises were mainly generic drugs, and the focus of drug management was on the production link. In this special historical period, the main body of drug development is basically state-owned enterprises. The combination of drug development subjects and production subjects is compatible with the economic and social conditions at that time. Today, under the conditions of market economy, this system has severely restricted the division of labor and cooperation in the pharmaceutical industry, wasting a lot of social resources, and hindering the growth and progress of enterprises. In addition, the binding model of drug marketing license and enterprise production license is also a product of natural economic concepts and traditional management thinking to a certain extent.

Comparative Advantage

Compared with the drug management system as defined in the Drug Administration Law, the holder system has four advantages.

In May 2016, the General Office of the State Council issued the “Pilot Program for the Drug Listing License Holder System”, and the pilot program for the drug listing permit holder was officially launched. Compared with the drug management system as defined in the Drug Administration Law, the holder system has the following advantages:

First, encourage drug innovation and enhance competitiveness. After years of accumulation, China's drug research and development innovation capabilities have made significant progress, but there is still a certain gap with developed countries. According to statistics from relevant parties, the global innovative medicine market in 2015 was nearly 600 billion US dollars, while the innovative drugs in China's market were less than 10 billion US dollars. In October 2016, the report of “Building a Sustainable Chinese Medicine Innovation Ecosystem” jointly issued by four major industry organizations such as China Pharmaceutical Enterprise Management Association pointed out: “Across the world, the vitality and competitiveness of the pharmaceutical innovation industry must come from A healthy, virtuous cycle of innovative ecosystems." Institutions are a core element of an innovation ecosystem. Implementing the holder system, encouraging R&D institutions and scientific research personnel to engage in drug innovation, and obtaining drug marketing approval, will change the embarrassing situation that researchers in the original system can only obtain short-term interests or hidden interests through technology transfer or anonymous holding. Effectively stimulate the vitality of the market. At the same time, the implementation of the holder system, R & D units or scientific research personnel can quickly industrialize drugs through entrusted production, form a stable investment relationship and better return on investment expectations, which will greatly mobilize R & D institutions and researchers to participate in drug R & D innovation The enthusiasm to accelerate the international innovation and competitiveness of China's pharmaceutical industry.

The second is to optimize resource allocation and promote industrial concentration. At present, China has 4,246 various types of pharmaceutical production enterprises, of which more than 60% are enterprises with a production scale of less than 50 million yuan. The number of approved drugs in China is about 15,000, and the number of drug approvals is about 168,000. Generally speaking, China's pharmaceutical companies still have the phenomenon of “multiple, small, scattered, low”, with overcapacity, competition for homogenization, and huge waste of resources. This phenomenon is related to the stage of the development of China's pharmaceutical industry, and also to the value orientation of China's drug management legal system. After the implementation of the holder system, drug research and development institutions and scientific research personnel can establish their own production of medicines, or they can entrust enterprises to produce medicines. This can avoid the “big and complete” and “small and complete” low-level repetition of enterprises. At the same time, developers can also quickly industrialize drugs, quickly occupy the market, and effectively improve the use of resources. It can be expected that after the implementation of the holder system, China's pharmaceutical industry will quickly enter a period of differentiation and restructuring. The pace of concentration and innovation of the pharmaceutical industry will be further accelerated, and the vitality of market competition and ecological optimization will further increase.

The third is to implement corporate responsibility and strengthen the whole process of management. Risk is the core of management, and responsibility is the essence of management. The drug management legal system is the systematic arrangement of the rights, obligations and responsibilities of drug stakeholders. The core content can be summarized as the comprehensive prevention and control of risks and the full implementation of responsibilities. Under different legal systems, the breadth, depth and intensity of corporate responsibility implementation are different. Under the holder system, the holder is responsible for the full life cycle of the drug quality. This clear and strict liability system will effectively strengthen the holder's full implementation of the “from laboratory to hospital” management responsibility. The holders will pay attention not only to the research and development of drugs, but also to the production, storage, transportation and sales of drugs, because the quality of drugs is the interests of the company and the life.

The fourth is to promote management innovation and achieve management upgrades. From the perspective of management, the concepts, resources, elements, priorities and methods of management are not exactly the same in the agricultural, industrial and information ages. The agricultural era is a natural economic society, and it is a static view of property ownership; the industrial era is a market economy society, and it is a dynamic concept of property utilization; the information age is a shared economic society, and the concept of open wealth sharing is pursued. Some experts and scholars believe that China's Drug Administration Law is born out of the era of planned economy, with more or less, or explicitly or implicitly with some traces of the planned economic system, natural economic society and traditional management thinking. Implementing the holder system, the direct target of drug management will be transferred from multiple entities to a single entity. The core content of management will be transferred from access qualification management to system capacity management. The basic management method will be transferred from traditional management to modern management. Management will enter a new era of smart management. In addition, after the implementation of the holder system, a series of profound changes will occur in the drug management method. For example, the administrative license will be further simplified, the regulatory efficiency will be further improved, and the service level will be further improved. This is in line with the current simplified administration and decentralization integration optimization service. Basic requirements.

Institutional risk

From the perspective of institutional design, is there any endogenous deficiency in the holder system? What aspects need to be strengthened to manage?

From the perspective of historical development, any system design will not be perfect. Each system has its advantages and disadvantages, gains and losses, and the art of legal system design is to benefit the disadvantages and show the loss. The comparative advantages of the holder system have been briefly described above, and the qualifications of the holders are also briefly described. Then, from the perspective of institutional design, is there any endogenous deficiency in the holder system? What aspects do you need to strengthen management?

From the current research, under the holder system, the risk of management ability of the holder may increase, that is, whether the holder has the ability to effectively supervise the trustee when entrusting other enterprises to produce or sell drugs. . From the experience of foreign countries, the holders can supervise the trustees themselves, or they can entrust professional institutions to supervise the trustees. The supervisory department shall conduct a continuous inspection of the supervisor's ability to supervise and, if necessary, promptly conduct risk warnings or accountability interviews.

From the situation reflected at the grassroots level, some people expressed concern about whether the holder could find a suitable trustee. At present, the pilot system is still underway, and the division of labor of pharmaceutical production enterprises is still under investigation. It can be expected that with the deepening of the reform of China's drug management system, especially the steady advancement of the holder system, some pharmaceutical manufacturers may be transformed into manufacturing enterprises that are entrusted with drugs, and holders may choose to be eligible trustees. A period of market operation, but this is itself a market trading behavior, not the risk faced by the holder system design itself.

From the situation reflected at the grassroots level, some people are worried about whether the holder can report adverse drug reactions in time. Monitoring and reporting adverse drug reactions is the legal obligation of the holder and is a requirement for the full life cycle risk management of the drug quality. At present, some pharmaceutical companies in China have a weak sense of risk awareness and responsibility, and the monitoring and reporting obligations for not strictly implementing adverse drug reactions are still relatively common. It should be acknowledged that if the holder entrusts others to produce, if the good interest constraint mechanism is not established, the adverse drug reaction monitoring reporting obligation may face a more difficult situation. Therefore, it is necessary to establish a report that intentionally concealed the adverse drug reaction event and caused damage. The punitive damages mechanism, at the same time, the regulatory authorities should further strengthen supervision and enforcement, and use the adverse drug reaction monitoring report as the focus of the inspection of the holders. Strictly speaking, this kind of difficulty is not unique to the holder system itself, but also to the improvement of the overall design and operational mechanism of the drug management system.

In addition, at present, during the pilot period, the holder entrusts other companies to produce, and there are regional restrictions. After the full implementation of the holder system, commissioned production should not be subject to geographical restrictions. At this time, the production and operation activities of the entrusted enterprise are the responsibility of the regulatory department at the place where the holder is located, or the supervision department at the place where the entrusted enterprise is located, and further research is needed. In the future, drug trusteeship production may become a more common phenomenon. Therefore, it is necessary to revise and improve the Regulations on the Supervision and Administration of Drug Entrusted Production, and strengthen the regulatory division and cooperation of the regulatory authorities at the locality of the holders and the regulatory authorities at the place where the trustees are located. Do a good job in the supervision of pharmaceutical production and management activities under the holder system.

Qualification

From research and development capabilities, management capabilities to accountability, it is a progressive management requirement for qualification conditions. Time and space arrangements need to be managed from the full life cycle management of drug quality, and should not be limited to drug marketing licensing

In the pilot study of the holder system, the “people” can become applicants and holders with special attention. The main reasons are: First, how much do you want to know the dividends of the holder system reform? Is it a civil subject or a part of a civil subject that can become an applicant and holder of a marketing permit? Second, what is the value orientation of the listing permit holder system? Is it encouraging drug innovation or optimizing resource allocation? Is it to implement corporate responsibility or to promote management innovation? Here, what is the value choice for freedom and security, efficiency and fairness? This has also become the key to the design of this system.

From the perspective of legislative technology, it can be described in three ways: First, enumeration. For example, the "National People's Congress Standing Committee's Decision on Authorizing the State Council to Launch the Drug Listing Permit Holder System and Relevant Issues in Some Places" clearly stipulates that drug research and development institutions and scientific research personnel are allowed to obtain the drug approval number and bear the corresponding quality of the drug. responsibility. The Notice of the General Office of the State Council on the Pilot Project for Printing and Issuing the Permit System for Drugs for the Listing of Drugs is determined as a drug research and development institution or a scientific researcher or a pharmaceutical production enterprise. The advantage of this method is that it can better reflect the policy orientation of institutional innovation. The deficiency is that it does not highlight the equal status of various market players. The second is the description. That is, the direct description in the legislation can become the basic conditions for applicants and holders, such as innovation ability, management ability, and responsibility ability. The Notice of the General Office of the State Council on the Pilot Project for Printing and Issuing the Permit System for Drug Listing Licenses stipulates the basic conditions for applicants and holders. The third is hybrid. The combination of enumeration and description is coming. The Notice of the General Office of the State Council on the Pilot Project for Printing and Issuing License Holders for Drug Listings is actually a hybrid.

From the experience of foreign countries, there are no strict restrictions on who can become holders in the drug management laws and regulations of the United States and the European Union. Natural persons, research and development units, production enterprises, and even wholesale enterprises can become holders. Moreover, the holder is not necessarily the owner of the technology contained in the actual application materials, but the holder must master all the application materials and bear responsibility for the safety, effectiveness and quality controllability of the drug's entire life cycle.

In studying the qualifications or conditions of applicants and holders, an important premise needs to be considered, that is, due to inheritance, acquisition, merger and transfer, etc., applicants and holders can proceed during the application process and after the products are approved for marketing. Change, this is the need for the free flow of pharmaceutical production factors. At present, China's pilot program only allows scientific research units, R&D personnel, and production enterprises to become holders, and the system is more positioned to encourage drug innovation. In the study of the holder system, the following three aspects should be considered in relation to the conditions of the applicant and the holder:

The first is the ability to develop. This is the primary condition for becoming an applicant and holder. The ability to develop, that is, technical capabilities, innovation capabilities. Whether the applicant can eventually become a holder depends mainly on whether the medicines it applies for are safe, effective and quality controllable. Whether it is a new drug or a generic drug, whether it is a Chinese medicine or a western medicine, the general conditions of the applicant and the holder should be the same, that is, the applicant and the holder should have certain research and development capabilities. Some scholars also believe that applicants and holders may not have the ability to develop because they can apply for registration by purchasing the technology of others. In essence, from the obligations of the holders, even if they purchase technology, they should have research and development capabilities directly or indirectly. Regardless of the original owner of the declared technical data, the applicant or the holder should have all the technical information submitted, otherwise the holder cannot fulfill the guarantee responsibility for the safety and validity of the drug's life cycle.

The second is management ability. Due to the separability of applicants and holders, and the transferability of pharmaceutical production technologies, the requirements for the management capabilities of applicants and holders are different. Management capabilities include a variety of content, such as drug clinical trial management capabilities, sample trial management capabilities, drug production and management capabilities. As the applicant and holder, it should have the drug clinical trial management ability and sample trial management ability. As a holder, if it produces itself or commissions others to produce, it should also have production management capabilities. What needs to be noted here is that, for different management capabilities, the regulatory department requests and conducts inspections and examinations when listing licenses, or requests and conducts inspections and reviews separately during the listing application process and after product registration, which needs to be carefully studied. . In short, the drug registration link should implement the principle of simplicity, grasp the essence and key points, and avoid cumbersome requirements and excessive supervision.

The third is responsibility. Strictly speaking, responsibility includes management and compensation. Here mainly focuses on the ability to compensate. Here are five questions to answer: First, what is the ability to compensate? The so-called compensation capacity generally refers to the economic compensation ability of the applicant and the holder when the drug development, production and business activities cause damage to others. Second, who is compensatory? In the study of which subjects have the ability to compensate, most people have no doubts about the ability of the legal entity to compensate, and generally have concerns about the compensation capacity of unincorporated organizations and natural persons. Starting from the concept of "accidental ownership", it is not that the compensation capacity of a legal entity is necessarily stronger than that of an unincorporated entity. Third, where does the compensation capacity originate? Is it necessary to use its own property as the basis for compensation, or can it be compensated by purchasing insurance or other guarantees? In contemporary society, the answer to this question is clear and affirmative. Fourth, when is the need for compensation. Is it necessary for the applicant and the holder to have the ability to compensate when registering the drug, or is it necessary to have compensation for the production of the drug? In this "time difference", will the compensation capacity of the applicant and the holder change? Fifth, is it necessary to stipulate this civil matter in the design of the administrative management system? Does the government have certain management responsibilities for the holder’s civil compensation obligations? What is the legal value orientation of the system design? These issues actually involve some deep-seated issues of regulation.

In fact, from research and development capabilities, management capabilities to accountability, this is a progressive management requirement for applicants and holders. Here, it is necessary to carry out time and space arrangements from the whole life cycle management of drug quality, and should not be limited to the drug marketing permission. In the drug registration process, the applicants and holders' research and development capabilities and corresponding management capabilities should be emphasized, without having to consider more compensation capabilities. This can not only solve problems for the applicants, but also reduce the burden on the regulatory authorities, which is conducive to the establishment of Encourage a good ecological environment for drug innovation.

Basic right

Disputed aspects include: transfer, entrusted rights, supervision, release rights and obligations, and monitoring and evaluation and reporting obligations

The content of legal relations is the relationship of rights and obligations. As an independent civil entity, holders of drug marketing licenses enjoy the basic rights of pharmaceutical companies as stipulated by law, and also bear the basic obligations of pharmaceutical companies as stipulated by law. How to clarify the division of rights, obligations and responsibilities of holders and trustees in legislation is a more complicated and difficult issue. Which should be clearly defined by legislation and which can be stipulated by the entrustment agreement between the parties, it is worthy of serious study. Any rights and obligations are not abstract. When examining rights and obligations, they must be placed in specific legal systems and legal practices. When studying the rights and obligations of holders of drug marketing licenses, it can be carried out in two aspects: First, the rights and obligations of the holders themselves to produce and sell their own drugs. At this time, the holders have all the rights enjoyed by the market participants. At the same time, it also bears corresponding obligations; the second is the rights and obligations of the holder when entrusting other enterprises to produce and sell drugs. At this time, the relationship of rights and obligations between the holder and the entrusted enterprise shall be subject to the dual constraints of law and contract. Below, only a few of the rights and obligations that are controversial in the design of the holder system are analyzed.

The first is the right to transfer. Whether the holder can transfer the listing permit documents is a long-term controversial topic. A brief description of the legal attributes of the listing permit documents is given above. In theory, the listing permit document is the right to contain the dual attributes of property rights and personal rights, which is the key to the study of this issue. Starting from the property rights, the listing permit document is transferable. Starting from the personal rights attribute or the administrative management attribute, the transfer of the listing license document requires a certain procedure. Article 9 of the "Administrative Licensing Law" of China stipulates that: "Administrative licenses obtained in accordance with the law may not be transferred unless they are transferable in accordance with statutory conditions and procedures. The transfer of the documents listed in the license shall be clearly stipulated by laws and regulations. At present, China's current laws and regulations do not stipulate that the documents for listing licenses can be transferred, and the relevant judicial interpretations of the Supreme People's Court also prohibit the transfer of documents for the listing of drugs. In practice, the transfer of the listing permit documents is “variable” through the transfer of technology. Therefore, the transfer of the document to the listing permit can be transferred, which is conducive to stimulating the vitality of drug innovation, and is conducive to promoting the division of labor in the society, which is conducive to the optimal allocation of resources.

The second is the right to commission. The biggest highlight of the holder system is that the license holder can no longer be bundled with the pharmaceutical manufacturer. From this derivation and extension, there are three paths for the holder's business activities: self-built production and sales, entrusting other companies to produce and sell, and transferring the listing permit documents. By entrusting other companies to produce and sell drugs, holders can quickly expand production capacity and occupy the market without increasing plant facilities and personnel, which is of great significance for curbing low-level redundant construction. The relationship between the holder and the production and operation enterprise belongs to the entrusted relationship. This kind of entrustment relationship, which content is included in the legal adjustment, and which is stipulated by the agreement, requires careful study.

The third is the right and obligation to supervise. When the holder entrusts the enterprise to produce and sell the drug, the holder has the right to supervise the production and sales of the trustee. At the same time, supervision is also a basic obligation of the principal, the holder. This is in line with the basic principles of the entrusted legal relationship. What is covered by the supervision needs to be studied in depth. Whether the production and operation activities of the entrusted enterprise meet the requirements for the production and operation of the drug, whether it meets the requirements of the quality management regulations for production and operation, and whether it meets the requirements of the entrustment agreement, should be included in the scope of supervision.

The fourth is the right and obligation to release. When the holder entrusts other enterprises to produce, the final decision on who owns the release of the drug is a matter of intense debate in the study of the holder system. In fact, the final release is the inherent right of the holder. Since the holder is the owner of the drug marketing license and the producer of the drug, the holder naturally has the right to inspect the quality of the drug and the right to release the drug. The EU requires the quality licensee (QP) of the listing license holder to release the final product, while the United States does not explicitly require the actual production company to replace the holder release. The holder may delegate the final release to the manufacturer or a third party, but this does not exempt the holder from the legal liability.

The fifth is the obligation to monitor evaluation and reporting. The monitoring and evaluation of adverse drug reaction after listing is the obligation of the holder or the obligation of the actual production enterprise. This is also a controversial topic in the study of the holder system. Monitoring and evaluation are the main content of the whole life cycle management of drugs, and an important part of the management of drugs after listing. The monitoring and evaluation of adverse drug reactions after listing is the inherent responsibility of the holder. In theory, the holder can also entrust the adverse reaction monitoring evaluation and report to the production enterprise or a third party, but this does not exempt the holder from the legal responsibility.


Legal liability

The legal liability of the holder of the drug marketing license is divided into civil liability, administrative liability and criminal liability.

First, civil liability. If the quality of the drug produced or sold by the holder of the drug marketing license causes losses to the consumer, the holder shall bear the corresponding legal responsibility. If the quality problem is caused by the actual producer or seller, the holder may recover the compensation from the actual producer or seller after compensation. Similarly, when a consumer makes a claim for compensation to an actual producer or seller, if it is not the responsibility of the actual producer or seller, the actual producer or seller may, after undertaking the first responsibility, recover from the holder.

The second is administrative responsibility. In the process of production and operation, the entrusted enterprise has violated laws and regulations. When investigating the administrative responsibility of the entrusted enterprise, is it necessary to hold the holder accountable? It depends on whether the holder has fulfilled his obligations as a good manager. If the holder of the listing license does not have intentional or gross negligence in the violation of the law of the trustee, the holder of the listing license shall not bear legal responsibility. What is the responsibility of a good manager? At present, China's relevant laws and regulations are not clearly defined. There are many case law, review law and model law in common law countries that have established some relevant rules and are worth learning. In China, in addition to the relevant laws and regulations, guiding cases can also gradually determine some rules. If the listed license holder and the trustee jointly implement the violation of laws and regulations, they shall jointly bear legal responsibility.

The third is criminal responsibility. The holder of the listing license produces and sells counterfeit drugs and inferior drugs, and means that the entrusted enterprise produces and sells counterfeit drugs and inferior drugs, and conspiring to produce and sell counterfeit drugs and inferior drugs with the entrusted enterprises shall bear corresponding criminal liabilities.

Special problem

Can the holder system be implemented in the field of Chinese medicine and special management drugs?

In the holder system innovation, there are still some issues that need to be further explored:

First, whether the holder system can be implemented in the Chinese medicine field. The holder system originated in the West. Some scholars believe that the holder system is not suitable for Chinese medicine. The reason is that many Chinese medicines are difficult to obtain patent protection or trade secret protection, especially the ancient classics, which are well-known public technologies. In fact, the ownership status of technology is not the key to the implementation of the holder system. Generally speaking, determining whether a certain drug field can adopt the holder system mainly depends on three factors: first, whether the drug production needs to obtain the product marketing permission; second, whether the drug marketing permission can be transferred; third, whether the drug can be entrusted produce. According to the analysis of the above factors, Chinese medicine production needs to obtain a marketing license, and Chinese medicine can also be commissioned for production or license transfer. The holder system can be implemented in the Chinese medicine field. As for some Chinese medicines, such as the transfer of ancient classics, whether there is market demand, it is not a problem that the holder system needs to pay attention to. The ancient classics of traditional Chinese medicine also involve other complicated issues. For example, whether the ancient individual-based medication can be suitable as a problem of drug listing and traditional knowledge protection should be given special consideration when the drug is marketed. Special cases should not be the basis for legislation. This is a problem that needs attention when improving the drug management system.

The second is whether the holder system can be implemented in the field of special management drugs. Specially administered drugs such as narcotic drugs and psychotropic drugs are strictly controlled drugs. This strict control involves the development, production and supply of drugs, including fixed-point production, fixed-point business licenses, and circulation channel control. Therefore, it is not appropriate to implement the holder system in the special medicine field. Some experts have argued that the policy of holding, transferring, and entrusting special management drugs is likely to trigger the occurrence of drug abuse.

Summary

The holder system is a drug management system commonly used in the international community today. It is a drug management system under the market economy system, a basic system in the drug management legal system, and an important system representing the future direction of drug management. At present, the pilot system of the holder system is also restricted by geographical and variety, and the dividend of the system has not been released to the maximum extent. We should boldly learn from international successful experiences, accelerate the revision of the relevant systems of the Drug Administration Law, and comprehensively promote the implementation of the holder system.

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