The Symposium on the System of Drug Marketing Authorization Holder in China & the First Anniversary of the Amendment of the Drug Administration Law was successfully held on Xueyuanlu Campus on 4 Dec, 2020.
The conference was hosted by the Centre for Health Law Research and it held both online and onsite. Over 30 experts and scholars from the Legislative Affairs Commission of the Standing Committee of the National People’s Congress (NPC), Tsinghua University, Nankai University, East China University of Political Science and Law, Capital University of Medical Sciences, China University of Political Science and Law and other institutions attended the meeting. Dean of the College Prof. Xie Zhiyong moderated the opening ceremony and delivered a speech.
Xie Zhiyong extended a warm welcome to all the guests. He introduced the theme of this conference and expressed his own views on the Drug Administration Law and the system of marketing authorization holder. He pointed out that the Drug Administration Law plays an important role in the availability and effectiveness of drugs in the country, but there were some problems. Based on this, following changes were made last year to the Law.
He said: “First, the system of drug marketing authorization holder was added, under which the holder should take full responsibility for the effectiveness, safety and R&D, production, circulation and use of drug. At the same time, the quality management, risk control and compensation ability of the applicant need to be evaluated. Second, the law emphasizes the whole process of regulation, which embodies some of the particularities for drugs. Third, it clarified regulatory responsibilities and regulatory measures. On the one hand, the governments at the county level and above, the drug marketing authorization holders, and the inspection teams will be brought into the supervision scope; while on the other hand, a system of “drug credit files” will be established, which is consistent with the social environment. Finally, the severity of the punishment was increased. It has increased both the amount of illegal payments and the scope of penalties. It has also strengthened the management of illegal and dereliction of duty by executive branches and local government regulators”.
Xie further pointed out that the Symposium, which coincides with the first anniversary of the promulgation of the Drug Administration Law, is of great significance for the study of the drug marketing authorization holder system. He urged the experts and scholars to explore the system and sum up experience from many angles and all directions, so as to make suggestions for promoting drug regulation and protecting citizens’ rights of life and health.
The conference consisted of two thematic modules and a discussion session. The first unit was moderated by Prof. Wang Qingbin, Deputy Director of the Scientific Research Department of CUPL. He pointed out that currently the problem in the system is that holders carry too much responsibility. The participants then expressed their own views on the establishment of responsibility system for the drug marketing authorization holders.
Li Shenqiu, Director of the Administrative Law Office of the Legislative Affairs Commission of the NPC Standing Committee, introduced the whole legislative process of the Drug Administration Law, and clarified the original intention, innovation and practical problems of the drug marketing authorization holder system, and that the future should be combined with practice to further improve the system of responsibility. Prof. Yang Yue from the School of Pharmacy of Tsinghua University, Prof. Zhao Peng from CUPL, Professor Shen Weixin from the School of Law of the Tsinghua University, General Manager Yu Lihui from a pharmaceutical enterprise and Professor Song Hualin from Nankai University respectively pointed out various problems in the responsibility-sharing mechanism for drug management.
The problems included “the responsible parties are not clear”, “it is difficult to assign responsibility to the overseas holders”, “it is difficult to realize zero risk of drugs”, and “drug enterprises do bear excessive responsibility in the whole process of supply chain”. To this end, the experts suggested that international judicial assistance should be enhanced, cooperation between drug marketing licensees and regulators should be promoted, industry self-discipline should be encouraged, the insurance system should be improved and the responsibility sharing of both entrusted parties of drug production should be clarified.
The second session was chaired by A/Prof. Wang Wei, Director of the Centre for Teacher Development of CUPL. She pointed out that the system of drug Marketing authorization holder should be analyzed in accordance with the legislative purposes and principles of the Drug Administration Law to finally solve the problem of how to co-govern the state and society.
A/Prof. Li Xiaoyong from the Department of Health Law of College of Medical Humanities of Capital Medical University analyzed the construction of legal liability system in pharmaceutical field, put forward the difference and connection between administrative liability and civil liability, and explained the different stipulations of drug liability in the Drug Administration Law and the Civil Code. She pointed out that drugs and products should be distinguished, and drug liability should not be abandoned completely. Prof. Wang Jing from the East China University of Political Science and Law introduced the Spanish regulation system of medicines, and pointed out that the real problem behind the problem of medicine regulation is how to deal with the conflict between the protection of civil society rights and the innovation of pharmaceutical products.
In the light of the provisions of the Drug Administration Law, Dr. Zhao Yingnan from the College of Comparative Law put forward several pointed that needed to be further improved from angles of the examination and enforcement the transfer and transfer standards of drug marketing authorization holder, whether natural persons are included in the subject of the licensing, and the small and medium-sized scientific research companies and scientific research institutions have the ability and conditions to control the entrusted enterprises. From the perspective of practical experience, General Manager Chen Changxiong and General Manager Ming Xingxing from two pharmaceutical enterprises affirmed the role and effectiveness of the system of the Drug Marketing Authorization Holder in practice, and shared the difficulties and problems pharmaceutical industry encountered in the implementation of the Drug Management Law.
After the keynote speech, the participants entered the free discussion session, and had in-depth discussions on the administrative liability of drug marketing authorization holders, the applicability of the punitive damages system and the double penalty system.
Xie Zhiyong summed up the results of the symposium and pointed out that it was conducted by scholars from various fields based on different fields and professional perspectives. He said that the in-depth communication and opinions on the new system of drug marketing authorization holder had both theoretical depth and practical guidance. He further pointed out that the drug marketing authorization holder system may lead to the discussion on whether administrative liability can be transferred and whether the quality standards and technical standards should be regarded as laws. Xie Zhiyong said,
“The College of Comparative Law will continue to pay attention to and enhance the theoretical and practical progress of the Drug Administration Law, and further promote the prosperity of the medical and health legal system, back-feeding the theory and practice of administrative law”.
