The revision of "Drug Administration Law" mainly promotes marketization concept

2014-01-03 source: after years of deliberation and discussion in the economic reference newspaper, the newly established CFDA recently started the revision of the drug administration law, and is scheduled to solicit opinions from the whole society after August 2014 The revised proposal will be studied by China Pharmaceutical University and Tsinghua University law school respectively Drug administration law was implemented in 1985, first revised in 1998, and formally promulgated in 2001 It has been nearly 13 years since then The law will be revised from which aspects become the focus of many people in the industry The reporter recently learned from CFDA that the concept of market mechanism promoted by this revision will touch on the industry transformation "I believe that this revision is not a minor change or a partial sentence adjustment, but a complete reversal of regulatory thinking, a clear definition of regulatory functions, corporate responsibilities, and the mobilization of the concept of social co governance." Wu Zhen, deputy director of CFDA, pointed out at the kick-off meeting of the revision of the drug administration law that whether some projects can consider the implementation of the filing system, whether some phase III clinical trials of drugs do not need to be approved, whether some approval rights still need to be placed in the central government and other issues need to be implemented into the revision opinions According to him, many problems of the original drug administration law were exposed as early as 2007, but with the development of the domestic pharmaceutical industry in recent years, people are increasingly aware that this law is obviously not suitable for economic and social development After the institutional reform function of the General Administration of food and drug was finalized in 2013, the time for revision is ripe The reporter learned that there are four major problems in the current drug administration law: first, there is no clear identification of government functions and market mechanism, which brings great obstacles to law enforcement The implementation objectives of the examination and approval system and the filing system are not clear; second, there is no clear division between the central and local authorities; third, there is no full reference and reference to international experience; finally, industry insiders have pointed out that the most prominent problem is that some provisions do not allow the market mechanism to fully play its role and guide the full and healthy development of the pharmaceutical economy "The current laws and regulations have a strong departmental nature, leaving a strong color of planned economy, and many projects need to be approved." According to Wu Zhen, all these have affected its legal role Teng Jiacai, deputy director of CFDA, pointed out that the revision of the drug administration law will actively explore the law of drug safety work, innovate the concept and system of governance, clarify the rights and responsibilities of all parties related to drug safety, and strive to build a new pattern of social co governance of drug safety with corporate responsibility, industry self-discipline, government supervision, department coordination and social participation Adhere to the strict treatment of drugs in accordance with the law, strengthen the investigation of legal responsibility for drug safety, severely punish and punish illegal behaviors, and comprehensively improve the level of drug safety "At present, there is a big problem in our drug market and supervision work, that is, the credit problem." Ye yaoyu, deputy director of Jiangsu food and drug administration, pointed out that he had encountered many problems in the daily supervision process, which reflected the lack of credit of pharmaceutical enterprises If the market economy does not have good faith and credit as the basis, the market can not be established and developed "I hope that this issue will be fully reflected in the law during this revision." He also believes that some provisions limit the merger and reorganization of pharmaceutical enterprises It is difficult for enterprises to enter the market, but it is more difficult for enterprises to exit, and the market mechanism has not played a role "The sequence of drug production license and business license has not been solved GMP certification and license are now integrated What can we do in the future?" For the current problems reflected by the pharmaceutical industry, such as too slow drug review and too few staff, experts unanimously point to the participation of third parties and suggest that the government purchase services from third parties Tang minhao, deputy director of Shanghai food and drug administration, said that there are many third-party research institutions engaged in basic medicine, inspection and other work in China, but the regulatory authorities did not mobilize their enthusiasm and play the role of government purchasing services "How to involve the third party and how to restore the government laboratory should be solved." Song Ruilin, executive director of China Pharmaceutical Industry Research and Development Association, pointed out that the establishment of third-party evaluation institutions should be promoted "We now have a large number of laboratories in scientific research institutions, colleges and universities that can be used, or NGOs that can be used to undertake some technical work such as drug testing In this way, we can also save a lot of manpower and material resources; if we really can't see clearly, we will leave a window and a docking point, leaving room for future improvement " He said Industry insiders pointed out that the concept of purchasing services from third parties has been accepted, which will benefit the third-party inspection and diagnosis institutions It is also criticized that the current drug administration law is not clear about the legal responsibility and the punishment is too light Wu zhiang, a professor at the school of Business Administration of Shenyang Pharmaceutical University, believes that the current laws and regulations are too weak in economic penalties to highlight the civil compensation liability of pharmaceutical enterprises, which is not enough to correct some defects brought about by market competition Song Ruilin pointed out that the revision of the bill should strengthen the law enforcement ability of the drug administration, especially the law enforcement power, and increase the illegal cost "When a drug company breaks the law, it doesn't mean that it's ruined, but that it feels the huge pressure of it." Huang Wei, deputy director of the administrative law office of the law working committee of the National People's Congress, pointed out that in the future, it will be open to the public whether all the stains of pharmaceutical enterprises can be recorded Through information disclosure, we will supervise this pharmaceutical enterprise, so that it can truly assume the responsibility of the first responsible person "In addition, star endorsements and implanted advertisements shall bear joint and several liabilities There are a lot of drugs advertised by stars When you turn on the TV (first look), you are doing drug advertisements, which can't be ignored for the social guidance " She pointed out (Zeng Liangliang)