[Interpretation] The new version of the drug administration law: "new" full of meaning? "strict" word head

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On the morning of August 26, the 12th meeting of the Standing Committee of the 13th National People's Congress voted to pass the newly revised Drug Administration Law. The law will be implemented from December 1, 2019.

What are the highlights of the newly revised Drug Administration Law? Yuan Jie, Director of the Administrative Law Office of the Legal Work Committee of the NPC Standing Committee, and Liu Pei, Director of the Policy and Regulation Department of the State Food and Drug Administration, made a detailed interpretation at a press conference held by the General Office of the NPC Standing Committee.

Highlight one: four of the most "new"

The Drug Administration Law was enacted in 1984, first revised in February 2001, and then revised twice in December 2013 and April 2015 respectively. The drug management law "overhaul", Yuan Jie believes that reflects the "four latest".

The first and latest is to closely integrate drug management with people's health. The new law clearly stipulates the protection and promotion of public health, and proposes in Article 3 that drug management should focus on people's health.

The second latest is to adhere to risk management. The concept of risk management runs through all aspects of drug development, production, operation, use and post-marketing management, and adheres to social co-governance.

The third latest is to adhere to the problem orientation of the new development period. In view of the problems existing in the development of drug management, we should adhere to the problem orientation, respond to social concerns, and resolutely implement the "four strictest" principles.

The fourth latest, focusing on improving the quality of drugs, a comprehensive and systematic regulation of the drug management system.

Highlight two: encourage the creation of "new"

Encouraging innovation is one of the highlights of the new law. "One of the major benefits of the newly introduced drug marketing authorization holder system is to encourage innovation in system design." Yuan Jie said that in addition to manufacturers, scientific research institutions that have the ability to innovate new drugs must make them obtain huge benefits after the product is launched.

What is the drug marketing authorization holder system? Liu Pei said, drug marketing authorization holder system, that is, with drug technology drug research and development institutions and manufacturers, through the application of drug marketing authorization, to obtain a drug registration certificate, in their own name to put the product on the market, the full life cycle of the drug responsibility of a system.

"By drawing lessons from international experience, the 17th meeting of the Standing Committee of the 12th National People's Congress authorized the State Council to carry out pilot drug marketing license holder system in ten provinces and cities including Beijing. In the past four years, positive results have been achieved, which has played a positive role in strengthening the management of the whole life cycle of drugs, encouraging innovation, reducing low-level duplication and optimizing resource allocation. In the process of amending the Drug Administration Law, the standing Committee of the National people's Congress summed up the pilot experience, took people's health as the center, improved the scientific supervision system, set up a special chapter, and made clear in the relevant chapters the main responsibility of drug marketing license holders for drug quality and safety, and strengthened the supervision of the whole process." Liu Pei believes that the establishment of a drug marketing license holder system is to implement the main responsibility of the drug life cycle; the second is to stimulate market vitality, encourage innovation, and optimize resource allocation.

At the same time, drug innovation is also one of the important contents to encourage innovation. According to statistics, applications for innovative drugs in China increased by 75% in 2018 compared with 2016. In 2018, 48 new drugs were approved, including 18 new anti-cancer drugs, an increase of 157 compared to 2017.

Liu Pei believes that the newly revised General Provisions of the Drug Administration Law clearly stipulates that the state encourages the research and creation of new drugs. At the same time, more than a dozen clauses have been added and improved, and a number of institutional measures have been added to speed up the listing of new drugs and better meet the needs of the public. Good drugs and affordable drugs have released a series of system dividends.

The specific system mainly includes: first, a clear direction of encouragement, focusing on supporting drug innovation that is guided by clinical value and has clear curative effect on human diseases; second, innovating the review mechanism; third, optimizing the management of clinical trials; fourth, establishing a related review and approval system; fifth, implementing a priority review and approval system; sixth, establishing a conditional approval system.

Liu Pei also said that the new law also encourages and promotes the development and innovation of drugs for children, and gives priority to review and approval to meet the drug needs of the people.

Highlight three: strict supervision, severe punishment

Drug safety is a matter of people's health. Yuan Jie believes that the new law embodies many characteristics in terms of regulatory penalties: first, the comprehensive use of a variety of punishment measures, including confiscation, fines, ordering to suspend production and business for rectification, revocation of license documents, non-acceptance of license applications within a certain period of time, prohibition of employment, and so on.

Second, the amount of fines will be greatly increased. The amount of fines for the production of counterfeit drugs will be increased from two to five times the value of illegal production and sales of drugs to 15 to 30 times. Moreover, it is stipulated that if the value of the goods is less than 100,000 yuan, it shall be calculated as 100,000 yuan.

Third, implement a "double penalty system" for some serious violations and punish people.

Fourth, the principle of punitive damages is proposed.

Fifth, in accordance with the responsibilities of the relevant departments stipulated in the three fixed plans of the State Council and the new law, the competent departments should work together. If there is dereliction of duty and dereliction of duty in the investigation and punishment of counterfeit and inferior drugs, the competent department directly responsible and other responsible personnel shall be severely punished in accordance with the law.

Sixth, those who violate the provisions of the law and constitute a crime shall be investigated for criminal responsibility according to law.

Regarding the issue of online sales of prescription drugs, which is of general concern to the public, Liu Pei said that in the process of revising the Drug Administration Law, the Standing Committee of the National People's Congress has adopted an inclusive and prudent attitude and also put forward requirements for the drug regulatory authorities. In the next step, the State Food and Drug Administration will take the implementation of the new law as an opportunity to extensively listen to opinions with relevant departments, further speed up the drafting of measures for the supervision and management of drug network sales, and strive to standardize and guide the healthy development of drug network sales. to better protect the public's drug rights and interests.