China will intensify the punishment of illegal drug acts

On the 20th, the 10th meeting of the 13th Standing Committee of the National People's Congress heard a report from the Constitution and Law Committee of the National People's Congress on the amendment of the Drug Administration Law. This is the second time that the Standing Committee of the National People's Congress has considered the revised draft of the Drug Administration Law.

Some members of the Standing Committee, departments and the public have proposed that the requirements for drug registration applications should be clarified, the requirements for conditional approval of medicines urgently needed for the treatment of serious diseases should be stipulated, the transfer of drug registration certificates should be allowed, the management of changes in drug production process should be strengthened, and the online sales of medicines should be standardized. Accordingly, the Constitution and the Law Commission recommended that additional provisions be added: the applicant should provide authentic, sufficient and reliable research data, data and samples to prove the safety, effectiveness and quality controllability of drugs; the urgently needed drugs that meet the requirements can be approved conditionally; after approval, the holder of drug marketing license can transfer the drug registration certificate and clarify the conditions and meanings of the transferee. Business affairs; To implement classified management of changes in drug production process, major changes shall be examined and approved, other changes shall be filed or reported, and the impact of changes shall be comprehensively assessed and verified; third-party platform providers of drug network sales shall file, fulfill the obligations of qualification review, stopping and reporting illegal acts, stopping the provision of online sales platform services, and so on. It is clear that prescription drugs should not be sold directly through the third party platform of drug network sales.

Post-marketing management of drugs is an important link to continuously improve drug quality and ensure drug safety. Some members of the Standing Committee, departments and local governments suggest that special provisions should be made for post-marketing management of drugs, stipulating that drug license holders should actively carry out post-marketing research, drug license holders should carry out adverse reaction monitoring and identify risks of drugs. Take timely risk control measures. The licensee of drug market shall take corresponding risk management measures for the drugs approved by conditions and complete relevant research work within the prescribed time limit.

In view of the problem of high drug prices and shortage of supply, some members of the Standing Committee, local governments and the public have proposed that measures should be taken to strengthen drug price supervision and ensure drug supply. The Constitution and the Law Commission have proposed the following contents: the State monitors drug prices, conducts cost price surveys when necessary, strengthens supervision and inspection of drug prices, investigates and punishes drug price violations according to law, and maintains drug price order; the State implements a system of early warning and list management for drug shortages; the State encourages the development and production of drug shortages, and urgently needs the shortage of drugs in clinic; and Priority shall be given to the examination and approval of APIs; the relevant departments of the State Council may take appropriate measures for the production, price intervention and organization of imports of drugs in short supply to ensure the supply of drugs; the holders of drug listing licenses and pharmaceutical production and marketing enterprises shall fulfill their social responsibilities to ensure the production and supply of drugs.

To further strengthen the punishment of drug violations, increase the cost of violations, and severely punish heavy penalties, the second review draft made the following modifications: First, increase the types of punishable acts. If ADR monitoring or reporting is not carried out in accordance with the regulations, the representative offices of drug licensee holders or designated enterprise legal persons established by overseas enterprises in China fail to fulfill relevant obligations in accordance with the law, the third-party platform for drug online sales fails to fulfill the obligations of qualification examination, reporting illegal acts, stopping the provision of online sales platform services, and fabricating and disseminating false drugs. Four types of illegal acts of product safety information shall be increased by stipulating corresponding legal liabilities. The second is to increase the intensity of punishment. The amount of fines shall be increased for unlicensed production and marketing of medicines, fake and inferior medicines, violations of the norms for quality control of drug production or drug management. Punishment shall be imposed on the legal representatives, principal responsible persons, directly responsible persons and other responsible persons of the units engaged in the production and sale of counterfeit and substandard drugs. Provisions for investigating criminal responsibility according to law shall be increased. Provisions for administrative detention shall be increased for those who are not considered as crimes or do not constitute crimes according to law. Third, increase punitive damages. If counterfeit or inferior drugs are produced or are still sold knowingly, causing death or serious health damage, the victim may claim corresponding punitive damages.