China to separately legislate for vaccine supervision: the law has been submitted to the NPC for deliberation for the First Time on Dec. 23, which will be the strictest Law for the vaccine industry in the country.

Following the "Shandong illegal vaccine case" in 2016, the Changchun Changsheng rabies vaccine case that occurred this year has cast another shadow over China’s vaccine industry. And the State Administration for Market Regulation of China has issued the Vaccine Administration Law (Draft for Comment) soon thereafter on Nov. 11, to seek for opinions from the masses.

The draft of the Vaccine Administration Law has been submitted to the 7th meeting of the Standing Committee of the 13th National People's Congress of the People's Republic of China for deliberation on Dec. 23, 2018. The separate legislation for vaccine administration will be conductive to the further improvement of the authority and stability of vaccine administration measures.

According to the introduction of relevant person in charge of the Department of Policies and Regulations of the National Medical Products Administration of China, the draft of the Vaccine Administration Law submitted for deliberation this time explicitly specifies vaccine development, production, circulation, prophylactic vaccination, indemnity, and compensation, etc. in the form of law, which will be conductive to the establishment of a systematic and whole-chain vaccine administration system.

The person in charge said that the draft adheres to the strategic and public benefit nature of vaccines, and incorporates the development, production, and stockpile of vaccines that prevent serious diseases into China’s national strategy, for example, it proposes that China should make the vaccine industry development plan and industry policy, encourage large-scale and intensive production, establish the department coordination mechanism, coordinate, as a whole, vaccine safety regulation work, further strengthen the state immunity planning system, and formally adopt the mechanism of no-fault compensation following adverse events.

To reflect the strictest regulation, the draft proposes that China should implement the access system for vaccine production stricter than that for common pharmaceutical production; requires vaccines should not be entrusted for production in principle, and requires the legal representative, main person in charge, and other personnel on key posts to have good credit, corresponding professional background, and working experience; it proposes to implement the vaccine release system and compulsory insurance system for vaccine liability; furthermore, it specifies that the vaccine clinical trials should be implemented or organized implementation by tertiary medical institutions or disease control and prevention institutions above provincial level.

Relevant articles of the draft explicitly require fulfilling responsibilities of relevant parties for the whole process of vaccine development, production, circulation, and prophylactic vaccination. The draft proposes that China should implement the information traceability system for the whole process of vaccines, and carry out quality tracking and analysis of marketed vaccines; in terms of the circulation, it requires disease control and prevention institutions to organize distribution of vaccines to the vaccination entities, and other entities or individuals should not supply vaccines to the vaccination entities.

The draft makes clear the regulatory responsibilities, strengthens the regulatory capacity building, and severely cracks down illegal activities; it requires the pharmaceutical product regulators and health administrative departments to establish information sharing mechanism and implement uniform disclosure system of vaccine safety information; it requires building professional and specialized inspector teams at state and province levels and strengthening responsibility investigation on regulators and local governments, to show the principle of heavier punishment on vaccine-related illegal activities.

In my opinion, the vaccine event this year ended as Changchun Changsheng suffered administrative punishment such as being revoked its Pharmaceutical Production License and fined RMB9.1 billion, and was ordered to be delisted compulsorily, however, problems with vaccine production and administration, etc. exposed are still fresh in people’s minds. It’s hoped that the Vaccine Administration Law will pass deliberation soon, to escort the vaccine production and management as well as people’s health.

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