In the wake of a case of illegal trading of vaccines that implicated more than 300 people, ranging from businesses operating without proper licenses to hospital personnel, China's State Council has released amendments to the Regulations for the Circulation and Inoculation of Vaccines. The amendments, which became effective immediately, place tighter controls on the distribution and management of vaccines in China.
Some of the key changes introduced by the amendments are summarized below:
Reforming the vaccine procurement process: The amendments eliminate the role of vaccine wholesalers and require all type-1 and type-2 vaccine purchases to be made through provincial public resources transaction platforms (Article 10). Each county-level Center for Disease Control and Prevention (CDC) will supply vaccines to inoculation units within its administrative district after they have purchased vaccines from manufacturers (Article 15).
Reinforcing cold chain management for vaccines: Compared with the broad language in the previous version, the amendments now specify in greater detail the cold chain and temperature monitoring requirements in the storage and transportation of vaccines (Article 16). CDCs and inoculation units are required to obtain a temperature monitoring record when they receive vaccines (Articles 18 and 23).
Establishing a system to trace the circulation and use of vaccines in China: The amendments now require vaccine manufacturers, CDCs, and inoculation units to keep accurate and complete sales and purchase records to trace the production, storage, transportation, and use of vaccines (Articles 18 and 23; new Article 54). CDCs and inoculation units must accurately register, report, and destroy vaccines that have failed to meet standards as specified by the amendments (new Article 55). The Amendments also require medical personnel to keep a better record of vaccines and their use (Article 25).
Enhancing enforcement measures and increasing penalties: The amendments increase the penalties for illegal trading and improper handling of vaccines, including:
- Increasing potential fines from a fixed range of CNY5,000 to CNY20,000 (approximately US$750 to $3,000) to between two to five times the value of the improperly handled vaccines (new Article 66)
- Adding criminal liabilities for sales and purchases of type-2 vaccines in violation of the amended storage and transportation requirements (new Articles 60, 65 and 66) and
- Imposing a ban of five to ten years to conduct any business in the pharmaceuticals industry for persons who are directly liable for the offenses (new Articles 65 and 66).
These amendments mean that the players in the vaccine business are now subject to heightened obligations and liabilities imposed by the amendments. However, it remains to be seen whether this will lead in the near term to broader enforcement action by Chinese authorities across the food and drug sectors. Certainly, in terms of new regulations, the authorities have issued a number of new measures in recent months, including the Administrative Measures on the Registration and Record Filing of Health Foods (effective July 1, 2016) and the Norms on the Quality Management for the Clinical Trials of Medical Devices (effective June 1, 2016). Other new laws and regulations regarding food safety and product labeling also look to be in the pipeline for 2016.
Find out more about China's new rules regarding sales of vaccines as well as other safety and labeling issues by contacting either of the authors.