Staff of the market supervision and management department in Hefei, Anhui Province, inspect a private clinic's records of vaccine sales (XINHUA)
After a half-month investigation, first-phase reports on a vaccine scandal were submitted to an executive meeting of the State Council, China's cabinet, on April 13.
The matter was revealed in February when police in east China's Shandong Province arrested two persons for selling substandard vaccines worth more than 570 million yuan ($87.96 million) to 18 provinces and autonomous regions. The vaccines had been bought illegally and stored improperly by the mother-and-daughter pair.
This aroused public concerns countrywide. In a response, the State Council appointed a cross-departmental investigation team on March 28, pledging to thoroughly investigate the matter and trace all the supply sources and sales chains of the substandard vaccines.
As of April 11, 192 criminal cases had been filed, 202 suspects detained and 22 others' arrest approved, according to the first-phase investigation results. Meanwhile, 45 pharmaceutical enterprises were found implicated in the cases and 357 officials in 17 provinces and regions removed from their posts or demoted.
After the reports, Premier Li Keqiang reiterated the Central Government's stand and said that it would show no tolerance for such behavior and acts. "Vaccine quality and safety are closely related to people's life and health. They represent a red line that cannot be crossed," Li said.
Other than tough punishment for those held accountable, Li also urged the development of a long-term mechanism to supervise and manage the country's vaccines more strictly.
"The Shandong case further exposed the loopholes in vaccine supervision and management. We must learn from the lesson and find an efficient method to institutionally address the flaws," Li said.
A press conference held by the China Food and Drug Administration, the Ministry of Public Security and the National Health and Family Planning Commission on March 24 announces the findings of the probe into the Shandong vaccine case (XINHUA)
A serious situation
In 2010, Wang Keqin, then a journalist with the Beijing-based China Economic Times , published a report on a vaccine scandal in north China's Shanxi Province, predicting that if the chaos was not correctly addressed, it would be duplicated around the country in a few years.
Unfortunately, Wang's prediction has proved to be true. "In the two incidents, the problems occurred through the same links--the transportation and storage of secondary vaccines," Wang said at a forum on social management.
In China, vaccines are divided into two categories. Residents are required to be vaccinated with the primary ones that are free. Secondary vaccines are not free and people can choose whether they want to be vaccinated or not.
According to reports by the Shanghai-based news website ThePaper.cn, the 25 kinds of vaccines being sold in the Shandong case all belong to the secondary category, including inoculations for polio, mumps, rabies and hepatitis B.
Even though many of the vaccines were purchased from licensed producers, their quality was questionable as they might not have been stored or transported under the required conditions, ThePaper.cn reported.
According to regulations on management and distribution of vaccines, they are required to be refrigerated at 2-8 degrees Celsius during storage or transportation. In the Shandong case, the suspects were reported to keep the vaccines in their storehouse in temperatures of more than 14 degrees Celsius.
Besides, the two suspects were reported not to have a valid license for vaccine sales. "Under the regulations, individual sellers cannot obtain licenses from the government. If you ask for receipts, they can give you many from different vaccine wholesale companies," said Chen Taoan, former Director of the Information Division of the Shanxi Center for Disease Control and Prevention, and the whistleblower in the Shanxi vaccine case.
Chen told Beijing-based Minsheng Weekly that vaccine wholesale companies appoint dealers indiscriminately without ensuring the quality of vaccines during storage and transportation to dealers.
Another problem revealed by the Shandong case is the private purchase of secondary vaccines, Liu Peng, an associate professor with the School of Public Administration and Policy of Renmin University of China, told Minsheng Weekly .
According to the regulations on vaccine management and distribution, primary vaccines are distributed through a government immunization program conducted by disease control and health departments at different levels, while secondary vaccines are sold in the market.
"With high profit margins involved in the trading of secondary vaccines, many people and organizations want to get into the business," Liu said.
Liu urged a sound system to supervise and regulate the management and distribution of vaccines. "Since vaccines are closely related to people's health, the government should take measures to guarantee the safety of every link in the distribution chain of all kinds of vaccines," Liu said.
In the wake of the Shandong scandal, the executive meeting of the State Council took a decision on April 13, requiring stricter management of vaccine distribution.
"Though the country's vaccine system is safe in general, problems should be dealt with seriously once they surface," the decision said.
It proposed some revisions to China's current regulation on the management of vaccine circulation and use. An important one is including secondary vaccines in the provincial-level procurement platform for public resources.
"The inclusion of secondary vaccines in the procurement system will help reduce risks in the distribution of such vaccines as the entire process is under the government's supervision," Zhou Zijun, a professor with the School of Public Health of Peking University, told Beijing Times . Meanwhile, the decision banned pharmaceutical wholesale enterprises from trading in vaccines. No institution or person is allowed to sell vaccines online or give them for free.
Besides, according to a statement on the website of the National Health and Family Planning Commission (NHFPC), in the future, vaccination institutions will be prohibited from directly buying secondary vaccines from manufacturers. Vaccine manufacturers will be required to directly deliver, or consign a qualified enterprise to deliver secondary vaccines to disease control and prevention institutions at or above county level.
"With the middle links being greatly reduced, it is hoped that the current chaos in the management of secondary vaccines will be addressed in the near future," Zhou said.
On the management of vaccine chains, the statement said that the food and drug supervision authorities will draw up specific operation rules for vaccine production, storage and transportation.
For the use of vaccines, the NHFPC said that a centralized vaccination model based on township-level health institutions will be established in rural areas. Village doctors will be prohibited from providing secondary vaccines to patients.
A system to track the entire process from manufacturing, storage and transportation to use will be set up, and institutions or hospitals must request storage temperature records upon receiving vaccine products, according to the State Council decision.
Punishments for those illegally selling or improperly storing and transporting vaccines will be increased. Violators will be prohibited from taking up the vaccine business again. Government officials will be required to resign if they fail to perform their supervision duties effectively.
Copyedited by Dominic James Madar
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