A Booster Shot of Legislation
New Law to better regulate China’s vaccine industry
A vaccine administration law was adopted by the National People’s Congress (NPC) of China, the top legislative body of the country, on June 29, marking the beginning of improved vaccine administration. The law will go into effect on December 1.
As biological products used on healthy people, mostly infants, vaccines pertain to public health, and hence to public safety and national security, said Jiao Hong, head of the National Medical Products Administration (NMPA), at a press conference on June 29 at the Great Hall of the People to announce the adoption of the law.
“Vaccine supervision will cover the whole process, from vaccine development, production and distribution to vaccination,” she said, noting that in light of their unique characteristics, vaccines should be subject to the strictest regulation.
The law spells out specific requirements for every link of vaccine administration and requires stringent research and development management. For instance, it stipulates that clinical trials of vaccines can only be conducted by qualified medical institutions or disease control authorities, and subjects for clinical trials should be carefully selected.
In addition, market access to vaccine production is to be strictly controlled. Producers will be required to not only comply with the drug administration law, but also rules specific to the vaccine industry. They must have appropriate capacity and facilities to ensure biosafety. Their legal representatives and their principal heads should have good credit records, while people in other key positions should have competent professional backgrounds and experience.
Moreover, the law demands strict process control. Vaccine production must follow proper procedures and quality control standards, after-sale research should be actively carried out and the production process should be continuously optimized. Changes that may affect the safety and efficacy of vaccines should be adequately validated, while every batch of products should be tested and approved by regulators before going onto the market.
Furthermore, the law provides for strict control of vaccine distribution, where vaccines will be directly delivered to disease control authorities and then distributed to vaccination units. The distribution process should be traceable in real time to ensure vaccine quality.
According to the law, an electronic information system will be set up to make all information of vaccines traceable, including information about vaccine production and packaging, period of validity, date of vaccination, along with the medical workers who conduct the vaccinations and vaccine recipients.
The law emphasizes information disclosure and sharing, said Yuan Lin, Director of the medical products supervision division of the NMPA, at the press conference. Vaccine license holders are mandated to release product and other relevant information to the public in a timely manner.
Professional vaccine inspection teams will be established at the central and provincial levels to conduct supervision, Yuan said, adding that there are no more than 100 vaccine inspectors at the national level currently, which is completely inadequate.
Punishment and Compensation
The law is a response to problems exposed in vaccine administration recently. In particular, last year, a scandal involving Changchun Changsheng Biotech Co. Ltd. in northeast China’s Jilin Province put vaccine production and administration under scrutiny.
On July 15, 2018, the NMPA announced that the company was found to have falsified production records in making rabies vaccines for human use. Last October, the Jilin Food and Drug Administration revoked the company’s pharmaceutical production license and confiscated illegally produced vaccines and 1.89 billion yuan ($274 million) of profits from sales of defective vaccine. It also imposed a fine of 7.21 billion yuan ($1.05 billion).
Hefty punishment is conducive to enhancing the quality of the country’s vaccines and boosting the public’s confidence of vaccine safety, said Jiao.
Under the new law, penalties for illegal acts involving the production and sale of fake or inferior vaccines, falsifying vaccine registration data and violation of relevant quality standards will be much higher than those involving ordinary drugs.
Those producing or selling fake vaccines will face a fine of 15 to 50 times the value of the illicit products, while substandard vaccine makers or sellers face a fine of 10 to 30 times the value.
In addition, the minimum fine for producing or selling fake or substandard vaccines was raised, and vaccines worth less than 500,000 yuan ($72,900) will be fined as much as those worth 500,000 yuan.
The new law also makes it clear that violation of its provisions constitutes a criminal offense, therefore perpetrators will be investigated for criminal responsibility according to relevant law.
Legal representatives, principal responsible persons, directly responsible persons, as well as other responsible persons in a law-violating organization shall be severely punished, Jiao said.
In addition to penalties, the law also introduces a compensation scheme for people who suffer side effects from vaccinations.
Compensation for damage incurred by mandatory vaccinations will be paid from local fiscal revenue; while damage from voluntary vaccinations will be paid by vaccine license holders, according to the law.
In addition to provisions on the whole-process supervision, the law also specifies measures encouraging innovation in vaccine development, Jiao explained.
It states that the government supports basic research and innovation in vaccines, including providing necessary funding for the development of new types of vaccines such as polyvalent vaccines, and joint research and development among vaccine license holders as well as research and medical institutes. The government has always bolstered the structural optimization of the vaccine industry, encouraging large-scale and intensive production.
In the past four decades, China’s vaccine industry has grown rapidly, Jiao said, adding that China has 45 vaccine producing enterprises, with a combined annual production capacity exceeding 1 billion doses. Altogether, they can produce more than 60 types of vaccines against 34 diseases, with four of them pre-certified by the World Health Organization and exported to more than a dozen countries and regions.
China has been an example for many countries for many years with its support for child vaccination programs at home and abroad along with policies and actions, said Seth Berkley, CEO of GAVI, the Vaccine Alliance, at the opening ceremony of the Global Health Forum of the Boao Forum for Asia on June 11.
Vaccination is one of the best investments in global health; it is the most cost-effective with a huge impact, he said. Since the 1970s, global immunization coverage for children has increased from only 5 percent to 86 percent, leading to a 60 percent drop in the child mortality rate, he said.
“Vaccination has played a multifaceted role in protecting people’s health and promoting the construction of a healthy China,” said Cui Gang, Deputy Inspector of the Disease Prevention and Control Bureau of the National Health Commission, at the press conference announcing the law.
He cited the examples of smallpox, polio and diphtheria, which were previously serious threats. Smallpox was eliminated in China in 1979, polio after 2000, and diphtheria after 2006, he said.
China once had a very high incidence of Hepatitis B at 9.7 percent. But since the vaccine against the virus was included in the Chinese children’s immunization program in 2002, its prevalence has dropped to the current rate of below 1 percent, Cui said.
Measles and meningococcal disease, which used to be common in children and adolescents, are now very rare, plummeting to historical low levels, he added.
Vaccination has played an important role in raising the life expectancy of Chinese citizens from 35 years old at the founding of the People’s Republic of China in 1949 to the current 77 years old, Cui said. This has been mainly achieved by lowering the mortality rate of children under five years old.
Vaccines are strategic and public-benefiting products, said Yuan Jie, Director of the Office for Administrative Law with the Legislative Affairs Commission of the NPC Standing Committee. “Because of the extreme importance of vaccines and related work, it is necessary to make a law governing them,” she said.