Criminal Liability For Selling Unsafe Vaccines
Case 1: Changsheng Biotechnology Vaccine Scandal (Jilin, 2018)
Facts:
Changsheng Biotechnology produced substandard DPT vaccines and falsified production records. Millions of doses were distributed nationwide. Investigations revealed serious violations of production standards and record-keeping.
Legal Issues:
Production and sale of unsafe vaccines.
Violation of Criminal Law of PRC Article 144 (production and sale of counterfeit or substandard medicines).
Endangerment of public health.
Court Reasoning:
The company knowingly falsified production data and released substandard vaccines.
Public trust and health were severely threatened.
Criminal liability applies due to intent, scale, and potential harm.
Outcome:
CEO and top executives sentenced to 15 years imprisonment.
Fines exceeding ¥9 billion.
Company criminally liable; recall of all affected vaccines.
Significance:
Landmark case demonstrating severe punishment for unsafe vaccine production.
Emphasizes accountability of corporate executives for public health.
Case 2: Vaccine Distributor Selling Expired Vaccines (Shandong, 2016)
Facts:
A vaccine distributor sold expired vaccines to local hospitals and clinics, affecting thousands of children.
Legal Issues:
Sale of expired vaccines.
Violation of public health and safety laws.
Court Reasoning:
Intentional distribution of expired vaccines constitutes a criminal act.
Potential harm to recipients increased culpability.
Courts considered both scale and economic gain in sentencing.
Outcome:
Distributor sentenced to 7 years imprisonment.
Confiscation of illegal profits (~¥2 million).
Mandatory public apology and compensation to affected families.
Significance:
Shows that even if no immediate harm occurs, selling expired vaccines is criminal.
Case 3: Illegal Production of Rabies Vaccines (Guangdong, 2014)
Facts:
A small pharmaceutical company produced rabies vaccines without proper licensing and quality testing. The vaccines were sold to rural clinics.
Legal Issues:
Production and sale of unlicensed, unsafe vaccines.
Potential threat to public health due to rabies risk.
Court Reasoning:
Lack of license and testing demonstrated intent to bypass safety regulations.
The endangerment of human life was a critical aggravating factor.
Outcome:
Company owner sentenced to 10 years imprisonment.
Factory shut down, and vaccines confiscated.
Significance:
Highlights that production without government approval or testing is criminally punishable.
Case 4: Fake HPV Vaccines Sold Online (Beijing, 2017)
Facts:
A criminal group sold counterfeit HPV vaccines online, claiming they were imported and FDA-approved. Buyers were unaware the vaccines were fake.
Legal Issues:
Production and sale of counterfeit vaccines.
Fraud and public health endangerment.
Court Reasoning:
Deliberate deception and sale of counterfeit vaccines endangered recipients’ health.
Online distribution increased potential exposure to a large population.
Outcome:
Head of the criminal group: 12 years imprisonment.
Other members: 5–8 years imprisonment.
Confiscation of illegal profits (~¥3 million).
Significance:
Shows that online sale of fake vaccines carries severe criminal liability.
Public health endangerment is key to sentencing.
Case 5: Mislabeling Vaccines to Bypass Expiration Checks (Henan, 2015)
Facts:
A vaccine producer relabeled near-expired vaccines to extend their shelf life and sold them to hospitals.
Legal Issues:
Fraudulent mislabeling of vaccines.
Sale of unsafe vaccines threatening public health.
Court Reasoning:
Deliberate mislabeling showed intent to deceive.
Large-scale distribution aggravated the potential risk.
Criminal liability applies even if adverse effects were not reported yet.
Outcome:
Producer sentenced to 9 years imprisonment.
Confiscation of profits (~¥1.5 million).
Significance:
Illustrates that falsifying expiration dates is criminal.
Case 6: Vaccines with Insufficient Active Ingredients (Sichuan, 2013)
Facts:
A manufacturer produced vaccines with substandard active ingredients, reducing efficacy. Tens of thousands of doses were sold in rural clinics.
Legal Issues:
Sale of ineffective vaccines.
Endangerment of public health.
Court Reasoning:
Intentional reduction of active ingredients constitutes criminal liability.
Scale of distribution and number of potential victims increased severity.
Outcome:
Manufacturer sentenced to 8 years imprisonment.
Profits confiscated, and mandatory public notice issued.
Significance:
Shows that efficacy issues, not just toxicity or expiration, can trigger criminal liability.
Key Legal Principles from These Cases
Intentional production or sale of unsafe vaccines is criminal.
Falsifying records or mislabeling (expiration or content) aggravates liability.
Scale, distribution method, and number of affected recipients increase sentencing.
Corporate executives and production managers are directly liable.
Public health endangerment is the primary factor in criminal liability.
RELATED Blog
0 comments