This is the language that boiled over on the internet after the Changchun Changsheng Corp. vaccine debacle.
But perhaps, this time, it will be disappointing again.
Workers were lucky enough to find Adam, a former legal professional in their circle of friends, and asked him to analyze from a legal point of view why "evildoers" can't be punished in the way we think they should be.
Changchun Changsheng produces bad drugs, not fake ones
Is the vaccine produced by Changchun Changsheng a fake or a bad drug? Once it is clearly defined, the sentencing and penalties are different.
First, let's look at the legal definition of the two in the People's Republic of China*** and the State Drug Administration Law (hereinafter referred to as the Drug Administration Law).
The difference between fake and substandard medicines is that substandard medicines have a license to manufacture and sell, while fake medicines do not.
According to the Jilin Food and Drug Administration's decision on administrative penalties, Changchun Changsheng's batch of DPT is a vaccine with an approved license number, and is therefore not a fake drug but a substandard drug.
An administrative penalty decision has not yet been made in the case of Changchun Changsheng's freeze-dried human rabies vaccine, but in conjunction with the relevant notification from the State Drug Administration, the batch of freeze-dried human rabies vaccine should also be considered a bad drug.
How the 3.44 million penalty amount was formulated
Articles 73 and 74 of the People's Republic of China (PRC) Drug Administration Law stipulate that the penalty for substandard drugs is 1-3 times the value of the goods, and the penalty for counterfeit drugs is 2-5 times the value of the goods.
The current penalty of more than three million dollars is already the highest limit stipulated by law. According to the current drug management law, the drug administration has to administer the law, and they can't possibly impose a heavier penalty on Changchun Changsheng.
Whether the victim can get compensation for civil liability
Civil liability can be broadly divided into two aspects, one is the liability for breach of contract, the other is the liability for tort.
There is no contract between the person who received the vaccine and the vaccine manufacturer. There is no contractual agreement, there is no breach of contract, so it is tort liability.
On the composition of general tort liability, there are four elements in civil law.
1. There is a result of the infringement occurs, the vaccine got sick, there is a significant obstacle to health, which is the result of the infringement.
2. The perpetrator is subjectively at fault, the vaccine manufacturer is subjectively at fault.
3. There has to be an act of aggression.
4. There is a causal relationship between the act of aggression and the result of the aggression. Because the pharmaceutical company's vaccine is substandard, causing damage to physical health.
As a victim of the vaccine, claiming vaccine damage, to prove that there is a causal relationship between the defective vaccine and the child's damaging outcome, i.e., convulsions and fever, or death, there must also be an exclusive causal relationship. Exclusive means that the damage could have been caused by something else, such as another illness in the past two days.
This is very difficult for ordinary people. They don't have the specialized knowledge, they don't have the relevant testing equipment, and they don't have the relevant expert consulting services, they just have sensory perception.
This is the first difficulty in civil litigation.
The lack of effectiveness of the vaccine is called "failure of potency", which means that it does not achieve immunity, but does it pose an imminent danger to human health? No, it doesn't.
Bad-quality vaccines are a useless injection into the body that won't make you sick or kill you, but won't give you antibodies either. It exposes you to the risk of infection, but again, that risk of possible infection cannot be determined.
If it's difficult to get evidence from the consumer side, can we resort to reversing the burden of proof?
According to civil law, in litigation it is generally the case that "whoever claims, whoever proves". According to Article 92 of the Drug Administration Law, the general burden of proof applies to damages arising from drugs.
Another "Supreme People's Court on the trial of food and drug disputes on the application of law on a number of issues" of the judicial interpretation of the provisions of Article 5 clearly stipulates:
This is equivalent to a clear food, drug infringement litigation applicable to the general burden of proof, the burden of proof is borne by the consumer. As for the "preliminary proof" of the preliminary need to prove to what extent, it is accepted by the court, the specific trial judge to judge.
From the legal provisions, the burden of proof of tort damages, according to the current law, for the vaccine consumers is a very big obstacle. To realize the rights of consumers, to raise the so-called manufacturers of illegal costs, which is a very big problem.
In 2013, eight children died after being injected with a hepatitis B vaccine produced by Shenzhen's Kangtai Biological.
Jurisdictions at the time were the State Food and Drug Administration (SFDA) and the National Health Planning Commission (NHPC), which jointly investigated the case for a month and concluded that the deaths of the eight children and the vaccine injections were episodic in nature, meaning that no causal relationship could be proved between the two.
After the conclusion of the investigation was made, the production license was returned, and Shenzhen Kangtai could continue to produce.
This also shows that it is very difficult to prove a causal relationship in a medical sense.
So from the level of proof, as a user of the vaccine, it is very difficult to obtain civil damages through civil litigation.
How much to pay and how to pay
When encountering counterfeit manufacturers, the public often say that we should fine it to "lose all the money" and increase the cost of violating the law. This should be taken as an emotional outpouring.
Because according to the current "Tort Liability Law," Article 16, for personal injury compensation has a clear compensation program:
"Compensation shall be provided for medical expenses, nursing costs, transportation costs, and other reasonable expenses for treatment and rehabilitation expenditures, as well as reduced income due to lost wages. In the event of disability, compensation shall also be paid for disability living aids and disability compensation. Where death results, compensation shall also be paid for funeral expenses and death compensation."
Obtaining compensation:
1. It must be supported by evidence, such as how many days I was hospitalized for this disease and how much I spent on medical expenses.
2. be able to calculate it based on criteria.
"The Supreme People's Court on the trial of personal injury compensation cases on the application of law of a number of issues of the interpretation" provides that the death compensation "in accordance with the location of the court under appeal in the previous year per capita disposable income of urban residents or per capita net income of rural residents standard, calculated by twenty years. However, for those over sixty years of age, the amount shall be reduced by one year for each additional year of age; and for those over seventy-five years of age, the amount shall be calculated at five years."
A large first-tier city had a per capita disposable income of 60,000 yuan for urban residents in the previous year, and for 20 years, that would be 1.2 million.
But if you are in a remote certain fourth-tier city, the previous year's per capita disposable income of urban residents if only 20,000 yuan, 20 years is 400,000 yuan.
Therein lies the reason for the different prices for the same life.
So there is a cap on damages under the Tort Liability Law. Death and injury, as well as disablement, can be calculated according to the current law corresponding to the amount of compensation.
To penalize the family, the law has to have punitive damages, basically a multiple of the calculated result, which is left to the discretion of the judge.
The law of punitive damages in China in fact also has, is the "Protection of Consumer Rights and Interests Law," Article 49 of the provisions of the law, but also we are very familiar with the "double compensation". But in other areas there is no punitive damages.
The United States has jurisprudence on punitive damages, which is particularly evident in tobacco litigation. Some of them pay billions of dollars in damages, and the reason is that there are so many victims that there are punitive damages in order to penalize them to the point of losing their homes.
Summary of civil liability:
Firstly, due to the limitation of the principle of burden of proof, it is difficult for consumers to win in litigation.
Secondly even if they win the case, the compensation they can get is limited and will not be astronomical.
So, analyzing from the perspective of civil liability, the vaccine case is likely to be the result.
Whether the vaccine case can ultimately be sentenced to death
Changsheng this batch of vaccines belong to inferior drugs, according to Article 142 of the Criminal Law:
"The production and sale of inferior drugs, causing serious harm to human health, shall be sentenced to fixed-term imprisonment of not less than three years and not more than ten years, and shall be sentenced to a fine of not less than 50% and not more than two times of the amount of sales; Where the consequences are particularly serious, the penalty shall be fixed-term imprisonment of not less than ten years or life imprisonment, and a fine of not less than fifty percent and not more than two times the amount of the sale or confiscation of property."
There is also a crime of producing and selling counterfeit drugs in the criminal law, and the maximum penalty for this crime is death, but the maximum penalty for the crime of producing and selling substandard drugs is life imprisonment.
In criminal law, the crime of producing and selling substandard drugs is a crime of result, and the absence of a result does not constitute this crime.
So what does it mean to "cause serious harm to human health"? What is meant by "particularly serious consequences"?
Supreme People's Court, the Supreme People's Procuratorate on the handling of the production, sale of counterfeit drugs, substandard drugs criminal cases on the specific application of the law of the Interpretation of Article 3:
"production, sale of substandard drugs are used, resulting in more than minor injuries, or mild disability, moderate disability, or organ and tissue damage resulting in general dysfunction or serious dysfunction, or other serious consequences. Serious dysfunction, or other serious harm to human health" shall be recognized as "serious harm to human health".
"Causing death, serious disability, serious injury to more than three persons, moderate disability to more than three persons, or organ and tissue damage resulting in serious functional impairment, light injury to more than ten persons, mild disability to more than five persons, or organ and tissue damage resulting in general functional impairment, or other particularly serious circumstances endangering human health" shall be recognized as "particularly serious consequences". "particularly serious consequences".
So in the vaccine case, the vaccinator, if hospitalized and identified as seriously injured, belongs to constitute a serious consequence to human health, and the producer may be sentenced to 3-10 years in prison if convicted.
The seriousness of the situation or lead to serious consequences, causing death, serious disability, more than three people seriously injured, resulting in such serious consequences in order to be sentenced to more than 10 years or life imprisonment, the judgment is based on the results of the damage to occur.
Back to the issue of evidence, the criminal law also pay attention to the behavior and the results of the damage to have a causal relationship.
Criminal law causation is more stringent, not the civil so-called "prima facie". The common law system even requires "beyond all reasonable doubt" in order to be convicted, the requirements are much stronger than in civil law.
While the burden of proof in criminal law is not on the victim, the prosecutor on behalf of the state prosecution. But the prosecutor is not a medical expert, and he also has to rely on administrative and regulatory authorities and medical experts to issue investigation reports or make expert conclusions.
In 2016, the case of Pang Hongwei's illegal vaccine operation broke out in Shandong. She strung together an underground vaccine trading network consisting of more than 100 uplines and more than 200 downlines over a five-year period.
After the incident, 357 public officials were dismissed, demoted and other punishments. The illegal vaccines, which have been distributed to 24 provinces and cities across the country, were purchased for 260 million yuan, while the sales amounted to 310 million yuan. Because the vaccines are not refrigerated for storage and transportation, most of these vaccines face the possibility of expiration.
In the end, Pang Hongwei was sentenced to 19 years, but the crime was not production and sale of substandard medicines, but illegal business operation, because she was not qualified to produce and sell medicines, and was finally held accountable for illegal business operation.
The first trial of the Pang Hongwei case in 2016
How much does it cost pharmaceutical companies to break the law
Summarizing, according to the current law, the administrative responsibility can be to confiscate the illegal products, confiscate the illegal income and impose a fine of more than double or triple the amount. In serious cases, the drug production license is revoked.
In terms of civil liability, consumers of vaccines have to pay the burden of proof, and even if the lawsuit is supported by the court, the compensation they can get can be calculated.
Criminal penalties: these are the harshest penalties. However, for pharmaceutical companies, obtaining proof is still difficult.
So, the cost of counterfeiting for pharmaceutical companies is nothing more than these three aspects, regardless of public pressure, administrative, civil and criminal, according to the current law, the risk faced and the cost paid is limited.
If the proceeds of the drug is 1 million, plus the fine is but 4 million. If there is a death, against an individual depending on town income *20 years, it's $2 million at most, with a 10 year sentence.
The author of the "King of Vaccines" post is upset about the confiscation of 186 vaccines and a fine of over 3.4 million dollars, but if one understands China's current legal requirements, one can only say that the FDA made this the harshest punishment within the limits of the current law.
Why sell bad drugs is only fined, sell "real drugs" but want to go to jail
Additionally clarify a few points, in the field of medicine, "to do the God of medicine" why will be faced with breaking the law.
On January 5, 2018, Guo Qiao, the legal representative of Shanghai Meihua Lilac Women's and Children's Outpatient Clinic Co. Ltd. was sentenced to seven years in prison for purchasing and selling 13,000 vaccines that had been imported without authorization. It was Pfizer's pneumonia vaccine, a Type II vaccine that is voluntary and has been out of supply for three years.
The Procuratorate believes that "the purchase and sale of imported vaccines in large quantities, the subjective malignancy is deeper, and the illegal sale of drugs and vaccine injections, should be severely punished according to law. At the same time, taking into account that the sale of the vaccine was not found to be directly damaging results, 13-valent pneumonia vaccine has been approved and listed in the country, discretionary lighter punishment."
The protagonist of "I Am Not the God of Medicine" sold medicines that were also not approved to enter the country.
The crime that was prosecuted by the procuratorate was the crime of selling fake medicines, which is something that many people can't understand.
In fact, this is the proverbial "one size fits all". The production of substandard drugs according to the Drug Administration Law can only be confiscated 186, fined you 3.44 million; the sale of foreign drugs without approval is the sale of fake drugs, suspected of producing and selling fake drugs. The relevant legal provisions are written in black and white very clearly.
How we push for justice in every public ****ing incident
In 1955, when Cutter Laboratories in Berkeley, California, was making a polio vaccine, the inactivation of the germs was not thorough enough leading to the emergence of a live virus, which was not found to be a problem in safety tests.
The oversight led to 40,000 illnesses among the 120,000 children vaccinated, 113 lifelong paralysis, 56 cases of paralytic polio and 10 deaths.
The Carter incident was one of the worst pharmaceutical disasters in U.S. history and had an impact on the entire U.S. vaccine market that no one expected.
The U.S. courts ruled in 1958 that there was "no-fault liability". No-fault liability is stricter than reversing the burden of proof.
The reversal of the burden of proof is simply for you to prove that you are not at fault, and for the vaccine manufacturers to prove that they are not at fault.
No-fault liability is awesome, in that the victim doesn't have to prove that the vaccine manufacturer is at fault, and the vaccine manufacturer doesn't have to prove that it's not at fault.
Once this comes up, it's the vaccine manufacturer's responsibility whether you're at fault or not.
As a result of the court's "no-fault liability," pharmaceutical companies have begun to re-examine the commercial rationale for vaccine development. After all, vaccine development cycles are long and have become a "thankless" business. As a result, over the next 30 years, vaccines almost became the first "extinct" product in the U.S. healthcare market.
The U.S. government later also thought about the pain, set up a compensation fund, each sale of a vaccine to draw $ 0.75 in taxes, put into the compensation fund, all the vaccine-related adverse reactions, can be to the federal fund to file a request for compensation, the federal review of the request for compensation in accordance with the relevant standards.
After the fund was established, from 1988 to 2017, 17,281 lawsuits were received, of which 6,085 were deemed to provide compensation, one-third were paid out, and two-thirds were withdrawn. 6,085 total **** payouts of $3.9 billion, an average of about $500,000 per case.
This approach protects both the incentives of the vaccine manufacturers and the people who are vaccinated under normal circumstances, and are able to receive compensation for adverse reactions after a normal vaccination. This is a more inspiring institutional arrangement for China.
The vaccine incident is not a one-day event, and we are following up to observe the progress, but we hope that this analysis will allow us to rationally safeguard our rights and interests.
If it is a place that is not yet covered by the current law, we also hope that from this, a rational mechanism will be established so that the wicked will be punished, and the motivation of manufacturers who really want to do a good job with vaccines will be protected, as well as the rights and interests of consumers.
We hope that every mistake is the beginning of progress.
Looking for adoption, thank you