Analysis on the legal liability of adverse drug reaction damage

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As a special commodity, drugs not only have the effectiveness of disease treatment, but also have the characteristics of inevitable different degrees of side effects. In 1968, the World Health Organization clearly defined the side effects as adverse drug reactions (adverse drug reaction,ADR), which refers to harmful and unexpected reactions found in common doses of drugs during the prevention, diagnosis, treatment or recovery of the body's functions.

my country's "Adverse Drug Reaction Reporting and Monitoring Management Measures" stipulates that: Adverse Drug Reaction (ADR) refers to the adverse reactions of qualified drugs that are unrelated to the purpose of medication or accidental adverse reactions that occur under normal usage and dosage.

In other words, ADR is neither a drug quality problem nor a medical accident. It is an inevitable and unexpected risk. It is precisely because of the damage caused by "qualified" drugs that it brings troubles to enterprises, patients and regulators in the determination of legal liability. The author believes that the legal liability of ADR damage should be clarified, and timely and effective channels for patients to obtain legal relief should be opened.

 legal attribute

There are two preconditions for ADR, one is that the drug must be qualified; the other is normal use. In line with the above preconditions, according to the nature of the drug, the degree of medical research can be expected and the differences in the constitution of the drug itself, generally divided into common and predictable adverse reactions, common and unexpected adverse reactions and idiosyncratic drug allergic reactions.

For common and predictable adverse reactions, most countries have legislated to provide adequate instructions on drug labels or instructions. ADR records in drug instructions can make doctors and patients predict the safety and risk of drugs. Under normal circumstances, ADR adopts the principle of "risk-taking", and only when the damage of ADR is serious enough, it is necessary to consider the sharing of risk, but at this time the interests and risks have been seriously unbalanced.

Common and unexpected adverse reactions refer to a kind of ADR that has not been found, unforeseen and failed to be reflected in the instructions for use of drugs. It is an unexpected ADR damage that is beyond the reasonable limit allowed by medical knowledge in the drug research and development stage or manufacturing stage due to the latent toxicity of drugs and the limitations of clinical trials. It is customary for States to add a warning to the instructions. my country adopts a non-mandatory approach, that is, drug manufacturers can take the initiative to add warnings on drug instructions or labels, and the national drug regulatory authority can also add warnings on instructions or labels for special drug requirements.

Atypical drug hypersensitivity is a type of abnormal genetic reaction caused by drugs, which usually occurs in individuals with inherited drug metabolism or response variation. Individuals belong to the "specific constitution", showing a special reaction to a specific agent, and there is no definitive answer to the medical reasons for the occurrence of specific constitution. Such ADRs are known internationally as "systemic risk". Such as glucose -6-phosphate dehydrogenase deficiency, patients taking sulfonamide, primaquine caused severe hemolytic anemia. In this ADR, the damage is more caused by the patient's own constitution, and the drug is only a predisposing factor. Therefore, some experts proposed that the "systemic risk" caused by individual differences should be regarded as the "reasonable risk" of drugs ".

 Identification criteria

The relief of ADR damage should be based on the legal attribute of ADR damage to find the corresponding legal basis. The above-mentioned types of ADR damage mainly focus on drugs and individual constitution, that is, the product attributes of drugs and the effectiveness and risk of individual. Therefore, the main criteria for determining liability for ADR damage are as follows:

First, the judgment standard of drug defects. ADR is based on the defects of the drug itself, and the judgment standard of drug defects in each country is closely related to the medical policy of each country and the degree of protection of people's health. Under the current legal framework of our country, there is no special regulation on the liability of ADR damage, so we can only choose from the similar legal system. Of these, the Product Quality Act is the closest. Article 46 of the Product Quality Act establishes a double standard for the identification of defects, namely, unreasonable danger and non-conformity. However, the "unreasonable danger" is too abstract and difficult to judge in judicial practice.

The second is the reasonable risk standard of drug defects. The "reasonable risk" standard of drug defects mainly refers to the safety that does not meet the reasonable expectations of consumers or has unreasonable risks. When applicable, the "consumer expectation standard" is generally introduced. The reason is that the "unreasonable risk" standard itself It is full of ambiguity and needs to be judged in conjunction with consumer expectations.

Third, the risk benefit standard of drug defects. Drugs directly point to the legal benefits of life and health, and in principle, it is not appropriate to take economic factors into account. However, the "consumer expectation standard" focuses on protecting the interests of the public, while the risk-benefit standard tends to protect the interests of the industry and the industry. Therefore, how to not be too harsh on the industry and industry to hinder its development, and not ignore the real interests of the people, is the scope that legislators need to consider. The liability for drug damage in China adopts no-fault liability, so there may be a conflict between the standard of risk-benefit judgment and the nature of no-fault liability.

 imputation principle

ADR damage is caused by "qualified" drugs, but China's "Drug Administration Law" does not provide for the responsibility of ADR, therefore, the damage caused by it can not find a way to remedy.

Although Article 59 of the Tort Liability Law stipulates that if a patient is damaged due to defects in drugs, disinfectants, medical devices, or unqualified blood input, the patient may request compensation from the producer or blood provider, or from the medical institution. Claim compensation. If a patient requests compensation from a medical institution, the medical institution shall, after making the compensation, have the right to recover the compensation from the responsible producer or blood supply institution. However, it only applies to the subjective fault of the responsible subject (producer, blood provider or medical institution), and does not apply to ADR damage. Therefore, ADR damage cannot be classified into the traditional category of tort, nor can it find a legal basis from the tort liability system, and the fact that the damage it produces also needs to be valued and measured.

In the Drug Law promulgated by Germany in 1978, it is clearly stipulated that ADR is a drug defect, the liability for damage caused by drug defects is a strict liability without fault, and damages are borne by drug producers by purchasing commercial insurance or providing financial guarantees. And it is stipulated in the Drug Law that drug manufacturers cannot defend with technology, as long as the victim can prove that the drug has been used, and the defects of the drug have caused major personal injury or death, even if the scientific and technological means at the time cannot be discovered. And to improve this defect, you must also unconditionally bear the liability for damages.

However, scholars from various countries generally believe that strict liability is not absolute liability, compared with the theory of negligence, the producer's defense is only limited in scope, it still has the right to defend. For example, defenses such as "the product was not put into circulation", "the defect did not exist when the product was put into circulation", "the scientific and technological level at that time could not find the product defect. Such defenses can basically be attributed to the "development risk defense", also known as the "technological level defense", which means that the producer is not responsible for the damage caused by product defects that cannot be discovered by the scientific and technological level at the time. In this case, the general victim and the producer are not at fault, and the producer has done the highest degree of attention.

The original intention of the establishment of strict product liability is to protect the victims in a vulnerable position, strengthen the producer's prudent safety attention obligation, highlight social equity, and try to keep the rights and interests of consumers and producers in a relative balance in the legal value. At present, in order to adapt to the rapid changes in scientific and technological progress, some countries and regions in the world are gradually narrowing the scope of application of strict liability, or on the basis of strict liability for producers, their liability is shared by various relief models. This approach is worthy of our reference and consideration.