Adverse effects of drugs and vaccines in China

1.1 Which are the main kinds of responsibility (contractual, in tort, criminal) of the following subjects with respect to adverse drugs reactions?

A. Manufacturers

• The Drug Administration Law of the PRC (with effect from July 1, 1985, last revised and effective as of December 1, 2019) (“Drug Administration Law”) requires that drug marketing license holders (the responsible entity for whole-process safety of the drug, could be the manufacturers or those who license manufacturers for manufacturing) shall carry out monitoring of post-marketing adverse reactions of drugs, proactively collect, track and analyse information on suspected adverse drug reactions, and promptly take risk control measures for drugs with identified risks and report any suspected adverse reaction.

• There is no explicit legal rule in this regard under PRC laws. From jurisprudential perspective, in case of adverse drugs reactions, the responsibility of the drug marketing license holders should not be contractual, tort or criminal, but rather should fall under equity-based liability. However, in legal proceedings, the PRC courts will hold different views, and will most probably rely on the tort liability.

B. Healthcare professionals

• Drug Administration Law requires that medical institutions carry out investigations, on a frequent basis, into the adverse reactions of drugs used by them, and in the case of any suspected adverse reaction, promptly report it to the competent medical products administration and health administration.
• If any adverse reaction is caused by malpractice, it will incur tort liabilities (in accordance with the Regulation on the Handling of Medical Malpractice (with effect from September 1, 2002) or even criminal liabilities.

C. State

• The State shall establish a drug alert system for monitoring, identifying, assessing and controlling adverse drug reactions and other drug use-related harmful reactions.

Which are the conditions for claiming compensation (including the burden of proof)?

2.1 In order to be able to claim compensation under the Civil liability regime, the following conditions must be met:

• Proving the existence of adverse drug reactions (burden of proof to be borne by the patient)
• Proving the causal link between the drug and the adverse drug reactions (burden of proof to be borne by the patient)

2.2 Which are the grounds for exclusion of liability?

For drug marketing license holders, they will not be liable for adverse reaction liability if the adverse reactions are due to, including without limitation:

1. negligence of the medical institutions or healthcare professionals;
2. quality defect of the drug itself (but product quality liability shall be pursued instead);
3. common responses to the drug;
4. the patient fails to provide sufficient information about his health situation prior to taking the drug;
5. the injury results from psychological factors;
6. the patient was sick before taking the drug and this disease appears by coincidence after taking the drug

2.3 Which are the time limits for submitting a claim for compensation?

The general PRC limitation of action applies, which is three years from the date on which the obligee knows or should have known that his or her rights have been infringed and who the obligor is. However in practice usually such claims are submitted right after the adverse event rises and no agreement can be reached between the parties.

2.4 Which damages can be compensated?

There is no unified statutory standard for compensation. It is decided by the court on a case-by-case basis.

2.5 Is it possible to claim compensation directly to the insurance company of the damaging party?

Based on the insurance policies known to us, this type of claim would not be supported.

3.1 How would the answers above change if adverse drugs reactions occur within a compassionate use program?

There is no specific guidance concerning adverse reactions occurring during a compassionate use program.

4.1 How would the answers above change if the adverse drugs reactions occur as part of an off-label use?

There are no special rules. But normally the hospitals and healthcare professionals will be the defendants in such cases for their liabilities for the off-label use instruction, and the drug marketing license holder could claim that they did not use the drug in line with the drug specification and therefore it should not be liable.

5.1 How would the answers above change if the adverse drugs reactions concern a vaccine?

Vaccines are categorized as immunisation programme vaccines and non-immunisation programme vaccines. The State shall be responsible for immunisation programme vaccines.

5.2 Is any public indemnity/compensation provided in the case of both compulsory and not compulsory vaccination?

• Unlike for drugs where there is no clear rule, it is regulated in the PRC Vaccine Administrative Law (with effect from December 1, 2019) (“Vaccine Administration Law”) that in case of unusual vaccine reactions, there shall be compensation.
• According to Article 56 of the Vaccine Administration Law, compensation for immunisation programme vaccines shall be borne by the state while compensation for non-immunisation programme vaccines shall be borne by vaccine marketing license holders.

6.1 Which liabilities can be insured? Is there any compulsory insurance?

• Adverse drug reactions insurance policies are not compulsory in China.
• According to Article 68 of the Vaccine Administration Law, vaccine liability insurance is compulsory under Chinese Law. This relates primarily to the quality of the vaccine rather than adverse drug reactions.

7.1 Are there particular procedural issues to be highlighted in relation to ADR claims?

Normally forensic expertise is needed in ADR cases, and sometimes it is difficult to find institutions having the capacity for delivering the forensic expertise opinion for certain ADR.