Chinese Medical Law

Sources of Chinese Medical Law

The Basic Health and Health Promotion Law of 2019 is the fundamental law of the Chinese health system, establishing the state’s commitment to the right to health. The Law on Practicing Doctors of 1998 regulates the qualification and practice of medical professionals. The Regulation on the Handling of Medical Accidents of 2002 provides the administrative framework for resolving medical disputes. The Tort Liability Law of 2009, now codified as Book VII of the Civil Code (Articles 1218–1228), governs medical liability. The Drug Administration Law, revised in 2019, regulates pharmaceutical products.

The Healthcare System

Public hospitals (公立医院) are the main providers of health care, operating under the supervision of the National Health Commission. The basic medical insurance system covers over 95% of the population through two programmes: the Urban Employee Basic Medical Insurance (UEBMI) for employed persons and the Urban and Rural Resident Basic Medical Insurance (URRBMI) for all other residents. The tiered diagnosis and treatment system (分级诊疗) directs patients to primary care facilities before accessing specialised hospital care. The national essential drugs policy establishes a list of basic medicines available at controlled prices.

Rights of Patients

Article 55 of the Law on Practicing Doctors requires written informed consent for surgery, high-risk diagnostic procedures, and clinical trials. The patient must be informed of the treatment plan, alternatives, and risks. The right to privacy and confidentiality is protected by law, and medical institutions must not disclose patient information without authorisation. Patients have the right to access their medical records, including admission records, progress notes, and discharge summaries, through established procedures.

Medical Malpractice Liability

The Civil Code establishes four categories of medical liability: liability for medical damage caused by negligent treatment (Article 1218), liability for violation of the duty of informed consent (Article 1219), liability for violation of the duty of confidentiality and privacy (Article 1226), and liability for defective medical products (Article 1223). The burden of proof operates on a sliding scale: while the general rule requires the patient to prove fault, the law presumes fault in certain circumstances, including the concealment or destruction of medical records and the failure to comply with regulatory standards.

Dispute Resolution

Medical disputes in China may be resolved through negotiation between the parties, mediation, administrative processing under the Medical Accidents Regulation, or civil litigation. Court mediation (法院调解) is particularly significant, with courts actively facilitating settlement before trial. The medical liability appraisal system provides expert evaluation of whether the medical conduct fell below the required standard and whether it caused the damage alleged. Appraisals may be conducted by medical associations or judicial appraisal institutions.

Pharmaceutical Regulation

The National Medical Products Administration (NMPA, formerly the China Food and Drug Administration) regulates pharmaceutical products, medical devices, and cosmetics. The Drug Administration Law 2019 introduced enhanced pharmacovigilance requirements, stricter penalties for violations, and a marketing authorisation holder system that separates the marketing authorisation from the manufacturing licence. Traditional Chinese medicines are regulated under a parallel framework recognising their distinct theoretical basis.

Criminal Liability

The Criminal Law imposes liability for medical malpractice resulting in serious consequences. Article 335 provides for the conviction of a medical professional for practising negligently and causing death or serious harm to the patient’s health. The offence carries penalties including imprisonment. Article 336 covers the unauthorised practice of medicine by unqualified persons. Criminal liability also attaches to the production and sale of counterfeit and substandard drugs.