[Direct answer]In the Beijing area, whether it is legal or not depends on different circumstances, such as emergency treatment, clinical research, and off-label drug use. Article 121 of the Civil Code of the People's Republic of China stipulates that medical personnel shall explain the patient's condition and medical measures during the diagnosis and treatment activities. If surgery, special examination, or special treatment is needed, they shall promptly explain the medical risks, alternative medical options, and other relevant information to the patient and obtain their explicit consent. If it is impossible or inappropriate to explain to the patient, they shall explain to the patient's close relatives and obtain their explicit consent.

I. Problem background and typical scenarios

Disputes over unapproved therapies are common in the fields of new technologies, new drugs, and off-label drug use. Typical scenarios include: hospitals recommending therapies that have not yet been approved for marketing and charging high fees; conducting treatments under the guise of clinical research but failing to conduct ethical reviews and obtain informed consent; using drugs off-label without adequately explaining the risks and alternative options; replacing standard treatment protocols with empirical therapies; and patients having significant misunderstandings about the nature and risks of treatment. When cases are heard by Beijing courts, the court will review whether the therapy has been approved, whether it has passed ethical reviews, and whether informed consent has been obtained, as well as the causal relationship between the harm and the therapy. Moreover, such issues often involve multiple parties and legal relationships. Clarifying the parties' positions, responsibilities, and applicable rules is a prerequisite for resolving the disputes. The more complete the materials and the clearer the timeline, the greater the initiative that can be seized in subsequent negotiations and litigation. When conducting a detailed analysis, it is recommended to take the timeline as the main line and match contracts, vouchers, communication records, and relevant legal bases one by one, forming a clear processing framework to facilitate the determination of the order and feasibility of various claims.

II. Key points of contention

Firstly, whether the therapy used has been approved or falls within the scope of legitimate clinical research. Secondly, whether the ethical review and informed consent procedures have been carried out. Thirdly, whether the off-label drug use complies with regulations and whether sufficient information has been provided. Fourthly, whether it constitutes an exceptional measure in an emergency situation. Fifthly, whether there is a causal relationship between the adverse consequences and the unapproved therapy. Sixthly, how to determine the scope of compensation and the apportionment of liability. Seventhly, whether the order of rights assertion and preliminary procedures have been met. Eighthly, how to balance the interests of third parties with the public interest. Ninthly, how to trade off the advantages and disadvantages of settlement, mediation, and adjudication in terms of efficiency and outcomes. In addition, attention should also be paid to whether the form of evidence is legal, whether key facts can be corroborated by each other, and the differences in cost, time, and feasibility among different treatment options. On this basis, the priority path to be pursued can be determined.

III. Professional analysis by Henglue Lawyers

The practical experience of Henglue Lawyers is that such cases should first clarify the legal nature of the therapy, and then review whether the procedures are compliant. First, distinguish between three situations: emergency treatment, experimental treatment for clinical research purposes, and off-label drug use. The legal requirements for different situations vary. Second, review the compliance of the procedures, including whether they have undergone ethical review, whether informed consent forms have been signed, and whether the medical risks and alternative solutions have been fully explained. Third, check the medical records and informed consent documents to confirm whether the patient's or their next of kin's consent is genuine and sufficient, and whether there are major misunderstandings or inducements. Fourth, confirm the causality and contributory factors between the damage and the therapy through expert appraisal. Fifth, claim reimbursement of relevant expenses, compensation for medical expenses, nursing care fees, disability compensation, and compensation for mental distress based on evidence. Sixth, if the case involves illegal medical treatment activities, report it to the competent authorities and hold them accountable. The lawyers will formulate a protection plan based on evidence and regulatory requirements.

IV. Practical suggestions and legal basis

Action list: First, copy and seal the medical records and informed consent documents; Second, confirm whether the therapy has been approved and passed the ethical review; Third, verify whether the explanation and consent procedures are adequate; Fourth, keep the invoices and treatment records; Fifth, apply for appraisal to confirm the causality when necessary; Sixth, report to the competent authorities and consult a lawyer in time if the treatment involves illegal practices. For medical disputes, you can refer to the relevant provisions.Personal injury and medical disputesFor disputes involving service contracts and fees, you can refer to the following cases for reference.Business and contract disputes in enterprisesLegal basis: Article 1,219 and Article 1,220 of the Civil Code of the People's Republic of China (both of which came into effect on January 1, 2021) and the Basic Medical and Health Promotion Law of the People's Republic of China (which came into effect on June 1, 2020). The specific application shall be subject to the currently effective laws, regulations and judicial decisions.

5. Henglu Law Firm's Reminder

First, determine whether the therapy belongs to emergency treatment, clinical research, or off-label use. Second, ethical review and informed consent are key procedures for ensuring legality. Third, medical records and consent documents are core evidence for compliance with review procedures. Fourth, causality is typically determined based on appraisal conclusions. Fifth, any illegal medical treatment should be reported to the competent authorities immediately. For cases involving unapproved therapies and medical injury compensation, legal action can be taken through the appropriate channels.Personal injury and medical disputesThe service receives support, and disputes over fees and service contracts can be resolved jointly.Business and contract disputes in enterprisesFor the plate, you can refer to the cases involving the enforcement of compensation payments for referenceCreditor's rights and debts, and enforcementColumn.

VI. Frequently Asked Questions

Q1: Is it legal for hospitals to use unapproved therapies?

This cannot be generalized. If it is an emergency response to a life-threatening situation, or a clinical study conducted in accordance with the law after ethical review and obtaining informed consent, it may be legal. However, if it is used without approval, ethical review, or informed consent, and causes harm, the responsible party should generally bear corresponding legal responsibilities. Such issues also require comprehensive materials and statutory timeframes for judgment. The parties involved should promptly secure evidence, pay attention to statutes of limitations and procedural deadlines, confirm key matters in writing, and, if necessary, seek assistance from professional lawyers to choose appropriate legal strategies and assert their rights in a timely manner, in order to reduce the adverse effects of insufficient evidence or expired time limits.

Q2: Can patients refuse unapproved therapies?

Yes. For special treatments or experimental therapies, medical staff have the obligation to provide full explanations and obtain the explicit consent of patients or their next of kin. Patients have the right to understand the nature of the treatment, the risks, and alternative options, and to make an informed decision on whether to accept or refuse it without being subject to unreasonable pressure. Such issues must also be judged based on complete materials and statutory timeframes. The parties involved should promptly secure evidence, pay attention to statutes of limitations and procedural deadlines, confirm key matters in writing, and, when necessary, choose appropriate approaches with the assistance of professional lawyers and assert their rights in a timely manner to reduce the adverse effects of insufficient evidence or expired timeframes.

Q3: Is it illegal to take medication beyond the dosage specified in the instructions?

This requires specific judgment. Off-label drug use may be permitted under certain circumstances, but it generally requires reasonable medical justification, full disclosure, and proper recordkeeping, and must be reviewed through relevant hospital procedures if necessary. If the patient is not fully informed of the risks and alternative options, or if harm results from a lack of reasonable justification, the patient may claim corresponding liability. Such issues must also be assessed based on comprehensive materials and statutory timeframes. The parties involved should promptly secure evidence, pay attention to statutes of limitations and procedural deadlines, confirm key matters in writing, and, if necessary, choose appropriate legal strategies with the assistance of professional lawyers to mitigate the adverse effects of insufficient evidence or missed deadlines.

Q4: Can I protect my rights if I'm induced to accept expensive treatments?

If a hospital exaggerates the therapeutic effects, conceals the risks, or fails to explain alternative treatment options, resulting in patients receiving treatment under major misunderstandings, they may claim to revoke the relevant consent and pursue corresponding responsibilities, and claim compensation based on the damage consequences. It is necessary to pay attention to preserving communication and charging records, and to verify whether the therapy has been approved and complies with regulations. Such issues must also be judged based on complete materials and statutory periods. The parties involved should promptly fix evidence, pay attention to the statute of limitations and procedural deadlines, confirm key matters in writing, and, if necessary, choose appropriate paths with the assistance of professional lawyers and claim rights in a timely manner to reduce the adverse effects of insufficient evidence or expired time limits.

Q5: What evidence do I need to prepare?

It is necessary to prepare medical records, informed consent forms, treatment plan descriptions, invoices, and communication records, and verify whether the therapy has been approved and passed ethical review. If necessary, apply for an appraisal to confirm the causal relationship between the damage and the therapy. The more complete the evidence is, the more conducive it will be to determining whether the procedure is compliant and the extent of liability. Such issues must also be judged in light of the complete materials and statutory time periods. The parties concerned should promptly fix the evidence, pay attention to the statute of limitations and procedural deadlines, confirm key matters in writing, and, if necessary, choose appropriate paths and assert claims with the assistance of professional lawyers to reduce the adverse effects of insufficient evidence or the passage of time limits.

The above questions and answers are mainly based on the judicial practice in Beijing. There may be differences in the adjudication guidelines in different regions. It is recommended to consult a professional lawyer based on the specific circumstances of the case.

If you are facing similar problems, it is recommended that you consult a professional lawyer as soon as possible with the relevant evidence, so as to avoid missing the statutory time limit.Personal injury legal services·Beijing Henglu Law Firm

Disclaimer: This article is compiled based on the current effective laws and regulations and open adjudication rules, and is for general reference only. It does not constitute a formal legal opinion on specific cases. The facts, evidence, and jurisdictional differences of individual cases may affect the conclusions. If you encounter disputes, please consult a practicing lawyer in time.