Import unapproved medicine into China

个人进口用于自用的未在中国批准或供应的救命药物的要求

随着全球医药行业的发展，越来越多的新药和特效药在国外上市。然而，由于审批流程和供应渠道等原因，这些药物可能尚未在中国获得批准或供应。对于需要这些救命药物的患者来说，如何合法地将其进口用于自用成为一个重要的问题。根据《中华人民共和国药品管理法》（2019年修订版），个人进口此类药物有特定的要求和程序。

《药品管理法》的修订背景

2019年8月26日，第十三届全国人民代表大会常务委员会第十二次会议对《药品管理法》进行了修订，新法于2019年12月1日起施行。此次修订强调了以人民健康为中心，加强了对药品全生命周期的监管，提高了违法行为的处罚力度，同时也对个人进口药品的行为作出了新的规定。

个人自用药品进口的法律框架

根据修订后的法律，未经批准进口药品被认定为假药。然而，法律也考虑到了特殊情况，对于个人为治疗疾病从境外携带少量、自用的药品，给予了一定的宽容度。在实践中，针对未在中国上市的救命药物，患者个人进口用于自用在一定条件下是被允许的。

合理数量的界定

法律并未明确定义“少量”的具体数量，但一般认为应限于个人治疗所需，不应超过正常疗程所需的剂量。携带过多可能被视为有销售或分发的嫌疑，从而违反法律规定。

医疗必要性的证明

患者需要提供由正规医疗机构出具的诊断证明，说明其患有特定疾病，且需要使用该未在中国批准的救命药物进行治疗。此证明应包括医生的签名、医疗机构的盖章，以及详细的诊断和治疗建议。

药品的合法来源

进口的药品应当来自合法的渠道，如国外合法注册的药店或医院。购买时应保留购买凭证、药品说明书和其他能证明药品合法性的文件。

海关申报与检验检疫

在入境时，患者应主动向海关申报所携带的药品，提交诊断证明、购买凭证等相关文件。海关将根据法律法规，对药品进行查验，并决定是否允许携带入境。

法律风险与处罚

尽管法律对个人自用的药品进口有所宽容，但如果违反相关规定，可能面临以下风险：

• 药品被没收：海关有权对未申报或不符合规定的药品予以没收。
• 行政处罚：可能被处以罚款，情节严重的，可能受到更严厉的行政处罚。
• 刑事责任：如果被认定为走私、贩卖假药等行为，可能面临刑事指控。

实际案例分析

近年来，有一些患者通过个人渠道进口国外的新药用于自我治疗。例如，某些罕见疾病的患者，由于国内缺乏有效的治疗药物，不得不寻求境外药品。在这些案例中，患者通过合法途径获取药物，按照规定进行申报，通常能够顺利入境并使用药物。

专业机构的建议

医疗机构和法律专家建议，患者在进口药品之前，最好咨询专业人士，了解最新的法律法规和政策。同时，可以寻求正规渠道，如通过国家批准的临床试验、医师临床用药申请等方式获得所需药物。

如何降低风险

• 提前了解法规：仔细阅读《药品管理法》及相关规定，确保自己的行为符合法律要求。
• 保留所有文件：保存所有与药品相关的文件，包括处方、购买凭证、物流信息等。
• 选择合法渠道：通过正规、合法的渠道购买药品，避免购买假冒伪劣产品。
• 与海关沟通：如有疑问，可提前与海关部门联系，了解申报流程和要求。

政策的未来发展

随着社会对进口自用药品需求的增加，以及对患者权益的重视，相关政策可能会进一步完善。例如，建立特殊药品的绿色通道，加快国外新药在国内的审批进程等。这些措施都有助于患者合法、便捷地获得所需的救命药物。

结论

个人进口未在中国批准或供应的救命药物，需要在法律允许的范围内，遵循正确的程序和要求。患者应提高法律意识，积极主动地寻求合法途径，确保自身的健康权益得到保障。

参考资料

• 中华人民共和国药品管理法（2019年修订版）
• 中华人民共和国海关总署
• 中华人民共和国国家卫生健康委员会
• 国家知识产权局
• 国家药品监督管理局

本指南旨在为患者提供有益的信息，帮助其在法律框架内获取必要的医疗资源。如需进一步了解，请咨询专业的医疗和法律人士。

English version

Requirements for Importing Life-Saving Medicines for Personal Use into China That Are Unapproved or Unavailable in China

With the advancement of the global pharmaceutical industry, numerous new and effective medicines are being launched abroad. However, due to approval processes and supply channels, these medicines may not yet be approved or available in China. For patients who require these life-saving medicines, understanding how to legally import them for personal use becomes crucial. According to the "Drug Administration Law of the People's Republic of China" (2019 revision), there are specific requirements and procedures for individuals importing such medicines.

Background to the Revision of the Drug Administration Law

On August 26, 2019, the 12th Meeting of the Standing Committee of the 13th National People's Congress revised the Drug Administration Law, with the new law taking effect on December 1, 2019. This revision emphasized a people-centered approach to health, strengthened supervision over the entire lifecycle of drugs, increased penalties for illegal activities, and introduced new provisions regarding individual drug importation.

Legal Framework for Personal Use Drug Importation

Under the revised law, importing unapproved drugs is considered importing fake drugs. However, the law also considers special circumstances, providing some leniency for individuals carrying small quantities of drugs from abroad for personal use in treating diseases. In practice, patients importing life-saving medicines not available in China for personal use are allowed under certain conditions.

Definition of Reasonable Quantity

The law does not explicitly define the specific amount of "small quantities," but it is generally understood to be limited to what is needed for personal treatment and should not exceed the dosage required for a normal treatment course. Carrying excessive amounts may be suspected of intent to sell or distribute, thus violating legal provisions.

Proof of Medical Necessity

Patients need to provide a diagnosis certificate issued by a regular medical institution, stating that they have a specific disease requiring treatment with the life-saving medicine not approved in China. The certificate should include the doctor's signature, the medical institution's seal, and detailed diagnosis and treatment recommendations.

Legal Source of Medicines

The imported medicines should come from legitimate channels, such as legally registered pharmacies or hospitals abroad. When purchasing, patients should retain purchase receipts, medicine instructions, and other documents that can prove the legitimacy of the medicines.

Customs Declaration and Inspection

Upon entry, patients should proactively declare the medicines carried to customs and submit relevant documents such as diagnosis certificates and purchase receipts. Customs will inspect the medicines according to laws and regulations and decide whether to allow entry.

Legal Risks and Penalties

Although the law provides some leniency for personal use drug importation, violating relevant regulations may entail the following risks:

• Confiscation of Medicines: Customs has the authority to confiscate undeclared or non-compliant medicines.
• Administrative Penalties: Individuals may face fines, and in severe cases, more stringent administrative penalties.
• Criminal Liability: If deemed to involve smuggling or selling fake drugs, individuals may face criminal charges.

Analysis of Practical Cases

In recent years, some patients have imported new overseas medicines through personal channels for self-treatment. For example, patients with rare diseases may need overseas medicines due to the lack of effective treatments domestically. In these cases, patients who obtain medicines through legal means and declare them as required can usually enter the country smoothly and use the medicines.

Recommendations from Professional Institutions

Medical institutions and legal experts recommend that patients consult professionals before importing medicines to understand the latest laws, regulations, and policies. Additionally, they can seek legitimate channels, such as participating in nationally approved clinical trials or applying for physicians' clinical use of unapproved drugs to obtain necessary medicines.

How to Reduce Risks

• Understand Regulations in Advance: Carefully read the Drug Administration Law and related provisions to ensure compliance.
• Keep All Documents: Retain all documents related to the medicines, including prescriptions, purchase receipts, and shipping information.
• Choose Legal Channels: Purchase medicines through regular, legal channels to avoid counterfeit products.
• Communicate with Customs: If in doubt, contact customs authorities in advance to understand declaration procedures and requirements.

Future Policy Developments

With the increasing demand for imported personal-use medicines and the emphasis on patient rights, related policies may be further refined. For example, establishing special channels for particular medicines and accelerating the domestic approval process for new foreign drugs. These measures help patients legally and conveniently obtain the necessary life-saving medicines.

Conclusion

Importing life-saving medicines that are unapproved or unavailable in China for personal use requires adhering to legal allowances and following correct procedures and requirements. Patients should raise their legal awareness and proactively seek legitimate means to ensure their health rights are protected.

References

• Drug Administration Law of the People's Republic of China (2019 Revision)
• General Administration of Customs of the People's Republic of China
• National Health Commission of the People's Republic of China
• China National Intellectual Property Administration
• National Medical Products Administration

This guide aims to provide beneficial information to patients, assisting them in obtaining necessary medical resources within the legal framework. For further information, please consult professional medical and legal personnel.