Promulgated by: National Health and Family Planning Commission; State Administration of Traditional Chinese Medicine. Document No.: 国卫纠发〔2014〕1号. Adopted November 20, 2014. Effective January 1, 2015.
Article 1. These Provisions are formulated in accordance with the Notice on Issuing the “Nine Prohibitions” for Strengthening Conduct in the Healthcare Sector (Document No. 国卫办发〔2013〕49号) and relevant laws and regulations, in order to further standardize medical and health service conduct, strengthen industry ethics, strictly prohibit prescription-volume statistics (tongfang) for improper commercial purposes, and maintain normal working order.
Article 2. As used in these Provisions, “prescription-volume statistics (tongfang)” means the statistical compilation, by healthcare institutions, their departments, or healthcare personnel, of information on the volumes of drugs and medical consumables used by healthcare institutions, departments, or healthcare personnel, through certain methods and channels, based on work needs. “Tongfang for improper commercial purposes” means the compilation or provision, by healthcare institutions, their departments, or healthcare personnel, of information on the volumes of drugs or medical consumables used by healthcare institutions, departments, or healthcare personnel, for improper commercial purposes, or the provision of assistance to pharmaceutical marketers in conducting such compilation.
Article 3. Local health and family planning administrative authorities, traditional Chinese medicine administration authorities, and healthcare institutions of all levels and types shall establish and improve relevant working systems, strengthen the administration of prescription-volume statistics, and strictly prohibit tongfang for improper commercial purposes.
Article 4. The principal responsible person of a healthcare institution shall be the first responsible person for prescription-volume statistics administration within that institution. Healthcare institutions shall strengthen legal education for healthcare personnel, establish and improve廉洁 supervision systems for risk-sensitive posts, implement focused supervision and management over key links and positions involving tongfang, establish a system of regular rotation for personnel in key posts, and establish and implement systems of positional responsibility and accountability.
Article 5. Healthcare institutions shall strictly implement the Provisions on Establishing Adverse Records for Commercial Bribery in the Pharmaceutical Procurement and Sales Sector (Document No. 国卫法制发〔2013〕50号). In no form shall healthcare institutions provide pharmaceutical marketers, non-administrative-management authorities, or industry organizations not authorized by administrative-management authorities with information on the drug or medical-consumable usage volumes of individual healthcare personnel or departments; nor shall healthcare institutions provide convenience for pharmaceutical marketers to conduct such compilation.
Article 6. Drug and medical-consumable usage information that healthcare institutions provide to administrative-management authorities or industry organizations authorized thereby shall be institution-level aggregate information. When healthcare institutions provide drug or medical-consumable usage information, and when they apply such information in day-to-day management, they shall strictly implement relevant working systems to ensure information security at every stage.
Article 7. Healthcare institutions shall establish and improve management systems for information systems, and shall implement dedicated-person responsibility and encrypted management for statistical functions relating to drug and medical-consumable usage volumes and similar information within information systems.
Article 8. Healthcare institutions shall implement strict tiered management and approval procedures for access permissions to query drug and medical-consumable usage volumes and similar information through information systems. Information systems shall be configured with query-logging functions for important and sensitive information; query logs shall be established, periodically analyzed, and reviewed so that anomalies are identified and dealt with in a timely manner.
Article 9. Healthcare institutions shall enter into information-confidentiality agreements with information-technology personnel and entities that provide routine maintenance, upgrades, or installation of new systems or equipment for information systems, and shall set reasonable access permissions. Upon completion of work, external information-technology personnel and entities shall complete handover procedures to ensure that passwords, devices, technical documentation, and related sensitive information are transferred in accordance with prescribed procedures. Information-technology personnel and entities that obtain information for improper commercial purposes shall be dealt with in accordance with relevant laws, regulations, and the terms of business contracts, and corresponding liability shall be pursued.
Article 10. Healthcare institutions shall not link the income of healthcare personnel to the volumes of drugs or medical consumables used. Compilation of drug and medical-consumable usage volumes by healthcare personnel or departments shall not be used for prescription-based commission payments.
Article 11. Healthcare personnel shall not participate in tongfang activities in violation of relevant provisions, and shall not provide pharmaceutical marketers with information on drug or medical-consumable usage volumes or related information. Healthcare personnel are strictly prohibited from providing convenience to pharmaceutical marketers for conducting tongfang, or from acting as agents for pharmaceutical marketers in conducting tongfang in violation of relevant provisions.
Article 12. Health and family planning administrative authorities and traditional Chinese medicine administration authorities at all levels shall strengthen supervision and inspection, while fully leveraging the role of external supervision and inspection forces.
Article 13. Healthcare personnel who violate relevant provisions by engaging in tongfang for improper commercial purposes shall be dealt with seriously in accordance with law and discipline, and the violation shall be recorded in the adverse practice record system for physicians. Personnel who have not violated the Criminal Law shall, by the employing unit in accordance with relevant provisions, be given criticism and education, have their eligibility for performance awards and professional title advancement for that year cancelled, or be subject to demotion, deferred appointment, suspended appointment pending reassignment, or dismissal. Those suspected of criminal offences shall be referred to judicial authorities for handling.
Article 14. In respect of healthcare institutions that violate relevant provisions by engaging in tongfang for improper commercial purposes, health and family planning administrative authorities and traditional Chinese medicine administration authorities shall, in accordance with their jurisdiction and relevant provisions, give the institution a public criticism, require rectification within a time limit, or reduce its rating, depending on the seriousness of the tongfang conduct.
Article 15. Health and family planning administrative authorities and traditional Chinese medicine administration authorities at all levels shall, in conjunction with the establishment of an integrity-based professional credit management system for healthcare personnel, incorporate the violations of healthcare institutions and healthcare personnel into institutional calibration records and physicians’ adverse practice records, respectively, in accordance with relevant provisions.
Article 16. Local health and family planning administrative authorities, traditional Chinese medicine administration authorities, and healthcare institutions of all levels and types shall, pursuant to these Provisions and taking into account actual local and institutional conditions, study and formulate implementation measures.
Article 17. As used in these Provisions, “healthcare personnel” means management personnel, physicians, nurses, pharmaceutical technicians, medical technicians, information-department staff, and other relevant personnel within healthcare institutions.
Article 18. These Provisions shall come into force on January 1, 2015. The Notice on Strengthening the Administration of the Drug and High-Value Consumables Statistical Functions of Hospital Information Systems (Document No. 卫办医发〔2007〕163号), issued by the former General Office of the Ministry of Health on September 7, 2007, is hereby simultaneously repealed.