We are a student team from Dalian University of technology. During the process of studying phages, we found that the domestic phage therapy has not been well developed yet while it has formed an industrial chain at abroad. Through research and interviews among specialists, we believe that phages would and should be applied in internal medical treatment near future due to its advantages that antibiotics does not have. Thus, we suggest that the relevant laws of bacteriophage medicine should be improved as soon as possible in order to pave the way for the development and industrialization of phage therapy in China.
1 The urgent need to develop and improve the related laws and regulations
1.1 The prospect of bacteriophages
Antibiotic therapy is the mainstream solution to the bacterial infection in China at present. However, with the increasing antibiotic resistance, we need another method to deal with superbacterias. Current studies have showed that bacteriophages can lyse host bacteria with high specificity and do not infect the body’s owe cell. This provides the possibility for phage therapy. Phage therapy has not been used in clinical practice because of the existence of toxin gene with toxic effect, the narrow spectrum and bioethics, etc. But this problem can be solved through the follow-up research.
Phage therapy has begun to take shape at abroad. At current, Georgia, Poland, Russia, Belgium, the Netherlands, the United States and other countries devote great effort to phages to promote the application of phage therapy while many countries have legislated to ensure the proper use of phage therapy. In 2017, the FDA (US Food and Drug Administration) mentioned bacteriophage drugs will be considered in a regulatory approach similar to vaccines at a seminar on bacteriophage therapy mentioned that bacteriophage drugs would be considered to be included in the regulatory approach similar to vaccines, that is, to modify the phage composition of the product when necessary (such as when resistance occurs) without the need for clinical trial and declaration. Phage will become a legal bacterial drug that can rapidly evolve to respond to antibiotic resistance to the original drug recipe with advantages over traditional antibiotics if the regulation is established. Besides, FDA has provided green channels for phage drugs for clinical use in emergency situations. For example, in 2019, the first clinical trial of intravenous phage therapy in the US was approved by the FDA while Phase 1 and 2 mainly evaluate the safety, tolerance and efficacy of phages.
However, EMA (European Medicines Agency) believes that any currently existing drug regulatory are not suitable for phage therapy while it need a special one. In general, Europe is more open and optimistic about phage therapy. The European Union has funded a multinational center clinical research program for phage therapy (Phagoburn Project). Scientists in France, Belgium and the Netherlands also conducted clinical trials of phage therapy in burn patients infected with Pseudomonas aeruginosa and Escherichia coli. In addition, we can see from EMA's Seminar on phage therapy application held in June 2015, EMA encourages drug developers and regulators to continue to work on how the regulatory framework supports and provides appropriate flexibility for upcoming phage tests and studies. All in all，the positive attitude these countries hold towards phage research also proves that phage therapy has the hope and potential to develop in China with an adequate medical system.
1.2 The domestic management and control of phage therapy in China
There are quite a number of companies in the field of phage or phage lyase (belonging to enzyme biopharmaceutical ) at abroad, due to the relatively clear regulatory path and open communication mechanism. These phage companies have a wide range of treatment study, including systemic infection, skin infection and gastrointestinal tract infection. In addition, these companies are very active in the field of cooperation and financing, and continue to attract the attention of investors and peer companies. In contras, the clinical trials of phage therapy have not been carried out yet in China because of the imperfect regulation of phage drugs. Only A few companies such as Phagelux, Dalian Hissen and Shanghai Hi-Tech-Bio are developing human phage therapy preparations. In this process of continuous. Among them, no company have disclose their progress except Phagelux.
2 The urgent need for NPC Standing Committee to issue relevant laws and regulations on bacteriophage therapy
2.1 The introduction of phage therapy related laws is in line with the short-term goal of the NPC Standing Committee.
According to the 2020 work report of the NPC Standing Committee (National People's Congress Standing Committe), affected by the epidemic situation, this year NPC Standing Committee will focus more on the field of public health. In particular, it will attach great importance to strengthening the legislation and revision of the law on legal protection of public health. For example, the basic medical and health promotion law, the vaccine management law and the drug administration law have been formulated. Bacteriophages, as a potential bacterial infection therapy in the next few decades, is an important aspect in strengthening public health.
2.2 The introduction of relevant laws on bacteriophage therapy is conducive to the standardization of the application of evidence rules in the arbitration and litigation stages of bacteriophage therapy related cases.
We think, the laws promulgated by the NPC Standing Committee can be applied to the whole country and can be used as the basis for the court to decide directly. We suggests that a special law for bacteriophage therapy should be established in China to avoid the loss of credibility of arbitration award or court award due to the inconsistency of arbitration and litigation award standards. Also, if laws and regulations are promulgated by other relevant departments, the order of application in law is lower than that promulgated by the NPC Standing Committee.
2.3 The law on phage therapy issued by the NPC Standing Committee can be more authoritative.
The NPC Standing Committee, as a permanent organ of the highest legislature in China, enjoys the highest legislative power. So the revised bill on phage therapy made by NPC Standing Committee can be applied nationwide, which will supply a gap of the law related to bacteriophages.
3 Conception of the draft related to bacteriophage therapy
3.1 Sorting out he existing laws
At present, there is a gap in laws related to bacteriophage pharmacy in China. We have collected the domestic and foreign laws and obtained some inspiration from the GMP(Good Manufacturing Practice) law issued by the EU. We have consulted experts at home and abroad who study in phage pharmaceutical and clinical, and their suggestions will serve as a supplement.
Good Manufacturing Practice,
3.2 Draft concept
Chapter I General Principles
Article 1
In order to strengthen the clinical application management of bacteriophage drugs in medical institutions, standardize the clinical application behavior of drugs, improve the clinical application level of bacteriophage drugs, promote the rational clinical application of bacteriophage drugs, and ensure the medical quality and medical safety, these measures are formulated in accordance with relevant domestic and foreign health laws and regulations.
Article 2
The Ministry of health is responsible for the supervision and management of the clinical application of bacteriophage drugs in medical institutions throughout the country. The local health administrative departments at or above the county level shall be responsible for the supervision and management of the clinical application of bacteriophage drugs in medical institutions within their respective administrative areas.
Article 3
The measures are applicable to the clinical application and management of bacteriophage drugs in various medical institutions at all levels.
Article 4
The clinical application of bacteriophage drugs should follow the principles of safety, effectiveness and economy.
Chapter II Organization and Responsibilities
Article 5
The main person in charge of the medical institution is the first person responsible for the clinical application and management of bacteriophage drugs.
Article 6
Medical institutions shall establish their own bacteriophage drug management system.
Article 7
A medical institution shall set up a bacteriophage drug administration institution or assign full-time (Part-time) personnel to be responsible for the bacteriophage drug management of the medical institution. Hospitals at or above the second level, maternal and child health care centers and specialized disease prevention and control institutions (hereinafter referred to as hospitals at or above the second level) shall set up a phage drug management working group under the pharmaceutical administration and pharmacotherapeutics Committee. The bacteriophage drug management working group is composed of persons in charge of medical, pharmaceutical, infectious diseases, clinical microbiology, nursing, hospital infection management and other departments as well as personnel with relevant professional senior technical post qualifications. The medical and pharmaceutical departments are jointly responsible for the daily management. Other medical institutions shall set up phage drug management working groups or appoint full-time (Part-time) personnel to be responsible for specific management.
Article 8
The main responsibilities of phage drug management institutions or full-time (Part-time) personnel in medical institutions are: (1) to implement the laws, regulations and rules related to bacteriophage drug management, and to formulate and implement the phage drug management system of the institution; (2) To review the list of bacteriophage drug supply in our institution, formulate and implement relevant technical documents for clinical application of bacteriophage drugs (3) to monitor the clinical application of bacteriophage drugs and bacterial drug resistance in our institution, regularly analyze, evaluate and report the monitoring data and release relevant information, and put forward intervention and improvement measures; (4) Medical staff were trained in the laws, regulations, rules and regulations and technical specifications related to phage drug management, and publicity and education on rational use of phage drugs were organized.
Article 9
Hospitals at or above the second level shall set up infectious diseases department and be equipped with infectious disease specialists. The infectious diseases department and infectious diseases professional doctors are responsible for the technical guidance of the clinical application of bacteriophage drugs in the clinical departments of the institution, and participate in the clinical application management of bacteriophage drugs.
Article 10
Hospitals at or above the second level shall be equipped with clinical pharmacists of bacteriophage medicine and other related specialties. Clinical pharmacists are responsible for providing technical support for the clinical application of phage drugs in our institution, guiding patients to use phage drugs rationally, and participating in the management of clinical application of bacteriophage drugs.
Article 11
Hospitals at or above the second level shall, according to actual needs, establish clinical bacteriophage laboratories that meet the requirements of laboratory biosafety. The bacteriophage laboratory cooperates with the original clinical microbiology laboratory to test the reliability of bacteriophage drugs and participate in the clinical application management of bacteriophage drugs.
Article 12
Health administrative departments and medical institutions should strengthen the construction of relevant disciplines related to the clinical application and management of bacteriophage drugs, establish professional personnel training and assessment system, and give full play to the role of relevant professional and technical personnel in the management of clinical application of bacteriophage drugs.
Chapter III Clinical Application Management of Bacteriophage Drugs
Article 13
Medical institutions should strictly implement the relevant regulations and technical specifications such as Prescription Management Method, Regulations on Pharmaceutical Administration medical institution, and National Formulary, and strengthen the management of phage drug selection, procurement, prescription, dispensing, clinical application and drug evaluation.
Article 14
A medical institution shall, in accordance with the Hierarchical Management Catalogue of bacteriophage drugs formulated by the provincial health administrative department, formulate the phage drug supply catalogue of its own institution, and file it with the health administrative department which has issued the practicing license of medical institution. The phage drug supply list of medical institutions includes the varieties and specifications of phage drugs purchased. Medical institutions are not allowed to purchase bacteriophage drugs without being put on record.
Article 15
Medical institutions shall strictly control the number of varieties in the phage drug supply list of their own institutions. There should be no more than two kinds of bacteriophage drugs with the same general name, injection type and oral dosage form. Bacteriophage drugs with similar or identical pharmacological characteristics shall not be listed in the supply list repeatedly.
Article 16
If the variety and quantity of bacteriophage drugs exceed the prescribed quantity due to clinical work needs, the medical institution shall explain the reasons and reasons in detail to the administrative department of health which issued the practicing license of medical institution; if the explanation is not sufficient or the reason is not tenable, the administrative department of health shall not accept the record of the variety and quantity of bacteriophage drugs.
Article 17
Medical institutions shall regularly adjust the variety structure of bacteriophage drug supply catalogue, and file with the health administrative department which issued the license for medical institution within 15 working days after each adjustment. In principle, the adjustment period is 2 years, and the shortest period shall not be less than 1 year.
Article 18
Bacteriophage drugs in medical institutions shall be purchased and supplied by pharmaceutical departments in a unified manner, and other departments or departments shall not engage in purchasing and dispensing phage drugs. Bacteriophage drugs purchased and supplied by non pharmaceutical departments shall not be used clinically.
Article 19
If a medical institution needs to use bacteriophage drugs beyond the phage drug supply list due to special treatment needs, the temporary procurement procedure can be started. The clinical department shall submit an application for temporary purchase, stating the name, dosage form, specification, quantity, object of use and use reason of the bacteriophage drug to be purchased. After being examined and approved by the phage drug management working group of the institution, the pharmaceutical department shall purchase and use the bacteriophage drug temporarily for one-time use. Medical institutions should strictly control the varieties and quantity of temporary procurement of bacteriophage drugs. In principle, the temporary procurement procedure for the same generic bacteriophage drug variety should not exceed 5 times a year. If there are more than 5 cases, it should be discussed whether to be included in the phage drug supply list of our institution. The total number of phage drug supply list after adjustment should not be increased. Medical institutions shall report the temporary procurement of bacteriophage drugs to the administrative department of health that issued the license for medical institution every six months.
Article 20
Medical institutions shall establish a system for the selection and regular evaluation of bacteriophage drugs. For medical institutions to select and introduce new bacteriophage drugs, the clinical departments shall submit the application report, which shall be deliberated by the bacteriophage drug management working group after the pharmaceutical department puts forward opinions. More than two thirds of the members of the phage drug management working group shall be reviewed and approved by more than two thirds of the members of the pharmaceutical administration and pharmacotherapeutics committee before they can be included in the procurement and supply list. In case of potential safety hazard, uncertain curative effect, high drug resistance rate, poor cost performance ratio or illegal use of bacteriophage drugs in varieties or specifications, clinical departments, pharmaceutical departments and phage drug management working group can put forward opinions on the removal or replacement. The withdrawal opinions shall be implemented with the consent of more than half of the members of phage drug management working group and reported to the pharmaceutical administration and pharmacotherapeutics Committee for the record; the replacement opinions shall be implemented after being discussed and approved by the pharmacy administration and pharmacotherapeutics Committee. In principle, the returned or replaced bacteriophage drugs shall not be re entered into the phage drug supply list of the institution within 12 months in principle.
Article 21
Doctors with senior professional and technical post qualifications can be granted the right to prescribe bacteriophage drugs of special use level; doctors with intermediate or above professional and technical post qualifications can be granted the prescription right of restricted use level phage drugs; doctors with junior professional and technical post qualifications can independently engage in general practice activities in medical institutions of townships, nationality townships, towns and villages Licensed assistant doctors and rural doctors can grant the prescription right of non restricted use phage drugs. Only after the pharmacist has been trained and passed the examination, can he obtain the qualification of bacteriophage drug dispensing. Hospitals at or above the second level shall regularly train doctors and pharmacists on the clinical application knowledge and standardized management of bacteriophage drugs. Doctors can obtain the right of prescription only after they have been trained and passed the examination. Local health administrative departments at or above the county level shall organize relevant training and assessment for doctors, rural doctors and pharmacists engaged in prescription dispensing in other medical institutions. Those who have passed the examination shall be granted the corresponding prescription right of bacteriophage drugs or the qualification of bacteriophage drug dispensing.
Article 22
The training and assessment of bacteriophage clinical application knowledge and standardized management should include: (1) Relevant laws, regulations, rules and normative documents, such as Pharmaceutical Administration Law, Medical Practitioners, Prescription Management, Regulations on Pharmaceutical Administration medical institutions, National Essential Medicine Formulary, National Formulary, and Hospital Prescription Comments Standard Management (trial scheme), etc; (3) The pharmacological characteristics and precautions of commonly used bacteriophage drugs; (4) drug resistance trend and control methods of common bacteria; (5) prevention and treatment of adverse reactions of bacteriophage drugs.
Article 23
Medical institutions and medical personnel should strictly grasp the indications of using bacteriophage drugs to prevent infection. Non restricted use grade phage drugs should be the first choice for the prevention and treatment of mild or local infection; restricted grade phage drugs can only be used when severe infection, low immune function and complicated infection or pathogenic bacteria are only sensitive to restricted use level phage drugs.
Article 24
Strictly control the use of special grade phage drugs. Special use phage drugs should not be used in outpatient department. Clinical application of special use bacteriophage drugs should strictly grasp the medication indications. After consultation and consent of the professional and technical personnel designated by the phage drug management working group, the prescription should be issued by the physician with the corresponding prescription right. Special use level phage drug consultation personnel shall be doctors and pharmacists with senior professional and technical qualifications in infectious diseases department, respiratory department, critical medicine department, microbiological laboratory department and pharmaceutical department with experience in clinical application of bacteriophage drugs, or clinical pharmacists with senior professional and technical post qualifications.
Article 25
Because of the emergency such as rescuing critically ill patients, doctors can skip the level to use phage drugs. The use of bacteriophage drugs by leaps shall be recorded in detail, and the necessary procedures for leapfrog use of bacteriophage drugs shall be completed within 24 hours.
Article 26
Medical institutions should formulate and strictly control the proportion of bacteriophage drugs used in outpatient intravenous infusion. The use of bacteriophage drugs for intravenous infusion in village clinics, clinics and community health service stations shall be subject to the approval of the county health administrative department.
Article 27
Medical institutions should establish and strictly control the proportion of intravenous infusion of phage drugs in outpatients. The use of phage drugs in village clinics, clinics and community health service stations for intravenous infusion activities shall be approved by the county-level health administrative department.
Article 28
Medical institutions should carry out monitoring of the clinical application of phage drugs, analyze the use of phage drugs in their own institutions and clinical departments, and evaluate the suitability of phage drug use; the trend of phage drug use should be analyzed, and effective intervention measures should be taken in time to deal with the unreasonable use of phage drugs.
Article 29
Medical institutions shall rationally select phage drugs based on the results of clinical microbial specimen testing. Before the clinical microbiological specimen test results are issued, medical institutions can select phage drugs based on the local and the institution’s experience in bacterial resistance monitoring. After the clinical microbiological specimen test results are issued, corresponding adjustments will be made according to the test results.
Article 30
Medical institutions should carry out bacterial resistance monitoring, establish a bacterial resistance early warning mechanism, and take the following corresponding measures: (1) For phage drugs whose main target bacterial resistance rate exceeds 30%, the early warning information should be notified to the medical staff of the institution in a timely manner; (2) Phage drugs whose main target bacteria have a drug resistance rate of more than 40% should be used with caution; (3) Phage drugs whose main target bacteria have a drug resistance rate of more than 50% should be selected based on the results of drug susceptibility tests; (4) If the drug resistance rate of the main target bacteria exceeds 75%, the clinical application of phage drugs against the target bacteria shall be suspended, and the decision on whether to resume clinical application shall be made based on the monitoring results of tracking the bacterial resistance.
Article 31
Medical institutions shall establish a ranking, internal publicity and reporting system for the clinical application of phage drugs in their institution. Medical institutions shall rank the usage, utilization rate and intensity of phage drugs of clinical departments and medical staff and make internal public announcements. Criticize and educate physicians who are in the lower ranks or found serious problems in the application of phage drugs, and if the situation is serious, it shall be notified. Medical institutions shall summarize the clinical application of phage drugs in clinical departments and medical staff as required, and report to the health administrative department that issued its " Practice License for Medical Institution ". The clinical application of unrestricted grade phage drugs should be reported once a year. Clinical application of limited-use and special-use phage drugs is reported semiannually.
Article 32
Medical institutions should make full use of information technology to promote the rational application of phage drugs.
Article 33
Medical institutions should investigate the following abnormalities in the clinical application of phage drugs, and deal with them according to different situations: (1) Phage drugs with an abnormal increase in usage; (2) Phage drugs whose usage is always in the forefront within six months; (3) Bacteriophage drugs that are often used in excess of indications or doses; (4) Phage drugs illegally sold by enterprises; (5) Phage drugs with frequent serious adverse events.
Article 34
Medical institutions shall strengthen the management of the sales of phage drug production and operation enterprises in their institutions, and shall promptly take measures such as suspension of drug intake and withdrawal of enterprises with improper sales activities.
Chapter IV Supervision and Administration
Article 35
Health administrative departments at or above the county level shall strengthen the supervision and inspection of the clinical application of phage drugs in medical institutions within their respective administrative regions.
Article 36
The staff of the health administrative department shall present their certificates when conducting supervision and inspection of the clinical application of phage drugs in medical institutions in accordance with the law, and the inspected medical institutions shall cooperate and provide necessary information, and shall not refuse, obstruct or conceal.
Article 37
Local health administrative departments at or above the county level shall establish a system for ranking, publishing and admonishing the clinical application of phage drugs. Rank the usage, usage rate and intensity of phage drugs in medical institutions in this administrative region, and announce the ranking to medical institutions in this administrative region and report to the higher-level health administrative department for the record. For those who are heads of medical institutions at all levels or of various types that are involved in serious incidents or risks related to medical quality and safety, conduct admonishment conversations, and report them if the situation is serious.
Article 38
The county-level health administrative department is responsible for ranking and publicizing the usage and usage rate of phage drugs in township health centers and community health service centers (stations) within their jurisdiction. Entrusted by the county-level health administrative department, the township health center is responsible for ranking and publicizing the use of phage drugs in the village clinics within its jurisdiction, and reporting to the county-level health administrative department.
Article 39
The Ministry of Health should establish the National Bacteriophage Drug Clinical Application Monitoring Network and the National Bacterial Drug Resistance Monitoring Network to monitor the national clinical application of phage drugs and bacterial resistance. According to the monitoring situation, the clinical application control indicators of phage drugs are regularly announced, and the clinical application quality of phage drugs is carried out. Management and control work. Provincial health administrative departments shall establish a monitoring network for the clinical application of phage drugs and a monitoring network for bacterial resistance in their respective administrative regions, monitor the clinical application of phage drugs and bacterial resistance in medical institutions, and carry out quality management and control of the clinical application of phage drugs. The technical plan for the clinical application of phage drugs and the monitoring of bacterial resistance shall be separately formulated by the Ministry of Health.
Article 40
The health administrative department shall include the clinical application of phage drugs in medical institutions into the evaluation index system of medical institutions and regard the clinical application of phage drugs as important indicators for the classification, review, and evaluation of medical institutions. If the medical institutions fail to pass the assessment, the medical institutions shall be subject to demotion and the evaluation of disqualification.
Article 41
The phage drug management agency of medical institutions shall regularly organize relevant professional and technical personnel to comment on phage drug prescriptions and medical orders, and use the review results as the basis for regular evaluation of physicians, clinical departments and medical staff performance evaluation.
Article 42
Medical institutions should warn physicians who have overprescribed phage drugs more than 3 times without justifiable reasons, and limit the right to prescribe bacteriophage drugs of special use grade and restricted use grade.
Article 43
The medical institution shall cancel the prescription right of the doctor in any of the following circumstances: (1) The phage drug fails the examination; (2) After the prescription right is restricted, there is still an abnormal prescription without a justified reason; (3) Failing to prescribe phage drugs in accordance with relevant regulations, resulting in serious consequences; (4) Failure to use phage drugs in accordance with regulations, causing serious consequences; (5) Prescribing phage drug prescriptions for illegitimate benefits.
Article 44
If a pharmacist fails to review phage drug prescriptions and medication orders in accordance with the regulations, causing serious consequences, or discovers that the prescriptions are inappropriate, abnormal prescriptions, etc., and fail to intervene without proper reasons, the medical institution shall cancel the qualifications for drug dispensing.
Article 45
After the physician’s prescription right and the pharmacist’s qualification for drug dispensing are cancelled, the prescription right and qualification for drug dispensing may not be restored within six months.
Chapter V Legal Liability
Article 46
If a medical institution is under any of the following circumstances, the administrative department of health at or above the county level shall order it to make corrections within a time limit. If the correction is not made within the time limit, it shall be notified and criticized and given a warning. If serious consequences are caused, the responsible persons in charge and other persons directly responsible should be given sanctions: (1) Failing to establish a phage drug management organization or no designated full-time (part-time) technical personnel to be responsible for specific management work; (2) Failing to establish phage drug management regulations; (3) The management of the clinical application of phage drugs is disordered; (4) Failing to implement phage drug classification management, physician phage drug prescription authority management, pharmacist phage drug dispensing qualification management, or not equipped with relevant professional and technical personnel in accordance with the provisions of these Measures; (5) Other violations of the regulations.
Article 47
If a medical institution has one of the following circumstances, the administrative department of health at or above the county level shall order it to make corrections within a time limit, give a warning, and may impose a fine of less than 30,000 yuan on the basis of the seriousness of the circumstances. The person in charge who is responsible and other persons who are directly responsible may be punished according to the circumstances: (1) Prescriptions for phage drugs issued by physicians who have not obtained the right to prescribe phage drugs or by physicians who have had the right to prescribe phage drugs revoked; (2) The suitability of phage drug prescriptions and doctor orders has not been reviewed, and the results it caused are serious; (3) Non-pharmaceutical departments are engaged in the purchase and sale of phage drugs, and adjustment activities; (4) Linking the purchase and sale of phage drugs and their clinical application with the economic interests of the individual or the department; (5) Improper seeking in the purchase and sale of phage drugs and clinical application beneficial.
Article 48
Persons in charge of medical institutions, drug purchasers, physicians and other relevant personnel request or accept property given by drug manufacturers, drug distributors or their agents, or obtain illegitimate benefits by prescribing phage drugs, the local health administration department at or above the county level Dispose of in accordance with relevant national laws and regulations.
Article 49
If a physician has one of the following circumstances, the health administrative department at or above the county level shall, in accordance with the relevant provisions of Article 37 of the "Practicing Physician Law," give a warning or order a suspension of practice activities for more than six months but less than one year; if the circumstances are serious, it shall be revoked Its practice certificate. If a crime is constituted, criminal responsibility shall be investigated according to law: (1) Failing to prescribe phage drugs in accordance with the provisions of these Measures, causing serious consequences; (2) Using a phage drug that has not been approved by the state pharmaceutical supervisory and administrative department; (3) ) The use of varieties or product regulations that are not in the institution's phage drug supply catalogue causes serious consequences; (4) Violation of other provisions of these Measures, causing serious consequences. If a village doctor has one of the circumstances specified in the preceding paragraph, the county-level health administrative department shall deal with it in accordance with the relevant provisions of Article 38 of the Regulations on the Administration of the Practice of Rural Doctors.
Article 50
If a pharmacist has one of the following circumstances, the administrative department of health at or above the county level shall order a correction within a time limit and give a warning. If a crime is constituted, the pharmacist shall be investigated for criminal responsibility according to law: (1) Failing to review and adjust the prescription of phage drugs in accordance with the regulations, and the circumstances are serious;(2) Failing to privately increase the varieties or product regulations of phage drugs in accordance with the provisions; (3) Violating other provisions of these Measures.
Article 51
Those who use phage drugs for intravenous infusion in village clinics, clinics or community health service stations without the approval of the health administration department at the county level shall be ordered to make corrections within a time limit and given a warning by the local health administration department at or above the county level; If the offender does not change within the time limit, a fine of not more than 10,000 yuan may be imposed according to the seriousness of the case.
Article 52
If local health administrative departments at or above the county level fail to perform their supervisory duties in accordance with the provisions of these Measures, causing serious consequences, the directly responsible supervisors and other directly responsible personnel shall be given administrative sanctions such as demerit recording, demotion, dismissal, and expulsion.
Article 53
Medical institutions and their medical staff who violate the "Drug Administration Law" shall be dealt with in accordance with the relevant provisions of the "Drug Administration Law".
Chapter VI Supplementary Provisions
Article 54
The State Administration of Traditional Chinese Medicine shall be responsible for the supervision and management of the clinical application of phage drugs in TCM medical institutions within the scope of its duties.
Article 55
All provincial-level health administrative departments shall, within 3 months from the date of promulgation of these Measures, formulate a catalog for the hierarchical management of phage drugs in their respective administrative regions.
