China Releases Measures for Management of Veterinary Institutions
The rural and agricultural department has released new measures for regulating China veterinary institutions, which will help to ensure clinics meet certain standards and improve the quality of services. The measures outline the requirements for qualifications, equipment, and facilities and clarify obligations for veterinary practitioners and institutions in disease prevention and control. We outline how institutions can obtain a license to operate in this growing space and the legal liabilities for non-compliance.
On September 7, 2022, the Ministry of Agriculture and Rural Affairs (MARA) released the Measures for the Administration of Animal Clinics (the “measures”), a new set of administrative measures governing animal clinics and medicine in China. The measures, which seek to standardize animal diagnosis and treatment and safeguard public health and security, are based on China’s pre-existing Animal Epidemic Prevention Law, which was last revised in 2021.
The new measures mark another step in improving and standardizing China’s veterinary service industry at a time when pets are exploding in popularity. In addition, participating in the veterinary services industry is permitted for foreign businesses in China, and “veterinary and pet nutrition research and technical services” in the Catalogue of Encouraged Industries for Foreign Investment (Edition 2022) (Exposure Draft).
The measures will come into effect on October 1, 2022, and replace the prior Measures for the Administration of Animal Clinics first passed in 2008.
For the purposes of this article, the term “veterinary institutions” is used to refer to all types of animal diagnosis and treatment clinics, hospitals, and institutions.
Who do the measures apply to?
The measures apply to institutions that engage in animal diagnosis and treatment within the territory of the PRC.
“Animal diagnostics and treatment” refers to activities such as the prevention, diagnosis, and treatment of animal diseases, and animal sterilization operations. This activity includes animal health checks, sampling, autopsy, dispensing, drug administration, acupuncture, surgery, filling in of medical certificate and issuing relevant certification documents for animal diagnosis and treatment, among others.
“Animal clinics”, meanwhile, includes animal hospitals, clinics, and other institutes that offer animal diagnosis and treatment services.
Requirements for veterinary institutions
All institutions engaged in animal diagnosis and treatment activities are required to obtain a license, and are only permitted to carry out these activities within the prescribed scope of diagnosis and treatment activities.
There are a series of logistical requirements that institutions must meet to be permitted to engage in animal diagnosis and treatment. To be eligible for a license, the institutions must:
- Have a fixed animal diagnosis and treatment facility which complies with the regulations of the local agricultural and rural departments.
- Be located at least 200 meters away from animal breeding farms, animal slaughtering and processing places, and animal markets.
- It has functional areas such as diagnosis and treatment rooms, isolation rooms, and pharmacies with reasonable layout.
- Have equipment for diagnosis, disinfection, refrigeration, routine testing, sewage treatment, and so on.
- Have temporary storage and treatment facilities for diagnostic and treatment waste, and entrust professional treatment institutions to handle the waste.
- It has quarantine control measures and facilities for animals infected or suspected of infection.
- Employ at least one licensed veterinarian capable of animal diagnosis and treatment.
- Have complete management systems for diagnosis and treatment services, epidemic reporting, health and safety protection, disinfection, isolation, temporary storage of diagnosis and treatment waste, veterinary equipment, veterinary prescriptions, drugs and harmless treatment.
The measures implement slightly stricter measures for institutions classified as “animal clinics” and “animal hospitals”. Animal clinics, in addition to the above requirements, must meet the two following conditions:
- Employ at least two licensed veterinarians.
- Have an operating room and surgical equipment.
Animal hospitals, meanwhile, are required to:
- Employ at least three licensed veterinarians.
- Have equipment such as X-ray or B-ultrasound machines.
- Have an operating room and surgical equipment.
Only animal hospitals are permitted to carry out cranial, thoracic, and abdominal surgery on animals.
Obtaining a license to carry out animal diagnostics and treatment
To get permission to engage in animal diagnostics and treatment, institutions must file an application with the license-issuing authority in the jurisdiction in which the facility is located. The license-issuing authority is the nearest municipal or county-level agricultural and rural department. If there is no such department at the county or municipal level, the certificate-issuing authority will be the agricultural and rural department at the next higher administrative level. Application and issuing of the license are free of charge.
The following materials must be submitted in the application:
- Application form for the animal diagnosis and treatment license
- A geographical orientation map, indoor floor plan and layout plan of each functional area of the facility
- Certificate of the right to use the facility
- Identity certificate of the legal representative (person in charge)
- Qualification certificate of the practicing veterinarian(s)
- List of facilities and equipment
- Text detailing the management system
The relevant authorities will review the documents within 15 days of receiving the application and issue a license if all the requirements are met.
The license will state the name of the institution, the scope of permitted diagnosis and treatment activities, the location of the practice and the legal representative, and other matters. Institutions are required to apply for a separate license if they want to set up a branch institution, or if they change the scope of their activities, location of the facilities, and other matters.
Animal diagnosis and treatment institutes must use standardized names, and cannot use terms such as “animal clinic” or “animal hospital” without obtaining relevant permission.
Management rules for the operation of veterinary institutions
The measures outline a series of requirements for the operation of veterinary institutions. These include requirements include:
- Placing diagnosis and treatment licenses in a prominent position in the facility and publicizing the basic information of the veterinary practitioners.
- Using standardized medical records indicating the name of the institution, including outpatient medical records and inpatient medical records.
- Retaining medical record files for a period of at least three years.
- Providing prescription paper that complies with the veterinary prescription formats and application specifications stipulated by MARA for practicing veterinarians.
- Setting up dedicated areas for activity such as the sale of pet supplies and pet food, pet grooming, and pet foster care that is separate from the veterinary services area, if they engage in these activities concurrently.
Disease prevention and control responsibilities of veterinary institutions
As mentioned in the previous section, veterinary institutions are required to have quarantine control measures and facilities for animals infected with a disease, as well as waste management and disposal systems and facilities. Under the measures, veterinary institutions are also obligated to take certain measures to prevent the spread of disease should an infected animal be discovered at the institution.
If a veterinary institution finds that an animal is infected with a disease or is suspected of having an infection, it must report the case to the local agricultural and rural affairs or disease prevention and control department. It must also immediately take measures, such as quarantining and isolating the animal and disinfecting the area.
If an animal is found to have a disease that by law requires it to be culled, the veterinary institution may not provide treatment to the animal without authorization. The veterinary institution is required to dispose of infected animals, along with their excrement, pollutants, and animal pathological tissues in accordance with national regulations.
Normal waste from veterinary activities must be disposed of in accordance with the Regulations on the Management of Medical Waste issued by the Ministry of Ecology and Environment (MEE).
Veterinary institutions are required to support practicing veterinarians in carrying out animal epidemic prevention, control, and eradication, and are permitted to
Veterinary institutions are also required to conduct regular training for staff on matters related to biosafety, policies, and regulations.
Liabilities for breach of the administrative measures
Violations of provisions of the Animal Epidemic Prevention Law
Several of the penalties for violations of the measures defer to provisions of the Animal Epidemic Prevention Law, issued by the MEE.
The applicable provisions in the Animal Epidemic Prevention Law are Paragraphs 1 and 2 of Article 105, Paragraph 1 of Article 106, and Article 108.
Paragraph 1 of Article 105 of the Animal Epidemic Prevention Law states that anyone engaging in animal diagnosis and treatment without the requisite license will be ordered to cease all relevant activities, have all illegally obtained income confiscated, and fined between one and three times the amount of the illegally obtained income. If the illegally obtained income amounts to less than RMB 30,000 (US$4,209), a fine of RMB 3,000 (US$421) to RMB 30,000 will be imposed.
Specifically, this fine will be imposed for the following violations of the measures:
- Engaging in animal diagnosis and treatment activities outside of the scope of diagnosis and treatment activities approved by the animal diagnosis and treatment license.
- Changing the place of practice and the scope of diagnosis and treatment activities without re-applying for an animal diagnosis and treatment license.
- Using forged, altered, assigned, leased, or borrowed animal diagnosis and treatment licenses.
Meanwhile, Paragraph 2 of Article 105 of the Animal Epidemic Prevention Law states that animal diagnosis and treatment institutions that fail to implement hygiene and safety protection, disinfection, isolation, and disposal of diagnosis and treatment waste will be ordered to make corrections and fined RMB 1,000 (US$140) to RMB 10,000 (US$1,402). If the violation causes the spread of animal diseases, the institution will be fined RMB 10,000 to RMB 50,000 (US$7,014) and, if the circumstances are serious, have its license revoked.
Paragraph 1 of Article 106 states that anyone who engages in commercial animal diagnosis and treatment activities without filing as a practicing veterinarian will be ordered to cease all related activities, have all illegal gains confiscated, and be fined RMB 3,000 to RMB 30,000. In addition, the institution in which they work will be fined RMB 10,00 to RMB 50,000.
Specifically, the following behavior, as outlined in the measures, may result in the above punishment:
- A practicing veterinarian engages in animal diagnosis and treatment activities outside of the county or practice scope filed in the records.
- A practicing veterinarian continues to engage in animal diagnosis and treatment activities during a period in which they have been ordered to suspend such activities
- A licensed assistant veterinarian fails to carry out surgical activities as required, issues prescriptions, fills in diagnosis certificates, or issues relevant certification documents for animal diagnosis and treatment.
- A student participating in teaching practice or a graduate participating in work practice conducts animal diagnosis and treatment activities without the guidance of a licensed veterinarian.
The measures also state that veterinary institutions that fail to report animal diagnosis and treatment activities as required will be punished in accordance with Article 108 of the Animal Epidemic Prevention Law. This article states that institutions and individuals that commit any of the following acts will be ordered to make corrections and may be fined up to RMB 10,000:
- Failing to report an infected animal or animal with a suspected infection, or failing to take control measures such as isolation.
- Failing to provide information related to animal epidemic prevention.
- Refusing or hindering the supervision and inspection by the competent agricultural and rural departments.
- Refusing or hindering animal disease prevention and control institutions from conducting animal disease monitoring, testing, and evaluation.
- Refusing or obstructing official veterinarians from performing their duties according to law.
The above violations apply to institutions and individuals engaged in animal disease research, diagnosis and treatment, animal breeding, slaughtering, business operation, isolation, and transportation, as well as animal product production, business operation, processing, storage, and harmless treatment.
Those who refuse to make the requisite corrections will be fined RMB 10,000 to RMB 50,000 and may be ordered to suspend business.
Violations of provisions of the measures
In addition to the violations of provisions of the Animal Epidemic Prevention Law, there are specific penalties for violations of articles in the measures.
Violations of Articles 6, 7, and 8, which outline legal requirements for veterinary institutions, clinics, and hospitals detailed above, will result in a warning from the competent agricultural and rural departments of the local people’s governments, as well as an order to make the relevant corrections. If the prescribed conditions are not met after the time limit is up, the original authority that issued the institution’s license will withdraw it.
In addition, if a veterinary institution commits any of the following acts, the authorities will order it to remedy the situation within a certain time limit and impose a fine of RMB 1,000 to RMB 5,000 (US$701):
- Changes the name of the institution or legal representative without going through the change procedures.
- Fails to place the animal diagnosis and treatment licenses in a prominent place in the facility or to publicize the basic information about their practitioners.
- Fails to use standardized medical records or provide prescription paper for practicing veterinarians as required, or fails to keep medical record files as required.
- Employs a licensed veterinarian who has not registered with the institution to engage in animal diagnosis and treatment activities.
Significance of the measures on China’s pet medicine and veterinary industry
There is huge potential for veterinary institutions to spread across China as more and more people begin to keep pets. Veterinary services are the second largest segment in China’s billion-dollar pet industry after pet food and have significant room for growth even among existing pet owners as awareness of animal health increases.
The release of the new measures will help to standardize veterinary institutions, ensuring better care and services for pet owners and their pets. Clearer requirements for the different types of institutions will also help to guide the development of the veterinary industry and ensure quality and consistency.
China Briefing is written and produced by Dezan Shira & Associates. The practice assists foreign investors into China and has done so since 1992 through offices in Beijing, Tianjin, Dalian, Qingdao, Shanghai, Hangzhou, Ningbo, Suzhou, Guangzhou, Dongguan, Zhongshan, Shenzhen, and Hong Kong. Please contact the firm for assistance in China at firstname.lastname@example.org.
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