China Veterinary Institutions – New Measures for Regulating the Industry – China Briefing

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, plus 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.  

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On September 7, 2022, the Ministry of Agriculture plus 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 steps, 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 vet services industry is permitted for foreign businesses in China, and “veterinary and pet nutrition research plus technical services” in the Catalogue of Encouraged Industries with regard to Foreign Investment (Edition 2022) (Exposure Draft) .

The particular measures will come into effect on October 1, 2022, and replace the prior Measures for the Administration associated with 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 therapy clinics, hospitals, and institutions.

Who do the measures apply to?

The measures apply to organizations that engage in animal diagnosis and treatment within the territory of the PRC.

“Animal diagnostics and treatment” refers to activities such as the avoidance, 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 regarding animal diagnosis and treatment, among others.

“Animal clinics”, meanwhile, includes pet hospitals, clinics, and other institutes that offer animal diagnosis plus treatment services.

Requirements for veterinary establishments

All institutions engaged in animal diagnosis and treatment activities are required to obtain a license, and are only allowed to carry out these activities within the prescribed scope of analysis and treatment activities.

There are a series of logistical requirements that institutions must meet to be permitted to engage in animal diagnosis plus treatment. To be eligible for this license, the institutions must:

1. Have a fixed animal diagnosis and treatment facility which complies with the regulations of the local agricultural and rural departments.
2. Be located at least 200 meters away from animal breeding farms, animal slaughtering plus processing places, and animal markets.
3. It has functional areas such as medical diagnosis and treatment rooms, isolation rooms, and pharmacies with reasonable layout.
4. Have equipment for diagnosis, disinfection, refrigeration, routine testing, sewage treatment, and so on.
5. Have temporary storage and treatment facilities intended for diagnostic and treatment waste, and entrust professional therapy institutions to handle the waste materials.
6. It has quarantine control measures and facilities for animals infected or suspected of infection.
7. Employ at least one licensed veterinarian capable of animal analysis and treatment.
8. 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 plus harmless treatment.

The measures implement slightly stricter measures to get 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 certified veterinarians.
• Have equipment such as X-ray or even B-ultrasound machines.
• Have an operating room plus surgical equipment.

Only animal hospitals are permitted to carry out cranial, thoracic, and abdominal surgery on animals.

Obtaining a license to carry out pet diagnostics and treatment

To get permission to interact 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 even municipal level, the certificate-issuing authority will be the agricultural plus 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:

1. Application form for the animal diagnosis and treatment license
2. A geographical orientation map, indoor floor plan and layout plan of each functional area of the facility
3. Certificate of the right to use the facility
4. Identity certificate from the legal representative (person within charge)
5. Qualification certificate of the practicing veterinarian(s)
6. List of services and equipment
7. 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 particular scope of permitted medical diagnosis and treatment activities, the location of the practice and the legal representative, and other matters. Institutions are required to apply for a separate permit 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.

Pet 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 summarize a series of requirements for the procedure of veterinary institutions. These include requirements include:

• Placing diagnosis plus 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 plus 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, when 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 pen control measures and amenities for animals infected with a disease, as well as waste administration and disposal systems and facilities. Under the measures, vet 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 plus rural affairs or disease prevention and control division. 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 particular 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, plus animal pathological tissues in accordance with national regulations.

Normal waste from veterinary activities must be disposed of according to the Regulations on the Management associated with Medical Waste issued by the Ministry of Ecology and Environment (MEE).

Veterinary institutions are required to support training veterinarians in carrying out pet 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, plus 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 actions defer to provisions from the Pet 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 Legislation states that anyone engaging in animal diagnosis and treatment without the requisite license will be ordered in order to cease all relevant actions, have all illegally obtained income confiscated, and fined between one and three times the amount of the illegally obtained earnings. If the illegally obtained revenue 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 procedures:

• Engaging in animal diagnosis and therapy activities outside of the scope associated with diagnosis and treatment routines approved by the animal diagnosis plus treatment license.
• Changing the place of practice and the scope of analysis and treatment activities without having re-applying for an animal medical 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, plus 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 associated with animal diseases, the organization will be fined RMB 10, 000 to RMB 50, 000 (US$7, 014) plus, if the circumstances are serious, have its license revoked.

Paragraph one of Article 106 says that anyone who engages in commercial animal diagnosis and therapy activities without filing as a practicing veterinarian will be purchased 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 ten, 00 to RMB fifty, 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 plus 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 even issues relevant certification documents for animal diagnosis and treatment.
• A student participating in teaching practice or a graduate participating in work exercise conducts animal diagnosis plus treatment activities without the guidance of a licensed veterinarian.

The measures also state that veterinary organizations 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 establishments and individuals that commit any of the following acts will be ordered to make corrections and may become fined up to RMB 10, 000:

• Failing to report an infected animal or pet with a suspected infection, or even failing to take control steps 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 pet disease monitoring, testing, plus 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 mating, slaughtering, business operation, remoteness, 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 ten, 000 to RMB 50, 000 and may be purchased to suspend business.

Violations of provisions of the measures

In addition to the violations of procedures of the Animal Epidemic Prevention Law , there are specific penalties for violations of articles in the actions.

Violations of Articles 6, 7, and 8, which outline lawful requirements for veterinary institutions, clinics, and hospitals detailed above, will result in a warning from the competent agricultural plus rural departments of the local people’s governments, as well as a good order to make the relevant modifications. If the prescribed conditions are not met after the time limit is up, the original authority that issued the institution’s license will certainly 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 organization or legal representative with out 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 pertaining to practicing veterinarians as required, or fails to keep medical record files as needed.
• Employs a licensed veterinarian who has not registered with the institution to engage in animal diagnosis and therapy activities.

Significance of the measures on China’s pet medicine and veterinary industry

There is huge potential for vet institutions to spread across China as more and more people begin to keep pets.   Vet services are the second largest segment in China’s billion-dollar pet industry after dog 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 organizations will also help to guide the development of the veterinary industry and ensure quality and consistency.

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