China is formulating new rules to bring the nation into line with developed countries. Wang Xiaodong reports.

Leading experts are working on a revision to a national regulation on the management of laboratory animals, which, if adopted, is expected to greatly improve the management and protection of the animals.

A draft of the new rules includes changes to the Regulation on the Management of Laboratory Animals, which was adopted in 1988, according to Sun Deming, chairman of the Welfare and Ethics Committee of the Chinese Association for Laboratory Animal Sciences, also known as CALAS, who is helping to formulate the new rules.

However, a number of areas of dispute still exist, according to Sun, who declined to provide further details such as when the new regulations, being overseen by the Ministry of Science and Technology, will come into force.

The Regulation on the Management of Laboratory Animals, a major guideline on the management of animals used in scientific testing, has been revised several times since it was enacted. It is primarily intended to ensure that animals used in laboratory experiments are of sufficiently high quality, in terms of health, to meet the demands of scientific research.

The regulation also includes a number of articles related to the animals' welfare, such as stipulations that the scientists conducting the experiments must "take good care of the animals and do not provoke or abuse them".

Other guidelines have also been introduced since 1988, including many related to the welfare of laboratory animals, such as conducting experiments on euthanized animals to minimize pain, providing the results of the experiments will not be affected.

In June 2014, the China Food and Drug Administration issued guidelines to allow domestic producers to market commonly used cosmetics, such as shampoos and perfumes, without the need for animal testing.

However, China still lags behind many countries in legislation to promote the welfare of laboratory animals, according to Yue Bingfei, director of the experimental animals division at the National Institutes for Food and Drug Control.

Although China has made great progress in the management of laboratory animals in recent years, a lack of laws and regulations has been a major obstacle to the prevention of violations, and has also reduced Chinese scientists' opportunities for international exchanges, Yue said.

About 20 million animals, mainly mice, are used in tests in China every year, he added.

The ministry said other animals, including rabbits, guinea pigs, dogs and monkeys, are also used.

According to Sun, from CALAS, the rapid development of biomedicine has resulted in large numbers of animals being used in a wide range of experiments, and their welfare is attracting increased attention from the public and animal rights groups.

"China should accelerate improvements to the legislation and management systems to regulate and maintain the interests of researchers and laboratory animals, and promote the sustainable development of animal welfare," he said.

Public outrage

The issue stirred public outrage in December in the wake of media reports that more than 10 dogs had been abandoned in a building at the Xi'an Medical University, in Xi'an, Shaanxi province. The dogs, which all bore scars from laboratory experiments, had been left to die.

In response, the university pledged to establish a special committee to intensify the management of laboratory animals and improve training for faculties and students. Several officials were also subjected to a range of punishments, including suspension from duty.

According to a statement by CALAS, the case showed that the university's researchers and students lacked sufficient know-ledge of the laws and regulations related to laboratory animals.

"We suggest all producers and users of laboratory animals provide strict training for their employees, improve management systems and strictly follow the national regulations," the statement said.

Sun said the case was an isolated incident, and pointed out that the abuse of laboratory animals has happened in many other countries.

"In general, most certified institutions in China adhere strictly to the welfare management rules for laboratory animals," he said.

Yue, from the institutes for food and drug control, said some internationally accepted practices and concepts, such as the "3Rs" - replacing and reducing the number of animals used in experiments, and refining the procedures to make them less painful - have been widely adopted across the country.

Huang Song, director of the Biological Resources Center at the National Institute of Biological Sciences in Beijing, said the institute's scientists must obtain approval from the Institutional Animal Care and Use Committee, comprising scientists from the institute and other establishments, before conducting experiments on live animals.

The environment for raising laboratory animals is carefully controlled to ensure better-quality research, so the temperature, humidity and even the air pressure in the hermetically sealed environments meet all national standards.

Laboratory animals possess specific characteristics that make them suitable for experiments that eventually benefit humans, Huang said.

For example, mice share many genetic similarities with humans, are easy to breed and have high rates of reproduction, making them the most commonly used mammals in laboratory experiments, he said.

Some animals, such as chimpanzees, share even greater similarities and live much longer than mice, so they can be used to test the long-term effects and potential damage of medicinal drugs, he said. However, their use is limited, partly because of the high cost of raising them, but also because their similarity to humans means researchers quickly develop emotional attachments to them, he added.

Qu Ping, deputy director of animal research at the institute, said about 40,000 mice, of more than 400 breeds, are raised every year for research into fields such as hepatitis B and lung cancer. They drink bacteria-free water and their food is produced especially for them, she said, adding that the institute has installed larger cages to ensure that each mouse has more room.

Jing Haijiang, who raises mice at the institute, said some are imported from, or donated by, other countries, such as the United States, while others are purchased from accredited breeding companies.

"The price of the mice varies greatly depending on their strain," he said. "Some, with rare characteristics, can cost as much as 200,000 yuan ($30,000) each."

Qu said that when an experiment is completed, all the animals are humanely destroyed. For example, mice are anaesthetized before being painlessly killed with carbon dioxide. Their bodies are stored in a large fridge before being transported and disposed of by certified companies, she said.

Huang, director of the Biological Resource Center, said the animals deserve respect. "We should treat laboratory animals well because they are being sacrificed for the well-being of human beings."

Sun, from CALAS, said animal protection is closely linked to a nation's general development and the education of its people. Simply relying on laws and regulations will not be enough to ensure the welfare of laboratory animals.

"They are totally defenseless in front of man," he said. "However, a normal person with a shred of decency would never abuse them."

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