Issue Type: Biomedical Research

Humane Society International

Feeding a drug to a mouse
Manjurul/istock

SEOUL — Korean laboratory animal statistics published this week by the Ministry of Agriculture, Food and Rural Affairs revealed record-high animal use in 2018, and that one in every three animals in a Korean laboratory (38%) is subject to a chemical poisoning experiment – the most severe category of experiment, in which animals are denied pain relief. In total 3,727,163 rodents, rabbits, dogs, fish, monkeys and other animals were used in Korean experiments in 2018, an increase of 21% over the previous year.

The continued upward trend in animal use has been slammed by Humane Society International as a reflection of the ongoing failure of Korean product safety regulators and industry to use all available non-animal approaches to testing and assessment for chemicals and other products. Local demand for animal testing under the Korea Act on Registration and Evaluation, etc of Chemical Substances (K-REACH) and Biocidal Products Act (K-BPR) are believed to be major contributors to this trend, because the government statistics show that companies used the overwhelming majority (89%) of animals, compared with national and public institutions (less than 9%).

Alarmingly, the statistics also revealed that 2,167 animals were used in 2018 for cosmetics testing in Korea despite the Cosmetics Act reform bill, which came into effect to limit animal use in 2017.

HSI Senior Policy Manager Borami Seo said, “It’s disgraceful that Korean companies are still performing cosmetic animal testing after the government has banned this practice, and that more than a million animals were made to suffer last year in the cruelest of animal tests for the sake of chemicals and other products. It’s an unacceptable betrayal to consumers, who mistakenly believe that cosmetics sold in Korea are now cruelty-free, and does little to improve consumer or environmental protection because tests on rodents, dogs and other animals are so often poor predictors of human response. It’s time for private testing facilities and public institutions to get serious about adopting existing non-animal approaches, and for Korean authorities to accept and require use of such methods when available instead of calling for new animal testing. We look forward to working with scientific communities in promoting the use of advanced technology such as in vitro bio-mimetic and computational methods, as well as investing their resources for human-relevant research, replacing animal use.”

HSI has been working closely with Korean politicians in the National Assembly to address the explosion in animal testing through legislative revisions to K-REACH and K-BPR to make it compulsory for regulatory authorities and companies to use available non-animal methods to the fullest extent possible. HSI is also working to establish legislation that will support scientific studies and research based on human-relevant methods without using animals.

Facts:

○ Animal use by testing purpose

Research area % Animal number
Regulatory test 38.0 1,415,631
Basic research 29.4 1,095,412
Translational & applied research 24.1 897,113
Production of genetically engineered animals 3.5 129,838
Etc. 3.1 114,518
Research for species conservation 1.4 51,910
Education or training 0.5 18,851
Forensic 0.0 1,322
Environmental protection research for human or animal health or welfare 0.0 568
Total 100 3,727,163

 

○ Use of animals by institutions under regulatory testing category

Institutions % Animal number
National/public institutions 8.5 120,268
Universities 2.0 27,930
Medical institutions 0.4 5,995
Companies 89.1 1,261,438
Total 100 1,415,631

 

○ Use of animals under toxicity and other safety assessments category

Regulatory toxicity and other safety assessments % Animal number
Test for human pharmaceutical related law 46.3 167,134
Test for animal pharmaceutical related law 5.3 19,194
Test for medical devices related law 18.6 67,121
Test for industrial chemicals related law 6.7 24,353
Test for plant protection product related law 4.2 15,177
Test for insecticide, pesticide related law 0.5 1,756
Test for food related law 6.1 22,114
Test for animal feed related law 0.0 46
Test for cosmetics related law 0.6 2,106
Other 11.6 41,998
Total 100.0 360,999

END

Media contact: Borami Seo, bseo@hsi.org

Humane Society International / Europe

BRUSSELS—Last week the European Pharmacopoeia Commission announced its decision to modernize Europe’s accepted process for safety assessment of vaccines for pertussis, commonly known as whooping cough, by adopting a modern cell-based method in place of an inhumane and unreliable test in mice. Pertussis is known for uncontrollable, violent coughing, which often makes breathing difficult. Previously, government health authorities required the extensive testing for vaccine quality and safety before products are approved and marketed for human use, a process that inflicts severe pain and distress on millions of animals each year worldwide.

Laura Viviani, HSI regulatory science advisor for vaccines, said: “Humane Society International welcomes the decision to remove the mouse histamine sensitisation test and associated testing requirements from the European Pharmacopoeia, and the adoption of a more reliable cell-based test in its place. The mouse test has long been scientifically criticized for its high variability and poor reproducibility, which often leads to repeat testing, with associated costs, delays and needless animal suffering. The European Commission is to be commended for embracing the use of historical safety data confirming the consistency of different batches of pertussis vaccine in place of cruel and repetitive animal testing of each and every new batch.”

Removal of the mouse histamine sensitisation test from the European Pharmacopoeia will become effective on 1 January 2020, and could spare as many as 36,000 mice used yearly for pertussis vaccine testing for the European market. This decision, coming exactly one year after the authority officially scrapped another notorious animal study, the Abnormal Toxicity Test, further reinforces Europe’s commitment to the elimination of animal testing.

HSI is urging vaccine manufacturers and authorities globally to follow Europe’s example by embracing the “consistency approach,” which combines good manufacturing practices to ensure quality and consistency of vaccines with an accurate historical analysis of safe use and of lot releases. This approach is ripe for application to a host of human vaccines, such as tetanus, diphtheria and rabies, which continue to undergo invasive animal testing for every new manufactured batch.

Facts:

  • Worldwide approximately 65,000 mice are used for the histamine sensitisation test each year: 48,000 by manufacturers and 17,000 by national control laboratories. These tests covered the release of approximately 850 lots of pertussis vaccines each year. (Hoonakker, M. et al. Safety testing of acellular pertussis vaccines: Use of animals and 3Rs alternatives. Hum Vaccin Immunother. 2017;13:, 2522-30)
  • The mouse histamine sensitisation test is used by manufacturers and control laboratories to verify the safety of the pertussis vaccines by checking the presence of residual toxin in the vaccine.
  • Most regulatory authorities require a “lethal challenge” procedure, in which groups animals are infected with a virus or other disease agent after being immunized with different dilutions of a vaccine. Animals in the “control” group are given no vaccine, and are left to suffer, without pain relief, until they die.
  • Humane Society International supports the “Three Rs” approach to animal testing: replace animal testing with alternative methods, reduce the use of animals in testing, and refine testing procedures to minimize animal suffering.

Media contact: Nancy Hwa (Washington, D.C.), nhwa@hsi.org

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