[비즈한국] With the amendment of the Cosmetics Act in 2017, the distribution and sale of cosmetics tested on animals were banned in South Korea. However, animal testing is still frequently used in procedures such as pharmaceutical product approval. Recently, the government issued a notice stating that data from non-animal or human biology-based tests, conducted using internationally recognized methods, could be used as alternatives. Yet, it appears it will take some time for the industry to fully adopt these changes.
According to data on the "Status of Laboratory Animal Usage" from the Animal and Plant Quarantine Agency, approximately 14.46 million animals have been used in experiments over the past three years. By year, this breaks down to 4.88 million in 2021, 4.99 million in 2022, and 4.58 million in 2023. Regarding pain levels, 76% of experiments in 2023 fell into pain categories D to E. The current Animal Protection Act classifies potential animal suffering into five levels (A to E). While the application form for animal experiment plans states that "experiments classified as pain level E are prohibited in principle," 49% of experiments still reached level E. Pain levels D and E involve experiments that subject vertebrates to unavoidable stress or pain, with the classification depending on the use of anesthesia and analgesics.
Beyond ethical concerns, animal testing is criticized for its low efficacy due to genetic differences between animals and humans. Last year, a research team led by Professor Benjamin Ineichen at the Center for Regenerative Medicine at the University of Zurich in Switzerland published a study in the international journal 'PLOS Biology,' revealing that only one in 20 new drugs tested on animals receives FDA (U.S. Food and Drug Administration) approval for human use. The researchers explained that out of 367 animal studies, 50% transitioned to clinical trials in humans, but only 5% were eventually approved as human drugs.
In response to such criticism, countries around the world are progressively introducing laws to regulate animal testing. The European Union (EU) banned the sale of cosmetics tested on animals in 2013 and is currently in the legislative process of extending this scope to pharmaceuticals. In the United States, after President Biden signed the 'FDA Modernization Act 2.0' in 2022, the mandate requiring animal testing before human clinical trials was removed. At the time, the U.S. adopted alternative technologies such as "Organ-on-a-Chip," which creates artificial organs by culturing cells on a chip. Recently, the 'FDA Modernization Act 3.0,' which includes measures to ensure rapid compliance with these standards, passed the Senate.
In South Korea, agencies including the Ministry of Food and Drug Safety, the Ministry of Agriculture, Food and Rural Affairs, the Ministry of Health and Welfare, and the Ministry of Science and ICT are working on the development and validation of alternative testing methods. The Ministry of Food and Drug Safety has operated the Korea Center for the Validation of Alternative Methods (KoCVAM) within the Toxicological Evaluation Research Department of the National Institute of Food and Drug Safety Evaluation since 2009. Recently, it amended the 'Regulations on the Approval and Review of Biological Products, etc.' to include provisions allowing toxicity data to be replaced with non-animal or human biology-based test data (such as cell-based tests, micro-physiological systems, bioprinting, and computer modeling) conducted via internationally recognized methods (OECD, ICH, etc.).
However, the pharmaceutical industry believes it is unlikely that companies will take the risk of choosing non-animal tests, given the conservative nature of the FDA. In fact, although various Korean ministries have established "guidelines for alternative animal testing methods" that avoid the use of animals since the early 2000s, the number of laboratory animals used has remained at a similar level.