Management Training,Outsourcing,Staff Training

With the accelerating pace of animal-based research being outsourced to Asia, as well as the heightened support for in-country biomedical research by the governments of several Asian nations, interest in laboratory animal care and use standards in this part of the world, and laboratory animal welfare in particular, is intensifying.

Reports regarding the increase in outsourcing of manufacturing, as well as research and development, in numerous industries are evident daily. Animal-based research is no exception to this trend. Less than two years ago, Steve Snyder reported in Contract Pharma¹ that economic indicators strongly suggested that preclinical outsourcing would continue to expand. Estimates of approximately a 12% increase in outsourcing between 2001 and 2011 have been suggested², and within the pharma sector, estimates of almost 50% of revenues for the mid-pharmas are projected to be derived from products discovered outside of in-house development pipelines³. It is estimated that China alone has more than 300 Contract Research Organisations (CROs), and that the number of partnering deals grew by 41% in 2009⁴. The economic downturn has impacted these estimates slightly. For example, in 2008, respondents to Contract Pharma’s annual outsourcing survey indicated that 72% expected outsourcing spending to grow in 2009. Thirty-nine percent of respondents to a slightly differently framed question indicated that they expected to increase their outsourcing spending in 2010, while 33% indicated that they would spend less than in 2008 and 25% reported they would not change their outsourcing spending level^5,6. When asked how likely the respondents were to outsource a project to Asia in the next year, the 2008 data showed an increase in the percent that definitely or probably would (30% in 2008 vs. 35% in 2009) and a reduction in the groups answering they definitely or probably would not (46% in 2008 vs. 43% in 2009). International collaborations between academic institutions are also increasing in frequency. A case in point is the Duke University-Peking University Center on Global Health. And, Yale University hosted a 2010 symposium on US-China Life Science Industry Collaborations. Regardless of the precise yardstick used to measure the expansion of preclinical work conducted outside of a company’s own facilities and international academic research projects, it is clear that external sourcing and collaboration will remain an integral component of animal research.

Recent problems identified with products (e.g., melamine in pet food, toothpaste containing ethylene glycol, lead paint on children’s toys, and counterfeit pharmaceuticals) manufactured in Asia, and in particular in China, have led to an understandable public skepticism regarding quality assurance measures in some overseas markets. An offshoot of this in the life sciences research sector is concomitant concern regarding the level of welfare afforded research animals. As Snyder noted¹, “Let’s hope we don’t see a catastrophic failure due to a quality crisis”. Indeed, in the face of increasing globalisation of animal-based research, harmonisation of animal care and use standards and practices becomes essential.

INFLUENCES ON ANIMAL WELFARE PERSPECTIVES
Several factors may play a role in the regulatory framework for and attention paid to laboratory animal welfare. For example, the economic development of the country can have a significant impact on how many resources are allocated to ensuring the research animal’s environment is appropriate, that trained and qualified individuals manage the program, and that quality assurance is sustainable. Heating, ventilation and air conditioning systems; mechanical cage washers; appropriately designed and manufactured animal caging; and other infrastructure elements come at a high cost. Also, recruiting top tier professionals requires a firm commitment to adequately resourcing the animal program.

Second, the religious and cultural context of the country where animal research is performed may influence animal treatment. Traditions of Confucianism, Taoism, Jainism, Hinduism, and Buddhism variably speak to a relationship between human beings and non-human animals. Some reflect the philosophy that humans are superior to other animals and view animals as a source of food, labour, and utility. In such a perspective, a person treats an animal with kindness “not because of their inherent value but as a reflection of one’s own refinement as a human being”⁷. Other schools of thought, particularly those that emphasise reincarnation, place value on animals as a component of the human-animal continuity. However, in addition to religious influences, societal mores—customs, teachings, etc.—can affect commonly held opinions regarding acceptable care and use of animals.

A third potentially significant influence on an individual’s concept of animal welfare is that person’s exposure to other cultures and philosophies. This exposure could occur through websites with an emphasis on laboratory animal medicine and science or animal welfare in general; published literature; and visits to other countries. It is recognised, however, that language barriers may be an impediment to an individual’s ability to take full advantage of the vast array of print and online resources available pertaining to laboratory animal care and welfare. A significant amount of this information is published in English, and many terms may be more technical in nature, and thus not readily understood by an individual whose primary language is not English. While translations of some documents are available (e.g., the Guide for the Care and Use of Laboratory Animals)⁸, such translations are complex and often costly, and the documents may be updated or revised, thus rendering the translation outdated (e.g., reference the 2010 edition of the Guide). Also, accuracy of the translation must be assured. While exposure to animal facilities outside of one’s own country is extremely informative, the cost and logistics of setting up such travel can be prohibitive. However, the value of such interactions cannot be understated. Indeed, China’s “sea turtles” (individuals who train outside of China and then return to the country with specific expertise) is an apt model for this approach.