Animal welfare: 3R's - Replace, Refine, Reduce

The pharmaceutical industry researches and develops new, safe and efficacious medicines for patients. The process that leads to the development of a new medicine is long and complex and involves a range of different research methods. The use of animals is an essential part of that process and provides vital safety information. Without animal research and testing, there would be no new medicines.

Animals hold the key to cures

• The biological similarity between humans and other animals means that most potential effects of a medicine can be predicted.
• Although there have been great advances in scientific knowledge and technology, the use of animals in research is essential for understanding the disease mechanisms and evaluating the safety and efficacy of potential medicines.

Animal research is required and regulated by European law

• All aspects of animal testing are highly regulated and controlled in Europe.
• European and national pharmaceutical laws set specific regulatory obligations for safety, quality and efficacy that can currently only be fulfilled with the results of animal studies.
• Safety and regulatory requirements are continuously being reviewed, which has resulted in an increase in requirements.
• It is unethical and illegal to use a new substance in humans without ensuring maximal possible safety prior to studying a compound in humans.
• The role for animal studies prior to human exposure is explicit in the World Medical Associations Ethical Principals for Medical Research Involving Human Subjects (“Helsinki Declaration”).

Developing and using alternatives is integral to the way industry works

• Good animal welfare results in quality medical science. There is also a strong business case as well as clear scientific benefits for using the minimum number of animals and replacing animal testing methods where possible.
• Alternatives to testing on animals such as computer modelling and simulation have significantly reduced the reliance on animals and the number of animals needed.
• The total number of animals used in medicine research is now less than half what it was 20 years ago.
• It takes up to 12 years to develop a new medicine. Only a small proportion of the research and development process involves animals.
• The 3Rs (Replacing - Reducing - Refinement) help create the balance between animal welfare and medical research by:

1. Replacing animal testing with non-animal methods whenever scientifically possible
2. Reducing the number of animals required,
   
3. Refinement of techniques so that the distress or pain of animals is avoided or minimised and that animals are always treated with care.

3R Alternatives: Replace - Reduce - Refine

For many years it has been thought that one day it would be possible to completely replace the testing of compounds by the use of modelling and test tube methods. Unfortunately, due to the complexity of the human body, this will not be possible in the foreseeable future.

The principles of the 3Rs - Replacement, Refinement and Reduction - were originally developed by, Professor William Russell and Rex Burch, and are now widely accepted internationally as criteria for humane animal use in research and testing.

Replacement refers to methods, which avoid or replace the use of animals in areas where animals would otherwise have been used.

Refinement refers to improvements to housing and care and procedures, which minimise actual or potential pain, suffering, distress or lasting harm and/or improve animal welfare in situations where the use of animals is unavoidable.Refinement refers to the lifetime experience of the animal. There is evidence that refinement not only benefits animals, but also improves the quality of research findings.

Reduction refers to methods which minimise animal use and enable researchers to obtain comparable levels of information from fewer animals or to obtain more information from the same number of animals, thereby reducing future use of animals.