IVTIP, the In Vitro Testing Industrial Platform, represents the interests of European industry with an active interest in in vitro testing to replace the use of animals in research, development and regulatory testing. Although much progress has been made and many of our member companies have been able to significantly reduce the number of animals used, the use of animals in research and development and regulatory testing is still necessary. EFPIA, the European sector federation which represents the research-based pharmaceutical industry of sixteen European countries, has recently issued a policy statement on the use of animals in research and development. This policy statement is reproduced below. The reader might also be interested in a position statement regarding "the use of animals in toxicology", issued by the Society of Toxicology, as well as their "Guiding principles in the use of animals in toxicology".
Pharmaceutical companies in Europe have been responsible for the research and development of medicines and vaccines which have saved millions of lives and improved the quality of life for countless people around the world. Major discoveries include important new treatments such as medicines for high blood pressure, heart failure, cancer, asthma, epilepsy and peptic ulcers. New antibiotic and anaesthetics have revolutionised modern surgery and hundreds of thousands of transplant recipients owe their lives to the discovery of medicines which prevent organ rejection.
Future research is needed to fund cures or to improve existing treatments for diseases such as tuberculosis, rheumatism, allergies and the many forms of cancer; and to deal with new or re-emerging diseases such as Alzheimer's, AIDS/HIV, Ebola, malaria and the large number of genetically based disorders about which we still know very little.
Morally and legally, industry is obliged to test potential new medicines rigorously to ensure that they are as effective and as safe as possible. Despite progress made in the development and validation of alternative methods, the research-based industry will still need animals for pharmaceutical R&D in the years to come, because they are still a necessary part of the research and testing processes which lead to the development of new medicines and which contribute significant knowledge relevant to human health and safety.
At the same time, industry believes that the number of animals required should be kept to a minimum by making maximum use of in-vitro techniques and by using appropriate statistical methods. The animals used in experiments should be treated humanely and be subjected to the least stressful experimental methods and housing conditions.
Animal research is necessary in order to gain a better understanding of the body's function in sickness and in health, and to evaluate the efficacy and safety of a new substance that may become a candidate for development as a new medicine for man. Today, computer studies and other alternative test methods, such as in vitri methods (i.e. tissue culture), provide important information which helps scientists determine which substances have the potential to become new medicines. As much information as possible is derived from these methods, which have contributed significantly to the market reduction in the number of animals used in recent years. Nevertheless, it is vital to conduct animal studies before doctors and scientists can justify testing a new medicine in people.
This is because of the effects (both wanted and unwanted) of a medicine will ultimately depend on what happens when all the body's systems interact together. Medicines in the whole body can have many effects which do not occur 'in the test tube' when using tissue culture and similar techniques. Nor, given the current state of our biological knowledge, can they be simulated in the necessary detail on a computer.
Only well-designed animal studies can bridge the gap. The remarkable biological similarity between ourselves and animals, together with the wealth of knowledge available about the biology of the various laboratory animal species, means that most of the potential effects of a medicine in man can be predicted from well-designed animal studies. It is therefore difficult to imagine a society which would be prepared to take the risk of allowing medicines to be tested in man with only the limited results of non-animal studies as an indicator of safety. In fact, all countries which regulate the approval of new medicines demand evidence from animal studies before they will allow the medicines or vaccines to be tested and used in patients.
While we believe the human welfare must take priority, we also believe that animal welfare must be respected and provided for. The principles of laboratory animal welfare promoted by EFPIA are set out below:
March, 1999