Law and Ethics Print

The European and international legislation regulates both the need for animal studies and the protection of laboratory animals.

There is widespread agreement that the use of animals as part of the long and complex research path is not a desirable or ideal situation. At this same time, it is widely acknowledged that research should continue to better understand diseases and find new treatments. If we accept this desire to progress in the area of healthcare, medical research, involving some animal studies, remain indispensable for the foreseeable future. It is vital - both for humans and for animals - to make sure that all the conditions for this research are in place.

European regulation on the use of animals and practices developed in research establishments across Europe, provide for the best protection standards in the world. The ongoing debate is looking at ways to improve even further the conditions for animal research.

It is unethical and illegal to use a new substance in humans without first ensuring maximal possible safety prior to clinical studies.

The role of animal studies prior to human exposure is explicit in the World Medical Association Clinical Principles for Medical Research Involving Human Subjects (the 'Helsinki Declaration').

European and national pharmaceutical legislation sets 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 sometimes results in increase in requirements.