Medical research continues apace. It needs to, as many health challenges still remain unmet. Animal studies continue to play an invaluable role in meeting these challenges – both in experimental research, and in ensuring maximum safety of treatments before their use in humans, which is legally required. Research involving animals poses dilemmas, not only for the researchers and scientists who use animals for medical research, but also for society as a whole. The current consensus is that research with animals is justified where there are clear benefits for our health and when the 3Rs are applied. Advances in science are leading to fewer tests and experiments on animals, and to new ways to reduce the impact on animals. This is why dialogue and transparency about the use of animals for medical research and developments in science need to be debated by everyone involved.
Medicines take between 10 and 15 years to develop and a very small proportion of this time needs animal research. Only when it is necessary and unavoidable, animals are used for research to help scientists bridge the gap between the theories developed in the test tube and the reality of introducing a new treatment to the patient. So, in short, without animal testing, there would be no new medicines.
Although pharmaceutical companies cannot avoid the use of laboratory animals to prove that medicines work, it is our priority to meet high standards of animal welfare. To put animal welfare principles into action, we systematically replace animals with alternative methods where possible, reduce and refine the use of laboratory animals (3Rs) and improve standards of care.
Use of animals in testing and research is highly regulated at both EU and Member State levels. The latest legislation passed at EU level in September 2010 came into force on 1 January 2013 and is based on the 3R principles (Directive 2010/63). The Directive sets full replacement as a long term vision and sets the most stringent protection framework worldwide to protect animals that would still need to be used after application of alternative research methods. The research-based pharmaceutical industry not only complies fully with the letter of the law, it goes beyond compliance.
The pharmaceutical sector continue to be involved in a number of initiatives, which affirm the key principles of the 3Rs (Reducing the number of animals used, Refining experiments to minimize the impact on animals, and Replacing animal experiments wherever possible with alternatives) or change the current research paradigm (such as the Innovative Medicines Initiative). Science, technology and research practice evolve every day and bring new tools to address scientific questions differently. This paradigm shift is operating seamlessly every day without necessarily being labelled 3Rs.
The pharmaceutical industry will work with regulators to ensure the fastest possible up-take of new alternatives to animals for safety and efficacy testing. We are also putting considerable resources into new and more predictive research methods, which also result in development of 3R approaches. However, there is currently no prospect of an end to the use of animals in medical research. In addition to current unmet needs, new diseases continue to emerge, such as new strains of malaria or pandemic influenza. At the same time, pressures for ever-safer treatments tend to strengthen and broaden safety requirements. For example, testing of each batch of vaccines being released on the market is still mandatory for public health reasons. In many cases, animals are needed for these tests. Until the law is changed and new sciences emerge, animals will continue to be necessary. In the meantime, exciting advances in biotechnology, and our understanding of the human genome, offer the prospect of radical new approaches to how we go about achieving the 3Rs.
Magda Chlebus, Director Science Policy