Animal welfare and the European Pharmaceutical industry – explain, track, and talk
08.01.13
Pharmaceutical industry and 3Rs
European Federation of Pharmaceutical Industries and Associations (EFPIA) and individual pharmaceutical companies 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). As part of this commitment, the European pharmaceutical industry promotes these initiatives internally and externally. We also engage in dialogue with interested parties.
Explain: Why use animals?
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.
Track: What is the regulatory framework and how does industry comply?
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 is due to come into force on 1 January 2013 and is based on the 3R principles (Directive 2010/63). The research-based pharmaceutical industry not only complies fully with the letter of the law, it goes beyond compliance, and leads by example. Our 2011 report tracks not only what the industry is doing, and the steps it’s taking to apply the 3Rs across Europe but also globally. This report is also part of our commitment to open communication underpinned by our respect for scrutiny and dialogue.
Talk: Why it is important to communicate and be transparent on this issue?
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 – so why not join our blog and contribute to the discussion?
What can we expect from the industry going forward?
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.
For more information, contact:
Magda Chlebus, Director Science Policy
magda.chlebus@efpia.eu