In light of recent research which highlights the impact industry is having on scientific literature on the 3Rs (Replacement, Reduction and Refinement) principles of animal research, ABPI Policy Officer Nicola Platt considers the increased contribution and collaboration of industry towards reducing, refining and replacing animal testing in medicine development.
Research using animals plays a crucial role in the discovery and development of new medicines. The use of animals in medical research facilitates our understanding of disease processes and improves medicine design. Also, all new medicines are required to be tested on animals to ensure patient safety. However, no one wants to use animals in research when it is not necessary.
The pharmaceutical industry is fully committed to the 3Rs principles of animal research: to replace animals with non-animal methods as appropriate, reduce the numbers of animals used and refine procedures to minimise harm to the animals involved. This is enshrined in the ABPI Policy Statement on the use of animals in research.
This commitment to the 3Rs is being demonstrated by an increase in published research with a specific 3Rs objective by the pharmaceutical industry.
An analysis of published literature, coordinated by the ABPI, has found that the number of research papers published by the pharmaceutical industry with a specific 3Rs objective has almost doubled in 10 years – from 20 in 2002 to 39 in 2012.
The analysis also showed a small increase in the proportion of primary research studies carrying out novel research on the 3Rs, compared to those reviewing the field. These encouraging results suggest that the pharmaceutical industry is taking its commitment to the 3Rs seriously, and is increasingly investing resources in research to drive forward the replacement, reduction and refinement of animal research.
This is not a simple or easy task. Because humans and animals are incredibly complex organisms, many 3Rs techniques require significant scientific research and validation before they can be implemented. As an example, we may aspire to completely replace whole animal tests for liver toxicology with laboratory tests on liver cells in culture. However, in a whole animal, medicines do not act on liver cells in isolation, but also affect other cells or systems, which will in turn modify the effect of the medicine on the liver cells. In addition, developing a cell culture model will have its own challenges: Do the cultured cells really have the characteristics of mature liver cells? Can the cells be grown in a reproducible manner? Does a 2-D culture sufficiently model the real liver or should a 3-D model be developed?
In answering these and many other challenging questions, the pharmaceutical industry recognises the need to work in partnership with academic institutions in order to share ideas, expertise, funding and findings. Encouragingly, over the past decade there has been a large increase in the number of 3Rs studies published with multiple affiliations, and in studies with authors from both industry and academia. Additionally, there has been a substantial increase in studies with authors from contract research organisations (CROs). This suggests that the whole bioscience sector, including the pharmaceutical industry, is increasingly working collaboratively towards the 3Rs goals.
Looking forward, there is every reason to expect that these trends will continue. For example, a number of ongoing collaborative projects supported by the jointly industry-EU funded Innovative Medicines Initiative (IMI) are likely to have implications for animal research. Computer modelling will be explored in the eTox project, which aims to improve in silico toxicology prediction, whilst the STEMBANCC project is developing stem cells for drug discovery and toxicology.
An ongoing challenge will be to encourage the widespread uptake and implementation of new scientific advances. This is recognised in the recently launched vision of the NC3Rs (National Centre for the Replacement, Refinement and Reduction of Animals in Research) for the next 10 years, which emphasises how NC3Rs will continue to work in partnership with the bioscience sector, both on 3Rs research, and to increase implementation of such research.
We look forward to seeing more innovative scientific advances in the coming years, which will allow for further replacement, reduction and refinement of the use of animals in medicine discovery and development.
Dr Nicola Platt
R&D Policy Officer
Graphs modified from Cunningham et al (2015) Quantifying the pharmaceutical industry’s contribution to published 3Rs research 2002-2012, Advance article, Toxicol. Res. - Reproduced by permission of the Royal Society of Chemistry.