3Rs in the pharmaceutical industry

The use of animals in research is underpinned by the guiding framework for humane use of animals in science, the 3Rs – Replacement, Reduction and Refinement.

The pharmaceutical industry is strongly committed to the principles of the 3Rs, and the ABPI [and its members] work[s] in partnership the National Centre for the Replacement, Refinement & Reduction of Animals in Research (NC3Rs) in the UK, and alongside the European Federation of Pharmaceutical Industries and Associations (EFPIA) in Europe to help achieve these.

To further promote action surrounding the 3R’s, the ABPI sponsors the Andrew Blake Tribute Award, which is presented by the Institute of Animal Technology to an animal technologist who has made a significant contribution to improving the welfare of laboratory animals.

For more information on these initiatives, as well as case studies from ABPI members outlining their work in this field, please see the sections below.

ABPI-NC3Rs Partnership

The ABPI works in partnership with the National Centre for the Replacement, Refinement & Reduction of Animals in Research (NC3Rs) in the UK. The role of the NC3Rs is to ensure best practice in all areas of laboratory animal welfare, and to work towards reducing, replacing and refining the use of animals in research. Since 2005, the ABPI has provided funding for a programme manager post at the NC3Rs to support this work.

This partnership has delivered massive 3Rs impacts:

Opportunities for use of a single species in drug development | NC3Rs

Regulatory change to end the requirement for single dose acute toxicity studies.

The impact of regulatory change: the proportion of clinical trial applications from drugs going into humans for the first time in the UK which contain the results from conventional single dose acute toxicity tests. The saving in animals is significant with up to 100 rodents used per drug for these tests.

Opportunities for minimising the use of non-human primates in the development of biotherapeutics.

Any similar indications of impact – use of NHP in mAb development programme? Reduce from 144-64 recommended, any tracking of this?

CRACK IT challenge to develop in vitro human cell-based models for testing of antibody-based therapeutics

Ongoing work includes:

Opportunities for use of one species only in toxicity studies.

A major area of industry support for the work of the NC3Rs is in the CRACK IT Challenges, focussed on funding collaborations between industry, academics and SMEs to solve business and scientific challenges which will deliver 3Rs benefits.

Challenges currently in progress include:

Challenge 40 – Virtual Second Species, aiming to develop a suite of virtual dog tissues and organs to model toxicological endpoints, reducing the number of animals used in this process.

Sponsors: Bayer AG, Eli Lilly and Company, Genentech Inc., Gilead Sciences Inc., GSK, Merck Healthcare KGaA, Roche

Challenge 38 – Mouse Mapp, aiming to develop an app that uses artificial intelligence and machine learning to automatically detect changes in facial expression and/or body condition, refining the monitoring of mouse welfare.

Sponsors: AstraZeneca, GSK, CRUK Manchester Institute (University of Manchester), The Sainsbury Wellcome Centre (University College London), Agenda Vets

Challenge 36 – Animal-free in vitro, aiming to modify an established in vitro assay, replacing animal-derived reagents used in the process with animal-free alternatives, whilst still generating scientifically robust and reproducible data.

Sponsors: AstraZeneca, Unilever.

EFPIA 3Rs Brochure

The European Federation of Pharmaceutical Industries and Associations (EFPIA) publish regular reports giving an extensive overview of ongoing work to put animal welfare principles and the 3R’s into action. The most recent report was published in 2019, containing over 70 examples of activities and successes of the pharmaceutical industry, leading to improved animal welfare and high quality science.

Andrew Blake Tribute Award

The Andrew Blake Tribute Award commemorates the work and life of Andrew Blake, who died in 2002 aged 39, having suffered from a hereditary neurological disease. Andrew advocated strongly for the medical science sector, founding the Charity Seriously Ill for Medical Research, which articulated powerful arguments, based in scientific fact, against unreasonable and unfounded accusations of cruelty in animal research.

The ABPI are proud to sponsor this award, which is presented by the Institute of Animal Technology, to recognise the essential contribution that animal technologists make to ensuring the 3Rs are adhered to and incorporated into research culture. The award is presented to an animal technologist who has made a significant contribution to improving laboratory animal welfare.