Tag Archives: 3Rs

EARA findings on how to improve Non-Technical Summaries for the general public published

As part of its strategy to improve openness and transparency on the use of animals in research in Europe, EARA has been working closely with the EU to help improve the information provided to the general public.

Earlier this year the EARA working group on Non-Technical Summaries (NTS) submitted its guidance document to the EU Commission on how NTS could be made more understandable for the ordinary reader.

EARA has now heard that the Commission will produce additional guidance on NTS for Member States based on the EARA guidance document.

EARA Executive Director, Kirk Leech, said: “We are very pleased to hear that the Commission has found the EARA working group’s observations useful.

“NTS are a small part of the overall need to improve openness and transparency on animal research, but they could be a valuable resource, in particular, for the media and other influencers who communicate with the public directly, in explaining issues such as animal welfare and the benefits that biomedical research can bring for society.”

Every research project application, that intends to use animals, is required to include a publicly available NTS which includes a simple explanation of the project’s objectives, predicted harms, benefits and number and types of animals used. It must also demonstrate compliance with the 3Rs (replacement, reduction and refinement).

NTS are widely seen as a positive development in improving transparency on animal research to the public. However, it is widely agreed that there are a number of problems in the compilation, accuracy, standardisation and accessibility of NTS.

In November 2017, the EU Commission published its Review of Directive 2010/63/EU on the protection of animals used for scientific purposes. The Commission reported that there had been some progress on transparency, but suggested that further improvements were needed. In particular further work is needed on the publication of statistical information on animal use and on non-technical project summaries (NTS).

EARA identified clear opportunities to improve NTS for the general public and set up its working group in 2018. The working group brought together representatives from the user community, with a range of experts from backgrounds in animal welfare, communications and private and public biomedical research, including membership of institutional ethics committees and welfare organisations.

As an example of its guidance the EARA working group said that a simplified project title should be included in the NTS alongside the formal technical title. For instance:

’Effect of oncolitic adenovirus in embryonic high grade pediatric tumours of the central nervous system in NOD.Cg-Rag1tm1Mom Prf1tm1Sdz/Sz mice (Measuring the effects in mice of different potential treatments for childhood cancers)’

The members were Javier Guillén, AAALAC International (Chair), Michael Addelman University of Manchester, Peter Janssen FENS_CARE, Serban Morosan GIRCOR , Barney Reed RSPCA , Kirsty Reid EFPIA , Bob Tolliday EARA and Hanna-Marja Voipio FELASA.

For further information contact EARA Communications Manager, Bob Tolliday, btolliday@eara.eu on +44 (0)20 3675 1245 or +44 (0)7970 132801

A look back at recent biomedical breakthroughs thanks to animal research

On the eve of Biomedical Research Awaerness Day (BRAD 18 April), EARA looks back at some of the important medical advances over the last year that have involved research using animals.

Among the breakthroughs reported, that benefit both humans and animals, are:

  • Research using mice led to many new breakthroughs, such as multiple sclerosis research, at the University of Cambridge and to fight chronic pain using synthetic Botox at University College London, UK.
  • In surgical research on sheep at Lund University, Sweden, freeze-dried valves – later rehydrated for transplantation – were used in animal heart surgery for first time.
  • A team from the Spanish National Cancer Research Centre (CNIO), Madrid, Spain, succeeded in curing pulmonary fibrosis disease in mice using a gene therapy.
  • In Belgium, researchers at EARA members VIB, KU Leuven and UZ Leuven used mice to develop new antibacterial drugs.
  • Building on a technique developed in rats, Swiss researchers at the Swiss Federal Institute of Technology, in Lausanne, have announced that stimulating a person’s spinal cord can restore voluntary movement in some paralysed patients (see picture).

Scientists are also developing new biomedical treatments and techniques that replace, refine or reduce (3Rs) the use of animals in research.

  • A team from the University of Oxford, UK, and EARA member Janssen Pharmaceutica, Belgiumwon the International 3Rs Prize using a computer model that predicts accurately the risk of drug-induced heart arrhythmias in humans.

Animal research is integral to ongoing research in areas such as spinal cord repair, stem cell treatments (Parkinson’s and Alzheimer’s), gene therapy (muscular dystrophy, diabetes) and molecularly targeted cancer medicines.
Historically, animal research has also led to new diagnostic tests for early treatment (cancer, heart disease); and effective treatments for serious illnesses (diabetes, leukemia, HIV/AIDS, cardiovascular disease).

The same research often helps humans and animals (treatments for arthritis, neurological disorders, organ transplants, cancer therapies) and contributes to farm animal welfare and techniques to save endangered species.

EARA Executive Director, Kirk Leech, said: “Without the use of animals the pace of advances in biomedical research would be dramatically slower.

“Finding alternative methods to animal research, such as computer models and cell cultures are extremely important, but animal testing remains the safest and most effective way to produce drugs and treatments for us all.”

Why Belgium still needs animal testing in the fight against cancer

In a piece first published in the Belgian news magazine Knack (in Dutch), Prof. Damya Laoui, from the Flemish Institute for Biotechnology (VIB, an EARA member), in Belgium, together with Dr. Liesbeth Aerts and Dr. Jeroen Aerts from Infopunt Proefdieronderzoek (IPPO, also an EARA member), explain that researchers don’t take the use of animals in biomedical research lightly. 

Many people are critical of animal testing, and from an emotional point of view this is very understandable. Animals are living beings. They have basic emotions and they also experience physical pain. As researchers, we are not blind or insensitive to animal suffering, but neither can we ignore the pain of almost 10 million people who die of cancer worldwide every year.

In 2018, some 70,000 Belgians received a new cancer diagnosis. Fortunately, their prognosis is in many cases a lot better than for people who received the same diagnosis 10 or 20 years ago. Thanks to advances in biomedical research – including through animal testing – the treatment options for cancer are rapidly expanding. Nevertheless, the number of cancer cases continues to increase as well, and the disease continues to take many lives.

To the people who claim that we can face this challenge without animal research, we would say: please walk the talk. From our hands-on experience as biomedical researchers, we would like to argue for greater nuance in the debate against animal testing. Let’s bust some often heard myths:

Myth One: Animal testing is no longer necessary because we can get the same results through computer simulations

Unfortunately, we cannot simulate what we do not understand; that’s kind of the definition of a simulation. Despite our increasing knowledge, there are still a lot of body processes that we do not understand well enough to be able to fully predict them. If we could, we would already have a solution to all diseases.

Just like animal experiments, computer simulations are one type of tool in our experimental toolbox and they can certainly help us in the search for answers. For example, computer simulations are useful to screen different versions of a candidate drug molecule, or to predict possible negative effects of a drug on a cell. Depending on the substance and the application, additional (animal) tests will nevertheless be required.

Myth Two: Researchers use laboratory animals because it is easier and cheaper

Researchers who work with laboratory animals don’t do this for fun. The breeding and housing of experimental animals is – depending on the species – time-consuming and very expensive. There are strict rules and conditions (and rightly so!) which mean that for each test an ethical file has to be drawn up and submitted to an ethical committee.

If an experiment can be done in a cell culture dish, then the animal experiment simply cannot take place. Can human samples be used instead? Also then, animal tests are prohibited.

Myth Three: Animal experiments are useless, because mice are not the same as humans

Mice are indeed not people, but they do show a lot of similarities. The functioning of many organs is similar and by changing certain genes in mice, we are able to answer very fundamental questions, for example about the interaction between the immune system and cancer cells in a complex organism. That’s exactly why mice are used to study new immunotherapies.

Exactly because there are also important differences in mice and humans, researchers sometimes need to use other animal species such as dogs or monkeys. As these are more evolved animal species, they are only used in very exceptional situations.

We have achieved many medical breakthroughs thanks to animal experiments; think of organ transplants, blood transfusions, treatments for diabetes and AIDS, or the development of vaccines against polio, hepatitis and, most recently, the Ebola virus. More than 80% of the Nobel Prizes in Medicine also went to breakthroughs that were based on animal research.

VIDEO: In a lecture for the University of Flanders, Prof. dr. Damya Laoui, of VIB, in Belgium, underscores the need for animal research for her pioneering work into immunotherapy for metastatic breast cancer.

Animal experiments are not a perfect fix; of course they also have limitations. They shouldn’t be the default option, rather, it’s about using the right model for the right questions. Just as for other non-animal research methods, such as computer simulations or experiments in cell lines, there are advantages and disadvantages that have to be weighted.

The legislation on animal testing is therefore built around the principle of the 3Rs: Reduce, Refine, Replace.

  • Reduction means that only the absolutely required number of animals is used for each experiment. It is up to the researchers to make a statistically solid estimate for each experiment, and up to the ethics committee to finally decide.
  • Refinement means that an animal test must be done under the best possible conditions, e.g. with painkillers if necessary, and that animal welfare should be considered at all times. This includes legally specified conditions relating to the number of animals per cage, the control of temperature and humidity in the room, and the provision of toys.
  • Replacement emphasises the legal need to replace animal testing where alternatives exist.

As researchers, we also apply the fourth ‘R’ of responsibility. It goes without saying that there should be zero tolerance policy of researchers who would flout these rules.

Scientists would love to have the tools available to map the complex mechanisms of cancer metastases, for example, or to explore new avenues for immunotherapy, without animal testing. For the time being, however, we don’t. That does not stop us from trying to do better every day. We keep pushing, not only for new treatments for patients, but also for better, more refined research methods.

End

EU Directive ‘cannot be implemented in isolation’ Brussels roundtable agrees

At a roundtable discussion on the use of animals in scientific research there is overwhelming agreement that Europe has appropriate and detailed legislation regulating the use of animals in scientific research, that adapts to and encourages scientific progress.

Conclusions also show that successful implementation of the Directive is a shared responsibility. The round table identified opportunities to join forces and work together, as the Directive 2010/63/EU cannot be successfully implemented by organisations or individuals working in isolation.

At the meeting in Brussels, representatives from the diverse sectors within the biomedical community (academia, industry, research organisations, medical charities, etc.) and policy-makers discuss the recommendations of the European Commission review report of the Directive 2010/63/EU on the protection of animals used for scientific purposes.

The objective of the roundtable was to  inform policy discussion in EU institutions and to identify recommendations for the users’ community on this basis. Topics under discussion were: the implementation of the Directive; improving openness and transparency; ideas for further areas to be tackled. Continue reading

Primate poposal by Netherlands government ‘will severely limit progress on biomedical research’.

EARA has responded to a call by the Dutch Science Minister for the Biomedical Primate Research Centre (BPRC), in the Netherlands, an EARA member, to draw up a proposal, by the beginning of next year, to reduce the number of experiments with no-human primates (NHP) by up to 40%.

Ahead of a debate, which took place in the Netherlands House of Representatives earlier this month, EARA wrote to Ingrid van Engelshoven, Minister of Education, Culture and Science and Carola Schouten, Minister of Agriculture, Nature and Food Quality, urging them not to set an artificial limit on the number of NHP used in research.

The letter, written by EARA, said that any reduction was “highly likely to severely limit the progress that can be made in both fundamental research and the development of innovative medicines and treatments for life-threatening diseases and infectious disease control”.

Currently the main areas of primate study are infectious diseases, neuroscience and fertility and foetal research. Primates are an important model for the development of vaccines and treatments for HIV/AIDS, Ebola, Zika and malaria and for investigations into treatments for conditions ranging from Alzheimer’s disease to Schizophrenia. They are also used in safety testing for new medicines and vaccines. Continue reading

European scientific community welcomes EU review of the Directive for the protection of animals used for research

PRESS RELEASE

LONDON, UK – 10 November, 2017

The European scientific community supports the view of the EU Commission, that the Directive on the protection of animals used in biomedical research is bringing significant benefits in animal welfare and a sound foundation for future best practice in the sector.

The European Animal Research Association (EARA), which represents more than 60 organisations across Europe in the biomedical research sector, has welcomed the Commission report, published today. The report reviews the requirements of Directive 2010/63/EU – all uses of live animals for research or education and testing must be carried out in compliance with the Directive.

In particular, the EU recognised that measures to improve transparency to the general public on the performance of research establishments in the areas of animal use and welfare are starting to have an effect. Requirements to publish non-technical summaries of the objectives and benefits of research projects, as well as annual statistical data, are also seen to have greatly improved openness in Member States. Continue reading

Environmental factors can improve reproducibility

At a meeting on improving mouse models of disease held last week at the Wellcome Genome Campus in Cambridge, scientists and technicians came together to discuss opportunities to improve the reproducibility of research results obtained using mouse models. Nature reported on some of the environmental and biological factors that affect mouse studies.

Continue reading

European Partnership for Alternative Approaches to Animal Testing: 10 years of promoting development and acceptance of alternatives

The European Directive 2010/63 that protects animals required for scientific purposes was enforced in Member states in 2012. The Directive introduced the 3R principles of replacement, reduction and refinement of animal procedures into regulation. The scientific community has recognised the Directive as the world’s most progressive and stringent framework seeking to ensure high animal welfare standards while encouraging the development of alternative methods. As a result of this new legislation, there has been a growing interest in the development and implementation of alternative methods. One initiative pursuing this goal is the European Partnership for Alternative Approaches to Animal Testing (EPAA). Continue reading

Panel Discussion on the effectiveness and reliability of alternative methods used for regulatory purposes

On December 1 of last year the European Partnership for Alternative Approaches to Animal Testing (EPAA) celebrated its tenth anniversary with a conference in the European Parliament. As part of the conference Julie Girling, Member of the European Parliament and EPAA stakeholder, chaired a roundtable to discuss challenges in developing alternative methods seeking to replace, reduce and refine animal procedures. Around the table were Maurice Whelan from the European Commission Directorate General Joint Research Centre, Erwin Roggen from Novozymes, Sonja Beken from the European Medicines Agency (EMA) and Joop de Knecht from the Organisation for Economic Co-operation and Development (OECD). Continue reading