Animal use and welfare in Pharmaceutical research and developmentMedical 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.

Why use animals?

Only when it is necessary and unavoidable, animals are used for research to help scientists bridge the gap between the theories developed and the reality of introducing a new treatment to the patient. It is legally required that new medicines ensure maximum safety to humans, making the use of animals an essential step in the medical development process. 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.

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 regulating use of animals in research passed at EU level in September 2010 came into force on 1 January 2013 and makes the 3R principles a legal requirement (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.

Culture of care

Directive 2010/63/EU aims to improve the welfare of animals still needed in scientific research by, amongst other things, enhancing the Culture of Care, referred to as the “climate of care” in Recital 31. Establishing, promoting and maintaining a good culture of care is a fundamental component if ethical, scientific and animal welfare obligations, along with wider responsibilities towards employees and the public, are to be met.

A Culture of Care goes beyond strict adherence to legal requirements. It refers to an organisational culture that sets the tone at senior level and that supports and values caring and respectful behaviour towards animals. The culture should instill responsibility and accountability in those planning and implementing research programmes and those taking care of animals, so that they do what is right and strive continually for excellence.

EFPIA members have been reflecting on the concept of a Culture of Care and how it is understood and applied across research institutions and companies in Europe. Moreover, they have examined good practices and areas for improvement within the user community. This reflection process was facilitated by a survey containing a series of questions.

EFPIA is pleased to share this list of questions (in English, French and German) with the wider research community as a “checklist” to help engage in or enhance discussions on a Culture of Care within your establishments.

Pharmaceutical industry and 3Rs

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 strive to go beyond what is legally required and work to implement 3Rs to ensure high animal welfare and high quality science and ultimately improve the lives of the people and animals that stand to benefit from the research. Since the adoption of the EU legislation governing animal use, EFPIA and its member’s have ben publishing reports giving an extensive overview of their actions on putting animal welfare principles and the 3Rs into action.

Good Transportation practice of live animals for research

European legislation and good research practice require animals used in research to be purpose bred, however those animals cannot always be bred in or close to research sites, and therefore transportation in good conditions greatly contributes to the overall welfare of laboratory animals.

The primary objective while ensuring that legislative requirements are met, should be that animals are transported in a manner that does not jeopardise their well-being and ensures their safe arrival at their destination in good health, with minimal distress or fear which is important to ensure good animal welfare and the validity of scientific procedures.

Therefore, the Research and Animal Welfare Group recommends that EFPIA members, breeders, Contract Research Organizations and transporters consider the LASA guideline as a reference document when planning and carrying out transportation of laboratory animals. The document “Laboratory Animals – Good transportation practice” provides reference and links and highlights specific points to consider for the transportation of non-human primates, dogs and (mini-)pigs.

What can we expect from the industry going forward?

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. The research-based pharmaceutical industry not only complies fully with the letter of the law, it goes beyond compliance. Furthermore, the pharmaceutical industry will continue to 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. The Pharmaceutical industry will engage in dialogue and collaboration between all stakeholders and disciplines and facilitates exchange of good practice between life science community stakeholders to improve animal welfare and scientific outcome.

 

For more information, contact:

Magda Chlebus, Director Science Policy
magda.chlebus@efpia.eu

Kirsty Reid, Manager Science Policy and Animal Welfare
Kirsty.reid@efpia.eu