AlternativesTo Animals
There is a huge range of non-animal research techniques that, as well as being a more humane approach to science, can also be cheaper, quicker and more effective. These include cell, tissue and organ culture; micro-organisms such as bacteria; molecular research; studies with post-mortem tissues; computer simulations, including QSARs; population studies (epidemiology) and clinical research with human volunteers.
Alternatives and the law
European law clearly states that where a non-animal alternative is available, the animal-test equivalent must not be performed. Article 7.2 of EU Directive 86/609/EC (which deals with animal experimentation in the EU) states that:
"An experiment [animal] shall not be performed if another scientifically satisfactory method of obtaining the result sought, not entailing the use of an animal, is reasonably and practically available."
Article 23.1 also states that EU governments should promote non-animal alternatives:
"The Commission and Member States should encourage research into the development and validation of alternative techniques, which could provide the same level of information as that obtained in experiments using animals but which involve fewer animals or which entail less painful procedures."
REACH legislation (which aims to establish whether chemicals are safe for humans and the environment) also promotes "alternative methods for assessments of hazards of substances" and points to the development of alternatives as a priority for future EU research. It makes it clear that animals must only be used as a last resort.
However, despite the protection laboratory animals are supposed to receive by law, the reality is often very different due to:
- inadequate funding for alternatives development
- lack of political will to make non-animal research a priority
- reluctance of animal researchers to find alternatives because they view animal tests as 'traditional'
- the conservative approach of regulatory authorities that still insist on animal experiments even when there is a proven non-animal method available and even in use.
- the process of test method validation can take many years (typically 9-11 years) before a non-animal method is accepted for use as a complete replacement to animal tests.
QSARs (Quantitative Structure/Activity Relationship programs)
These are computer programs which can predict the toxicity of new chemicals or drugs based on their similarity to more established compounds.
Silicon chip technology
Allows rapid identification of genes whose activity changes in response to certain diseases and drugs. Can help identify both whether a drug or chemical is going to be therapeutic or harmful.
Cell cultures
Almost every type of human cell can be grown in culture, although the cells behave more simplistically than in the living body. Cellular systems have been central to key research into cancers, sepsis, kidney disease and AIDS, and are routinely used in chemical safety testing, vaccine production, drug development and to diagnose disease.
Human tissues
Both healthy and diseased tissues can be donated from human volunteers after biopsies, surgery or death. Blood or urine samples can also be easily taken. Post-mortem brain tissue has provided important leads to understanding brain regeneration and the effects of MS. One important alternative is the Reconstituted Human Epidermis (RHE) skin model (Trade names, Episkin, Epiderm and SkinEthic). These used reconstituted human skin derived from donated, unwanted skin from cosmetic surgery. The models are used to test the likely irritancy of chemicals and cosmetics to the skin. One model has recently been shown to be more effective than the original rabbit Draize skin test which it replaces.
Volunteer studies
Examples of this include Magnetic Resonance Imaging (MRI) which generates detailed pictures of the brain and, when used in conjunction with other techniques, can identify the location of specific brain activities, and microdosing which involves giving very tiny doses of a chemical compound to human volunteers in order to monitor where it goes in the body.
Population research
Studying illnesses in human populations to understand the roles of genes, lifestyle, diet and occupation, has had a tremendous impact on saving lives, especially from cancer and heart disease.
Implementation of alternatives
In many countries, such as Japan or the USA, there is no legislative requirement obliging researchers to use alternatives. So in those countries there is absolutely nothing stopping researchers from continuing to conduct cruel animal experiments even if a non-animal replacement is widely available.
In other countries, such as the UK and the rest of the EU, there is provision in the law to say that if an alternative method exists, it is against the law for the Government to continue licensing the traditional animal method. However there are a number of issues with this…
The legal obligation to use alternatives where available relies on those alternatives being officially seen to be available, and that in itself is a long and complex process. Once a non-animal method has been developed, it is then required to go through a formal validation process to demonstrate that the method is reliable, relevant and repeatable. This validation usually includes development, trial, further development, further trial and assessment, all of which can take many years, particularly if funding is tight (which it invariably is for non-animal research).
In addition, even though EU legislation dictates that animals must not be used when alternative methods are available, in practice enforcement of this is very weak and punishments for researchers who disobey the law are usually minimal. The BUAV has had to take the UK Government to court, and threaten to do so on another occasion, because it was misapplying the law relating to alternatives. The BUAV also regularly comes across published research papers where animal experiments have been performed in areas such as fundamental (curiosity driven) research, despite the fact that there were very obvious and more appropriate non-animal methods of research that could have been used instead.
Acceptance in Europe
In the EU validation is conducted by the European Centre for the Validation of Alternative Methods (ECVAM) and if a method is successful it will be considered an officially validated method, see TSAR . But that is not the end of the story. Although the non-animal method has gone through validation (a process that most animal tests have never had to go through), that doesn't necessarily mean that it will be considered ready as a replacement method. National governments, individual EU Member States for example, are free to accept ECVAM validation as sufficient in order to discontinue licensing an animal test within their national borders if they so wish. However, more usually a further layer of acceptance is considered necessary and that involves acceptance at OECD level-contrary to the law, in our view.
Acceptance internationally
The Organisation for Economic Co-operation & Development (OECD) sets and reviews the international test guidelines for all OECD countries around the world. Many countries will insist on waiting for an OECD panel to officially accept the validated non-animal method before they will consider it a replacement method. Obtaining OECD acceptance can in itself take a number of years. So whilst a non-animal method may be technically available relatively early on, because it has to go through such a convoluted and lengthy validation and acceptance process, it can actually take many years before it is officially considered available to replace its equivalent animal test. That means that animals will continue to die in labs for years even though a suitable non-animal test could replace them.
BUAV is a member of ICAPO that has a seat at the table of some OECD discussions, in order to help speed up this process.
The International Council on Harmonisation (ICH) and the International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Products (VICH) are the equivalent of the OECD but for human and animal pharmaceuticals respectively.
They produce guidelines for how drugs should be tested before and during human trials. Europe, USA and Japan are the main regions involved and if they all sign up to an ICH/VICH guideline then that becomes the standard guideline in that country. However, in order to facilitate harmonization, guidelines at this level are very vague and it is extremely hard to include any kind of new method in them when they are revised, which happens only every few years.
BUAV is a member of ICAPPP which is seeking to influence discussions at this level.
