Brussels, 12 May 2003
Today in Brussels the European Commission presented new methods of drug testing to replace animals with safe alternatives. The set of six tests, developed by EU-supported research and validated by the Commission, detects potential fever-causing agents (pyrogens) in drugs, by using human blood cells instead of rabbits.
Can the new tests finally replace the rabbit test?
This will have to be established by EU Member States' regulators on a case-by-case basis, to ensure consumer and patient safety and animal welfare. However, so far no examples have been encountered where the tests failed to serve this purpose.
When will the methods be formally accepted?
European and other Pharmacopoeias are independent with regard to the implementation of new methods, although strongly favouring alternatives. The creation of an international expert group parallel to the EU validation study, which was charged to draft a General Method for the new tests, might have slowed down acceptance of the new tests. But some individual countries such as Brazil and South Korea are already considering implementation.
Are there differences between the new tests?
Yes, the tests differ with regard to labour, standardisation and applicability. Therefore, it is not possible to try to define a single procedure to use them. The Commission is therefore offering a series of alternatives to be chosen for the individual application.
Might the use of human cells pose ethical or safety problems?
From the ethical point of view, voluntary blood donations represent no problem. As far as health hazards are concerned, human cells are potentially infectious since they can harbour pathogenic viruses (fresh blood cells as well as cell lines). However, for both blood donation and laboratory practice strict guidelines for safe handling are available. Members of the EU-sponsored research consortium have developed a method for cryopreservation (freezing) of blood thus solving safety problems related to human blood cells.
Do patents restrict the use of the tests?
Some patents exist, which do not restrict scientific use, but enable commercialisation. The consortium is currently preparing a patent application for certain novel uses of the tests.
Can the methods be used already?
Yes, although not formally introduced. Competent regulators accept these tests on a case-by-case basis. The US Food and Drug Administration (FDA) has already applied one of the tests as a routine control for a specific drug. However, the product-specific validation required for any product is more difficult if the methods are not yet formally included in Pharmacopoeia.
Can the rabbit test still be used now?
EU legislation states that no animal experimentation can be carried out, if a validated alternative is available. The new tests are now in a transition phase, where they were found scientifically valid but the actual use will have to be defined for each and any possible use. However, the Commission encourages regulators to foster the implementation of the tests.
Can other experiments on animals be replaced?
These new tests, as well as recent successes in safety toxicology of chemicals, as endorsed by the Organisation of Economic Co-operation and Development (OECD), show there is further scope for reducing, replacing and refining animal testing. Few people believed earlier that a complex function such as fever could be transferred to the test tube. However, state of the art science combined with technological development can achieve key results without impairing consumer safety.
Are validations too expensive?
A new test requires about €100,000 for pre-validation, and €200,000 for final validation. Many animal experiments require more than one alternative, depending on the product, either for additional confirmatory tests or for more complex testing strategies.
Given the advantages of alternatives once established (reduction in costs and use of animals, replacement of non-validated animal experiments by validated state-of-the-art scientific alternatives, higher through-put), and the overall expenses for animal testing (estimated as more then €3 billion per year), this appears to be a reasonable investment.
Does the EU invest enough in the development and validation of alternatives to animal testing?
There is an increasing demand from the public and policy-makers to make validated alternative tests available. The Commission has responded with an increased research effort, with €67 million allocated to this priority over the last 5 years, and with the work of the European Centre for the Validation of Alternative Methods (ECVAM).
In the EU 6 th Research Framework Programme (2003-2006), one of the topics within thematic Priority 1: "Life Sciences, Genomics and Biotechnology for health"
is the development of new in vitro tests to replace animal experimentation.
This area will focus on the development of alternatives that will replace the need for animal experiments, reduce the number of animals required, or reduce significantly experimental animal suffering. The topics considered will have to contribute directly to the aims of Directive 86/609/EEC on the protection of animals used for experimental and other scientific purposes. Priority will be given to alternative methods that will be ready for formal validation and wide industrial application.
While EU-funded research projects develop new tests, ECVAM validates them so as to make sure they meet the highest health and safety standards, thereby fostering their take-up by industry and health organisations. Validation should not slow down the process on the contrary, it aims to improve it. But industry is also called upon to develop and make available its promising in-house methods, since private companies are the ones to benefit from validated alternatives.
DN: MEMO/03/104 Date: 12/05/2003
DN: MEMO/03/104 Date: 12/05/2003