n tests sur animaux horreur , mensonge = "aucune' cruauté!

News release








New action programme to accelerate research into alternative approaches to animal testing
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Brussels, 21 June 2006 - The European Partnership for Alternative Approaches to Animal Testing (EPAA) today announced details of its first action programme, which aims to make significant progress in refining, reducing and replacing animal use (the ‘3Rs’) in the areas of regulatory testing. The Partnership – an unprecedented collaboration between the European Commission and industry – has agreed 21 key activities that will be carried out over the next five years. These range from assimilating best research practice from across seven industry sectors, to the evaluation of the regulatory drivers for animal testing, and ultimately the validation and acceptance of Alternative approaches to safety testing.
The overall programme will be co-ordinated by the Partnership’s steering committee co-chaired by Georgette Lalis from the European Commission and Colin Humphris representing European industry. In a joint statement they said: “The European Commission and European industry have both achieved much in recent years to refine, reduce and replace the need for animals in safety testing, but society rightly demands that we all increase our efforts. The adoption of this ambitious action programme clearly shows our commitment to pool resources and to work together to drive research forward in this crucial area. The refinement, reduction and replacement of animal testing is the goal of all members of the partnership, and we hope that the publication of this programme will encourage others to work with us.”
The action programme is divided into the following five principal themes which are interlinked and dependent upon one another:

The five areas will be managed in an integrated fashion to ensure consistency. An annual report from the Partnership on the implementation and impact of the Action Programme will be published for the public. The first report on implementation should be available by December 2006. The programme will be reviewed on a regular basis.
For further information please contact http://ec.europa.eu/enterprise/epaa/index_en.htm
Notes to Editor:
1. The European Partnership was created in November 2005 on the occasion of a Conference "Europe goes alternative" in Brussels hosted by Vice President of the European Commission Günter Verheugen and Commissioner Janez Potočnik.
2. The European Commission and the following seven industrial trade associations agreed on a “3 Rs Declaration”: the European Chemical Industry Council (CEFIC), the European Crop Protection Association (ECPA), European Association for Bio-Industries (EuropaBio), the European Cosmetic Toiletry and Perfumery Association (COLIPA), the European Federation on Pharmaceutical Industries and Associations (EFPIA), the International Association for Soaps, Detergents and Maintenance Product Industry in Europe (AISE), the International Federation for Animal Health Europe (IFAH-Europe).
3. The following companies have also endorsed the Declaration and joined the Partnership (BASF, Bayer, Henkel Phenion, Johnson&Johnson, L'Oréal, Pfizer, P&G, Unilever).
4. The Declaration establishes the framework for cooperation of the European Partnership, which aims at replacing, reducing or refining (3 Rs) animal use by applying advanced methodologies from biosciences and medicine to develop novel approaches to assessing safety.

Innovation in animal welfare


ECPA is participating in a new project to reduce, refine and, where possible, replace the use of animals in safety testing. This initiative is a multi-year project involving government, academia and industry representatives. Its aim is to develop an innovative, improved tiered testing scheme for the safety assessment of crop protection products.




Balancing ethical concerns
Crop protection products must be tested to ensure they are safe – but the industry also has a duty to respect animal welfare. Peter Day, ECPA’s Manager for Science and Technical Affairs, explains:
“As an industry, we have regulatory and ethical responsibilities to produce products that are safe to human health and the environment – and we have a responsibility to ensure the protection of animal welfare. We will work in partnership with the Commission and other stakeholders to explore all feasible opportunities to reduce, refine and replace the use of animals in safety assessments.”
Progress made
This new project has developed scientifically credible and viable methods for assessing the safety of crop protection chemicals more efficiently with the reduction, refinement and, where possible, the replacement of animal testing. The project was officially launched on 16 November at a conference hosted by the ILSI Health and Environmental Sciences Institute (HESI).

European partnership – the ‘3 Rs’
The announcement of this new project came just days after ECPA officially signed up to the ‘European Partnership to Promote Alternative Approaches on Animal Testing’ at a European Commission-hosted conference in Brussels (on 7 November 2005). This is the first time that so many industry sectors have had the opportunity to collaborate so broadly, not only amongst themselves but also with regulators and those concerned with validation methods.
This ‘3 Rs Declaration’ (“Replacement, Reduction and Refinement”) was signed by the leaders of seven industry associations, who all outlined their commitment to work together and in partnership with the European Commission to identify new alternative approaches to animal testing and to collaborate with all those concerned with the validation of new tests to speed up their acceptance and implementation.
This partnership will include the development of an Action Programme to implement practical aspects of the declaration, with annual reports on progress. The programme will identify barriers to progress and propose appropriate solutions to promote the development, validation, regulatory acceptance and practical implementation of alternative approaches. It will be published probably in the first quarter of 2006, with the first annual report in December 2006.
Key concerns
ECPA looks forward to collaborating with the Commission to minimise any requests for additional data, and to accept existing data. However, ECPA is concerned that certain regulatory requirements on testing go against the principles of the 3 Rs Declaration, and this should be avoided. ECPA strongly believes that a reduction in animal testing can be achieved by recognising the validity of existing data.
Further information
· ECPA press release (14 November 2005)
· ILSI-HESI (Health and Environmental Sciences Institute) workshop on agricultural chemical safety assessment (16 November 2005)
· ILSI-HESI Technical Committee on Agricultural Chemical Safety Assessment (ACSA)
· European Commission-hosted conference – ‘Alternative Approaches to Animal Testing – Europe Goes Alternative’ (7 November 2005)
· 3 Rs Declaration and addendum on next steps
· Press release issued jointly by the signatories of the 3Rs declaration
· Organisations supporting the 3 Rs Declaration are:
- CEFIC
- EFPIA
- Colipa
- EuropaBio
- AISE
- ECPA
- IFAH-Europe

HESI Workshop on Framework Approaches to Risk Assessment - Part 3, Wednesday, November 16, 2005


Workshop #2: Agricultural Chemical Safety Assessment
9:00 am – 3:00 pm


In 2004, the HESI Technical Committee on Agricultural Chemical Safety Assessment (ACSA), an international group of government, academic, and industry scientists, completed a multi-year project to develop an improved testing strategy for assessing the safety of crop protection chemicals. The tiered testing approach integrates metabolic and kinetic data into the safety assessment process; takes an integrated approach to evaluating life stage effects, systemic toxicity, and kinetics; and is guided by human exposure predictions. During this workshop, leaders of the ACSA Technical Committee will describe the tiered testing strategy and its underlying scientific basis, logic, and flexibility. In addition, speakers will quantify the reduction in the number of experimental animals required to perform a sound assessment using this approach and summarize government reception to the proposal to date.
Tentative Program


Welcome and Introduction:
Nancy G. Doerrer, MS (HESI) (confirmed)
Speakers:
Chair: Dr. Neil Carmichael (Bayer CropScience) (confirmed)
<BLOCKQUOTE dir=ltr style="MARGIN-RIGHT: 0px">
ADME
Dr. Hugh Barton (US Environmental Protection Agency National Center for Computational Toxicology) (confirmed)
Systemic Toxicity
Dr. John Doe (Syngenta CTL) (confirmed)
Life Stage
Ms. Lorraine Irvine (toXcel International) (confirmed)
Integration of Approaches
Dr. Neil Carmichael (Bayer CropScience) (confirmed)
US Government Perspective
Dr. Vicki Dellarco (US Environmental Protection Agency Office of Pesticide Programs) (confirmed)
"OECD Perspective" Dr. Drew Wagner (Organisation for Economic Cooperation and Development (confirmed)</BLOCKQUOTE>

Panel Discussion:
<BLOCKQUOTE dir=ltr style="MARGIN-RIGHT: 0px">
Moderator: Prof. Alan Boobis (Imperial College London) (confirmed)
Rapporteur: Dr. Angelo Moretto (University of Padua) (confirmed)
Panelists:
Dr. Vicki Dellarco (US Environmental Protection Agency Office of Pesticide Programs) (confirmed)
European Food Safety Authority Representative (invited)
Dr. Claire Franklin (University of Ottawa; formerly with Health Canada) (confirmed)
Dr. James Klaunig (Indiana University School of Medicine) (confirmed)
Dr. Roland Solecki (Federal Institute for Risk Assessment, Berlin) (confirmed)
Dr. Drew Wagner (Organisation for Economic Cooperation and Development)(confirmed)
</BLOCKQUOTE>

• 
  
  Speeches and presentations are available on this page.
  
• 
  
  Press release (07.11.2005) : Reducing animal testing: Commission agrees partnership with industry
  

Overview

Vice President of the European Commission Günter Verheugen and Commissioner Janez Potočnik held a Conference on Animal Testing on 7 November 2005. Speakers and participants included high-level representatives and experts from industry, animal welfare organisations, academia and national, European as well as international institutions.

The conference was the starting point for a European Partnership between the Commission and industry to promote alternative approaches to animal testing. Through this partnership, the European Chemical Industry Council (CEFIC), the European Federation on Pharmaceutical Industries and Associations (EFPIA), the European Cosmetic Toiletry and Perfumery Association (COLIPA), the European Association for Bioindustries (EuropaBio), the European Crop Protection Association (ECPA), the International Association for Soaps, Detergents and Maintenance Product Industry in Europe (AISE), and the Commission agreed to the “Three Rs Declaration” (text and addendum ) aiming at refining, reducing or replacing (3 Rs) animal use.

Based on the declaration, a task force made up of representatives of the European Commission and stakeholders will set up an action programme with concrete activities during the first quarter 2006. It will be designed in the perspective of identifying barriers to progress and propose appropriate solutions in order to promote the development, validation and regulatory acceptance of alternative approaches, as e.g.

• 
  
  mapping of research activities and current strategies
  
• 
  
  cooperation in research to strengthen and enlarge current activities between the partners and other relevant stakeholders
  
• 
  
  development of alternative approaches, including intelligent testing strategies
  
• 
  
  practical mechanisms to improve the validation process using available knowledge
  
• 
  
  practical mechanisms to facilitate the regulatory acceptance process of alternative approaches
  
• 
  
  widening stakeholders' dialogue
  
• 
  
  practical mechanisms to foster innovation in the areas of alternative approaches.
  

An annual report from the partnership on the implementation of the action programme will be published for the attention of the Council, European Parliament and other relevant stakeholders. The first report should be published by December 2006.





Speeches and presentations

1. Introduction
<BLOCKQUOTE>

• 
  
  Günter Verheugen, Vice President of the Commission for Enterprise and Industry : A new partnership to reduce Animal Testing
  
• 
  
  Janez Potočnik, Commissioner for Science and Research : Speech
  

</BLOCKQUOTE>

. Animal Welfare and European Action

Chair: Catherine Day, Director General of DG ENV
<BLOCKQUOTE>
<BLOCKQUOTE>

• 
  
  Concerns and Priorities for Animal Welfare, Sonja van Tichelen, Eurogroup for Animal Welfare (EWLA)
  
• 
  
  Corporate Responsibility & Animal Testing, Martin Kayser, BASF AG
  
• 
  
  Corporate Responsibility: A Consumer Goods Company Perspective, Luca Virginio, The Procter & Gamble Company
  
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  International Framework for Animal Testing and Alternative Methods, Rob Visser, OECD
  
• 
  
  Alternative Methods and Animal Use in Pharmaceutical Industry, Wolfgang Hartwig, Bayer AG
  
• 
  
  Animal Testing and Alternative Methods - A Scientific Perspective, Coenraad Hendriksen, Netherlands Vaccine Institute (NVI)
  

</BLOCKQUOTE></BLOCKQUOTE>

3. Risk Assessment and Alternative Methods
<BLOCKQUOTE>
<BLOCKQUOTE>

• 
  
  Development & Validation of Alternative Methods to Animal Tests, Thomas Hartung, ECVAM
  
• 
  
  Framework for Alternative Test Methods in the US, Leonard Schechtman, FDA/ Chairman of ICCVAM
  
• 
  
  Alternative Methods to Animal Testing - A Cosmetic Industry Perspective, Odile de Silva, L’Oréal
  
• 
  
  Assuring Safety without Animal Testing, Bart Sangster, UNILEVER
  

</BLOCKQUOTE></BLOCKQUOTE>

4. Round Table “The Way Forward”

Chair: Dagmar Roth-Behrendt, Vice-President of the European Parliament
<BLOCKQUOTE>
<BLOCKQUOTE>

• 
  
  Presentation of the 3 Rs Declaration, Heinz Zourek, Acting Director General, DG ENTR
  
• 
  
  Introductory Remarks on the 3 Rs Declaration, Sonja van Tichelen, EWLA
  
• 
  
  Statements of CEFIC, EFPIA, EuropaBio, COLIPA, ECPA, AISE on the 3 Rs Declaration
  
• 
  
  Concluding Remarks, Dagmar Roth-Behrendt, Vice-President of the European Parliament
  

</BLOCKQUOTE></BLOCKQUOTE>

European Commission
Directorate-General for Enterprise and Industry
Avenue d’Auderghem 45
B-1040 Bruxelles (Belgium)
Tel.: +32 2 29 60820/ 91976
Fax: +32 2 29 66467
E-mail: entr-conf-animal-tests@ec.europa.eu

EU in pact to limit use of animals in product testing



Reuters, The Associated Press

Published: June 21, 2006BRUSSELS The European Union and the leaders of major industries agreed Wednesday on a five-year plan to limit the use of animals in product- safety testing.
The program, undertaken by the European Commission and leaders of the cosmetic, chemical and pharmaceutical industries, will examine research practices and regulations with the goal of eliminating the use of animals in testing where possible.
The plan also included EU guidelines covering when the industries could label products "not tested on animals." To use such labels, the industries would have to meet EU criteria and prove that no animals had been used to test the products.
"We know from public opinion surveys that animal rights are very close to the hearts of Europeans," said Janez Potocnik, EU commissioner for science and research. "Through research, we can develop ways of offering consumers a greater choice of products that have not been tested on animals."
The European Partnership for Alternative Approaches to Animal Testing was created in 2005 as a forum for collaboration among the EU and federations representing chemical, cosmetic, pharmaceutical, crop protection and other industries.
It is backed by companies like BASF, Johnson & Johnson, L'Oréal, Pfizer, Unilever and Procter & Gamble and that have faced protests by animal welfare organizations.
"I invite more companies to join our common effort to reduce the number of animals used in safety testing," Günter Verheugan, an EU commissioner, said

About 20 percent of tests carried out on animals in Europe are to fulfill regulatory requirements because of safety standards in areas like pharmaceuticals, chemicals, cosmetics, biotechnology and food.
EU governments and industry leaders are moving to meet a 2009 deadline after which most cosmetic products that employ animal testing would be banned within the 25-nation bloc.
The commission said that it had validated 23 alternative testing methods that do not involve animals and about 30 others were being evaluated.
Animal rights groups welcomed the plan as a step in the right direction, but said that faster action was needed to end animal suffering.
"This initiative shows that there is a strong desire amongst politicians and business to leave cruel and outdated animal tests behind," said Sean Gifford of the British Union for the Abolition of Vivisection.
"However, 10 million animals continue to suffer and die in EU laboratories, and that's 10 million animals too many," he added.
"We need an immediate shift away from animal-based testing."

La Commission présente de nouvelles méthodes de test réduisant l'expérimentation animale et maintenant la qualité des médicaments[en]

Publié: mardi 13 mai 2003

Le 12 mai, la Commission a annoncé que grâce à de nouvelles méthodes d'essais pharmaceutiques, les agents causant de la fièvre (pyrogènes) seront dorénavant détectés à l'aide de cellules de sang humaines comme biodétecteurs au lieu des lapins.

Le Parlement donne son approbation finale à la législation sur les cosmétiques[en]

Publié: jeudi 16 janvier 2003

Le 15 janvier, le Parlement a donné fin à la discussion, longue d'une décennie, sur les tests des produits de beauté sur les animaux en donnant à l'industrie la date limite de 2009 pour trouver des méthodes de test alternatives.

Réussite de la deuxième réunion de conciliation sur l'interdiction des tests de produits cosmétiques sur les animaux[en]

Publié: vendredi 8 novembre 2002

La deuxième réunion de conciliation du Parlement et du Conseil a permis de parvenir à un accord sur l'interdiction des tests sur les animaux et sur la mise sur le marché des produits de beauté testés sur les animaux.ù

Success at second conciliation meeting on animal testing ban for cosmetics

Published: Friday 8 November 2002

The second conciliation of the Parliament and the Council resulted in an agreement on the banning of animal testing and marketing for cosmetics.
Background:


Other related news

• Commission face-off with cosmetics companies
  
• EU bans 22 hair dye substances on health concerns
  
• Industry commits to reduce animal testing
  
• Commission-industry partnership aims to reduce animal testing
  
• Commission presents new testing methods to save animals, maintain drug safety
  

At their second conciliation meeting on 6/7 November, the Council and the European Parliament reached an agreement on the main points of the seventh amendment of Directive 76/768/EEC on cosmetics. The new directive aims at improving animal welfare without jeopardising consumer safety and the protection of human health, while enabling the Community to respect its international obligations.




Issues:


The debate centered around the following main issues:

• Improve animal welfare by introducing a ban of thetestingof cosmetics products on animals;
  
• Maintain consumer safety and the protection of human health in the absence of animaltesting. This will be achieved by introducing an immediate ban where alternative non-animal tests are available. Where an alternative is not readily available, the deadline for the complete ban is 2009. In the case of three tests that are particularly difficult to replace, the due date is 2013;
  
• Ban themarketingof animal tested products, including third-country imports;
  
• Validate new testing methods by the Organisation for Economic Co-operation and Development (OECD);
  
• Align the provisions of the cosmetics directive with the rules of the World Trade Organisation (WTO).
  

Positions:


<strong>MEP Dagmar Roth-Behrendt (PES, D) , rapporteur, regarded the outcome of the conciliation meeting as a "huge success" for Parliament since the outcome was close to the EP's second reading position.

The Chairman of the Council Delegation, Danish Environment Minister Hans Christian Schmidt, said he was pleased that such an important decision as the end to animal testing of cosmetic products, was agreed during the Danish Presidency.
TheEurogroup for Animal Welfareas well asRSPCA International, expressed disappointment over the compromise deal. The animal welfare groups are dissatisfied with the decision to allow three of the tests to continue for ten years after the directive enters into force, with a possible further extension if no alternatives are found. Both groups find the testing of cosmetic products and ingredients on animals "unnecessary and morally indefensible".

Latest & next steps:


The Council and Parliament delegations will now have to reach agreement on additional amendments that do not concern the testing and sales ban. The agreement will then have to be approved by the Council and Parliament at third reading.




Links


Official Documents:

• European Parliament: News report 7 November 2002 [ FR ]
  

• Danish Presidency: Agreement on the banning of animal testing for cosmetics
  

• Eur-Lex: Directive on the approximation of the laws of the Member States relating to cosmetic products [ FR ] [ DE ][76/768/EEC] (27 July 1976)
  

• Council: Common position with a view to the adoption of a Directive of the Eur opean Parliament and of the Council amending Council Directive 76/768/EEC on the approximation of the laws of the Member States relating to cosmetic products
  

• European Parliament: Recommendation for second reading on the Council common position for adopting a European Parliament and Council directive amending Council Directive 76/768/EEC on the approximation of the laws of the Member States relating to cosmetic products [FR] [DE] (24 May 2002)
  

EU Actors' positions:

• Eurogroup for Animal Welfare: Eurogroup disappointed over compromise reached in Conciliation on cosmetic testing (7 November 2002)
  

• RSPCA: Cosmetics testing decision condemned
  

• Press articles: Reuters , The Guardian , The Telegraph , BBC , CNN , Yahoo/France , Yahoo/Germany
  

Parliament gives final approval to cosmetics legislation

Published: Thursday 16 January 2003

The Parliament finalised on 15 January the decade-long discussion over animal testing of cosmetics giving industry a 2009 deadline to find alternative testing methods.
Background:


Other related news

• Commission face-off with cosmetics companies
  
• EU bans 22 hair dye substances on health concerns
  
• Industry commits to reduce animal testing
  
• Commission-industry partnership aims to reduce animal testing
  
• Commission presents new testing methods to save animals, maintain drug safety
  

Following the conciliation agreement reached on 6-7 November between EU Member States and the Parliament regarding the seventh amendment of Directive 76/768/EEC on cosmetics (see also EurActiv[url=xlink:href="tcm:25-112862"]8 November 2002[/url]), the Parliament cast its final approval vote in plenary on 15 January. The new directive that covers products including shower gels, shampoos and creams, aims at improving animal welfare without jeopardising consumer safety and the protection of human health.

Parliament agreed a 2009 deadline for the complete ban on animal testing of cosmetics where alternative non-animal tests are currently unavailable. The industry managed to secure a 2013 ban date for the case of three tests that are particularly difficult to replace. As an internationally debated element in the decision, the animal testing ban includes a ban on imports into the EU of beauty and hygiene products produced outside the bloc.
The Council's final approval of the new legislation is expected in the coming days.

Commission presents new testing methods to save animals, maintain drug safety

Published: Tuesday 13 May 2003

Thanks to new methods of drug testing revealed by the Commission on 12 May, fever-causing agents (pyrogens) from now on will be detected using human blood cells as biosensors, instead of rabbits.
Background:


Other related news

• Commission face-off with cosmetics companies
  
• EU bans 22 hair dye substances on health concerns
  
• Industry commits to reduce animal testing
  
• Commission-industry partnership aims to reduce animal testing
  
• Parliament gives final approval to cosmetics legislation
  

The new set of six tests developed by an EU-supported research team is less laborious, cheaper and more sensitive compared with the rabbit test. As a result, interest from both regulatory authorities and industry is high and the tests are already in use in about 200 laboratories worldwide.

While EU Research Commissioner Philippe Busquin maintained that unfortunately animal testing remains necessary to safeguard human health, he said its use could be reduced "leading the way at world level", while ensuring drug safety and quality.
The tests, developed through funding under the EU Fifth Research Framework Programme for parenteral (non-oral) drugs, are currently being validated by the Commission for each and any possible use. This will have regulatory implications as under EU legislation, no animal experimentation can be carried out if a validated aternative is available. A patent is also in the pipeline to encourage the successful transfer of pyrogen testing to other fields, including medical devices and cellular therapies.

Fewer tests on animals and safer drugs: new EU tests save 200,000 rabbits per year







Reference: IP/03/662 Date: 12/05/2003








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IP/03/662
Brussels, 12 May 2003

Fewer tests on animals and safer drugs: new EU tests save 200,000 rabbits per year


New, groundbreaking methods of drug testing to replace animals with safe alternatives, saving up to 200,000 rabbits per year, were unveiled today in Brussels by European Research Commissioner Philippe Busquin. The set of six tests detects potential fever-causing agents (pyrogens) in drugs, by using human blood cells instead of rabbits. The new tests have been developed by a EU-supported research team, involving national control laboratories, test developers, and companies. The tests are being validated by the Commission. They are already being used in over 200 laboratories across the world. Thanks to these alternative methods rabbits will no longer be needed to test the presence of pyrogens in parenteral (non oral) drugs.
"The use of animals to test drugs is unfortunately necessary to safeguard human health," said European Research Commissioner Philippe Busquin. "But we can reduce, replace and refine animal testing, with EU-sponsored research leading the way at world level. The EU's validation of these new testing methods will encourage their broad take-up by industry, ensure drug safety and quality, and reduce the use of animal research. This is an example of the European Research Area in action, developing an environment in which scientific results can be rapidly exploited and transformed into products and processes that improve quality of life, increase competitiveness and benefit animal welfare."
The safety and potency of commercially available medicines and vaccines must be guaranteed. Innovative research, funded and validated by the Commission, aims to replace existing animal-based test methods for fever-causing agents (pyrogens) in parenteral drugs with a new generation of in vitro tests that are more accurate, quicker and more cost-effective.
Blood cells replace rabbits
Understanding of human immunology has advanced rapidly in the past 20 years. Work on human fever reaction and development of test systems for fever mediator molecules, combined with improved cell biology techniques, now enables the innovative use of human cells as biosensors for pyrogens (fever-causing agents). The EU study(1) set out to compare and harmonise six in vitro assays to develop a "state-of-the-art" method for inclusion into the European Pharmacopoeia - which sets the requirements for the quality control of drugs in Europe - thus improving consumer safety.

The EU role
The research project funded by the Commission under the EU Fifth Research Framework Programme (1998-2002) brought together the best teams from academia, industry and regulatory bodies. The Commission's Joint Research Centre (the "ECVAM" facility, or "European Centre for Validation of Alternative Methods") played a major role in the project through provision of scientific and technical advice on the design of the validation study, application of good laboratory practice procedures and distribution and coding of test material.
Industry and regulators jump on board
Interest from both regulatory authorities and industry is very high, with many contributions coming from outside the project consortium that included national control laboratories, test developers, a major pharmaceutical company and a producer of diagnostic kits. For example, the European Pharmacopoeia has set up an international expert group to draft a general method on these new tests. In fact, the tests are already in use in about 200 laboratories worldwide, with great success.
Further take-up and new applications
The Commission will take responsibility for further application of this multidisciplinary, international validation study, including an intended patent. This will encourage successful transfer of the tests and help open new fields for pyrogen testing, such as cellular therapies, medical devices and pollution control in the work place.
Reducing, replacing or refining animal experimentation
Drug quality control is a trans-national matter, which is standardised and regulated in Europe at EU level, thus requiring international collaborative efforts. The European Commission ensures full support for applications to reduce, replace or refine animal experimentation as required by the 1986 Council Directive(2). This aim is echoed by the European Pharmacopoeia. The "Three Rs" provide a strategy to minimise animal use, without compromising the quality of the scientific work being done.
ECVAM's role is to co-ordinate international validation studies, act as a focal point for the exchange of information, to set up and maintain a database on alternative methods, and to promote dialogue among legislators.
Background: pyrogen and non-oral drugs
Parenteral drugs are commonly employed throughout Europe for treating a variety of illnesses. Ensuring the safety of such widely used drugs requires strict monitoring and control against any possible pyrogenic contamination on a batch-by-batch basis. The most important pyrogen is endotoxin, a constituent of the cell wall of gram-negative bacteria that can generate endogenous fever mediators by white blood cells, particularly monocytes and macrophages.

Rabbits or…
In the rabbit pyrogen test, the test substance is injected into rabbits and any subsequent change in body temperature recorded. A significant rise in temperature indicates the presence of pyrogens. While it has served drug safety control for more than 50 years, it fails for important new therapies such as cellular products or species-specific agents.
… horseshoe crabs?
Until now, the only in vitro alternative available is the LAL test, based on coagulation of blood from the horseshoe crab (Limulus polyphemus). However the LAL test detects only one class of pyrogens endotoxins from gram-negative bacteria leaving patients at risk from "non-endotoxin" pyrogens such as gram-positive toxins, viruses and fungi. It is also subject to interference by various non-pyrogenic substances. And, as it is based on the defence system of an arthropod, it cannot provide results perfectly relevant to humans.
No human blood cells!
Six alternative cellular assays have therefore been developed to replace the animal rabbit pyrogen test and close the safety gap presented by use of the LAL test in controlling parenterals. All these test systems are based upon the response of human leukocytes (principally monocytes), which release inflammatory mediators (endogenous pyrogens) in response to pyrogenic contamination (exogenous pyrogens).
Quicker, more accurate and more effective
The new tests have several advantages compared with the rabbit test: they are less laborious, cheaper and more sensitive. Results of the validation study suggest that testing on animals can be completely replaced. In contrast to the LAL, the new assays are not restricted to endotoxins from gram-negative bacteria but detect all classes of pyrogens and reflect the potency of different endotoxins in mammals, without suffering interference from endotoxin-binding components in blood products. A commercial kit version for one of the assays has already been developed and standardised, and pre-tested cryopreserved (frozen) blood as a versatile test reagent containing the blood cells as biosensors is under development.
For further information please visit:
http://ecvam.jrc.it/index.htm
http://ec.europa.eu/research/quality-of-life/cell-factory/volume1/projects/qlk3-1999-00811_en.html
(1)Cell factory project: Comparison and validation of novel pyrogen tests based on the human fever reaction, with a view to the ultimate replacement of the rabbit pyrogen test and the Limulus assay (QLK3-1999-00811)
(2)Novel in-vitro testing as alternatives to animal testing; Council Directive 86/609/EEC

Moins d'expérimentation animale et des médicaments plus sûrs: les nouveaux essais de l'UE sauvent 200.000 lapins par an







Reference: IP/03/662 Date: 12/05/2003








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IP/03/662
Bruxelles, le 12 mai 2003

Moins d'expérimentation animale et des médicaments plus sûrs: les nouveaux essais de l'UE sauvent 200.000 lapins par an


Philippe Busquin, membre de la Commission européenne chargé de la recherche, a annoncé aujourd'hui à Bruxelles de nouvelles méthodes révolutionnaires d'essais pharmaceutiques afin de remplacer l'expérimentation animale par des solutions sûres et sauver ainsi près de 200.000 lapins chaque année. En effet, cette série de six essais permet de détecter les substances pyrogènes potentielles dans les médicaments à l'aide de cellules sanguines au lieu de lapins. Les nouveaux essais ont été mis au point par une équipe de chercheurs soutenue par l'UE et réunissant des laboratoires de contrôle nationaux, des développeurs d'essais et des entreprises. La Commission procède actuellement à la validation de ces essais qui sont déjà utilisés dans plus de 200 laboratoires à travers le monde. Grâce à ces méthodes de substitution, les lapins ne seront plus nécessaires pour détecter la présence de pyrogènes dans les médicaments parentéraux (administrés par voie non digestive).
"Afin de préserver la santé humaine, il est hélas nécessaire de recourir aux animaux pour expérimenter les médicaments," a déclaré Philippe Busquin, membre de la Commission européenne chargé de la recherche. "Mais, grâce à des activités de recherche parrainées par l'UE et ouvrant la voie au niveau mondial, nous pouvons limiter, remplacer et affiner l'expérimentation animale. La validation par l'UE de ces nouvelles méthodes d'essai encouragera les entreprises à les adopter, garantira l'innocuité et la qualité des médicaments et limitera l'utilisation des animaux dans la recherche. Il s'agit là d'un exemple des effets de l'Espace européen de la recherche, à savoir créer un environnement dans lequel les résultats scientifiques puissent être rapidement exploités et transformés en produits et procédés qui améliorent la qualité de vie, accroissent la compétitivité et contribuent au bien-être des animaux."
L'innocuité et l'activité des médicaments et vaccins disponibles dans le commerce doivent être garanties. C'est pourquoi des activités de recherche innovantes, financées et validées par la Commission, visent à remplacer les méthodes actuelles, basées sur l'expérimentation animale, de recherche de substances pyrogènes dans les médicaments parentéraux par une nouvelle génération d'essais in vitro qui sont plus précis, plus rapides et plus rentables.