Deputy Director General of Enterprise and Industry DG. Global Cooperation on alternatives (3Rs) to animal testing

Transcription

1 Ref. Ares(2012) /11/2012 SPEECH Antti PELTOMÄKI Deputy Director General of Enterprise and Industry DG Opening speech for the 8 th EPAA Annual Conference Global Cooperation on alternatives (3Rs) to animal testing 8 th EPAA (European Partnership for Alternative Approaches to Animal Testing) Annual Conference Brussels Centre Borschette, rue Froissart November

2 Ladies and Gentlemen, On behalf of the European Commission I would like to welcome you to this year's Annual Conference of the European Partnership for Alternative Approaches to Animal Testing. Since its creation in 2005, the EPAA has been one of the pioneers in promoting alternative approaches to replace, reduce and refine animal testing, the so-called 3RS. The issues we are discussing right now are of high importance. While we are meeting here today to give you an update of our work, you will hear that we are working on very diverse issues. These are research and the application of ADME/PBTK (Administration Distribution Metabolism Excretion/ Physiologically Based Toxicokinetik) modelling, computational toxicology, read across and QSAR methods are examples of other alternative methodologies we are considering. This work can be truly successful only if it is carried out on an international basis, so that the result can also be applied globally. What makes EPAA so unique is that it results in co-operation between the public sector and industry. It also cuts across a wide range of sectors. This interesting mix is a good breeding ground for new innovative ideas and therefore an example for the global community. 2

3 Innovation and research are the motors of our work. Animal welfare and ethical issues are our Leitmotiv! Since 2007, animal welfare is a principle in the EU Treaty. Therefore it is natural that the promotion of alternative approaches is high on our political agenda. Europe has pioneered efforts to replace, reduce and refine animal testing the 3Rs (Replacement, Reduction and Refinement of Animal Testing). Since Russell and Burch s concept of 3Rs was developed in 1959, Europe has led the way. The 3Rs principle is enshrined in many of our activities. I will mention five of them. 1. Firstly, research and innovation are the drivers for a full implementation of the 3Rs. The search for alternatives to animal testing is part of the EU Research Framework Programme. For example, considerable attention has been paid to this research under the health theme of the Co-operation programme of FP7. Examples are research projects 1, co-funded by FP7 and Cosmetics Europe to the tune of 50 million. This research is developing replacement methods for in vivo repeated dose systemic toxicity testing. 1 SEURAT-1 cluster of research projects 3

4 And we have also established an EU Reference Laboratory - for Alternatives to Animal Testing (EURL- ECVAM) that leads and co-ordinates validation activities for the development of alternative approaches in the EU. And, internationally, it operates as a partner of the International Co-operation on Alternative Test Methods (ICATM). 2. Secondly, you will also be aware of the REACH Regulation a Regulation to improve the protection of human health and the environment from the risks that can be posed by chemicals. One of REACH's objectives is the promotion of alternative methods for the assessment of hazards in chemicals. The principles of the 3R's of animal testing are mentioned and the use of alternative methods is encouraged 2. On the basis of REACH the Commission adopted the Test Methods Regulation. ECHA is mainly working on the use of the test methods in the testing proposals submitted in registration files. It also evaluates these files under REACH. ECHA examines the testing proposals to check that the proposed test is suitable to generate reliable data for fulfilling the standard 2 Article 13(1) 4

5 information requirement and prevents unnecessary animal testing. Every proposal that involves vertebrate animals is published on the Agency's website and third parties are invited to submit scientifically valid information and studies addressing the substance and hazard, which ECHA takes into account before taking a decision. Through its echemportal, ECHA facilitates the sharing of available data and information by companies, scientists and citizens and thereby helps to avoid unnecessary animal tests. ECHA contributes to the development of test methods via OECD. It supports the development of alternative methods and promotes their use. For example, the Agency is developing (in co-operation with the OECD) the QSAR Toolbox 3. It is a software application to be used by governments, the chemicals industry and other stakeholders to fill gaps in (eco) toxicity data needed for assessing the hazards of chemicals. 3. Thirdly, in pharmaceuticals over the past years a shift has been observed towards the regulatory acceptance of 3 Quantitative structure activity relationship models (QSAR models). QSARs predict chemical behaviour directly from chemical structure and simulate adverse effects in cells, tissues and lab animals, minimising the need to use animal tests to comply with regulatory requirements for human health and eco-toxicology endpoints. 5

6 scientifically valid in vitro methods as well as formally validated in vitro methods as part of an integrated testing strategy. Moreover, the focus has broadened to the application of all the 3Rs (replacement, reduction and refinement). This is in contrast to the emphasis that has been historically placed only on replacement of animal studies by one or more in vitro or in silico approaches. EU initiatives such as the European Centre for the Validation of Alternative Methods (ECVAM) and the EPAA facilitate progress in this field. The application of all 3Rs is currently embedded in the drafting process of non-clinical regulatory guidance both at the European Medicines Agency and the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) level. 4. Fourthly, in the case of the Cosmetics Directive, the Commission even imposed a testing ban and a marketing ban on animal testing for products and ingredients. 5. Finally, the Directive on the protection of animals used for scientific purposes 4 will take full effect on 1st January The Directive spells out the 3Rs as a clear and 4 Directive 2010/63/EU 6

7 explicit requirement in the text of law in all areas of animal use for scientific purposes regardless of the sector. Indeed, not only the EU but also the U.S.A., China, India, Japan, Brazil and many more countries are now looking at solutions to replace, reduce and refine animal testing where possible. In a global context of scarce resources and interdependence, the need for improved international co-operation is growing. The EPAA has been pushing the adoption of alternatives at the international level, through bodies such as the OECD or the ICH (The International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use), and through the International Co-operation on Alternative Test Methods (ICATM). The international dimension is thus an essential part of our strategy, as underlined by the EPAA theme of the year for 2012: Global implementation of 3Rs methodologies through international cooperation. Synergies, economies of scale and mutually improved knowledge on alternatives are the obvious benefits of such collaboration. We welcome perspectives of future collaboration with the American Food and Drugs Administration (FDA), whose representatives are speaking today. Further 7

8 international co-operation opportunities have been explored with the US-based Institute for In Vitro Sciences, and we will sign a Memorandum of Understanding with them today! Ladies and Gentlemen, I would like to thank all those who are involved in the EPAA - companies, European Trade Associations and Commission services alike. I wish you all a successful day. 8