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Janez Potočnik

European Commissioner for Science and Research

Research into alternative approaches: Are we on the right track?'

Conference EPAA 2008 (European Partnership for Alternative Approaches to Animal Testing)
Brussels, 3 November 2008

Ladies and Gentlemen, dear Colleagues,

It is a great pleasure for me to open the annual EPAA Conference – and a particular pleasure because the focus of the conference is on research – something I have a strong interest in.

Do you remember last year? I said "We can and should do better". Many of you in the EPAA took this seriously and many scientists took note. The progress made over the last year is impressive as you will learn from today's conference. Nevertheless, in some areas – such as in the 'full replacement of animals in safety testing' – we are not there yet. Only recently in the press, the on-going debate about whether or not to use animal testing in research cropped up again, with both sides presenting their reasons for supporting or not supporting the issue. It is time that we make progress in this debate as well.

This coming Wednesday, the European Commission will table its long-awaited proposal for a revision of the directive of 1986 on the use of animals in research. Our proposal will be to modernise and further harmonise rules in Europe in order to minimise the use of animals in research, to strictly regulate their use and to replace as much as possible animal testing by alternative methods.

The EPAA's research Working Group 2 has become an important element in implementing the '3Rs' of reduction, refinement and replacement in many scientific and industrial areas. It is in all our interests to avoid the use of animals in testing wherever we can, for both ethical and animal welfare reasons. We need fast, reliable and cost-effective test methods which ensure the safety of products for users and help European industry and which satisfy regulators.

I'm glad to tell you that the five EPAA working groups have cranked up their engines and intensified their efforts over the last years. From our side, the RTD Framework Programmes contributed significantly to this process and will continue to do so.

A number of FP6 projects have not yet ended and expectations of their final results are high. FP7 started a significant number of new initiatives ranging from integrated testing strategies to co-ordination and support actions aimed at making best use of limited amount of money available.

There have been crucial structural changes in the world of research too. New models for research co-operation between Europe, Member States, industry and academia have been built. One example is the Joint Technology Initiative on Innovative Medicines – IMI – a public-private partnership between the pharmaceuticals industry represented by EFPIA and the European Commission. Launched this year, it promotes the inclusion of the 3Rs principle in numerous topics of the work programme and did so specifically in its first call. This will continue in future IMI calls prepared jointly by the EFPIA and the Commission.

Our approach with JTIs is new and builds on earlier models for cooperation which often resulted in the fragmentation and isolation of research results. IMI research will, of course be a part of any further RTD strategies which will help implement the 3Rs.

We need to coordinate our research activities better to avoid doing the same things twice. Furthermore, the activities and results need to be monitored, evaluated, disseminated and, in particular, brought to application by relevant stakeholders. Following my speech, you will find out how the Commission plans to implement these strategies hand-in-hand with industry, among others.

The EPAA is a well-placed to help us to do this job. With some 40 member companies and industry associations plus the involvement of five Directorates General of the European Commission AND the European Centre for the Validation of Alternative Methods (ECVAM) - it is the engine we need to shunt these challenging reforms into the right direction.

So now, ladies and gentlemen, I need to pose a different question: "how can EPAA make an even greater difference in research"? This is, after all, the crucial point of today's conference.

First, let me highlight some important examples of work which would not have taken place at all if not for the EPAA and which demonstrates how important research is in this area.

Let us imagine a timeline which compares the implementation of the '3Rs' alongside the research work necessary to fully replace animal testing. It is clear that the high level research required is going to take longer.

Yet by selectively and strategically emphasising 'replacement' we can make it more achievable. This is what the Research Working Group has decided to do. Under FP6 and FP7, EPAA activity is supported through coordination and support actions like the project START-UP, through specific targeted research projects, and through large Integrating Projects. From these we can get a detailed description of the current state-of-play for each individual 'R' and recommendations on what the next steps in research should be and can be put forward. The STREPs and the IPs are doing that real research work now.

A key element of the EPAA's Research Working Group in 2008 was the preparation, organisation, and evaluation of results of a workshop on "New Perspectives of Safety" without animals, focusing on repeated dose systemic toxicity. To help with the challenge, I invited a group of twelve top scientists from various disciplines to participate and advise on the research needed to enable future hazard identification with alternative methods. We used a little 'disruptive science' to help shake things up a bit. It took place in a closed session in April this year in Brussels.

The result? We identified some truly novel approaches for the characterisation of the potential hazards of chemicals and drugs. And a better view of which areas of science and technology should be exploited to create new approaches to safety assessment. As regards the interpretation of testing results, an important message emerged: that we need to move "from correlations towards causalities".

Coming back to my question about how you can make an even greater difference, I can give you two other examples:

  • Next year, under FP7, the Health Programme will launch a call for proposals based on a new research cooperation initiative between the Commission and the cosmetics industry. This will intensify research on "repeated dose systemic toxicity". What's new about this is that industry –through COLIPA,[1] will match the Commission's funding, to a grand total of €50 million.
  • A group of some 10 experts is now working on the definition of a work programme to put in place the long-term building research blocks for 'the full replacement of animal tests in safety testing'. This Joint Research Initiative is a fully fledged ally of the EPAA and will be carefully covered over the coming years by the relevant EPAA Working Groups and experts.

I have spoken about replacement as a key and perhaps priority element of our strategy to implement alternative approaches to animal testing. None of this means, however, that we have forgotten about reduction and refinement.

Through the FP6 Environment programme, 3R research is being supported to anticipate the expected future massive use of testing for industrial chemicals under the REACH Regulation.

There are two main areas of research: the use of mathematical modelling to predict – for example, bioconcentration; and the development of Intelligent Testing Strategies in order to substantially reduce the need for animal testing.

In FP7 research continues on computer simulated testing methods. This is being carried out within a Scientific Cooperation Agreement with the US, using a coordinated call under the FP7 Environment Theme and the US-EPA on screening methods.

* *

Ladies and Gentlemen

I've described a number of areas in which we are supporting EPAA issues but I don't want to leave you with the impression that what we are doing is a little too piecemeal, too gradual or too haphazard.

Our work needs structure. And we know how important it is to coordinate action and transfer knowledge, know-how and technologies in all of this through appropriate mechanisms. These mechanisms will help us to validate alternative methods and we have a tenacious partner to help build them: the Institute for Health and Consumer Protection of the Joint Research Centre in Ispra.

Most of the toxicological 'endpoints' require an integrated testing approach, combining laboratory and computer simulation methods and the use of test batteries. By building competences in this area, the Ispra Institute will be well placed to scientifically assess and potentially validate suitable new technologies which may have great potential to even further reduce the use of animals for toxicity testing.

In the near future and in close collaboration with DG ENV and DG ENTR, the JRC will launch a dedicated website called TSAR[2]. This will present information on the status of alternative methods - starting from the submission to ECVAM - for validation by the regulatory process. The launch of this website is a step forward in addressing concerns about the limited availability of valid alternative tests up to now and provides more transparency in the whole regulatory approval process beginning from the moment a new method is proposed until it is finally approved.

Recognising that rapid results and further research and scientific progress are necessary, I would like to underline the Commission's commitment to fostering the development and use of alternatives to animal testing. Arrangements are now being put in place to speed up internal procedures for validation and regulatory acceptance of new alternative test methods to achieve the use of alternative test methods within the shortest possible amount of time.

Our commitment is matched by the International Cooperation on Cosmetics Regulation. They have also recognised the importance of alternative testing and agreed recently on a Framework for International Cooperation on Alternative Test Methods. The purpose of this is to promote consistent and enhanced voluntary international cooperation, collaboration, and communication among the national validation organizations.

In the spirit of this, it is my great pleasure to announce that a special memorandum of cooperation will soon be signed between various scientific validation bodies. Representatives from the Commission's validation body ECVAM, the US Interagency Coordinating Committee, The Japanese Centre and the Environmental Health Science and Research Bureau of Health Canada will meet right after this conference to discuss further details in order to prepare the document for signature in the very near future.

So where does this all leave us? We are facing, with the development of alternative testing strategies, a heavy and complex workload where all the steps we need to take, from research to validation and regulatory acceptance need, to be carefully orchestrated. The EPAA has been a crucial partner in that process.

And, if the EPAA is to make an even greater difference we need more of the same, and more intensively if we want to stay on track. And we have to stay on track: it is our duty and moral obligation.

I thank you for your attention and wish you a very successful Conference.

[1] The European Trade Association representing the interests of the cosmetic, toiletry and perfumery industry.
[2] TSAR stands for: Tracking System for Alternative test methods Review, Validation and Approval in the Context of EU Regulations on Chemicals

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