SESSION 1. VIEWS AND REQUESTS OF RELEVANT PUBLIC ORGANISATIONS
Prof. V. Rogiers (B)
“Welcome and introduction”.
Prof. V. Rogiers welcomed all participants on behalf of the three organisers (Dr. Garthoff, Dr. van Iersel and herself).
Much more people wanted to attend the workshop but the total number had to be limited to about 50 in order to allow discussion and a fair participation of different countries and organisations.
A short introduction was given on the basis of this initiative, namely as a follow-up of Workshop 25 during the World Congress held in Bologna in 1999.
Funds were provided by the Doerenkamp-Zbinden Foundation (CH), Zorg Onderzoek Nederland – ZON) (NL) and the Federal Ministry of Education and Research (D). For the next meeting support is expected from the EU.
The intention of ecopa is to bring all national platforms in Europe together, with the strict limitation, however, that these platforms should be represented by all parties concerned, being industry, academia, animal welfare and government. It is by no way meant to change the specific character of the different parties involved, but rather to bring them together to reach consensus with respect to key issues in the 3R’s strategy in the EU. The aim of ecopa is thus to come to consensus opinions and consensus projects among the different platforms and parties in order to bring these forward at the European and international level. This, of course, implies that consensus cannot be found for all matters of concern.
For the moment, it seems that several consensus platforms or structures that could develop into consensus platforms exist in Europe, in such countries as The Netherlands, Germany, Belgium, Spain, Sweden, Austria, Denmark, Norway, Switzerland, etc. It is accepted that Academia are sometimes represented indirectly, namely in the ioscientific evaluation of projects of the platforms.
As a guidance, the role and function of national platforms, being
(i) information, exchange, communication,
(ii) scientific mission,
(iii) ethical issues and education,
(iv) follow-up on legislation and validation.
were briefly discussed. The advantages of dealing with the 4 points mentioned within a European consensus framework were considered to be numerous: facilitating a better mutual understanding of each others specific identity; coming to more constructive dialogues; strengthening of financial and intellectual power, setting priorities and proposing consensus opinions and projects; creating more realistic ethical and educational programmes; less emotion and a better collaboration with ministries and legislators; maximising results and minimising conflicts within 3R’s strategy; coming to a strong plea and a bigger impact at the European level.
The wish was expressed to create ecopa as a flexible co-operation group of active people coming from national consensus platforms and from all parties involved and with a headquarter in Brussels. It was proposed to firstly discuss priority issues before making proposals for a possible structure.
Dr. B. Garthoff (D)
“The concept of consensus in animal welfare and implementation of alternative methods as the basis for further progress in the 3R’s concept”.
In his presentation, Dr. Garthoff discussed on issues related to consensus and the scope of tasks arising. Apart from giving definitions and issues to consider, he dealed with those in the context of the 3R’s thereby providing some alternatives and chances for a basic agreement among the parties concerned. Some practical examples were presented such as endocrine disrupters.
A definition of consensus was given: “agreement in opinion, collective opinion”, “practice of proposing policies which will be given support by nearly all parties” (Oxford Advanced Learner’s Dictionary). Attention was drawn to the fact that total consensus never can be achieved but that one can try to get as close as possible.
With respect to the 3R’s:
Between 1989 and 1997 e.g. a 51% reduction in the use of lab animals in German pharmaceutical research was achieved due to a combination of new technology being available and the interest of industry because of ethical and financial reasons. Thus a connection of interests could move things forward and not so much legal restrictions.
In basic research and in other legally required testing, other conditions were present and the decrease in animal use was accordingly smaller.
With respect to refinement, application of statistics brought significant improvement. Since refinement is an ongoing process, it should get some priority. The standardisation issue should be taken up again today.
After years of decreasing numbers in the use of animals in most European countries, the number is levelling off and again increases in specific areas are ob ?erved. The use of transgenic animals, but more importantly additional legal and new requirements for testing of endocrine disruptors, high volume production chemicals and water quality are at the origin of actual and further increases. Other factors are the appearance of new diseases (BSE, HIV) and in particular ensuring consumer protection.
Thus new ideas and new efforts should come forward to counteract this trend and revitalise the area of developing alternatives
Possibilities for consensus as there are examples already could be:
- standardisation issues but applicable throughout countries (not only limited to the Member States) e.g. housing of lab animals, drawing of blood volume,…
- reducing lab animal tests and replacing ageing lab animal tests by new high-tech methodology.
- general acceptance of specific in vitro tests by all parties and countries.
- solving the problem of the second species, dog, in long-term toxicity studies, taken up already by different groups but in a non-coordinated way.
- bringing forward the issue of endocrine disruptors, which entails massive animal testing, and proposing validation of in vitro tests rather than considering in vivo tests. All voices raised until now serve their own specific interest and not that of animals!
These examples showed that further development and implementation only are possible when action is done on a global scale, at least European.
ecopa is a new and powerful concept that could make the difference: enforcing the impact of national platforms by avoiding duplication, intensifying dissemination of information on alternatives, serving as a counterpart to ECVAM, EC-DG’s and individual countries, taking up the valuable initiatives of local groups.
Dr. J. Vogelgesang (EU, DG Environment/E2)
“How can platforms assist in fostering the pan-European approach to animal welfare issues and alternatives implementation?”.
Mr. Lübke pointed to the importance of animal protection and animal testing for consumers. A survey in 1999 to assess aspects of corporate behaviour having a positive impact on the purchase behaviour of consumers, showed as the top two the rejection of child labour and products tested on animals. Environmental issues were decreasing while social ones were on the rise. These data only give an idea of consumers’ attitude.
Assessing the number of aspects a consumer would try to follow with respect to his purchase behaviour, taught us that 21 per cent followed 3-5 aspects, 19 per cent claimed to follow 6-9 aspects and 26 per cent even 10 or more. This seems, however, be quite difficult, if not impossible in daily practice.
For consumers it is very difficult to take decisions according to ethical lines because of lacking the appropriate information. The issue of animal testing is a good example showing that consumers need and want the help of independent experts to provide them with valid, reliable, accessible, comprehensive, understandable and usable information to weigh the pros and cons. Then they would be able to take decisions and to exert a positive influence upon corporate behaviour.
In this context, ecopa could play a role and support the interests of the consumers provided that they met the basic requirements of equal representation, transparency, quality of work as well as positive results. A consensus platform, however, must be credible, comprehensible and effective thereby cu?onvincing people that it is worth supporting it.
Prof. M. Balls (ECVAM, Institute for Health & Consumer Protection, JRC, DG Environment EU)
“Ecopa – Possible interaction with ECVAM and the other interacting partners”.
Prof. Balls stated that ecopa is badly needed because alternatives are not well represented within national governments, the European Parliament, the Commission and international bodies. There is a slow but steady and scientifically-credible progress in alternatives but at the same time animal use is drastically increasing, therefore ecopa has an important role to play.
Prof. Balls made it clear that he was speaking for himself and not for the Commission but that he was very against what appeared to be the Commission’s policy on toxicological testing of the chemicals on the EINECS list, the policy explained earlier by Dr. Vogelgesang. He called it appaling that half a million animals more might be used in addition to the 11 million already used today, every year for the next 20 years!
He proposed the following areas for ecopa action:
- the political debate on extra testing of existing chemicals already on the market as mentioned above
- transgenic animals for which welfare aspects are being overwhelmed by scientific excitement
- food safety for which consumers expect total protection, but which cannot be provided
- endocrine disruptors, for which non-validated animal tests are proposed
Ecopa should select specific items for concerted action and develop effective routes for communication with the EU-DG’s, ECVAM, the European Parliament, the Council of Europe, the European Pharmacopoeia, the Eurogroup for Animal Welfare and scientific journals with interest in alternatives.
ECVAM could help ecopa by functioning as a route for contacts with the Commission Services, providing the ESAC meetings minutes and helping by organising a meeting every year.
On the other hand, ecopa could help ECVAM to gain support on all levels for its actual work, to disseminate and promote the activities of ECVAM and help by identifying methods that are ready for prevalidation and validation. In all these activities the PECO-countries should not be forgotten.
Mrs. S. Abdulla: (The Scientific Media, represented by “Nature” , UK)
“How can the existence of platforms work to diffuse the confrontation, and support the alternative approach of scientists?”.
Mrs. Abdulla differentiated between the mass media and the scientific media and gave a short notion of the needs and requirements of a working journalist in order to provide ecopa withs the tools to best target the media. It was stressed that not many journalists had a particular specialisation and many journalists know “little about a lot”.
The news media can be characterised by the terms “simplicity”, “speed” and “sexiness”.
- “Simplicity” means that in one story one can only get one point across. This is crucial when writing an article or organising an event attended by the media. If the message on alternatives is too hard to put across then it does not get any coverage at all no matter how interesting or ground breaking it might be. It is therefore important to start with a clear and easy to grasp message that needs to be repeated throughout the interview, article, discussion, etc.
- “Speed” means that the journalist getting information usually needs to have the article ready by the late afternoon of the same day. Therefore it is important to be available and to have the information ready to be sent by fax or e-mail right away when being asked.
- “Sexiness” means that a story must catch one’s interest and keeps one reading. Especially science is a difficult topic to sell.
There are three aspects that get attention for the subject of alternatives:
À Animal experimentation and alternatives form a conflict story and a conflict is a seller. Á Scandals are sellers. Â The ec “Wow-Factor” such as “11 million animals used each year”.
Ecopa should provide visuals, voices and views: information being presented on a plate will be covered. It is thus advisable to provide a whole package of information like a press release accompanied by contact details, computer graphics or other visual aids. When it comes to TV and radio, then of course it is good to have some “media babes” at hand. Media love people that have a clear say and feel comfortable in front of camerasbr>
The interest of the public is present since ecopa pushes open doors with the topic of alternatives. Many people have pets and also have a general interest in animal welfare. However, the ignorance of people and their short memory should never be underestimated. That’s why it is necessary to keep the messages simple and to repeat them over and over again.br>
With respect to scientific journals it was stressed that a journal like “Nature” is about publish or perish. If the things one is talking about are not being published then they do not reach the scientists. The rule at “Nature” is that the best science is being published and the only requirement in a legal sense is that the experimentation is based on the rules of the country in which it has been carried out. Another characteristic of scientific journals is that they put out press releases to have a farther reach for their news. This again shows the importance for ecopa to prepare sharp press releases and good medecia kits.
Podium discussion chaired by Prof. B. van Zutphen (NL)
“Is a EU consensus platform useful from the point of view of the Eurogroup (Dr. D. Wilkins), EBRA (Mr. I. Aune), academia, (Prof. J. Castell) and legislation (Prof. N. Thorn)?”.
(v) Dr. Wilkins started by saying that the Eurogroup was founded in 1980 with the intention to have a united voice of animal welfare at the level of the European institutions in order to promote animal welfare legislation that would improve animal welfare. To achieve this, frequent and detailed communication between the member organisations and the headquarters was necessary. This is an important factor that must be considered when talking about ecopa. It was stated that the Eurogroup represents the leading animal welfare organisations in Europe with approximately 5-10 million people and one can say that the vast majority of people in Europe are either interested in or clearly supportive of the principle of the welfare of animals.
Regarding the question whether a EU consensus platform is useful from the point of view of the Eurogroup was not answered, but putting the question as to whether a EU co-ordinating platform is useful from the point of view of the Eurogroup received a definite yes answer.
The first important job of ecopa was seen as to harmonise the national platforms in the Member States. Equivalence appeared to be a better wording than harmonisation, since a balance of interests between academia, industry, government and animal welfare is highly necessary with animal welfare representation at an equal level to the other three.
The second task for ecopa after having established a number of national platforms would then be to start to co-ordinate, to stimulate, to disseminate informatio wn and perhaps to help funding as well. The third task concerned international partnerships that ecopa would also need to establish with the OECD and others as well as stimulate the exchange of information internationally.
About consensus, Dr. Wilkins stressed that the word “animal suffering” should be central and ecopa should be reducing and eradicating animal suffering. The Eurogroup puts its emphasis on replacement. Consensus quite often means a compromise but it is clear that on certain ethical issues the Eurogroup can not compromise. Thus, asked whether a EU consensus platform is useful from the point of view of the Eurogroup, the answer is “no”, but in the context to what was said before, ecopa was indeed useful and would get the full support of the Eurogroup.
(i) Mr. Aune speaking on behalf of the EBRA council explained that EBRA has 35 member societies in Europe. Among the EBRA objectives three are directly related to the welfare of lab animals since good housing and living conditions are a prerequisite for undistorted research results. Therefore EBRA stresses refinement within the 3R’s and is always ready to discuss matters in this field as well as the 3R’s as a whole.
The idea of EBRA is to disseminate information about regulations, ways of using alternative methods etc. and to convince senior scientists of the idea of the 3R’s. A great opportunity is therefore present for of ecopa, since a consensus among the four concerned parties makes it easier for r wesearchers to accept the concept of the 3R’s. Nowadays, researchers are mostly confronted with the 3R’s by animal welfarists in the media. Ecopa can offer an opportunity to reduce the confrontation and to change the attitude of many scientists to make them listen, understand and learn more about the ideas behind the 3R’s. There currently is no such body at the European level, but co-operation across national borders is crucial to improving the situation.
It was also said that the legal difference between the Member States, allowing certain experiments in one country, while being forbidden in another one, should be reduced in order to prevent that researchers are leaving Europe to work in the USA or Japan. Research knowledge in Europe should be kept there.
Another aspect related to reducing scientific barriers is that the number of animals used in the various Member States differs considerably. It is therefore necessary to find a balance of interest between the countries using many animals for research and those using only a small number.
Mr. Aune called ecopa the starting point of a useful co-operation among the four parties with respect to the European institutions. EBRA members are willing to participate and to provide their knowledge and skills to make this idea work.
Ø Prof. Castell speaking on behalf of the academic community expressed the view that there is a change of attitudes and wthinking in progress. This would also have a long-term effect with respect to the professional work. He therefore welcomed the ecopa initiative and the intention to get all four parties, including academia, around one table.
Possible actions within the framework of ecopa need to be based on consensus and priorities must be set. Arguments to convince colleagues are much stronger when decisions are not those of a single national platform but taken in consensus at the European level. Actions on a local or even national level are no longer sufficient but need to be global in order to be successful.
Ecopa could assist in providing an inventory of the best experts in the 3R’s in Europe by identifying and listing them. Ecopa could provide the direction to go and define very precise goals to be achieved.
Ø Prof. Thorn stated that a EU consensus platform for the implementation of the 3R’s is connected to the aspect of in vitro methods. He therefore was convinced that there is a need for a coherent, co-ordinated and continued dialogue between scientists, safety experts, toxicologists, industry and animal protection organisations and finally the political and administrative system.
Regarding initiatives to be taken by ecopa, discussions could focus on humane endpoints in all kinds of experiments. Interest could also go to studying pain and its treatment in animals because animal experiments still are w necessary for a longer time since today only a limited number of in vivo techniques can be replaced by in vitro methods.
Furthermore, a European consensus platform has to define its relations to the various other organisations and institutions such as ECVAM or the European Parliament. It could also be a good platform for discussions with candidate countries as well as other non-European countries like the USA and Japan.
Ecopa could also help at the European level to prepare changes in laws and administrative procedures that up to the present differ considerably in the various Member States.
The presentations were followed by a general discussion:
Dr. Wilkins stressed that from his point of view dialogue was essential and that an animal welfare group not wanting dialogue would not be very significant or influential. According to his experience consensus means compromise, usually brought about for political and economic necessity. From an animal welfare point of view it needs to be accepted, in legislative terms, that compromises need to be improved at a later stage. When it comes to the outcome of a dialogue he believed that, apart from a consensus on supporting the idea of ecopa, all other matters do not need to have a consensus. There are certain areas that everyone can support but there also are differences in emphasis. It is clear that changes take place step by step but from an animal welfare point of view replacement is the objective while refinement only is a step towards it.
Prof. Thorn made a strong point for ecopa to set priorities for example in the field o wf endocrine disrupters. He acknowledged that it was a political issue that, however, needed to be discussed by people that had a fair knowledge of what was actually going on.
Mr. Aune disagreed with Dr. Wilkins on the level of consensus already existing. In his opinion there was more consensus than Dr. Wilkins acknowledged. The problem, however, was that the public as well as the politicians and the media did not know that there was already a considerable amount of consensus between the various parties. Of course, there was not consensus on all single issues but there was consensus on the major points and this would needs to be communicated to the public by ecopa.
Prof. Rogiers and Dr. Garthoff pointed out that consensus should not be misunderstood as an attempt to find agreement on everything. The task of ecopa would be to define the burning issues on which consensus could be reached in order to bring solutions and proposals forward at the European level. Nobody and certainly not ecopa intends to change the identity of the other groups and parties.
Dr. Bottrill expressed her surprise at the statement of Mr. Aune that scientists felt confronted by the concept of 3 R’s. She wondered how that could be the case when it was generally accepted that consideration of the 3R’s actually resulted in better science and better data. She then suggested that one very initial task for ecopa could be to use the weight and the credibility of the more enlightened scientists from academia and industry to make this wpoint to their peers.
Prof. Balls stated that this was a pivotal moment in the history of ecopa. He warned not to allow oneself to be seduced into becoming a part of an overlapping organisation with all kinds of activities. Ecopa should not be a copy of other already existing organisations but do something different and new.
Prof. Spielmann pointed out that there exist examples of even important advances in alternative testing that never have been published by the appropriate European institutions. He pointed to the three alternative teratogenicity methods that were accepted by the Commission in spring 2000 but were never published in the Official Journal or announced in a press release of DG Environment. This clearly shows the need for an organisation as ecopa to follow-up all developments and disseminate the information. Besides, Prof. Spielmann added that education was another important issue that ecopa should deal with since it is very difficult to bring the 3R’s into the field of education especially at the university level.
Mrs. Abdulla suggested that ecopa should at least have one press officer whose responsibility would be to keep up speed with science and legislatory aspects on alternatives. This press officer should also make sure that the news is released widely, simply and accurately and co-ordinate the availability of scientists to give comments.
Dr. Sauer agreed with Prof. Rogiers a wnd Dr. Garthoff that consensus should not mean that one tries to change the mind of others but that people focus on the issues worth discussing and to come up with solutions. She then stated that a crucial turning point of the day’s discussion was reached and that it had become necessary to talk about the structure of ecopa. Since a discussion on the structure was only foreseen for the second day of the workshop she therefore asked for a change of the programme in order to be able to discuss it first before turning to the issues.
Prof. Rogiers answered that she thought that is was necessary to firstly discuss to find out whether consensus could be reached and common actions could be taken before focus was turned to the future structure of ecopa. If this workshop came to the conclusion that there was no common ground or no need for ecopa then it would also be useless to talk about a structure. Once the issues and possible projects were clear then one could also get into detail about the structures that would be desirable and useful to accomplish these objectives. Since no objections were made by other participants, it was agreed not to change the programme but to continue as planned.
SESSION 2. THE CREATION, FURTHER DEVELOPMENT AND CURRENT PROGRAMMES OF NATIONAL PLATFORMS.
Dr. de Greeve explained that the Dutch platform on alternatives to animal experimentation was founded in 1987 and that it is characterised by a very balanced representation of interests. It has representatives of the four parties being government, industry, academia and animal welfare.
The platform serves as a forum for open dialogue. All kinds of topics related to animal experimentation can be discussed during the meetings or afterwards in an informal way. He recommended this as being a strong point for any national platform since it facilitates a free dialogue among the parties concerned.
Later, under the auspices of the national platform the National Centre on Alternatives for Animal Use (NCA) was established. It plays a quite active role by organising workshops, keeping in contact with ECVAM, etc.
With respect to funding, he explained that the Dutch platform was financed by the government, patient organisations, industry and animal welfare organisations with the government providing the biggest amount, namely 1.1 million ECU out of the 1.4 million ECU budget of 1999.
Dr. de Greeve then illustrated that the Dutch platform had subsidised already 123 projects in the past with special emphasis on toxicology (47), immuno-biology (23), basic research (14) and refinement (9). Many more projects were submitted but rejected for funding. The results of c?the supported projects must be published by the researchers in relevant scientific journals e.g. ATLA., Sponsored scientists are also obliged to give a presentation of their results at meetings of scientific associations. Besides, all the results are published as summaries in annual reports. Yet, some of the success stories like the tetanus vaccine potency testing did not receive enough publicity and were not made known enough to the public.
Another way to implement results is by means of a specific Dutch law that stipulates that no animal experiments should be conducted for a purpose but by expert consensus. Education and training is one field where this article can be applied since a lot of curricula contain animal experiments. In this particular case ALTON, one of the NCA working groups, is the expert group that is asked by the Inspectorate to list alternative methods that can be included in educational programmes. ALTON in turn can provide methods and then the Inspectorate can ask the different research groups why in vivo experiments are performed and why the respective alternative methods are not being applied. Then the expert group can be asked again about the validity of the arguments and if non valid, the Inspectorate can forbid the experiment (under consideration). Dr. de Greeve stated that this was a very effective way of implementing results.
Asked by Prof. Spielmann about the structure of the ethics committee that accepts certain tests, Dr. de Greeve replied that this was not simple since there were a number of local ethic committees in the Netherlands.
Dr. Beaufays provided a brief overview of the history of the Belgian platform, called BPAM, which was officially launched in 1999 at the initiative of the Belgian Ministry of Health and with support of the Prince Laurent Foundation. He explained that the platform, comprising the four parties, is active in supporting scientific research and promotion. The scientific research activities are carried out in co-operation with academic and scientific centres.
The actual programme for the year 2000 consists of three projects and is being developed in co-operation with the pharmaceutical company Janssen Pharmaceutica, the Scientific Institute of Public Health in Brussels and the Flemish Institute for Technology and Research. One project deals with food safety and the two other ones with using alternative methods in toxicological research. The platform plans to select five scientific projects per year for financial support.
Dr. Beaufays said that the platform had identified important issues in Belgium such as alternatives to the classic LD50 test, transgenic animals, and analysis of the statistics on animal use and animal experimentation in Belgium. For 2001, planned activities are an educational programme on TV and participation in exhibitions in order to disseminate information on alternative methods by means of brochures and leaflets. Monographs and educational programmes are planned for a later stage.
Dr. Schlitt speaking on behalf of the German platform Set explained that the foundation, started in 1986, was originally not based on the concept of consensus, because of a disagreement between animal welfare organisations and industry. The disagreement was caused by a new amendment of the Animal Protection Law with more stringent provisions for industries using animals for their tests. By intervention of the Minister of Agriculture it was agreed to establish a foundation with the main objective of promoting alternative methods. The capital of the foundation was raised by industry and amounted at that time to 1 million DM.
The board of Set is equally composed out of four representatives from animal welfare groups and four persons from industry. The scientific decisions of the foundation are taken after consultation of a scientific advisory committee. The members of this body represent industry, university, government and animal welfare. In addition there is a council with an advisory function.
Dr. Schlitt illustrated that the activities of Set are exclusively sponsored by the industry, which roughly gives about 400.000 DM per year. Due to the financial structure Set was not able to carry out permanent public relations work like other organisations can in the field of health and science. With respect to the projects that are being financed by Set, about 500.000 DM are made available per year which finances a wide range of projects including research and development, workshops, training courses and congresses. Over a period of 14 years 120 applications were proposed for pr aoject funding but only 49 were accepted.
The experience with young scientists that want to learn alternative methods and afterwards can apply these in their job encouraged Set to make education one of its main objectives. The same applies to workshops in which experts discuss their ideas and the results of their work. Less positive are the experiences with research work that was contracted out to institutes or universities. In many cases the results remained on paper and were not leading to validation or were not applied in practice. A European platform could support the national platforms in obtaining better results in this field.
Finally, Dr. Schlitt concluded that Set could be more successful and that greater progress could be made in the development and implementation of alternative methods if there was more and better co-operation with other national platforms at the European level. Therefore he welcomed the initiative of ecopa. A joint effort to focus on the most promising projects would be a better way to proceed, considering the limited resources that all platforms have available.
Prof. Castell stated that the Spanish platform on alternative methods, called REMA, was officially launched in 1999 after a series of meetings resulting from a workshop on alternatives in 1997. There a task force was nominated that tried to define the structure and objectives of the platform thereby getting in contact with other platforms in Europe (e.g. Belgium) to exchange information and to learn from their experiences. Indeed, a consensus was reached and transformed into a document that became the official constitution of REMA and subsequently lead to the nomination of an executive committee which had since then met several times. The nomination of representatives took place in June 2000 and recently the decision was taken to create the REMA Foundation.
The objectives of REMA are to be a meeting point for academia, industry, administration and social representatives in order to identify the needs and to promote discussion on the application of alternative methods. It also co-ordinates the efforts on development, teaching and validation of methods throughout Spain. Furthermore it disseminates information on legislative proposals and serves as a forum of discussion for the problems associated to its application. REMA also participates in the decision-making forums in Spain and Europe with respect to the development, validation and implementation of alternative methods. It also serves as an independent body, as a Scientific Advisory Panel for the administration, industry and social groups.
Regarding the representation of the different parties in REMA, Prof. Castell said that in the case of academia there has been a big discussion whether universities were to be involved. The decision taken was that the scientific societies but not the universities by themselves were to be represented. Thus the most relevant scientific societies were approached of which 20 agreed to participate. The same was done with respect to industry. Individual companies were not asked but only the respective umbrella organisations. Regarding animal welfare groups three were contacted out of which one finally agreed to participate from the very beginning on the basis of free discussion. For the government four important agencies are represented, among them the Ministries of Agriculture and Health.
Prof. Castell also explained that there was a particular problem in Spain with the structure of the country. Autonomous regions have their own structures including their own guidelines on animal welfare. At least two autonomies (Madrid and Catalonia) that had issued some laws on animal protection were invited to participate.
The more the goals were developed, the more challenges arose with respect to the structure of REMA. Long discussions lead to the conclusion to create the REMA Foundation as a non-profit, independent and public service foundation that serves as the official body of this institution. He explained that the foundation has a board of trustees and an executive committee composed of members of the task force, governmental agencies, industrial associations and social representatives.
Finally, Prof. Castell closed by adding that future activities would focus on education and the dissemination of information. Currently there is not enough money available to fund research projects, so it is believed that REMA should rather influence the government’s research plans and priorities than become an institution that directly funds projects.
Asked by Mr. Lübke whether the representation of the various groups was not unbalanced with respect to animal welfare groups, Prof. Castell replied that all three groups had been invited. However, only one had accepted and that this was primarily due to fighting between these groups and the putting up of unacceptable preconditions.
Dr. Wilkins congratulated Prof. Castell for taking the initiative to set up a platform in Spain. He further added that he understood the Spanish situation quite well and was therefore delighted that a dialogue had finally been initiated.
Prof. Thorn informed the audience that there is only one animal experiment inspectorate (committee) in Denmark. It is appointed by the Ministry of Justice but independent in its function, which means that the minister can not change any of the decisions taken by the inspectorate.
Until 1987 this ten-member committee was composed of a High Court judge and medical or veterinary doctors. In 1993 this was changed on the principle of having a good balance between representatives of “users” and representatives of animal protection organisations, the independent chairman’s vote being decisive.
The committee, chaired by a High Court judge, is now composed of a group of which each time one person represents the National Health Sciences Research Council, the Public Health Service, the Veterinary Research Council, the industry, organisations fighting diseases and the government animal ethics committee and finally four persons represents animal protection organisations.
The committee has no money for funding in vitro methods but there is a great interest in promoting in vitro methods.
Prof. Thorn said that there is considerable interest in Denmark to participate in a European consensus platform since the issues at hand can no longer be solved solely at the national level. Once ecopa is functional, there would be efforts made by the Danish nationt?al platform to support ecopa.
Prof. Smith pointed out that with reference to the different national platforms, it probably would also be necessary to define the meaning of national platforms, their objectives and how diverse they could be in order to fit into ecopa. Prof. Thorn agreed and added that the goals would to be clarified in order to avoid duplication of work.
Prof. Rogiers expressed the view that there should not be any interference with the internal structures of platforms and/or centres. It is not the intention of ecopa to tell national platforms what to do but to help them by providing additional information. She stressed that, although a certain diversity is acceptable, one must understand that a basic roule is that a platform needs to include the four parties and that their representation should be as balanced as possible.
The chair of the Swedish Fund for Research without Animal Experiments, Mrs. Gabrielson, explained that there is no platform in Sweden where the 4 parties could meet on equal terms. It is, as she put it, a bit difficult to get the parties interested in setting up such a platform, since many people think that the present system in Sweden is quite sufficient.
She furthermore described Sweden as probably the first country in the world to support research into alternatives with governmental grants. This happened already in 1980, after a decision of the parliament in 1978. The same year, the parliament stated that animal experiments were an ethical problem and that experiments on animals should be minimised. To this end, ethical review committees were established to evaluate applications for animal experiments. At the same time, the National board of laboratory animals (CFN) was established as a regulatory authority.
Sorting under the Ministry of Agriculture, the Board of Laboratory Animals is responsible for the long-term planning of the use of laboratory animals and for reducing the need of laboratory animals by promoting the development of alternatives to animal experiments. She said that it also collects and publishes statistics on animal use, arranges conferences on topics related to animal experiments and alternatives, publishes a series of articles and issues recommendations to the ethical committees in relation to specific procedures on animals.
The Board of Laboratory Animals has a budget to award grants to develop and validate alternatives to animal experiments, and additional money is donated by the pharmaceutical industry, to be distributed through the board. This year, their total budget for research grants is 470 000 Euro. In addition to this, the Swedish Fund for Research without Animal Experiments has awarded 141.000 Euro in research grants this year.
To assist in considering applications for grants, the National Board of Laboratory Animals has a a sub-committee on alternatives, with representatives from academia and industry. There also is a committee on education and one on ethics.
Mrs. Gabrielson also said that the Board of Laboratory Animals sometimes refers to itself as the Swedish alternatives centre. But with a total staff of 4, to deal with the many tasks of the Boards, their time, skills and resources are hardly enough even to assist the ethical review committees to research into the availability of alternatives to the animal experiments detailed in applications, although the situation has improved by adding new staff recently. She said that the board and its sub-committees consists of members from the parliament, industry, academia and animal welfare organisation, but that it is a regulating authority and not a forum for open discussions between equal parties.
To complicate things further, the future of the Board of Laboratory Animals is under revision. There had been proposals to establish a new regulatory authority for all animal welfare related issues, including animal experiments. The Minister of Agriculture has expressed an interest in this idea and has asked for an investigation into the possibilities to create such an authority. A report would be presented later this year. If such a new regulatory authority is created, this board might cease to exist by the end of next year.
Mrs. Gabrielson said that prior to this workshop she had met with Dr Cecilia Clemedson of NICA and a few other people to discuss the idea of setting up a Swedish platform. There is some interest from the parties, to meet and discuss strategies on how to replace animal experiments. Some of the topics that could be discussed during these informal meetings are toxicity testing and testing of chemicals, validation, distribution on information about alternatives, databases on alternative methods and so on. She finished by announcing that they are going to draft a proposal for a first meeting between the parties hoping that there is enough interest to plan for a first meeting early next year.
Mrs. Riitta Salmi, Director of the Juliana von Wendt Foundation for research without animal experimentation, said that there are two statutes regulating animal research, the statute for animal experimentation (1986) and the European Convention, which became part of Finland’s legislation in 1991. Like in most countries of the EU, the 3 R’s principle is an integral part of the national statute, even though the 3 R’s concept is not mentioned. She said that the statute includes the normal requirements to choose methods that spare animals and cause as little pain as possible. Also, an in vivo experiment has to be replaced by another research or teaching method if possible. However, the requirement to actively promote the development and application of alternative methods is not clearly stated.
The main body to promote the 3R’s is the Veterinary and Food Department at the Ministry of Agriculture and Forestry (MAF). The Ministry gives recommendations and guidance to researchers concerning the 3R’s. It also supports financially the development of alternatives by small yearly grants.
Besides MAF, she explained that there is only one other body that gives some funding to alternatives research, namely the private Juliana von Wendt Foundation, founded in 1971 by Animalia-FPA. Its aim is to promote scientific research in which alternatives to animal use are developed or applied. Financial support is given to research and information activities enhancing the use of alternatives and welfare of animals. The amount of funding is about 10.000 Euro per year.
Mrs. Salmi further said that in last December the first-ever Cell Research Centre (TCRC) was opened. Located at the University of Tampere the centre, focusses on the development of new in vitro methods that can be used for testing of safety and therapeutic properties of drugs and other chemicals. Emphasis lays on human cell lines and human tissues.
Also the Ministry of Education has lately been active in the question of the 3R’s. In 1998 it appointed a Working Party on ethics and laboratory animals, with the aim to handle the issue of animal experimentation in universities. The report of the group was published in April 2000. Several recommendations were made, including suggestions to promote the 3R’s. The most important of these are the recommendations to adopt the 3Rs principle as a starting point in all animal research, to establish funding for both development of alternatives and welfare research, to organise training courses for scientists in replacement methods and to form a co-ordination group for animal experimentation in universities. The group also expressed the wish that a national platform on alternatives should be established. Nothing has been decided yet, but if the suggestions come true, then the 3R’s would get substantial additional funding and scientists could be better trained in the use of alternative methods.
Finally she commented that she is in favour of forming a national platform in Finland in order to encourage research and the implementation of the 3Rs nationally and Euro ?ean wide. A better interpretation of the text of the Directive and the European Convention would thereby help member countries to understand that they need an active policy for 3Rs promotion to fulfil the requirements of the legislation. An official, high level statement would be able to convince the responsible ministers of the importance of a national platform and increased funding for alternatives, in proportion to the funding used for R & D in life sciences in total.
Dr. Stammati told the participants that there actually is no national platform in Italy. She therefore focussed on the intention of establishing one. The Comparative Toxicology and Ecotoxicology Laboratory of the Istituto Superiore di Sanità (ISS) in Italy has been involved in the use of alternative methods for many years. However, since alternative methods also need to be used in fields other than toxicology, other parties must be involved in a national platform in Italy.
Contacts must be established with people working in the fields of immunology and pharmacology, and with the 4 parties necessary to establish a national platform (government representatives, universities and scientific centres, industry and animal welfare representatives). Dr. Stammati explained that as far as government is concerned ISS, being the scientific body of the Ministry of Health, could serve as a representative of the government. Involvement of the department in the Ministry of Health in charge of legislation in the field of alternative techniques is necessary. Universities and industry could be informed through the Italian Society of In Vitro Toxicology (Celltox). With respect to animal welfare representatives, they had already been informed on the possibility of establishing an Italian national platform and some of them had shown to agree with this initiative.
Looking at the main objectives of national platforms, she felt that most of these were objectives that are handled by groups working at ISS or Celltox. Among other activities she mentioned that a number of courses either on thn?e implementation of the Legislative Decree n° 116, or on the use of in vitro alternatives has been organised already.
Dr. Stammati concluded that there actually is already a sound basis and, considering that Celltox could be a very good starting point, it was reasonable to say that an Italian national platform could be established. In this regard the role of ecopa would be essential, mainly by challenging such priorities as the harmonisation of national platforms in the European countries, by giving advice, as well as by establishing criteria and helping in the creation of platforms.
Prof. Hughes first said that the background situation in the United Kingdom is characterised by a great number and diversity of groups that have a long-standing involvement in animal issues pursuing diverse objectives. Furthermore, the situation is marked by polarised views that even lead to violence by animal rights activists against scientists. There was an atmosphere of deep-rooted distrust among all groups, which makes the creation of a national consensus platform a quite difficult task to accomplish.
Actually there are many groups but most are short of at least one or more players and because of their origins the other side would also distrust them. So, forming one particular group into a consensus platform is not going to be an easy task. Generally speaking there are the following two possibilities in the UK. One could create a totally new platform but it might actually be better to let an existing organisation grow into a platform. The three possible options in that case are:
1° the Boyd Group which is a consensus group, though not solely on alternatives, where three parties apart from the government are represented, but a government observer is present.
2° the Animal Procedures Committee, which is a statutory committee operating through the Home Office. No government representative is present. It has a Research and Alternatives Sub-Committee, which advises the Animal Procedures Committee and sponsors research, develops and promotes awareness and the use of alternatives.
3° the Minister’s Forum, which is a recent development. In this Minister’s Forum the minister gathers with a number of people to hear their views. This forum appears to have algained a degree of favour in governmental circles and is likely to grow. It could develop into a national forum with an open dialogue of all the four parties.
Any of these three options could develop into a four-party consensus platform. Regarding the question about what could be done to help the formation of a platform in the UK, Prof. Hughes pointed out that there should be a clear set of requirements and terms of reference as to what is looked for in a national platform. Not to be prescriptive about exactly how it ought to be done but providing a minimum set of what is required. He also asked for some guidelines to where the organisation might be going, objectives and requirements. They would be helpful to get a group coming forward in the UK.
If such a proposal could be sent to the aforementioned organisations then it is possible to find out if any of them are interested in developing into a four-party platform. This is one way of promoting a national platform. The other way is to give a task to accomplish rather than just being a talking shop. One of the things he felt missing at the present stage is education about alternatives at the undergraduate level. There is a need for a lecture on alternatives for undergraduate students. Certainly ecopa could prepare such a lecture and then provide it to the national platforms where they could translate it into their respective language and use it.
Asked by Dr. Sauer what would be done if all three bodies opted to become aal national platform Prof. Hughes replied that this chance was very slim indeed. If they all agreed to develop into a national platform, they need have to give details on whom they want to have in, what they want to do and how. One would have to examine their case for it and circulate it among the other organisations. It must be an open process and the UK organisations themselves must find a solution and then present it to ecopa.
Dr. Appl, secretary of zet, presented the Austrian Centre for Alternatives to Animal Testing which was founded in 1996 by scientists of the University of Graz together with activists from animal welfare. He said that zet was identical to the national platform on alternative methods and a registered organisation according to Austrian law. It was an NGO and NPO that financed itself mainly by sponsoring from individual persons. Most of the Austrian public authorities had accepted and supported zet right from the beginning although none of the Austrian regulatory bodies involved in animal testing has shown much interest in contributing to a solid financial basis for its activities.
When it was founded one of the basic ideas was to connect science and animal welfare and to establish animal welfare as part of scientific research. Experiences in the past had shown that radical positions from both sides did not contribute to progress and to promote alternative methods. The activities based on the principle of the 3R’s were therefore focused on establishing communication links between all groups concerned that is industry, public authorities, universities and animal welfare. In fact Dr. Appl stressed that this communication lead to a much better understanding of the different interest groups and also lead to a far more tolerant view of the problems related to alternatives to animal experimentation and testing.
Within the framework of zet it is further believed that it is necessary to improve the situation with respect to experimental animals not only by reducing the numl,ber of animals used but also by refinement and replacement.
With respect to the activities of zet, Dr. Appl said that the education on alternatives and the dissemination of information by various means such as brochures and leaflets are among the key tasks. Furthermore zet participates in congresses and supports research projects for example an evaluation of suffering and stress of transgenic animals in animal testing as compared to conventional animal testing. Dr. Appl closed by stating that one could classify zet as a reasonably successful national platform under the 3R’s-objectives.
Prof. Maier explained that the 3R Research Foundation is the Swiss platform on alternatives and has the 4 parties concerned. It was set up in 1987 as a foundation for animal free research at the initiative of a parliamentary group and Interpharma Basel.
It is a foundation providing grants for 3R related research projects and is funded equally (approx. 600.000 Euro each year) by Interpharma, Novartis, Roche, Ares Serono and the Swiss Federal Veterinary Office. It has an administrative board as well as an evaluation council. All four parties are represented in the evaluation council including a strong representation from universities in the ration of 3-4 members. In the administrative council, however, academia is not officially represented but members of the parliament are strongly represented in the ratio of 2 to 3. The political influence is thus vested in the administrative but in the evaluation council where it would be misplaced. Prof. Maier added that the two councils elect their members themselves that have to be approved by the administrative council. It is a well balanced system that works well in daily practise.
The research priorities are in the field of arthritis, convulsion and shock models. One of the major problems at the moment, however, is that there are not enough good applications that fulfil requirements of funding, namely the aim and the scientific quality.
The research results are being published and disseminated for instance by means of an info bulletin and a website that provides extensive abstracts of all projects (more than 70 within 13 yearsr,) that have been supported by the foundation. On this website, there are more than 60 links to other 3R institutions and data banks. Furthermore, all forms for grant application can be downloaded.
With respect to ecopa Prof. Maier welcomed the initiative and added that the exchange of information between national platforms could be a major task for a European platform. Further activities could be related to the implementation of alternatives as well as the setting up of a data bank providing information on submitted projects, funded projects as well as priorities for funding.
Prof. Smith pointed out that Norway has about 80 relatively small laboratory animal units throughout the country and that there is already a national platform in place comprised of all four parties. Norway also has a long tradition for field and fish research with fish actually being one of the major research tasks. He also emphasised that Norway was the first country to ratify the European Convention.
Regarding existing communication lines he mentioned that a lot of contact is maintained via closed e-mail discussion groups, among others for the competent persons who lead each laboratory animal unit. The National Reference Centre for Laboratory Animal Science at the Veterinary School in Oslo has its own Internet server where a considerable amount of information, including an electronic tour of the Unit is available: http://www.oslovet.veths.no
Concerning the issues at hand he told the audience that transgenic animals were less of a problem while fish was the main topic. Fish represent about 90 per cent of all animals used for experimental purposes in Norway. Refinement of shellfish toxicology testing and refinement of vaccine testing in fish are for instance areas of great interest and basis for further activities.
There are also a number of ecopa style activities in Norway such as the establishing of the NORINA-database on alternatives and the European Resource Centre for Alternatives with a particular focus on higher e ?ucation and the creation of a working group, comprised the four relevant parties, on the validation of serological tests for potency testing of tetanus toxoids.
Dr. Jírová explained that the “Animal Protection Programme” was based on the Act on Protection of Animals against Cruelty. This act was harmonised with the EC law in 1992. A long-term programme regarding the implementation of alternative methods is being performed under the supervision of the Central Commission for Animal Welfare. This commission integrates representatives and specialists from the Ministry of Health, Ministry of Agriculture, Ministry of Environment, Ministry of Education, universities, scientific organisations, commercial companies and animal welfare organisations.
Although an official platform for alternatives has not been established yet, the National Institute of Public Health in Prague performs various related functions. Besides basic research, some of its main tasks are to put scientific results to practice in laboratories, to provide methodological guidance, to promote the development and validation of new methods and to participate in graduate and postgraduate education programmes. The institute forms a common focal point for science, industry, animal welfare organisations and the relevant ministries.
The short-term objectives of the current work with respect to alternatives focus on public information and communication between the parties involved, laboratory implementation of selected alternative methods and the introduction of alternatives to practise as well as documentation of their advantages. The long-term objectives focus on promoting scientific development and implementation of methods, education and information an od scientific support for responsible authorities and legislation.
Regarding financial resources Dr. Jírová pointed out that there is no specific financial support to promote the implementation of alternatives in the Czech Republic. The work is based on enthusiasm of the people involved and depends on the limited budgets of institutions as well as national research grants.
Concerning the contacts with institutes abroad, she noted that there are sometimes communication problems since these foreign laboratories perform alternatives on a commercial basis or for purposes of their own companies. Some of them are not interested in providing methodological assistance. According to her view ecopa is very necessary and could thus help to give Czech laboratories the opportunity to get more information, practical training and so on.
Prof. Rydzynski said that there have been a number of seminars, conferences and courses between 1994 and 1999 to raise awareness and to promote the implementation of the 3 R’s in Poland. Furthermore, in 1998 a National Ethics Committee for Experimental Animal Testing was established with 17 regional divisions located at major university centres. In 1999 a National Centre for Alternative Methods in Toxicity assessment was established by the Ministry of Health at the Nofer Institute of Occupational Medicine in Lodz.
The aim of this centre is the dissemination of the idea of applying alternative methods for toxicity assessment to replace, reduce and/or refine experiments on animals. Among the main objectives are the collection and distribution of data on the concept and use of alternative methods, networking of research centres employing alternative methods and the information exchange on research projects conducted in Poland and in other countries. Furthermore it provides information on application possibilities regarding Polish and international grants for research on alternative methods, organising workshops and conferences as well as editing and distributing the newsletter “Vitryna” (www.imp.lodz.pl/vitryna), which is an important source of information.
Prof. Rydzynski then informed the participants that a recent survey of 21 research institutions had shown that 14 would already use alternatives and/or do research while the remaining 7 facilities are intending to do so. Finally he stated that any inf>?ormation from other countries made available through ecopa is very welcome and would be disseminated especially by means of the “Vitryna” newsletter.
At the end of the first day of this workshop Dr. Garthoff and Prof. Rogiers asked all participants to prepare suggestions for the next day regarding the structure of ecopa as well as three topics/issues that they regarded as prime objectives for ecopa to deal with in the future.
SESSION 3. FURTHER ISSUES TO BE COVERED BY ecopa
The participants were split up into two discussion groups chaired either by Prof. Mulder (NL) or Prof. Spielmann (D) to identify the three most important issues to be covered by ecopa and suggestions for the structure of ecopa.
These were then presented in Session 4.
SESSION 4 (PART I). FUTURE PROGRAMME OF ecopa
Results of Group 1: Guided by Prof. Spielmann (D) and presented by Prof. Maier (CH)
Prof. Maier pointing out that consensus had been reached on having English as the official and only working language of ecopa which meant that all translation work would have to be done and paid for by national platforms. It was also agreed that ecopa should be European in a true sense of the word and therefore not be limited to EU Member States only but be open to all other European countries provided that they comply with the basic requirements of a consensus platform, namely all four parties should be included and there should be only one platform per country.
It was further agreed that ecopa is necessary and that it should serve a number of purposes such as facilitating the exchange of information between national platforms, giving advice to national platforms and co-ordinating information concerning ongoing projects (inventories). Furthermore, ecopa should define priorities for the implementation of the 3 R’s, set priorities concerning achievable goals and make links with European and international institutions.
A lot of ideas for potential priorities that could be taken up by ecopa were brought forward such as the European pharmacopoeia, endocrine disrupters, the zero option on primates, HPVC testing, monoclonal antibodies and dog as a second species.
With reference to the three main goals for ecopa Prof. Maier explained that the group had agreed on the exchange of information as the most important one, followed by giving advice to national platforms ano?d setting priorities for achievable goals.
Results of Group 2: guided by Prof. Mulder (NL) and presented by Dr. Morris (UK) and Dr. Sauer (D)
They had identified short and longer-term objectives. Regarding short-term objectives it was agreed that networking between national platforms and exchanging news and information on workshops and educational programmes were important. It was agreed that it would be desirable to locate funding opportunities, to reciprocally place links to national chapters on the respective websites as well as to have an own ecopa website, and to work out a list of key speakers.
Concerning the rather longer-term objectives it was discussed to aim for an input and impact at the European level for funding and legislative change and to establish links with the EU institutions, the OECD and so on. There was consensus in the group with respect to having a follow-up meeting in 2001.
In group 2, 2 representatives explained the different points of views existing within the group.
– Dr. Sauer summarised that the following points were seen as the key tasks for ecopa to deal with: to establish a website that would facilitate the information exchange to focus on matters related to education and to promote the 3 R’s. She furthermore added that no “we-are-ecopa-feeling” had been encountered which meant that there should be no institutionalised ecopa but merely a loose forum for discussion and the exchange of information with partial co-operation. This view, however, got contested quite importantly by various other members of group 2 that expressed their desire of having a more structured organisation than just a discussion forum. What structure it should be, was not clear.
– In the subsequent discussion Prof. Smith expressed the view that funding ought not to be so much of a problem once ecopa got off the ground and had some good objectives to present.
Prof. Rogiers added to this that it should be clear to everyone that funding was not to come out of the budgets of national platforms but new sources were to be found.
Dr. Morris emphasised that there would be great reluctance in the UK to accept priorities that seemed to be imposed on them. One ought to be more realistic when it came to the issue of achieving consensus in different countries. Dr. Bottrill added that there were a number of platforms in the UK but that none would define itself as a national platform. Even if one did, then the other groups would not accept it. Dr. Jane Smith said that there were various groups in the UK that could evolve into a national platform but that it would take time. Out of the discussion, it became clear that a lot of discussion within the UK would be necessary before they could come with a consensus proposal.
Dr. Garthoff stressed that there was always a scale of consensus and that it would be futile to aim for a 100 per cent since that was impossible to achieve. One had to aim for the centre but there would always be some left out on the extreme left or right at one’s own wish. Prof. Rogiers and Prof. Castell pointed out that it couldn’t be the task of ecopa to solve internal problems of different national platforms. Once a country had solved its own problems, only then one seriously could think of becoming an ecopa member. Prof. Spielmann b?mentioned that the definition of a platform could actually have a catalytic effect in those countries that did not have a platform yet to get their act together and to get started.
Dr. Morris stressed that within group 2 no consensus was found on who should set the priorities and that the zero option on primates was definitely one that would cause major disagreement in the UK. One would have to go back first and consult with its own members. Dr. Sauer said that this was the case anyway and that people would return and discuss the results at home which would in turn bring up new questions and issues also with respect to the structures. Dr. Sauer very much focussed on the importance of spending more time to the structure of ecopa. Several participants agreed but did not saw it as a priority of this first meeting. It has to be dealt within a later meeting.
Dr. Küsters expressed the view that one should not get too caught up in discussing structural aspects but that emphasis ought to be put on setting priorities. Prof. Svendson expressed his view that the purpose of this workshop was to see where consensus could be reached within achievable goals but that no ultimate and final master plan was to be drawn up. Mr. Aune added that the aforementioned priorities were to be understood as examples. If there was no consensus on one of them, then that one could be dropped. But if there was agreement found on a particular issue that could save the lifes of animals then it ought to be picked up and pursued as a common goal. Regarding the aspect of setting priorities Dr. J. Smith sb?aid that once the dialogue started there would also be more consensus evolving thereby reducing the issue of who was deciding what.
Dr. Garthoff chairing this session summarised the discussion by pointing out that both groups had in effect defined very similar tasks for ecopa. The tasks were first of all networking and promoting the exchange of information, second dealing with matters related to education and third the setting of achievable priorities and specific common action.
SESSION 4 (PART II). FINAL RECOMMENDATIONS: DEFINITION OF ACTION PLAN AND FOLLOW-UP STRUCTURE/ TASK OF ecopa
Dr. van Iersel (NL) chairing this part of the session, explained that the three organisers had discussed ways to give ecopa a face and that they had agreed that coming with an action plan, structures and tasks are vital.
Regarding an action plan it was decided to have in a first stage at least a conference report that would be submitted to all participants, the sponsors and others parties such as the European Commission and the European Parliament. The action plan should also include the formal foundation of ecopa which could take place in autumn 2001 as well as the setting up of a working group supported by a consultation group that would work out the action plan in further detail, organise the next meeting and so on. Finally, the website of ecopa should also be included.
A working group comprising four to seven people with administrative support should be sufficient for the time being. Its tasks would be to give ecopa a face by compiling a policy paper including statutes, laws etc., to find funding opportunities and to organise the next meeting.
The consultation group Dr. van Iersel pointed out should consist of all the participants of this workshop. It should further be enlarged by nominated key persons for example of countries that were not attending this meeting or of the four parties involved.
Concerning the set-up of the working group it was intended to have a balanced approach, as good as possible, with regard to the regional distribution as well as their affiliation. The following proposal was done. Prof. Vera Rogiers (Belgium/act?ademia), Dr. Garthoff (Germany/industry & platform), Dr. van Iersel (Netherlands/platform), Mrs. Gabrielson (Sweden/animal welfare), Prof. Maier (Switzerland/industry & platform), Mr. Lyngset (Norway/government), Prof. Castell (Spain/academia). The proposed working group members were not asked before, so it was up to them to accept or refuse.
Mr. Lyngset expressed his reluctance to participate on the basis of being from a non-EU Member State and suggested Dr. Kokkonen from Finland government to take his place in the working group. Dr. Kokkonen expressed her interest in joining the working group provided that her government ministry would not object which is not the case, as informed later on. The other proposed candidates also expressed their willingness to take part. Since there were no objections to the proposed candidates they were elected unanimously to form the working group.
Concerning the possible structure of ecopa Dr. van Iersel proposed that the working group would evaluate the collected structure proposals of all participants (in the meantime written down on paper) and condense them into proposals that would then circulate among the consultation group. This way everyone had the chance to discuss these proposals at home and to comment on them which would also be done in writing to ensure that everyone enjoyed the same degree of information.
Nevertheless there were already some points coming up out of the discussion which gave an idea of how the strut?cture could look like. Everyone seemed to agree as Dr. van Iersel summed that the structure of ecopa should be as little bureaucratic as possible but needed to be flexible and that a minimum should be secretariat and an executive committee.
On behalf of the three organisers, Dr. van Iersel finished by thanking everyone for attending and contributing so actively and constructively to this workshop.
BPAM Belgian Platform for alternative Methods
CELLTOX Italian Association of In Vitro Toxicology
CFN National Board of laboratory Animals (S)
CMA National Centre for Alternative Methods in Toxicity Assessment (PL)
EBRA European Biomedical Research Association
ECB European Chemicals Bureau
ECVAM European Centre for the Validation of Alternative Methods
EFPIA European Federation of Pharmaceutical Industries and Associations
ERCA European Resource Centre for Alternatives (N); a combined project between UK, NL and N
Eurogroup Eurogroup for Animal Welfare
FRAME Fund for the Replacement of Animals in Medical Experiments (UK)
MEGAT Mitteleuropäische Gesellschaft für Alternativmethodenzu Tierversuchen (A)
NCA National Centre on Alternatives for Animal Use (NL)
NICA Nordic Information Centre for Alternative Methods (S)
NORINA Norwegian Inventory of Alternatives
NVH Norwegian School of Veterinary Science(N)
ISS Instituto di Sanità (I)
PECO Pays d’Europe Centrale et Orientale
REMA Red Española de Métodos Alternativos (E)
set Stiftung zur Förderung der Erforschung von Ersatz- und Ergänzungsmethoden zur Einschränkung von Tierversuchen (D)
TCRC Tampere University Cell Research Centre (SF)
ZEBET Zentralstelle zur Erfassung und Bewertung von Ersatz- und Ergänzungsmethoden zum Tierversuch (D)
zet Zentrum für Ersatz-und Ergänzungsmethoden zu Tierversuchen (A)
ZON ZorgOnderzoekNederland (NL)
Appendix of Comments and Remarks regarding the Minutes in Alphabetical Order
(Underlined words are to be deleted or replaced by the following words in brackets.)
Prof. Michael Balls (18th April 2001):
(ECVAM, Institute for Health & Consumer Protection, JRC, DG Environment EU).
“Ecopa – Possible interaction with ECVAM and the other interacting partners”.
Prof. Balls stated that ecopa is badly needed, because alternatives are badly (not well) represented with in national governments, the European Parliament, the Commission and international bodies. There is a slow but steady and scientifically-credible progress in alternatives, but at the same time, animal use is drastically increasing, therefore ecopa has an important role to play.
Prof. Balls made it clear that he was speaking for himself and not for the Commission, but that he was very against what appeared to be the Commission’s policy on toxicological testing of the chemicals on the EINECS list, the policy explained earlier by Dr. Vogelgesang. He called it appalling that half a million animals more will (might) be used in addition to the 11 million already used today, every year for the next 20 years!
He proposed the following fields (areas) for ecopa action:
Ø the political decision of (debate on) extra testing of existing chemicals already on the market, as mentioned above
Ø transgenic animals, for which welfare aspects are being overwhelmed by scientific excitement
Ø food safety, for which consumers expect total protection, but which cannot be provided
Ø endocrine disruptors, for which non-validated animal tests are proposed.
Ecopa should select specific items for concerted action and develop effective routes for communication with the EU-DGs, ECVAM, the European Parliament, the Council of Europe, the European Pharmacopoeia, Eurogroup for Animal Welfare, and scientific journals with an interest in alternatives.
ECVAM could help ecopa by functioning as a route for contacts with the Commission Services, providing the ESAC meeting minutes, and helping by organising a meeting every year.
On the other hand, ecopa could help ECVAM to gain support at all levels for its actual work, to disseminate and promote the activities of ECVAM, and help by identifying methods that are ready for prevalidation and validation. In all these activities, the PECO countries should not be forgotten.
Prof. Ian Hughes (20th March 2001):
I have looked over the ecopa papers and they look fine to me – a nice job of putting things together. Well done.
The views expressed are my personal views.
Prof. Dagmar Jírová (30th March 2001):
I have carefully read the materials from ecopa meeting and I have handed it over to other people involved in the Czech platform, i.e. representatives of government, animal welfare and university. Let me summarize our opinion. We consider the materials very instructive, clearly arranged and well documenting the discussed topics. There are no specific comments from our side, we fully agree and support the activities and we are ready to cooperate in any way.
Mr. Roman Kolar (9th April 2001):
I have no comments apart from asking you to correct my email
address which is email@example.com (not: firstname.lastname@example.org as given in the address list).
Dr. Jane A. Smith (30th March 2001):
Thank you for sending the interesting and helpful summaries of the presentations at the ecopa workshop in October. I have a few comments:
Summary: Is it agreed that consensus platforms should be based on EQUAL representation of all four parties? Very few of the existing platforms meet this criterion. The important point, I feel, is that all four parties should have a clear voice, that is listened to, within each platform.
Minutes: These are a very helpful record of the proceedings.
I’d like to make two amendments in relation to my comments(for some reason, I can’t write directly on the document, so will have to try to describe where the comments are!):
In the section titeled ‘Results of Group 2’:
(i) paragraph beginning “Dr. Morris emphasized that…”.
Comments are recorded about the possibilities for a UK platform in this paragraph.I think they are too pessimistic!
I’d like the comments from “Dr. Botrill” … to the end of this paragraph to be DELETED, as I think these might prejudice our current work to get the Boyd Group recognised as the UK’s national platform.
As you know, the Group has representatives from most of the key players in the UK (including FRAME).
(ii) My comment recorded at the end of the penultimate paragraph in this section is unclear. It should read “Regarding the aspect of setting priorities, Dr. J. Smith said that once dialogue started, more consensus might evolve on which issues should be tackled”.
Dr. Annalaura Stammati (April 9, 2001):
In regard to ecopa minutes, I have revised my presentation which is correct and reflects my personal view.
Dr. Jürgen Vogelgesang(March 30, 2001):
If complete testing of all 30,000 chemicals were necessary, it would consume an enormous number of animals (half a million animals on top of the 11 (12) million used every year).
Taking all together, only a small (only a certain) reduction of the animals to be used can realistically be expected. (However, leaving chemicals in the market without sufficient testing would mean continued damage to human health and the environment.)