This volume contains the final reports of twenty-one of the projects supported by the Commission of the European Communities within the framework of the Medical and Health Research Programme (1987-1991) - MHR4 - in the area of biomedical engineering.

Despite the social and economic importance of biomedical and health research, it is only fairly recently that the European Community became involved in research and technological development in this research sector. It was not until 1978 that the Commission of the European Communities was authorized to promote coordination of research projects in the various countries in very limited and strictly defined areas of common interest. Since this “pilot” work proved successful and considerably improved the effectiveness of efforts made at national level in the fields chosen, the EC Member States showed both interest and confidence in this then new form of EC action. As a result, in 1982, the Council of the Ministers of the Member States finally adopted a wider-ranging and more coherent research coordination programme in biomedicine and health. Since then, this programme has grown substantially both in size and content.

The general goal of the programme is clearly to contribute to a better quality of life by improving health, and its distinctive feature is to strengthen European collaboration in order to achieve this goal.

The 4th EC Medical and Health Research Programme (MHR4) consisted of six research targets. Four were related to major health problems: cancer, AIDS, age-related problems, environmental and life-style related problems; two were related to health resources: medical technology (i.e. biomedical engineering) and health services research.

Biomedical engineering has formed an integral part of the EC biomedical and health research programmes since their quite modest beginnings in 1978, when only three collaborative research projects - “concerted actions” - were supported by the EC; as a matter of fact one of those early projects dealt with extra-corporeal oxygenation. Collaboration is not natural and spontaneous within the scientific community which rather believes in competition to ensure scientific progress. In the early period of the EC programme, biomedical engineering may be said to have served as the driving force in the process of fostering some collaboration spirit in the European biomedical research community. It was so successful that in 1987, biomedical engineering consumed nearly 45% of the total programme's budget with sixteen projects running!

The ultimate goal of the biomedical engineering part of the programme has been to contribute to the improvement of the quality of health care, as well as to the containment of its costs. Health technology assessment has gained further importance in view of the completion of the internal market within the EC. Such assessment may provide essential information for decision making at all levels, (i.e. political, health services, medical). Because of the extremely rapid development of technology, results of assessment studies should become available quickly. Besides evaluation of biomedical devices is expensive in financial and manpower terms, mainly because of the qualified personnel it involves and the need to recruit patients. Inappropriate use, or wrong application of technology, adds to the increase in health costs, not so much technology in itself. These are the major reasons justifying performing such evaluation at European level, as this makes it possible to obtain more reliable data more quickly, because of large sizes of samples. Accordingly, health technology assessment, in particular assessment of technical and clinical efficacy, has come under biomedical engineering in the EC medical research programmes.

Multi- and inter-disciplinarity has always characterized the projects supported in the biomedical engineering part of the EC programme, and such an approach still remains strongly encouraged. In biomedical engineering, the necessity for a closer collaboration between engineers and clinicians has always been felt, and this has been encouraged by making it an essential condition before recommending a research proposal for support.

A study performed a few years ago by Centre de Sociologie de l'Innovation (Ecole des Mines, Paris) (*) was the first attempt at defining the characteristics of the EC medical research programmes. It confirmed that, although the level of EC funding remains modest (**), these programmes stand among the major EC research programmes when using the number of involved teams as an indicator, and the only one which has adopted an original approach to financial support, namely the concerted action, as its principal mode of implementation. In 1990, the 117 ongoing actions within MHR4 involved 3,500 teams altogether, that is an average of 30 teams in each action all over Europe (i.e. the twelve EC Member States plus Austria, Norway, Finland, Sweden, Switzerland, Turkey).

Concerted actions remain the principal mode of implementation, together with centralized facilities and fellowships. Funds are provided by the EC for activities which consist of research collaboration and co-ordination in EC Member States and in other European participant countries. Networks of research institutes can be set up and supported by means of meetings, workshops, short-term staff exchanges and visits to other countries; preparation and distribution of materials and reference products, that is, for quality control; centralised data handling, storage and statistical analysis. The concerted action budget also covers the dissemination of information as early, as fully and as frequently as possible. The funds are not primarily intended as direct research grants; the institutes must fund the research activities carried out within their own countries - it is the international coordination activities which are eligible for Community support. Each research network is placed under the responsibility of a project leader; he/ she is generally assisted by a project management group representing the teams participating in the network.

The Project Leader, that is the author of each of the following chapters included in this volume, is the cornerstone of the concerted action system, as he is accountable vis-à-vis the Commission and is the only recipient of EC funds. “He is fully responsible for the operational definition of the project from mobilizing teams to disseminating results, for organizing the work and arranging the logistics of staff exchanges, often considered to be the strategic hub of concerted actions.” (*)

But successful projects are based on the favourable collaborative atmosphere which has developed among the participants themselves, without whom, in the end, nothing could be achieved. Accordingly, the Project Leaders indicated here as authors should be considered rather as spokesmen for the participants involved in the projects.

In addition, within the concerted action system, the role of COMAC-BME should not be underestimated; COMAC-BME was the advisory committee for biomedical engineering until the end of MHR4. It consisted of usually two experts in the field of biomedical engineering for each participating country. The list of COMAC-BME members is provided in the annexes. Together with the project leaders and participants, COMAC-BME members substantially contributed to the definition of this original approach to public support for research, that is the concerted action. During the course of MHR4, COMAC-BME has witnessed a major change in its role. Before 1989, its tasks were in fact to contribute to the initiation and preparation of proposals, as well as to supervise and monitor the progress within ongoing projects. At that time, it was thought that this process of going through a nurturing phase for potential new projects was an essential ingredient for success, although it took time; mainly, collaborative spirit could develop during that phase. Since 1989, calls for proposals were introduced, and COMAC-BME, together with the other advisory committees for MHR4, was changed into more of a usual selection committee, while keeping its role as a supervising and monitoring advisory committee. Since then, the calls for proposals have been extremely popular, showing the very high level of demand among the European biomedical research community. As underlined in the previously-mentioned study (*), “the key to the success of concerted actions lies in the capacity to rally teams (at least an active core) behind the same objective”. In such an endeavour, investment in human resources is the decisive factor. This was understood by COMAC-BME which tried to implement among themselves what it was preaching to others, that is the collaborative spirit, especially among engineers and clinicians coming from a variety of backgrounds.

Because of the original features of the concerted action mechanism, it is not easy to evaluate the outcome with usual criteria and indicators, but this should not lead to underestimate the achievements.

In spite of modest financial incentives imposing little obligation, in the previously-mentioned survey (*), the participants, on average, declared quite a high degree of involvement in the concerted action activities. Nearly all concerted actions brought together researchers and clinicians, who are in fact the potential users. Such “interweaving” of research and clinical practice enabled operational results to be directly integrated into practice in harmonized ways throughout Europe; this may be considered similar to “industrial” developments found in other contexts. At the same time, new research structures, that is research networks, have been established; they are both irreversible and flexible, because they are based on human relations, and imply a certain degree of harmonization among experimental practices.

The EC biomedical research programmes have undeniably reached a key stage in their evolution, mainly because of the high level of demand revealed by the numbers of applications received for each call for proposals. The issues are many and multi-faceted, such as selection, monitoring, management, information dissemination and exploitation of results, but also survival of established networks. The major challenge lies in fact in the definition of EC research programmes and their integration with national ones. As a matter of fact, the new Treaty on the European Union, better known as the Maastricht Treaty, when ratified, opens new possibilities in relation to a novel EC competence in health. The potential enlargement of the EC, i.e. the negotiations with Austria, Finland and Sweden to join, the European Economic Area, close collaboration with Central and Eastern Europe, gives new geographical dimensions.

Our enriching experience of promoting collaboration in the biomedical engineering community at European level enables us to be optimistic about the future. One caveat, though: there is no doubt that the approach to biomedical research at European level should undergo a thorough review, in particular with regards to appropriate financial means and more varied support mechanisms. In such an evolution, the value of maintaining, even protecting, the concerted action system should not be overlooked; its originality and its flexibility are at the same time its strength and its weakness. We hope that the chapters in this volume will contribute to a better recognition of this approach.

Prof. Dr. Ir. Jan EW Beneken

Eindhoven University of Technology (NL)

Chairman of COMAC-BME

Dr. Viviane Thévenin

Commission of the European Communities DGXII-E-4

Secretary of COMAC-BME

(*) Commission of the European Communities

“The Research Networks built by the MHR4 Programme”

Authors: P. Laredo, B. Kahane, J.B. Meyer, D. Vinck

Research Evaluation EUR 14700 EN

Luxembourg: Office for Official Publications of the European Commission, 1992

(**)It has been estimated in the order of 5% of the total research expenditures in the fields covered by the EC programme.