Biomedical Engineering in the BIOMED-2 Program of the European UnionSince a number of years the European Union has been supporting research in biomedical engineering. It had already started in 1978 as the COMAC-BME activity and continued until 1991 when a more formal program BIOMED-1 was launched within the Third Framework Program for R&D of the European Union. This ended in 1994 and was followed by the BIOMED-2 program within the Fourth FP. The Fifth FP is about to be launched now. The first call for proposals is expected to be published at the end of January 1999. Biomedical engineering had a 'good slot' in both BIOMED programs and was clearly identified as an area from where project proposals were invited. It also had a preallocated budget. Now in the Fifth FP, that slot has disappeared and instead biomedical engineers must find other ways to be included in future projects. This article comprises three parts. The first one explains the projects and the 'bureucracy' needed in making successful proposals. Next, the BIOMED-2 program and the biomedical engineering projects are presented and in the end the future is briefly discussed. From concerted action to shared cost projectsProjects funded through COMAC-BME were of the type 'concerted action'. This meant that only concertation costs were funded, not direct research. In BIOMED-1, projects were also of this type. In BIOMED-2 a new approach was adopted (which is more in line with the general R&D funding policy of the EU). Projects were required to be of the type 'shared cost'. This meant that funding can be used towards a percentage of the research costs (normally 50%) and that the applicants must fund the remainder themselves. Depending on the type of the organisation this translates into two approaches. Enterprises and research organisations who apply accounting and project management practices throughout their activities can get 50% of their costs reimbursed through a contract. Universities and other organisations (such as hospitals) can claim costs on an 'additional cost basis'. This means that only the direct costs related to hiring additional personnel can be reimbursed. The projects are run by networked teams from the European Union Member States or from the associated countries having established an agreement with the EU (at this time Iceland, Norway and Israel). Teams from the Central and Eastern European countries may also participate to these projects, if selected in the frame of the International Co-operation Programme (INCO). The partners are typically researchers, clinicians and industrialists from academia, research institutions, large companies and SMEs. Minimally there must be partners from at least two EU countries. In practice it is better to have more than two countries present. In BIOMED-2, it was also required to have industrial partners. Also more emphasis was given to the exploitation potential of results. Proposals undergo a peer review process. Those that pass will then be given a contract. The progress of projects is monitored using milestones and deliverables. In addition projects are requested to annually submit a report, cost statement and an updated plan to conclude the project on time and on budget. There has also been a (semi-) annual project leaders meeting in connection with a conference arranged by ESEM. Last year ESEM arranged a workshop on these projects (Brussels, 27-28 April, 1998) with the title 'Biomedical Research and Industrial Participation in Europe : Trends and Future - A Review'. Biomedical engineering in BIOMED-2The Biomedicine and Health Programme, or BIOMED 2 for short, has been running from 1994. As its title indicates it comprises many other fields in addition to biomedical engineering. Those interested in the whole program can find the information in one of the web-servers of the EU (e.g. http://www.cordis.lu). In EU terminology area 2 is devoted to 'research on biomedical technology and engineering'. The objectives of this action line are defined as 'Coordination of basic and applied research in biomedical devices, instruments and techniques as well as in cellular engineering, in order to develop or improve diagnostic and therapeutic tools, methods and standards will contribute to further improve their quality and reduce the cost of healthcare. …'. The action line is further divided into research tasks and projects that have been selected and they can be found under these headings. Table 1 illustrates these tasks and the selected projects by title. The same information is available on the web (http://www.cordis.lu/biomed/src/project.htm). There is also a synopsis of each project and a listing of the partners. Unfortunately the server does not store any information about the progress of these projects. If you are interested in these projects you need to contact the partners of these projects. In addition to the shared cost of the R&D projects of Table 1, BIOMED-2 also supports 'demonstration projects'. They represent a new modality of implementation. They are funded on the shared cost basis. The aim is to speed up the adoption of new technologies, methodologies or therapeutic practices by reducing the uncertainties and risks associated with innovation and to enhance the attractiveness of new approaches in the medical community, industries and services. All elements necessary to implement the demonstration project must be ready and available to the proposers. No research or technology development activities is accepted within a demonstration project. A strong user's need orientation is mandatory. 'Stand up and walk' is an example of demonstration projects funded in BIOMED-2. Biomedical engineering in the Fifth FPIn the past EU programs biomedical engineering and more generally the application of technologies in health and biomedicine has had a quite a good visibility. In addition to the BIOMED-2 activity described above a few other slots have existed for projects specifically in the area of health telematics and technologies for the integration of the disabled and elderly. The total funding in these areas by the EU in the Fourth FP was well over two hundred MECU. The Fifth FP which is about to soon to begin is going to be very different. Based on the proposal of the European Commission, it will follow a completely new structure, with a reduced number of thematic programmes, designed to meet the European Union's economic and social objectives (improving employment; promoting the quality of life and health; preserving the environment). New modalities will be implemented, for example the so-called 'key-actions' which will address objectives that have been identified as deserving a convergent mobilisation of public and private European and national resources. The First thematic programme entitled 'Improving the quality of life and the management of living resources' includes the five key actions: health, food and environmental factors, control of viral and other infectious diseases, the cell factory, the ageing population and integrated development of rural and coastal areas. RTD activities of a generic nature will also be supported in the following areas: degenerative diseases, cancer, diabetes, cardiovascular diseases, diseases of genetic origin, rare and orphan diseases, research into the genomes and the neurosciences, improvement of health systems, enhancement of health and safety at work, study of the social, medical or public health aspects of the use of drugs. Bioethics and biomedical ethics, socio-economic aspects of development of the life sciences and technologies, as well as research infrastructures will be supported. Other thematic programmes, such as the 'User-friendly information society' also offer opportunities for researchers in biomedical engineering, for example under the key action 'systems and services for the citizen', where professional healthcare and personal health systems are adressed. The horizontal activities to support innovation and demonstration, research projects in the interest of SMEs and broad international co-operation will continue to be developed into integral parts of the Fifth Framework Programme. Objective: The main objective of SUAW is to achieve a European Program for some restoration of locomotion on paraplegic patients. SUAW is a demonstration project, the objective of which is to implant six selected patients in six different European countries at the same period of time, and to evaluate them for a period of nine months. General Information: The only realistic possibility, at the present time, for restoring locomotion is to stimulate the sublesional muscles by means of an electrical current, in order to generate an artificial contraction of muscle fibres. A European clinical network, grouping twelve rehabilitation centres in twelve European countries was created in 1992, for the preparation clinical protocols, corresponding to the five phases of the project: selection of patient, presurgical training, surgical implantation on patients, post surgical training and daily use. Everything is, at the present time, ready on the clinical side and a non-profit association was created in which all the clinicians, scientists and engineers have contributed to the project. The rehabilitation team belongs to the Spinal Injury Centre of Southport. The surgical team from Aalborg, was especially trained for the implantation of electrodes on animal and few tests were made on patients. The technical team is coordinated by the Faculty of Medicine, University of Montpellier. In the framework of this project a new industrial dynamics has been created with more powerful partners who able to invest, in addition to the European community contribution. In this way, IBM France, THOMSON CSF, BTS Italy and ROESSINGH R and D, Netherlands, are the industrial partners. The six selected patients, after implantation, will be evaluated by the European clinical network for a period of nine months. Keywords:Paraplegia, neuroprosthesis, functional electrical stimulation, rehabilitation. Timing: Start: 1 July 1996, end: 30 June 1999 Prime Contractor: Université de Montpellier 1, Laboratoire d'Anatomie et de Bioméchanique Humaine, France. Contact person: Professor Pierre Rabischong Other Contractors:
Table 1. Biomedical engineering projects in BIOMED-2 (http://www.cordis.lu/biomed/src/project.htm)
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