Medical and Biological Engineering and the European Union
In 1991 IFMBE established a European working group with the aim of creating a forum for the European member societies to discuss common problems and formulate responses to these. This was around the same time that the European Society on Engineering and Medicine, ESEM, was created.
In the early 90s the role of the European Union (EU) and the Commission (CEC) as its administrative machinery was not that great from the perspective of medical and biological engineering. There was the concerted action committee on biomedical engineering (COMAC-BME) with funding for MBE projects from DGXII. Additionally, within DG XIII a small program on advanced informatics in medicine (AIM) was running. Since those early days, the role of the Commission has grown considerably for those of us working in medical and biological engineering. There have been two thematic programmes funding R&D in biomedical engineering (within the BIOMED-programs) as well as in medical informatics (or health telematics, as it was called in the programs) and technologies for the disabled and elderly (TIDE).
The Commission is actively establishing directives for medical products. These are similar to the requirements that FDA requires in USA. The point here is that EU member states are required to implement these directives. This is the way to create harmonised markets inside the EU. Parallel to this, the Commission is seeking to harmonise requirements for professions and educational systems. In our case, this affects clinical engineering in particular.
These initiatives are not confined to the EU member states. Agreements have been reached for other European countries to join R&D programs. There are economic and political reasons for non-EU countries to implement EU directives.
In the setting up of the current Framework Programme of R&D, medical and biological engineering suffered a big defeat. Whereas in the past, there had always been funding earmarked for this activity, in the Fifth Framework this is no longer the case. Nevertheless, health telematics and the disabled and elderly are still included both in the Information Society Technologies program (IST) and in the Quality of Life program (QoL).
So what happened, why is MBE not there anymore? In my view, simply because we failed to make a good enough case to have it there. The reasons for failing are mainly that the medical and biological engineering community in Europe has neither a single voice nor a unified message that we can deliver to the Commission. We are now in danger of repeating this in the activities dealing with professional issues and higher education. In medical products, our absence has not been that detrimental as the European industry has effective collaboration bodies who can be present when these matters are discussed.
There is, of course, another aspect to the above issue. MBE projects can still be funded through Commission programmes. The problem is that you then have to orient your project proposal according to the declared goals of the relevant programs. This in turn means that MBE cannot be central in such proposals. We can support but we cannot apply directly. In other words, do not be discouraged by the fact that MBE is not specifically mentioned. There are possibilities in both the IST and QoL programs. The Future and Emerging Technologies program (FET) especially welcomes MBE proposals (as announced in the previous September newsletter).
Should we try to remedy this situation so that in the future when the Sixth Framework Programme is prepared we have a single voice and can be represented properly in the professional issues and in issues dealing with higher education including the drafting of the directives (and the standardisation work on which it builds)? The original idea in 1991 when the European working group was set up was just that, i.e. to bring the member societies together to decide what kind of mechanism we need.
We might also want to look at examples of how other disciplines have solved this. In Europe, examples include
- For medical physics there is EFOMP, established by European medical physics organisations and also a member of IOMP. However, the European national societies are members of both IOMP and EFOMP. In medical physics, there are interests in professional issues and higher education including directives and standards (mainly on radiation safety) where EFOMP needs to talk to the EU Commission. There are no medical-physics-related research topics in the current Fifth Framework Program of the EU (nor was there anything in the previous program).
- In medical informatics, a similar structure exists with EFMI (European Federation for Medical Informatics) and its international counterpart IMIA. IST applications for health, the disabled and elderly are included in the current IST program. The topics included, such as imaging, signal processing, etc., touch on MBE (but are essentially restricted to information society technologies, as this sub-program is under this main program, IST).
- In biomedical engineering we have a very fragmented situation. First of all, we have the national societies and our European working group. Also we have ESEM, which because of its history has a relationship with the EU Commission (with DG XII, the old Biomed Program, which no longer exists). Additionally, there are European societies in specific fields of MBE or, to put it differently, between certain technologies and medicine, like ESAO (European Society on Artificial Organs), the European Society for Biomaterials, and others.
My belief is that we need better concertation in what we traditionally call medical and biological engineering across Europe, i.e. not only between the EU member countries but between all European countries. I also believe that the goal of this concertation should be well represented in MBE-related affairs discussed with the EU Commission and EU Parliament.
Approaching the EU Commission is not an easy task. The interests we have are spread into a number of Commission administrations (Directorate Generals). Therefore, we need to mobilise resources to be there, to monitor and to intervene, to take initiative, etc. There are at least two stages in this process. Firstly, can we agree on a single representative for MBE in Europe, i.e. is there a way to find a common ground for all European IFMBE affiliated national MBE societies and ESEM? Secondly, once we have this, the next step is to discuss with the other European MBE-related organisations, especially EFOMP and EFMI, whether we can agree at that level.
One success story that we should look at is that of our American member, AIMBE. It has been rather successful in addressing the Federal Government (see story in the July issue of this newsletter). I am not suggesting that we should copy that model but I am suggesting that we should learn from that experience and that we need to get our act together now.
I therefore suggest that we first decide on the goals and after that on the means needed to achieve them. For my part, the priority is developing relations with the EU Commission.
Niilo Saranummi
Email: Niilo.Saranummi@vtt.f