Q&A: MICHAEL C. BAKER
EUCOMED Seeks More Dynamic Role in Commercial Issues
Michael C. Baker is director-general of the European Confederation of Medical Devices Associations (EUCOMED). Prior to that appointment in January, he was secretary-general of the European Sterilisation Packaging Association from 1994 through 1996.
Q: What do you see as EUCOMED's major thrust in the next couple of years? What issues are going to be hardest to tackle?
A: In the past four or five years, EUCOMED has demonstrated that it is a force to be reckoned with in terms of regulatory and standards issues. The confederation has developed a good reputation for representing industry well in those areas, and we obviously need to continue doing so.
But we also need to be seen acting in conjunction with our national association members to address commercial issues such as reimbursement, cost containment, health-care economics, increased R&D innovation, and technology assessment. These sorts of issues are of increasing importance within the European market as well as elsewhere. They have an impact on all of us, and EUCOMED has to be seen taking a much more dynamic role in discussions on these issues.
In addition, of course, are the problems related to the European single market. The single market is a fantastic concept, and I have faith that it will work in due course. But there may be a tremendous number of problems in getting there. As the date for full implementation of the Medical Devices Directive gets closer [14 June 1998], we're beginning to see the problems generated by the principle of subsidiarity among European member states, which gives them liberty to tweak the directive to suit their own national requirements. Overuse of that liberty could create an uneven playing field, which is exactly what the directive was intended to avoid. So, obviously, EUCOMED will need to address issues created by differences in implementation, and to represent the best thoughts of industry about how to control such differences.
Q: Are there instances in which EUCOMED's national members differ over the ways that legislation has implemented the directive? Do some members see their own interpretation as a means to protect their national industry?
A: I don't think it is quite as cut and dried as that. But there are obviously certain circumstances where local implementation is designed to be beneficial to local industry, and therefore the rest of Europe is potentially disadvantaged. If those circumstances arise and can be proven, then they would be construed as barriers to trade. And then they can be taken before the Commission and eliminated.
Obviously, that is the sort of obstacle that we have to be on the outlook for. And identifying such barriers is really a EUCOMED responsibility. You can't expect a national association to admit that its national implementation presents a barrier to trade.
The truth is, almost no medical device company's business is really restricted to its national borders these days. Most companies are trading across borders, so they are going to be affected by what happens in neighbouring countries. Generally speaking, the trend is toward making the playing field as level as we can. And I believe that the national associations accept that principle and are endeavouring to work toward it.
Q: Is there an unevenness within Europe in terms of the pressure for health-care cost reductions? Are different nations at different stages of evolution?
A: Yes, very much so. Reimbursement issues are generally a problem, but they are more acute in certain markets. Germany has recently had some particularly harsh discussions about reimbursement, but there is no question that all across Europe budgets are under pressure. Everybody wants to see health-care provision improved, but at a lower cost. Cost-related problems affect European countries in different ways: France has problems related to high technology, Spain with delegation to regional--as opposed to national--authorities, Italy with continual payment delays.
If industry is to meet government objectives, it has to look at different ways of approaching the problem. It cannot be a case of simply cutting prices by 10%, because that is not a practical possibility. So we have to develop other ways of meeting the goals.
Q: Is the innovation of Europe's small and middle-sized manufacturers endangered by cost-containment pressures?
A: Probably so. The big companies spend a fair amount on R&D, and their propensity to produce new products continues. Frankly, the rate at which they do it amazes me. But in terms of pure innovation, you are probably looking to the little man in his laboratory to produce something that is startlingly new. Regrettably, cost-containment issues might stifle some of that initiative.
Michael C. Baker was interviewed by Steven Halasey, the editor of EMDM's sister publication, IVD Technology.
