Q & A: MICHAEL BAKER
Reimbursement Reform Remains High on EUCOMED Agenda
EUCOMED formalized its merger with the International Association of Medical Prosthesis Manufacturers (IAPM) during the recent general assembly in Seville, Spain. After signing the agreement, director general Michael Baker commented that EUCOMED enters the new millennium as a stronger, more robust organization. In this question and answer session, Baker discusses some of the primary issues confronting the expanded association this year. Q: You must be pleased with the merger and the clout it gives you to further EUCOMED's goals.
A: We are very pleased, indeed. As you know, industry is going through a phase of mergers and acquisitions, and representative associations do need to follow developments within industry. Companies can't afford to belong to umpteen different associations. Our voice as EUCOMED is now considerably stronger.
Q: What issues are on the shortlist for 2000?
A: There are a number of hot potatoes. First and foremost is the basic question of how the provision of healthcare in Europe is funded. How do we ensure that new technologies are available to patients in Europe as readily as they are in the United States? How do we make sure that we get reimbursement for them? If there's no reimbursement, patients will not have access to them. This is a key issue, but one that is related to the funding scenario. The socioeconomic problems aren't going to go away, and governments within the European member states must recognize the need for a change in procedure. Failing that, the standard of healthcare in certain European nations is going to fall behind and we will start to see people that have the resources getting on the Concorde and flying to the US for an operation, because that's where you'll find the latest technology.
Q: Regarding reimbursement, what would you consider to be a successful and realistic outcome for industry within the next few years?
A: We need to find a way through the morass of individual governments' approaches to reimbursement. Although in Europe we have to accept—at least for the time being and probably for the foreseeable future—that the actual levels of reimbursement will remain the decisions of the member states, I think we should be able to achieve a common procedure. Any company introducing a product that involves a new technology should not have to go through more than one procedure for obtaining reimbursement, irrespective of where the reimbursement is coming from. At the moment, firms marketing a product in the EU have to go through 15 different procedures! [Achieving a single procedure] would be a fairly major move for industry. We're still several years away from that, but I think we can start to lay the groundwork.
Q: The mutual recognition agreement (MRA) with the United States seems to be running out of steam. Historically, EUCOMED has been a fervent supporter of MRAs. Considering the current lack of enthusiasm for the terms of the agreement on either side of the pond, do you think it still has a meaningful future?
A: It has to have a future. There's no doubt about that in my mind. The MRA is designed to encourage greater bilateral trade between the two largest trading blocs in the world. There has to be a benefit to industry on both sides of the Atlantic but—and this is where the initial problems have been—industry has failed to recognize any benefits from the first 12 months of the MRA. We should now be one year into the confidence-building programme, but of course we're not. And this is basically because of misunderstandings between European and US regulators. In a nutshell, we have to believe the MRA will benefit our industry. The problem is actually seeing that benefit and gauging how it will affect individual companies.
Q: EUCOMED has been at the forefront of the debate on the reuse of single-use devices. Lately, the issue has been getting a lot of attention from legislators and the mainstream press. How do you see this situation evolving?
A: This is going to be one of the major issues of the year, no doubt about it. We have a lot of people sitting on the fence, including US FDA. The Belgians now are in a situation where they've got to do something about their decree [to require manufacturers to prove that single-use devices are in fact not reusable], although we don't know yet what exactly they will do.
A lot of useful points on this issue were brought up at our general meeting in Seville. The US Association of Disposable Device Manufacturers came over in force to talk to us about what is happening in the United States. Europe is faced with the same sort of problems, although it is more severe in the United States, where you have something like 28 reprocessors compared to a handful in Europe.
Q: The mutual recognition agreement (MRA) with the United States seems to be running out of steam. Historically, EUCOMED has been a fervent supporter of MRAs. Considering the current lack of enthusiasm for the terms of the agreement on either side of the pond, do you think it still has a meaningful future?
A: It has to have a future. There's no doubt about that in my mind. The MRA is designed to encourage greater bilateral trade between the two largest trading blocs in the world. There has to be a benefit to industry on both sides of the Atlantic but—and this is where the initial problems have been—industry has failed to recognize any benefits from the first 12 months of the MRA. We should now be one year into the confidence-building programme, but of course we're not. And this is basically because of misunderstandings between European and US regulators. In a nutshell, we have to believe the MRA will benefit our industry. The problem is actually seeing that benefit and gauging how it will affect individual companies.
Q: EUCOMED has been at the forefront of the debate on the reuse of single-use devices. Lately, the issue has been getting a lot of attention from legislators and the mainstream press. How do you see this situation evolving?
A: This is going to be one of the major issues of the year, no doubt about it. We have a lot of people sitting on the fence, including US FDA. The Belgians now are in a situation where they've got to do something about their decree [to require manufacturers to prove that single-use devices are in fact not reusable], although we don't know yet what exactly they will do.
A lot of useful points on this issue were brought up at our general meeting in Seville. The US Association of Disposable Device Manufacturers came over in force to talk to us about what is happening in the United States. Europe is faced with the same sort of problems, although it is more severe in the United States, where you have something like 28 reprocessors compared to a handful in Europe.
We can't really bury our heads in the sand, because there are legal aspects to this, and sooner or later there is going to be a major claim on a manufacturer for something that has gone wrong as the direct result of the reuse of a device by a hospital. If the practice exists, then we need to make sure that we have some legislation against which the performance of the reprocessing industry can be judged. Reprocessors need to be subject to the same sort of regulatory requirements as an OEM. That is probably the way it should go. But the EUCOMED position has always been straightforward: a device should only be used as instructed by the manufacturer.
Q: On the other hand, the Belgians among others have remarked upon the inconsistent labelling of devices, depending on where they are marketed.
A: The manufacturers obviously need to be very careful how they describe a product. You're right in that one of the things that has been thrown in our face is that devices marketed for single-use in certain European markets are openly sold as reusables in developing countries. This doesn't help us, and it doesn't help the manufacturers of genuine single-use devices.
Q: Are there any other looming controversies on EUCOMED's radar?
A: The European Commission is looking attentively at materials right now, and it looks like PVC could be a major headache for the device industry. Because of the phthalates issue, the Commission has just issued a ban on their use in soft PVC for toys. There are moves afoot to ensure that the use of PVC in medical devices is reviewed next. It's not just Denmark, either: authorities in Germany, Italy, Austria, and Sweden have suggested that medical devices should not use the material. The potential negative impact of phthalates in the PVC used for medical devices has not been scientifically investigated as far as I am aware. Yet there are millions of people all over the world who have benefitted enormously over the past 40 years because medical devices made from PVC were available. We have to do a basic risk-benefit analysis, if you like. But I believe that the benefits, which have been gigantic, far outweigh the potential risks.
Q: It will take some doing to reverse the momentum created by anti-PVC lobbyists.
A: Absolutely. There are powerful consumer groups out there saying that what the medical device industry is doing is wrong. But we know that any device manufacturer worth his salt is continuously searching for alternative materials. The industry says, quite legitimately, that if there is a satisfactory alternative to PVC for devices, then manufacturers will use it. At the moment, however, there is no straight replacement that provides the same technical capabilities at reasonable cost. To withdraw devices containing or made from PVC from the market would be catastrophic in terms of maintaining the current standards of healthcare.
Q: Since this interview is taking place on the eve of the new millennium, would you care to make a new year's resolution for EUCOMED?
A: To further a greater understanding of our industry and its needs. The more involved I get with politicians, the more impressed I am as to how little they know about our industry and the major contributions we are making to the advancement of healthcare.
Michael Baker, director general of EUCOMED, can be reached at rue du Collège Saint-Michel 17, B-1150 Brussels, Belgium; phone: +32 2 7722212; fax: +32 2 7713909; e-mail: eucomed@eucomed.be; Internet: http://www. eucomed.be.
