John Wilkinson took the helm at Eucomed, the European Confederation Of Medical Devices Associations, in April.
Before he had settled into his new office in Brussels he found himself facing an unexpected and far-reaching proposal by the European Commission (EC) to completely overhaul the regulation of medical devices among the 27 member nations. He has since developed positions on a range of hot topics such as single-use devices, procurement and purchasing, and patient rights and safety.
Wilkinson came to Eucomed from the Association of British Healthcare Industries in the UK, where he served four years as director general. He was influential in the creation of the Healthcare Industries Task Force (HITF) within the Department of Health and acted as co-secretariat. He was a familiar face before the UK Health
Select Committee giving evidence and testifying on the cost benefits of new medical technologies or barriers to the adoption of innovations within the NHS.
His 25 years in the medical devices and diagnostics industry included senior positions at Becton Dickinson and Ohmeda, and a stint as CEO of a medical imaging start-up.
BB&T: The first General Assembly of Eucomed under your direction has been expanded to include a two-day MedTech Forum. What is this all about?
Wilkinson: Actually, the MedTech forum was already in play before I arrived and our director of communication and external affairs, Mark Grossien, has done most of the work, so I don't want to take credit for that. I am fully supportive of the intent here, which is to move away from what has been a somewhat internally focused event to a much more external focus. Where previously the general assembly was held in different locations around Europe, moving it here to Brussels is the logical choice as Eucomed is primarily charged with managing the inteface between industry and the national associations of Europe with the European Union.
Since the foundation of the European Community, progressively more and more legislation is derived from Brussels, even if it is implemented at the national level. The role of Eucomed in this context has been steadily growing as well from the early days where there was relatively little that was driven by Europe policymakers to now where it touches every aspect of doing business across Europe. Some of our stakeholders remain skeptical of actions from Brussels, so bringing them to the meeting here reinforces more substantially our role, which is first to identify and interpret the implications of what is going on in Brussels, and then second, to get involved in shaping that policy and legislation.
BB&T: You know something of what you are talking about on the national level, having led one of Europe's more active national industry groups for medical technology and one that is famously Euro-skeptic.
Wilkinson: My background does give me an ability to understand the challenges that face the national med-tech organizations. Eucomed has its roots in being an association of national associations, and it is very easy for people looking from the outside to think there is some kind of corporate parallel where Eucomed is a kind of head office for these national associations. That is definitely not the case. Each of these national associations is an independent organization with specific governance and local challenges.
Understanding the pressures within these organizations, understanding what they are good at and knowing where their role can be complementary is key to what I bring to the position. It also means I know how to work the other way around to ensure that we have effective collaborative relationships with the national associations and are not operating at cross-purposes. This is essential to making Eucomed successful.
BB&T: The dynamic between Brussels and the nations of Europe, the Member States, is at the heart of several problems, isn't it? The uneven implementation of medical device directives was cited by the European Commission recently for the principal reason for its recommendation to overhaul the existing regulatory framework. Isn't it a barrier?
Wilkinson: It is the enduring feature of Europe that we are a union of sovereign nations. Europe will never be anything like a United States of Europe. There is a range of legnilative processes, some of which are very direct and go straight into national law without any changes. But you are right that there are others that have to be translated, and the intent has to become embedded in national law. And sometimes things can go wrong when that happens. Our role is precisely to try to identify the parts that can potentially cause difficulties.
There are things happening around Europe in terms of legislation of products that often are at cross purposes with having a single, open European market. While they are being done with the best of intentions, authorities either nationally or even regionally in Europe can distort the aspiration for this single market.
The reality, from a regulatory perspective, is that it is working extremely well. There are products that come onto the market quickly and consistently. The system has shown itself to be safe and fast, all the things you looking for in a good regulatory environment. There are some difficulties around the fringes, yes.
BB&T: How much are you able to discuss the recasting of Europe's Medical Device Directive proposed by the European Commission in July and now in discussion?
Wilkinson: Not a great deal. The industry, collectively, made a very strong statement earlier in this year. Though if you read the details, it is less critical than it was made to seem and many of the statements are quite supportive of a change to regulations. We have subsequently moved to working with the Commission in the process they are going through.
It is not entirely clear to us why it was so sudden. The industry acknowledged the system is not perfect and there are areas that have to change to grow with changing times, particularly in the post-market areas of vigilance. But it was unexpected.
You need to understand it in the political context of the DG (directorat general), which more broadly is snipping away at red tape. Everyone agrees that where possible it is in everyone's interest to tidy up legislation. Industry questioned chiefly whether the IVD Directive, which is substantially different in character, should be pushed into one single directive with devices.
Being new on the block, I would not want to be quoted on how the Commission works and where this is going to go. But the reality is that this is clearly the start of a lengthy process and you are not going to see anything hit the streets for several years. Yet it is equally true that once these processes start it is going to run to some end, and being involved early in the process is key to making sure the outcome is appropriate. They have asked us for information following the public commentary and we are submitting that information for their consideration.
The Commission's proposal will go to the European Parliament, and again, I would not want to say what may come out of that process. But I note that next year there are elections in June for the Parliament, and then there will be a new Commission elected in September. This will result in a lot of change on the institutional side, with a lot of new faces coming on the scene by this time next year.
BB&T: Payments and procurement are high on Eucomed's agenda for a policy push from Brussels. Yet in 2000 there was legislation aimed at increasing performance of business being paid, and you have said the effect of this legislation was zero, is that fair to say?
Wilkinson: Yes, that is fair to say, though I might have said that it is unfortunate the situation has not improved. My personal view on late payments is that there is an ethical dimension to contracting for something and then not paying for it. But more than that, it costs everybody a lot of money. You soon have government and industry hiring lawyers to sort things out, and that is never a high-value adding activity.
One set of interesting data points on this issue are coming from Spain, where the national association is doing a wonderful job of documenting problems. There we see public sector debtor days for general business are considerably shorter than the debtor days in this sector.
The medical device industry is vulnerable to late payment on several counts, and perhaps the most important is an ethical dimension for industry. We cannot just stop supplying medical devices. If someone is selling timber to a furniture manufacturer and the manufacturer stopped paying his bills, then we all know what to do. We stop supplying the timber until he starts paying his bills. That leverage of comercial business is not available to medical device makers because there is a patient at the end of the chain.
There is increasing evidence that governments do look upon this sector as one area where they do not have to pay their bills and it will not have any impact. The evidence is that this allows public sector authorities to abuse their position in respect to this sector.
Of course, there is a terrible impact, and most especially for small and medium sized enterprises who are bringing often innovative products to patients. When their bills are not paid, it can take them over the edge and put them out of business. That is not to say this is not a major issue for the larger companies as well. Larger corporations feel the effects and it impacts their decision to do business in Europe.
The other issue is procurement. There is an increasing concern procurement is being disconnected from the running of healthcare and the consequence of that is the predominance of procurement thinking to buy whatever was purchased last year except buy it more cheaply. This is particularly a problem when you consider that the new technologies being introduced often offer opportunities to restructure the way that you deliver healthcare. If you just carry on buying year after year but more cheaply, you will disconnect procurement of devices from the clinician's need for devices and will miss a tremendous number of opportunities. And this is clearly happening right across Europe.
We are getting professional buyers, which is quite welcomed by industry and represents good news, but they are being located away from the people who deliver healthcare and this creates a difficulty to get clinical input to these buying decisions. The power of the doctors is being diminished while the power of procurement organization is getting stronger and without the right measures.
If the sole measure is cash savings, then there is absolutely no incentive to realize greater value in healthcare, and ultimately cash savings by reinvesting in technology that is going to reengineer the system.
I come with a lot of experience in this area. But what I am seeing today in the UK is that there is a recognition of the shortcomings that have arrived as a result of taking this approach. There is a lot of work being done to try to capture the value of available technologies. They have been through this phase and are coming out with a much more balanced view of the world.
BB&T: Single-use devices is a divided territory in Europe with the demonstration of cost savings in Germany and an policy that welcomes this development elsewhere. Where is Eucomed on the issue?
Wilkinson: Our position has not materially moved. The essence is that if you use recycled devices designed for single use, it is very difficult to predict what the outcomes will be. Yet it is happening, and the industry worry is that this is going to happen more and more. And when something does go wrong, the problem ends up back at the original equipment manufacturer.
Look back at why single-use products were brought into play, which are some very serious infection control issues, which sadly have not gone away. Single use was brought in to manage a wave of infection control problems, and the contribution they have made to push back this wave is enormous. There is a perspective that single-use devices are something industry has done to make more money. Yet it has proven instead to be very cost-effective. The cleaning and sterilizing is demonstrably impossible to do for many devices. And the workload on centralized sterilization centers has grown tremendously with the time and effort proving very costly.
While it is tempting to say single use is a driver of costs, a lot of the evidence that has been put on the table is to the contrary showing the costs of use of these devices at high volumes is actually very low. And the single use argument remains very strong.
Another important point is informed consent for patients. In Germany it is the case that endoscopic devices used in procedures are known to be reused and patients have no idea about this.
Finally, like a lot of environmental arguments today, it is quite challenging to work out the data on savings from re-use of medical devices. Shipping these devices to the specialized sterilization centers uses a lot of energy, these centers are high energy users, and then they need to shipping the device back, and none of this is fully documented and continues to change the savings as the price of a barrel of oil changes.