BRUSSELS, Belgium — The voice of the medical technology industry in Europe needs more bandwidth, according to John Wilkinson, the new director general of Eucomed (Brussels), the European Confederation of Medical Devices Associations, as its first-ever MedTech Forum gets under way here.
The prospect of tighter regulation from the European Union (EU) seems increasingly likely, and even worse in the eyes of seven affected industry associations, it will probably be rolled into the authority of a superagency covering both medications and devices.
Called a recast of the Medical Device Directives, the legislation proposed for debate next year would end a 23-year history of industry self-regulation and, according to opponents, will effectively kill the one advantage Europe has held in international competition, which is speed to market.
Meanwhile manufacturers are feeling more sharply than ever the deliberately slow payment of public health authorities, the primary payers for healthcare in Europe, which in some countries have all but formally adopted the practice to camouflage ever-deepening expenses.
Finally, there is a full agenda of issues now being defined under the banner of patient safety that would have significant impact on markets from single-use devices to health information systems.
Organized by Eucomed, the three-day MedTech event is the trade association's first full-scale external event gathering dozens of national associations to meet with their delegations at the European Union and winning the support from several multinational heavyweights such as Johnson & Johnson (New Brunswick, New Jersey) and Medtronic (Minneapolis).
More than 400 participants are expected for the three session tracks focused on regulation, patient safety and economic value.
"I rather like bandwidth as a way of describing this," said Wilkinson, who formerly was the head of the Association of British Healthcare Industries in the UK, serving four years as the director general.
"People are not just turning up here, they are engaging this week with representatives' offices from their nations," he said. "However effective we are as an organization, we will never be as effective as these organizations all working with the policymakers, so I call this increasing the bandwidth for Eucomed."
Traditionally an internally focused association, he explained, the MedTech Forum was built on top of the annual Eucomed General Assembly to force a shift toward external relations.
At the conference Eucomed also will present the first series of what Wilkinson called harder data points about the significance of the medical device industry for Europe, which while generally appreciated by policymakers, are not specifically known due to a "research gap."
Created in October 2007 to address that gap, the European Health Technology Institute for Socio-Economic Research (EHTI) has been conducting research to quantify the value of medical technology for Europe and will present preliminary findings on Wednesday.
Eucomed is a partner in EHTI with three of Europe's leading business schools — the London School of Economics, the Universit Bocconi in Milan and the Technische Universit t Berlin.
A study benchmarking reimbursement in Europe, comparing the differences for given products among countries, is expected to be revealed.
Another example of the hard data points Eucomed is seeking to help inform policymakers includes, "The link between reference pricing and procurement," a session to be led by Professor Reinhard Busse from the Technische Universit t Berlin.
Eucomed also engaged Martin Dewhurst with the London office of McKinsey & Co. to conduct an online survey of over 200 medical device executives in Europe that will be presented in a Thursday session titled "10 Changes in the 21st Century," covering a market outlook, the changing European landscape and an industry profile.
Wilkinson brings to Eucomed a deep experience pushing and prodding British policymakers that served as a warm-up for playing in the championship league in Brussels.
He was influential in the creation of the Healthcare Industries Task Force (HITF) within the UK Department of Health and served as its co-chair.
He was also a familiar face before the UK Health Select Committee, giving evidence and testifying on the cost benefits of new medical technologies and on the barriers to the adoption of innovations within the National Health Service (NHS).
In an interview with Medical Device Daily, Wilkinson said, "Procurement is increasingly an issue for industry across Europe as there is a disconnect between professional being brought in to trim costs and the clinicians charged with treatment and workflows.
"The guiding principle for a procurement professional is to purchase whatever was purchased the previous year, but to buy it more cheaply," he said.
"This is particularly a problem when you consider that new technologies being introduced often offer opportunities to restructure the way that we deliver healthcare, such that if you just carry on buying year after year but more cheaply, you devices from the needs of clinicians and miss a tremendous number of opportunities," Wilkinson said.
"In the UK, there is increasingly a recognition of the shortcomings that have arrived as a result of taking this approach," he said, adding, "there is now a lot of work being done to try to capture the value of available technologies."
As for the other end of the procurement process, Wilkinson said, "the medical device industry is vulnerable to late payment on several counts, and perhaps the most important of these is an ethical dimension for industry.
"We can not just stop supplying medical devices," he said. "This leverage of commercial business is not available to medical device makers because there is a patient at the end of the chain."
A second ethical dimension is the growing evidence "that governments look upon this sector as one area where they do not have to pay their bills and it will not have any impact."
Here Wilkinson said public sector authorities abuse their position, with a "terrible impact, most especially for small- and medium-sized enterprises who often bring innovative products to patients.
"When their bills are not paid, it can take them over the edge and put them out of business," he said, adding, "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 one finding from the McKinsey report previewed in a pre-event press conference speaks ominously to this point, with 43% of med-tech executives saying they believe their company will invest less in Europe over the next five years.