BRUSSELS, Belgium — In the middle of a morning filled with Brussels-speak, the European version of the same language spoken by policymakers in Washington, there suddenly came a clear voice that boomed over the microphone with a Kalamazoo — i.e., Midwestern, or "flatlander" — accent.

"What the hell can you do to help us?" asked Luciano Cattani, executive vice president-international public affairs for Stryker (Kalamazoo, Michigan), who also is the vice chairman of the board for Eucomed, the European trade association for medical devices that organized the session, "Medical Device Value Day," as part of its MedTech Forum being held here this week.

Perhaps Cattani chose to be so blunt because it was a rare opportunity to put the question to two highly influential policymakers for medical devices, Ludovica Serafini, a European Commissioner responsible for the Directorate General (DG) for Research, and Sabine LeCrenier, the head of the unit responsible for medical devices with the DG Enterprises and Industries.

"We need help," Cattani said. "We have late payments, procurement price registries in Italy and soon in the Netherlands, and we are getting closer to a pharmaceutical model of regulations.

"Everywhere we see a tightening and a severity toward medical devices," he continued, "and frankly, we do not see a light at the end of the tunnel."

The response from the representatives of the European Commission (EC) was polite and necessarily indirect as the EC has only soft tools available to influence the implementation of its recommended rules among the 27 member states.

LeCrenier said the role of industry is to provide information to the EC to help it achieve "a balanced approach," Brussels terminology for "reflection" of input from every possible interest group before issuing any statement, ruling or regulation.

"We need cooperation because we cannot know all your programs and products," she said, adding pointedly, "work with us in a constructive way."

Herb Riband, vice president for legal and external affairs for Medtronic International Trading (Tolochenaz, Switzerland), tried a different approach, saying "Thank you for taking up procurement and pricing. We need some best practices identified in this area, as they can impose barriers to access to medical technologies."

The exchange between the highest-placed authorities of Europe and representatives of companies with the highest market share for medical devices sold in Europe was the highlight of a session where Eucomed sought to bolster an evidence-based argument favoring a separate consideration of regulation for medical technology with the EC that suddenly this summer proposed grouping devices with drugs under the control of a single agency.

"We are having a better dialogue with the Commission on this issue," Cattini told Medical Device Daily following the session, when he had rediscoverd his Brussels voice.

"We are presenting evidence now to start moving devices out of being considered as a sub-class of drugs and to build a greater appreciation of how much the industry contributes to gross domestic product, and especially to job creation," he said.

In a series of presentations, Eucomed rolled out the fruit of the labors of the European Health Technology Institute on Socio-Economic Research (EHTI) that it created in 2007 to provide robust information on the social and economic value of medical technology.

Three prestigious universities collaborated to provide the first-ever comparison of how regulation and reimbursement affect six different devices in a "health basket" across the five major markets of Western Europe.

The products selected for the comparative study were grouped in three categories: Medical Aids, with incontinence pads and negative pressure wound care therapy; Implants, with cardiovascular defibrillators, knee endoprostheses and coronary stents; and Assistance for Professionals, with laparoscopic colorectal surgical devices.

Reimbursement status for each device and any incentives are detailed with data.

The study of "Financing Medical Devices in Germany" was led by Professor Reinhard Busse, head of the department for healthcare management at Technische Universität (Berlin), who explained in his report, "Although the European Union (EU) directives may give the impression of uniform regulation in the EU, all regulations concerning the financing of medical devices are made at the level of the member states.

"Thus, there are in principal 27 different national approaches regarding the financing of medical devices," he wrote, adding, "in some countries decisions concerning the financing of medical devices are taken at a regional level."

Touching on the heart of Eucomed's purpose in funding the research, Busse said, "There is broad evidence that improvements in life expectancy may be associated with innovative medical devices. However, up to now, the number of analyses dealing with the financing of medical devices is rather limited, compared with studies analyzing the policies dealing with pharmaceuticals.

An identically structured report detailing the financing of medical devices in France and the UK was led by Professor Panos Kanavos with the department of social policy at the London School of Economics.

The report on Italy and Spain was led by Professor Elio Borgonovi with the Center for Research on Health and Social Care Management at the Universitä Bocconi (Milan, Italy).

The shared experience for marketing a medical device in Europe is that while it seems easier to get to market with the CE mark, things get decidedly tougher the closer you come to local buyers.

The conclusions in the reports from the three research teams, which are made up of in-country experts intimate with the health systems under study confirm the complexity with labyrinthine layers of rules, pricing and reimbursement that varies between regions and even local governments.

In Germany, which is presented as having a more up-to-date and coherent system, Busse warned that manufacturers should stop complaining about reference pricing points because there is a greater menace on the horizon with a trend toward public tendering. where price points so far are coming in 30% lower still.

France and the UK share a national authority over health policy, but both have been steadily decentralizing their systems — France towards its hospitals and the UK towards local cares organizations, called trusts.

Purchasing follows the pattern, with regional groups formed around hospital centers in France and a patchwork decentralization in the UK, where the bulk of procurement is done regionally or locally through trusts, primary care trusts and emerging collaborative procurement hubs.

Procurement in both countries is generally by public tendering with price being the nearly unique hot point in France, while there is a greater emphasis, in principal, the authors note, on value-for-money in the UK with evidence-based procurement.

There is a move toward centralization in Italy and Spain to address the deeply fragmented landscapes formed by political divisions that stretch back to the dawn of healthcare.

Yet centralization in these countries has nothing to do with a northern European's ideas and it is being done at different levels and with different mechanisms, the Boccioni team notes.

Compounding the problem of knowing who is going to pay is the obsolescence in both countries of the reimbursement rates for technologies and devices.

In Spain, the maximum prices to be paid for what are now outdated technologies was set in 1988 and has not been revisited.

In Italy, national caps on prices were removed in 1999, with current ceilings based exclusively on negotiated quantities.

The authors warn that a major issue for device providers is that they need to be prepared to pay out-of-pocket for services necessary to support a new piece of hardware, "since in both countries funding systems cannot automatically guarantee that additional resources are made available to new health technologies."

Wrapping up the "Value Day": discussions, Eucomed issued a Brussels-speak press release that aimed to point the way forward saying its next steps are to "further engage with the commission in a constructive dialogue to address the identified concerns with solutions that are supportive of innovation and patient safety."

Meanwhile, at the assembly of its members Eucomed is winning financial support for a new round of research to document procurement and late-payment practices across the continent.