Report Highlights Issues Facing EU Device Sector

A ¹ report on the future of the medical device industry in the European Union highlights the need for more standardized technology assessment systems among member states, and for more robust mechanisms to support innovation.

Posted on the European Commission Web site Jan. 28, the report is intended to concisely explain to the new European commissioners the broad range of challenges facing the device industry.

The report stems from an "exploratory process" begun last year by a diverse group of public and private stakeholders, which authored the report. The group included the European device trade association Eucomed.

Health Technology Assessment Needs Improvement

Among other issues, the report points to a "lack of vision in relation to the measurement of value of medical devices, and, in particular, the differences in the use of health technology assessment [HTA] systems within and between Member States."

The report says technology assessment is necessary "in order to have an independent analysis of effectiveness, or when possible relative effectiveness, long-term outcomes and cost effectiveness of new medical devices and to reassess value of technologies and healthcare services."

Technology assessments can help decision makers ensure fair access to medical interventions and make the best use of scarce resources, the report adds.

But the report notes that the usefulness of technology assessments in informing health policies is hindered by variability throughout the EU "in the application of key principles of health technology assessment." It also expresses concern that technology assessment might be used only as a cost-containment tool.

Eucomed CEO John Wilkinson noted that unlike the U.S., which he says is "just flirting" with health technology assessment, Europe has well established systems for the practice. The problem, he said, is that the methodologies are almost entirely designed for pharmaceuticals.

"And, actually, with medical devices if you're going to do effective health technology assessment, you need to design and develop not just a different methodology from pharmaceuticals, but several different methodologies," Wilkinson said in an interview.

For example, he pointed out, the methodology used to assess an advanced wound dressing would differ from that used to assess an implantable defibrillator.

Wilkinson also said that if technology assessment is performed on a device too early in its development, "you'll kill the project." Assessments often need to wait until the technology has gone through several iterations of refinement and improvement, he said.

"A lot of the products that we are now utterly dependant on for delivering health care, [which] nobody would dream of living without, wouldn't be on the market at all, if technology assessment had been inappropriately applied at too early a stage of their development," Wilkinson asserted.

More R&D Support Also Needed

The report also highlights a need for more enhanced R&D support at the EU level, "combined with a clearer and simplified structure and better access to funding."

In particular, it suggests that the European Commission increase innovation incentives for small medical enterprises, or small medical device businesses (² 'The Gray Sheet' Dec. 21, 2009).

"The Members also recognized the importance of medical devices, and associated services, as well as the coordinated development at [the] European level of technological and/or disease focused clusters, in order to boost innovation," the report says.

The report urges the European commissioners to reflect further on R&D policies and intellectual property rights that could affect the development of innovative products.

A "true EU-wide patent providing the same level of protection across the EU would be beneficial," it says.

"Europe has a pretty good track record of producing innovation," Wilkinson said. "We've got a less good track record of converting that smart thinking and research into commercial products, and I think there's a lot of scope for the EU, collectively, to wire the system up better to do a better job in that respect."

He added, "Clearly most major developments in medicine have a technological component. So you can do all the research you like in a hospital or a university, but if you're not going to have an industrial machine on the end of it to produce the stuff, then it's arguable whether [the research] serves any useful purpose at all."

[Editor's note: More news on the medical device and diagnostics industries is available each week in ³ 'The Gray Sheet.' Visit our Web site to sign up for a free trial, or call 1-800-332-2181.]

- Ingrid Mezo (⁴ i.mezo@elsevier.com)