Europe Responds to Medical Device 'Crisis'

Back in February, European Union health minister John Dalli conceded that the EU regulatory framework for medical devices needs an overhaul to—as he coyly expressed it—"remedy certain weaknesses that have come to light." Looming large over these was the discovery of the fraudulent use of non-medical-grade silicone in breast implants manufactured by the Poly Implant Prothèse company in France. The risks spread anxiety among thousands of women who had received these implants; more recent reports of the premature disintegration of prosthetic hip joints intensified this concern among the general population.

The overall effect has been to erode still further the European public's faltering confidence in the regulatory system that is, in principle, guaranteeing their safety.

The European Commission called for "immediate actions," including tightened controls, increased surveillance, and moves to restore public confidence. It plans to present proposals for new EU regulations governing medical devices later this year, with the intention of creating "a more transparent regulatory system." The new rules will retain the "innovation-friendly character" and "cost-efficiency" of the current system, Dalli promised. But they will also "ensure that the rules are effectively enforced across the EU."

At the same time, the requirements concerning clinical evidence will be strengthened and clarified to demonstrate the safety and performance of a device. And improvements will be made to ensure timely and uniform action in the areas of vigilance and market surveillance.

Above all, the new rules will be directly binding on member states, eliminating the margin for maneuver that member states currently enjoy in interpreting the rules.

The European Union is currently handicapped because virtually all it can do in the legislative framework is urge member states to act at the national level. EU legislation exists, but it is national authorities who are responsible for ensuring "full and stringent implementation of the current legislation on medical devices," the commission pointed out. So the commission has been reduced to encouraging member states "to tighten controls, provide a better guarantee of the safety of medical devices, and to restore patient confidence in the law that protects them."

Dalli called on health ministers for "a joint plan of immediate measures," asking for their "full cooperation in beginning work without delay." But not a lot has happened since then. Things don't move that quickly in Brussels—particularly when the member states haven't agreed to give some powers to the European Union to make things happen. Often, national interests—or simple national inertia—triumph over even the best-intentioned Brussels-led initiatives.

However, some sense of guilt over inaction may help to explain why ministers allowed themselves to be bullied or embarrassed into a formal decision in late April to use the existing Health Security Committee (HSC) as "a platform for crisis management in the field of medical devices."

This is a sign of the times in more ways than one. For starters, it shows just how few and inadequate are the control measures the European Union has over this sector of the healthcare industry. And for lack of any better option, the responsibility has been placed on an obscure and unofficial body.

The HSC is already overburdened and under-resourced, and was certainly not designed with this task in mind.

Knife-Edge Reputation

At the same time, the way the move came about itself served to underline how desperate the European Union is to show that it is coming to grips with a troubled sector. The formal decision was taken at an informal meeting of health ministers, hosted by the current Danish Presidency of the European Union, Astrid Krag, with the aim of some leisurely strategic reflection on comfortably broad themes such as innovation, or the challenges of chronic disease. Informal meetings of ministers are not, in the normal scheme of things, supposed to make any decisions at all. But the concern over a regulatory vacuum in which things are perceived as getting out of hand was so great that ministers broke with tradition and signed up to a new initiative.

The European Parliament is baying for vigorous action to remedy the deficiencies in the current system. The background to the health ministers' hasty decision included parliamentary debates on a resolution demanding "strengthened cooperation within the existing legal framework to tighten controls, in order to provide a better guarantee of the safety of medical technology." Citing the PIP case, the draft resolution emphasized that "this health fraud has shown a malfunctioning at European and national levels."

Conflicting pressures

The European Commission may be the European Union's principal conscience in such matters, but it is equally vulnerable to conflicting pressures and priorities. While conscious of the need to protect the public against risks, it simultaneously champions healthcare innovation both for its potential economic benefits to Europe, and for its capacity to come up with new answers to the seemingly insoluble problem of keeping European healthcare sustainable in the face of public spending difficulties and an ageing and chronically sick population.

This is why Dalli has been treading so carefully in his pronouncements. Speaking recently to high-tech medical equipment manufacturers, he said, "Innovation—and more specifically harnessing innovation for the public good—holds great promise for the future of healthcare systems." He told the European Coordination Committee of the Radiological, Electromedical, and Healthcare IT Industry, "There is tremendous potential for such innovation and your companies have an important contribution to make—for patients, for the healthcare sector, for health professionals, and for the wider economy."

"We need to work together to find better innovative models that address the unfolding challenges—not least the ageing society," he went on, listing some of the moves that, he claimed, were supporting innovation. He spoke of "appropriate regulation in the health sector that provides incentives for future growth whilst safeguarding patient safety, increased cooperation on health technology assessment to avoid duplication of research and to speed up reimbursement, and uptake of eHealth solutions to support health systems as they strive for better health outcomes and more efficient models." In his February missive to health ministers he added, "There can be no compromise on safety." Citizens, he said, "should be confident in the safety of medical devices."

Reflector is Pharm Exec Europe's anonymous columnist, a commentator so close to the action in Europe that his identity must remain secret.