Europe Responds to Medical Device 'Crisis' - Pharmaceutical Executive

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Europe Responds to Medical Device 'Crisis'


Pharmaceutical Executive


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.


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

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.


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