EU Responds to Troubled Medical Devices Sector

Apr 25, 2012
By Pharmaceutical Executive Editors

EU health ministers have stepped carefully around medical devices, but the recent scandal concerning breast implants has the European Parliament baying for action. As a result, no pharmaceutical executive should ignore what happens in the sector over the coming months, says Reflector.

European health ministers agreed in late April to a new procedure for responding to healthcare emergencies arising from medical devices.

It’s a sign of the times in more ways than one. For a start, it showed just how few and inadequate are the control measures it has over this sector of the healthcare industry. For lack of any better option, the responsibility has been placed on an obscure and unofficial body known as the European health security committee — which 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 EU is to show that it is getting to grips with a troubled sector. The decision was taken at an informal meeting of health ministers, hosted by the current Danish presidency of the EU 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 sense of urgency is understandable. Already back in February, following the discovery of the fraudulent use of non medical grade silicone in breast implants manufactured by the Poly Implant Prothèse company in France, the European Commission called for “immediate actions”, including tightened controls, increased surveillance, and moves to restore confidence. The risks spread anxiety among thousands of women who had received these implants. More recent reports of the 2premature disintegration of prosthetic hip-joints have intensified concern among patients. And 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 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 co-operation 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 emphasised that “this health fraud has shown a malfunctioning at European and national levels”.

But the EU is handicapped because virtually all it can do in the current legislative framework is to urge member states to act at 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 was 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”.

EU health commissioner John Dalli wrote to health ministers outlining “a joint plan of immediate measures” and “asking for their full co-operation in beginning work without delay.” But not a lot has happened since then. Things don’t move that fast in Brussels — particularly when the member states haven’t agreed to give some powers to the EU to make things happen. Often, national interests — or simple national inertia — triumph over even the best-intentioned Brussels-led initiatives. Some sense of guilt over inaction may help to explain why ministers allowed themselves to be bullied or embarrassed into a formal decision at their informal meeting in late April.

Conflicting pressures

The EU’s principal conscience in such matters, the European Commission, 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 treads so carefully in his pronouncements. Speaking recently to high-tech medical equipment manufacturers recently, 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”, and “increased co-operation on health technology assessment to avoid duplication of research and speed up reimbursement”, and “uptake of eHealth solutions to support health systems as they strive for better health outcomes and more efficient models”.

Specifically in the field of medical devices, Dalli recognises that the EU regulatory framework needs to be adapted to technical and scientific progress and — as he coyly expessed it — to “remedy certain weaknesses that have come to light.”  The Commission 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, he 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 manoeuvre that member states currently enjoy in interpreting the rules. He insisted that “there can be no compromise on safety”.  Citizens, he said, “should be confident in the safety of medical devices.”

Knife-edge reputation

That confidence has not been entirely destroyed by what Dalli calls recent “weaknesses”. A new survey entitled the ‘Corporate Reputation of the Medical Device Industry — the Patient Perspective’ suggests that the sector enjoys greater respect than the pharmaceutical sector — with 52% of patient groups considering it has a ‘good’ or ‘excellent’ corporate reputation, compared to 40% for the pharmaceutical industry.

However, the report, from a consultancy called PatientView, says that only 33% of the respondent patient groups think that the reputation of the medical device industry has improved during the past five years. 32% say that the industry’s reputation has declined, while 35% believe that its reputation remains has remained unchanged.

Innovative capacity gets a better score, with 64% of the respondent patient groups saying the medical device industry is ‘good’ or ‘excellent’ at being innovative, and 57% said it is ‘good’ or ‘excellent’ at ensuring patient safety — “even though a number of the respondent groups mention recent medical-device-related scandals”, the report adds.

Where the sector is most vulnerable is in terms of ethics and pricing. Only 32% of the respondent patient groups say that the industry is ‘good’ or ‘excellent’ at practising ethical marketing, and only 30% say it is ‘good’ or ‘excellent’ at being transparent with external healthcare stakeholders. And just 22% of the respondent patient groups say that that the medical device industry is ‘good’ or ‘excellent’ at adopting fair pricing practices.

For the record, the companies that emerge best in the study are Coloplast, Medtronic, Smith & Nephew, Roche, Abbott, and Johnson & Johnson — half of them, of course, also major pharmaceutical firms. What happens in the devices industry is no longer a matter of indifference to pharmaceutical industry strategists. Technology, takeovers and health technology assessment are forging ever-closer links between the two sectors, and their fates in an increasingly risk-averse and cash-straitened environment are bound inextricably together.  No pharmaceutical executive should ignore what happens over the coming months in the devices sector.


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