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Jeremy Hunt: I will not tolerate British patients being put at risk – Telegraph.

Jeremy Hunt: I will not tolerate British patients being put at risk

Like many people, I was shocked and appalled to read in The Telegraph that a regulator in Europe said that it was “on the side of the manufacturer” when it comes to licensing products — such as hip replacements — for use in British patients.

By Jeremy Hunt, Health Secretary

9:57PM BST 23 Oct 2012

These words undermine everything I believe about the health sector in Britain. Anyone working in health care must always be on the side of patients, and patients – not profits – should always be the number one priority.

Hip replacements are so important because they can make such a significant difference to the quality of life of patients. Unfortunately, they have often hit the headlines for the wrong reasons in the past two years.

A brand of metal-on-metal devices was recalled after evidence showed they were not performing well enough. These implants were taken off the market, but yesterday, The Telegraph exposed a worrying and completely unacceptable weakness in the regulatory system which means, in theory, a device with similar problems could legally be sold in the UK.

I want to be absolutely clear that I will not tolerate British patients being put at risk. I have asked the regulator — the Medicines and Healthcare products Regulatory Agency (MHRA) — and the British Orthopaedic Association to bring forward plans to do more to make sure patients can be confident they will get the highest quality of devices when they need them.

I can reassure patients that in this country we do not just rely on European approval before we use implants. Thankfully, we can be confident that approval by a European regulator alone would not mean a device finds its way into the NHS. We have our own checks and balances in place so the hip replacement mentioned in the Telegraph article yesterday would not automatically be used in the NHS.

But let’s be clear, there are problems in the European regulatory system and we need to address them so we can protect our patients.

Firstly, through the regulator we will raise concerns about the current system through an EU review that is already in hand.

However, if any changes to legislation are made, they will not come into effect for a number of years, so we must tackle the weaknesses that currently exist. So secondly, the MHRA will continue its work with the European Commission and other European regulators to make sure the approving bodies are properly audited and have the expertise to assess high-risk devices.

The EU has rules to make sure a device has been fully tested before it can be approved for use. As The Telegraph exposed, the system cannot guarantee that companies determined to put profits before patients will not get approval for improperly tested products. This is plainly wrong, it could compromise safety and put patients at risk.

So thirdly, we are working with clinicians, the NHS, the MHRA and the National Joint Registry to make sure surgeons can get earlier and more accurate information on how well new hip and knee implants are working. This means they can choose which ones are best for their patients. This new project, called Beyond Compliance, will also use information given by patients to measure success.

The NHS is the largest health care system in the world and we will use its influence to encourage worldwide manufacturers to make their products safer.

The results will be better patient care, better quality of life for those who have had joints replaced, and a lighter burden on the NHS.

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