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Letter in response to ‘The EU's system for regulating medical devices’ by Peter McCulloch (BMJ 2012;345:e7126).
Don’t forget evidence of cost effectiveness and resource impact
We agree that EU medical device regulation is unfit for purpose and McCulloch is right to propose that evidence of efficacy as well as safety should be collected before a medical device is given a full licence. Also, we like the idea that devices could be marketed in the context of studies to collect evidence, the so called ‘coverage with evidence development’, but perhaps it is too early to expect the degree of collaboration and cooperation that would be required between the industry and the NHS for this to be successful.
We suggest that a further step is required. The NHS, is the main purchaser of new health technologies including devices in the UK, and has to consider the opportunity cost when a new device is being proposed. In order to do this the NHS requires, as well as efficacy and safety, to determine cost effectiveness and the resource implications of adopting new devices to the overall service. This is especially important at the present time when commissioners in England and health boards in Scotland have to make difficult decisions on health service spend to determine what will be the greatest benefit for their patients within a finite health service budget. Without this information a new health technology is less likely to be introduced.
The Scottish Health Technologies Group (SHTG) in Scotland reviews the evidence of clinical and cost effectiveness of health technologies and considers this in context with current practice in NHSScotland. The SHTG aims to do this as rapidly as possible and produces Advice Statements to help health boards decide on the introduction of health technologies. To recognise that this information is required at an early stage would speed up the process, provide the necessary information, and would be more likely to lead to a positive response from NHS purchasers, reward innovation by the industry and benefit patients. The industry should note that whether information about cost effectiveness and resource impact information is collected at the regulatory stage, or later, it is an essential requirement for NHS decision makers.
Re: The EU’s system for regulating medical devices
Letter in response to ‘The EU's system for regulating medical devices’ by Peter McCulloch (BMJ 2012;345:e7126).
Don’t forget evidence of cost effectiveness and resource impact
We agree that EU medical device regulation is unfit for purpose and McCulloch is right to propose that evidence of efficacy as well as safety should be collected before a medical device is given a full licence. Also, we like the idea that devices could be marketed in the context of studies to collect evidence, the so called ‘coverage with evidence development’, but perhaps it is too early to expect the degree of collaboration and cooperation that would be required between the industry and the NHS for this to be successful.
We suggest that a further step is required. The NHS, is the main purchaser of new health technologies including devices in the UK, and has to consider the opportunity cost when a new device is being proposed. In order to do this the NHS requires, as well as efficacy and safety, to determine cost effectiveness and the resource implications of adopting new devices to the overall service. This is especially important at the present time when commissioners in England and health boards in Scotland have to make difficult decisions on health service spend to determine what will be the greatest benefit for their patients within a finite health service budget. Without this information a new health technology is less likely to be introduced.
The Scottish Health Technologies Group (SHTG) in Scotland reviews the evidence of clinical and cost effectiveness of health technologies and considers this in context with current practice in NHSScotland. The SHTG aims to do this as rapidly as possible and produces Advice Statements to help health boards decide on the introduction of health technologies. To recognise that this information is required at an early stage would speed up the process, provide the necessary information, and would be more likely to lead to a positive response from NHS purchasers, reward innovation by the industry and benefit patients. The industry should note that whether information about cost effectiveness and resource impact information is collected at the regulatory stage, or later, it is an essential requirement for NHS decision makers.
Competing interests: No competing interests