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25 March 2020updated 09 Sep 2021 3:34pm

Why the NHS needs regulation to keep pace with science

As it tackles the coronavirus pandemic and exits the European Union, the UK has the opportunity to embrace medical technology.

By Anne Marie Morris

Earlier of this year, the Health Secretary Matt Hancock, said: “Better technology is vital… and embracing it is the only way to make the NHS sustainable over the long term.” These words have never been truer, but we have some way to go to realise the potential that Medtech holds. As we tackle the coronavirus pandemic and exit the European Union, the UK has the opportunity to embrace technology and shape our own approach to regulation, access and uptake.

In order to do so we face challenges on three fronts. We must ensure that our regulation is fit for purpose, that adequate funding for the best technology is in place, and that products that deliver the greatest benefits are used in the NHS.

For too long the UK has lagged behind in our readiness to make the most of life-changing technology. For example, the British scientist Godfrey Hounsfield invented CT scanners in 1972, a mainstay of current medical care. But the UK has among the lowest number of CT scanners per capita in Europe. Equally, the development of continuous glucose monitoring systems for diabetes has the potential to improve patient experience and safety, but this is only available on the NHS for a fraction of the patient population. Against this backdrop it is imperative that we ensure the safety of all patients who may be treated with a medical technology. The recent coverage of the risks posed by vaginal mesh brings home the importance of regulation that keeps pace with the science.

Any technology-related adverse event is one too many. That is why policymakers must ensure patient safety remains top of the agenda when forming Medtech policy. The UK is making good progress in this area, with the Medicines and Medical Devices Bill introduced to parliament earlier this year. However, there are areas where the proposed legislation could go further to support patient safety and evaluate the way CE certifications, the stamp of regulatory approval for Medtech, are awarded through the Medicines and Healthcare Products Regulatory Agency. The UK has the opportunity to align with global standards.

I would like to see provision for a central registry of all implanted devices stipulated in the bill, which would build on, and go beyond, the current European registry. Such a resource would support the better tracking of devices and patients as they move through the system. It would also provide accountability for industry and the health service.

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Patient safety issues have far-reaching consequences beyond the immediate risks to patients’ lives. The annual cost of “preventable adverse events” in the NHS is likely to be more than £1bn, according to a report prepared for the Department of Health and Social Care. With better tracking and registering of technologies, this sum could be reduced and patient safety and experience improved. However, it is essential that these provisions translate into practice when the bill passes into law.

Furthermore, as the UK exits the EU, there is increasing pressure on the few notified bodies that award CE marks. As well as ensuring the regulation is in place, government should be concerned with establishing sufficient capacity in the system to evaluate technologies that come through the pipeline.

It can take time for a medical technology to be assessed and made available on the NHS following its approval by regulators. This can limit the number of patients who can benefit from the latest innovations. It is vital, however, to rigorously assess a new technology in terms of its clinical benefit, as the National Institute for Health and Care Excellence (NICE) does for some products.

These assessments must find the balance between data requirements, speed of access, and the handling of uncertainty. Conducting clinical trials for Medtech brings a number of challenges not seen elsewhere in the life sciences sector. For example, varying levels of clinical experience within trials can mean an intervention is represented as being less effective than it is in reality in a trial setting. Equally, choosing the correct time to assess a technology is also difficult; devices often undergo frequent changes in design after their initial launch.

Such challenges require a unique solution. It is more important now than ever that policymakers consider the role that access together with evaluation can play. Programmes such as Commissioning Through Evaluation (CtE) enable a product to be trialled in the NHS while allowing data collection and patient access. These are seldom used, however. Equally, the current consultation on the Medtech Funding Mandate offers the perfect opportunity for the government to introduce meaningful funding for high-benefit technologies that may not save costs, but will likely be cost effective and good for patients. The government should consider the expansion of CtE and other interim access pathways for promising Medtech.

The NHS is world-leading on many counts, but encouraging uptake of new technologies is an area for improvement. Once an innovation has cleared regulatory and evaluation hurdles we often fail to use it. If we are to realise the improved outcomes the Health Secretary envisions then something needs to change.

The Innovation Scorecard reports on the uptake of medicines and medical technologies in the NHS in England that NICE has positively appraised. While on occasion the Innovation Scorecard has been used to measure uptake of Medtech, this has been too infrequent and not inclusive of all NICE-recommended medical devices. Harnessing the potential of the Innovation Scorecard would be one route to improving uptake.

Alternatively, adapting HealthTech Connect, a platform which aims to support products as they move from inception to adoption, could provide a solution. Policymakers should look at adapting HealthTech Connect to record and pool data on uptake of Medtech as it is introduced to the NHS.

Finally, the importance of leadership cannot be overstated. The Health Secretary’s call to have “a digital and tech leader on every board” is commendable. Local leadership is important, and will be key to ensuring that the national momentum is fed into local systems. But national oversight is also required.

We must introduce the regulations, collect the data, speed up access and increase adoption. If we progress in these areas ultimately patients will be better off, and our valuable Medtech will be supported to grow sustainably in a post-Brexit Britain that is battling a pandemic.

Anne Marie Morris MP is chair of the all-party parliamentary group on access to medicines and medical devices.

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