Licensing of Medical Devices

Jackie Doyle-Price Excerpts

Tuesday 12th February 2019 Commons Chamber

[The Parliamentary Under-Secretary of State for Health and Social Care (Jackie Doyle-Price)]

I congratulate the hon. Member for Pontypridd (Owen Smith) on securing this debate and again challenging me on the regulation of medical devices. Obviously, we have discussed issues relating to mesh before, but this evening he has given a comprehensive critique of the weaknesses in the regulation of medical devices. We have to be very conscious that, unlike drugs, once a medical device is implanted, it stays there for good; the body does not process it and it does not leave the body. We can, therefore, imagine that clinical evidence and trial evidence will take many years to build up. Our perspective, from the point of view of trying to guarantee patient safety, needs to consider that in any future method of regulation.

The hon. Gentleman has highlighted some of the weaknesses. It is fair to say that perhaps in the past regulation has focused excessively on what is in the commercial interests of businesses to maintain competition, rather than having patient safety at its heart; I think that, when it comes to medical regulation, it should have that at its heart. Naturally, he referred to mesh, which he and I have discussed many times before. There is no doubt that mesh has transformed the lives of some women when they were living with the debilitating consequences of stress incontinence, but it is becoming clear that mesh was deployed far too insensibly—far too many women were given this treatment, often at comparatively young ages, given that this was going to stay in their body for a long time.

I do not want to pre-empt what will come out of the Cumberlege review, but I have discussed some of the findings with Baroness Cumberlege. On the whole issue of how our medical establishment have dealt with this, the conversations that have taken place with women who were having this treatment were utterly inadequate and we will learn many lessons. I say to those women who have suffered badly at the hands of mesh treatment that there are clear medical criteria relating to that product and, if they have any complaint about the treatment they have received, they should be pursuing claims for clinical negligence against their practitioners. We look forward to the conclusions of Baroness Cumberlege’s review.

The hon. Gentleman and the right hon. Member for Cynon Valley (Ann Clwyd) mentioned the issue of the national devices registry. I will say, up front, that I can assure them that this matter is already under consideration by the Department and it is linked to our wider digitisation agenda for the NHS. We have the technology and we should use it, in the interests of patient safety. We will be implementing that under new EU regulations to trace medical devices through unique device identifiers. I would be more than happy to meet him at a later date as we progress these proposals. As we depart from the European Union, we have an opportunity to alter our regulatory system. I am not sure that all my Conservative colleagues, in pushing Brexit, see it as an opportunity to tighten regulation, but that opportunity remains, so I look forward to that dialogue.

We clearly need to improve the existing system of regulation. As the hon. Gentleman mentioned, the EU directive currently under consideration will deliver that improvement, and we fully intend to take that forward. As he has described, medical devices are regulated in an entirely different way from medicines, and we need to make sure that regulation remains fit for purpose and that it responds to technological innovation. We also need to make sure that we have sufficient pre-market assessment, so that in assessing their efficacy we can really give evidence of how these devices are used by patients. That is why manufacturers, notified bodies and the MHRA conduct ongoing post-market surveillance. We will all wish to be made more confident that that is fleet of foot where it identifies any potential weakness. The more data we can collect, the more we can make those judgments earlier. The emergence of a better registry will enable us to do exactly that. I acknowledge wholeheartedly that there is scope for improvement and that systems and processes need to be constantly tested against the ultimate purpose—that guiding star, the principle of patient safety. No patient who presents themselves to any area of the national health service should expect anything other than the best possible care. They should be able to trust that we have in place a regulatory regime that will protect them. I am personally committed to that review and challenge.

As I mentioned, we will implement the regulatory improvements currently being taken through the EU, even though we are now leaving the EU institutions. We are confident that the regulation will drive system-wide improvement, including to the levels of clinical data mandated before products can be placed on the market. That will establish a strong and improved baseline for any system we implement after our departure from the EU. These changes to our system will place more stringent requirements on those manufacturing and supplying medical devices and will enhance the MHRA’s market surveillance responsibilities, resulting in clearer obligations to conduct inspections and the ongoing safety monitoring of devices.

In advance of those new regulations, the Government have taken a number of actions to ensure that existing legislation is operating as effectively as possible. That includes a programme of joint assessments of notified bodies, including inspections by multiple competent authorities to ensure that notified bodies’ assessments of new products and robust implementation of new standards for the clinical data are required for the new high-risk devices coming to the market.

It is true, I have to confess, that there has been a historic lack of transparency in the current system. It has not always been easy for patients to investigate and find more data about the things being put in their bodies. That is why the Government have prioritised the issue in negotiations on the new EU legislation. When those changes are implemented, there will, as the hon. Gentleman said, be an EU database that will contain details of all devices on the UK market, including where safety issues are identified. We are committed to ensuring that that will happen as part of our planning for a no-deal exit from the European Union.

Before I run out of time, I again want to mention the Cumberlege review, which will report later this year. It will give us many lessons about just how our medical device regulation has been less than optimal in the past. We will of course commit ourselves to any changes to respond to that review. I thank the hon. Gentleman for securing this debate and I look forward to further debate with him on these issues.

Question put and agreed to.