Medicines and Medical Devices Bill

Sharon Hodgson Excerpts

2nd reading & 2nd reading: House of Commons & Money resolution & Money resolution: House of Commons & Programme motion & Programme motion: House of Commons & Ways and Means resolution & Ways and Means resolution: House of Commons
Monday 2nd March 2020 Commons Chamber

[Mrs Sharon Hodgson (Washington and Sunderland West) (Lab)]

This has been an excellent debate—and we seem to have plenty of time left for winding up. I thank all Members from all parties who have taken part, and particularly my hon. Friends for their excellent speeches: my hon. Friend the Member for Blaydon (Liz Twist) made the case for Kuvan for sufferers of PKU, which I shall mention again in a moment, and my hon. Friend the Member for St Helens South and Whiston (Ms Rimmer) made a powerful speech about organ harvesting that I am sure we will discuss in more detail in Committee.

The hon. Member for Bosworth (Dr Evans) raised an issue that is not currently on the face of the Bill but perhaps should be. It is something that I have discussed with Health Secretaries for well over a decade now—probably around 12 years—starting with the then Member for Kingston upon Hull West and Hessle when Labour was in government, and I raised it with the Minister only last week. The issue is the waste of prescription medication. The hon. Gentleman mentioned a possible figure of £300 million a year from the House of Commons Library, and that did not surprise me. I can well believe that that could be the figure and agree that there has to be a way to reduce that waste. As the hon. Gentleman said, we should start by measuring it, and perhaps consider the active, safe charitable donation of such medicines, because £300 million-worth of perfectly good medicines being put into an incinerator every year cannot be the best outcome. There has to be a better way. I am grateful to the hon. Gentleman for raising that issue, which the Minister will remember we discussed just last week.

I thank the Minister and her officials, who have taken the time last week and since to brief me and my team on the Bill. As my hon. Friend the Member for Leicester South (Jonathan Ashworth) said in his opening remarks, the Opposition support the principle of the Bill, but we have some concerns that I shall briefly outline and to which I hope the Minister will respond, if not now then perhaps at a later stage in the Bill’s progress through the House. The Bill deals with both human and animal health, and I shall start with human health.

Patient safety is of the utmost importance and I recognise that with the Bill the Government are taking steps to improve both patient safety and the availability of medicines and medical devices to patients in the UK after the transition period is over on 31 December this year. However, as the Minister knows, in the cases of valproate, Primodos and surgical mesh, which we have heard about already in the debate, patient safety and patients’ experiences in the past—sometimes even now, in respect of mesh—have sometimes been disregarded when they have reported issues to their GP. The independent medicines and medical devices safety review has been looking into that, and I very much look forward to seeing Baroness Cumberlege’s recommendations later this month.

I should also mention that there are questions of patient safety in respect of other devices, such as breast implants and metal-on-metal hip implants. There are a host of examples of patient safety having been compromised. We must ensure that that does not happen again.

Medical devices are not subject to the same strict regulations as medicines. Faulty washing machines are treated with far more caution than a medical device that goes wrong. A case in point is that we will all have been written to recently by Whirlpool. Regulations must be tightened for both medicines and medical devices. I am sure that the Government will consider seriously the forthcoming recommendations from Baroness Cumberlege in the review.

One mechanism in the Bill to increase patient safety is the provision to establish a database for medical devices and provide the Secretary of State with new powers to share information about medical devices in limited circumstances. However, there are approximately 80,000 different medical devices on the UK market. Will every device be entered into the database? What steps have been taken to establish such a database? Will the Minister please provide some more information about the point at which the Secretary of State will be mandated to share the information held on a medical device with the public? I wholeheartedly agree that there should be a database of this nature, but it must be fit for purpose and healthcare professionals must be able to access an updated database to make sure that they can provide the best treatment and care for their patients that is safe. I hope that the database would go further and become a register or even a registry, as the hon. Member for Central Ayrshire (Dr Whitford) suggested. A barcode could be included on each device that is scanned into a patient’s records so that a register or registry is created.

As I have mentioned, the Bill makes provisions for access to medicines and medical devices after 31 December. However, it is causing concern for some patients who are currently participating in EU-wide clinical trials and for patients who fear that they may miss out on future trials. Can the Minister provide any assurances today about access to EU-wide clinical trials, especially for those patients who are already on them? Access to such clinical trials would especially benefit patients with rare diseases, who have a small patient group here in the UK. Will the Minister please set out what provisions will be made for patients with rare diseases who could benefit from participating in a clinical trial?

As this Bill comes into force on 1 January 2021, will the Minister reassure the House that the supply of medicines and medical devices will be maintained in the run-up to the end of the transition period? This Bill could enhance access to medicines, but what does that mean for patients with rare diseases? For example, as we heard from my hon. Friend the Member for Blaydon, who spoke so passionately about PKU, patients have been waiting for more than 10 years for the drug, Kuvan, to be made available on the NHS. We know that Kuvan works for patients with PKU, because some have raised funds for it and been paying for it privately. Although it is expensive, the cost is not outwith the reach of some patients, but patients in the UK should not have to go without effective drugs. I am sure that we have all had constituents who have brought these cases to us. I therefore hope that provisions will be made to improve access to medicines, particularly for those people with rare diseases.

I welcome the Government’s announcement today about faster access to cannabis-based medicines, and I would be very grateful if the Minister could please expand on that announcement and how that relates to this Bill in particular. I also welcome the provisions in the Bill that allow for prescription powers to be granted to some bodies within the healthcare system—for example, to physiotherapists. Will the Minister set out what she envisages this system will look like, who will be able to prescribe, and what they will be able to prescribe and under what circumstances? Will these new prescribers be trained sufficiently to fulfil this role? Where will they get their information from about medicines and medical devices that they are prescribing, especially if there are new warnings on them, as we have seen, for instance, with Valproate.

The Bill also allows for pharmacy hubs to be established under a Henry VIII power, so will the Minister give the House a timescale for this power to be used? I would also be grateful if she outlined how these pharmacy hubs will work in practice, as I am concerned that this could open up an Amazon-style prescription service.

Let me move on to animal health and veterinary medicine. Although this subject is more likely to come under a DEFRA brief, I know that there is a link between human health and animal health, not least when it comes to antimicrobial resistance. Keeping our animals fit and healthy and ensuring that vets have the medicines that they need to provide treatment and care for animals is, of course, crucially important to many of us. Will the Minister please assure the House that the supply of veterinary medicines in the UK will be maintained in the run-up to the end of the transition period and that standards for veterinary medicines will be upheld to ensure that animals are given the best possible treatment after the transition period.

The Bill gives powers to relevant bodies to amend regulations as necessary, so will the Minister assure the House that the regulators are equipped with the right finance and resources to take on these new responsibilities? I am pleased that, in non-urgent cases, there will be consultations held before any regulations are changed, but can the Minister outline how long these consultations will run for and how soon after the consultation closes the new regulation will be implemented? What formal processes will be put in place to ensure that industry is involved in these consultations and, finally, how will the Government monitor the effectiveness of the regulations? What bodies will be able to scrutinise the performance and delivery of the regulators?

As I mentioned at the beginning of my speech, we do not want to find ourselves in several years’ time with news that a medical device or medicine is causing serious harm to patients—more than we have already, given what Baroness Cumberlege is looking into. Regulators must be held to account on this as much as the manufacturing industry and healthcare system.

In closing, human and animal safety is of the utmost importance, which is why we on the Labour Benches welcome this Bill, but I would be grateful if the Minister could answer these questions. If that is not possible in the time available tonight, especially given the rate at which I have put these questions to her, then perhaps in writing or indeed, during the passage of the Bill in Committee.