Medicines and Medical Devices Bill

Baroness Walmsley Excerpts

Committee stage & Committee: 5th sitting (Hansard) & Committee: 5th sitting (Hansard): House of Lords
Wednesday 11th November 2020 Grand Committee

The key issue, as I see it, is that Clause 16 is silent on the issue of which data should require the patient’s consent. My amendment would require that the types of data subject to consent should be clear when set out in regulations. I hope the Minister will agree that clarity for all concerned, not least for patients themselves, is essential. I look forward to his reply, as I have already given notice of my concerns and what I intended to say today.

[Baroness Walmsley (LD) [V]]

My Lords, I add my voice to those of the noble Baroness, Lady Finlay, and the noble Lord, Lord Ribeiro, on their Amendments 86, 88 and 102, about having unique identifiers for medical devices. In these days of barcodes, this should not be too difficult nor add much, if any, cost for the manufacturers. Indeed, it has been proved to work with medical devices, as the noble Baroness explained.

It is important that products found to be faulty are speedily traced. If my digital radio can be recalled speedily because it might burst into flames, surely a medical device implanted in someone’s body must also be able to be recalled speedily. Recall could also be useful when something better comes along; it could be vital for the future treatment of the patient.

There are occasions when an individual product develops a fault, although the majority of products of that model are perfectly okay. If we are to learn lessons and improve products, as the noble Baroness, Lady Cumberlege, has just pointed out, it would be essential to know where they are and how the receiving patient has reacted to them. A unique identifier could facilitate that, and also provide some protection for the patient concerned, especially in the case of a recall.

I look forward to the Minister’s answers to the questions that the noble Baroness, Lady Cumberlege, asked about patient consent. It is vital that patients have confidence in the system. Confidence in their own privacy is part of that, and patients can have that confidence only if they know what is being shared, and by whom.

[Baroness Redfern (Con) [V]]

My Lords, I am pleased to speak to this group of amendments, and to thank the noble Baroness, Lady Cumberlege, who has been so diligent in her review in proposing such needed changes, and making good for the recipient and building user confidence in the devices offered. It is a pleasure to follow the noble Baronesses, Lady Finlay and Lady Walmsley, and the noble Lord, Lord Ribeiro—as well, of course, as the noble Baroness, Lady Cumberlege.

I spoke on Second Reading in support of an extensive programme for medical devices, to provide for high standards of safety and to share vital information, with data central to effectiveness. The noble Baroness, Lady Cumberlege, in her review, regarded being able to track which treatments and implants people have had as being of particular importance. A barcoded wristband, with equipment used in treatment, including implantable medical devices, being scanned and tracked to a patient’s record, would save much precious time for product recalls, and reduce drug errors.

This means knowing who has had a device used in their treatment, so that they can be swiftly notified if there is a problem. Having unique device identification is therefore very important. The noble Lord, Lord Ribeiro, said—and I agree—that we must consider tracking all medical devices used in the UK, rather than a select few.

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[Baroness Walmsley (LD) [V]]

My Lords, I heartily support the noble Lord, Lord Field, and the noble Baroness, Lady Meacher. I thank the noble Lord for his important evidence, and congratulate the noble Baroness on her many years of energetic campaigning on this matter. Noble Lords may know that I too have campaigned long and hard for medicinal cannabis projects, that have been proved to be safe and effective, to be prescribed on the NHS for UK patients. When the Home Office changed the status of medicinal cannabis two years ago, many of us thought that, given the mass of evidence that there are many such safe and effective products in widespread use abroad, such medicines would become available free to UK patients. That has turned out not to be so. Although some expert clinicians are prescribing them for appropriate patients—including the noble Lord, Lord Field—in a private capacity at high cost, very few patients have received their medicine free on the NHS. Why is this? It seems that it is because NICE has not approved them because there have not been any random controlled double-blind trials. Therefore, several health trusts are forbidding consultants who want to prescribe these medicines to do so, on pain of losing their jobs.

There are children with intractable epilepsy in this country whose lives have been saved by the medicines, for which their parents have had to fundraise. The lives of some of those children have been put at risk because the coronavirus has prevented that fundraising, and they suffered serious preventable fits. Many of these children have been treated with approved pharmaceutical medicines that have never been approved for use with children and have serious side effects. That is why we need a proper regulatory framework based on the full cadre of available evidence, which this amendment proposes. It will not be difficult to establish the safety of these medicines, as required by subsection 3(a). If those making the regulations are allowed to take into account the health records of people who have already been taking these medicines, and also the vast amount of evidence from other developed countries which the noble Baroness, Lady Meacher, has listed, that will subsection 3(c). Subsection 3(b) requires that availability be considered when making the regulations. These medicines are readily available. Indeed, a lot of them are being made in this country and exported because they cannot be sold here. How mad is that? Nor are they expensive as medicines go, and the NHS can bulk buy at a discount anyway.

In order to satisfy those who do not trust evidence from other countries—although why is beyond me—we also need to collect data from UK patients who are managing to get cannabis medicines in order to provide the information required by NICE, but there is no system in place to do that. Will the Minister say why the NHS Commissioning through Evaluation system is not being used? It is a well-established and approved system that collects patient data and clinician observation on the use of novel medicines and treatments. It strikes me that, given that cannabis medicine’s illegal status made it impossible to collect much UK data before 2018, it would be an ideal candidate for this trusted method of evaluation. Finally, I would welcome the Minister’s response to this suggestion.

[The Deputy Chairman of Committees (Baroness Watkins of Tavistock) (CB)]

I call the noble Lord, Lord Norton of Louth. Lord Norton? We will move to call the noble Lord, Lord Patel, and come back to the noble Lord, Lord Norton if we have time. I call the noble Lord, Lord Patel.

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[Baroness Penn (Con)]

I thank the noble Baroness for her comments about the importance of evidence. The Government and the MHRA recognise some of the difficulties around these trials. That is part of the reason that NIHR is supporting two trials and is asking people to come forward. The MHRA has also indicated that it is willing to work with those who have these products in order to support them in the process for licensing.

That has reminded me of one other point. The noble Baroness, Lady Walmsley, asked me about the NHS commissioning through evaluation programme. I undertake to write to her with a response, perhaps when I update the noble Baroness, Lady Thornton, on prescription numbers.

[Baroness Walmsley (LD) [V]]

My Lords, I thank the Minister for that. With regard to her earlier response, if it were as easy as that, there would have been tens of thousands of NHS prescriptions in the past two years, but clearly that has not been the case. The noble Baronesses, Lady Finlay and Lady Meacher, have both made it clear why it is very difficult to conduct randomised double-blind clinical trials for these products. That is why I have suggested that, while we wait for many more than two trials, the commissioning through evaluation system could be used. I am grateful to the Minister for promising to write to me about that.

[Baroness Penn (Con)]

I thank the noble Baroness for her comments. I emphasise that there has been a great deal of discussion in the debate about the use of evidence. That is what will guide the Government and the MHRA in this, and that is why we are supportive of these RCTs taking place.