Medicines and Medical Devices Bill

Baroness Burt of Solihull Excerpts

Committee stage & Committee: 6th sitting (Hansard) & Committee: 6th sitting (Hansard): House of Lords
Tuesday 17th November 2020 Grand Committee

[Lord Lansley (Con)]

My Lords, I am very glad to have the opportunity to follow my noble friend Lord Ribeiro and to speak to my Amendment 104. I am grateful to the noble Baroness, Lady Finlay of Llandaff, for bringing forward her amendments as well. They highlight some useful points and—particularly Amendment 101—focus on the necessity for patients to be provided with information and for patient experience to have its place in the information systems to be created under Clause 16. My noble friend Lord Ribeiro very helpfully illustrated that the benefit of the joint registry and similar information systems is not simply to promote safety but also to improve outcomes. We can certainly look forward to seeing both happening in the future.

My Amendment 104, to which the noble Baroness, Lady Finlay, and the noble and learned Lord, Lord Woolf have added their names, requires that the regulations made under Clause 16 include specific reference to the Caldicott principles. Noble Lords will recall the establishment of those principles back in 1997. They say that an organisation should:

“Justify the purpose for using confidential information”


and that the NHS should not

“use confidential data unless absolutely necessary”.

The NHS should:

“Use the minimum necessary personal confidential data”,


while

“Access to personal confidential data should be on a strict need-to-know basis … Everyone with access to personal confidential data should be aware of their responsibilities”


and, when using data, NHS personnel should “comply with the law”. In 2003, a seventh principle was added:

“The duty to share information can be as important as the duty to protect patient confidentiality.”


In a sense, a balancing principle was added as number seven. The amendment refers to those two reports, which have given rise to those principles. I am interested generally in the proposition of how certain we are that the Caldicott principles are being applied in every case. I think in these regulations it would be to the benefit if they were restated, given the importance of this as an information system.

I will ask three questions of my noble friend. First, can he assure us that the regulations themselves will make specific reference to the Caldicott principles? This would mean that we did not need to put it in the Bill. Secondly, in establishing these information systems, can we be assured that Caldicott Guardians will be appointed specifically in relation to each of the information systems that are to be established? Thirdly, can my noble friend tell us any more about the National Data Guardian’s consultation, which opened in June and closed in September, on an eighth principle:

“Inform the expectations of patients and service users about how their confidential information is to be used”?


This ties very directly into Amendment 101 in the name of the noble Baroness, Lady Finlay of Llandaff.

If it is endorsed by the National Data Guardian, that principle would give rise to an additional principle being reflected in the regulations. I freely confess that this is a good reason not to put my amendment in the Bill, because the nature of the Caldicott principles might well change in the immediate future, so it is not very helpful to entrench it in its current form. If we get the assurance that we are looking for from my noble friend, I hope the regulations, when they are made, will be able fully to reflect the Caldicott principles.

[Baroness Burt of Solihull (LD) [V]]

This string of amendments all talk about recording information, and I broadly agree with all of them. I particularly mention Amendment 104, in the name of the noble Lord, Lord Lansley, because of the mention of the Caldicott principles. Many people, particularly noble Lords in the Liberal Democrat party, jealously guard our right to privacy—hence the promissory tone of Amendment 100 in the name of my noble friend Lady Jolly.

The purpose of the proposed new clause in Amendment 107, to which I have put my name, is slightly different from that of the other clauses because it seeks to ensure that a proper systematic analysis is made of the effectiveness of mesh implants through registers. The Cumberlege review notes that registries are

“few and far between and all too often prompted by catastrophe”

in relation to transvaginal mesh and PIPs. This is obviously a good phrase because the noble Baroness, Lady Finlay, has already picked it out of the report.

This clause proposes a register. It requires the Secretary of State to report on progress towards creating databases relating to other devices. I appreciate that there are many databases out there—far more than I anticipated when first became involved in this Bill. The idea of the registries is to draw all this information together. As the Cumberlege report says,

“a ‘registry’ … would act as a repository for more complex patient related information datasets enabling research and investigation into patient outcomes.”

This would be more holistic and far more useful than just a database, enabling any adverse outcomes to be spotted early and not allowed to fester, literally, for years before defaults are spotted.

Patient groups must be consulted on devising the register. Time and time again, victims reported that they had not been listened to, despite the fact that the mesh felt “like razor blades” inside them. Never again must a patient feel patronised, unheard or left to suffer in silence. Of course, those healthcare professionals at the coal face, as it were, of the issues must have their say. We know that some registries exist today, but this database would bring everything together, instead of the piecemeal system we have at the moment.

I will go back to the lady whose poignant testimony I quoted at Second Reading, whom I called Jane. Jane had an estimated five pieces of mesh inside her, although the health professionals treating her maintained that there were only two. How can this be? I leave noble Lords to speculate but, in my view, this is a sharp indictment of the state of the service our health service gives to patients in this area. Unless we have a proper register of everything that is inside a patient, when it was inserted and what its performance record is, how are we going to enable them to be given the appropriate treatment when problems arise? The Royal College of Surgeons endorses this view—it wants all medical device implants overseen by registries.

Finally, I express my gratitude to the noble Lord, Lord Bethell, for the briefing this morning. I was very heartened to learn of the hard work going on in this area and the aspiration that a register for vaginal mesh implants could be up and running in only a year. I wish the Bill well.

[Baroness McIntosh of Pickering (Con) [V]]

My Lords, first, I apologise for not being able to participate at earlier stages of the Bill because of the clash with speaking in the Chamber. I congratulate the noble Baroness, Lady Finlay, on introducing these amendments and, especially, my noble friend Lady Cumberlege for all her work in preparing her report in advance of this. I also thank the Minister, my noble friend Lord Bethell, for briefing us this morning. I will particularly speak in favour of Amendments 100 and 101.

I hope that my noble friend the Minister will look favourably on patients being able to report directly to the register. The testimony that my noble friend Lady Cumberlege and others heard in the context of her report was very moving. As my noble friend Lord Ribeiro said, it is absolutely essential that the voice of patients is heard. This absolutely goes to the heart of medical and surgical treatment. We must ensure that, whether they have had a good or a bad experience, patients are able to place their experiences on the record. Amendments 100 and 101 go some way to achieving that. Were my noble friend not to like those amendments, I hope that the Government would come forward with a similar provision to put our minds at rest. I thank the noble Baroness, Lady Finlay, for these amendments, and I lend my support to them.