My Lords, I very much appreciate the support that I have already received today from the noble Baroness, Lady Finlay, and my noble friend Lord Ribeiro. I am going to go into a bit of detail on what we found during the review, but I want to say to both noble Lords that I strongly support their views on Scan4Safety. Indeed, I spent a day in Derby going through the whole process with the clinicians, support staff and policymakers, and it was very impressive.
The noble Baroness, Lady Finlay, is absolutely right to say that we should look at more than just one example. Her research, which she has told us all about today, took on the six different areas, which is excellent. However, I agree with her that we should think seriously about introducing this system across the country.
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During our review, we uncovered systemic failings at the healthcare system’s very core: lack of data and information. We discovered, to our astonishment, that no one in the healthcare system could tell us exactly how many women had received pelvic mesh implants and what had happened to those women. There is not a complete record of how many have suffered terrible, life-changing complications and the damage we heard so much about from so many women.
No one could tell us how many women taking sodium valproate to control their epilepsy had given birth while on the medication. As I know I have mentioned to your Lordships previously in Committee, there is a
one in two risk of a baby being damaged by sodium valproate. This means that the system could not tell us how many babies have been born with physical and cognitive problems as a result of it. No one in the healthcare system knows how many women who took the hormone pregnancy test Primodos all those years ago went on to give birth to a damaged baby, or had a miscarriage and lost their baby for ever.
We were shocked by this, and concluded in our report that the system is flying blind. If the numbers of people affected by these medical interventions are not known, we do not know their health outcomes, what kind of help and support they need, and, crucially, whether a medicine or a medical device is safe, so we cannot act to prevent harm and, above all, learn from our mistakes. So collecting data, as noble Lords have already said, is vital. It is what enables us to provide the right care and support to those who need it. It informs our understanding of whether treatments are safe and it determines our actions.
In the review’s report, First Do No Harm, we set out how we could see this working. Take mesh implants as an example. If a woman were to choose to have a pelvic mesh implant, we said that the basic information about her and the procedure itself must be entered on a national database, as the noble Baroness, Lady Finlay, also referred to. We suggested it should contain the woman’s name or NHS number, her date of birth, the name of the hospital, the date of the procedure, the name of the implanting surgeon and the unique identifier of the device used. We felt that this basic information is so essential in being able to identify and trace safety concerns that it should be mandatory. In other words, we suggested that we really should have the patient’s consent, but not for the first mandatory identifying and trace database, because we felt we should collect that information without requiring the patient’s consent.
We met the Secretary of State last year and explained what we wanted and why we wanted it. He agreed with us. We also said that, in addition to this database or core data, it was important to collect further information about the short-term and long-term outcomes of the procedure, including patient-reported outcomes and experiences, and the patient’s wider medical record—what the information centre in the Bill refers to as the clinical data module. As the noble Baroness, Lady Finlay, said, we will discuss that later when we talk about registries.
We said that the registry would analyse all the data to identify patterns that give rise to safety concerns. As the noble Baroness said, this is more detail. Personal data should, in my view and that of my team, be subject to the patient’s consent, unlike the database. Patients should have the right to refuse or to give consent to their most intimate personal information being assessed by NHS Digital or the Health and Social Care Information Centre, as it is called in Clause 16. These consultations with hospital doctors and GPs are very personal stuff. It is important that if it is to be shared with others, consent should be given.
I am worried about how our recommendation is being interpreted by the Department of Health and Social Care. We argued for mandation to ensure 100% compliance with creating a database of all operations.
However, to study outcomes and learn how to improve care, we need much more information about each patient treated, including personal medical information, the patient’s experience and functional outcomes. We believe that such registries, linked to the database, should be subject to patient consent. So, there is a difference between the two: we do not need consent for the first, but we do for the second.
Of course, this is not a new idea; it is simply a matter of human rights, as in the European convention and rooted in our common law. Our deep concern is that, as things stand, it appears that the Department of Health and Social Care and NHS Digital believe they have the right to access and cull patients’ hospital and GP records—to extend that database, as we defined it, into a register. That would then be without the patient’s consent or, indeed, their knowledge.
This might be legal under the GDPR and the 2012 health Act, but the fear is that this will lead to another care.data. We have been there before and seen the disaster that can be caused. It really did damage trust and ended in tremendous controversy. It is also not necessary as we will have the mandated database and the MHRA register of devices. Experience shows that most—indeed, nearly all—patients want to co-operate with the pelvic floor and other registers because it is very much in their interest to do so. They do so now with the joint and bone register, which has been very well used and put together, and is very much valued by clinicians and patients.
I am sure we all agree on the vital importance of collecting data and using it to improve safety and outcomes. I think we also agree that patients have rights, not least the right to know where, when and how their most personal medical information is being used and by whom, and the right to give or withhold their consent for such use.
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.