My Lords, I support and welcome Clause 87 on medicine information systems. My amendments would simply add to the regulations on information systems. I want to explain why I want to do so and set out how.
Amendments 306A to 306C would require the linking of information systems to ensure engagement with equivalent international bodies and enable better sharing of data for post-market surveillance, and Amendment 306D would require the linking of information systems relating to medical devices to ensure engagement with equivalent international bodies and enable better sharing of data for post-market surveillance of devices. They are intended primarily as probing amendments to enable me to thank and congratulate my honourable friend Anne Marie Morris in the other place, who brought forward these amendments, and to explain why they are needed.
Registries for both medicines and devices are a critical tool in effective commissioning of medicines and in post-market surveillance, which the report by my noble friend Lady Cumberlege rightly noted is essential for patient safety. Although clinical trials can provide some evidence, this needs to be continually updated to ensure that the knowledge is current and that any adverse reactions can be monitored.
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This measure would work like a more proactive version of the MHRA yellow card system and would allow us to identify issues with a medicine or device as quickly as possible and to locate all patients who are using it. If a fault develops in a washing machine, for example, we can notify all customers promptly—surely we must be able to do so in the same way if a product that has been installed in our own bodies is identified as faulty.
A devices registry has been hypothetically established in the Medicines and Medical Devices Act, and the Health and Care Bill establishes provision for a similar registry for medicines. Both need to be as inclusive as they can be. Can my noble friend the Minister confirm that, as yet, no devices registry has been established, although I understand that a statutory instrument needs to be laid as soon as possible to deliver one to ensure that patient safety is indeed a priority? Equally, a medicines directory should be created and implemented as soon as possible, and the architecture of both directories needs to enable links to be established with patient data within the NHS to enable health outcomes from individual medicines and devices to be monitored
and assessed. An architecture sympathetic to international standards would achieve more than the international reach of these medicines and devices.
Together with the MHRA, the NHS should be obliged to undertake an annual review of any new medicine or device approved by a UK regulator within the preceding 24 months for evidence of abnormal outcomes. In dealing with the reactive discovery of an adverse event, the NHS must put in place protocols and procedures to examine the relevant registries forthwith to determine what action to take; this may be a call for further evidence gathering or recall.
NHS patient data is currently collected and stored in siloes within primary care, secondary care and other systems. The Bill is designed to enable standardised data collection and sharing across the NHS. This must include the NHS and healthcare systems in their broader sense and include public health and social care. The data collected by the NHS, in primary and secondary care, regarding patient experience of these medicines and devices needs to be linked to these directories so that any medicine or device can be monitored and anything adverse identified early. Patient safety has to be paramount. The ease of use by healthcare professionals is crucial if adoption is to be achieved.
Digitisation across all healthcare systems will be necessary, not just nice to have. We need to create a system to ensure patient safety for the long term and to ensure that data-management architecture is put in place to join together the data-gathering processes, registry format and storage protocols, as well as to enable inquiries of it, both to support research and, again, to ensure patient safety, using robust data-mining techniques. The critical path must focus on the outcomes to be achieved rather than simply on collating information that is already being gathered.
Finally, on medical research, the Bill currently has provision for better data sharing between primary and secondary care. However, health data is the building block for medical research, and, without it, new medicines simply will not happen. Medicine development requires access to real-world data, alongside data from clinical trials—which we discussed earlier. Therefore, the data collected by the NHS needs be securely anonymised so that it can be used for research without fear of compromising patient confidentiality. To achieve this, NHS England must develop a new system to securely anonymise data and to establish access to ensure that that data can be accessed for research purposes. I understand that the department is already undertaking work to anonymise this data and, therefore, my request is that we put in place a system which maximises the data which can become available for research, rather than adopt a minimalistic approach focused merely on today’s research priorities.
These four modest amendments before us this evening are intended simply to plug a gap and loophole in the current Clause 87. I beg to move.