My Lords, in moving Amendment 108, I will also speak to Amendment 114. I am immensely grateful to my friend, the noble and learned Lord, Lord Mackay of Clashfern, for his support. I beg noble Lords’ indulgence because I intend to explore these two amendments in some depth as I have some concerns about them.
Amendment 108 places a duty on the Secretary of State to disclose information
“where there is a clear threat to public safety.”
Clause 35 provides that the Secretary of State
“may disclose information for the purpose of warning members of the public about concerns that the Secretary of State has in relation to the safety of a medical device.”
This is welcome, but the power is discretionary. There is no duty to disclose information in these circumstances. It is not clear why there should not be an unambiguous duty to disclose information to the public where their safety is an issue. The Government have repeatedly committed themselves in their guidance and policy documents to patient safety as their primary concern, and have given reassurances about it in the other place. However, this clause is yet another example of where there is no explicit legal commitment to patient safety. For this reason, an amendment to this clause is suggested to create a duty to disclose information where there is a threat to medical device safety.
In addition, it must be queried what is meant by a “threat to public safety” and how any such threat is to be judged or even detected. The Cumberlege review reviewed the failure of medical professionals and the system in general to listen to patients’ own reports of pain and the seriously adverse effects of their implants. The duty to disclose a threat is only as meaningful and effective as the processes behind it that monitor and capture the information relating to patients’ adverse events. A safety issue will not be recognised if patients are not being taken seriously.
Part of the findings of the Cumberlege review related to the ineffectiveness of the current yellow card system for self-reporting adverse events. There is a lack of a clear and well-publicised route for patients to report their experiences. Clear and effective processes need to be in place to capture the information relevant to identifying potential threats to public safety. This duty to disclose should be supported by such processes.
Clause 16 gives the power to create an information system, and a later amendment introduced by the noble Baroness, Lady Cumberlege, on the setting up of a patient safety commissioner, could form part of the processes needed to ensure that the experiences of patients and the reporting of adverse events are effectively monitored, recorded and evaluated. However, effective self-reporting processes and clear routes for patients to self-report need to be established. Clarification of how such reporting is to be integrated into effective communication across the NHS and the medicines and medical device regulatory framework as a whole is needed.
As the Bill stands, so much is left unsaid and what has been laid out for Parliament to discuss was drafted and conceived before the findings of the Cumberlege review were published. Any patient safety commissioner would need to be properly resourced if they were to work in practice—equally there should be more consideration by the Government of processes for patient reporting and communication across the system. That ought to be put before Parliament.
Amendment 114 would mean that Regulation 3B on the requirement for confidentiality in the Medical Devices Regulations 2002 would remain in place. It is suggested in the Bill that this is removed. Clause 37 provides for “Consequential and supplementary provision”. Subsections (3) to (7) of Clause 37 variously amend the Medical Devices Regulations 2002. In particular, subsection (5) removes Regulation 3B from the 2002 regulations. This was only recently inserted into the law by the Medical Devices (Amendment etc.) (EU Exit) Regulations 2019. Regulation 3B requires that
“all parties involved in the application of these Regulations must respect the confidentiality of information and data obtained in carrying out their tasks in order to protect … (a) personal data in accordance with the Data Protection Act 2018; (b) commercially confidential information … (c) the effective operation of … inspections, investigations or audits.”
It is not clear why the requirement for confidentiality has been removed so soon after it was created. While Clause 35 provides that commercially sensitive data cannot be disclosed except where necessary for the Secretary of State to warn of serious harm in civil proceedings or criminal proceedings, no other clauses in the Bill reflect the similar requirements that have now been removed by Clause 37. It is concerning that in removing the requirement for confidentiality, the Bill seems to emphasise protection for commercial interests more than those of patients and users.
The Government should provide clarity on why they wish to remove this condition to respect patient confidentiality in operating the Medical Device Regulations. This not notwithstanding, Clause 37(5) should be removed.