My Lords, I thank the noble Lord, Lord Patel, for his amendment, designed to ensure that the public are always warned about concerns relating to a medical device where there is a clear threat to public safety. The Government agree that sharing information with the public—as well as the healthcare system—is important. Safety information is provided already to relevant special interest groups and through social media channels to ensure that messages are accessible and reach those affected who need to be aware or take action. This can include patients, healthcare professionals and members of the public. For example, MHRA recently urged users of Safe and Sound Infrared Ear Thermometers to check their product code and lot number due to a voluntary recall of specific lots because of a two-degree temperature overreading fault. This is a safety concern for members of the public who are monitoring their temperature, particularly in view of the pandemic. However, noble Lords are correct that it is critical that we do more to improve transparency and share more safety information to support patient safety. This has been made even more apparent in the findings of the report by my noble friend Lady Cumberlege.
Clause 35, along with Clause 13(1)(h)(iii), is designed to ensure that in future we can share information with key parts of the healthcare system, academia and the public in a considered and effective way. Under the current medical device legislation, MHRA does not have a clear legal basis to report all incidents involving medical devices occurring in the UK. By contrast, this has been common practice in the USA, via the FDA’s MAUDE database, and in Australia, via its DAEN database. Medicines legislation already enables MHRA to provide its interactive drug analysis prints, or iDAPs. It is therefore right that, via the information-sharing powers in this Bill, we are able to disclose in an appropriate manner all medical-device serious incidents. This will provide greatly improved transparency about the safety of medical devices in the UK.
Amendment 108 would place a legal requirement on the MHRA to disclose information to the public to warn them about concerns relating to a medical device where a clear threat to public safety had been determined. The amendment is unnecessary, as the MHRA would always share safety information with the public where it was necessary to do so. However, issuing warnings and safety information to the public needs careful management, a good understanding of the situation, full verification of the data and consideration of wider complexities. There is a high risk that mandating the disclosure of clear threats to public safety would commit
MHRA to regular disproportionate direct communication to the public about safety issues that the public cannot act on.
The great majority of MHRA’s medical device safety alerts require healthcare workers, not members of the public, to take action to remove a public health threat. For example, MHRA’s national patient safety alert of 23 September 2020, addressing a clear threat to public health, instructed all hospital trusts and other healthcare providers on actions to be taken to avoid potential unexpected shutdown, leading to a complete loss of ventilation, when using the Philips Respironics V60 ventilator. Such messages should not be targeted and promoted to the public but should be made available passively to the public; for example, via access to a website. Otherwise, this would likely create unwarranted anxiety in the public about safety issues that they themselves could address because they required the intervention and clinical support of healthcare professionals.
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Clause 35(2) will ensure that the public are warned of concerns about the safety of devices in the most appropriate and effective way. We can proactively warn the public when there are actions that they can take to protect their own or others’ safety. In addition, we will be able to ensure that the public have access to wider information about the safety of devices, passively through the MHRA website. All adverse incidents with medical devices, for example, are published on the MHRA website.
Amendment 108 would risk the MHRA being forced to put out information that may cause harm. We must ensure that patients receive safety information in a proportionate manner, and that they will be in a position to engage with the information when serious safety warnings are given that affect them.
In response to the question about who makes the decisions on issuing such safety warnings and what that process is, I undertake to write to noble Lords with more detail.
Amendment 114 from the noble Lord, Lord Patel, would retain Regulation 3B of the Medical Devices Regulations 2002, as amended by the Medical Devices (Amendment etc.) (EU Exit) Regulations 2019. This imposes certain confidentiality requirements on those operating the regulatory system for medical devices. I believe that the noble Lord’s intent is to ensure that confidentiality requirements apply when information is shared under Clause 35. I reassure the noble Lord that subsections (5) and (8) already take into consideration the disclosure of commercially sensitive information and personal data, as described under Regulation 3B of the Medical Devices Regulations 2002, and provide safeguards to ensure that commercially sensitive information will not be disclosed unless necessary and proportionate and that any disclosure of information will not contravene data protection legislation.
Keeping in place Regulation 3B of the Medical Devices Regulations 2002 would create two conflicting provisions: Regulation 3B, which would, on its face, restrict the regulator operating under those regulations; and what is currently Clause 35, which, with certain restrictions and limitations, would allow the regulator
to disclose some information to which that restriction in Regulation 3B might apply. The Government seek to use the powers within this Bill to improve transparency around medical devices and want to be as clear as possible in law about what they can and cannot disclose and the circumstances in which that disclosure could take place. By leaving Regulation 3B in place, there would be contradictory and overlapping provisions concerning confidentiality and disclosure of information that would be unnecessarily confusing.
I reassure noble Lords that the provisions relating to confidentiality that we are talking about in respect of these clauses is the confidentiality of manufacturers and not patient confidentiality. While respecting manufacturers’ confidentiality, the measures that we are taking in this Bill will allow us once we have left the EU at the end of the transition period to share more information with a view to patient safety than is currently allowed under EU regulations. The steps that we are taking are about being able to do more on patient safety than we currently can under the EU and do not contravene any of the measures on patient confidentiality that noble Lords have expressed concerns about.
I hope that I have reassured noble Lords that Clause 35 provides for an appropriate level of transparency while providing appropriate safeguards, and that neither of these well-intentioned amendments are therefore necessary or appropriate. I therefore hope that the noble Lord, Lord Patel, feels able to withdraw his amendment.