Recall of medical device by enforcement authority

Medicines and Medical Devices Bill – in a Public Bill Committee am 9:45 am ar 10 Mehefin 2020.

Danfonwch hysbysiad imi am ddadleuon fel hyn

Photo of Alex Norris Alex Norris Shadow Minister (Health and Social Care) 9:45, 10 Mehefin 2020

I beg to move amendment 28, in clause 30, page 16, line 23, at end insert—

“(4) The Secretary of State must, within 24 months of this Act receiving Royal Assent, lay a report before Parliament reviewing uses of this clause.”

This amendment requires the Government to review any use of the recall powers made in the first 2 years of the Act.

Again, this is a simple amendment. The clause governs the recall of a medical device by the MHRA. That is of significant public interest—recall, obviously, is important to people. It is also really challenging, and we have all seen that, whether with washing machines, cars or whatever. Once devices are out there, it is hard to recall them, so we want to know that these powers are working effectively.

The obligation that the amendment would put on the Secretary of State is to provide, within two years, a report on when recall has been used. That would do two things: first, it would allow us to evaluate how effectively recall was being used; and, secondly, it would act as a further publicity tool, so that people understood that the device has been recalled and, if they were still in possession of it, that they could do something about it.

At the moment, subsection (2) states: “The authority”—the MHRA—

“may take such steps as it considers necessary to organise the return of the device”,

but the clause does not quite say anywhere that the MHRA will then tell people what it has done. If that is implied, I am probably willing to accept that answer, but I am keen for the Minister to note that the Government’s clear intent is not only to organise the recall of unsafe devices, but to publicise that significantly, such that it will be reasonable to expect people to see such publicity and therefore to act on it.

Photo of Jo Churchill Jo Churchill The Parliamentary Under-Secretary for Health and Social Care

The Government consider the new recall power to be crucial to ensuring that unsafe devices are removed from the market. It is important to note, however, that subsection (3) requires that the power is used only as a last resort.

The Bill introduces this statutory power for the MHRA, on behalf of the Secretary of State, to conduct recalls on the rare occasions when a manufacturer is either unwilling to carry out a recall imposed under clause 18 or is unable to do so because the manufacturer no longer exists as an entity. I am sure Members will agree with this power, as it is intended to ensure the safety of devices for patients and, without it, there would be a gap. In the case of companies unwilling to take action, devices that are not recalled might well present risks to patients. It is right that the regulator can take action if and when companies fail to recall devices.

The statutory power also addresses an anomaly in the existing enforcement regime, whereby the MHRA has the statutory power to conduct a recall under the General Product Safety Regulations 2005 where the medical device in question meets the definition of a consumer good—typically, a low-risk medical device—but the MHRA does not currently have the commensurate statutory power to conduct recalls for higher-risk medical devices that are not also consumer goods under the GPSR. That would appear to be an inconsistency that does not align with risk to patients. I am sure all hon. Members would agree that, where possible, that is what good legislation should do, and the Bill seeks to correct that anomaly.

The Bill already provides the Government with the power to make public the details of recalls they conduct, because clause 34(2) allows the Secretary of State to disclose information for the purpose of warning the public—this is what I think the hon. Gentleman was alluding to—about concerns relating to the safety of a medical device. The Government consider that such information could include information about whether a medical device has been recalled. Accordingly, I reassure hon. Members that the Government intend to act transparently when they conduct recalls, using the power provided in clause 30. On that basis, I ask the hon. Gentleman to withdraw the amendment.

Photo of Alex Norris Alex Norris Shadow Minister (Health and Social Care) 10:00, 10 Mehefin 2020

I will not labour the point, but the Government must act not just transparently, but transparently, publicly and proactively. That is something we would be really keen on.

Photo of Matt Western Matt Western Opposition Whip (Commons)

On a point of clarification, at what point does the MHRA intervene? At what point is the threshold—that is perhaps a better way of putting it—at which a recall is demanded? Depending on the product, at what point is that necessary and who bears the cost? I am not sure whether that should be covered by the clause, or whether it is simply within the remit of the MHRA.

Photo of Alex Norris Alex Norris Shadow Minister (Health and Social Care)

That is interesting, and if the Minister wants to intervene to address that point, I will take an intervention. Otherwise, my best guess is that it would be covered by the regs and, presumably, subject to consultation. However, I hope the Government have a clear trigger point, so that we are all clear and transparent about what will happen.

Photo of Jo Churchill Jo Churchill The Parliamentary Under-Secretary for Health and Social Care

The MHRA has a specific compliance department. It works on a case-by-case basis, and it would issue a notice—see clause 18—and it would move forward on that basis with an individual recall against a company. I hope that clarifies the situation.

Photo of Alex Norris Alex Norris Shadow Minister (Health and Social Care)

I am grateful for that clarification. On the basis of the answer I have received, I beg to ask leave to withdraw the amendment.

Amendment, by leave, withdrawn.

Clause 30 ordered to stand part of the Bill.

Clauses 31 to 36 ordered to stand part of the Bill.