Medicines and Medical Devices Bill – in a Public Bill Committee am 10:00 am ar 10 Mehefin 2020.

Danfonwch hysbysiad imi am ddadleuon fel hyn

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

I beg to move amendment 19, in clause 43, page 24, line 17, leave out

“on such day or days as the Secretary of State may by regulations made by statutory instrument appoint” and insert

“six months after this Act receives Royal Assent.”

This amendment brings the enforcement regime into force at a defined period after Royal Assent rather than at a date of the Government’s choosing.

Having accepted the principle of the new enforcement regime and seeing its potential, I am keen to know when it will be in place and what the Government’s intentions are for getting on with it. Clause 43(3) says:

“Chapters 2 and 3 of Part 3”— the bit that governs the enforcement and disclosure around medical devices—

“come into force on such day or days as the Secretary of State may by regulations made by statutory instrument appoint.”

Basically, that means at some point in the future.

The amendment, which is in my name and the name of the hon. Member for Central Ayrshire, suggests the regime should come into force within six months of Royal Assent. As was said in our earlier discussion, I imagine that the Government want to return to consultation on that point, so that might not be the right period. We are keen to know that the Government intend to get on with it, however, because there may be some push-back from those with vested interests who do not want the scheme to go ahead. I talked about there being three prosecutions in 12 years; we are likely to see much greater activity than that, and there will be those with vested interests who do not want that to happen.

I am keen for the Government not to leave this forever. If we accept in primary legislation that the regime is going to happen and is a good idea, that is what matters, and it should happen at a defined point. I am keen to know what the Government see as the timeline for introducing it. As Parliament has decided that we will do this, I would like a firm commitment on the record that we are actually going to do it.

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

I am grateful to the hon. Gentleman for raising, through amendment 19, the issue of the commencement of chapters 2 and 3 of part 3 of the Bill, which is concerned with medical devices. Chapter 2 introduces a new enforcement regime that includes the civil sanctions set out in schedule 1, which we discussed. Chapter 3 concerns data and disclosure provisions, and contains a number of consequential amendments, which facilitate the introduction of the new enforcement regime in chapter 2.

On chapter 2, as I have said, a key element of the new enforcement regime is the addition of civil sanctions, which will act as a flexible, proportionate enforcement mechanism to enhance the MHRA’s ability to incentivise compliance. Supplementary regulations must be made under paragraph 9 of schedule 1 before the new civil sanctions can be fully operational. Those regulations, which could relate to matters such as the enforcement of a monetary penalty regime, monitoring compliance with an enforcement undertaking, and the provision of appeals, are subject to a consultation requirement, as set out in clause 40. It is right that we consider the views of stakeholders before bringing the regulations into force, and it is important to allow for time to engage effectively, so that we can ensure that we act in the best interests of patients, and thereby in the best interests of the healthcare sector that serves them.

The data and disclosure provisions in chapter 3 will provide greater transparency about the safety and effectiveness of medical devices on the UK market. I am sure we all agree that that is what we are after: knowing what is going where and helping whom, and, if there is an issue, being able to isolate and highlight it, and then provide a remedy. The Government are exploring how we can ensure that the new powers are as effective as possible and secure the needs of the healthcare community, patients and the wider public. It is therefore appropriate that due consideration be given to how the powers can most effectively be used before they are commenced. An amendment putting in place a deadline by which the powers must come into force could limit the MHRA’s ability to find the most effective route, and it could limit the time that MHRA has before commencement for the important process of engaging with stakeholders on the powers.

Finally, the consequential provisions in clause 36 are linked to the disapplication of the previous enforcement regime in part 2 of the Consumer Protection Act 1987. They too must be commenceable by regulations, so that they come into force at the same time as the new enforcement regime.

I reassure hon. Members that the Government are committed to bringing the enforcement, data and disclosure chapters of the Bill into force as soon as is appropriate, in order to enhance the safety of the medical devices regime, which I think we all see as important. I therefore ask the hon. Member for Nottingham North to withdraw the amendment.

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

The final part of that answer answered my question. I beg to ask leave to withdraw the amendment.

Amendment, by leave, withdrawn.

Clause 43 ordered to stand part of the Bill.

Clauses 44 to 45 ordered to stand part of the Bill.