Medical devices: civil sanctions

Medicines and Medical Devices Bill – in a Public Bill Committee am 9:25 am ar 10 Mehefin 2020.

Danfonwch hysbysiad imi am ddadleuon fel hyn

Photo of Alex Norris Alex Norris Shadow Minister (Health and Social Care) 9:25, 10 Mehefin 2020

I beg to move amendment 20, in schedule 1, page 31, line 16, after ‘guidance’ insert

‘within three months of this Act receiving Royal Assent’.

This amendment requires the relevant guidance relating to enforcement to be published within 3 months rather than at an undetermined time.

The schedule compels the Secretary of State to provide guidance on sanctioning powers and how they are likely to be used. Those are the new civil powers—among the bigger changes in the Bill—and the guidance will cover when they are likely to be used, the likely level of fines, and the cost recovery, which we spoke about earlier. They are clearly an area of significant interest. Those civil powers are new and important, and we will cover them a bit when we debate the next amendment. At the moment, schedule 1 states that:

The Secretary of State must prepare and publish guidance”.

That is it. The amendment seeks for that to be done within three months. Three months might not be the right period of time, but I am keen to test when we are likely to see the guidance and whether we should put a bit of structure around that.

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

I would like first to address the intention behind the amendment. I recognise that it is driven by the desire to ensure that the Government issue guidance on the new civil sanctions regime within three months of the Bill gaining Royal Assent. The new civil sanctions regime will complement the consolidation of the current enforcement regime, enabling the Medicines and Healthcare products Regulatory Agency to impose a monetary penalty, an enforcement cost and a recovery notice, or to accept an enforcement undertaking as an alternative to criminal prosecutions. That will enhance the MHRA’s ability to incentivise compliance with the Medical Devices Regulations 2002.

Under paragraph 13 of schedule 1, the Secretary of State has to publish guidance on the new civil sanctions regime. However, the timeframe for doing so is not specified on the face of the Bill. Before it is fully operational, the new civil sanctions regime provided for by the Bill will require further provision, to be set out in supplementary regulations made under paragraph 9 of schedule 1. The regulations will cover matters such as enforcement and monitoring of compliance with enforcement undertakings and appeals.

Clause 40 provides that any regulations made under paragraph 9 of schedule 1 must be consulted on. There needs to be enough time to do that, which is why a three-month period is perhaps too truncated. The Government wish to allow sufficient time for such a consultation on these matters before we make the regulations, in order to ensure that they best fit the situation that we are trying to enforce. As I have explained, the civil sanctions regime will not be fully effective before the regulations are made. Under paragraph 13 of schedule 1, the Secretary of State must also consult before issuing guidance on the new regime.

It is right that we consider the views of stakeholders. As we discussed at length on Monday, this is about getting it right for patients and all stakeholders before we bring the regulations into force. It is important that we allow sufficient time to engage effectively and to ensure that we act in the best interests of both patients and the healthcare sector. The effect of the amendment would be that the Government are required to consult on, and publish guidance on, the civil sanctions within a tight three-month period before the regulations have been made, and at a point when the consultation might still be ongoing, so that we arrive at the best place.

Paragraph 13 of schedule 1 already places a duty on the Secretary of State to publish the guidance in order to be transparent, and the new civil sanctions regime will require consultation and secondary legislation. It is therefore impractical to specify on the face of the Bill that we would have a timeframe for doing so. On that basis, I hope that the hon. Member understands that we wish to get this right, and that he will withdraw the amendment.

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

I am happy with that, certainly for the purpose of greater consultation, because a theme in the written evidence is that the sector wants to continue to talk about such things and get them right. We will return to this issue when we debate the next amendment.

I hope the Government will not leave it too long. There is a very important bit of guidance that the Secretary of State is compelled to publish under the Modern Slavery Act 2015, but we have still not seen it. The regulations are likely to be less challenging than that. I do not like the open-ended space, so I hope the Government will move on precipitously. On the basis of the Minister’s answer, I beg to ask leave to withdraw the amendment.

Amendment, by leave, withdrawn.

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

I beg to move amendment 21, in schedule 1, page 32, line 18, leave out “from time to time” and insert “every 12 months”.

This amendment requires the Secretary of State to report back on their use of civil sanctions every year rather than at an undetermined frequency

Again, this helps us to delve into the new sanctions regime and to talk about the Medicines and Healthcare products Regulatory Agency. As we see from the written evidence, there is a lot of interest in that. The Bill seems to do two things, certainly regarding the Medicines and Healthcare Products Regulatory Agency: consolidate disparate bits of legislation that govern its activity, and provide it with new civil powers.

On the former, it is clear from the explanatory notes to the Bill that, in the Government’s opinion, the current structure of legislative powers hinders the MHRA. As an Opposition Front Bencher, I share their view and support the principle. The latter point, about the new civil powers, came up frequently in conversations with patient safety campaigners, and I know that the Independent Fetal Anti Convulsant Trust mentioned it in its written evidence. Generally, the Opposition are reticent about the Government relying on civil rather than criminal powers, especially when it comes to things that can cause significant and serious harm to individuals.

We know about the issues covered by the Cumberlege review and the incredible potential for life-altering harm through negligence, malpractice or similar. I would not want to see a situation where the ease of prosecution meant that we downgraded those things to a massive fine on a massive company, because they can eat those—it is almost priced in—and carry on regardless. That would not feel like justice, so I am keen to hear from the Minister that that is not the case and that the Government do not think that it would be the right thing to do.

However, on the broader point about the civil powers, I think this is the right thing to be doing. Paragraph 96 on page 19 of the impact assessment says:

“MHRA prosecutions for non-compliance are rare but do occur. Since 2008, the MHRA has brought 3 prosecutions, 2 of which ended in convictions, and one ended in acquittal.”

That is only three in more than a decade. We need to balance that against the fact that, in 2017-18 alone, the MHRA seized 9.5 million falsified medical products. Not all of them would be covered by what it could do through prosecutions on medical devices, but that shows the balance of risk and how hard those pursuing nefarious ends will push these things.

Frankly, if I had got that information about three prosecutions in over a decade via a written question rather than an impact assessment, I would be pushing the Minister on what she was going to do differently in the future. Therefore, I do not think I can start sniping when an alternative regime is proposed, and I will not do so, but there is a risk that we could downgrade exceptionally serious breaches of patient safety, and I hope we will not.

Come what may, whatever the intentions, this is a bit of a leap into the dark in terms of whether these provisions will work. In amendment 21, we therefore ask the Secretary of State to report every 12 months so that they can be monitored. I think the Government accept the basic principle, because they have put a similar burden on the Secretary of State, but only to report from “time to time”. I did not like that phrase, or really know what it meant, so perhaps, in a spirit of co-operation, the Bill could be tidied up, either today or at a later date. I would certainly be keen to press the point in the remaining stages of the Bill.

The amendment would also allow us to establish two further things. First, page 19 of the impact assessment states that these civil powers will operate at the burden-of-proof level of a criminal charge, rather than the traditional civil balance-of-probabilities level. That is interesting, and it sent me off for hours and hours, looking through all sorts of civil orders. Criminal behaviour orders—what we might have called antisocial behaviour orders in the past—have that criminal burden-of-proof level. Current domestic violence prevention orders work on a balance of probabilities. That sent me to the new Domestic Abuse Bill, in which the new domestic abuse prevention orders also work on a balance of probabilities, or on the civil, rather than the criminal, level. Can the Minister give us clarity about how the Government chose to set the burden of proof at a criminal level? This is important and will no doubt restrict the use of such civil orders. An annual review would allow us to see whether it has been hindered unnecessarily or undesirably.

Secondly, an annual report allows us to evaluate the MHRA itself. Let me start by saying that the MHRA has a really challenging job. It is our major line of defence in protecting the public from potentially catastrophic harm. It is regulating a massive industry with exceptionally powerful stakeholders on all sides. Given the extra powers, I am keen to know what extra capacity it will have in order to use them effectively.

I mentioned this on Monday, and to an extent I am laying breadcrumbs for remaining stages of the Bill, but we will see Baroness Cumberlege’s report on 8 July, by which time we will probably not have gone through the remaining stages. The report could have profound implications for the structure and operation of the MHRA; it is going to tell us about significant harm, what happened and perhaps how it could have been prevented.

It is unthinkable that the regulator would not be part of that conversation, so the Minister may have to return to make significant changes before the Bill passes. Even if not, we will need to know that our regulator can cope and is sufficiently resourced, and that it is independent enough and effectively operating the new powers. An annual report would do that. I know that the Government are committed to the principle of a report, and I wonder whether “annually” might be better than “from time to time”.

Photo of Jo Churchill Jo Churchill The Parliamentary Under-Secretary for Health and Social Care 9:45, 10 Mehefin 2020

Once again, I recognise that the hon. Gentleman is probing, to ensure we make good legislation. For that, I am extremely grateful.

The Government have every intention of providing greater transparency about the safety and effectiveness of medical devices on the UK market, including on how our use of civil sanctions will achieve that aim. On that basis, I confirm that the Cumberlege report will definitely be with us on 8 July, which I do not think I stated during proceedings on Monday. I take on board the hon. Gentleman’s point that we may well be looking at things in the round.

Civil sanctions will provide an alternative to criminal prosecution where the latter is not suitable. If, for example, a breach is judged to have had the potential to cause harm but it does not, the civil sanction is a second tool in the toolbox. As the hon. Gentleman said, there have been very few prosecutions in the last decade. Criminal prosecutions can be used where the breach of regulations leads to a serious incident or death, or where a manufacturer has directly contravened the conditions set out in a safety or suspension notice. As I am sure he will agree, other incidents very often need a flag raising, and that is the point of bringing civil sanctions into the legislation.

Currently, as the hon. Gentleman said, the Secretary of State is committed, under paragraph 15 of schedule 1, to publishing reports on the use of civil sanctions from time to time. The requirement to publish reports on the use of civil sanctions is in line with existing obligations on other Government agencies that already operate a civil sanctions regime for their sector. The Environment Agency is one—in respect of environmental civil sanctions—while the Secretary of State for Business, Energy and Industrial Strategy, who is responsible for enforcing the Ecodesign for Energy-Related Products Regulations 2010, is another. Those regulations explicitly state that reports on the use of civil sanctions will be published “from time to time”.

The new civil sanction regime would require supplementary legislation, as per paragraph 9 of schedule 1. A consultation on the supplementary legislation would be necessary to ensure that the new regime is operational. I assure Members that the Government intend to publish reports on their use of those measures at regular and appropriate intervals, and the hon. Gentleman will bring me up on that. The Government may indeed decide that reporting annually is appropriate. However, as the new regime will require secondary legislation, which must be consulted on before it comes into force, it is not practical to specify at this point the frequency of Government reports on the use of civil sanctions.

On the hon. Gentleman’s specific point about burden of proof and how we arrived at that, I will write to him. On that basis, I invite him to withdraw the amendment.

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

On the principle of civil sanctions, we are content. I am really grateful to the Minister for her offer to write to me about the burden of proof, and I will definitely take her up on that. It is important to reflect on why that is different in different cases.

I meant to refer to the potential to do harm, which is something worth reflecting on that, and we can talk about it in the remaining stages. At the risk of going into pub chat—if only—let us imagine that I throw a stone at someone. Whether I hit or miss, have I committed an offence? Does it matter that I have good or poor aim? When it comes to medical devices, if we find something with the potential to do significant harm, the fact that it has not yet done so would certainly not be a good enough reason to downgrade the way in which that was treated. Again, we can reflect on that another time, and it is also tied up with the burden of proof, but on the basis of the answers so far, I beg to ask leave to withdraw the amendment.

Amendment, by leave, withdrawn.

Schedule 1 agreed to.

Clauses 27 to 29 ordered to stand part of the Bill.