Health and Care Bill (Second sitting)

Debate between Jo Churchill and Alex Norris

Committee stage
Tuesday 7th September 2021 Public Bill Committees

[Alex Norris]

Q Finally, I remember from my time in local government that we would talk about the desire in social care to share data with the health service. We talked about, obviously, regulatory barriers that stopped us and we would welcome provisions that removed that, but a very practical obstacle on our list of things in the way was that the systems did not necessarily speak to each other. Do you think that health service systems and social care systems are ready to speak to each other now, or will there need to be, across all integrated care systems, a whole new provider brought in?

Simon Madden: Obviously, interoperability is absolutely key. The information standards piece that I spoke about is part of that, but also, outside the legislative piece, work is going on to create a unified data architecture. This is not about driving or having everything from the centre, so that everybody uses the same things, but about making sure that the architecture enables that interoperability so that the systems can speak to each other. There is certainly a degree of levelling up to do in terms of digital maturity, which is another area in which NHSX is involved, supporting the Department and NHS England. But yes, interoperability is key. We are not there yet; we have some way to go to make sure that everything will flow as it should and the systems speak to each other.

[The Parliamentary Under-Secretary of State for Health and Social Care (Jo Churchill)]

Q Mr Madden, I would like to know specifically how the strategy will help us to deliver integrated care within the confines of the Bill, so that we can give better patient outcomes, because ultimately that is what I have assumed the Bill is striving for. You did allude to how that interoperability gives us greater vision into the system. I wonder whether you could help us by bringing that to life. Thank you.

Simon Madden: The best example is something that I have already cited to a certain degree, which is the shared care record. To some degree, that would happen irrespective of whether ICSs and the Bill were in place, because health and social care need to come together; that is something that needs to happen in any event. But what the Bill does is create the proper framework of integration and collaboration. There are other powers in the Bill, for instance the duty to co-operate and collaborate, that I think are going to be absolutely crucial. From a public perspective, they see the NHS and see one organisation, whereas we all know that it is a confederation of organisations, each sometimes with different aims, pulling together. The ICS structure set out in the Bill, plus the data provisions that support that broader approach, will help provide that free flow of information so that clinicians and care professionals have access to the information they need to be able to treat patients in the most effective way.

Oral Answers to Questions

Debate between Jo Churchill and Alex Norris

Tuesday 13th July 2021 Commons Chamber

[Jo Churchill]

I go back to the answer I gave: we do not allow data to be used for commercial purposes. NHS Digital will not approve requests for data where the purpose is for marketing and so on and so forth. The hon. Member would not expect me to respond on behalf of another Department, but I reiterate that we are communicating and building trust. There will be a public information campaign. We will be working across the professions and across research to make sure that access is appropriate and proportionate. In the Health and Care Bill, we will be redoubling our efforts to make sure people have that confidence.

[Alex Norris (Nottingham North) (Lab/Co-op)]

At the previous health questions, we secured a commitment from the Minister to delay the implementation date for this data grab in order to properly communicate with the public. However, rather than a significant delay so there could be the public information campaign the Minister says she is so keen to have, on the basis set out by the BMA and the Royal College of GPs, what we have instead is a short pause. The Minister says she wants to listen and to build trust, so why on earth is this being snuck out during the summer recess? The reality is that the Government simply have not passed the test for informed consent. Will the Minister take this moment today to stop this process and commit to a proper engagement campaign, rather than running off during recess?

[Jo Churchill]

I really respect the hon. Gentleman, but nothing is being snuck out. We are not doing a data grab. I refer him to the answer I gave a few moments ago. It is important that we get this right. We have heard the concerns and will respond to them. We will take the appropriate amount of time—even if that means going beyond 1 September—to ensure that we have engaged properly.

Oral Answers to Questions

Debate between Jo Churchill and Alex Norris

Tuesday 8th June 2021 Commons Chamber

[Jo Churchill]

I pay tribute to all the cancer charities out there who have done sterling work during the pandemic. As I have said, GP services are open, and they are offering different forms of communication with patients. We are running the Help Us, Help You campaign so that people can come forward when they have symptoms. As my hon. Friend says, identifying cancers early to save lives is part of the long-term plan, but I would like to assure him that my latest data showed that in March 2021 we had the highest ever recorded number of GP referrals for cancer. GPs are working really hard, and if patients are worried about any symptoms, they need to come forward.

[Alex Norris (Nottingham North) (Lab/Co-op)]

For GPs and for the NHS more broadly, using data effectively is an important way to restore our health services. However, the current plans to take this data from GPs, assemble it in one place and sell it to unknown commercial interests for purposes unknown has no legitimacy whatsoever. There has been no public engagement and no explanation; this has simply been snuck out under the cover of darkness—[Interruption.] I will get there, Minister; do not worry. This is an NHS data grab. The news of the delay is welcome and I am glad that the hon. Lady has made that commitment, but within that, will she commit to ensuring that the 23 June opt-out date is also moved to 1 September and that there will be a full public consultation on whether people want their data used for these purposes?

[Jo Churchill]

I refer the hon. Gentleman to the answer I gave earlier to my hon. Friend the Member for High Peak (Robert Largan). We will be considering everything in the round. As I have said, I have spoken to many of the stakeholders involved and as we move forward we will be ensuring that we take all trusted individuals with us to build confidence in the system.

Oral Answers to Questions

Debate between Jo Churchill and Alex Norris

Tuesday 23rd February 2021 Commons Chamber

[Jo Churchill]

I thank the hon. Gentleman for his question. The latest official data for December, as I say, suggests that two-week wait GP urgent referrals were 7% higher than for the same month last year, 62-day GP urgent referrals were 6.7% higher, and urgent referrals for cancer were 151% higher than in April, showing the month we were most impacted. As I say, we are straining every sinew to make sure that cancer services not only recover but go on and are better to deliver more care for patients.

[Alex Norris (Nottingham North) (Lab/Co-op)]

Going into this pandemic, staff shortages were already causing increased waiting times for cancer treatment. Despite being short-handed, our wonderful NHS cancer staff have done a heroic job maintaining services while fighting this virus, but given the size of the backlog, cancer services will need to go above and beyond pre-pandemic levels for a significant period of time—straining every sinew, as the Minister says. They need extra resources to be able to do so. Next week’s Budget must contain these resources. Has the Minister asked for them?

[Jo Churchill]

Cancer has been prioritised with funding throughout the pandemic. It is, as I say, a key priority. Not only have we invested in radiotherapy equipment to the tune of some £325 million but there is a £160 million initiative to provide covid-friendly cancer treatments that are safer for people. We still have the same objective in the long-term plan to diagnose more cancers early, and appropriate funding, such as the billion pounds targeted at the NHS to drive down cancer backlogs and to ensure that people can access care, is part of that strategy.

Oral Answers to Questions

Debate between Jo Churchill and Alex Norris

Tuesday 12th January 2021 Commons Chamber

[Jo Churchill]

I can unreservedly say yes to that. The NHS is under huge pressure and there have been some instances where, for totally understandable and unavoidable reasons such as staff ICU capacity or the safety of patients themselves, treatment has been rescheduled. Any such decisions are always made as a last resort. However, we have changed the way we operate, making sure that we have covid-secure cancer hubs, consolidated surgery and centralised triage to prioritise those patients whose need is most urgent. We have utilised the independent sector, and will continue to do so, to increase capacity. These measures, and, as the hon. Member said, the tremendous efforts of our NHS cancer workforce and their teams, are helping to ensure that those who need treatment can continue without delay.

[Alex Norris (Nottingham North) (Lab/Co-op)]

Throughout the pandemic we have been calling for a cancer recovery plan, so we were glad to see one published in December, but disappointed that it ran only for a couple of months. Events have clearly overtaken us since that publication, and the unprecedented demand on our NHS risks further delays to treatment and to people entering the system for treatment. These plans must now go much, much further. Will the Minister make a commitment today to work with the sector and interested parliamentarians to develop the recovery plan into one that properly addresses the backlog and builds improved treatment pathways for the future?

[Jo Churchill]

The cancer services recovery plan was worked on by clinicians and stakeholders, including the charities, to make sure that we had a robust plan for addressing the challenges that have come about throughout the pandemic. The levels remain high for referral and treatment, despite other pressures on the NHS. I assure the hon. Gentleman that I regularly meet Cally Palmer and Professor Peter Johnson, who lead for the NHS in this area. We have made it absolutely clear, since the beginning of the pandemic, that the continuation of urgent cancer treatment is a priority, as is its restoration. We are doing what we can to ensure that swift treatment is there for everybody. I regularly meet all-party parliamentary groups—indeed, I am meeting one on Thursday of this week—so I can assure the hon. Gentleman on that front.

Medicines and Medical Devices Bill

Debate between Jo Churchill and Alex Norris

Report stage & 3rd reading & 3rd reading: House of Commons & Report stage: House of Commons
Tuesday 23rd June 2020 Commons Chamber

[Alex Norris (Nottingham North) (Lab/Co-op)]

It is a thrill for a Government Minister to move my amendments, although that might be giving me false hope. But I just wanted to put on record for colleagues that the purpose of amendment 21 is to make patient safety the uppermost priority.

[Jo Churchill]

I thank the hon. Gentleman for his intervention. We are in completely unusual times: I get to respond to his amendments before he has actually spoken to them himself, but we will crack on.

I recognise that the hon. Gentleman said at the time that he wished to return to these issues during the proceedings and I was expecting him to do so. We agree that patient outcomes and patient safety are matters that we would expect the House to consider very seriously.

Amendments 21, 22 and 23 all seek to establish a hierarchy of considerations applied by the Secretary of State or the appropriate authority when making regulations under the Bill, making safety the primary consideration. It is important to say at the outset that there is a consensus on both sides of the House on patient safety. It matters to us as individuals and as MPs representing our constituents, who rightly wish to know that their safety and their animals’ safety is of uppermost importance when we look to make regulatory change.

Oral Answers to Questions

Debate between Jo Churchill and Alex Norris

Tuesday 23rd June 2020 Commons Chamber

[Jo Churchill]

I would say that, as soon as people notice any signs that might worry them, they should seek help. We have worked at pace to ensure that services have been resumed and are able to deliver for patients. Ensuring both early diagnosis and that patients can access the treatment that they need swiftly is our key ambition. We know that, following the guidance that has been delivered, we are achieving that throughout the system. Covid-19 has upended all our lives, and some decisions have been made to ensure the safety of patients, but we are now firmly back on track and will ensure that patients get the care they need.

[Alex Norris (Nottingham North) (Lab/Co-op)]

Yesterday, the One Cancer Voice network of 25 charities published plans for restoring vital cancer services. I wrote to the Minister on 17 April with my own suggestion. Ideas included advanced radiotherapy, new models of chemotherapy, better cancer pathways and renewed screening and communication plans. This is not just about rebuilding what we had, but about making services better. If the Government are slow to do that, we face a cancer bubble that risks thousands of lives. Will the Minister commit to working with those charities and with me and other interested parliamentarians to form a cancer recovery plan to head off this looming crisis?

[Jo Churchill]

I assure the hon. Gentleman that, just as we have seen from working closely on the Medicines and Medical Devices Bill that is going through Parliament, there are lessons to be learned. There have been improvements in certain areas of radiotherapy in which it has been determined that fewer treatments actually mean a quicker and—I would not use the word “gentler”—an easier path for the patient. I would be happy to continue working both with him and with the cancer charities to ensure that we can improve that pathway for patients.

Medicines and Medical Devices Bill (Third sitting)

Debate between Jo Churchill and Alex Norris

Committee stage & Committee Debate: 3rd sitting: House of Commons
Wednesday 10th June 2020 Public Bill Committees

[Alex Norris (Nottingham North) (Lab/Co-op)]

I beg to move amendment 29, in clause 17, page 10, line 12, at end insert—

“(f) advertising it.”

This amendment allows the enforcement authority to prevent an individual who has been served a suspension note from advertising their product.

It is a pleasure to be back. Monday’s discussions were of a high quality and in a good spirit, which is what we need at this time, so I am glad to be here and back at it.

This is a short amendment: again, I want to talk about the issue rather than do anything else. Clause 17 sets the context and is mirrored in clause 18, to which I have tabled amendment 18. It sets out what the Secretary of State or the enforcement authority can do in relation to a faulty product, a medical device that is presumably dangerous or certainly not known to be safe. It includes a list of five things that can be prohibited under either a suspension notice or a safety notice. This prevents an individual from

“(a) supplying the medical device;

(b) offering to supply it;

(c) agreeing to supply it;

(d) exposing it for supply;

(e) possessing it for supply.”

I would add a sixth one—advertising it for supply. I flagged this up with the Minister the other day and will obviously be interested to hear her reply. I am conscious that she has the collective might of the legal brains of the whole Government. It could be that I have spotted a gap, or that I have not. That depends on whether advertising is covered by “offering to supply it” or “exposing it for supply”.

I want to talk about a particular phenomenon—the current way in which clickbait is used. For example, over the weekend, I saw an article that normally would be up my street. It said, “Jason Statham says he no longer needs to do the ‘Fast and Furious’ films”. I am a big fan of the “Fast and Furious” franchise, and that would grieve me enormously. I did not click on the article, because it was obviously nonsense, but I later saw an article about the very same thing. It mentioned Jason Statham and other people, and when you click on that type of thing, it takes you through to bitcoin. It basically said that he does not need to do films anymore, because he has made so much money on bitcoin and so can you. There is an argument to be had about cryptocurrencies, but the issue there is people being shown one thing that actually leads them to something else.

In the medical devices space, it is very easy to see equivalent things for people to click on. They will show someone with dramatic weight loss and then say, “You won’t believe how they did it.” In this case, there will be a picture of a medical device, and the idea is that someone says, “Wow! I’ve found a magical device. I can do the same. I can do it just like this celebrity.” Then they click through and it takes them to diet pills. I would argue that at no point there—there is no price; the article may not name or price the product, but just picture the product—have those responsible exposed it for supply, because it would be possible to argue that we literally cannot buy it, it is just a picture and certainly it has not been offered for supply.

Again, I am happy to take the lawyers’ guidance on this, and I hope that the Minister will help us with that. I just want to ascertain whether that gap—the thing that would legitimise a product, the demonstrating of it for another end—is one that we have to close.

[The Parliamentary Under-Secretary of State for Health and Social Care (Jo Churchill)]

I would also like to say what a pleasure it is to resume under your chairmanship, Mr Davies.

Amendment 29 seeks to amend clause 17 with regard to the suspension notices. I understand totally why hon. Members are looking to double-check where we are. The clause provides an enforcement authority with the power to serve a suspension notice on a person, where doing so is considered necessary to restrict the availability of a medical device in order to protect health and safety. It lists a number of prohibitions that may be imposed, and seeks to add a specific prohibition on advertising a medical device.

The Government recognise that the intention behind the amendment is to equip the enforcement agency with the ability to prohibit a recipient of a suspension notice from advertising a medical device where there is a need to protect health and safety. I assure hon. Members that the enforcement authority has the ability to do what the hon. Member for Nottingham North is asking and prohibit the advertising of a product already catered for in the clause. That is already in the Bill as it is currently drafted.

Hon. Members will note that prohibitions that may be impose include, in clause 17(2)(b), “offering to supply”, which encompasses advertising or an advertisement. Although I am grateful for the probe, I respectfully ask the hon. Gentleman to withdraw the amendment.

[Alex Norris]

I am content with that. I beg to ask leave to withdraw the amendment.

Amendment, by leave, withdrawn.

Clause 17 ordered to stand part of the Bill.

Clause 18

Safety notices

[Alex Norris]

This is exactly the point that I just made, so I will not labour it.

[Jo Churchill]

My explanation covered both points. Clause 18 provides an enforcement authority with the power to serve a safety notice on a person where doing so is considered necessary to restrict the availability of a medical device in order to protect health and safety. It provides the enforcement authority with discretion about the prohibitions that may be imposed. The amendment seeks to add a specific prohibition on advertising a medical device. We recognise that the purpose behind it is to equip the enforcement agency. I would like to reassure hon. Members that that sits in the Bill. On that basis, I commend the clause to the Committee.

[Alex Norris]

I beg to ask leave to withdraw the amendment.

Amendment, by leave, withdrawn.

Clause 18 ordered to stand part of the Bill.

Clauses 19 to 23 ordered to stand part of the Bill.

Clause 24

Defence of due diligence

[Jo Churchill]

I beg to move amendment 2, in clause 24, page 13, line 26, leave out ‘case’ and insert

‘proceedings for such an offence’.

This amendment, and amendments 3, 4, 5, 6 and 7, amend certain provisions to ensure they operate effectively in relation to Scotland.

[Jo Churchill]

Amendments 2 to 7 relate to the clauses about defences available for offences under clause 23 and regulation 60A to be inserted into the Medical Devices Regulations 2002 by schedule 2.

Clause 23 will provide that it is an offence to fail to comply with a compliance, suspension, safety or information notice. Schedule 2 makes it an offence to fail to comply with certain provisions of the Medical Devices Regulations 2002. Further, the Bill provides that a defence of due diligence will be available with respect to each of those offences. That means that a person charged with an offence under either clause 23 or regulation 60A will be able to argue that they have not committed an offence because they took reasonable steps to avoid doing so.

The provisions that make those defences available are in clause 24 and schedule 2. It is those provisions that we seek to amend. Amendments 2 to 4 are to clause 24 and amendments 5 to 7 are to schedule 2.

[Alex Norris]

I do not have an awful lot to say. I am comfortable with the amendments, and I know that the hon. Member for Central Ayrshire is, too, as she put her name to them. I always find it reassuring when there are Government amendments during Committee, as it means they are still reading the Bill, which is a good thing. So, yes, we are content.

[Jo Churchill]

On that basis I commend the amendment to the Committee.

Amendment 2 agreed to.

Amendments made: 3, in clause 24, page 13, line 32, after ‘hearing’ insert ‘of the proceedings’.

See the explanatory statement for Amendment 2.

Amendment 4, in clause 24, page 14, line 2, at the end insert ‘, and

(b) the reference in subsection (3) to “the hearing of the proceedings” is to be read as a reference to “the trial diet”.’—(Jo Churchill.)

See the explanatory statement for Amendment 2.

Clause 24 , as amended, ordered to stand part of the Bill.

Clauses 25 and 26 ordered to stand part of the Bill.

Schedule 1

Medical devices: civil sanctions

[Alex Norris]

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.

--- Later in debate ---

[Jo Churchill]

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.

[Alex Norris]

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.

--- Later in debate ---

[Jo Churchill]

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.

[Alex Norris]

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.

Clause 30

Recall of medical device by enforcement authority

[Alex Norris]

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.

[Jo Churchill]

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.

--- Later in debate ---

[Alex Norris]

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.

[Jo Churchill]

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.

[Alex Norris]

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.

Schedule 2

Offence of breaching provisions in the Medical Devices Regulations 2002

Amendments made: 5, in schedule 2, page 34, line 8, leave out “case” and insert

“proceedings for such an offence”.

See the explanatory statement for Amendment 2.

Amendment 6, in schedule 2, page 34, line 14, after “hearing” insert “of the proceedings”.

See the explanatory statement for Amendment 2.

Amendment 7, in schedule 2, page 34, line 28, at the end insert “and

(b) the reference in paragraph (3) to ‘the hearing of the proceedings’ is to be read as a reference to ‘the trial diet’.”—(Jo Churchill.)

See the explanatory statement for Amendment 2.

Schedule 2, as amended, agreed to.

Clauses 37 to 42 ordered to stand part of the Bill.

Clause 43

Commencement

--- Later in debate ---

[Jo Churchill]

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.

[Alex Norris]

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.

New Clause 6

Registration of Medical Devices

‘(1) The Secretary of State shall by regulations establish a UK Registry of all devices implanted into patients on a long-term basis.

(2) The identifier details of any devices implanted into patients, on a long-term or permanent basis, must be registered.

(3) The information registered must include—

(a) The unique identifier of the patient into whom the device is implanted;

(b) The Clinician responsible for the procedure;

(c) The hospital or clinic in which the procedure is performed;

(d) A standardised description of the device;

(e) The unique identifier code of the device implanted.

(4) Efforts must be made for this unique identifier data to be gathered by barcode reader as in the trial of ‘Scan for Safety’.

(5) This Registry shall require linkage from all currently established speciality device registries, in current operation, to avoid duplication of registration.

(6) Devices without any form of specialist registry currently available shall be registered in this UK Registry.

(7) Governance structures regarding the management and access to registry data shall be established after consultation with stakeholders including but not limited to—

(a) the appropriate authorities as defined in Section 1 (4);

(b) all UK based Royal Colleges of Surgery or Radiology and any others representing clinicians involved in such procedures;

(c) Managers of current speciality device registries;

(d) the Medicines and Healthcare products Regulatory Agency;

(e) the Directors of each of the four UK based National Health Services;

(f) healthcare quality improvement bodies from each of the four UK based National Health Services;

(g) representatives of the Healthcare device manufacturing sector;

(h) academics with expertise in the design and maintenance of registries;

(i) additional stakeholders as identified during the development and maintenance of such a registry.

(8) Patient information from such a registry shall be provided to clinicians if there is concern regarding the management of or complications from any implanted device to allow closer monitoring or removal if so warranted.”

The aim of such a UK register is to ensure earlier recognition of complications from implantable devices and allow the easy identification and urgent recall of affected patients should such a concern be recognised.

Brought up, and read the First time.

--- Later in debate ---

[Jo Churchill]

I thank the hon. Member for his intervention. We are not talking about cosmetic devices here, but I very much take his point. If it involves implantation, it is worth talking about, in the round, during consultation; however, many of the cosmetic issues he refers to may be temporary—if, for example, a device is inserted and then taken away. The legislation is about implanted devices. Again, it is something that we would talk about and ensure that we had consulted on, but for the purposes of the Bill, we are specifically looking at medical devices, and the definition of them.

As I said, I welcome discussion with those interested in these matters, particularly as we look forward to Baroness Cumberlege’s review, which is coming very shortly. On that basis, I ask the hon. Members for Central Ayrshire and for Nottingham North to withdraw the motion, but I will commit to following up with arrangements to have those discussions in a timely fashion.

[Alex Norris]

We are in vicious agreement on this point. The new clause provides a possible destination, but through conversations and the expertise of colleagues, we may end up going in a similar but different direction. It is right that we start with the goal in mind and then work to where we get to. I think there is real potential in this area. As the Minister said, my hon. Friend the Member for Warwick and Leamington made a very important point, because the principles are very similar. There may be scope to include the areas that he mentioned also.

I thank the Clerks and you, Chair, for your support in this process. We have had some very good discussions, and laid the groundwork to do even more. I beg to ask leave to withdraw the motion.

Clause, by leave, withdrawn.

Question proposed, That the Chair do report the Bill, as amended, to the House.

Medicines and Medical Devices Bill (Second sitting)

Debate between Jo Churchill and Alex Norris

Committee stage & Committee Debate: 2nd sitting: House of Commons
Monday 8th June 2020 Public Bill Committees

[Alex Norris (Nottingham North) (Lab/Co-op)]

I beg to move amendment 11, in clause 5, page 3, line 39, at end insert—

“(1A) The Secretary of State must publish a fees regime within three months of the date on which this Act receives Royal Assent.”

This amendment requires the Secretary of State to publish their proposed list of fees in respect of human medicines.

It is a pleasure to resume serving under your chairship, Mr Davies. We move to the rapid-fire round, which will almost inevitably lead to me at some point giving a speech to a previous or future amendment—I am sure colleagues will be gentle and generous with me when I do so. This short probing amendment relates to fees in the discharge of the human medicines sphere. The principle is that, in the exercising of clause 1(1) it is conceivable that the Secretary of State, the Department and the Government in general will incur costs, so clause 5(1)(a) allows for provision to be made to exercise a function to charge for that, which makes perfect sense.

The Medicines and Healthcare Products Regulatory Agency has previously worked on a cost recovery basis, which makes a lot of sense, but the amendment is designed to test whether it would not be better to have a comprehensive, clear and consistent fees regime. The MHRA and the Government in general have a tough job against a potential occasional big foe in the pharmaceutical industry—or big partner to work with, at least. I assume, but would like to hear from the Minister on the record, that the expectation is that there will be equal pay for an equal job, so a bigger firm that is better equipped to lobby would not end up paying smaller fees than a smaller firm, simply because that firm was better at arguing or making its case. Is cost recovery still in general the preferred option? If so, might it not strengthen the Secretary of State’s hand if that were put in the Bill?

[The Parliamentary Under-Secretary of State for Health and Social Care (Jo Churchill)]

It is a pleasure to be back this afternoon. I am grateful to the hon. Member for raising the important issue of fees in his amendment, and I recognise the intent of that probe. I am sure we agree that it is important that all new fees for human medicines are set in an open, fair and transparent way. I want to reassure him that what the amendment seeks to achieve is already standard practice and is happening. I will rapidly set out the steps already in place to ensure the fairness, openness and transparency that underpin the fees regime for human medicines.

The current fees have been subject to consultation and are provided for in legislation. They are published online and publicly available at gov.uk. All of that is supported by a formal and standardised process for reviewing existing fees and for the introduction of new fees for human medicines. The standard approach for setting statutory fees is full cost recovery, as the hon. Member alluded to, which means that fees must be set at a cost that reflects the activity involved in carrying out such a specific regulatory function.

The full cost recovery approach is set out by Her Majesty’s Treasury in its “Managing public money” guidance, which ensures that the Government neither profit at the expense of consumers nor make a loss for taxpayers to subsidise. Therefore, fees cannot be set arbitrarily, and the fee must reflect the cost of the regulatory work carried out. I think that goes some way to addressing the hon. Member’s probe on size.

Existing fees for human medicines are kept under active review by the Medicines and Healthcare Products Regulatory Agency. The amendment is specifically concerned with new fees that might be introduced under the powers in the Bill. It is already a requirement that new fee proposals are subject to consultation, and that duty continues for fee proposals under the Bill. We will publish impact assessments with the new proposals, which will set out the effects of any changes to fees in the UK on Government, industry or the general public. Her Majesty’s Treasury will be engaged throughout the fee proposal process, and any proposals for new fees will be subject to approval from HMT. It is also standard practice for the MHRA to engage with industry and trade bodies through regular meetings to discuss any new fee proposals that might be coming up.

I trust my explanation has reassured the hon. Member for Nottingham North that the requirements are and will continue to be in place so that fees for human medicines are fair, open and transparent. I therefore ask him to withdraw his amendment.

[Alex Norris]

I beg to ask leave to withdraw the amendment.

Amendment, by leave, withdrawn.

Question proposed, That the clause stand part of the Bill.

[Jo Churchill]

Clause 5 provides that changes can be made to the law relating to human medicines with respect to fees, criminal offences and the powers of inspectors. Regulations made under clause 1(1) allow us to change the UK’s regulatory framework for human medicines as science, technology and clinical needs evolve. When the regulatory regime is updated, it is important that the regulator—in this case, the MHRA—can continue to regulate effectively and maintain compliance with all elements of the regime. To ensure this, it may be necessary to make provision about charging fees, creating criminal offences, and updating inspectors’ powers when making changes to the regulatory regime. Regulations made under clause 1 and relying on clause 5 will enable us to do this. We will consult before making any of those changes.

Clause 5(1)(a) allows us to make provision about the charging of fees. The regulator is self-funding for the purposes of medicines regulation. This work includes assessment for marketing authorisations and clinical trials of human medicines and inspections. It is funded by fees payable by the pharmaceutical industry in relation to the services and regulatory work provided. The current fees are set out in the Medicines (Products for Human Use) (Fees) Regulations 2016 and vary according to the specific areas of work.

It is important that existing fees can be amended, or fees can be introduced in connection with the MHRA exercising functions conferred by human medicines provisions as they evolve. Any proposal to introduce new fees is subject to consultation. The impacts on industry, Government and the general public would be evaluated through the usual process of an impact assessment. As part of its regulation of human medicines, the MHRA is able to impose criminal sanctions for certain regulatory breaches. As the regulatory regime is updated in future, it is important that we have the ability to also update the corresponding list of offences against which the MHRA can take action.

Clause 5(1)(b) allows us to create criminal offences with a maximum of two years’ imprisonment to cover updated requirements to supplement the evolution of the regulatory regime. MHRA inspectors play a critical role in ensuring compliance so that medicines are safe and effective for patients, and so that manufacture, research and surveillance processes are carried out to recognised standards. Inspectors already have all the powers to enter premises at any reasonable time to determine whether there has been a contravention of medicines regulations. For example, they may take samples or copies of documents if it is suspected that an offence has been committed. We have published two illustrative statutory instruments to demonstrate how provision can be made in regulations, relying on clause 5(1)(b) in combination with subsections of clause 2, to create a criminal offence for failing to comply with the new requirement set out in the regulations.

Clause 5(1)(c) allows us to update the relevant powers of entry and other powers of inspectors to align with new elements of the regulatory regime as it evolves. I commend the clause to the Committee.

Question put and agreed to.

Clause 5 accordingly ordered to stand part of the Bill.

Clauses 6 and 7 ordered to stand part of the Bill.

Clause 8

Power to make regulations about veterinary medicines

[Alex Norris]

I beg to move amendment 12, in clause 8, page 5, line 17, at end insert “services.”

This amendment broadens the range of issues that the Secretary of State must consider to include access to the relevant services to dispense veterinary medicines.

I did not want us to miss out the veterinary medicines part of the Bill, because it is important. We are a nation of animal lovers and we are keen that the laws we make are sympathetic to all living beings. The issue was also raised on Second Reading, because it has an impact on the food chain, so we must be mindful of setting an effective regime, as I know the Government are keen to do.

The amendment is simple. Again, I hope that it is redundant, but I want to test that with the Minister. There is a clear read-across between parts 1 and 2 of the Bill, which is that the powers being reserved for human medicines are largely the same as those being reserved for veterinary medicines. The word that I would like to be added in clause 8(2)(b) after

“the availability of veterinary medicines”

is “services”, because one way in which veterinary medicine differs from human medicine is that we do not have a universal service, so that access point is an important consideration for the Secretary of State.

I have not drafted the amendment elegantly enough. When we get to amendment 13, we will discuss something called the cascade, which was new to me until a couple of weeks ago. The principle of the cascade is that, whereas in human medicine we have expectations that certain medicines will be used to treat certain conditions and doctors do not have a massive amount of latitude to go outside that, in veterinary medicine, if such a thing is not available, the veterinarian can fall down the chain and use a different painkiller—perhaps a human painkiller. That is obviously important.

I wonder—and this is what I am testing with the amendment—whether that creates a possible inequity. If there is better access to veterinary medicines or supplies in certain communities, perhaps rural versus urban, that could create not a two-tier service, but a slightly different service from the one we want. It would therefore be useful for the Secretary of State to have regard to the services, as well as the physical ability to get pills, potions or whatever. That is all the amendment seeks to test and I am interested to hear what the Minister says.

[Jo Churchill]

I am grateful to the hon. Gentleman for raising the important issue of the availability of veterinary medicines. The intention is clear: to ensure continued access to veterinary medicine equitably for all the nations’ animals.

The Bill provides the power to amend or supplement the Veterinary Medicines Regulations 2013, which cover the full supply chain of veterinary medicines from development to supply. The requirement for the appropriate authority to have regard to the availability of veterinary medicines, as set out in clause 8, therefore ensures that when making regulations under the clause, the availability of veterinary medicines throughout the supply chain is considered.

Although the intended effect of amendment 12 is to expand on those factors, the actual effect would be to inadvertently narrow their scope to focus only on the availability of veterinary medicines services, such as the dispensing of veterinary medicines, rather than the availability of veterinary medicines more widely and more equitably. Veterinary medicines services alone are not the determining factor in the availability of veterinary medicines.

Clause 8, as drafted, ensures that the appropriate authority must have regard to the availability of veterinary medicines throughout the supply chain, so that the rural versus urban comparison the hon. Gentleman used would not be a comparator and medicines would be equally available. I therefore ask him to withdraw the amendment.

--- Later in debate ---

[Jo Churchill]

Clause 8 provides the power to amend or supplement the Veterinary Medicines Regulations 2013. Subsection (1) gives the appropriate authority a power, by regulation, to make amending or supplementing provision within the scope of the matters set out in clauses 9 and 10. The appropriate authority may use this power only to build on—in other words, amend and supplement —the current regulatory framework for veterinary medicines. Clauses 9 and 10 set out an exhaustive list of matters about which regulations could be made on veterinary medicines. An in-depth explanation of those clauses will be shared with the Committee throughout the course of these sittings.

Subsection (2) sets out three matters to which the appropriate authority must have regard when making regulations under clause 8: the safety of veterinary medicines in relation to animals, humans—including consumers of produce from treated animals—and the environment; the availability of veterinary medicines; and the attractiveness of the relevant part of the UK to industry for developing or supplying veterinary medicines. Subsection (3) explains that

“the relevant part of the UK”

depends on where the UK regulations will apply. The environmental safety aspects could include considering the potential impact of veterinary medicines on terrestrial and aquatic eco-systems and their flora and fauna—for example, the environment can also be affected by slurry application and excretion by grazing animals.

Subsection (4) sets out the appropriate authority for the purposes of regulations made under clause 8(1). The appropriate authority able to exercise this delegated power for England, Scotland and Wales is the Secretary of State. For Northern Ireland, the appropriate authority is either the Department of Agriculture, Environment and Rural Affairs in Northern Ireland acting alone, or the Secretary of State and the Northern Ireland Office acting jointly. This means that the powers can be exercised on their own, as well as jointly on a UK-wide basis.

[Alex Norris]

I will speak briefly to new clause 5. I was happy to withdraw amendment 12, but the principle was about trying to ensure that there is equitable access to services, because that is how veterinary medicine differs from human medicine. New clause 5 follows that principle through to its logical conclusion. This may have been done; I have been looking but have been unable to find it. I am sure the Secretary of State for Health and Social Care has seen hundreds and hundreds of health equity audits: how are things in Nottingham different from in Shipley, and how does that impact on health outcomes? For all the reasons I mentioned at the beginning, I wonder whether it is the same in the veterinary industry and whether there are regional, rural-urban and north-south disparities that mean access is different. The potential fall-outs from that are worth considering.

The new clause is intended to probe and to see whether the Government have that sort of information. If so, maybe they could let us see it—either shortly or during the rest of the proceedings on the Bill.

[Jo Churchill]

I am grateful to the hon. Member for raising the matter of capacity within the veterinary industry as it stands, in order to provide equity throughout. I recognise that he has given us examples of north-south disparities and so on, and I recognise the good intentions behind the new clause and his desire to ensure that the veterinary industry is working to full capacity and in unanimity across the piece. We agree that vets are an essential part of our animals’ lives and a key component of the UK system of protecting food safety, providing international assurance and upholding standards in welfare.

The Government are already working with various veterinary sector stakeholders, including the Royal College of Veterinary Surgeons and the British Veterinary Association, to understand the UK’s veterinary resourcing needs and ensure that there are adequate numbers of vets in the short and long term. We are working with a variety of initiatives to build a sustainable, diverse and modernised UK veterinary infrastructure to ensure that we maintain access to the right people, with the right skills and knowledge, supporting food safety and animal health and welfare, as well as trade. DEFRA has successfully secured a place for the veterinary profession on the Home Office shortage occupation list, and we are grateful to the Royal College of Veterinary Surgeons and British Veterinary Association for their work on the issue. It makes it easier for veterinary employers to gain visas.

To turn to specifics, as Members will know, the Bill introduces a statutory duty to consult before making changes to the Veterinary Medicines Regulations 2013. That consultation duty, in clause 40, requires that the appropriate authority must, before making regulations, consult those it considers appropriate. That is the most suitable route for ensuring that all those in the veterinary industry who need to be consulted are included. We are working across Government and with the veterinary profession to help to develop a flexible, skilled workforce that meets UK needs and irons out disparity of service. I want to assure the hon. Member for Nottingham North that it is a key priority to enable an innovative, productive and competitive veterinary medicine sector that invests in its people and skills. To help to achieve that, we shall ensure that there is access to sufficient appropriately skilled labour to drive continued industry growth and productivity, while ensuring that the environment for humans and animals is safe.

[Alex Norris]

I appreciate that answer, and the detail in it. I guess the only way in which I would supplement my questions is to ask that, once the fruits of the work with the relevant stakeholder bodies are available, they should be shared. That would be of great interest to Members on both sides of the House.

Question put and agreed to.

Clause 8 accordingly ordered to stand part of the Bill.

Clause 9

Manufacture, marketing, supply and field trials

[Alex Norris]

I beg to move amendment 13, in clause 9, page 6, line 11, at end insert—

‘(1A) The Secretary of State must by regulations make provision about the use of the Cascade.”

This amendment gives the Secretary of State the responsibility to make provisions regarding the Cascade, a process where veterinarians can dispense different medicines to animals, such as human medicines, should appropriate conventional animal medicines not be available.

I have buried the lede, obviously, by talking about the cascade already; but I am interested to hear a little more detail about the Minister’s vision for the cascade. It is obviously an entrenched principle across the European Union, and an industry standard. It has a significant impact on the lives of animals and, by proxy, humans as well. It seems to me an important principle, but it is not on the face of the Bill. The Government would, on Royal Assent, have the immediate ability to diverge away from the cascade quite quickly, but I wonder about the safety of that and whether that is in the Government’s plans. It was not in the impact assessment, so I am keen to scope out whether we expect the cascade to continue to be a principle in this country, and, if so, whether we expect our cascade to reflect closely the one used by our EU counterparts.

[Jo Churchill]

A clause or so back, the hon. Gentleman gave us a snapshot of what a cascade is, and I do not think I could put it better. My notes say that veterinary surgeons can prescribe gabapentin, a human medicine, to treat chronic pain in animals, particularly if it is of a neuropathic origin, as there is no equivalent in veterinary medicine. As the hon. Gentleman said, the cascade is about making sure that there is something in the veterinarian’s bag to enable appropriate care to be given to animals.

I am grateful to the hon. Member for Nottingham North and to the hon. Member for Central Ayrshire, who I think also signed the amendment, for raising the important issue of the prescribing cascade. However, not only is the amendment not necessary, but I argue that it could be unhelpful in certain instances. I recognise the desire to ensure that the use of prescribing cascades is regulated. The cascade enables veterinary surgeons to have access to a wider range of medicines to treat animals under their care and, in particular, to prevent the unacceptable suffering that might occur if they could not prescribe those alternatives.

The provisions with regard to the cascade are set out in schedule 4 to the Veterinary Medicines Regulations 2013 and the Bill already confers discretionary powers that would allow the appropriate authority to decide, following consultation, whether and how cascade requirements in the existing regulations might be amended in the future. That is provided for in clause 9(1), for the professionals to decide, arguably.

The amendment as drafted would appear to obligate the Secretary of State to update the regulations with regard to the cascade, as opposed to making those changes when it is appropriate to do so, and evaluate the cascade above other important aspects of the veterinary medicines regulatory framework. Although the cascade is important, it is our position that the regulations should be updated when it is clear and necessary to do so, rather than operating under a compulsion to do so for any one element, as putting it in the Bill might lead to. In that light, I ask the hon. Gentleman to withdraw it.

[Alex Norris]

I am happy to withdraw the amendment on that basis. The point of putting it in was to shoehorn the subject into the conversation, which was obviously effective. I did not hear from the Minister whether she felt that we are likely to continue to reflect the EU arrangements on that. Given that it is novel and specific to this area of medicine, and given that it is not risky, but diverges from what we consider basic medical practice in humans, it is of interest to people.

Perhaps now is not the moment to hear about the Government’s plans to reflect, or not, the judgments made by EU colleagues in future, but I hope that, over time, we can continue to have that conversation because I think there is public interest in that. I beg to ask leave to withdraw the amendment.

Amendment, by leave, withdrawn.

Question proposed, That the clause stand part of the Bill.

[Jo Churchill]

On amendment 13, I will write to DEFRA to seek clarification for the hon. Gentleman if that would be helpful. As we move through the Bill in the spirit of co-operation, I am more than happy to continue the conversation.

Clause 9(1) provides that amendments may be made to the Veterinary Medicines Regulations 2013 about the manufacture, marketing, supply and field trials of veterinary medicines. The Committee will note that in large part, clause 9(1) makes very similar provision to clause 2(1). I will take each subsection of clause 9(1) in turn.

Subsection (1)(a) sets out that the regulations made under the power in clause 8(1) may make provision about authorisations to manufacture veterinary medicines. The subsection means that it will be possible to update the rules around manufacturing authorisations—for example, to reflect the latest scientific advances in manufacturing and to address the manufacture of novel and innovative veterinary medicines. The subsection is therefore needed to future-proof the regulatory regime.

Subsection (1)(b) allows provision to be made about authorisations to import veterinary medicines, which is needed to continue to secure supply chains for those medicines entering the UK. By updating our existing regulatory framework, we can maximise the availability of veterinary medicines, while taking care that our approach does not place an additional burden on those who import medicines. Such a change can benefit animal owners, as it can lead to quicker access to veterinary medicines, a point that my hon. Friend the Member for Penrith and The Border brought up on Second Reading. We could use the subsection to allow additional professions, for example veterinary nurses, to import certain types of veterinary medicines with appropriate controls.

Subsection (1)(c) allows for provision to be made about authorisations to distribute veterinary medicines by way of wholesale dealing, which would ensure that we can provide further assurance on the quality and security of the full distribution chain for veterinary medicines. We could, for example, amend the application process for a wholesale dealer’s authorisation, supplement the requirements that must be met by the holder of such an authorisation, or amend the exceptions to the requirements for an authorisation.

The subsection could also be used to change the requirements for a wholesale dealer’s authorisation to cover new and novel products that may have new or additional storage and distribution requirements. That would maintain the quality and security of the distribution chain for such veterinary medicines and ensure that they are stored appropriately and safely throughout.

Subsection (1)(d) allows for provision to be made about marketing authorisations for veterinary medicines. This would help to ensure that the UK remains an attractive place for the pharmaceutical industry to bring to market both new and established medicines, and that UK animal owners do not have to wait for new, innovative or generic veterinary medicines. As an example, regulations could offer statutory rewards or incentives for certain types of applications for marketing authorisation.

--- Later in debate ---

[Alex Norris]

I beg to move amendment 14, in clause 10, page 6, line 35, at end insert—

‘(1A) The Secretary of State must publish a fees regime within three months of the date on which this Act receives Royal Assent.”

This amendment requires the Secretary of State to publish their proposed list of fees in respect of veterinary medicines.

This amendment is substantially the same as amendment 11, but it relates to veterinary medicines rather than to human medicines. So, assuming that the answer will be pretty much the same as for amendment 11, I do not really want to labour the point.

[Jo Churchill]

The short answer is probably yes, but I will just give the hon. Gentleman half a page of explanation.

I recognise that, as before with amendment 10, amendment 11 would ensure transparency, in essence, on fees that stakeholders may have to pay with regard to veterinary medicines, such as fees for marketing, manufacturing and distribution. The fees relating to veterinary medicines are set out in schedule 7 to the Veterinary Medicines Regulations 2013, and the power in the Bill is to amend the fees where necessary, rather than to create anything new. Indeed, it is unlikely that any new or amended fees would be introduced within three months following Royal Assent. The fees are already published online and are publicly available on the gov.uk website, as I mentioned earlier.

Therefore, the amendment would create an obligation for the Secretary of State simply to republish the existing fee regime, which is already publicly available; hence the continuity element. Any proposal to amend fees or to introduce new fees would be subject to consultation. In addition, potential impacts on businesses or organisations based in the UK would be evaluated through an impact assessment, which would also be made publicly available during the consultation process.

In light of that explanation, I cordially ask the hon. Gentleman to withdraw his amendment.

[Alex Norris]

I beg to ask leave to withdraw the amendment.

Amendment, by leave, withdrawn.

Question proposed, That the clause stand part of the Bill.

[Jo Churchill]

Clause 10 provides that regulations made under clause 8(1) may make provision about charging fees, criminal offences and powers of inspectors. It enables the recovery of costs incurred in the administration of improvement or seizure notices under the Veterinary Medicines Regulations 2013.

We need to ensure that the regulator—the Veterinary Medicines Directorate, which I will now call VMD for ease—can continue to effectively regulate and confirm compliance with new or updated elements of the 2013 regulations. Therefore, it may be necessary to make appropriate changes to fees, offences and inspectors’ powers before making any such change; as I have constantly said, consultation will take place if that is the case.

The VMD is required to recover the costs of the regulatory services that it provides from fees and charges. It is important that existing fees can be amended or that fees can be introduced to meet the cost of functions exercised by the VMD. An essential part of protecting animal, human and environmental safety is ensuring compliance with the Veterinary Medicines Regulations 2013. The existing regime imposes criminal sanctions for breaches of the regulatory framework. This clause would allow for making the breach of requirements or prohibitions introduced under clause 8(1) a criminal offence, punishable by imprisonment of up to two years.

VMD inspectors play a critical role in ensuring compliance with the 2013 regulations, helping to ensure that medicines are safe and effective for animals by monitoring their manufacture and supply. Inspectors already have powers to enter premises at a reasonable time to ensure compliance with the 2013 regulations. Clause 10 would allow for the extension of existing powers of entry and inspection to new prohibitions and requirements introduced by regulations made under the Bill.

Subsection (2) provides that regulations made under clause 8(1) may not confer a power of entry to premises used wholly or mainly as a private dwelling, unless those premises or any part of them are approved, registered or authorised for the sale of veterinary medicines under the 2013 regulations.

I commend clause 10 to the Committee.

Question put and agreed to.

Clause 10 accordingly ordered to stand part of the Bill.

Clause 11 ordered to stand part of the Bill.

Clause 12

Power to make regulations about medical devices

[Alex Norris]

I beg to move amendment 15, in clause 12, page 7, line 27, at end insert—

“(d) the environmental sustainability of medical devices.”

This amendment obliges the Secretary of State to pay regard to the environmental impact of medical devices.

This is the “climate in all policies” amendment. We are in the middle of a global pandemic—an extraordinary time that we will all remember for the rest of our lives —but we are also in the middle of a climate emergency. Obviously, that was uppermost in all our thoughts a few months ago, and it must not fall down the order of priorities, because a similar existential threat exists as existed six months ago and it behoves us to act on it.

Amendment 15 is the first one relating to medical devices. To the principle that applies throughout the Bill of safety, availability and attractiveness, I think it would be suitable to add environmental sustainability, given that the types of materials used to create these devices could be finite resources. There could be opportunities for things to be reusable where they might at the moment be single use. I thought it important to probe this to see what the Government are doing, and could be doing, to ensure a medical devices market that promotes sustainability where that is responsible.

After tabling the amendment, I had a couple of emails from people making very fair points about things that could not be reusable. Of course, that applies to very many things in medicine; it is a very basic principle. I am very mindful of that. It is why the explanatory statement says “pay regard”. However, I think that the two things are compatible. There will be contexts where things that are currently single use do not have to be single use. I think that we should be seeking to promote that. There will be contexts where the market and the industry should be under pressure not to use finite resources, but to use all the considerable innovation to find other solutions. I feel that if Governments do not drive that in shaping the market, nobody else will. There should be pressure for, or at least interest in, buying British, for a variety of reasons. As well as being good for jobs and our local economies, that would be very good for reducing travel miles and therefore for sustainability. We have to decarbonise every industry we possibly can, so that applies to this industry also.

This is a basic principle that I seek in every policy—even though it might be a bit boring to hear me go on about it. We have to say, “But what about the climate? What about climate change?”. I think that this is the point in the Bill at which to do that. I would be interested to hear the Minister’s views on it, but also to hear what the vision is for shaping this market so that it is as sustainable as it can be.

--- Later in debate ---

[Alex Norris]

I thank my hon. Friend for that intervention. It is important to seek quality and build to last, and to be sure that the products that enter the market are the best possible products in the round—not just those that have the best price on the box. There are other considerations of which we have to be mindful, whether they be patient safety, the long-term experiences that my hon. Friend has referenced or environmental sustainability.

[Jo Churchill]

I do not think anybody in the room is unmindful of the issues of environmental impact and durability, but the hon. Gentleman’s point is well made. He alluded to Baroness Cumberlege’s report, which will be out on 8 July. One of the challenges is that when something is implanted in the body, it is often there for a long period of time, and we would not want it to not be durable. That is always a consideration because, for example, we would not want something biodegradable sitting in a moist, wet environment—that product is not going to be doing its job in the long term.

I will address amendment 15, which relates to the requirement on the Secretary of State to have regard to certain factors when making regulations for medical devices. Clause 12(2) sets out those factors as

“(a) the safety of medical devices;

(b) the availability of medical devices;

(c) the attractiveness of the United Kingdom as a place in which to develop or supply medical devices.”

As I understand it, amendment 15 would oblige the Secretary of State to have regard to

“the environmental sustainability of medical devices”

as part of the assurances contained in clause 12(2).

I assure all hon. Members that the Government are fully cognisant of the need to ensure the ongoing sustainability of the environment, and have made major commitments not only on the broader issue of climate change, but to make sure that we are mindful of the reusability or sustainability of the things we use. All of this has to bring us back to the points that were made this morning about the need to be mindful of patient safety and so on. My understanding is that the intent of the amendment relates to the safe and environmentally friendly production of devices, which could include the transportation and sale of those devices, their import, and—where achievable—the reuse of devices after reprocessing. The hon. Member for Nottingham North has mentioned people getting in contact with him to say, “You’re not having my hip after I’ve used it,” but there are cases in which reuse would be appropriate, and we should be mindful of those.

The Bill is designed to support the safety of patients by maintaining a robust framework for the regulation of medicines and medical devices. The medical device regulations that clause 12 seeks to enable focus principally on the standards of pre-market and post-market assessment, as well as the vigilance required when placing devices on the UK market, so that UK patients feel safe about the products they can access. Amendment 15 would require consideration of facts beyond the regulator’s purview and introduce an added burden on the development of regulations, particularly when changes might be needed expediently to address issues of patient safety.

I totally understand the hon. Gentleman’s intention to put these issues at the forefront of our minds. However, I say gently that legislation to protect the environment, such as the Environmental Permitting (England and Wales) Regulations 2016, already exists and runs throughout the statute book, so checks and balances are in place. It is appropriate that manufacturers, suppliers and users of medical devices continue to have regard to the legislation specific to their circumstances, including the appropriate existing regulations that achieve the hon. Gentleman’s aim. I therefore ask him to withdraw the amendment. If the Opposition have points to press—with specific items, for example—they should write to me directly.

[Alex Norris]

I feel that I have made my point. I also discussed veterinary medicine and, with a Whip in the room, it might be misinterpreted that I am making a bid to be a shadow DEFRA Minister—I would not want that to be the sense that the Committee got. I beg to ask leave to withdraw the amendment.

Amendment, by leave, withdrawn.

Question proposed, That the clause stand part of the Bill.

[Jo Churchill]

Clause 12 provides the power to make changes to the Medical Device Regulations 2002, which regulate medical devices in the UK. Those regulations provide for the assessment of requirements and standards that must be met to place medical devices on the UK market, including in relation to packaging, labelling and user instructions, and for the requirements on manufacturers to conduct post-market surveillance of devices.

The first subsection of the clause is a delegated power allowing the Secretary of State to make amending or supplementing provisions to the Medical Devices Regulations. The exercise of that power is limited to making provisions about matters specified in clauses 13 to 15. Those clauses provide an explicit and exhaustive list of topics and give more detail on how the regulation-making power may be exercised. The Committee will, I am sure, hear in-depth explanations of those clauses during our consideration of them.

Subsection (2) explains that the Secretary of State must have regard to three factors when making provisions under subsection (1): the safety of medical devices; the availability of medical devices; and the attractiveness of the UK as a place in which to develop or supply medical devices. Those three factors must be taken into account, and they have been included to provide reassurance that future provisions are made with the best intentions for the safety of people and patients in the UK, as well as the continued development of our life sciences sector.

[Jo Churchill]

I will not bluff but, off the top of my head, I think that the MHRA would look at medical devices, as it does medicines—I was looking to where my box of officials would normally be. I am fairly sure that the MHRA pays regard to devices, as with the centre at Watford to which the hon. Gentleman alluded. That centre used to do its practices at the Cardington air hangars many years ago, I think, on fire in buildings, for example. Yes, I believe that there is sufficient regulatory oversight to ensure the safety of medical devices.

Medical devices are a reserved matter in relation to Wales, Scotland and Northern Ireland. As a result, unlike the enabling powers at clauses 1(1) and 8(1), regulations made under clause 12(1) can only be made by the Secretary of State.

Question put and agreed to.

Clause 12 accordingly ordered to stand part of the Bill.

Clause 13

Manufacture, marketing and supply

[Alex Norris]

I beg to move amendment 16, in clause 13, page 8, line 22, at end insert—

“(1A) In making regulations under section 12(1), the Secretary of State must evaluate the extent to which the market is meeting medical need.”

This amendment requires the Secretary of State to ensure that the market in devices is keeping pace with the UK’s medical needs.

This is the very nub of the Bill, and of the process of leaving the European Union and transitioning away from the relationship with it. That bears some important consideration, because presumably one does not leave unless one intends to do something differently; otherwise it would not be worth it. What is not clear is whether we intend to do something differently across all pieces, or whether that just happens inevitably over time because others choose to do something within this topic area and we, by default, do not and we start to diverge.

We could make this argument for medicines, but I have restricted it to medical devices because I think it only needs to be discussed once, and it is more easily conceivable and easier for me to explain my case when we talk about medical devices. I wrenched my wrist a few weeks ago, so I went to find some wrist support. I was thinking about it in this context, because I was starting my prep for the Bill, and it is striking how I started to see things on the box that perhaps I would not previously have seen or was not looking for, about all the different codes and regulations. The schedules to the Bill have a whole litany of them, and every medical device has some configuration of them on there.

In the future that will change, or at least the Secretary of State will be able to make that change. He can make it more complicated, much easier or more onerous, depending on our perspective; but it is almost inevitable, if only by the passage of time, that it will diverge from our friends on the continent. At that point, we create a market force. We know that companies developing medical devices will now have to make a choice about how they span the two markets. Of course, these issues have had hundreds of hours of parliamentary time, so I do not intend to rehash them much further, but I think there is a legitimate anxiety about the risk—and there must be a risk—that manufacturers prioritise the EU market over us and therefore we are behind in the queue and cannot get access to meet medical need.

The purpose of amendment 16 is to be clear about that, because that will give us a chance to do something about it as a Parliament, and for the Government it will act as a call to action. The amendment asks the Secretary of State to keep the matter under constant evaluation. I am perhaps willing to take the point that any responsible Secretary of State would do so anyway, but I would like to hear that it will be uppermost in the Government’s mind.

The changes we make are driven by the things we have talked about, which we see repeated for a third time under medical devices: safety, availability and attractiveness. We understand that, but because those changes could be very small, there could be a butterfly effect where we change something on a leaflet, or a badge that has to go on a box, and thus create a “Sliding Doors” moment where we start to diverge in different places. Then there will be a choice, and manufacturers will have to try to work out whether they prioritise bigger markets or smaller ones, or try to do something that pleases everybody.

I would be interested to know what conversations have happened with manufacturers and what lobbying of Government they have done about the sort of regime they want, because that is the substance of this Bill. The Bill remains a blank canvas for Ministers to paint on later; we are taking a leap of faith with Ministers here, and that is why we have sought to restrict that. It is worth understanding this, because it is one of the most profound implications of the Bill, and I am keen to know from the Minister how it has been mitigated and, importantly, how, and how actively, it is being considered.

[Jo Churchill]

Once again, I understand fully the intention of the amendment: to tease out the fact that small, incremental changes might lead to a divergence further down the line. However, I gently say that the purpose is to enable, so that, come January, we are in exactly the same place.

I will also say that innovation is a two-way street.An example is our ability to publish online to help people who might find it difficult to read the small print on paper in a packet of medicines, or who might be better able to understand from pictures how a device can be enabled or can help them. There is the chance, once we are in January 2021, to make those positive movements. That may lead to the Europeans looking and thinking, “Actually that would be useful.” There is no unique place for the good idea—I think that that is what I am gently trying to say. There is no place for a particular divergence, and we would not want there to be. As I said, there is consultation with stakeholders and the industry to be done on the exact points that have been alluded to.

--- Later in debate ---

[Alex Norris]

I beg to move amendment 17, in clause 13, page 8, line 22, at end insert—

“(k) enabling the Secretary of State to compile a register of representatives for non-UK manufacturers.”

Manufacturers of medical devices based outside the UK must designate a UK representative. This gives the Secretary of State the power to compile a list of them.

This is a brief and probing amendment based on something I picked up on the road, as it were, while talking to people in the sector about what they wanted to see from the Bill and the areas that we ought to go at. I have not been able to quite stand it up in the way that I would have liked, but I am sure the Minister will humour me, in the spirit of an open constructive dialogue.

At the moment, a medical device manufacturer that is not based in the UK has to have a UK representative—and it makes absolute sense that there should be someone who is accountable for the manufacturer’s actions and the impact of its products. However, the suggestion is that there may be inconsistencies as to who that person is, whether they are a genuine person of corporate interest in the company who is in a position to make or shape decisions or whether they were an appointee almost like a paper candidate. I picked that up in a couple of places, but it is anecdotal rather than something I could stand up, despite having done quite a bit of digging. I would be keen to know whether the Minister recognises that characterisation, or at least that risk.

I have not pushed the point too far in the amendment. All I am asking is that the Secretary of State would be able to make a register for the purposes of transparency. One of the suggestions was that an individual might be acting as a representative for multiple manufacturers, and that a register would help tease that out and give us a bit of transparency. I appreciate that there may be commercial sensitivities or personal identity issues, but I am sure that such issues could be managed in a sympathetic way. Indeed, I have not suggested any obligation that the register be public.

I am interested in the concept. Do we think it is a risk, and as we move into this brave new world, is this a chance to try to close that loop? Perhaps there is a better way to do it. I am interested in the Minister’s views on that.

[Jo Churchill]

I am grateful to the hon. Member for mentioning the importance of establishing a UK device register that records UK representatives for non-UK manufacturers. We have actually spoken more broadly, but we both appreciate—as does the hon. Member for Central Ayrshire—that it is something on which we will probably need to have broader discussions in order to go forward.

First, I will look at the spirit of the amendment. I recognise that there is a desire to strengthen the Secretary of State’s ability to conduct market surveillance by including in the Bill a power to compile a register of representatives for non-UK manufacturers. I wish to reassure hon. Members that the regulation-making powers in the Bill are sufficiently robust to enable the Secretary of State to conduct effective market surveillance. In particular, clause 13(1)(h) empowers the Secretary of State to make provision for the creation of a device register. Discussing how that is to be done is the next step. As hon. Members can see, the intention is already laid out.

The register would hold information about the medical devices that become available for sale on the UK market. That could include information on non-UK manufacturers, if they have devices that are sold within the UK on the UK market. Government policy is to record the responsible person for all devices available on the UK market after the transition period. Furthermore, current registration requirements allow the Secretary of State to record manufacturer information for the lowest-risk devices, custom-made devices and all in vitro diagnostic devices in the UK. Mandatory registration with the MHRA provides a level of additional scrutiny on such products that would otherwise be absent.

The Bill provides a power to expand current registration requirements to deliver a more comprehensive record of information about a wider range of medical devices entering the UK market, in order to support the role of the MHRA and its post-market vigilance activity. The will is there but, as the hon. Member for Nottingham North knows, I am very keen that we get such a register, registry or data collection, over which there is already quite a lot of confusion out there. We need to work hard with clinicians and others to ensure we get this right. On that basis, I ask the hon. Member for Nottingham North to withdraw the amendment.

[Alex Norris]

I really appreciate that answer, and I appreciate the Minister’s commitments outside the Chamber—her work with me and the hon. Member for Central Ayrshire, whom we are all missing and who would have contributed considerably to our proceedings but cannot, for a very good reason. There is room in the space of registration. That is obviously one narrow aspect of it, so I am happy to withdraw the amendment in order to pursue the greater prize. There are subsequent amendments in my name that also look at this issue. As the Minister says, it is very complicated and there are myriad different aspects. It is potentially a barrier. It needs to be done well; otherwise, it would be a barrier to trade, which would be bad. The opportunity to come together and to hear from clinicians—to do this once and do it right—is a big prize, and I will certainly be keen to provide support in any way I can. I beg to ask leave to withdraw the amendment.

Amendment, by leave, withdrawn.

Question proposed, That the clause stand part of the Bill.

[Jo Churchill]

Clause 13(1), which is similar to clause 2(1) on human medicines, provides for amending supplementary provisions to be made to the medical devices regulatory framework. Clause 13 lists the matters relating to the manufacture, marketing and supply of medical devices that may be under clause 12(1). The list is exhaustive in order to provide clarity.

Paragraphs (a) to (d) of subsection (1) provide the changes that can be made to regulatory requirements, which must be met before a product can be placed on the UK market, and outlines who can make such an assessment. The provision includes requirements about the characteristics of devices, such as design, manufacture and packaging, and the requirements placed on people involved in the marketing and supply of devices. Those paragraphs also allow for changes to be made to the rules governing the appointment of a specified person or persons, UK-based or not, to assess and certify that medical devices meet all relevant requirements. Changes may be made to conformity assessments, which are assessments of whether requirements, which could include conforming to agreed standards, have all been met. Under subsection (1)(e) and (f) provision could be made about the information to be provided to demonstrate that a device has met regulatory requirements. That could include specifying declarations that manufacturers must make, or certificates that must be provided, to show that a device has been through the appropriate kind of conformity assessment.

Clause 13(1)(g) enables provision to be about labelling, packaging, and information requirements for devices. That might, for example, include specifying warnings or expiry dates that must be included on the label or packaging for a device, and what information to include in the instructions for the use of the device.

We have considered additional ways in which we can improve our regulatory system to improve patient safety and aid market surveillance activities undertaken by the Medicines and Healthcare Products Regulatory Agency. One is the provision made in clause 13(1)(h), which would empower the Secretary of State to make registration requirements for devices marketed in the UK about the registration of devices and their manufacturers and suppliers, including information—this is probably our starting point—to be entered in a register. That is where I do not want the landscape to get confused. It is important that the register sits as that important piece.

Regulations made under clause 12(1) and relying on clause 13(1)(h) will enable the MHRA to create a register of medical devices available on the UK market. That could be requirements to increase the scope of current registration rules. Currently the lowest risk class of device—where they have been self-assessed by the manufacturer rather than assessed by a notified body—is required to be registered with the MHRA. Specified information in such a register, which would not include commercially sensitive information or personal data, could be made publicly available under clause 13(1)(h)(iii), allowing clinicians and patients access to information on the device that they intend to use. Again, there would be transparency.

Under clause 13(1)(i) and (j) changes could be made to the rule around investigations and evaluations for safety, performance and clinical effectiveness, and monitoring of performance through market surveillance. Having the ability to update the rules is essential to maintaining patient safety standards.

The UK does not operate in isolation to the rest of the world, and we have provided at subsection (2) that, where regulations are made relating to matters in clause 13(1)(a)—requirements that must be met in relation to medical devices—those requirements can refer to international agreements or standards for marketing or supplying medical devices.

Question put and agreed to.

Clause 13 accordingly ordered to stand part of the Bill.

Clauses 14 to 16 ordered to stand part of the Bill.

Ordered, That further consideration be now adjourned.–(Maggie Throup.)

Medicines and Medical Devices Bill (First sitting)

Debate between Jo Churchill and Alex Norris

Committee stage & Committee Debate: 1st sitting: House of Commons
Monday 8th June 2020 Public Bill Committees

[Alex Norris (Nottingham North) (Lab/Co-op)]

I beg to move amendment 9, in clause 1, page 1, line 5, at end insert

“for a period of two years following Royal Assent.”

This amendment provides a sunset provision for the Bill requiring the Government to return with primary legislation.

It is a pleasure to serve under your chairship, Mr Davies. As the shadow Secretary of State for Health and Social Care said on Second Reading, we understand the need for, and urgency of, the Bill. We will therefore be supportive during its passage, but we will seek to improve it. These improvements will take three forms: a focus on patient safety, a focus on promoting greater transparency about the development and use of medicines and medical devices, and seeking to contain the massive and extraordinary powers the Secretary of State is securing for himself.

I am conscious, certainly in this first sitting, that we have an awful lot on. I hope that colleagues will be understanding if it feels like I am moving at pace, because there is quite a lot of ground to cover. However, I wanted to say how grateful I am to the Clerks for having helped me put these amendments together, and to the Minister and her officials for their constructive support so far. The tone of discussions about the Bill has been really good, and I am sure we will continue in this way.

Finally, a lot has happened since the First Reading of the Bill, not least the fact that I have taken over from my hon. Friend, the unstoppable Member for Washington and Sunderland West (Mrs Hodgson), as the Opposition public health lead. As I have been telling stakeholders, they will probably find me similar in approach—committed, but in good humour—but perhaps lacking the same colourful jackets.

This is an enabling Bill. It is a necessary Bill, but we cannot give the Government a blank cheque. We are talking about the power to decide critical, life-and-death matters involving medicines, devices, humans and animals, and we should not just wave that off to secondary legislation without understanding what that might mean and whether there might be a better way to do it. As such, amendment 9 seeks to put a limit on that power.

The proposed arrangements allow the Secretary of State and his successors to make hundreds or more individual decisions to change our current regulatory regime into a markedly different one, one statutory instrument at a time, which I do not think is desirable. Instead, this amendment offers the Secretary of State two years of that considerable power, but asks him to return in two years’ time with a comprehensive set of regulations across medicines for both humans and animals; for medical devices; and, critically, for the proposed new regime surrounding the Medicines and Healthcare Products Regulatory Agency.

That would provide a chance for proper consultation across the sector, including with patient groups, industry bodies and interested companies, as well as more parliamentary scrutiny to set up the regime that we all want—a safe one, an effective one and a world-class one. It would also give us two years of life outside the European Union and would really help us to land in that place and find out how different we intend to be, certainly in this sector. It would provide time for piecemeal change, but it would at least then reset things, and then I would be at the point where I would be much more relaxed about the use of secondary legislation to diverge from that as circumstances require, because we would have reset things in the full knowledge of Britain’s new place in the world.

There is a case to be made that the arrangements being proposed in the Bill reflect current arrangements; after all, we do not have parliamentary scrutiny over the regulations that have come traditionally in previous decades from the EU. However, that is a political argument—a very effective one—and we know that, outside the white-hot light of public debate around the EU, the EU works differently from that. That was a theme developed by the Member for Central Ayrshire on Second Reading.

Page 4 of the Government’s impact assessment of the Bill describes how a higher-risk medical device enters circulation in the UK for use, saying that for a high-risk medical device to enter the market “a Notified Body”—for us, that is the Medicines and Healthcare Products Regulatory Agency—has to “certify” it. So far, so similar—that is essentially what the Bill would allow, as well. However, at the moment the device would be checked by two further notified bodies from within EU structures and the European Commission, as it says on page 5. That is quite a protection; that is a triple lock. It is not just our own MHRA saying whether or not a device is safe; there are two other equivalent bodies saying that, too.

That system will go and instead we will have a Secretary of State, we will have a Department, and I am sure that NHS England will have a view, too, but fundamentally we will just have a Committee of the House—a statutory instrument Committee. That is quite a diminution. Surely we at least need to know that there will be adequate safeguards in place. If the Government do not accept the amendment, I would be very keen to know what can be done to protect that triple lock.

I will move on to tell a story about two page 10s. Paragraph 42 on page 10 of the impact assessment refers to the potential to move to “hub and spoke dispensing” for pharmacy. That is a very live debate in the field of pharmacy at the moment, I have to say. I have probably not checked this with the shadow Secretary of State, but I see some positive arguments for it, although I can also see significant risks. It is the sort of thing that I think parliamentarians from all parties will be very interested in. I think that we would form different views on it, and not on party lines, because we are basically saying that pharmacy changes—that it is less about dispensing and more clinical, and that bigger nationally based pharmacies, as it were, will instead provide an outsourced dispensing arm. I can see efficiencies in that system; we are doing an awful lot of that at the moment in the context of coronavirus. However, that would be a radical change for pharmacy. At the moment, paragraph 42 on page 10 of the impact assessment says it is a potential direction for where things will go for pharmacy.

If we look at the Bill, we do not see the words “hub and spoke” anywhere, which is very significant. I gently say to Back-Bench Members of the governing party: “You could be in a situation in a year’s time where you are in a statutory instrument Committee being asked, basically, to make the most significant change to pharmacy in decades, and one that you will get a lot of emails about from your local pharmacists, certainly in community pharmacy, and I really do not think that is the sort of power that the Bill is intended to give.”

I said that this was a story of two page 10s. Page 10 of the delegated powers memorandum refers to clause 1 of the Bill and justifies the use of delegated powers:

“The human medicines regulatory regime is ever-changing and requires technical changes in order to keep up to date. These are changes we cannot predict in advance and therefore would not be practical or appropriate for these amendments to be made through primary legislation each time an update is required.”

That is saying, “Something changes a little bit and we would not want a whole new law to keep pace.” Of course, I understand that. However, we are talking about something really significant here; I would argue that it is an entire model change for pharmacy. We know that this is of interest to the Government, because it is in their own impact assessment. They say that it is a possibility. We really need to square that.

I accept that the Secretary of State will need powers and will have to do things through secondary legislation to keep us up to pace with, or to diverge from, European regulations. However, I am not confident that this is a mandate to make really significant changes to something that is very important to us all. That is why I have moved amendment 9. It would say to the Secretary of State, “Go and have a look at this for a year-plus, and then develop legislation to reset that.” Let us have proper consultation with the sector and with citizens. Let us have proper parliamentary scrutiny. Then, if we come to the view that this is the best way to do it, by all means that is what we should do.

I hope that the Government are minded to accept the amendment, but I am sceptical of that chance, so I would be keen for the Minister to return to these two points. First, will this provision mean a diminution of protection, certainly when it comes to the triple lock on medical devices? Secondly, there needs to be at least an acceptance from Government that the liberty to make quite big and bold changes is not licence to make any changes that they want, bolstered by a Committee majority, because I do not think that that is in the spirit of the legislation or of this exercise, which is about getting us to a safe position following the end of the transition period.

[The Parliamentary Under-Secretary of State for Health and Social Care (Jo Churchill)]

It is a pleasure to serve under you, Mr Davies. I agree with the hon. Member for Nottingham North that we have worked on the Bill in a spirit of co-operation, and I would very much like that to continue, because sitting at its heart is the patient, and patient safety is what we are after here. I will come on to the two specific points, but I shall address now the sunset element and why, in our opinion, that is not the way to proceed, because of its time-limited nature.

As the hon. Gentleman said, the Bill is necessary because at the end of the transition period, we will lose the ability to update. I am grateful for his words saying that both he and the shadow Secretary of State for Health and Social Care understand what we are trying to do. We need to be able to amend the legislation that governs human medicines and medical devices and veterinary meds. This measure will enable us to update the regulations in the light of patient needs and in the light of changes and innovation. I am sure that the hon. Member for Nottingham North would agree that one challenge is the dynamic nature of how medical devices in particular, but also medicines, are changing—at the bedside, but also right across healthcare. Patients and their best interests are at the heart of the Bill, and that is where I want to start.

On amendment 9, what the hon. Gentleman says is important, but the explanatory statement, while giving clarity, still leaves us with the challenge of an overarching sunset clause for the Bill, such that two years after Royal Assent, the primary legislative framework would fall away and Parliament would have to re-legislate for the provisions in the Bill once again. I understand that the hon. Gentleman’s intention is to ensure that Parliament reconsiders, and those checks and balances are important —it is important that we think about the legislation that we are passing. One would hope that at that time, Parliament will be sitting under normal circumstances, but, to be frank, we are not sure. That said, I would like to set out specifically why this proposal would be unhelpful and cause a potential risk to patient safety.

The Bill, in the main, does not deliver any immediate change to the regulation of medicines and medical devices. It provides a framework of powers to ensure that regulatory change can be made as and when necessary. It does, as I hope all hon. Members will recognise when we reach the relevant clauses, increase the level of parliamentary scrutiny, and it is that that enables us to look before something goes forward. There is going to be more scrutiny, under the affirmative procedure, for us to look and understand what it is we are legislating for than we have had thus far. Use of the affirmative resolution is made near universal, other than in the event of an emergency and for very minor changes.

--- Later in debate ---

[Alex Norris]

I take the point about not wanting to rely on primary legislation all the time. I would be much more comfortable—in this Bill in its entirety, but certainly in any future legislation—with provisions for technical updates. Nobody would think that we would need to return to primary legislation, especially not in an emergency, but I do not think that anything in the clause says that would have to be the case. I would probably accept that two years is too short a period, given the amount of work that has to be done prior to something coming into law. However, that might be an argument for a greater sunset clause rather than none at all.

I did not quite agree that nearly everything would be covered under the affirmative procedure. I am very happy to be wrong on this, but the delegated powers memorandum states, on clause 1 alone, that the scrutiny will be by the affirmative procedure

“with the exception of…the labelling and packaging of human medicines…advertising human medicines…prohibitions in the supply provisions for human medicines…the charging of fees in relation to human medicines”

and emergency powers.

If we discount the emergency powers because of the need to move quickly, we are still talking about the labelling, advertising, prohibiting and charging of fees for human medicines. Those are quite significant areas that will not be covered under the affirmative procedure. That may be a distinction without a difference, given that fundamentally there are devices that the Opposition could use if we wanted those to get an airing. However, it is important that hon. Members know that not everything will be covered by the affirmative procedure except for some very small elements.

Finally, I really appreciate the clarity on the hub and spoke model, for which the Minister made a very strong case. The argument is going on sector-wide. I do not think that there has been much of a political conversation on it. I cannot remember it in the Conservative manifesto, but I might be wrong. It feels a little bit as though we have reached the conclusion without having done all the work behind it—the Minister may well have done; I mean more generally.

[Jo Churchill]

This will be done in consultation with pharmacists, in a discursive way. As the hon. Gentleman has articulated, we have found ourselves in unusual times. Ensuring that we seize the advantage, in a way that is clear, transparent and consultative, is the aim of what we are trying to set out.

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[Alex Norris]

I completely agree. I think that if we stood in the street for a bit and just straw-polled people, everybody would say that safety is uppermost and they would see the value in its being set on a higher tier, which is what I am suggesting. We are at this possibly significant moment—I believe it is 8 July—when the noble Baroness Cumberlege will come back with her review into what has happened. Obviously, it is a sign of the times and where we are, but at Second Reading people talked about it coming out in March. The world has passed us by, but I understand that publication of the review is imminent and I am keen for that date of 8 July to be confirmed.

If the review says that there are issues around patient safety, we would expect there to be recommendations and changes, which I think is reasonable. I will return to this theme later in the day. What might this say about the MHRA? Is it possible that the regime that we seek to put in place through the Bill might be overrun by events? If recommendations come out of that, is there a possibility of revisiting that in future stages to be clear about it? That is an argument against the sort of piecemeal regime that the Bill proposes, instead of coming back in, if not two years, then three or four, to set a full codified bringing together of the different Acts into one Bill.

I will finish on amendment 23 by referring to one of my favourite contributions from Second Reading:

“Patient safety is not a partisan issue; it is paramount.”—[Official Report, 2 March 2020; Vol. 672, c.689.]

The Minister may recognise her words. I completely agree with her.

Amendments 24 to 27 essentially make the same provisions across veterinary medicines and medical devices, and I do not intend to rehearse the arguments. On medical devices, surgical matters was a good example. There is the potential for life-changing and wonderful things, but also the real potential to do harm. We want to know that with every hip, breast, knee—whatever it is that is done—safety is paramount. Amendments 22 and 23 seek to create a special place for patient safety. I hope that the Minister will accept them.

[Jo Churchill]

First, patient safety is paramount. That is where I began my journey into Parliament. In my case, it was access to cancer drugs—something close to my heart. With regard to Orkambi, I understand and share the frustration felt by everyone. My heart goes out to those affected, who are very often parents. The cystic fibrosis campaign has, I think, a 98% sign up of all parents who have had children with cystic fibrosis. On their fight for Orkambi, I am sure everybody feels sympathy for them, because it took so long to provide access.

Drug companies have a responsibility here. This refers slightly to the comments the hon. Member for Nottingham North made about life science sectors or pharmaceutical companies all being large. The drug companies have a responsibility to price their drugs responsibly in a way that reflects the benefits that they bring to patients. I feel that the arrangements that we have in place in the National Institute for Health and Care Excellence and the cancer drugs fund have helped people to get access to medicines rapidly. There is still work to do, but they need to be marketised at a fair price. We made a commitment in our manifesto to establish an innovative medicines fund to address slightly some of the points that he made.

Amendments 22 to 27 relate to the three considerations the appropriate authority must have regard to when making regulations in relation to medicines for human and veterinary use and medical devices. The effect of the amendment would be to remove the requirement to have due regard to the attractiveness of the UK as a place to market and develop these products, and to assert the primacy of patient safety above all other considerations.

The safety of patients and the environment, people and animals—when moving into the area of veterinary medicine—absolutely underpins the regulatory decisions that are made. It is absolutely the case that we would never seek to make a regulatory change that puts somebody’s health at risk; that would be counter-intuitive. However, I do not think that patient safety or safety in general is in conflict with the other considerations that these amendments are intended to affect.

The purpose of the regulation is to ensure that we do what is in the best interests of UK patients, or the veterinary sector when it comes to animals, so that they receive the best possible treatment without undue impact on the environment. It is likely that having a dynamic and innovative market, where treatments or technologies are developed in the UK, contributes to the overall benefit of the patient, as those treatments will become available to them. These are not binary principles where regulation works only in the interests of one or the other.

The hon. Member for Nottingham North mentioned Nottingham—I also shout out to Cambridge, which is just down the road, and London, which the hon. Member for Bethnal Green and Bow mentioned. This country’s life sciences sector is envied. The Government have committed to supporting it through the life science industrial strategy, in which we have sought to address the challenges faced by the industry and provide an environment that encourages companies to start and grow. All large companies start somewhere, and the hon. Member for Nottingham North knows that in the incubators around Nottingham, Cambridge and even my constituency of Bury St Edmunds, lots of small firms are working on the most incredible things to help patients.

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[Alex Norris]

My hon. Friend has made a persuasive and powerful case, as she did on Second Reading. From the debate on Second Reading, I took away the phrase that this gives us a chance to “strike a blow” against this heinous industry. I certainly support her in that regard.

[Jo Churchill]

I thank the hon. Member for St Helens South and Whiston for raising this issue and the pack that she so diligently sent to us all over the weekend, which I read with great interest. I know she holds this issue dear to her heart and she is passionate about it. I fully understand the intention behind the amendment. It is absolutely right that medicines that enter the UK supply must not have been manufactured or developed to using organs or human tissues that do not come from authorised sources.

I can assure the hon. Lady that safeguards are in place to provide surety on these issues. The requirements around the donation, procurement, testing, processing, storage and distribution of organs, tissues and cells intended for human application are set out in the Human Tissue (Quality and Safety for Human Application) Regulations 2007 and the Human Tissue Act 2004, which are separate from measures on medicines manufacture.

Medicines legislation already ensures that human tissues and cells used in the manufacture of medicinal products must meet those requirements. Safeguards are in place in those Acts to ensure that the appropriate quality, safety and origin of human tissue is known—for example, consent and traceability requirements apply to any human tissue or cell component imported into the United Kingdom and used as a material in the manufacture of a medicinal product. Importantly, a researcher is not able to conduct research on human tissue in the UK if they cannot provide evidence that it has been obtained ethically and in accordance with legal requirements. The Government will ensure that, under the new deemed consent arrangements for organ donations, donations of cells for advanced therapy and medicinal products cannot happen without expressed consent.

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[Alex Norris]

I am conscious that our carriage will turn into a pumpkin shortly, so I will move with some tempo.

New clause 2 is the Porton Down clause, and the world has changed greatly in the last few months. We now know, in a way we could never have grasped before, how an air-borne virus can lock us up in our homes for months on end, and even longer for many. We also know that what happens on the other side of the world can be with us quickly, and that at times, as with the current coronavirus, there is not much we can do about that.

We ought to reflect on what we are doing at home. We have reached a point where we could have a greater public understanding and scrutiny of the sorts of things being developed in our name by our Government. Porton Down is a world class facility full of incredibly talented people serving our national interest, but we do not know what they do. We get snippets. We know that in the past decade they have experimented on 52,00 animals, which is six times the rate of any other UK lab. I have absolutely no idea whether that is too high, too low, or just right, because we do not know. I am trying to probe the ways in which we can get greater transparency about what potentially life-saving or possibly life-ending products are being developed on our doorstep. If the Minister thinks there are better ways to do that, I am happy to consider those. The drafting does not refer to everything developed in the UK, but things developed by the Government. It is behind closed doors, very secretive, and potentially quite dangerous, so I am keen to know how we might get greater scrutiny.

New clause 4 on antimicrobial resistance is a passion of my predecessor, my hon. Friend the Member for Washington and Sunderland West. It is topical now as we wrestle with a horrendous virus, and I express my solidarity with the Minister and her colleagues on their efforts in doing so. Clearly, microbial organisms can adapt and have an incredible impact, as we are seeing. They can also disrupt much more conventional matters such as the antibiotics that are crucial for transplants and chemotherapy. It is laudable that the Government have a 20-year vision for this, although I hate long strategies. What is done in year one is much more important than what is done in year 20. I know there is a five-year plan sitting behind that, but even that feels too long a time. The new clause gives the opportunity instead for an annual report, which would be an improvement. If that is not the right vehicle, how might we be able to play our role in the conversation around antimicrobial resistance, and how do we get an appropriate period in which to hold the Government to account to ensure that we make progress?

[Jo Churchill]

I am grateful to the hon. Gentleman for raising the development of new medicines in new clause 2, which are important in new clause 3 as well. Antimicrobial resistance, as he has mentioned, is an absolutely critical issue of today. I will first set out what we are doing in that area. The development of medicines is an integral part of the UK life sciences sector, and we are committed to making sure that we can develop such medicines. The Bill gives us powers to maintain an effective system for regulating, including with respect to clinical trials. New clause 4 allows us to adapt the regulatory framework around them in a way that best suits the industry. The development of medicines is the role of the pharmaceutical industries and researchers, and we want to support them fully. The Government are committed to supporting a thriving sector, investing more than £1 billion a year in health research through the National Institute for Health Research, which is committed to openness and transparency about where the funds go. It ensures that all trials publicly register before any patient intervention, and key trial outcomes are made publicly available. However, the arrangements for Government support and funding through trials is not within the Bill.

I will address some of the work that the hon. Member for Nottingham North alluded to at Public Health England’s Porton Down campus, sometimes referred to in the context of medicine developments. The current PHE facilities at Porton Down do not develop medicines for Government, but engage in a range of scientific work for commercial and public sector customers. This includes the safety and efficacy of testing vaccines and therapeutics, and discovery work relating to novel and dangerous pathogens. Porton Down is also the site for work by Porton Biopharma Ltd, which is a public non-financial corporation and is outside central Government. Although PBL develops and manufactures biopharma products, this falls outside the Government and we are therefore not in a position to publish reports on the development of its work.

The hon. Gentleman also raised the important issue of AMR in new clause 4. I want to reassure the Committee that tackling AMR is a high priority for the Government and that its impact remains on the national risk register. The UK continues to lead the way on global action to tackle AMR, working alongside international partners, the most famous of whom is probably the most recent chief medical officer before Professor Sir Chris Whitty, Professor Dame Sally Davies, who has taken up her position as the special envoy for AMR. Her role will continue to underline the UK’s position as a world leader in developing and delivering international action in that space.

In January 2019, the UK Government published their vision to contain and control AMR by 2040. Achieving that is supported by the delivery of a five-year national action plan from 2019 to 2024. The delivery of the cross-Government commitments in the action plan is being overseen by a joint DHSC and Department for Environment, Food and Rural Affairs-chaired programme board, established in October 2019. The commitments in the national action plan cover all sectors, including human health, animal health, food and the environment.

The UK has already made good progress in reducing its use of antibiotics in humans and animals, and we now have the fifth-lowest level of antibiotic consumption in food-producing animals out of 31 European countries. We have also seen unprecedented levels of investment in collaboration in research on AMR nationally and globally. The UK invests significantly in AMR through the Fleming Fund and the global AMR innovation fund.

The hon. Member for Nottingham North is correct that the Government should prioritise the development of new medicines to address antimicrobial resistance, including antibiotics. Indeed, we already do. Having a pipeline full of antimicrobial drugs is critical to our efforts to contain, control and mitigate AMR, as outlined in the strategy towards 2040.

In July 2019, the UK formally launched a project for developing and testing the world’s first subscription-style payment model for antibiotics. If successful, it would mean that pharmaceutical companies received payment up front for access to their antibiotic products, based on the products’ value to the NHS, as opposed to the volume used. We are the first country in the world to test such a model and more information will be published on it in due course.

Although we know how important new medicines are in tackling antimicrobial resistance, a strengthened focus on prevention and the control of infection will help to contain the emergence and spread of resistance to antibiotics. By limiting and reducing the need to use antibiotics in the first place, we are taking a zero-tolerance approach to avoiding infection in human healthcare settings, as set out in the action plan. Our plan will result in at least 15,000 fewer UK patients being affected by infections each year by 2024, and 5,000 fewer drug-resistant infections.

In parallel, we are focusing on reducing animal exposures and susceptibility to pathogens that could result in the need for treatment with antimicrobials. By working closely with the veterinary profession to implement those preventive measures, we will reduce the need for new antimicrobial medicines as we reduce them in the food chain.

I hope that hon. Members will agree that the UK Government are working hard to ensure that AMR is controlled and contained through the vision for 2040 and the five-year action plan. New clause 4 is not necessary for the Bill. If the hon. Member for Nottingham North has further specific questions in relation to either medicines by the Government or AMR, I would be happy for him to write to me and I will endeavour to answer those points in a closed format. On that basis, I ask him to withdraw the new clause.

[Alex Norris]

I do not intend to press new clauses 2 and 4 to a Division. The Porton Down answer was helpful. In the terms of the amendment, it is not necessary, but I will have to work out how to get from accepting the principle about not developing medicines to accepting the next sentence about testing vaccines. That is a distinction without a difference, but I accept that it would not quite work in the Bill. The answer about the limited company does not hold either. As a wholly owned subsidiary of the UK Government, I think we could take an interest in that.

I was grateful for the detailed answer about AMR. I will take up the offer of engaging directly as and when. To be clear, we are keen to engage on that, because it is a significant issue and we want the Government to succeed at it. I hope that can be part of an ongoing conversation about it. On that basis, I will not press the new clause.

Question put and agreed to.

Clause 2 accordingly ordered to stand part of the Bill.