Medicines and Medical Devices Bill (Third sitting)
Jo Churchill ExcerptsWednesday 10th June 2020
(3 years, 10 months ago)
Public Bill CommitteesRead Full debate Medicines and Medical Devices Act 2021 View all Medicines and Medical Devices Act 2021 Debates Read Hansard Text Read Debate Ministerial Extracts Amendment Paper: Public Bill Committee Amendments as at 10 June 2020 - (10 Jun 2020)
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.
The Chair
With this it will be convenient to discuss the following:
Government amendments 3 and 4.
Clause stand part.
Government amendments 5 to 7.
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.
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.
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.
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
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.
Jo Churchill
As the hon. Gentleman knows, I am also enthused and excited about the register, because it offers us a space to do something good. I am very grateful to him and the hon. Member for Central Ayrshire, to whom I spoke at the weekend, as I said on Monday, and I noted that she would not be with us for Committee proceedings.
A registry of long-term implantable medical devices as suggested in new clause 6 is of significant interest to many Members. On Second Reading, many Members put forward good ideas on how we could make a register work for the benefit of patients. We should consider this in the context of the forthcoming report from the independent medicines and medical devices safety review and the matters it looked into, particularly the use of pelvic mesh, and how we oversee medical devices, including post-market surveillance. It is not only the point when the device is implanted that is vital, but also the potential impacts some years later. I know we all recognise the critical importance of ensuring that patients are heard and that concerns about medical devices are identified and dealt with quickly and effectively. That must be at the forefront of our minds. As the hon. Gentleman said, the impact on an individual’s life can be significant.
New clause 6 is similar to new clause 1, which was tabled in the name of my hon. Friend the Member for Newton Abbot (Anne Marie Morris). I know that she and many other Members in the House and the other place are interested in what more we could do to improve the tracking of implantable medical devices. The issue has also been a subject of interest to the Health Quality Improvement Partnership and the Royal College of Surgeons. It is very topical.
Clause 13(1)(h) provides for the creation of a register of medical devices to capture which devices are available on the UK market and to ensure that the MHRA can identify which device has been produced by which manufacturer. There has been some confusion in some of the written evidence as to whether that is intended to constitute a registry. A registry as in new clause 6 suggests bringing together patient and clinical information with device information. We have device registries, such as the national joint registry in the UK, which is seen as a global exemplar, so it is important to make sure that we do what we need to in order to enhance what is already in the system.
I understand the intent behind the new clause and, as ever, I am keen to understand what more we can do to protect patients in a fast-moving and constantly innovating environment, but I am not sure that new clause 6 is practical. The hon. Member for Central Ayrshire and I discussed the fact that it was heading in the right direction, but we need to work on it.
Patient safety absolutely underpins everything in our approach to regulation of medical devices in the Bill. It is the key consideration for all of us, as set out in clause 12(2)—the Government have put it there as the key priority. That is why we have introduced the ability for the Secretary of State to disclose information in the event of a safety concern, as we discussed.
I am not sure that the new clause achieves what the hon. Members for Central Ayrshire and for Nottingham North want it to. The intent is to establish a UK registry linking together all existing device registries, so that duplication of the entry of information is reduced, and to require the information entered to include the specifics of a device, such as the clinician who implanted it—information that, in the event of something going wrong, would give a clear picture of what happened. Although that is a commendable aim, the existing registries have been established over time and have expanded into different regions, evolving as they go. We have not had conversations on linkages to the registers in various parts of the country and in devolved Administrations. It is right and proper that we pull back and ensure that we have taken in the views of all stakeholders, and done the proper engagement to ensure that we collect the information from registers appropriately. That needs some work, partly due to the differing operating approaches in each registry. I gently suggest that the proposal in subsection (6) that all implanted devices without a specialist registry be logged on a national registry is a little broad at this stage. We perhaps need to talk about that with stakeholders and others.
The new clause also seeks to establish a governance structure, after consultation with a range of stakeholders, on the management of and access to the proposed registry. I suggest that the consultation requirement is out of step with the consultation duty in clause 40, which provides that consultation with those considered appropriate must take place before we make the regulations. It is a little cart before the horse but, that notwithstanding, this is very much the direction of travel. I remain of the view—no doubt we will come to this point—that we must ensure that we do not inadvertently rule out consulting those who ought to be consulted.
The hon. Member for Nottingham North and I have had discussions in this space, and we are united in wanting this idea to get to the right place. I appreciate the careful consideration that was given to the new clause, and I am grateful for it. I would welcome further discussions in the near future.
Matt Western
I am keen to clarify, not having been party to previous debate, what happens with non-medical cosmetic devices implanted by a medical procedure. Should registry for them be part of this consideration? There is a subsequent impact on our NHS when things go wrong.
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 (First sitting)
Jo Churchill ExcerptsMonday 8th June 2020
(3 years, 10 months ago)
Public Bill CommitteesRead Full debate Medicines and Medical Devices Act 2021 View all Medicines and Medical Devices Act 2021 Debates Read Hansard Text Read Debate Ministerial Extracts Amendment Paper: Public Bill Committee Amendments as at 8 June 2020 - (8 Jun 2020)
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.
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.
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.
Rushanara Ali
Nobody doubts that innovation will thrive if there are proper frameworks and safeguards in place, but it is clear that, in a post-Brexit world, our Government will want to see more innovation in research and development and investment, and sometimes the choices will come into conflict. There will be a trade-off, and we must ask what is a greater priority. Frankly, in recent years, some of the narrative that we have heard from the Government has not inspired confidence. I am looking for a very clear message that public safety will be set in stone. It is not good enough for Ministers to give reassurance; it has to be set in stone. We have to have confidence that public safety will not be compromised in the interest of getting investment. That is necessary, but it should not come at the cost of public safety.
Jo Churchill
I thank the hon. Lady for her intervention. The reason why the safety of human medicines is listed first is because safety is the paramount objective in everything.
In the life sciences industrial strategy, we have sought to address the challenges faced by the industry, provide an environment that helps companies to grow, and support collaboration between the NHS and industry better to adopt innovative treatments and technologies. Life science is one of the most productive and strategically important parts of the UK economy—it is worth more than £74 billion per annum—and we wish to cement our position as a world leader in that field to allow patients to benefit from cutting-edge treatments as soon as possible. The Bill is a key part of that, and it also keeps safety right at the top of the agenda. It is therefore right that, when we make regulations, the appropriate authority considers their impact and looks at whether they would constrain companies from seeking to bring new and innovative medicines or medical devices to market.
The concern of the hon. Member for Nottingham North is that the consideration of the UK’s attractiveness, if applied, would mean a reduction in regulation on the sector, such that safety concerns would arise. That is simply not the case. I appreciate that he would like clarity on how the attractiveness consideration would work in practice, and the hon. Member for Central Ayrshire quizzed me about that too. The consideration would not mean reduced regulatory barriers to manufacturing, for example, as that would be to the detriment of patient safety. No! We have not sought to define attractiveness in the Bill, because the definition is as it is in ordinary language. There is no hidden or nefarious intent here. We want the UK to remain at the cutting edge of medical advancement, and that is done by recognising that the pharmaceutical industry benefits patients by making innovative therapies available through clinical trials and bringing them to market, or, indeed, collaborating in the event that expedited access to treatments is necessary.
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.
Ms Rimmer
I am sorry about this—really sorry—because I understood that being a Minister was about co-operation, patience and morals. I do not disbelieve what the Minister says. However, there has been a public and independent inquiry, which found beyond all reasonable doubt. Those running the inquiry were people of stature and good regard, with a history of working for human rights.
I cannot withdraw the amendment. I ask that, at the very least, the Committee considers meeting Sir Geoffrey Nice and a Chinese surgeon who was forced to carry out the removal of organs in China, and who is now a taxi driver in London. They could meet somehow—I am sure we could do it on Teams or something like that. Before we get to Report, I urge the Committee to agree to such a meeting or to listen to and read the evidence. I cannot in all conscience accept that the learned people who sat on the China tribunal would have not researched and challenged—people such as Lord Alton, Lord Hunt and others in the House of Lords. Indeed, many hon. Members spoke about China’s treatment of Uighur Muslims in a Westminster Hall debate that was led by a Conservative Member on 11 March. I am sure some of them would have looked and questioned.
I will not and cannot withdraw the amendment, but I urge the Committee to have neutrality and meet the relevant people so that we can check. I would certainly have to check with learned people before I can begin to consider withdrawing the amendment. I cannot accept that the learned people who have engaged with this issue for so long—we have worked on it for nearly two years and, coincidentally, the Bill came along. I have tried to get a private Member’s Bill but have not succeeded. I have tried every nook and cranny to do anything I can to stop this practice. I do not want to risk our health service or our country’s reputation, which could be tarnished by being involved. I have dear friends who are Chinese, but I do not trust the Chinese Government in any way. I urge the Minister please at least to let us meet and consider this issue before Report. I have not sat on a Bill Committee before, Mr Davies, so I am not sure of procedure and, as you know, I am profoundly deaf. I urge the Minister please not to throw out amendment 1 without us doing that and rechecking every nook and cranny.
Jo Churchill
I understand the hon. Member’s passion for this area. As she said, she has tried to find every nook and cranny. I gently repeat that the Bill is not the right place for amendment 1, but I commit to writing to my Foreign and Commonwealth Office counterpart on this point and to exploring it further, if that would be of assistance to her. However, I say again that the Bill is not the vehicle for the amendment and I ask her to withdraw it.
Rushanara Ali
I welcome the Minister’s offer to write to the Foreign Office, and I commend in particular my hon. Friend the Member for St Helens South and Whiston for what she said. I have worked on human rights issues for other at-risk groups and there is a sense of concern about the position we may inadvertently find ourselves in. Will the Minister, in addition to writing to the Foreign Office, commit to ensuring that there is a review within Government to ensure that our safeguards are up to date? While I accept that the legislation is there, some gaps may need to be addressed and, if they cannot be addressed by the Bill, we need to find a way to assure ourselves that we have all the right safeguards in place. That will require a Health Department lead working with the Foreign Office and others.
Jo Churchill
As I said, I am willing to write to the Minister for Asia and the Pacific to explore this matter further, but I am afraid at this point that is all I can commit to.
Neil O'Brien (Harborough) (Con)
The hon. Member for St Helens South and Whiston made a hugely important and impassioned point, and I strongly support her. Will the Minister undertake to circulate her letter to members of the Committee?
Jo Churchill
Yes, of course, I will be happy to inform the Committee when I write to the Minister for Asia and the Pacific, if hon. Members would find that helpful. We heard from the hon. Member for St Helens South and Whiston, and I am sure we all read the pack she sent at the weekend about the trade in human organs, which is truly heinous.
The Chair
The hon. Member for St Helens South and Whiston said she was inexperienced in Bill Committees. I can happily tell her that at this moment in time she is in charge and it is entirely down to her whether she wishes to press her amendment to a Division or to withdraw it. It is for her to indicate which of those options she would prefer.
The Chair
With this it will be convenient to discuss the following:
New clause 2—Report on medicines under development—
‘On the date on which this Act is passed, and once every twelve months thereafter, the Secretary of State must lay before Parliament a report detailing what medicines the UK Government are developing.’.
This new clause requires the Secretary of State to lay before Parliament a report covering medicines that the UK Government are developing.
New clause 4—Antimicrobial Resistance—
‘(1) The Secretary of State must regard antimicrobial resistance a priority in the development of new medicines.
(2) The Secretary of State must, within 12 months of this Act receiving Royal Assent, lay an updated report before Parliament setting out a UK-wide strategy for tackling antimicrobial resistance.’.
This new clause requires the Government to prioritise tackling antimicrobial resistance and produce an updated report setting out how it shall do so.
Jo Churchill
The clause allows for changes to be made to the law relating to the manufacturing, marketing and supply of human medicines. It provides an exhaustive list of matters on which amendments can be made by regulation, giving clarity and limits on what may be done by secondary legislation. I will take each subsection in turn as these are important areas for the Committee’s consideration.
Subsection (1)(a) provides that changes may be made to update regulations in relation to manufacturing to reflect advances and innovation in the way in which medicines are prepared. That will enable us to take a revised approach to regulation, ensuring that regulations do not become barriers to patient access and to medicines manufactured in new ways while maintaining high regulatory standards to protect patient safety.
Subsection (1)(b) allows for changes to be made to the law governing the import of human medicines. It will support the continued ability to ensure that imported medicines are safe. We also want to be able to ensure that no unnecessary additional burden is placed on companies so that the UK remains an attractive place to supply medicines while protecting patients.
Subsection (1)(c) allows for changes to be made to the law governing the distribution of medicinal products by way of wholesale dealing. A wholesale dealing authorisation is required to supply or sell human medicines to anyone other than the patient using the medicine. In the light of any emerging safety concerns or innovative new techniques or technologies, changes may be required to maintain the quality of, and ensure proper distribution of, medicinal products. That could include such matters as providing and maintaining staff, premises equipment and facilities for the handling, storage and distribution of medicinal products under a wholesale dealer’s licence as are necessary.
Subsection (1)(d) provides that changes may be made to the law relating to marketing authorisations for human medicines. We want to ensure that UK patients have access to high-quality medicines and new treatments, so we need a regulatory system that maintains and enhances the UK’s attractiveness as a place to market novel and generic medicines while ensuring that medicines are safe and efficacious. We could, for example, amend the current regulations to offer additional statutory rewards or incentives for a certain type of application for a marketing authorisation, which would encourage new medicines to continue to come to the UK in a timely fashion.
Subsection (1)(e) allows for changes to be made to the law governing the manufacture, import or distribution of active substances. An active substance is an ingredient used to make a finished medicinal product and gives medicine its therapeutic effect. The ability to amend and update regulations in relation to active substances is necessary to protect public health, because if there is not adequate control of an active substance, contamination can carry over to the finished medicinal product. The ability to change the rules governing active substances means that we can update the UK regulations to react in response to emerging public health risks resulting from issues relating to active substances and ensure continued supply.
Subsection 1(f) allows for changes to be made to the law governing the brokering of human medicines. The brokering of medicinal products consists of negotiating independently and on behalf of another person in relation to the sale or purchase of medicinal products. We need to be able to amend the rules governing brokering in response to any new industry practices that arise and risk infiltration of the supply chain with falsified medicines. We could use this provision to restrict such activities, thereby securing the medicine supply chain and reducing the risk to patient safety.
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.
Medicines and Medical Devices Bill (Second sitting)
Jo Churchill ExcerptsMonday 8th June 2020
(3 years, 10 months ago)
Public Bill CommitteesRead Full debate Medicines and Medical Devices Act 2021 View all Medicines and Medical Devices Act 2021 Debates Read Hansard Text Read Debate Ministerial Extracts Amendment Paper: Public Bill Committee Amendments as at 8 June 2020 - (8 Jun 2020)
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.
The Chair
With this it will be convenient to discuss new clause 5—Capacity of the veterinary industry—
“(1) The Secretary of State must, within 12 months of making regulations under section 8(1), lay a report before Parliament setting out an assessment of the capacity of the veterinary industry, relative to the requirements of those regulations.”
This new clause requires the Government to make an assessment of the capacity of the veterinary industry.
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.
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.
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.
Matt Western
I thank the Minister for giving way; she is being very generous. I want to press her on that point. She talks about reassurance, safety and how important this sector is to our economy and our scientific status. When we talk about safety, we think about gauze and metal implants and so on, and the Minister mentioned how important it is for consumer protection and assurance. However, in the way that we have a building regs centre, or whatever it is called, at Watford—it came to light after the Grenfell disaster—where building materials are tested, is there such a body that does testing of these medical materials and products in the UK? If not, is one envisaged?
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.
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.)
Oral Answers to Questions
Jo Churchill Excerpts(3 years, 11 months ago)
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Jonathan Gullis (Stoke-on-Trent North) (Con)
The Parliamentary Under-Secretary of State for Health and Social Care (Jo Churchill)
I would first like to place on record my thanks to everyone on the frontline, be they in a hospital or in social care, as well as those in less obvious places such as my community nurses, pharmacists and others who are working ceaselessly on the frontline. We are working round the clock to ensure that everyone across the NHS and care sector has the personal protective equipment that they need. To date, we have delivered more than 1.11 billion items of PPE. We are ensuring that PPE is delivered as quickly as possible to those on the frontline. We have delivered to over 58,000 health and care organisations, and we are working closely with industry, social care providers, the NHS, NHS Supply Chain and the Army to ensure that all our NHS and care staff can get the protection they need.
Sir Edward Davey [V]
I thank the Minister for that answer, but given how care homes have become a tragic focus in this pandemic, with so many staff and residents losing their lives, when will she be able to guarantee that every care home will have all the PPE they need? And why is the Clipper system, which is meant to supply PPE to the care sector, now one month late?
Jo Churchill
Every NHS and social care worker must have the protective equipment that they need. Clipper has been rolled out, and it is important that it is able to deliver the products that are ordered online. This is now being rolled out to more than 1,500 general practices and care home providers, and as it is piloted and stood up to more and more individual organisations, that will help that stream of work to ensure that people have the personal protective equipment they need. That is on top of the national supply disruption response—NSDR—line that people can ring in case of emergency, and this is also backed up by the wholesale distributors, where only last week 52 million more items were placed into that line as well.
Jacob Young [V]
Across Redcar and Cleveland, we have fantastic businesses such as Pendraken Miniatures and BC-FX, who have switched their manufacturing lines to making visors, the Materials Processing Institute, which has switched to making hundreds of bottles of hand sanitiser for Marie Curie nurses every week, and 15-year-old Daniel Sillett, who is using his 3D printer to make PPE for local care facilities such as Marske Hall. Will the Minister join me in commending those businesses and individuals as part of our national effort in overcoming this crisis?
Jo Churchill
I would indeed like to join my hon. Friend in congratulating them, and I congratulate him on the way he has just explained that this is the most enormous national effort, from large-scale businesses down to individuals such as Daniel, to whom we must give our special thanks. This national effort—the way in which individuals and businesses have stepped forward, and the many offers from all the different suppliers—has been extraordinary. We are working with industry partners across the piece to make PPE. We are working with Ineos and Diageo to produce hand and hygiene products and to ensure that we get these to the frontline, using services such as Clipper. Thanks to the work we have already seen, we have seen novel products arrive on the frontline. Seven companies have now been contracted in the UK to make over 25 million items of PPE and to send some 6 million square metres of fabric to NHS Supply Chain.
Jonathan Gullis [V]
Like my hon. Friend the Member for Redcar (Jacob Young) , I too have local initiatives—including Scrubs for Stoke and the Heywood Academy—that have produced amazing amounts of PPE for our local health care sector. Can the Minister inform us what steps she is taking to ensure that staff in care homes—[Inaudible.]—and to enable people to make optimal use of PPE and minimise the transfer of infection from one client to the next?
Jo Churchill
I would like to pay tribute to businesses in my hon. Friend’s area. I think the crux of his question was about making sure that people are receiving the appropriate infection control training in order to utilise PPE effectively. We publish guidance—including videos, which are easier to watch and immediately understand—on the appropriate PPE for health and careworkers, based on clinical expertise. The guidance has been written and reviewed by all four UK public health bodies and informed by NHS infection prevention and control experts. It is consistent with World Health Organisation—
Liz Kendall (Leicester West) (Lab) [V]
Thank you, Mr Speaker.
I have listened carefully to the Minister’s answers, but on the ground there are still serious problems. Maria, who is a careworker in the north-east, told me on Friday that she has only just received face masks and has to wear the same ones throughout the day. Kenzie in Leeds told me exactly the same thing: one mask, all day, even though one of the elderly ladies she cares for has coronavirus and cannot help coughing and spitting on her mask. With almost 8,000 deaths in care homes so far, what changes will the Minister make and what will she do differently to get a grip of this problem, which is still increasing, to help bring this terrible death rate down?
Jo Churchill
As I said, there are the three strands of guidance on making sure that the appropriate equipment is used in the appropriate place. We have also used the local resilience forums in order to ensure that individual care organisations can have a back-up of personal protective equipment so that people can use it in line with clinical guidance. I will contact the hon. Lady after this session, because I would like to ensure that the young lady she spoke about has seen that guidance, and the videos that accompany it, in order to make sure that she feels properly protected, which is the aim that we are all working for.
Alec Shelbrooke (Elmet and Rothwell) (Con)
The Parliamentary Under-Secretary of State for Health and Social Care (Jo Churchill)
NHS England and NHS Improvement have published detailed guidance setting out the support for NHS dentistry during the pandemic. To minimise the spread of infection, routine dentistry is currently suspended. NHS practices are providing telephone advice and triage at urgent dental centres to patients with urgent needs. NHS dentists will receive their usual remuneration in full, or in part if they do part-NHS, part-private work. Dentists can also seek help via all the Treasury means for lost income.
Alec Shelbrooke [V]
My constituents in Elmet and Rothwell have reported difficulties in obtaining emergency dental care in Leeds. Will the Minister detail what actions her Department is taking when this specific issue comes up in, say, Leeds so that patients can access emergency care during the lockdown?
Jo Churchill
Of course. As of the week ending 30 April, there were two urgent dental care centres in the Leeds area to provide urgent dental treatment and care for patients on referral either from the patient’s own dentist or from NHS 111. As with all urgent dental care centres, there is also a triage service that will give people advice, antibiotics or painkillers and then refer them through if clinical work is required. There are 308 urgent dental centres open across the country. I regularly talk to the chief dental officer and to the British Dental Association about the needs and requirements in the profession so that we can care for patients in the best way.
Sarah Jones (Croydon Central) (Lab)
The Parliamentary Under-Secretary of State for Health and Social Care (Jo Churchill)
It is vital that we find out what groups are most at risk so that we can help protect them. That is why we have asked Public Health England to conduct a rapid review of the different factors that might influence how someone is affected by the virus. Among other things, it will explore age, ethnicity and gender. As our deputy chief medical officer outlined yesterday, this is important but complex work.
Sarah Jones
I am sure the Minister would want to join me in paying tribute to the staff at Croydon University Hospital and those in our local community for the resilience, bravery and good grace they have shown during this crisis. Over 250 people have died in Croydon, and we are all thinking of their families and their loved ones who will be suffering so much. High levels of deaths in Croydon appear to be down to the underlying health of the population. Although of course it is early days in terms of analysing the data, it is clear that in Croydon covid has disproportionately affected people from black, Asian and minority ethnic backgrounds. Does the Minister agree that on early sight it looks like poorer people, often from BAME backgrounds, are being hardest hit by covid, and that we need to tackle the longer-term underlying health issues that have got us to this place of gross inequality?
Jo Churchill
It is so important that we do the research before we draw conclusions. Every death is a tragedy. Everybody who has died during this pandemic is somebody’s mum, dad, brother, sister and therefore we owe it to them to give Public Health England and all those researching this area all the support we can, so that we do not rush to conclusions, but draw conclusions that will truly help us to address the pandemic and those who are most affected by it in the right way.
Mr Speaker
I am sorry that we did not get more questions in, but maybe we can speed up the teams next time and we will get through more.
We come to the urgent question to the Secretary of State for Health and Social Care. I will follow the practice for substantive questions whereby I will call the Secretary of State to answer the question first. Before doing so, I have a short statement to make, which is relevant to this urgent question.
It has been widely reported that the Government will make a major announcement about the review of lockdown this Sunday. I consider this a matter of regret. It is important that the press is kept informed, but it is the duty of this House to hold the Government to account, not the media. Major Government announcements should be made first in the House and this is more important than ever during this time of crisis.
Ministerial Correction
Jo Churchill Excerpts(3 years, 12 months ago)
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The Parliamentary Under-Secretary of State for Health and Social Care (Jo Churchill)
My noble Friend the Under-Secretary of State for Innovation (Lord Bethell of Romford) has today made the following written ministerial statement:
I would like to inform the House that a written answer I gave on 15 April to the noble Lord Sharkey contained information that was out of date at the time of answering. I wish to correct the formal record.
In my reply, I stated that information on the National Institute for Health and Care Excellence’s (NICE) methods review was not yet available. However, information had been shared by NICE that updates my answer as it originally stood, therefore, making the information provided on 15 April out of date.
The updated position is that NICE has considered its ability to carry out and complete the methods and process update and has decided to extend the timelines. NICE now plans to hold a six-week public consultation on proposals in October 2020 and a further consultation on a draft programme manual in February 2021, with implementation in June 2021.
[HCWS215]
Public Health Grant
Jo Churchill Excerpts(4 years, 1 month ago)
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The Parliamentary Under-Secretary of State for Health and Social Care (Jo Churchill)
Today I am publishing the public health allocations to local authorities in England for 2020-21, based on the 2019 spending round.
Funding for local government’s health responsibilities is an essential complement to our plans to invest strongly in both the NHS and social care, and an important element of our commitment to focus on prevention of ill health. The 2019 spending round provided a 0.9% real-terms increase (£85 million cash) for local authority public health funding in 2020-21. In addition to this increase I now intend to make an additional £60 million available through the grant, from DHSC central budgets.
Through the public health grant and the pilot of 100% retained business rate funding for local authorities in Greater Manchester, we are spending £3.279 billion on local authority public health in 2020-21. This in addition to what the NHS spends on preventive interventions such as immunisation and screening.
The 2020-21 grant will continue to be subject to conditions, including a ring fence requiring local authorities to use the grant exclusively for public health activity.
Full details of the public health grants to local authorities can be found on gov.uk and are attached. This information will be communicated to local authorities in a local authority circular.
[HCWS163]
Lesbian, Bisexual and Trans Women’s Health Inequalities
Jo Churchill Excerpts(4 years, 1 month ago)
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The Parliamentary Under-Secretary of State for Health and Social Care (Jo Churchill)
I congratulate the hon. Member for Livingston (Hannah Bardell) on securing this debate and on the sensitive but frank way she has approached it. We came into this place together, and I am grateful to her for the way she has given a voice to other women. As the hon. Member for Ellesmere Port and Neston (Justin Madders) said, that is the theme this year, and as my hon. Friend the Member for Reigate (Crispin Blunt) said, having this debate on the Floor of the House and giving a voice to those who feel their voice is not heard sufficiently is something we really can do. It was great to see hon. Members from all four nations coming together in the Chamber today to give a voice to the LBT community.
I have drawn from the contributions of all hon. Members a selection of themes, especially around mental health barriers and discrimination. As the hon. Member for Livingston said, we are on a journey. My hon. Friend said we were making history today, but history is yesterday; tomorrow is the future, and that is where we need to refocus and start to deliver. I thank him, the hon. Member for Sheffield, Hallam (Olivia Blake), my hon. Friend the Member for Runnymede and Weybridge (Dr Spencer) and the hon. Member for North Down (Stephen Farry) for their considered contributions.
We have heard about the challenges facing those for whom life is so tough they think of taking their own lives —I know that the 52% figure, which the hon. Member for Livingston mentioned, is for Scotland, but the figures do not vary particularly across the nations—and about the higher rates of self-harm and eating disorders, and the barriers to conversations about people’s health that can prevent them from taking responsibility for their health and the effect that can have on general wellbeing. I pay tribute, as several Members did, to the charities and institutions working hard, day after day, to give people a voice and provide better access to services.
As my hon. Friend the Member for Reigate said, the global LGBT rights position is very different. We have made great strides in legislation in this country, but health outcomes are the key. Individuals should not have to fit the system; the system should adapt to them, because if it does not feel right or give the right outcomes, it is highly unlikely they will access it in the right way. My hon. Friend also highlighted the lack of training, and the fact that it was a mainstream problem throughout the healthcare system—as the hon. Member for Sheffield, Hallam also did, very eloquently. He pointed out that this was a challenge for all elements of the healthcare profession, from general practice and nurses to social care and care towards the end of life.
I thank my hon. Friend the Member for Runnymede and Weybridge for making such an informed speech. “Recognising the minorities within the minority” is a phrase that I will take away. He mentioned intersectionality. Stigma does ruin lives, and compounds issues involving gender, sexuality and a plethora of other matters before people even reach the point of access to services.
I was struck by my hon. Friend’s comment about the need to tailor services to the needs of the communities whom we serve. I have been up and down the country, but I particularly remember sitting and talking to people at a charity in Manchester. I learnt that young people in particular will often move towards towns because they feel that services will be better, that there is a degree of invisibility, or that there will be others there with whom they have some connection. So tailoring services in a more compassionate and reasoned way should be at the front and centre of what we do.
In his frank speech, the hon. Member for North Down described how many challenges still exist, but made it clear that if we all work together it will be much easier to overcome that. I noted what he said about the need for a better understanding of the guidelines, and about the position of women who find themselves in need of a termination having suffered sexual crimes and abuse. The beauty of these debates is that sometimes we are given something to think about something that we may not have thought about before.
As we have heard, the debate is timely, given that this is National Lesbian, Bisexual and Trans Women’s Health Week. We have made great strides in advancing equality for LGBT people, from changing the law to allow same-sex couples to marry to introducing the world’s first transgender action plan in 2011. However, we know that we must maintain the progress, and continue to work together on implementing the LGBT action plan.
It is only right that all of us, irrespective of gender or sexual orientation, are able to lead happy and fulfilling lives, with equal opportunities and without fear of discrimination—lives that allow us to look forward to what we have ahead of us, and not back to what we might have missed. People should be able to access healthcare free of discrimination and on the basis of who they really are, and we should ensure that education helps all those in the health sphere to deliver.
Back in 2017 the Government launched a national survey targeting LGBT individuals in order to understand better the real issues impacting communities. Attracting some 108,000 responses, it remains the largest national survey of its kind. My hon. Friend the Member for Reigate spoke very well about that. Such an overwhelming response is a clear demonstration of the strength of feeling in the LGBT community among people who want to be heard and to make a difference wherever they live in the UK, in inner cities or rurally. Living in a rural village can be more isolating then living in a town or city.
In response to that survey, we committed ourselves to bold action, publishing the LGBT action plan in July 2018. It acknowledged the need for a cross-Government approach to tackling inequality. The plan, led by the Government Equalities Office, highlighted key areas of focus including health, education and safety among others. For the purposes of this debate, I will focus on the health commitments.
It is unacceptable that, as the evidence shows, LGBT individuals face significant inequalities, especially in their health outcomes. The provision of comprehensive health and social care for all, irrespective of gender or sexual orientation, remains a cornerstone of the national health service, and one to which we remain committed. Delivery of our health commitments outlined in the LGBT action plan remains a priority for us. We have made significant progress, including appointing the first national LGBT health adviser, Dr Michael Brady. To answer the question put by the hon. Member for Ellesmere Port and Neston, the Secretary of State for Health and Social Care gave a commitment to the Women and Equalities Committee last July that the health adviser’s role would continue beyond March this year. Final arrangements to confirm that are currently being agreed with NHSE&I. Starting to identify the organisations best able to deliver adult gender dysphoria services and funding the Royal College of Physicians to develop the UK’s first accredited training course in gender medicine are examples of the significant progress that we have made.
It is worth reflecting for a minute on the appointment of Dr Brady, who is a sexual health and HIV consultant at King’s College Hospital, as well as medical director of the Terrence Higgins Trust. He remains committed to working across the NHS and to ensuring that the needs of LGBT people are considered throughout the health service. He is passionate about the creation of a workforce equipped with the relevant knowledge and skills to enable them to better deliver patient care that is focused on the needs of individuals. We have heard repeatedly this afternoon that the individual is sometimes lost when they are trying to access healthcare out there. I would like to take this opportunity to thank him and his team for their continued efforts and dedication in driving that work forward.
We have focused on the needs of the community as a whole, but it is important that we do not fall into the trap of thinking that this is a homogenous group. That was something that my hon. Friend the Member for Runnymede and Weybridge bought up. I recognise that we must think carefully about different needs, including understanding the needs of lesbian, bisexual and trans women within their own communities. It is vital that we develop a sound evidence base to support future policy improvements. That will also help with the education of others, because unless we can explain why we are doing something, it is hard to train others in why they should be doing it.
I have heard the concerns about the lack of data on sexual orientation and the impact of this on evidence-based policy decisions. We know that robust data collection on sexual orientation enables policy makers, commissioners and providers to better identify potential health risks. We can then provide targeted preventive early interventions to address health inequalities. As with most things, when these issues are tackled early, there is often much less consequential damage further down the line.
The national LGBT health adviser continues to lead on the introduction of effective sexual orientation, gender identity and trans status monitoring across the NHS and social care system. That is no easy task. It is imperative that lessons are learned from the previous sexual orientation monitoring information standard pilot, and that the work is aligned across Government. The national adviser plans to relaunch the SOM across the system to raise awareness about why we need to collect data on sexual orientation and how we share the learning from areas that are already implementing things successfully. If we can learn from best practice, we should do so. I understand that progress on this seems slower than some would hope, but we want to make this happen in the most effective way in order to reduce health inequalities.
Access to, and the provision of, mental health services for LBT people is constantly reported as a major inequality. The GP patient survey last year found that lesbian women were nearly three times as likely, and bisexual women more than four times as likely, as heterosexual women to report a long-term mental health condition. As the hon. Member for Livingston articulated so well, this has a real effect on real lives. I firmly believe that the publication of the NHS long-term plan and the actions it contains will enable us to better identify such inequalities and implement tailored interventions. Local areas are being supported to redesign and reorganise core community mental health teams, and to move towards more place-based, multidisciplinary services that align with the primary care networks.
We remain focused on the need to reduce suicide across the LGBT community, while recognising that today we are talking specifically about women. There are several cross-Government initiatives, including the national suicide prevention strategy, the cross-Government suicide prevention workplan, which was published in January 2019, and the local authority suicide prevention plans. Suicide and self-harm is more prevalent among LGBT communities. It should not surprise anyone that the right to be happy includes being able to be who you are.
I recognise that there is concern about access to screening programmes, particularly for the trans community and for trans women in particular, and that that might lead to poorer outcomes for this population group. It is imperative that all groups are treated with dignity and respect at all times, and that they should not fear embarrassment or intrusive questions when accessing such services. The focus must be on ensuring that trans and non-binary people are aware of the screening programmes for which they are eligible, and understand those to which they will not routinely be invited. Public Health England’s comprehensive screening leaflet, “Information for trans people”, aims to improve accessibility to screening for trans and non-binary individuals. It has been developed in collaboration with NHS Choices and representatives of the trans community.
As I am sure many Members are aware, there has been a significant increase in demand for adult gender identity services. These crucial NHS services treat individuals with gender dysphoria, whereby they experience distress and discomfort due to a mismatch between their biological and gender identity. In response, NHS England launched an ambitious programme of work to tackle waiting times and improve access—which I know is still challenging —setting out places to establish new gender services in primary and community settings, and increasing the amount of surgical services and the number of gender dysphoria clinics. That is critical if the Government are to achieve their ambition to support everyone, irrespective of gender and sexual orientation, to live a happy and healthy life.
In conclusion, it is clear that, while we have made significant progress, there is still much more to do. As the hon. Member for North Down (Stephen Farry) said, we are all the same, no matter where we live in the UK. I reiterate that the Government have made real progress and we will continue to make a positive change. I am sure that the House is united on the need to reduce LGBT health inequalities. We all have the right to have our healthcare needs met. The contributions made to this debate will undoubtedly help drive forward our commitment and keep us focused.
Oral Answers to Questions
Jo Churchill Excerpts(4 years, 1 month ago)
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The Parliamentary Under-Secretary of State for Health and Social Care (Jo Churchill)
We are creating an extra 50 million appointments a year in primary care, and we are growing the workforce by some 6,000 more GPs and 26,000 other clinical staff on the frontline. We are encouraging everyone to “Think Pharmacy First”, so that access to the right healthcare professional is there when people need it.
Jo Churchill
Shortly—I thank my right hon. Friend for that. First, I should like just to whip over the statistics. In December, there were nearly 400 more nurses, 200 more doctors and 1,000 more other staff providing patient care in primary care than there were a year earlier. By encouraging recruitment and retention, and minimising unnecessary bureaucracy, we will help primary care to support the patients in the most appropriate way and ensure that everyone has faster access to appointments sooner. If you would indulge me for a second, Mr Speaker, I would like to thank all those in primary care and across the NHS, who are working harder than ever to provide support to patients as our response to coronavirus ramps up. Everyone has a part to play in getting through the next few weeks and months. We are rightly proud of how our NHS has and will continue to support anyone affected, but we need also to support them.
Edward Timpson
At a time when the Government are rightly committed to increasing GP provision, my constituents and I are deeply concerned that Sandiway surgery in the north of Eddisbury has been earmarked for closure by its practice group. What can my hon. Friend, or Cheshire clinical commissioning group, do to help the practice to improve its overall standard so that it can continue to treat its 3,700 patients for many years to come?
Jo Churchill
The closure of any GP practice stirs up understandably strong emotions in the local community. The Care Quality Commission inspection last May highlighted safety concerns at Sandiway surgery, and significant investment is required to bring the premises up to standard. I believe Danebridge medical centre has consulted on and looked into the difficult decision to close the practice and increase appointments and services at the other two local practices. As ever, I am happy to meet my hon. Friend to discuss how we can ensure that Sandiway residents have access.
Jonathan Ashworth (Leicester South) (Lab/Co-op)
I note what the Minister said about GPs and their role in responding to covid-19, and I entirely agree with her. GPs want to do their very best for their patients. They need quicker access to protective equipment and they need clear guidance. Will the Minister lift all the bureaucracy that GPs currently face? I am talking about appraisals and the quality and outcomes framework end-of-year requirements. Will she suspend those requirements so that GPs can focus entirely on responding to coronavirus?
Jo Churchill
I am currently having discussions to make sure that, within the bounds of making sure that patients stay safe, we can lift all bureaucracy where appropriate. We now have more than two thirds of personal protective equipment rolled out into GP surgeries, with the rest arriving imminently.
Jonathan Ashworth
Many of our constituents, especially those with underlying conditions—from emphysema to chronic obstructive pulmonary disease, diabetes and asthma—will look to GPs for guidance. When they see what is happening today in Italy, they will be extremely frightened. What is the Government’s advice to those with underlying conditions? Will the Minister tell the House, for the benefit of our constituents, what lessons the Government have learned from the Italians about their handling of coronavirus to date, and why we are taking a different approach?
Jo Churchill
As we have laid out from the beginning, our approach will be science-led and about the safety of everybody. That is why at some point in future doctors will make decisions and clinical judgments, and those with existing co-morbidities or at the more serious end of an illness will be triaged up into an appointment first. That may mean that some people have to wait a little longer during this period, but it will always be done on clinical advice and with the safety of the patient at the heart of things.
Martyn Day (Linlithgow and East Falkirk) (SNP)
Last year, 85% of doctors surveyed by British Medical Association Scotland said that the pension taxation crisis would have a significant effect on NHS services, such as through waiting times. The Government’s proposal to raise the taper threshold to £150,000 does not fully solve the problem and would cost the Treasury more than it would to reverse the policy, so what is the Minister doing to address the issue?
Jo Churchill
I am sure the hon. Gentleman will understand that my right hon. Friend the Chancellor might be a little upset if I started to make announcements from the Dispatch Box today. It is a work in progress. It has been a little trickier with general practice than it is in the health service, because GPs do not do specific shifts, making it a little trickier to organise.
Martyn Day
Scotland’s Cabinet Secretary for Health, Jeane Freeman, wrote to the Chancellor last month to call for a sustainable resolution on this matter in the Budget. Ahead of tomorrow’s Budget, what assurance can the Minister offer that the joint Department of Health and Social Care and Treasury review of the impact of pension taxation on the NHS will produce a long-term solution that will work for all doctors?
Jo Churchill
I gently refer the hon. Gentleman to the answer that I gave a few moments ago.
Scott Mann (North Cornwall) (Con)
Jo Churchill
Yes, they most definitely can. Many surgeries are making sure that “Digital First” is becoming part of their everyday offer to patients across the land. We have a real chance to ensure that we both protect the health of the nation and embrace digital technology to improve access to GPs still further.
Bridget Phillipson (Houghton and Sunderland South) (Lab)
For years, GP numbers in Sunderland have been falling at a much steeper rate than in the rest of the country. Since 2015, we have lost 29 permanent family doctors. Given the major health inequality issues that we already face, when will the Minister get to grips with the worsening situation that we face in Sunderland?
Jo Churchill
We are committed to providing those extra 6,000 GPs across the country. We have also made sure that incentive schemes are in place in areas where it is difficult to recruit, and they have been found to be very effective in driving additional GP numbers into challenging areas such as the hon. Lady’s constituency. We are working on the matter.
Mr David Davis (Haltemprice and Howden) (Con)
Abena Oppong-Asare (Erith and Thamesmead) (Lab)
The Parliamentary Under-Secretary of State for Health and Social Care (Jo Churchill)
Last year, 1.5 million more people with suspected cancer were seen by a specialist compared with the numbers in 2010, thanks to our dedicated workforce. We want to go further and diagnose three quarters of all cancers early—more if possible. I am grateful to those charities, particularly ovarian cancer charities, that are raising awareness this particular month. For cancers like ovarian, where symptoms are vague and can be harder to detect, it is more difficult. To achieve the ambition, we are radically overhauling screening to improve access to uptake and investing £200 million in diagnostic equipment.
Abena Oppong-Asare
What is the Minister doing to ensure that all women who are referred on this are diagnosed for ovarian cancer or ruled out within 28 days, in line with the faster diagnosis standard?
Jo Churchill
Under the long-term plan, we are rolling out the rapid diagnostic centres, giving GPs another important route to patients. With the Mike Richards screening review, we are making sure that we get patients to the clinicians—where they need to go—so they can access treatment faster. It is more important than anything else that we get the cancer early, so we can treat it well and give people a real chance of a long life.
Mr Alistair Carmichael (Orkney and Shetland) (LD)
The Parliamentary Under-Secretary of State for Health and Social Care (Jo Churchill)
As I say, cancer survival is our priority and that was made clear in the long-term plan. Unlike many cancers, we have not moved the dial really far enough for patients with brain cancer. To ensure better outcomes for those affected by brain tumour, we need to focus and redouble our efforts on innovative research and new methods of diagnosis and treatment. That is why we have pledged £40 million over five years to stimulate brain tumour research, working alongside the Tessa Jowell brain cancer charity.
Mr Alistair Carmichael (Orkney and Shetland) (LD)
That is welcome news. Ten per cent. of all cancer deaths of people under 50 are from brain tumours, but the cancer receives only 2% of the money spent on cancer research funding. The previous Government established an inquiry into this to see what more could be done. Does the Minister agree that this month, which is Brain Tumour Awareness Month, would be a good time to re-establish that inquiry?
Jo Churchill
I would be more than happy to meet the right hon. Gentleman to talk about his ambitions. The funding is going up and, as I have said before, it is always welcome to me when cancer charities drive awareness, so that people are more aware of the symptoms, particularly of cancers where we are not moving forward fast enough.
Mr Barry Sheerman (Huddersfield) (Lab/Co-op)
The Parliamentary Under-Secretary of State for Health and Social Care (Jo Churchill)
I strongly urge all parents to ensure that they vaccinate their children. Public Health England and the NHS are implementing actions from the measles and rubella UK elimination strategy, designed to increase the take-up of the MMR vaccination in children, adolescents and adults. That includes providing additional opportunities to catch up on missed vaccines and improving information to the public that emphasises the importance of getting the MMR vaccination.
Mr Sheerman
I hear what the Minister says and of course all our thoughts are on coronavirus virus at the moment, but is she aware that last year 143,000 people, mainly children and young people, died from measles and that the measles epidemic is going to come here as the rate of protection from the MMR vaccine decreases? This is a real issue. Will she join my campaign to make sure that every child who goes into pre-school care and early school has a certificate saying they have had the MMR vaccine?
Jo Churchill
I would love to meet the hon. Gentleman to talk about his campaign because the Government are looking at any way we can improve vaccination rates. Vaccinations work on protecting the herd and losing the World Health Organisation status on measles last year was very sad. That is something that we should all be mindful of. We should make sure that we all look to help people to access MMR vaccines for their children.
Duncan Baker (North Norfolk) (Con)
Health Protection (Coronavirus) Regulations 2020
Jo Churchill Excerpts(4 years, 1 month ago)
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The Parliamentary Under-Secretary of State for Health and Social Care (Jo Churchill)
I beg to move,
That the Committee has considered the Health Protection (Coronavirus) Regulations 2020 (S.I. 2020, No. 129).
In the time available to me, I will remind hon. Members of the seriousness with which we should address the threat of covid-19, and the context for the Government’s response. I will then explain the workings of the regulations and how they fit into our wider strategy for addressing the outbreak.
On 31 December 2019, Chinese authorities notified the World Health Organisation of an outbreak of pneumonia in Wuhan city, which was later classified as the new disease covid-19. Based on current evidence, the main symptoms of covid-19 are a cough, a high temperature and, in severe cases, shortness of breath. It is a new virus, so there is a lack of immunity in the general population and, as yet, no effective vaccine. This means that covid-19 has the potential to spread extensively in the population, as we are seeing.
As of 9 March, 36 further people in England have tested positive for covid-19, bringing the total cases in England to 280. The total for the United Kingdom now stands at 319, including 23 in Scotland, four in Wales and 12 in Northern Ireland. Fifteen cases have been discharged following two consecutive negative test results, and contact tracing is still under way for all cases, including where the route of transmission is not yet clear.
Although our knowledge is growing by the day, much remains unknown. The four UK chief medical officers have been clear that the disease currently presents a moderate risk to the public, but that planning and preparation for the potential of a more widespread outbreak is sensible. As the Prime Minister made clear, there could be a “very significant expansion” of the number of coronavirus cases in the UK.
Tackling covid-19 requires a robust, integrated and proportionate response. On 3 March, the Prime Minister introduced the UK’s coronavirus action plan, providing the public with information on what the Government have done and plan to do to tackle the coronavirus outbreak. The Government’s approach to tackling covid-19 can be summarised in four succinct phrases: contain, delay, research—this underpins everything—and mitigate. The Government have focused over past weeks on the containment phase, taking measures to limit the spread of the virus as much as possible. A crucial aspect of that is ensuring that people who are contacts of known cases, or who are considered to be at high risk of infection, are isolated from others for a period of time, ensuring that they cannot infect others but can readily access help if they fall ill.
However, we are acutely aware of important gaps in our public health legislation that could undermine the success of this policy. It was to address these gaps that the Secretary of State for Health and Social Care laid the instrument before Parliament on 10 February 2020 and made a statement to the House on 11 February 2020 about that action. The regulations provide the power to screen, isolate and detain those at risk of spreading covid-19 and, if necessary, to keep them isolated for a period of time.
I will explain the powers in the regulations for the benefit of the Committee. Regulation 3 places stringent requirements on when the regulations can apply. First, the Secretary of State must declare
“that the incidence or transmission of Coronavirus constitutes a serious and imminent threat to public health”.
Secondly, the incidence or transmission of the virus must be at such a point that the regulations may reasonably be considered effective in preventing further transmission.
Regulation 4 sets out that the Secretary of State or a registered public health consultant may require that someone is detained for screening and assessment, either if they reasonably believe that that person is, or may be, infected with coronavirus and may infect or contaminate others with that virus, or if that person has arrived into England from an affected area. Regulation 5 permits them to impose various restrictions to ensure that screening and assessment can take place. Regulation 6 outlines in more detail what screening may involve. Regulation 7 sets out further restrictions that may be applied, including restrictions on travel, activities and contact with others.
Regulation 8 covers the isolation of persons who are or who are suspected to be infected with coronavirus. Regulation 9 places a requirement on the Secretary of State to have regard to the wellbeing of anyone who is detained and to review any continued detention over a 14-day period. Those are important safeguards when imposing restrictions on individuals.
Regulation 10 relates to the application of the provisions to groups. Regulation 11 enables a registered public health consultant or the Secretary of State to apply for a part 2A order for powers to protect public health. Regulation 12 covers appeals, while regulations 13 and 14 enable police constables to enforce detention requirements or to initiate detention if they have reasonable grounds to suspect that someone is or may be infected with coronavirus. Regulation 15 covers offences, while regulation 16 sets out that the regulations are subject to sunsetting two years from the date of commencement.
The regulations enable the Government to take the necessary steps to minimise onward transmission by individuals who are or who may be infected with the covid-19 virus, and to ensure that those steps are proportionate and effective. I therefore commend the regulations to the Committee.
Jo Churchill
I do not know whether I caught every one of those questions, but if I have missed any, I promise I will write to the hon. Lady to fill in the gaps. I will give it my best shot.
The legislation was made to ensure that we had the means of detention there, should we need it. If we go back—I see that one of the hon. Members from the Wirral, or near the Wirral, is here—
Jo Churchill
Liverpool. I will take this moment to put on record how brilliant not only the health service, but the local councils and everybody involved in the self-isolation of individuals at both Arrowe Park and Kents Hill Park have been. However, the need to have a deterrent was made clear during that period. That is why this statutory instrument was brought forward. It was deemed that the powers to invoke section 2A, go to the magistrates and use that route would perhaps take too much time for us to be able to effect what we may—but what, in the circumstances at that time, we did not—need to do. This piece of legislation is there so that we can invoke it.
On the sunset clause, this legislation will drop after two years. That was deemed a suitable period of time, but if during that period it is determined that coronavirus is no longer a threat, the Secretary of State has the power to revoke. The chief medical officer and chief scientific advisers have indicated that we are not totally sure of the trajectory, and it may be that we get another peak later in the year. We therefore have the flex to allow us to invoke these measures. I hope that that provides clarity.
The regulations give public health consultants, public health officers, the Secretary of State and members of the constabulary the power to detain. All appropriate safety measures would be taken if we were to use those powers. The hon. Member for Washington and Sunderland West was rightly concerned for anyone enforcing these measures. Instructions on how people are to behave at the point at which these measures are invoked is covered, with the personal equipment they may need and so on, to ensure that everyone is kept safe. Ensuring population safety and being led by scientific advice is at the heart of the Government’s response to coronavirus.
It may be that we move on from self-isolation and need the regulations for something different. As we move forward, isolation will probably be for different reasons, such as protecting the vulnerable, among others.
I totally understand the hon. Lady’s comments about statutory sick pay and so on, but the Secretary of State answered many of those points during the urgent question earlier. He said that many such challenges have been sorted out, but that some—particularly those for the self-employed—have proved trickier to deal with through the normal channels, because statutory sick pay is normally received from the employer.
Ms Karen Buck (Westminster North) (Lab)
The Minister may be coming on to this, although she has moved on from the question she was asked about capacity. What are the resource implications if a small but potentially significant number of people need to be detained against their will? Even if only 0.1% of people needed to be detained, that would have significant implications in respect of where they are detained and how that is enforced, as well as for the police. Will she give us some detail on that?
Jo Churchill
On enforcement, the police have powers to take individuals into custody and return them to designated places. Just as we invoked Arrowe Park and Kents Hill Park, we have other facilities around the country to ensure that people can be encouraged to complete their period of quarantine to protect others. That is the point of these powers. It is not envisaged that this would be used for a mass quarantining situation.
Tracey Crouch (Chatham and Aylesford) (Con)
I am sure that the Minister is coming to this point, but the hon. Member for Washington and Sunderland West asked a question that pricked up my ears, not just as a Member of Parliament but as the proud aunty of a police constable in Kent, about the advice officers will receive about maintaining their own wellbeing in the event of these powers being executed.
Jo Churchill
I am quite happy to write to my hon. Friend on the specifics, rather than give her something that is not correct, because I do not have the exact answers to hand and that is not really in the scope of the regulations. I hope she will forgive me.
Tracey Crouch
I will be happy to receive that correspondence, as I am sure will many colleagues, but it would be reassuring for Members of Parliament—as well as proud aunties—to know that such conversations are taking place with the Home Office and with police and crime commissioners, so that chief constables are getting out to their frontline police officers what protective measures they need to take when dealing with those who may need to be detained because of coronavirus.
Jo Churchill
I hear what my hon. Friend says and I assure her that conversations are under way with all elements of the public sector to ensure that people’s safety is paramount at all times: proud aunties, worried mums, brothers, sisters, all of them. She makes a serious point. We must have adequate information so that those whom we expect to do things feel safe. The same applies to the advice being given right through the health service. All those elements are extremely important.
However, I reiterate the point that this specific piece of legislation is to ensure that an individual can be encouraged to continue and fulfil their period in isolation if we are concerned that they might infect the broader population. The measure is for those single cases. It might not involve a police constable; it could just as likely be another individual if the powers are necessary. I stress that we have not used the regulations since they were laid on 10 February. They have been an excellent deterrent.
Ruth Cadbury (Brentford and Isleworth) (Lab)
I thank the Minister for her explanation of the purpose of the regulations. I absolutely understand they might not be needed, because we hope that people will comply with what is best not only for themselves, but for the population as a whole. Unfortunately, this is an instance where human rights have to temporarily take a back seat to the importance of the health of the whole population, including the person concerned.
My hon. Friend the Member for Washington and Sunderland West has raised specific questions, and the Minister has been very kind in answering them. I have one question that my hon. Friend did not raise about appeals in regulation 12, which states:
“A person in relation to whom a restriction or requirement is imposed under these Regulations may appeal to the magistrates’ court against the decision to impose that requirement or restriction.”
Ditto a person with parental responsibility. I recognise that the Minister might need to get back to me, but what if a magistrate finds in favour of the state and upholds the state’s restriction on that person? Does that person have a right of appeal? If the magistrate finds in favour of the person who is restricted and says, “No, it was not necessary to impose restrictions on you,” does the state have the power of appeal against the magistrate’s decision?
Jo Churchill
If I may, I will write to the hon. Lady with accurate clarification on that, but the move to detain somebody would be when they were known to have the virus, and therefore on the basis of public health and taking the advice of public health officials, they would be a known risk to others. I would therefore argue that what she suggests would not apply. However, I will write to confirm that.
I thank hon. Members for their contributions to the debate. We must continue to take the most appropriate and effective measures to tackle the new virus. Keeping people safe is our absolute top priority. The regulations are an important part of that work and I conclude that they are essential to support the Government’s response to the covid-19 outbreak. They are, as I have said, time-limited and include safeguards and requirements on those exercising the powers to ensure that they are used only for essential public health measures. I commend the regulations to the Committee.
Question put and agreed to.
WHO Framework Convention on Tobacco Control
Jo Churchill Excerpts(4 years, 1 month ago)
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The Parliamentary Under-Secretary of State for Health and Social Care (Jo Churchill)
I thank my hon. Friend the Member for Harrow East (Bob Blackman) for securing this important debate on the World Health Organisation framework convention on tobacco control. His passionate work on tobacco harms, including through his chairmanship of the all-party group, and the work of his worthy sidekick as co-chair, continues to keep us focused on what we have to do and on our goal of being smoke-free by 2030. I thank them for that. I agree with both of them that smoking is one of the most significant public health challenges that we face today and that, sadly, it is one that disproportionately affects disadvantaged groups, with the resultant impact on their health and their finances.
This year, the WHO framework convention is celebrating its 15th anniversary. Over those 15 years, the parties to the convention have worked towards a tobacco-free world. We have seen encouraging improvements in tobacco control worldwide, but there is still much more work to be done to protect the world’s population from the harms of a tobacco epidemic.
As a recognised world leader in tobacco control, the UK is firmly committed to the World Health Organisation’s framework convention on tobacco control—which I will now abbreviate to FCTC for all our sakes—and we will remain an active member. I thank my hon. Friend for continuing to remind us how important the obligations under the convention are. In answer to his direct question, we will remain fully committed to the convention and, importantly, to article 5.3 during the transition period and beyond. I can assure him, as my predecessor did, that we write to NHS trusts and local authorities to remind them of their obligations under article 5.3 to protect public health interests from tobacco industry interference. I am proud that, in the first global tobacco industry interference index, published last year, we were rated No. 1 for the work we do to protect health policy from tobacco companies, but I take on board the fact that we need to make sure we continue on that path.
It is estimated that at least 8 million deaths around the world every year are linked to tobacco—more than for AIDS, tuberculosis and malaria combined. Some 80% of the 1 billion smokers live in low and middle-income countries. That puts a huge strain on the development of those countries and their achievement of the sustainable development goals. There is high demand from such countries for help to implement tobacco control measures. That is why, as a global leader, the UK is providing support, via official development assistance, to the FCTC 2030 project, working with low and middle-income countries to support its implementation, with the ultimate aim of reducing the burden of tobacco-related deaths and diseases.
The project has received praise from countries participating, as well as from the global public health and development communities. It has also helped to raise the UK’s profile as a global leader in tobacco control, and is strengthening its global reach. Building on that success, we are increasing capacity within the existing budget to include several more countries to support over years four and five.
In the UK, smoking prevalence is at the lowest ever rate on record and is falling, but we are not complacent—as has been pointed out, the rate of decline is slowing. Around 78,000 people die every year in this country from smoking-related illnesses. As I said yesterday during the debate on health inequalities, and as my hon. Friend pointed out so eloquently, we know that the smoking habit particularly affects disadvantaged communities. We must end that, and our prevention Green Paper sets out the ambition to be smoke-free by 2030. That is undoubtedly a challenging ambition. The public consultation that closed in October had 1,600 responses—more than double the number we usually get—and it is taking some time to go through the analysis. We are analysing the proposals and developing our own response, which will be with Members shortly.
Alex Cunningham
I appreciate everything the Minister is saying. It is the 2030 target I am really interested in. The estimate a couple of weeks ago was that, with current programming, we are 20 years behind where we need to be. Will she tell us how we are going to achieve that target instead?
Jo Churchill
I thank the hon. Gentleman, and, yes, I will. There is a need to be smarter with what we do. As was stated, we will achieve the target in some communities, but not in others, so refocusing on where we have the problem must be part of the strategy. However, as I am sure my hon. Friend and the hon. Gentleman appreciate, I do not want to pre-empt what we publish in the Green Paper.
I acknowledge and thank my hon. Friend and the hon. Gentleman for the report by the all-party parliamentary group on smoking and health, which I have read and which sets out the group’s recommendations, including on the smoke-free 2030 fund. I assure them that the Department will speak to Her Majesty’s Treasury to discuss possible financial levers to support our smoke-free ambitions. However, I also expect that both of them—and particularly my hon. Friend, who is indefatigable in his lobbying on this matter—will lobby the Chancellor themselves.
Across the country, people are tackling the harms of tobacco every single day. During a recent visit to Tameside Hospital, I witnessed at first hand the commitment and dedication of healthcare professionals involved in the delivery of an innovative approach to reducing smoking in pregnancy. While the hon. Member for Stockton North (Alex Cunningham) was speaking, I was reflecting on the fact that many of the things that he was saying about his own constituency were very similar to those in this particular project. The prevalence within their local community to start with was much higher than average, and the people who were starting to smoke as a habit were of a much younger age. Therefore, by the time these young women were pregnant, they had been smoking for a longer period of time, making cessation more difficult. The project was thoughtful and holistic in terms of the agencies that it used, and the way that it wrapped around the young pregnant women. It actually reached out into their families, encouraging partners, mothers and other family members to support them. That gave the young women a great deal of motivation. I spoke to one young father who had not yet managed to quit his habit, but he had taken many of the messages on board, was not smoking in their home, and was actually attempting to change his behaviour for the long-term benefit of his future’s baby’s health.
This is a particular passion of mine. I believe that we give both people a much better, healthy start if we can tackle pregnant mums as a particular cohort, because, obviously, we not only help the mother, but, as my hon. Friend has said, help the future health of the baby and ensure that a health compromised by smoking in pregnancy is not something that then follows them through their lifetime. I spoke to those mums and partners about how using a joined-up approach could work and I would be delighted if my hon. Friend and the hon. Gentleman would talk to me further about the matter.
Bob Blackman
I thank my hon. Friend for her commitment to this undoubted health challenge and also for what she said about pregnant young women. It is not the case that these young women who are found to be pregnant are automatically routed to smoking cessation services yet—neither are their partners. It is, in the long-term, an NHS plan to do that. Given what my hon. Friend has said and that she has seen the success of the trials, will she try to bring that plan forward so that we actually give every pregnant woman who smokes the opportunity to be seen by smoking cessation services? In that way they can not only understand what they should do and how they can quit, but see the damage that they are causing to their unborn child as a result of continuing to smoke.
Jo Churchill
I can certainly assure my hon. Friend that I am speaking with my officials all the time about how we can make programmes such as this more effective and ensure that they reach out, but they have to be part of a comprehensive programme. We have to understand how we can best help communities most challenged by smoking, who fall outside the 2025 target; we need to pay attention to the detail if we are to address their 20-year trajectory. I would be delighted to have a further conversation on that matter with my hon. Friend at some point in the future.
I wish to assure my hon. Friend that we are determined to build on the success of work so far to sustain our global efforts to tackle the tobacco epidemic and work towards England becoming smoke-free by 2030. I can also assure him that I am committed to seeing more individuals receive help so that they can successfully quit the habit.
Bob Blackman
Before the Minister sits down, let me counsel her that one of her predecessors, my hon. Friend the Member for Winchester (Steve Brine), was asked during his first outing at the Dispatch Box in Health questions when the prevention Green Paper would be published, and—to the consternation of his officials—he announced, “This month”. Therefore, if the Minister would do us the honour of saying when we will get the response to the Green Paper, I am sure—to the consternation of her officials—we would get some urgent action.
Jo Churchill
I will resist the temptation to name a date, as I am sure my hon. Friend appreciates that I have one or two other things on my desk at the moment, but we will make sure that the document is with him as soon as possible.
Question put and agreed to.