Health Bill
House of Commons · Commons Chamber · 8 Sep 2026 · 412 speeches · Official Report
[2nd Allocated Day]
Further c onsideration of Bill, as amended in the Public Bill Committee
[ Relevant documents: First Report of the Health and Social Care Committee, Health Bill 2026-27, HC 219; and o ral evidence taken before the Health and Social Care Committee, on the Work of NHS England, 20 May, HC 583.]
New Clause 94
Medical devices regulation: Great Britain
“At the beginning of Part 4 of the Medicines and Medical Devices Act 2021 insert-
“Chapter A1
Medical devices regulations (Great Britain)
14A Licensing of medical devices
(1) The Secretary of State may by regulations (“medical devices regulations”)-
(a) prohibit a person from carrying out the following activities in the course of business otherwise than in accordance with a product licence-
(i) supplying medical devices;
(ii) advertising medical devices;
(b) prohibit a person from carrying out the following activities in the course of business otherwise than in accordance with a personal licence-
(i) manufacturing medical devices;
(ii) importing medical devices;
(iii) supplying medical devices by way of wholesale dealing;
(c) prohibit a person from carrying out a clinical investigation in relation to a medical device otherwise than in accordance with a personal licence.
(2) In subsection (1)(b)(ii) the reference to importing medical devices is to-
(a) importing medical devices into the United Kingdom as a result of their entry into Great Britain, or
(b) removing medical devices to Great Britain from Northern Ireland.
(3) The Secretary of State’s overarching objective in making medical devices regulations, and in exercising any functions under them, is to safeguard public health.
(4) In considering whether the exercise of a function would contribute to that objective, the Secretary of State must have regard to-
(a) the safety of medical devices;
(b) the availability of medical devices;
(c) the likelihood of the United Kingdom being seen as a favourable place in which to-
(i) carry out research relating to medical devices,
(ii) develop medical devices, or
(iii) manufacture or supply medical devices.
(5) In this Chapter-
“personal licence” means a licence, issued by the Secretary of State, authorising the licence holder to carry out an activity mentioned in subsection (1)(b) or (c) in relation to a medical device of a description specified in the licence;
“product licence” means a licence, issued by the Secretary of State, authorising the supply or advertising of a medical device of a description specified in the licence (whether by the licence holder or otherwise).
(6) Nothing in the later provisions of this Chapter limits the breadth of the power conferred by subsection (1).
14B Grant of licences
(1) Medical devices regulations may make provision about the grant of licences.
(2) The provision that may be made includes provision-
(a) requiring the Secretary of State not to grant a licence unless satisfied as to matters specified in the regulations;
(b) requiring the Secretary of State to have regard, in deciding whether to grant a licence, to matters specified in the regulations.
14C Licence conditions
(1) Medical devices regulations may make provision about licence conditions.
(2) The provision that may be made includes provision-
(a) enabling the Secretary of State to include conditions in a licence;
(b) requiring the Secretary of State to include in a licence a condition specified in the regulations;
(c) specifying conditions that, by virtue of the regulations, are to be treated as included in every licence.
(3) The provision that may be made includes provision about the variation of conditions included in a licence.
(4) Conditions may, in particular-
(a) impose requirements on the licence holder, or
(b) in the case of a product licence, impose requirements relating to the supply or advertising (by anyone) of the medical device to which the licence relates.
(5) Conditions imposing requirements on a licence holder may, in particular-
(a) require the monitoring, investigation or evaluation of the safety or performance of a medical device;
(b) require the provision of information to the Secretary of State;
(c) require the appointment by the licence holder of an individual who is resident in the United Kingdom and is authorised or required to act on the licence holder’s behalf in relation to matters of a specified description.
14D Duration of licences etc
Medical devices regulations may make provision about the duration, renewal, variation, suspension, revocation or transfer of licences.
14E Exemptions for public health purposes
(1) Medical devices regulations may authorise the Secretary of State to grant a temporary exemption from any provision of the regulations for the purposes of protecting public health.
(2) The regulations may provide for an exemption to be subject to conditions set out in the regulations or published by the Secretary of State.
14F Register of licences
Medical devices regulations may include provision for or in connection with the establishment of a public register containing information about licences.
14G Offences
(1) Medical devices regulations may create offences in relation to-
(a) a failure to comply with specified provisions of the regulations, or
(b) the provision of false or misleading information to a person for the purposes of anything required or authorised by the regulations.
(2) The regulations must provide for any such offence to be punishable-
(a) on summary conviction in England and Wales, by imprisonment for a term not exceeding the maximum term for summary offences or a fine (or both), or
(b) on summary conviction in Scotland, to imprisonment for a term not exceeding 12 months or a fine not exceeding level 5 on the standard scale (or both).
(3) In subsection (2)(a) “the maximum term for summary offences” means-
(a) if the offence is committed before the time when section 281(5) of the Criminal Justice Act 2003 comes into force, six months;
(b) if the offence is committed after that time, 51 weeks.
14H Enforcement
Medical devices regulations may confer functions on the Secretary of State or a local weights and measures authority in relation to the enforcement of the regulations.
14I Fees
(1) Medical devices regulations may make provision for the charging of fees that are payable-
(a) in connection with an application for the grant of a licence, or
(b) by the holder of a licence.
(2) Fees must not exceed an amount specified in, or determined in accordance with, the regulations.
(3) The amount, or method for determining it, may take into account the cost of exercising any functions conferred by virtue of the regulations.
(4) The regulations may confer power on the Secretary of State to waive fees.
14J Interpretation
(1) In this Chapter-
“clinical investigation” means an investigation that involves human subjects, or specimens from the human body, and is undertaken to assess the safety or performance of a medical device;
“grant” , in relation to a licence, includes vary or renew;
“licence” means a product licence or personal licence;
“manufacturing” includes assembling;
“medical devices regulations” has the meaning given by section 14A(1);
“personal licence” has the meaning given by section 14A(5);
“product licence” has the meaning given by section 14A(5);
“supplying” includes-
(a) agreeing to supply, or
(b) offering or exposing for supply.
(2) In this Chapter-
(a) a reference to doing anything in the course of business includes doing it in connection with the provision of services in pursuance of arrangements made under any legislation;
(b) a reference to the supply of a medical device by way of wholesale dealing includes the supply of it to a person who receives it for the purposes of providing services to a patient or for the purposes of supplying it to a patient.
(3) The Secretary of State may by regulations make provision as to the circumstances in which a person is to be treated, or is not to be treated, as carrying on an activity “in the course of business” for the purposes of section 14A(1).””
This introduces a new power to make regulations for the licensing of medical devices, which is intended to replace the current regulatory regime in Great Britain . - (Karin Smyth.)
Brought up, and read the First time.
I beg to move, That the clause be read a Second time.
With this it will be convenient to discuss the following: Government new clause 95- Disclosure of information relating to medicines . Government new clause 98- Disclosure of information relating to medical devices . Government new clause 99- Further and consequential amendments relating to medical devices . Government new clause 100- Power to amend meaning of “medical device” . Government new clause 101- Power to restate medical devices law in Northern Ireland . New clause 9- Powers for coroners and medical examiners to report suspected health system failings - “(1) The Secretary of State must, by regulations, establish a standard mechanism for coroners and medical examiners to refer cases where they suspect failings in the provision of health care. (2) A coroner or a medical examiner has a duty to report (a “duty to whistleblow”) using the mechanism established under subsection (1) if, in the course of their duties, they have reasonable grounds to suspect that a death or incident involved systemic failings in a health care setting. (3) A referral under this section must be directed to any or all of the following bodies, as the coroner or medical examiner considers appropriate, based on the nature of the suspected failing- (a) the chief officer of police for the relevant police area, (b) the Care Quality Commission, (c) the Department of Health and Social Care, and (d) the Health Services Safety Investigations Body. (4) Regulations under subsection (1) must specify- (a) the...
I know that many hon. Members want to talk about the provisions in the Bill covering many important issues. I will therefore speak briefly about two Government amendments relating to medical device licensing and information sharing. I will first address new clause 94 regarding medical devices licensing, and consequential amendments new clauses 99 to 101 regarding medical devices disclosure. These amendments are about ensuring that Great Britain’s medical devices regulatory framework remains fit for the future. As we know, medical technology is evolving rapidly, particularly in areas such as software and artificial intelligence, while our current framework was designed for a very different technological landscape. This set of amendments establishes the statutory foundation for a future medical device licensing regime, applying to Great Britain only. EU medical devices legislation will continue to apply in Northern Ireland. Such a regime would require medical devices to be licensed and certain persons operating within the supply chain to hold a licence. By placing the detail in the regulations, the amendment allows us to work with patients, healthcare professionals and the medical device sector to create a regulatory framework that protects patients, supports innovation and strengthens the UK’s life sciences sector.
In the aftermath of the Windsor framework and the damage done to intra-UK trade, section 45B of the United Kingdom Internal Market Act 2020 was passed, which was said to promise that there would be no further export procedures that could impact adversely on trade from Northern Ireland to Great Britain. Yet, in new clause 94, we have such constraints in the imposition of a licensing programme, whereby to bring-I will not say “export”, as it is an internal market-a medical device from Northern Ireland to Great Britain, a licence is needed by the recipient. How is that compatible with section 45B of the United Kingdom Internal Market Act?
As the hon. and learned Gentleman knows-we have spent many long hours in this place discussing the arrangements with regard to our leaving the European Union-there are different regulations, as a result of Brexit, between Great Britain and Northern Ireland. As is currently the case, due to the Windsor framework, that results in Northern Ireland following the EU device regulations. This has been discussed with the Northern Ireland and Windsor framework taskforce in the Cabinet Office, and we are content that the provisions are right, given the framework’s application. I know and understand the point that the hon. and learned Gentleman makes, and I am sure that he will pursue it with the Government in other areas. New clauses 95 and 98 update and clarify the Secretary of State’s information-sharing powers for medicines and medical devices. They provide a clearer legal framework for the Medicines and Healthcare products Regulatory Agency to share information with UK health systems, organisations and trusted international partners. The current legislative framework does not always provide the MHRA with the powers or clarity it needs to share information quickly and effectively, and this creates barriers to collaboration, including with the NHS. The new clauses will address these challenges, providing a clear statutory basis for information sharing. There is currently no explicit statutory domestic information-sharing power for medicines, whereas there is for medical devices. The...
Will the Minister give way?
I think the Minister has finished her remarks.
As is now routine, I declare an interest as an NHS consultant paediatrician, a member of the British Medical Association and a member of the Royal College of Paediatrics and Child Health. Yesterday the Government voted not to introduce a backstop to decide on the Hughes report. I submitted a written question that also had a deadline of last night to ask when they were going to respond, and they have not answered that either. Taking their time about something is one thing, but for the Government to completely ignore victims, refusing to give an answer and refusing to provide a backstop or a deadline, is frankly shameful. Patient safety is really important, and one key element to improving it is striking a good balance between accountability and blame. If we do not hold people accountable for their actions, they may not be as careful, but if they feel that their superiors are looking to find fault, they will be defensive and may cover things up. That makes it hard to get to the root cause and prevent mistakes from happening again. The Health Services Safety Investigations Body, or HSSIB, was set up with this problem in mind. Like the Air Accidents Investigation Branch, it has a safe space. This means that people are not held legally responsible for what they reveal to that team. They can then get to the bottom of why things are going wrong and find system errors. People come forward because they know and trust that HSSIB is independent, but this Labour Government want to...
On the question of how the CQC leadership becomes conflicted, will my hon. Friend reflect on the fact that, in an Adjournment debate I held in July, the then Patient Safety Minister, the hon. Member for Birmingham Edgbaston (Preet Kaur Gill), made it clear that the person responsible for deciding what safe space information might be released would be the chief executive of the CQC? If the chief executive of the CQC is to see all that information, how would he or she not be able to use it, or be tempted to use it, when he or she inspects hospitals for the purposes of the CQC? Would the safe space not then be hopelessly conflicted, and therefore lose public confidence?
Absolutely; my hon. Friend has obviously read my speech. What would happen if the new unit identified the CQC itself as the problem? Ministers have not provided good answers to these questions. To be honest, they cannot, because the Government cannot have their cake and eat it. Either HSSIB remains independent or it is folded into the CQC and loses its independence. The Government are either decluttering the landscape by removing an organisation or simply hiding it inside another organisation, to the detriment of both. We have tabled amendment 1 to protect HSSIB, and I urge the Government to support it in the interests of patient safety.
My hon. Friend is making an important point about HSSIB. We have heard time and again that frontline staff value the safety that HSSIB provides to them and the confidence they have in reporting. Given that we in this Chamber have heard some harrowing stories about maternity services around the country, does she not think it is important that we listen to the staff, and not just one individual with a different point of view?
As always, my right hon. Friend is absolutely right. HSSIB has recently produced a report, which it would benefit the Government to listen to. The House will be aware that the advice and guidance service provides GPs with specialist advice, which sometimes avoids referrals. However, Ministers have made it mandatory to ask for advice before certain types of referrals, and set an aim for one in four referrals to be diverted back. The Government said that they were not rationing care or meddling with waiting lists-that there was nothing to see here, and that the Opposition were spreading misinformation-but HSSIB has published an interim report linking this process to delays in patient care, including cancer diagnoses. New clause 141 asks the Government to suspend the new process until they have properly considered it.
The hon. Lady may be aware that the Health and Social Care Committee has a pre-appointment hearing with the incoming chair of the CQC tomorrow morning. One question I would like to ask them hinges on the answer to another question, on which I would have loved an update from the Minister. The previous Secretary of State said that HSSIB will not be merged with the CQC until the CQC is ready, but we have never had a list from the Government as to exactly what metrics they will use to decide when that happens. That will have a bearing on what kinds of questions we ask the chair and CEO. What specifically do the Government mean by “ready”? Does the hon. Lady not see that as a problem?
I absolutely do. The Government have said that the CQC is not fit for purpose, yet they are now asking it to do things it did not do before, including not only HSSIB but event healthcare management, as the hon. Lady will be aware. It is absolutely right that the Government pause and think this one through again. One of our other amendments concerns puberty blockers. One of the first rules of medicine is primum non nocere-first, do no harm-and yet here we have a Labour Government sponsoring a £10.6 million trial to put 226 physically healthy children as young as 11 on puberty-blocking drugs. That was said to make the former Secretary of State, the right hon. Member for Ealing North (James Murray), “uneasy”. Why was he uneasy? Perhaps because these are powerful drugs that could cause serious long-term harm, because most children get better by themselves, because we cannot reliably identify which children will persist with a trans identity and which will not, because the huge increase in girls experiencing gender dysphoria has not been adequately explained or because the Tavistock data has not yet been reviewed in the data linkage study. There are many reasons for concern, but I am aware that we are short of time. It is difficult for a clinician to tell which children’s symptoms will self-resolve and which will not. As a result, we risk putting a large number of children on puberty blockers to assess the effects on, as the former Health Secretary put it, a “very small subset of...
The Minister will note that there was a vote on this trial at the end of the Opposition day debate in the summer, where a large number of her party abstained and three voted against. There were also votes against from many other parties. As a doctor, I appreciate that voting on a clinical trial is unusual, but let’s be clear: this is the Labour Government’s trial, it is taxpayers’ money being spent and it is young British children who we are talking about. If the Government want to run this trial and pay for it, why not bring it before the House so that parliamentarians can decide whether it is the right thing to do? We have a new Prime Minister and a new Secretary of State. The country needs to know if they are content to pay for a trial of powerful drugs on an unnecessarily large group of children, the majority of whom have self-limiting, temporary feelings of distress.
We also have an amendment regarding single-sex spaces. When the Supreme Court ruled on 16 April 2025 that the legal definition of a woman refers strictly to biological sex, many up and down the country will have wondered, “Why do we need judges to tell us that?” We are all, including in the eyes of the law, male or female. Of course, there are people who feel more comfortable presenting as the opposite sex, and I am sure the whole House would agree that trans men and trans women need protection from harm and harassment in the same way as their fellow citizens. I hope that the whole House would also agree that a woman should never be forced to get undressed in the presence of a man, and vice versa. But that is what happened to the Darlington nurses. Seven nurses were forced to share a changing room with a transgender woman, someone who is male but who presents publicly as a woman. The Supreme Court was crystal clear: the legal definition of a woman is based on biological sex, and yet these nurses were subjected to pressure and intimidation for raising concerns about getting changed in front of someone who is a man.
I thank the hon. Member for giving way and the tone in which she is conducting this debate. Would she feel more comfortable, however, if a transgender man with balding hair and a full beard, who was behaving like a man and full of testosterone, was attending a female toilet facility at night at a motorway service station? I would not feel safe, but it seems she would feel safer in that situation than she would with a trans woman getting changed in front of nurses or attending a toilet.
I am not sure why the hon. Member has reached that conclusion. I am saying that this is based on biology, and people who are trans require the same protections as people who are not-that is what I have said very clearly. The Darlington nurses were particularly brave in bringing their case forward. The cost was £187,000 in damages after an employment tribunal ruled in favour of them. That is a victory for dignity, for women and for common sense, but it is also a significant cost of public money to an NHS trust because it decided not to follow the law. That money could have been spent on patient care. What steps is the Minister taking to ensure that this guidance is fully and properly implemented across the NHS? How will she ensure that a repeat of the Darlington nurses case does not happen again, and what guidance has been given to NHS managers on how to handle this? The Minister for Women and Equalities did not help matters. She had the responsibility to sign off the Equality and Human Rights Commission’s draft code of practice to inform businesses, services and public bodies how to implement the Supreme Court’s guidance in law. But for over a year, the Government failed to lift a finger to enforce the law. For over a year, businesses, hospitals, service providers and public bodies were left waiting for the Government to tell them what the official guidance said. Now that it is here, we need to know how it is being implemented. How will the Minister ensure that this guidance...
With the exception of Front-Bench speeches, there will be an immediate three-minute time limit.
I am speaking today in support of new clauses 113 and 114, which stand in the name of the hon. Member for Westmorland and Lonsdale (Tim Farron) and to which I have added my name. I say at the outset that I am in full support of this Government’s ambitions on cancer. I welcome the recent investment in radiotherapy equipment, and I sincerely want the national cancer plan, which was published in February, to succeed. But I speak as someone who worked in the health service, who is a cancer survivor and who has taken a particular interest in this issue, not least as vice chairman of the all-party parliamentary group on radiotherapy. It is in that capacity, and as a supporter of what the Government are trying to achieve, that I respectfully ask Ministers to accept one or both of these new clauses. By way of brief explanation, new clause 113 requires the Secretary of State to publish and maintain a national framework of agreed metrics for radiotherapy, requires integrated care boards to report annually against those targets and requires a report to this House once a year. New clause 114 asks very straightforwardly for a single review of access to radiotherapy and radiotherapy waiting times to be laid before Parliament within six months.
Does my hon. Friend agree that the ethnic inequalities we see in cancer outcomes and access to cancer treatment such as radiotherapy should also be included in the suggested review?
This is a huge issue that should concern everyone. I believe there is cross-party consensus on the issue of health inequalities and huge variation in access depending on which part of the country people live in. That is an absolutely valid point. We know the international consensus is that around half of all cancer patients have an evidence-based indication for radiotherapy at some point in their treatment. We should be aware that here in the United Kingdom in 2021, the last date for which figures were available, only 35% of cancer patients received it as part of their primary treatment.
I am extremely grateful to the hon. Gentleman for the excellent points he is making. Let me add that in Lancashire and south Cumbria, only 29% of cancer patients get access to radiotherapy. He will be aware the Government’s target is that 85% of people diagnosed with cancer should be treated within 62 days, but only 41% of patients who are recommended radiotherapy get treated in those 62 days. He will also know that for every four weeks of delay in cancer treatment, there is a 10% lower chance of survival. Should the Government not accept new clause 114 to make it mandatory for people to be treated within two months so that they get the best chance of survival?
The hon. Gentleman hits the nail on the head-that is perfectly put. I believe there is cross-party consensus that this is the way forward. Over the last 16 years that I have been a Member, along with the hon. Gentleman, I have presented the case to a whole succession of Ministers from various parties, all of whom seemed to be in agreement. We definitely have an opportunity to restore what was once a world-class cancer service and get us back to where the international benchmarks say that we should be. As I am sure Members are aware, responsibility for commissioning radiotherapies was devolved to the integrated care boards. I can understand the logic of moving commissioning closer to local populations. The hon. Member for Westmorland and Lonsdale, who tabled the new clause, and I do not seek to undo that. However, we wish to stress to the House that radiotherapy is not an ordinary local service, and it should not be considered as one. It is delivered from a very limited number of highly specialised centres dependent on capital equipment with long replacement cycles. It relies on a small, highly skilled workforce of about 6,000 people, all of whom take years to train, all the while relying on physical infrastructure that cannot be commissioned at short notice. Patients routinely cross integrated care board boundaries to reach these specialist centres. Many boards, entirely understandably, do not have dedicated radiotherapy expertise in house. In August 2023, 70% of integrated...
I call the Liberal Democrat spokesperson.
Yesterday, I highlighted our concerns about the implications of quick-fix, top-down reorganisation for the sovereignty of the NHS and the interests of patients. In a system that already spends too much time and money reacting to failure, rather than planning for success, patient safety is already under threat. Rather than addressing those failings, this Bill is at risk of making a bonfire of patient safety. Our amendments would reverse the gutting of safety mechanisms from the NHS, all of which have been painstakingly introduced after far too many scandals. Amendments 8 and 9 would restore Healthwatch England and local Healthwatch organisations, while new clause 14 would restore Healthwatch funding after 10 years of cuts to its service. Given that Healthwatch was originally established as a response to the devastating Mid Staffordshire scandal, its abolition would be a step backwards, showing that lessons have not been learned. An independent patient voice is essential to shape local services and highlight where they are not working well, and folding it into existing NHS structures risks destroying the trust that exists precisely because of its independence.
Will my hon. Friend give way?
I am not going to give way, because there are many colleagues who wish to speak and there is very limited time. I hope my hon. Friend will forgive me. Another vital body for safeguarding and investigating patient safety is the Health Services Safety Investigations Body, which again functions well because of the trust NHS professionals have in its independence and objectivity. Both would be lost under the proposal to roll it into the CQC. Our amendment 12 would ensure that HSSIB’s functions remain operationally independent of the CQC, so that the NHS is not left to mark its own homework. Together, these amendments are designed so that patients are protected from another Mid Staffordshire, another Shrewsbury and Telford, another Nottingham, another East Kent or another Morecambe Bay. Rash decision making must not be allowed to put patients at risk.
We would also go further than protecting existing patient safety measures and significantly strengthen whistleblowing routes through new clauses 9 and 10, which would create standard mechanisms for whistleblowing by coroners and hospital boards, new powers to report wrongdoing, and new requirements on managers and the Department of Health and Social Care to whistleblow where there are concerns about systemic medical malpractice or failure.
However, keeping patients safe goes beyond just blowing the whistle. My hon. Friend the Member for Epsom and Ewell (Helen Maguire) has tabled new clause 52 to give patients a right to start cancer treatment within 62 days of referral, with a scheme to deliver this. Liberal Democrat research earlier this year found that 80% of trusts failed to meet that 62-day target, with nearly 1,000 patients waiting over six months for treatment. People are suffering and dying because of these failures-it just is not safe.
The egregious patient safety failure that I will focus on today, though, is the corridor care crisis. The latest release of monthly corridor care statistics revealed the worst summer on record for A&E waits, with well over 300,000 waits of 12 hours or more in June and July. Nearly 100,000 people were treated in hospital corridors in July. After 2025 saw the worst level of 12-hour trolley waits in A&E ever recorded, this summer’s corridor care statistics show an ever-worsening trend.
The human reality of those numbers is that patients are left to deteriorate for hours in corridors, potentially without food or water, and staff are pushed to breaking point. One nurse described the conditions as akin to “torture”, with a 2025 survey from the Royal College of Physicians finding that 78% of physicians had provided care in a temporary space. The Royal College of Emergency Medicine’s recent “Safe to Care” campaign reveals the huge strain that this type of care puts on staff, with 96% of emergency department staff surveyed reporting that they had experienced violence or aggression as a result. That is totally unacceptable.
In a response to a written parliamentary question I asked in June, the Department of Health and Social Care revealed that it had not undertaken any assessment of the impact of A&E waiting times on excess deaths. Given that the Royal College of Emergency Medicine’s June report estimated that well over 15,000 excess deaths occurred in 2025 in connection with long waits, this lack of investigation by the Department is devastating for patient safety. Inaction on corridor care is costing lives in the thousands every year; it is incumbent on the Government to act now and act fast to put an end to this crisis. I have therefore tabled new clause 140, which would require the Government to end corridor care in NHS hospitals within one year and to launch an independent inquiry into corridor care, including into Government policy, if that is not achieved.
Many of the protections and organisations being abolished or weakened in this Bill were introduced following scandals during the Prime Minister’s tenure as Health Secretary. He promised lasting change and to listen, and previously opposed the removal of Healthwatch, but he is now due to oversee a big backward step in patient safety.
Finally, I am aware that Mr Speaker is provisionally minded to select the official Opposition’s new clauses 142 and 143 for separate decision, so I will briefly outline my concerns about them. New clause 142 seeks to politicise a drug trial in a way that is unprecedented and inappropriate. Drug trials must be protected by objective ethical and medical safeguards, and it is vital that they are undertaken in a way that follows a rigorous, accepted and predictable scientific process that prioritises the safety of patients. Baroness Cass has outlined her concerns about the misinformation surrounding this trial in her letter to all MPs, which was sent before the summer recess-I strongly recommend that all MPs read that letter. Allowing politicians to override objective ethical and medical safeguards would be a dangerous precedent to set, particularly in a world where vaccine deniers and anti-science fantasists have a clear route to getting their hands on the levers of power. As always, we stand firm in believing in an evidence-based approach, and argue strongly against the risks of political capture when we should be led by the science.
Liberal Democrat policy on single-sex spaces requires that everyone who needs access to a single-sex space can have it safely and feel comfortable and secure, while ensuring that nobody faces discrimination on the basis of their being trans. The Opposition’s new clause 143 is very poorly drafted and would create chaos and confusion within the NHS by applying requirements to spaces such as pop-up flu jab clinics, blood donation sessions in the community and potentially even care delivered in a private residence in a way that is clearly unworkable and would damage delivery of care. Therefore, I am also unable to support that new clause.
Given their haste in tabling the amendments to retain Healthwatch, I am disappointed that the official Opposition are not using this opportunity to push for a vote on that critical issue instead. I urge the Government to accept the amendments tabled in my name and those of my Liberal Democrat colleagues to protect patient safety if they, unlike the official Opposition, are serious about building a health service that works for staff and delivers for patients.
I have enjoyed working with the Minister here in the Chamber, in Committee and on a one-to-one basis, and I am sure that she has the best of intentions. I hope that she has listened to our genuine concerns about patient safety during the last two days, and will consider our amendments further in the other place. Otherwise, the Liberal Democrats will continue to fight for significant improvements for patient safety as the Bill progresses to the House of Lords.
I welcome the Bill, and was pleased to be a member of the Bill Committee. I also welcome the Government’s new clauses, about which the Minister has spoken today. New clause 159, to which I have added my name, seeks to address a long-standing legislative omission in our health service. I thank my hon. Friend the Member for Sunderland Central (Lewis Atkinson) for tabling it. For over a decade since the Health and Social Care Act 2012, Parliament has recognised the principle of parity of esteem between physical and mental health, but without statutory accountability that parity has remained an aspiration rather than a clinical reality. The scale of the problem is clear. NHS data shows that 1.87 million adults and more than 576,000 children and young people currently hold open referrals for mental health services. While the Government set clear targets to reduce physical healthcare waiting lists, mental health services are excluded from these core constitutional ambitions, and the division has severe consequences. A survey conducted by Rethink Mental Illness found that 83% of patients experienced a deterioration in their mental health while waiting for support, and that nearly a third of those whose health worsened attempted suicide. New clause 159 would require the Secretary of State to publish national waiting time standards for mental health services within 12 months of the Bill passing into law. The fact is that what is measured is addressed, so we need to give the same...
I will speak about new clause 41, which stands in my name. We put enormous, unquestioning trust in those who care for the bodies of our loved ones when they die. However, in this Chamber six months ago, I told a former Health Minister, the hon. Member for Glasgow South West (Dr Ahmed), about Elkin and Bell, the Gosport funeral directors who left 46 bodies decaying in an unrefrigerated room. One of them, an elderly gentleman whose family had already paid for his cremation, was left decomposing for 36 days. I said then that the funeral sector was nothing better than a lawless wild west with no mandatory qualifications to practise, no accreditation for professionals, no licensing of businesses, no inspection of premises, and no law to fall back on when things go wrong. It was only persistence and ingenuity on the part of Hampshire constabulary that saw Elkin and Bell brought to justice. The Minister at the time told me that a decision on regulation would come in the Government’s full answer to the Fuller inquiry, and we are still awaiting. Since then, matters have worsened. In July, Robert Bush, a funeral director in Hull, was sentenced to 20 years in prison after pleading guilty to 67 charges for bodies left decomposing in squalor. Forty-six grieving families had been reunited with the wrong ashes, but the real horror is that these will not be isolated cases. Under the law as it stands today, almost anyone can set themselves up as a funeral director.
I thank the hon. Lady for her work in this area in the neighbouring constituency. The vast majority of funeral directors operate with integrity, compassion and professionalism. Does she agree that, as reputable businesses, they are crying out for robust regulation?
I genuinely could not agree more. This is not at attack on the profession. The vast majority of funeral directors do their job with extraordinary skill, great care and huge professional integrity. It is precisely because of the trust that grieving families place in them every single day that we cannot allow a rogue minority to drag the reputation of the whole sector through the mud. In a written statement on 1 September, the Government said they intended that proposals for regulation would be forthcoming, but they set out no timetable, and detailed plans were promised only “in due course”. Families have already waited years and cannot be expected to wait indefinitely. New clause 41 would require the Secretary of State, within six months of the Bill passing, to extend the remit of the Human Tissue Authority beyond hospital mortuaries, which it currently covers, to funeral directors, private mortuaries, direct cremation services and any other organisation that transports or holds the bodies of the deceased.
Does my hon. Friend agree that Donna Ockenden’s report into what happened in Nottingham, particularly the harrowing stories of the mortuary issues there, adds to the case that she is making?
I pay tribute to my right hon. Friend for the fantastic work that he did as shadow Secretary of State for Health and Social Care, and he is absolutely right. We really need the full response to the Fuller report in order to implement not only changes to mortuaries, but all the other amendments that it recommended. New clause 41 would place a duty on the Human Tissue Authority to establish and maintain a register of every business brought within its oversight, with how that register operates set by regulation, so that for the first time a grieving family could check, before they hand over the body of a loved one, whether the business in front of them is properly overseen. I recognise that the hon. Member for Leeds South West and Morley (Mark Sewards) has tabled new clause 42 on a new, bespoke freestanding regulator. Both new clauses would fix the same issue, and either will do. The key thing is that this is a moment for the Government to seize, not resist. Ministers have already said that, in principle, they agree with what new clause 41 would require of them. Every trade body agrees. Every family who has been failed agrees. Every Member from across the House who signed our letter agrees. It feels like the Government agree, so I ask the Minister to tell the House exactly when a statutory scheme will be brought forward by the Department of Health and Social Care, and to set out the timetable for implementation. None of us is comfortable dwelling on our own mortality, which is...
I am sure that many Members from across the House are aware of the campaign in memory of Hugh Menai-Davis, the son of my constituents Ceri and Frances who tragically passed away at the age of just six. As part of that campaign, the amendments that I have tabled to the Bill are designed to support families at the most difficult time imaginable. Our national health service and welfare state have changed and evolved over almost a century, and we should always keep a close watch on how faithfully they remain connected to their founding principles. Support “from the cradle to the grave” should not a dusty slogan; it must be a constant aspiration. Wherever gaps or shortcoming are identified, we must address them. It should concern us all that support for parents of seriously ill children is one such gap. When a child becomes seriously ill, the NHS mobilises around the child, quite rightly, but parents must mobilise around everything else-getting to work and hospital appointments, looking after other children, managing existing caring responsibilities, and somehow keeping on top of bills, rent or mortgages that do not stop when a child becomes ill. When all of this takes place alongside the fear that their child may die, the pressure on families is near impossible to bear.
Too often our systems see a patient, a parent, an employee, a sibling or a pupil, but rarely a family, and we need our NHS to see the full picture. There is a clear gap in our safety net when parents of seriously ill children are left without the co-ordinated financial, practical and emotional support they need. The message from those with lived experience is that, in these scenarios, parents find themselves passed from pillar to post, endlessly repeating the devastating reality they are living through, which compounds their trauma. The stress and complexity this adds to the burden that parents and carers already face when caring for a seriously ill child contributes to longer-term health impacts for families in a way that we cannot ignore. A linked record cohort study of more than 35,000 mothers found high incidences of depression, cardiovascular disease and death among mothers of children with life-limiting conditions.
New clause 81 proposes a single named co-ordinator bringing together information on financial support, employment rights for parents and carers, and signposting to relevant charities and support as part of a written plan for the family. This would cut away repetitive bureaucracy and mean that parents are no longer left to their own devices in trying to figure out a way through the challenges their families face in these situations. It is a simple duty, but one that could make a massive difference. At one of the most difficult times imaginable in a family’s life, it would ensure that they are no longer simply left to navigate an overwhelming and unfamiliar system alone. Childhood illness is traumatic enough. We should do everything we can to stop it.
Order.
I would like to speak to new clause 137. Cancer Research UK estimates that, in the six months since the national cancer plan was published, over 168,000 people were diagnosed with cancer in England. The number of those diagnosed is at a record high and this is projected to continue. Almost one in two of us will get cancer in our lifetime, and no one in this country is untouched by the disease. I welcome the Government’s ambition to improve cancer outcomes in the national cancer plan. Alongside my amendment to the Health Bill, my current private Member’s Bill seeks to guarantee that the Government make progress towards delivering these targets and are held to account by Parliament on that. Over the past five decades, cancer survival has more than doubled because of lifesaving research, earlier detection and cutting-edge treatments. However, in the last decade progress has slowed, and the 10-year cancer survival index was better in the early 2000s than in the 2010s, so we are in danger of going backwards. The national cancer plan commits to meeting cancer waiting times targets by the end of this Parliament. The previous Government failed to do that, and I really hope that this Government will manage it. It is also important that these targets are met, alongside a full range of commitments in the plan. The Health and Care Act 2022 required the Secretary of State to include cancer outcome objectives in the annual mandate set by the Secretary of State for NHS England, and those...
Order. I call Kate Osborne.
If I may begin on a personal note, just three weeks ago I had a second operation on my back, and I wish to put on record my sincere thanks to the staff who cared for me, from the clinicians who treated me to everyone involved in my care and recovery. [Hon. Members: “Hear, hear.] Too often our access to healthcare depends on our postcode. That postcode lottery is stark in a number of areas, but nowhere more so than with IVF. As chair of the APPG on fertility, I have raised this issue repeatedly with Ministers. I again invite Ministers to attend our fertility roundtable tomorrow and to commit to ensuring that every ICB follows, at the very least, the NICE guidelines on access to IVF and fertility treatment. We must strengthen the role of voluntary, community and social enterprise organisations in neighbourhood health planning and NHS commissioning. Voluntary organisations understand the barriers to care for hard-to-reach communities and often have trusted relationships with communities that statutory services struggle to reach. We see that particularly clearly in HIV and AIDS provision. Voluntary organisations have been fundamental to the UK’s response for decades, through prevention, testing, peer support, tackling stigma and supporting people living with HIV. I am extremely grateful to the National AIDS Trust for working with me on the new clauses, and I thank Ministers for their constructive engagement. Members of the LGBT+ community must have trust in healthcare providers,...
Order. I call Sir Bernard Jenkin.
I would very much have liked to have discussed the medical devices questions arising from the Bill. The Minister made an incredibly short speech about that important matter. It is quite clear that these provisions are part of the covert dynamic alignment with the EU and the covert rejoin agenda being pursued by the Government. It raises all sorts of constitutional questions, but those are not for today. I will concentrate on HSSIB. I rise to support amendments 1 to 4, which would remove the abolition of HSSIB from the Bill. The Government have singularly failed to make the case for removing this crucial safety investigation function. It did not exist until recently, and now they want to scrub it out. I suspect that is because too many people in the health system do not like being held to account by an independent investigative body.
indicated dissent .
The Minister shakes her head, but she is yet to give a good reason as to why this measure is in the Bill. When we had an Adjournment debate in July with the then Minister for patient safety, the hon. Member for Birmingham Edgbaston (Preet Kaur Gill), she could not answer the question of who would conduct independent safety investigations in the NHS after the abolition of HSSIB. She said that safety investigations would be conducted by the Care Quality Commission, but she could not actually claim that they would be independent; as my hon. Friend the Member for Sleaford and North Hykeham (Dr Johnson) demonstrated, they would not be. If, as it seems, it is intended that safety investigations should be carried out by the CQC unaffected by the transfer, why make the transfer at all? How much is this transfer going to cost? I asked the Minister, in a letter I sent her after the debate in July, to give us the information on how much the transfer of all this would cost. Nothing has arrived. I never had a reply to the letter. Of course, the Government have changed the Minister and the new Minister for patient safety, the right hon. Member for Kingston upon Hull North and Cottingham (Dame Diana Johnson), is not in the House today. I rather suspect that she is more sympathetic to this argument than the Minister sitting on the Front Bench today. In our earlier exchanges we discovered and once again exposed how the safe space will be brutally compromised by the fact that it will be...
Clauses 5 and 6 place duties on the Secretary of State to promote patient involvement, patient choice and innovation. My new clauses 86 and 87 would apply those principles to psychedelic-assisted therapy treatments involving schedule 1 controlled substances. I have been pleased to be a trustee of the charity Drug Science, which has allowed me to talk to researchers who are looking at therapeutic treatments using what are called psychedelic drugs. Around the world there is growing evidence of the successful treatment of post-traumatic stress disorder, trauma, mental health issues and end-of-life distress using these drugs. For some patients they are absolutely revelatory. They change lives for the better and can relieve the burden of those conditions on the wider health service. Researchers tell me, however, that the barriers the current system puts in place really restrict research. Research involving schedule 1 controlled substances generally requires a Home Office licence, and the bureaucracy and inertia in the system adds delay, cost and an administrative burden to the extent that research grants are being lost because of delays. The issue has already been considered. In 2023 the Home Affairs Committee recommended urgently moving psychedelic drugs to schedule 2 in order to facilitate research. Later that year, the Advisory Council on the Misuse of Drugs recommended that research using schedule 1 drugs in universities and hospitals should be exempt from the Home Office...
I will speak to new clauses 116 and 117, which I have tabled. Clover Carkeet, from my constituency, is a delightful seven-year-old girl who has suffered from intractable epilepsy since she was 12 weeks old. Clover’s seizures could be controlled only by huge doses of steroids, leaving her very unwell, until her parents secured a private prescription for medical cannabis, reducing her seizures by 95%. Medical cannabis is legal and can be bought privately under NHS supervision, but it is not routinely available on the NHS. As a result, families are faced with an impossible choice: fund thousands of pounds a month to pay privately, or watch their child suffer while relying on the treatments available through the NHS. Why are parents being made to make that choice? Colleagues across the House, including the hon. Member for Gower (Tonia Antoniazzi), have long campaigned on the issue and support new clause 116, which calls on the Secretary of State to assess the availability of medical cannabis on the NHS for children. I hope the Government will support this new clause too.
On new clause 117, in June, thyroid surgery left me with vocal cord paralysis, as Members can particularly hear today. This has given me a real and unwelcome insight into the challenges faced by people who experience voice loss. According to the Lary Project, around 30% of adults will experience voice loss at some point in their life. Speech and language therapists could often resolve these issues entirely, but access to therapy is determined by a postcode lottery.
I was fortunate to get NHS speech therapy this summer, but not everyone is. That is why new clause 117, backed by the Royal College of Speech and Language Therapists, calls on the Secretary of State to publish a strategy tackling waiting times and unequal access to speech and language therapy. To do this job, we all rely on our voices, so I urge the House to support new clause 117.
That brings us to the Front Bench. I call the Minister.
We have genuinely had a wide-ranging and thoughtful debate, and I want to try to address all the points that have been raised. I think there is broad agreement across the House on the goals that we are seeking to achieve with the Bill: safer care, better outcomes and a stronger voice for patients. Every patient deserves safe and high-quality care, every community deserves to have its voice heard, and everyone should be able to access the care they need, when they need it. The question before us is how best to deliver those ambitions. In general, we do not believe that the current landscape works, and that better outcomes are always achieved through new reporting requirements, additional layers of statutory process or more bureaucracy. Instead, we are committed to devolving responsibility and to empowering leaders in the NHS, while also holding them directly accountable, so that the NHS is focused on delivery and improving care. I will begin with Healthwatch. I think there is broad consensus that we want to see patient voices heard strongly at every level of the healthcare system-it is something that all MPs feel strongly about, dealing with constituents as we do. Hearing the patient and user voice results in better decisions in a system that is designed around them-a system that is better able to correct when things go wrong. Our ambition is to ensure that insight and experience from patients, service users and communities is part of commissioning and service planning...
The CEO of Healthwatch Norfolk said today: “To cease the statutory functions of Healthwatch without a suitable alternative in place…is to risk another major failing in patient safety and scrutiny of the health system.” Did the Minister’s remarks just now suggest that the Government may be reviewing the plans to scrap Healthwatch?
It will not be a surprise to the hon. Gentleman that I do not agree with his proposition, although I commend the work that many people have done in Healthwatch. We want to work with people in the other place to make sure that this is the right way forward. I am sorry that we do not have more time to debate HSSIB, because it requires more discussion, although we had a good debate in Committee. We have heard many discussions today. I have met the hon. Member for Harwich and North Essex (Sir Bernard Jenkin), and I hear what he is saying; I will ensure that he gets a response to his letter from the new Minister for Patient Safety-asap, as they say. It is an issue that we need to get absolutely right. We all know, from our experience with patients and families, about the importance of creating a culture in which concerns can be raised without fear and lessons are learned effectively. The Government fully agree with those objectives. Our view is that patient safety, in line with the Dash review, is best served by clear lines of accountability, effective independent scrutiny, and a relentless focus on learning and improvement. We are therefore transferring HSSIB’s functions to the CQC to ensure that learning from investigations can more readily inform improvement activity across the system. We recognise the importance of ensuring that the investigation arm has the autonomy to investigate the qualifying incidents that it deems appropriate free from interference, and I can give the...
Will the Minister give way?
I apologise, but I am going to press on. There is a lot to get through. We are committed to tackling health inequalities wherever they arise. There are strong duties on both ICBs and the Secretary of State to tackle these inequalities, and we remain firmly committed to doing so. We continue to drive forward improvement plans including the national cancer plan and the mental health strategy, which will transform mental health care into a system that responds and intervenes early, reduces waiting times for support, and ultimately supports people to participate fully in education. I note in particular that the Government are already making record investment in mental health. All ICBs are expected to meet the mental health investment standard over the next three years, and all are forecast to meet it for 2026-27. We are also committed to delivering the national cancer plan and focused on driving improvements, including on diagnostic capacity, which is key to addressing waiting times and tackling variation in access to better treatment, as we have heard today from my hon. Friends the Members for Easington (Grahame Morris), whose work in this area I commend, and for Blaydon and Consett (Liz Twist).
Will the Minister give way?
I am going to press on a little bit, if I may. I remind the House that we are doing this within the existing legal structures, and that our approach is not to put in place additional duties and layers of detail and specificity in primary legislation. I think we should avoid the temptation to create separate statutory obligations for each condition or patient group, particularly in an age where people are living longer and very often with more than one health condition. Instead, we should commit ourselves to tackling inequalities for everyone, everywhere. We have again heard from the Liberal Democrat spokesperson, the hon. Member for North Shropshire (Helen Morgan), about corridor care. The Government have been consistently clear that corridor care is not an acceptable standard of care and should not be normalised, and it is our intention to reduce and ultimately eradicate it. I think it is worth reminding the House that corridor care does not occur everywhere; some places have made huge steps to avoid it, and we want to share that learning. I particularly commend Barnsley foundation trust, South Warwickshire foundation trust and the Dudley group foundation trust, where there have been zero incidents in the last reporting. We must recognise that corridor care is one of the most visible and distressing symptoms of systemic pressures across the urgent and emergency care pathway, and our focus is on taking action now to tackle those underlying pressures. We are improving patient...
I thank the Minister for giving way and wish her a happy birthday, too. The NHS trust in north-west London was recently found to be one of the most improved in London in terms of reducing waiting lists. Does she agree that all the changes that she is bringing in through the Bill, including those discussed today, will help us to bring down those waiting lists even further and address the issues with corridor care that she has outlined?
I thank my hon. Friend for her best wishes and commend the work that she and many other Members are doing directly with their trusts to understand the impact of the work that we are doing to bring down those waiting lists and improve access for patients. As I have said, corridor care is a sign of systemic failure in the system and is unacceptable. I think we have all witnessed it in our local trusts, but it is coming down in places, and we want to continue to see it eradicated. I pay tribute to my hon. Friend the Member for North East Hertfordshire (Chris Hinchliff) for his championing of the families of children suffering from life-threatening illnesses. I know that Members on both sides of the House recognise the profound impact that receiving a diagnosis of a life-threatening condition has on a child and their family. It is vital that all these families feel supported, informed and cared for, and I wholeheartedly recognise that the support that they are offered now is often not proactive or joined up, with the onus, as he said, being on families to navigate the system and seek support themselves. With that in mind, the Government commissioned a report on the mental health impacts of life-threatening childhood illness on families, named in the memory of Hugh Menai-Davis. I pay tribute to Hugh’s parents for their campaigning and offer them my deepest condolences. The report process is progressing well, and I can commit to the report being published in this Parliament, with...
Will the Minister give way?
I will carry on. As the hon. Member for Sleaford and North Hykeham knows well, provisions are already in place to appropriately control access to puberty-suppressing hormones for children and young people presenting with gender incongruence or dysphoria. Children and young people with gender incongruence deserve evidence-based care. The Cass review recommended a clinical trial to provide high-quality comparative evidence on the potential benefits and risks of the medicines. That is now under way. I agree with the comments from the hon. Member for North Shropshire, but I have to disagree with the view of the hon. Member for Sleaford and North Hykeham that, uniquely, access to these types of medicines must be subject to the scrutiny and approval of Parliament. I think that, as a clinician, she understands that. I would also like to address new clause 143. As the hon. Member for Sleaford and North Hykeham knows, the EHRC’s updated code of practice for services, public functions and associations commenced on 5 August. It provides guidance on how sex-based distinctions in the Equality Act can be applied, including in the NHS. This new clause is unnecessary. This legislation is the law and the law is clear. The NHS will obviously follow the law. New guidance has been drafted and will be published imminently. For the record, I am due next week to meet the Darlington nurses who she spoke for. I agree that they were brave; they should not have had to go through what they went...
Does the Minister accept that the Prime Minister said in July that the sector needed to be regulated and that this continues to be a priority for his Government?
Absolutely, and I am committed to working with my hon. Friend and many other hon. Members across the House. I was pleased to meet my hon. Friend the Member for Manchester Withington (Jeff Smith) to discuss his amendments concerning medicines. I hope that I reassured him-from his speech, I think that I did-that the Government do support well-designed research into innovative treatments using controlled drugs, where this is conducted safely and appropriately. We also understand the complexities involved, including the need to minimise the risk of harm and misuse. That is why we are working across government to consider how to implement the recommendations from the Advisory Council on the Misuse of Drugs to reduce barriers to research with schedule 1 controlled drugs. I committed to write to my hon. Friend to set that out further; I will do. A number of hon. Members tabled amendments on issues with their local infrastructure. We have already published the capital plan and improved long-term capital planning to improve local infrastructure. I think that I have addressed most things-
Will my hon. Friend give way?
I am so sorry; I will to talk to my hon. Friend later. The debate has been wide ranging. If there are things that I have missed, I commit to getting back to hon. Members. I know that my noble Friend Baroness Merron is committed to working co-operatively with all Members as the Bill proceeds through the other House.
Debate interrupted (Programme Order, 7 September ).
The Deputy Speaker put forthwith the Question already proposed from the Chair (Standing Order No. 83E), That the clause be read a Second time.
Question agreed to.
New clause 94 accordingly read a Second time, and added to the Bill.
The Deputy Speaker then put forthwith the Questions necessary for the disposal of the business to be concluded at that time (Standing Order No. 83E).
New Clause 95
Disclosure of information relating to medicines
“(1) The Medicines and Medical Devices Act 2021 is amended as follows.
(2) In the heading of Chapter 2 of Part 2 omit “International agreements:”.
(3) In section 8 (disclosure of information in accordance with international agreements)-
(a) in the heading omit “in accordance with international agreements”;
(b) for subsections (2) and (3) substitute-
“(2) The relevant authority may disclose such information-
(a) for the purposes of enabling or facilitating the exercise by a public authority of any of its functions,
(b) for the purposes of enabling or facilitating the carrying out by a person of an activity relating to human medicines,
(c) for the purposes of giving effect to an international agreement or arrangement (and the disclosure that may be made for this purpose includes disclosure to a person outside the United Kingdom),
(d) for the purposes of civil proceedings or the prevention, investigation, detection or prosecution of criminal offences, or
(e) for the purposes of warning members of the public about matters in relation to human medicines.
(3) The relevant authority may not disclose patient information in reliance on subsection (2)(c) without the consent of the person to whom the information relates.
(3A) The relevant authority may not disclose commercially sensitive information in reliance on subsection (2) unless the relevant authority considers that the disclosure is appropriate, having taken into account the public interest as well as the interests of any person to whom the commercially sensitive information relates.
(3B) In considering whether the disclosure of commercially sensitive information in reliance on subsection (2) is appropriate the overarching objective of the relevant authority must be to safeguard public health (taking into account the safety and availability of human medicines) where that is relevant to the disclosure in question.
(3C) Where information to which this section applies is disclosed to a person in reliance on subsection (2)(a), (b), (c) or (d), the person may not use or further disclose the information except-
(a) with the agreement of the relevant authority and for a purpose mentioned in subsection (2), or
(b) in accordance with an enactment or order of a court or tribunal.”;
(c) in subsection (4), for “subsections (5) and” substitute “subsection”;
(d) omit subsection (5);
(e) in subsection (6)-
(i) omit the “or” at the end of paragraph (a);
(ii) at the end of paragraph (b) insert
“, or
(c) contravenes any obligation or restriction created or arising by or under the Windsor Framework, whether or not an obligation or restriction to which section 7A(2) of the European Union (Withdrawal) Act 2018 applies.”;
(f) in subsection (8)-
(i) omit the definition of “relevant person”;
(ii) at the appropriate place insert-
““Windsor Framework” has the meaning given by section 20(1) of the European Union (Withdrawal) Act 2018.”” -(Karin Smyth.)
This creates a general information-sharing gateway for the Secretary of State and Department of Health in Northern Ireland in respect of information about human medicines. At the moment the statutory gateway is limited to disclosures made in accordance with international agreements.
Brought up, and added to the Bill.
New Clause 98
disclosure of information relating to medical devices
“(1) Section 39 of the Medicines and Medical Devices Act 2021 (disclosure of information relating to medical devices) is amended as follows.
(2) For subsections (2) to (7) substitute-
“(2) The Secretary of State may disclose such information-
(a) for the purposes of enabling or facilitating the exercise by a public authority of any of its functions,
(b) for the purposes of enabling or facilitating the carrying out by a person of an activity relating to medical devices,
(c) for the purposes of giving effect to an international agreement or arrangement (and the disclosure that may be made for this purpose includes disclosure to a person outside the United Kingdom),
(d) for the purposes of civil proceedings or the prevention, investigation, detection or prosecution of criminal offences, or
(e) for the purposes of warning members of the public about matters in relation to a medical device.
(3) The Secretary of State may not disclose patient information in reliance on subsection (2)(c) without the consent of the person to whom the information relates.
(4) The Secretary of State may not disclose commercially sensitive information in reliance on subsection (2) unless the Secretary of State considers that the disclosure is appropriate, having taken into account the public interest as well as the interests of any person to whom the commercially sensitive information relates.
(5) In considering whether the disclosure of commercially sensitive information in reliance on subsection (2) is appropriate the overarching objective of the Secretary of State must be to safeguard public health (taking into account the safety and availability of medical devices) where that is relevant to the disclosure in question.”
(3) In subsection (8)-
(a) in the words before paragraph (a), for “subsection (3) or (4)” substitute “ subsection (2)(a), (b), (c) or (d)”;
(b) in paragraph (a), for “subsection (3) or (4)” substitute “subsection (2)”.
(4) In subsection (10)(c), for “the Protocol on Ireland/Northern Ireland in the EU withdrawal agreement” substitute “the Windsor Framework (as defined by section 20(1) of the European Union (Withdrawal) Act 2018)”.
(5) In subsection (12)-
(a) omit the definition of “relevant person”;
(b) at the appropriate place insert-
““Windsor Framework” has the meaning given by section 20(1) of the European Union (Withdrawal) Act 2018.””- (Karin Smyth.)
This expands the purposes for which information about medical devices may be shared by the Secretary of State .
Brought up, and added to the Bill.
New Clause 99
Further and consequential amendments relating to medical devices
“(1) The Medicines and Medical Devices Act 2021 is amended as follows.
(2) Omit Chapter 1 of Part 4 (medical devices - regulations: general).
(3) The repeal of Chapter 1 of Part 4 of the Medicines and Medical Devices Act 2021 by subsection (2) does not affect any regulations made under section 15(1) of that Act before its repeal in so far as they extend to Northern Ireland.
(4) In section 21 (compliance notices)-
(a) in subsection (1) omit “involved in marketing or supplying a medical device”;
(b) in subsection (1A)(a), for “15” substitute “14A(1)”;
(c) for subsection (5) substitute-
“(5) Where-
(a) there is a failure to comply with a medical devices provision as it extends to Northern Ireland, and
(b) the person mentioned in subsection (1) is a manufacturer for the purposes of any provision in the EU Medical Devices Regulations,
a notice under subsection (2) may be served on the manufacturer or on another person who has been designated by the manufacturer to act as their representative (or both).
(5A) Nothing in subsection (5) limits the circumstances in which a notice can otherwise be given to a person by giving it to someone on their behalf.”
(5) In section 34 (recovery of expenses of enforcement), in subsection (1)(a), before paragraph (i) insert-
“(ai) regulations under section 14A(1),”.
(6) In section 42 of the Medicines and Medical Devices Act 2021 (interpretation of Part 4), in subsection (2) omit the definition of “manufacturer”.
(7) For section 43 substitute-
“43 Power to make consequential etc provision
(1) Regulations under this Act may make consequential provision.
(2) The Secretary of State may by regulations-
(a) make provision that-
(i) is consequential on regulations under section 14A(1) (medical devices regulations in Great Britain), and
(ii) extends to Northern Ireland;
(b) make provision that-
(i) is consequential on regulations under section 14K(1) (power to restate medical devices law in Northern Ireland), and
(ii) extends to England and Wales or Scotland.
(3) The provision that may be made by regulations under section 14A(1) by virtue of subsection (1) of this section, or by regulations under subsection (2)(b) of this section, includes provision amending-
(a) an Act (including this Act),
(b) an Act of the Scottish Parliament, or
(c) an Act of Senedd Cymru.
(4) The provision that may be made by regulations under section 14K(1) by virtue of subsection (1) of this section, or by regulations under subsection (2)(a) of this section, includes provision amending-
(a) an Act (including this Act), or
(b) Northern Ireland legislation.
(5) Regulations under this Act may-
(a) make supplementary, incidental, transitional, transitory or saving provision;
(b) make different provision for different purposes;
(c) make different provision for different areas;
(d) make provision for all cases to which the power applies or for those cases subject to specified exceptions or for any specified cases or descriptions of case.
(6) This section does not apply in relation to-
(a) regulations under sections 50 or 51 (commencement and transitional provision);
(b) regulations under paragraph 9 of Schedule 2 (supplementary provision about civil sanctions).”
(8) In section 45 (consultation), in subsection (3)-
(a) for “15(1)” substitute “14A(1)”;
(b) for “15” substitute “14A(4)”.
(9) In section 47 (regulations: procedure), for subsection (3C) (inserted by section 73 of this Act) substitute-
“(3C) Regulations under Part 4-
(a) are subject to the negative procedure if they contain only provision made in reliance on paragraph 9 of Schedule 2 (supplementary provision about civil sanctions);
(b) are subject to the draft affirmative procedure if they are not within paragraph (a).
(3D) Regulations under Part 5-
(a) are subject to the negative procedure if they do not contain provision made in reliance on section 43(3) or (4);
(b) are subject to the draft affirmative procedure if they are not within paragraph (a).”
(10) Omit Part 6 (duty to report on operation of medicines and medical devices legislation within 5 years of passing of Act).
(11) In Schedule 2 (medical devices: civil sanctions)-
(a) in paragraph 1(1), before paragraph (a) insert-
“(za) regulations under section 14A(1),”;
(b) in paragraph 4(1)(a), before sub-paragraph (i) insert-
“(ai) regulations under section 14A(1),”;
(c) in paragraph 5(1)(a), before sub-paragraph (i) insert-
“(ai) regulations under section 14A(1),”;
(d) in paragraph 13(1), in paragraph (a), after “under” insert “regulations under section 14A(1),””- (Karin Smyth.)
Brought up, and added to the Bill.
New Clause 100
Power to amend meaning of “medical device”
“In section 42 of the Medicines and Medical Devices Act 2021 (interpretation of Part 4), after subsection (2) insert-
“(3) The Secretary of State may by regulations make provision about the meaning of “medical device” in this Part (including by amending this section).””- (Karin Smyth .)
Brought up, and added to the Bill.
New Clause 101
Power to restate medical devices law in Northern Ireland
“After section 14J of the Medicines and Medical Devices Act 2021 (inserted by section (Medical devices regulation: Great Britain) of this Act) insert-
“Chapter A2
Power to restate law in Northern Ireland
14K Power to restate law in Northern Ireland
(1) The Secretary of State may by regulations restate, to any extent, the Northern Ireland medical devices legislation.
(2) In this section, “the Northern Ireland medical devices legislation” means-
(a) regulations under section 15(1) (before its repeal by section (Medical devices regulation: Great Britain) of the Health Act 2026),
(b) the Medical Devices Regulations 2002 (S.I. 2002/618),
(c) the Medical Devices (Northern Ireland Protocol) Regulations 2021, and
(d) the EU Medical Devices Regulations.
(3) A restatement may use words or concepts that are different from those used in the law being restated.
(4) A restatement may make any change which the Secretary of State considers appropriate for one or more of the following purposes-
(a) resolving ambiguities;
(b) removing doubts or anomalies;
(c) facilitating improvement in the clarity or accessibility of the law (including by omitting anything which is legally unnecessary).
(5) The provision that may be made by the regulations may be made by modifying any enactment.””- (Karin Smyth.)
This confers a regulation-making power to restate the legislation about medical devices in Northern Ireland. For Great Britain, the existing law will be replaced by the new licensing regulations. This power allows the law for Northern Ireland to be restated (with minor changes of the kind often found in consolidation Acts).
Brought up, and added to the Bill.
New Clause 140
Corridor care
“(1) The Secretary of State must end the practice of corridor care in NHS hospitals within one year of the passage of this Act.
(2) If the requirement under subsection (1) is not met, the Secretary of State must commission an independent inquiry into the Government's handling of corridor care.
(3) The inquiry under subsection (2) must-
(a) investigate the effectiveness of policies, funding and guidance relating to corridor care in the Department of Health and Social Care;
(b) assess the impact on patient safety and staff morale from the continued practice of corridor care; and
(c) recommend steps the Secretary of State should take to end the practice of corridor care.
(4) The inquiry under subsection (2) should be supported by patient safety professionals from the Health Services Safety Investigations Body and the Care Quality Commission.
(5) The inquiry under subsection (2) must be published and laid before Parliament as a final report within 6 months beginning on the day on which the inquiry is established.”- (Helen Morgan.)
This new clause places a duty on the Secretary of State to end Corridor Care within 12 months, if they fail to do so they must order an independent inquiry into corridor care and the failure to eradicate the practice.
Brought up.
Question put, That the clause be added to the Bill.
New Clause 142
Puberty blockers
“(1) Within three months of the passage of this Act the Secretary of State must make regulations which ensure that puberty blockers may not be prescribed, dispensed or supplied to persons under 18 years of age for the purposes of treatment related to gender dysphoria, gender incongruence or a combination of both, in the United Kingdom.
(2) Regulations under this section must ensure that such drugs cannot be given out or used as part of clinical trials for the treatment of gender dysphoria, gender incongruence or a combination of both, unless that trial has specifically been approved by a resolution of both Houses of Parliament.
(3) For the purposes of this section, puberty blockers means-
(a) a ‘gonadotrophin-releasing hormone (“GnRH”) analogue’ which means a medicinal product that consists of or contains buserelin, gonadorelin, goserelin, leuprorelin acetate, nafarelin or triptorelin, and
(b) any other drug which has the effect of suppressing or delaying puberty that the Secretary of State may by regulation appoint.”- (Dr Caroline Johnson .)
This new clause would create a requirement for the Secretary of State to make regulations which prevent puberty blockers from being prescribed to persons under 18 years of age for the purposes of treatment related to gender incongruence, or being given in clinical trials related to gender incongruence unless specifically approved by Parliament.
Brought up.
Question put, That the clause be added to the Bill.
New Clause 143
Single sex facilities
“(1) The Secretary of State is required to ensure that there are single sex-
(a) changing rooms for NHS staff,
(b) toilets and washing facilities for NHS staff,
(c) wards for NHS patients, and
(d) toilets and washing facilities for NHS patients.
(2) The Secretary of State may make exemptions to the duty in subsection (1)(c) and (1)(d) where necessary for-
(a) children,
(b) intensive care units,
(c) critical care, and
(d) specialist high observation areas such as resuscitation in Accident and Emergency and the initial recovery area in theatres.”- (Dr Johnson .)
This new clause creates a requirement for the Secretary of State to ensure certain single sex facilities are made available for NHS staff and patients. It provides exemptions in certain circumstances.
Brought up.
Question put, That the clause be added to the Bill.
Clause 63
Transfer of HSSIB’s functions to CQC
Amendment proposed: 1, page 45, line 39, leave out clause 63- (Dr Caroline Johnson.)
Question put, That the amendment be made.
Clause 70
Regulations: reference to agreements and standards
Amendment made: 65, page 49, line 1, leave out from “supply),” to end of line 7 and insert-“for subsection (2), substitute-
“(2) The provision that may be made in reliance on subsection (1)(a) includes provision that-
(a) refers to international agreements, including such agreements as they have effect from time to time;
(b) refers to international standards, including such standards as they have effect from time to time;
(c) refers to United Kingdom standards that are specified in a list published by the Secretary of State from time to time.””- (Karin Smyth.)
This amendment standardises the provisions enabling the Secretary of State to make regulations referring to international standards and agreements (already in section 16(2) of the Medicines and Medical Devices Act 2021), and United Kingdom standards (inserted by this Bill).
Clause 72
Consultation about medicines and medical devices regulations
Amendment made: 66, page 50, line 2, leave out “or 4” and insert “4 or 5”.- (Karin Smyth.)
This is consequential on NC99 and ensures that regulations under new section 43(2) of the Medicines and Medical Devices Act 2021 are subject to the consultation requirements imposed by new section 45(1ZA) (which is inserted by clause 72).
Clause 79
Extent
Amendments made: 67, page 54, line 19, at end insert-
“(ea) section 61 (sections 56 to 60: interpretation);”.
This is a technical amendment which ensures that the interpretation provisions in clause 61 relied on by clauses 56, 58 and 59 will have the same extent as those clauses.
Amendment 68, page 54, line 23, leave out “Section 71 extends” and insert
“Sections 71 and (Medical devices regulation: Great Britain) extend”.
This is consequential on NC94.
Amendment 69, page 54, line 23, at end insert-
“(3A) Section (Power to restate medical devices law in Northern Ireland) extends to Northern Ireland only.”- (Karin Smyth.)
This is consequential on NC101.
Schedule 12
Minor and consequential amendments
Amendments made: 72, page 150, line 15, at end insert-
“Mental Capacity Act 2005
91A In Schedule AA1 to the Mental Capacity Act 2005 (deprivation of liberty: authorisation of arrangements enabling care and treatment) (as inserted by section 1 of the Mental Capacity (Amendment) Act 2019), for paragraph 8, substitute-
“8 In paragraph 6(1)(d) “NHS continuing healthcare” has the meaning given by section 12(10) of the Care Act 2014.””
See the explanatory statement to amendment 73.
Amendment 73, page 191, line 36, at end insert-
“328A In section 12 (further provision about assessments), for subsection (10) substitute-
“(10) “NHS continuing healthcare” has the meaning given by regulations.””
This amendment and amendments 74 and 72 are consequential on the repeal by clause 16 of section 6E of the National Health Service Act 2006 and accompanying regulations. Existing regulations contain a definition of “NHS continuing healthcare” which this would replace with a power to define the term in regulations.
Amendment 74, page 192, line 7, at end insert-
“329A In section 52 (supplementary provision about provider failure), for subsection (10) substitute-
“(10) “NHS continuing healthcare” has the meaning given by section 12(10).””
See the explanatory statement to amendment 73.
Amendment 75, page 197, line 26, at end insert-
“Access to Medical Treatments (Innovation) Act 2016
369A (1) Section 2 of the Access to Medical Treatments (Innovation) Act 2016 (database of
innovative treatments) is amended as follows.
(2) In subsection (1) for “Health and Social Care Information Centre (“the HSCIC”)” substitute “Secretary of State”.
(3) In subsection (3)(a) in the words before sub-paragraph (i), for “HSCIC” substitute “Secretary of State”.
(4) In subsection (4)(a) and (b) for “HSCIC” substitute “Secretary of State”.
(5) Omit subsection (6).”- (Karin Smyth.)
This is a consequential amendment to section 2 of the Access to Medical Treatments (Innovation) Act 2016, which would replace references to the Health and Social Care Information Centre with references to the Secretary of State, and remove a requirement for the Secretary of State to consult with the Centre before making regulations.
Third Reading
I beg to move, That the Bill be now read the Third time. Let me thank all those who have been involved in bringing this Bill to this point, including all those involved in Committee. I thank the parliamentary staff, the departmental staff and the legal staff, and the Members on both sides of the House, who have debated so many different issues during the passage of the Bill. In particular, I pay huge thanks to the Minister for Secondary Care, my hon. Friend the Member for Bristol South (Karin Smyth), who has not only chaperoned this Bill through every stage from beginning to end-with some different Health Secretaries along the way-but has done today’s Report stage on her birthday; I wish her a hugely happy birthday. I am grateful to everybody for their engagement, including those who, as well as debating the issues covered by the Bill, have taken the opportunity of these debates to raise so many issues that are so important to patient care right across the country, and to the improvements we need to make to patient and family care. I include in those thanks the parents of little Hugh Menai-Davis, who were in the House today. Members in all parts of the House have been raising issues from special educational needs and disabilities to funeral regulation and health inequalities, and it is important that our NHS and health systems continue to improve.
I thank the Secretary of State very much for giving way, because I know time is short. She is talking about the various issues that have come up while the Bill has been debated. One of them is the most common cause of death in the UK: dementia. An amendment that I tabled with the Alzheimer’s Society suggested that we bring the data on dementia, which is scattered right across the health system at the moment, into a single place to drive progress on early diagnosis and treatment. Does she agree that that is an important priority for the Government?
My hon. Friend is exactly right to raise this vital issue. So many of us will have families and constituents who are affected by dementia. We are committed to introducing a dementia tsar as part of our response to Louise Casey’s commission, and we will be looking at data issues and evidence as part of that. As this legislation completes its passage through this House, I thank my predecessor Health Secretaries for the work that they have done in bringing down waiting lists, improving treatment and getting more appointments than ever before. There are thousands more doctors, nurses, midwives and mental health workers in place than ever before, and we thank our national health service staff across the country. They also recognised that we inherited a system that was still badly held back by the failed 2012 Lansley reforms, including the huge administrative issue and unaccountable bureaucracy, with lots of duplication, poor communication and no proper accountability. This legislation is about strengthening democratic accountability and the focus on patient care. To be clear, I pay tribute to the work done by many people across NHS England-including in particular the recent work of the current chief executive, Jim Mackey, to substantially improve patient care and to reduce that duplication-but the systems and structures have been holding people back. That is why we have brought this reform forward, part of which will not just end the wasteful duplication, but ensure that our NHS...
I welcome the Secretary of State back, as it were, to the Department. As we debate Third Reading of the Bill, she is the third Secretary of State for this Bill. It was about 40 minutes after First Reading that the right hon. Member for Ilford North (Wes Streeting) resigned. I wonder which bit he had just spotted. We wish the Secretary of State well, though, and not only because of her East Hampshire heritage. There will be times when we disagree entirely, and there will be times when we find commonality, but at all times it is our job to scrutinise the Government in the interests of the public and on behalf of the dedicated professionals and other staff in these most vital of sectors. It is also my first opportunity to pay tribute to my predecessor in this role, my right hon. Friend the Member for Daventry (Stuart Andrew). He took on that responsibility in the very finest traditions of this House. He had and has respect and admiration across the House, and I know his approach was much appreciated by so many working in and in support of health and social care. This has been a big Bill, and I thank the Public Bill Committee for all the work they did. In particular, I thank my hon. Friend the Member for Sleaford and North Hykeham (Dr Johnson), my hon. Friend the Member for Farnham and Bordon (Gregory Stafford), who was the Whip and is now a shadow Minister, and everybody on that Committee. We will not divide on Third Reading, because there are important things in this Bill that...