Karin Smyth
MP for Bristol South · Labour · United Kingdom
“It is a pleasure to serve under your chairship, Ms Lewell. I thank the hon. Member for Chippenham (Sarah Gibson) for securing this debate and for her well-informed and considered set of proposals about a contract of which I am aware. I will try to address most of her points.”
House of Commons28 October 2026Contains Parliamentary information licensed under the Open Parliament Licence v3.0Source ↗
“In addition, we are developing a modern service framework for palliative and end-of-life care, which will be a clinically led, evidence-based framework to support sustained improvement in outcomes for patients and carers, including identifying, measuring and reducing health inequalities, and reducing unwarranted variation in access, exper…”
House of Commons28 October 2026Contains Parliamentary information licensed under the Open Parliament Licence v3.0Source ↗
“That is why this Government are taking action to reduce unwarranted variation, cut waits and improve access to high-quality community services. That is where we want to get to.”
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“I will come on to some of that, because it is also tied up with the Health Bill and the things that we are proposing to do for the future. The hon. Lady also touched on one of my favourite subjects: the accountability of local health systems.”
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“Lady said, now we need to make sure that what was promised is delivered. That is what we all want to see for the people of her community and across the wider ICB. I want to be clear on our general expectations of community services: they are really vital to the left shift, particularly in rural areas.”
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“Lady is saying from her position in Chippenham, and that may be different from other positions—it is a large geographic area. That is one of the issues that we need to get right.”
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“Clause 62 underscores the importance that we place on special reviews and investigations, and it will maintain the Care Quality Commission’s ability to conduct them by ensuring that the CQC’s investigatory role remains properly aligned with its original statutory purpose. The CQC is the independent regulator of health and care providers, and in the case of commissioners, it has the powers to undertake a special review or investigation when requested to by the Secretary of State. On 30 January 2024, the then Secretary of State, the right hon. Member for Louth and Horncastle (Victoria Atkins), commissioned a section 48 review into mental health services in Nottinghamshire following the tragic events of June 2023. As we know, that revealed serious and systemic failings and led to strengthened oversight and a clear improvement plan.”
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“My understanding is that the clause will not change that particular power, but I will get back to the hon. Lady if I am wrong. Question put and agreed to. Clause 62 accordingly ordered to stand part of the Bill. Clause 63 Time limit for bringing proceedings Question proposed , That the clause stand part of the Bill.”
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“For example, the CQC may only receive information about an offence two and half years after it was committed, leaving little time in the remaining six-month period to investigate. Extending the period to five years would help mitigate such circumstances, and that is why we are extending the statutory limitation period. This will ensure that the CQC has the ability in far more cases to address the serious regulatory failings that it should and must address, without risking falling foul of a time limitation. I therefore commend the clause to the Committee.”
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“The coronial process serves a different purpose. A coroner’s role is to establish facts surrounding an unnatural death rather than to find fault. In a complex case, a police investigation or a coroner’s inquest—sometimes both—can take time to conclude. Those independent processes are a useful source of information for the CQC to form a full picture of a breach of regulation. A culture of learning from investigations, inquiries, errors and poor care should be the norm in the NHS. It is therefore expected that a service provider may also commission its own internal investigation to learn from an unnatural death. Furthermore, there are cases where the CQC is approached late with information after an offence may have been committed.”
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“Let me be clear: extending the three-year limitation from the time of the offence will not alter the first requirement that the CQC should act within 12 months of sufficient evidence of a serious breach of regulations becoming available. That 12-month window for action once the regulator is aware of the offence will remain unchanged. Extending the limitation period to five years from the date of the offence will mean that fewer events that should be considered by the regulator will effectively time out and go beyond the reach of the regulator’s action. The CQC is not the only body with an interest in investigating serious breaches of regulations that result in unnatural death; there are other investigatory bodies, such as the police, with equal interest and powers to investigate deaths for the purpose of pursuing criminal prosecution.”
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“The 10-year health plan reaffirms the Government’s commitment to families affected by bereavement or serious harm, ensuring that lessons are learned from their experience and that more cases are fully reviewed and acted on. Families seek closure following serious harm to or the death of a loved one by wanting to understand what went wrong and what could be done to stop other families experiencing similar trauma, and by wanting to hold someone to account. Families often turn to the Care Quality Commission for help. Clause 63 will extend the CQC’s power to bring proceedings against a health and social care provider for a serious breach of regulations from the existing limitation of three years from the date of the offence to five years.”
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“Put simply, the answer to the hon. Lady’s questions is that we are not seeking to change other aspects. The CQC wants to get to points as soon as possible, so the 12-month period has not been changed. The function of clause 63 is merely to recognise the issues around the three years and to change that to five years. We are not seeking to alter anything else in that regard. On her point about the commencement date, that is merely recognising what is considered to be parliamentary convention. Question put and agreed to. Clause 63 accordingly ordered to stand part of the Bill. Clause 64 Abolition of Healthwatch England Question proposed, That the clause stand part of the Bill.”
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“This is a popular clause, Ms Lewell—and rightly so. I recognise that this provision has elicited a lot of interest among our constituents and the wider public. I look forward to hearing Members’ contributions.”
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“It has to focus on the voices that are too often overlooked. The central priority of the directorate will be to reach under-represented and seldom heard groups and to ensure that engagement is accessible, inclusive and proactive, so that the experiences of vulnerable people help inform and shape the decisions that affect their lives.”
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“By coming inside the organisation, it has done exactly some of the things we want to do: drive cultural difference and change inside the organisation, rather than being outside of it. As I said before, this is a slightly philosophical argument and political argument. I appreciate that there are views on either side, but that is absolutely our intention. On the patient experience directorate, we recognise that public trust will be crucial. We need to ensure that there is system learning across the piece. The patient experience directorate has to earn the trust of the public and parliamentarians, so we will design it to operate transparently and sit at the centre of decision making rather than at its margins. Ministers will be accountable for and answerable to Parliament on the work of the patient experience directorate.”
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“Again, I commend work on that and the individuals involved in it. Hon. Members mentioned Jacob Lant of National Voices and the King’s Fund, which have worked with us very well to challenge us and try to make this legislation better. I really appreciate their work, and we will continue to talk with them. The hon. Member for Farnham and Bordon mentioned GIRFT. I cannot help but respond to his point, because he suggested that being inside NHS England has somehow made it less effective, and I could not disagree with him more. It is not because he has left and is here; his presence is obviously missed at GIRFT and welcomed here. To be serious, every meeting I have with NHS England and everything we are attempting to do in reforming outcomes for patients on the ground involves GIRFT. It is now at the very heart of what NHS England does.”
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“That is also true of other areas that have experienced shocking scandals, as we call them. I take that very seriously. I will pick up on the question of independence that we veered into before, which was mentioned by the hon. Member for Sleaford and North Hykeham. She highlighted her concerns and the issues raised by my right hon. Friend the Member for Makerfield, and I heard what she said. Independence was also raised by the hon. Member for Winchester and my hon. Friend the Member for Lichfield. We therefore return to that point about independence and, as my hon. Friend said, about being in the room, making those decisions and changing the entire culture of the organisation to do something different. The question is then whether bringing the functions of Healthwatch to the national level is the right method.”
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“I think that the record will show that I have taken several interventions in recent days, and I will continue to do so. I have been very clear that we have some fundamental disagreements on philosophy and approach. I will desperately try not to veer into the next groups, but it may be tricky. I am sure that you will steer me through, Ms Lewell. I want to pick up on some good, helpful points that have been made. I pay particular tribute to my hon. Friend the Member for Lichfield for the comments he made. I appreciate that certain areas, particularly Mid Staffs, have elicited a lot of debate and concern. I commend him for following that through on behalf of his constituency. I know that other Members in Staffordshire want to understand how the Government’s future plans will address their very real concerns.”
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“That is an important way of ensuring that the Department and the new experience directorate will be accountable. I recognise the important contribution that Healthwatch has made in capturing patient insight and informing the design and delivery of services, but we do not believe that new clause 78 is necessary. It is inconsistent with the purpose of the Bill. I am aware of the views of the hon. Member for North Shropshire, but the Government’s policy is to abolish Healthwatch and ensure that patient and public voice is more directly connected to decision making. It would therefore not be appropriate or consistent to legislate for a specific funding level for organisations that would no longer exist, or to constrain how funding is deployed to support the new arrangements.”
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“I thank my hon. Friend for making the intention of her comments clear to the Committee. It is right that we need to build trust in patient voice and experience. We will pick up on that in our debate on local healthwatch branches, because that is perhaps where Members of Parliament are particularly important. At a national level, there are many voices and organisations continuing to review the issue and challenge the Government, including through reports, meetings with Ministers and in Parliament, highlighting the good work that they do and numerous Committees. Health Ministers appear before the Public Accounts Committee, the Health and Social Care Committee and Lords Committees; I have appeared before the Science, Innovation and Technology Committee.”
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“I understand. I am grateful to the hon. Member for that clarification, but her new clause represents an incomplete picture of Government funding for Healthwatch. A £14.15 million grant has been provided to local authorities for local healthwatches, and that is only part of the overall funding; a larger proportion is rolled into the wider local government financial settlement, and because that is not visible as a distinct line, headline figures often understate the total funding available. All of this funding is not ringfenced.”
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“Bringing the patient and community voice closer to the organisations responsible for improvement—it is actually their job as commissioners—will help to make feedback more actionable, reduce confusion and support better services. I commend the clause to the Committee.”
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“We know exactly where they live, who they are, how old they are and what sex they are. We know largely what diseases they have. We know their level of income. We know their levels of education and attainment, and how they impact their health outcomes. They are not hard to reach; the system is not set up to listen to them. That is what we are determined to change. Dr Penny Dash’s review of patient safety described a cluttered landscape, with overlaps in how user experience and advocacy are organised. It described the burden that that can place on the frontline, producing multiple, poorly co-ordinated asks with limited impact.”
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“Friend the Member for Lichfield said, the people are in the room. It makes it easier to connect lived experience to priorities, quality improvement and the tackling of inequalities, rather than leaving intelligence at arm’s length from decision makers. This is about strengthening impact, not silencing criticism. Integrated care boards and local authorities will have a statutory duty to demonstrate how they have engaged with all people in their area, including seldom heard groups, and will be expected to have clear routes for people to raise concerns. We expect transparency about what people have told the system, what the system has done in response and how learning is shared across partners. As I said in my evidence, many constituents in my Bristol South constituency are said to be hard to reach. They are not hard to reach, in my view.”
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“Clause 65 and schedule 10 will abolish the current local healthwatch arrangements and place responsibility for gathering the views of local people firmly with the bodies with the clearest levers to act: integrated care boards and local authorities. At present, many organisations are gathering views, running engagement exercises and raising issues, often with the best of intentions, but the result can be duplication, variable coverage and uncertainty about who is accountable for responding. We can end up with lots of feedback but too little clarity on the action that follows. By placing those duties on integrated care boards and local authorities, we are ensuring that insight from patients, service users and communities feeds directly into where commissioning and service planning decisions are made for both health and care. As my hon.”
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“I understand the bumpy road—I have been part of that, with community health councils and links to Healthwatch, and it has been a long one. I think we will keep returning to this theme. Those organisations have not been changed to do what they are supposed to do, and that is the ambition of this Government. Question put, That the clause stand part of the Bill.”
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“To answer a previous question, the Secretary of State will have the power to issue directions to ICBs and local authorities if they are failing to exercise that function. As I have said in debates on previous groups, I understand that it is difficult when we are debating the abolition of something outwith the wider framework of the 10-year health plan, the Dash review, the patient experience directorate in the Department and changes to the national quality board. It is incumbent on the Government to make that architecture clear and to build confidence and trust. That is what we intend to do, and that is how this body will be taken forward. All comments have been noted. There is a fundamental difference of approach. We are making those bodies fundamentally different and rewiring them to do something different.”
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“ICBs will be expected to carry out proactive, inclusive engagement, particularly with so-called seldom-heard groups, including carers, those who do not have access to digital platforms, those less proficient with technology and people for whom English is a second language. Crucially, ICBs will be accountable for demonstrating reach and impact, not simply how many reports or engagement exercises they have done. Impact is what we will be looking at. As I have said, this is about moving from a model where voices can be collected but overlooked to one where they must be heard and acted upon. The new patient experience director in the Department will work closely with local systems to identify national themes and significant concerns, ensuring that patient experience informs policy and improvement at the national level.”
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“We assume that the independent voice is always clear, but it is not. We have heard that it is variable and fragmented. That is not the fault of anyone trying to provide it, but that is where it is. The system is supposed to listen and improve services, and it does not. Things need to be changed in order to achieve that, and that is what we intend to do. The changes will be supported by scrutiny, transparency and oversight arrangements. The alternative, which is maintaining a separate structure with limited levers to drive change, has not delivered, and it cannot continue to try. We are not removing patient and user voice; we are embedding it at the heart of the new system.”
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“We are changing that to force them to be commissioners, but it is not an add-on; it is fundamental to the commissioning process. It is a complete rewiring of the organisation to listen to patient voice, patient experience and the reality of health inequalities. In my constituency, I am afraid have not seen examples of the independent voice really speaking on behalf of the people I serve—some of whom have the worst health inequalities in the country, largely as a result of the tobacco industry and its legacy—whereas their experiences and their health outcomes are very well known and should drive the necessary changes. That is why we are driving all the changes in the 10-year health plan: to meet the needs of communities. We will continue to have this debate, but I wanted to make that absolutely clear.”
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“We know who they are and what is wrong with them. We know how remote they are from the system. That goes to the heart of why the taxpayer is so alienated in this country from public services and their poor functioning. That is what the Government want to change. It is not a matter of ICBs adding a new function; the Opposition have fundamentally misunderstood that. It is about rewiring these organisations to do something very different. Their function as strategic commissioners is to understand and to use all the data and evidence, including direct voice. We can argue about how that direct voice is taken in, but that is fundamentally what a commissioner is—I say that, having been a commissioner. It is not being done well, and that is why we are changing the legislation. Under previous legislation, ICBs had multiple functions.”
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“It is good that that has been valued by local Members of Parliament. I would argue that nobody should be closing services without fully engaging with the local population and setting out clearly why that is being done. That is a failure of those local organisations, and we need to address the cause of that failure. I am struck by the oral evidence to the Committee on those 20,000 reports in 52 years. It was suggested that it takes six months, as I think the hon. Member for Farnham and Bordon said when quoting the evidence, for somebody to “go out”—that is the phrase that is used: “Let’s go out and talk to people in these far-flung communities. What do they think? What is their experience? Who are they?” It constantly surprises me, as it did when I worked inside the system. These are not remote people.”
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“Again, we have had an important discussion, particularly around the issue of independence; I accept that it is difficult and that there are arguments on both sides. We have heard a lot about Professor Croisdale-Appleby’s evidence on behalf of Healthwatch. I made this argument on Second Reading: we have had this arrangement for 52 years, and I think we can all agree that the situation is not good. It has not worked. As I said earlier, 20,000 reports add a lot of work. There is a lot of work in this landscape—well-intentioned work by good people. We can argue about whether Healthwatch was set up appropriately to do the job it has been asked to do. I was pleased to hear the three examples from the Lib Dems and other individual examples of where light has been shone upon a closure, for example.”
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“Due to changing policies by the previous Government, references to NHS trusts were removed from the Civil Contingencies Act, yet under transitionary powers in other legislation, they remain category 1 responders. This has meant that their role has seemed unclear for some other responders and the public. I want to be clear that the clause does not change the position of NHS trusts, nor their duties or functions under the Civil Contingencies Act; instead, it simply clarifies the legislation, making their place and role clear. That is vital so that NHS trusts and other responders know exactly what is required of them during and after an emergency. I commend the clause to the Committee. Question put and agreed to. Clause 66 accordingly ordered to stand part of the Bill.”
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“As the UK resilience action plan sets out, we are living through a period of profound change. Ensuring that our institutions are clear in what they must do to prepare for, respond to and recover from emergencies is essential. With that mind, the clause is necessary. It clarifies the existing duties on NHS trusts under the Civil Contingencies Act 2004—the legislation that sets out how the UK prepares for, co-ordinates and responds to serious emergencies. Since the Civil Contingencies Act came into force, NHS trusts have been included as category 1 responders. That means that they have had specific legal duties to assess risks, plan for emergencies, maintain business continuity, warn and inform the public, and work together to co-ordinate an effective local response.”
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“(5) In this section “United Kingdom standard” means a standard that is— (a) set by the British Standards Institution, or (b) primarily developed for use in the United Kingdom, or part of the United Kingdom.’”— (Karin Smyth.) This new clause would amend the Medicines and Medical Devices Act 2021 to (a) enable regulations to refer to both international agreements and standards and standards developed in the United Kingdom and (b) enable the Secretary of State to dispense with requirements placed on devices which meet regulatory requirements applicable outside the United Kingdom. Brought up, and read the First time.”
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“(4) Regulations made under section 15(1) that contain provision made in reliance on subsection (1)(a) about relevant requirements (or exceptions from them) may include provision in relation to a medical device where— (a) the device complies with regulatory requirements applicable somewhere outside the United Kingdom which is specified in regulations, and (b) a description of the device and the regulatory requirements applicable to it are contained in a list published by the Secretary of State from time to time.”
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“(2) In section 2 (power to make regulations about human medicines), after subsection (4) insert— ‘(4A) Regulations under subsection (1) making provision in reliance on section 3, 4, 5 or 7 may refer to international agreements or standards relating to human medicines, including agreements or standards as they have effect from time to time.’ (3) In section 16 (manufacture, marketing and supply), after subsection (2) insert— ‘(3) Provision made in reliance on subsection (1)(a) may refer to United Kingdom standards that— (a) relate to the marketing, putting into service or other supply of medical devices, and (b) are specified in a list published by the Secretary of State from time to time.”
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“New Clause 23 Pharmaceutical services: appeals etc “Schedule ( Pharmaceutical services: appeals etc ) makes provision about the destination of appeals, and jurisdiction to determine certain matters, currently governed by Part 7 of the National Health Service Act 2006 (pharmaceutical services and local pharmaceutical services).”— (Karin Smyth.) The clause introduces a Schedule which amends provisions about certain appeals etc to the First-tier Tribunal. Those appeals will be transferred to an NHS body determined by regulations. It is expected that initially this will be NHS Resolution. Brought up, read the First and Second time, and added to the Bill. New Clause 91 Regulations: reference to agreements and standards “(1) The Medicines and Medical Devices Act 2021 is amended as follows.”
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“(4) The period must not be more than 6 months. (5) But the Secretary of State may by further direction extend the period for which a direction under subsection (2) has effect by up to 6 months at a time. (6) The Secretary of State must publish any directions under this section.’”— (Karin Smyth.) The amendments made by this clause (among other things) relax the legal test for making alternative provision to address the inadequate provision of pharmaceutical services owing to a disruption of services. Brought up, read the First and Second time, and added to the Bill.”
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“New Clause 22 Inadequate provision of pharmaceutical services “(1) Section 133 of the National Health Service Act 2006 (inadequate provision of pharmaceutical services) is amended as follows. (2) For subsection (1) substitute— ‘(1) Subsection (2) applies if the Secretary of State is satisfied that a situation or event has caused or is likely to cause a disruption resulting in the inadequate provision of pharmaceutical services in England or in an area within England.’ (3) In subsection (2)— (a) after ‘Secretary of State’ insert ‘may by direction’; (b) for paragraph (a) (but not the ‘and’ at the end) substitute— ‘(a) require an integrated care board to make other arrangements,’; (c) in paragraph (b) omit ‘may’. (4) After subsection (2) insert— ‘(3) A direction under subsection (2) must specify the period for which it has effect.”
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“(3) In section 134 (pilot schemes), in subsection (8) omit ‘by a medical practitioner or dental practitioner to a patient of his’. (4) In Schedule 12 (LPS schemes), in paragraph 1(8) omit ‘by a medical practitioner or dental practitioner to a patient of his’.”— (Karin Smyth.) This updates the legislation about the provision of pharmaceutical services by medical practitioners to conform with current law and practice whereby commissioning arrangements are generally made with the practice rather than individual doctors. It also removes a reference to dental practitioners that is not needed. Brought up, read the First and Second time, and added to the Bill.”
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“New Clause 21 Dispensing medical practitioners etc “(1) The National Health Service Act 2006 is amended as follows. (2) In section 132 (persons authorised to provide pharmaceutical services)— (a) for subsection (1) substitute— ‘(1) Except as may be provided for by or under regulations, no arrangements may be made by an integrated care board with a person providing primary medical services under Part 4 to provide pharmaceutical services.’; (b) in subsection (3), for ‘medical practitioners’ substitute ‘persons providing primary medical services under Part 4’; (c) in subsection (4)— (i) for paragraph (a) substitute— ‘(a) as to grounds on which an integrated care board may, or must, refuse to grant an application for inclusion in a list referred to in subsection (3),’; (ii) in paragraph (aa) omit ‘of medical practitioners’; (iii) in paragraph (b), for ‘NHS England by a medical practitioner’ substitute ‘an integrated care board by a person’; (iv) omit paragraph (c).”
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“(2) In subsection (6), for the words from ‘consultation’ to the end substitute ‘the making of arrangements by virtue of this section’. (3) Omit subsections (7A) to (7L). (4) In subsection (8), at the appropriate place insert— ‘“local authority” includes— (a) a combined authority, (b) a combined county authority, and (c) the Greater London Authority;’.”— (Karin Smyth.) This enables combined authorities, combined county authorities and the Greater London Authority to enter into arrangements with NHS bodies under section 75 of the NHS Act 2006 in relation to any of their functions, replacing the current different and more limited provision about combined authorities and combined county authorities. Brought up, read the First and Second time, and added to the Bill.”
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“Amendment 83, in schedule 11, page 191, line 35, at end insert— “Children’s Wellbeing and Schools Act 2026 400 In Schedule 1 to the Children’s Wellbeing and Schools Act 2026 (relevant authorities)— (a) omit paragraph 9; (b) in paragraph 12, omit ‘section 25 of’.”— (Karin Smyth.) This is a consequential amendment to Schedule 1 to the Children’s Wellbeing and Schools Act 2026, which would remove a reference to NHS England and update a reference to NHS trusts to take account of the new conversion procedure created by clause 35 of the Bill. Schedule 11, as amended, agreed to. New Clause 20 Arrangements between NHS bodies and local authorities “(1) Section 75 of the National Health Service Act 2006 (arrangements between NHS bodies and local authorities) is amended as follows.”
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“This removes an unnecessary consequential amendment to section 12E of the NHS Act 2006 (that section is replaced in its entirety by clause 10 of the Bill). Amendment 24, in schedule 11, page 148, line 9, leave out paragraph 139. This removes an unnecessary consequential amendment to a heading that is replaced by clause 11.”
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“Schedule 11 Minor and consequential amendments Amendments made: 20, in schedule 11, page 140, line 16, at end insert— “91A The Armed Forces Act 2006 is amended as follows.” This amendment and amendments 21 and 22 remove a reference to NHS England from section 343AZB of the Armed Forces Act 2006 (to be inserted by the Armed Forces Bill). Amendment 21, in schedule 11, page 140, line 17, leave out “of the Armed Forces Act 2006”. See explanatory statement for amendment 20. Amendment 22, in schedule 11, page 140, line 18, at end insert— “92A In section 343AZB (inserted by the Armed Forces Act 2026), in subsection (5)(a) omit sub-paragraph (i).” See explanatory statement for amendment 20. Amendment 23, in schedule 11, page 144, line 5, leave out paragraph 118.”
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“They mostly result from the abolition of NHS England, the conferral of NHS England’s functions on others—primarily the Secretary of State and integrated care boards—and the changes made to the NHS provider landscape. Those minor and consequential changes are made to a large number of enactments, but notably a significant number of such consequential changes are made to: the Mental Health Act 1983, the NHS Act 2006, the Health and Social Care Act 2008, the Health and Social Care Act 2012 and the Medicines and Medical Devices Act 2021. The changes are necessary to ensure the proper operation of the statute book and reflect the substantive changes being made elsewhere in the Bill. I commend clause 67 to the Committee. Question put and agreed to. Clause 67 accordingly ordered to stand part of the Bill.”
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“These are minor and technical amendments. Government amendments 20 to 22 make changes to the Armed Forces Act 2006 to remove references to NHS England, reflecting that NHS England will be abolished. Those amendments are consequential to the Armed Forces Bill 2026. Government amendment 83 makes changes to the Children’s Wellbeing and Schools Act 2026 to remove reference to NHS England and update a reference to NHS trusts to take account of the new conversion procedure created by clause 35 of the Bill. Government amendments 23 and 24 both amend the NHS Act 2006 by removing unnecessary consequential amendments to that Act. Clause 67 inserts schedule 11, which makes minor and consequential amendments that are required as a consequence of the provision made in other clauses of the Bill.”
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“The draft affirmative procedure will be retained for any substantive changes, such as the introduction of a new chargeable function. Finally, there are a number of consequential provisions related to those I have just discussed. Government amendments 80 to 82 primarily relate to the commencement period in which they come into force. In conclusion, the amendments will enable a faster and more responsible reform of the existing legislative framework, while preserving proportionate safeguards and necessary scrutiny. I commend the new clauses to the Committee.”
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“New clause 95 is the final measure in the regulatory framework package for the MHRA. It is designed to streamline the process for routine fee updates made using powers under the European Union (Withdrawal) Act 2018 by allowing the use of the negative parliamentary procedure for routine fee uplifts. That will bring the powers in line with those relating to fees in the Medicines and Medical Devices Act 2021, where uplifts to existing fees can be made with the negative procedure. That will also reduce delays in making and communicating such adjustments, while maintaining appropriate safeguards, including the requirement to set out the cost basis for any new uplifts with any legislation—whether it is made under the negative or affirmative procedure.”
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“The measure is designed to enable consultations that are proportionate to the scale of the change in hand. That will ensure that regulations can be updated more efficiently and in line with the needs of the health service. New clause 94 will enable certain technical updates to medicines and medical devices regulations to be made using the negative rather than the affirmative procedure. Specifically, it relates to changes that routinely arise as clinical practice evolves—for example, updating detailed lists of medicines or making limited adjustments to the professional groups who may prescribe, supply, sell or administer particular medicines. At present, even minor or time-sensitive changes of this sort can require a debate under the affirmative procedure, which is not always the best use of parliamentary time.”
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“For medical devices, the provisions also extend the current ambulatory reference power to make reference to lists of countries subject to mutual recognition agreements, lists of devices or categories of device that are eligible for an international reliance pathway, and lists of British technical standards. Amendment 80 sets out that the extent of new clause 92 will cover England, Scotland and Wales. The provisions of new clause 93 enable a more flexible approach to consultations on regulatory changes related to medicines and medical devices, rather than the current one-size-fits-all requirement. Under the amended powers, the MHRA and the Department will still retain a legal duty to consult relevant stakeholders, and significant regulatory changes will continue to be subject to public consultation.”
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“It is important that the regulatory regime remains aligned with the technical, scientific and international framework that is designed to evolve over time. Currently, there are limited powers for medical devices regulations to refer to external international agreements or standards that change over time, and there are no such powers at all for medicines. Without the ability to make ambulatory references to those documents, legislation is needed each time the standards are updated. That is disproportionate and risks unintentional regulatory divergence that creates uncertainty for industry. The new clauses introduce a power for human medicines regulations to refer to external international agreements or standards that are updated over time.”
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“The ability to make faster and more responsive updates to secondary legislation will enable the Department and the Medicines and Healthcare Products Regulatory Agency to address the current barriers that I have highlighted in the regulation more quickly. New clauses 91 and 92 provide for changes with regard to powers to make “ambulatory references”, which are references in legislation to external documents such as technical standards and lists, which can be updated from time to time. These changes will ensure that the legislation continues to capture updated versions of those documents without the need for further regulations. International and domestic standards are crucial in the highly technical areas targeted by the change.”
House of Commons7 July 2026Contains Parliamentary information licensed under the Open Parliament Licence v3.0Source ↗