Karin Smyth
MP for Bristol South · Labour · United Kingdom
“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.”
“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.”
“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.”
“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.”
“Member for Gosport (Dame Caroline Dinenage), who spoke powerfully on behalf of the whole House; I commend the work that she has done. My hon. Friend the Member for Kingston upon Hull West and Haltemprice (Emma Hardy) has spoken to me in great detail about this issue, as has my hon.”
“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.”
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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.”
“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.”
“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.”
“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.”
“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.”
“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.”
“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.”
“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.”
“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.”
“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.”
“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.”
“(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.”
“(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.”
“(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.”
“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.”
“(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.”
“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.”
“(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.”
“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).”
“(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.”
“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.”
“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.”
“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.”
“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.”
“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.”
“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.”
“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.”
“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.”
“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.”
“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.”
“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.”
“I will begin with Government new clauses 91 to 95. Many hon. Members will know that the current regulatory framework for medicines and medical devices is seen as overly complicated and difficult to navigate. It is also slow and burdensome to amend, limiting our ability to ensure that it keeps pace with developments. Maintaining the safeguards to public health is central to every decision we make. However, the regulatory framework currently slows down innovation and delays patient access to healthcare products. From a market growth perspective, it also places barriers to the UK market, particularly for small and medium-sized enterprises. These new clauses will deliver a more streamlined regime for making and updating secondary legislation.”
“(3) The person appointed as Commissioner must— (a) be a person with knowledge, expertise and experience relevant to the discharge of functions of the role; (b) have first-hand experience of working in maternity services, so far as reasonably possible; and (c) not be a sitting Member of Parliament.”— (Helen Morgan.) This new clause would require the Secretary of State to appoint a maternity commissioner within the Department of Health and Social Care to oversee national maternity services. This person should be someone with experience and expertise of maternity services, and not a political appointment. Brought up, and read the First time.”
“(2) The functions of the National Maternity Commissioner are to— (a) oversee NHS maternity services; (b) act as an independent voice for women and families; (c) ensure lessons are learned from identified failures and that the recommendations of maternity reviews are acted upon; (d) promote consistency, safety and accountability across NHS maternity services; and (e) advise the Secretary of State on matters relating to the safety, quality and provision of maternity services in England.”
“At the moment those regulations are subject to the affirmative resolution procedure. Brought up, read the First and Second time, and added to the Bill. New Clause 1 National Maternity Commissioner “(1) The Secretary of State must, within six months of the passing of this Act, appoint a National Maternity Commissioner, situated within the Department of Health and Social Care.”
“(1B) In sub-paragraph (1A)(b) ‘the EU medical devices Regulations’ means— (a) Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC, or (b) Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU, as they have effect from time to time by virtue of Article 5(4) of the Windsor Framework.”’ —(Karin Smyth.) This allows regulations altering certain fees in relation to medical devices etc to be made subject to the negative resolution procedure.”
“(b) after sub-paragraph (1) insert— “(1A) Provision falls within this sub-paragraph if it relates to— (a) altering the amount of a fee or charge to reflect changes in the value of money, (b) altering the amount of a fee or charge to be charged in connection with the exercise of a function which a public authority has by virtue of provision made under section 8C in connection with the EU medical devices Regulations, or (c) altering the amount of a fee or charge to be charged under the Blood Safety and Quality Regulations 2005 (S.I. 2005/50).”
“The changes all relate to regulations about medicines and medical devices (although the procedural provisions relating to certain other matters are restated in the amendment). Brought up, read the First and Second time, and added to the Bill. New Clause 95 Medical devices etc: parliamentary procedure for certain fees regulations ‘In Schedule 7 to the European Union (Withdrawal) Act 2018 (regulations), in paragraph 12— (a) in sub-paragraph (1) for “relate to altering the amount of a fee or charge to reflect changes in the value of money” substitute “fall within sub-paragraph (1A)”.”
“(3C) Regulations under Part 4— (a) are subject to the negative procedure if they contain only provision of one or more of the following descriptions— (i) provision made in reliance on— • section 17(1)(a) (fees), or • paragraph 9 of Schedule 2 (supplementary provision about civil sanctions); (ii) provision amending or revoking regulation 1ZA of the Medical Devices Regulations 2002 (expiry of certain provisions) or consequential on such provision; (b) are subject to the made affirmative procedure if they— (i) contain only provision made in reliance on section 18 (emergencies), and (ii) contain a declaration that the person making them considers that they need to be made urgently to protect the public from an imminent risk of serious harm to health; (c) are subject to the draft affirmative procedure if they are not within paragraph (a) or (b).”’ —(Karin Smyth.) This changes the parliamentary procedure for certain regulations from the draft affirmative procedure to the negative procedure.”
“(3B) Regulations under Part 3— (a) are subject to the negative procedure if they contain only provision made in reliance on section 12(1)(a) (fees), and (b) are subject to the draft affirmative procedure if they are not within paragraph (a).”
“(3A) Regulations under Part 2— (a) are subject to the negative procedure if they contain only provision of one or more of the following descriptions— (i) provision made in reliance on section 6(1)(a) (fees); (ii) provision amending the meaning of ‘appropriate practitioner’ or ‘approved country health professional’ for the purposes of Part 12 of the Human Medicines Regulations 2012 (see regulation 214 of those regulations); (iii) provision amending any of the following provisions of the Human Medicines Regulations 2012— • regulations 217C(3) or 217CA(3) (original pack dispensing for products containing relevant substances: definition of ‘relevant substance’), • Schedule 13 (prescription only medicines for which community practitioner nurse prescribers are appropriate practitioners), • Schedule 15 (requirements for specific products subject to general sale), • Schedule 16 (patient group directions and vaccine group directions), • Schedule 17 (exemption for sale, supply or administration by certain persons), • Schedule 18 (substances that may not be sold or supplied by a pharmacist without a prescription in reliance on emergency provisions), • Schedule 19 (medicinal products for parenteral administration in an emergency), or • Schedule 21 (medicinal products at high dilutions); (iv) provision amending regulation 250 of the Human Medicines Regulations 2012 (restrictions on persons to be supplied with medicinal products: exceptions) for the purpose of changing the products to which any exception from time to time provided for by that regulation applies; (v) provision that is consequential on provision of a description mentioned in any of sub-paragraphs (ii) to (iv); (b) are subject to the made affirmative procedure if they— (i) contain only provision that is made in reliance on section 7 (emergencies), (ii) contain a declaration that the person making them considers that they need to be made urgently to protect the public from an imminent risk of serious harm to health, and (iii) are not within paragraph (a); (c) are subject to the draft affirmative procedure if they are not within sub-paragraphs (a) or (b).”
“New Clause 94 Medicines and medical devices regulations: parliamentary procedure ‘In section 47 of the Medicines and Medical Devices Act 2021 (regulations: procedure), for subsection (3) substitute— “(3) Regulations under Part 1 are subject to the draft affirmative procedure.”
“(3) After subsection (1) insert— “(1ZA) Before making regulations under Part 2 or 4 the relevant authority must— (a) carry out a public consultation, or (b) consult such persons as it considers appropriate.” (4) In subsection (3), at the beginning insert “Where a public consultation is carried out”. (5) In subsection (4), in the words before paragraph (a), for “subsection (1)” substitute “subsection (1ZA)”.’— (Karin Smyth.) This amends the duty to consult in relation to regulations about human medicines and medical devices. It gives the option of consulting such persons as the relevant authority considers appropriate instead of a public consultation. Brought up, read the First and Second time, and added to the Bill.”
“(4) Omit Schedule 2 (mutual recognition agreements).”— (Karin Smyth.) This new clause would amend the definition of “mutual recognition agreement” in the Medical Devices Regulations 2002 (as it has effect in England and Wales, and Scotland) so that agreements are defined by a list published by the Secretary of State, rather than a Schedule to the regulations. Brought up, read the First and Second time, and added to the Bill. New Clause 93 Consultation about medicines and medical devices regulations ‘(1) Section 45 of the Medicines and Medical Devices Act 2021 (consultation) is amended as follows. (2) In subsection (1), for “a provision of Part 1, 2, 3 or 4” substitute “Part 1 or 3”.”
“(2) For regulation 1A (Schedules) substitute— ‘ 1A Schedule Schedule 2A has effect.’ (3) In regulation 2 (interpretation), in paragraph (1)— (a) in the definition of ‘mutual recognition agreement’, in paragraph (a), for ‘country listed in Schedule 2’ substitute ‘country specified in a list published by the Secretary of State from time to time’; (b) in the definition of ‘third country conformity assessment body’, for ‘established in a country which is listed in Schedule 2 and designated in accordance with a relevant’ substitute ‘designated in accordance with a’.”
“I thank the hon. Lady for her comments. The purpose of the new clauses is to support our life sciences and medicine sector, in order to make that more streamlined. She will be aware of the proposals about the negative and affirmative procedure. If there were particular issues of scrutiny, normal parliamentary rules and processes would apply if Members wanted to raise any particular issue. Question put and agreed to. New clause 91 accordingly read a Second time, and added to the Bill. New Clause 92 Medical Devices Regulations 2002: mutual recognition agreements “(1) The Medical Devices Regulations 2002 (S.I. 2002/618) are amended as follows.”
“The role will be discussed urgently with the taskforce and will have a relentless focus on driving those improvements, which will include co-chairing the taskforce. As the Committee knows, these are complex matters. The Government, having accepted the Baroness Amos’s recommendation, intend to legislate as soon as practicable. Our immediate priority is to work quickly through the taskforce to define the scope and responsibilities of the role. I know that the hon. Member for North Shropshire will not press the new clause, but I commit to keeping in touch with her and other hon. Members as this work progresses.”
“Member for North Shropshire a more detailed timetable at the moment, because we are currently looking at options to legislate at pace, including potentially through this Bill, subject to discussions through the usual channels, while also—this is crucial—giving the taskforce the opportunity to shape the scope of the role. That was one of Baroness Amos’s urgent actions, and we accept it as a crucial first step in overseeing systemic improvements to care and outcomes and earning back the trust of women and families. The maternity and neonatal commissioner will champion the voices of families and drive forward that necessary change. The Secretary of State will remain accountable to Parliament for maternity services.”
“Baroness Amos brought the findings from past reviews, local rapid reviews and new evidence from families and staff together into one clear national set of recommendations, which as we heard was published last week. The Government also launched the maternity and neonatal taskforce, chaired personally by the Secretary of State, which will translate Baroness Amos’s recommendations into action. As we heard, Baroness Amos recommended the appointment of a statutory maternity and neonatal commissioner. We have accepted that recommendation, and I know there is support for it across the House. To be clear, the Secretary of State stated last week that we are committed to putting the role on a “statutory basis” as soon as possible. I am afraid I cannot give the hon.”
“I am grateful to the hon. Member for North Shropshire for bringing this discussion before the Committee. I put on record our thanks for the work she has done in this area and for her engagement with me, and indeed with officials at the Department, to help us understand it more clearly, particularly in the light of the new clause. Hon. Members across the Committee are committed, as are the Government, to ensuring that women, families and babies receive the care and support they need. We know that the vast majority of births are safe and that there are outstanding examples of care in the NHS. However, where things do go wrong, it can have a devastating impact on women and their families. That is why the Government launched the national investigation into NHS maternity and neonatal care, chaired by the noble Lady Baroness Amos.”