Draft Food and Feed (Regulated Products) (Amendment, Revocation, Consequential and Transitional Provision) Regulations 2025
Ashley Dalton Excerpts(11 months, 3 weeks ago)
General CommitteesRead Full debate Read Hansard Text Read Debate Ministerial Extracts
The Parliamentary Under-Secretary of State for Health and Social Care (Ashley Dalton)
I beg to move,
That the Committee has considered the draft Food and Feed (Regulated Products) (Amendment, Revocation, Consequential and Transitional Provision) Regulations 2025.
It is a pleasure to serve under your chairmanship, Sir John. The statutory instrument, which was laid before the House on 29 January, uses powers conferred by the Retained EU Law (Revocation and Reform) Act 2023 to propose two reforms to existing regulations for the market authorisation process for regulated food and feed products in Great Britain. First, it removes the requirements for the periodic renewal of authorisations for three regulated product regimes. Secondly, it allows authorisations to come into effect following a ministerial decision based on evidence-based safety assessment advice. Those authorisations will then be published in an official register or list, rather than being prescribed by statutory instrument. These reforms form part of the Government’s mission to kick-start economic growth by increasing investment, driving up productivity and tackling regulatory barriers.
The UK food industry is worth £245 billion in consumer spending, and exports over £20 billion annually. The industry is driving innovation, and nowhere is that truer than for regulated products. Regulated products are food and feed products that need to be assessed for safety before they can be lawfully sold. They include novel foods at the cutting edge of research—for example, in the UK’s growing engineering biology sector, where emerging technology is being used to produce new and innovative foods.
That innovation and growth across the food sector will drive increasing demand for regulated product authorisations, and we therefore need to modernise the market authorisation service. As the regulators, the Food Standards Agency and Food Standards Scotland assess applications for regulated products and provide recommendations to Ministers across Great Britain on whether those products should be authorised.
We need proportionate and effective regulation to support innovation and investment in the UK food industry, while continuing to maintain safety and consumer trust. This SI will help to modernise the food and feed regulatory process by removing requirements that are unnecessary for food safety. Currently, certain products that have already been authorised for sale must be reauthorised every 10 years. The SI will remove that requirement; instead, the regulators will carry out safety reviews when new evidence emerges, and most of these products have many years of safe use. The reforms will result in a more efficient regulatory service, where the FSA and FSS are able to focus on detailed reviews of products that potentially pose the most risk, instead of continually reassessing products that have consistently demonstrated safe use.
The reforms build on the regulators’ existing powers to request information from businesses for review. The regulatory framework will remain comprehensive and adaptive, enabling the regulators to respond swiftly and effectively to emerging risks. Where necessary, approvals can be modified, suspended or revoked.
The FSA and FSS have earned the trust of the public through their rigorous approach to risk analysis, and food safety will continue to be a priority. The reforms will improve efficiency, while maintaining robust safety standards. There are 481 applications currently in the service. Around 100 are renewals, and almost 500 additional renewals are expected in the next three years. It is essential that we modernise the system. Removing set renewal periods will allow a more targeted approach to regulation.
The second part of the reforms will allow authorisations to come into force following ministerial decision and to be published in an official public register or list, rather than being prescribed by statutory instrument. That will enable new products to be brought to market more quickly, without compromising consumer safety. That approach aligns with other UK regulators’ authorisation processes for similarly regulated products, such as veterinary medicines and pesticides.
The FSA and FSS provide technical and scientific scrutiny through skilled and experienced staff and expert independent scientific advisory committees. They assess individual applications and provide safety assessments, which they use to develop risk management advice and recommendations for subsequent ministerial decisions. That process squarely aligns with internationally recognised principles. The FSA and FSS will continue to publish authorisation decisions and risk assessments in line with their commitments to transparency.
The FSA has a statutory obligation to consult, and the reforms do not change the consultation mechanisms that are used as part of the authorisation process for regulated products. Authorisations will continue to be subject to public scrutiny. When developing these proposals, the FSA and FSS engaged extensively with industry and consumer stakeholder groups. That included a public consultation, and the reforms have received substantial support.
This is an opportunity to deliver reforms that prioritise both efficiency and safety in the market authorisation service. The FSA and FSS will be able to focus resources on new and innovative products, which may require more input when seeking access to the market. I therefore ask hon. Members to support the reforms in this instrument, which will create a more efficient service that manages the level of risk in a proportionate way, without compromising the UK’s high food and feed safety standards. I commend the regulations to the Committee.
Ashley Dalton
I thank hon. Members for their valuable contributions to the debate. Removing renewals and statutory instrument requirements will not lower food and feed safety or standards.
On scrutiny, removing SI requirements for authorisations will not change the FSA’s or the FSS’s robust risk analysis and public consultation process. Public consultations will remain open to all for scrutiny, and recommendations to Ministers for all authorisations of products will take those responses into account.
The shadow Minister asked how Ministers will be able to keep track of decisions. Of course, whether decisions come under this new proposal or the existing process, they will need to be assessed. Under this new process, Ministers can take advice from the FSA and the FSS, and we will then lay those decisions in the public register. If we did not bring this proposal forward, everybody would be involved in multiple SIs, which I am sure the shadow Minister will agree is a far more onerous process.
In response to concerns about divergence with Northern Ireland, our priority is to ensure that Northern Irish consumers benefit from the same robust public health protections as the rest of the UK, while also facilitating the smooth movement of goods to consumers. The robust system of controls that applies across the UK enables all consumers to trust that the food they buy and eat is safe and is what it says it is. Any differences in approach are managed through the relevant common frameworks.
As has been stated, the current requirement for renewals applies only to three regulated product regimes: feed additives, food or feed containing, consisting of or produced from genetically modified organisms, and smoke flavourings. No other regulated products, including novel foods and food additives, have this requirement at the moment. These reforms introduce a consistent, proportionate and evidence-based approach.
The FSA and FSS will focus on horizon scanning and risk assessment so that they can respond to new safety evidence as it emerges. We are not going to ask businesses to bring their products routinely for review. However, if there are any changes in a product’s make-up, or it comes to light that the product has any new impacts, that will trigger the FSA and the FSS to look into those.
Dr Johnson
I did not quite understand the Minister’s point regarding Northern Ireland. At the moment, under the new regulations, it is clear what will be done in Great Britain to approve new products. However, if a new product has been produced in another part of the United Kingdom—that is, Northern Ireland—how will it be assessed? How will products that have been assessed under the system in GB be able to be sold in Northern Ireland? Will they require further investigation?
Ashley Dalton
Businesses in Northern Ireland that develop new regulated products and wish to place them on the market in the EU must apply to the EU for authorisation—that is all within the Windsor framework, and the reforms in this SI do not affect the operation of the Windsor framework in any way. Regulated products that are approved in Great Britain can be placed on the Northern Ireland market if moved via the Northern Ireland retail movement scheme. I think that that answers the question.
To return to the safety concerns, by carrying out horizon scanning and risk assessment, the FSA and the FSS will consistently provide insights into whether already authorised products are safe to remain on the market, instead of working arbitrarily to renew authorisations on fixed timetables. The burden on industry and the public sector of having a comprehensive review for all products, even if there is no evidence to suggest that a review is needed, will be removed. We are looking for an evidence-based review system to help focus resources on new and innovative products and on where there may be problems.
The reforms build on existing powers under which the FSA and the FSS can request information for review, and it is in the interests of businesses to proactively provide it. The reforms ensure that the regulatory framework remains comprehensive and adaptive, and enables regulators to respond swiftly and effectively to the emerging risks we have discussed. Where necessary, approvals can be modified, suspended or revoked if a safety concern is identified.
The FSA and FSS, along with the independent scientific advisory committees, have the expertise to assess all applications for authorisation. Ministers must provide reasoning if they disagree with the advice from the FSA and FSS when making authorisation decisions. So there are appropriate tools and resources to allow hon. Members and the public to scrutinise regulated product applications and authorisations. The reforms will speed up the process, use resources more productively, efficiently and effectively, and align with other UK regulatory systems.
In summary, the reforms will remove requirements for the periodic renewal of authorisations for the three regulated product regimes I mentioned, and will allow authorisations to come into effect following ministerial decisions. The changes will streamline the process, allow regulators to keep pace with innovation, and support economic growth without compromising consumer safety. I am grateful for all the contributions today.
Question put and agreed to.
Rare Diseases Action Plan
Ashley Dalton Excerpts(1 year ago)
Written StatementsRead Full debate Read Hansard Text Read Debate Ministerial Extracts
The Parliamentary Under-Secretary of State for Health and Social Care (Ashley Dalton)
The Government published England’s fourth Rare Diseases Action Plan on www.gov.uk on Friday, which was international Rare Disease Day. This Government remain committed to improving the lives of people living with rare diseases, and today’s action plan provides more detail on the steps we will be taking over the next year to meet these four priorities.
The UK Rare Diseases Framework was published in January 2021 following the National Conversation on Rare Diseases, which received nearly 6,300 responses. This helped identify the four priorities of the framework in tackling rare diseases: helping patients get a final diagnosis faster, increasing awareness of rare diseases among healthcare professionals, better co-ordination of care, and improving access to specialist care, treatment and drugs.
The 2025 action plan updates on progress we have made across the system—in the NHS, in health education, in regulation—to address the four priorities of the framework:
On faster diagnosis, the Generation Study has started recruitment to pilot whole genome sequencing of newborns to identify rare diseases before symptoms develop.
On raising awareness in healthcare professionals, specific strategies for increasing awareness of rare diseases in the nursing and midwifery, pharmacy and primary care workforce have been published.
On better co-ordination of care, research is now under way on how to improve better co-ordination of care in the NHS.
On improved access to specialist care, treatment and drugs, we have worked with industry, clinicians and patients to understand the challenges and opportunities of early access pathways for rare disease therapies.
The action plan also commits to three new actions for the year ahead. This will expedite improvements in co-ordination of care to patients, and looks ahead to enabling new therapies to reach people who need them as quickly as possible and maintaining the UK’s position as a leader in life sciences:
NHS England is incentivising providers to run multi-system “carousel” clinics to enable patients to see multiple specialists on the same day, reducing the logistical burden on people living with rare diseases and their families.
The new clinical trial legislation laid last year will enable the MHRA to address some of the challenges in research for new rare disease therapies.
NHS England will explore the development of an operational framework for service delivery of individualised, or “n-of-1”, gene therapies to patients within the NHS. These are truly cutting-edge therapies that have the potential to change and save lives.
Centring the voices of those with lived experience remains an underpinning principle of the approach to rare diseases. The advocacy and expertise of the patient organisations, patients and families, has raised the awareness of rare diseases and driven progress. The action plan will be monitored for progress and outcomes during 2025-26.
[HCWS489]
Women’s Health
Ashley Dalton Excerpts(1 year ago)
Westminster HallRead Full debate Read Hansard Text Read Debate Ministerial Extracts
Westminster Hall is an alternative Chamber for MPs to hold debates, named after the adjoining Westminster Hall.
Each debate is chaired by an MP from the Panel of Chairs, rather than the Speaker or Deputy Speaker. A Government Minister will give the final speech, and no votes may be called on the debate topic.
This information is provided by Parallel Parliament and does not comprise part of the offical record
Dr Rupa Huq (in the Chair)
Finally, for what we think is her first outing as a Minister in Westminster Hall—although she is a veteran of the Chamber already— I call Ashley Dalton.
The Parliamentary Under-Secretary of State for Health and Social Care (Ashley Dalton)
It is a pleasure to serve under your chairship, Dr Huq. I congratulate my hon. Friend the Member for Hastings and Rye (Helena Dollimore) on securing this really important debate on women’s health. She and all Members who have participated today have raised a number of important points.
Let me begin by agreeing that reading the Ockenden review is harrowing, and progress on women’s health has been far too slow. I want to address some of the key issues that Members have raised; I will attempt to cover as many as I can, but if I miss anything, please get in touch, and I will endeavour to fill any gaps after the debate.
My hon. Friend the Member for Hastings and Rye raised the story of our very good friend Margaret McDonagh and how her experience feeds into the medical misogyny that has been highlighted on a number of occasions. In addition, it was very powerful to listen to my hon. Friend the Member for Washington and Gateshead South (Mrs Hodgson), who put an important focus on women’s voices and said how important it is that those are heard in this space. Those voices can lead to the important cultural shift that my hon. Friend the Member for Stafford (Leigh Ingham) raised and that underpins all of this.
The hon. Member for Strangford (Jim Shannon) and my hon. Friend the Member for Cumbernauld and Kirkintilloch (Katrina Murray) spoke about the devolved Governments. We are committed to ensuring that we have closer working between the UK and devolved Governments so that we can share insight and best practice and cut waiting lists right across the UK.
My hon. Friend the Member for Cumbernauld and Kirkintilloch and the hon. Member for Wimbledon (Mr Kohler) raised issues relating to eating disorders and women in online content. The Government inherited a broken NHS, in which patients wait too long for eating disorder treatment. The 10-year plan will overhaul the NHS, and the Online Safety Act 2023 will prevent children from accessing harmful online content on eating disorders.
The hon. Member for Canterbury (Rosie Duffield) raised the differences in heart attack symptoms between men and women. NHS staff can now access guidance through the British Heart Foundation, and there are learning sessions available to support training. NHS England ensures that there is clear messaging on atypical symptoms in women in all public campaigns, and training on heart attacks and the identification of gender and sex are a core part of the cardiology curriculum. The hon. Lady will be aware that the National Institute for Health and Care Research has a very clear definition of sex and gender, which has an important impact on delivering the right healthcare to everybody.
I was really interested to hear from my hon. Friend the Member for Dudley (Sonia Kumar), who has expert knowledge of perinatal pelvic health services, which are being rolled out across England to ensure that women have access to physiotherapy for pelvic health issues during pregnancy and for at least one year after birth. Those services incorporate a range of interventions aimed at improving the prevention and identification of perinatal tears and other perinatal conditions.
The Chair of the Women and Equalities Committee, my hon. Friend the Member for Luton North (Sarah Owen), spoke about the Committee’s recent report, which we welcome and take extremely seriously. We are grateful to everyone who gave their time and expertise to the inquiry, and to the Committee for its thoughtful recommendations. My Department has looked closely at the findings, however chunky they are, and has worked with NHS England to consider the recommendations and develop a Government response. I assure her that it will be published very soon.
The hon. Member for Epsom and Ewell (Helen Maguire) spoke about contraception. Let me make one thing really clear: we are committed to ensuring that the public receive the best possible contraceptive services, which are vital in helping women to manage their gynaecological health. Since 2023, the NHS Pharmacy Contraception Service has allowed pharmacists to issue ongoing supplies of contraception that have been prescribed by GPs and sexual health services. That service was relaunched in December 2023 and will be continued.
We have also talked about fertility issues. Access to fertility treatment across the NHS has been varied across England, and funding decisions are made by integrated care boards, based on the clinical needs of the people they serve. We expect those organisations to commission fertility services in line with the guidelines set by the National Institute for Health and Care Excellence. We recognise that provision is variable across England, and we intend to support ICBs to implement the updated evidence in the revised guidelines to benefit all affected groups.
We recognise the significant physical and psychological consequences of birth trauma and the devastating impact it has on women. I thank hon. Members for their contributions to the report of the APPG on birth trauma—the hon. Member for Canterbury was intrinsic to it. The Government will ensure that lessons are learned from the recent inquiries and investigations, including the APPG report, and that the experiences of women and their families are listened to and woven into our efforts to improve services.
For too long, women have been let down by their healthcare. The system is broken—it does not work for them. This Government are committed to fixing women’s health as a key part of building an NHS fit for the future. As a first step, we have delivered 2 million more appointments since July, in line with our manifesto commitment of delivering 2 million more appointments in the first year. We have achieved that seven months early. That includes appointments for breast cancer care, for gynaecological conditions such as endometriosis and for many other conditions.
However, we are still nowhere near satisfied with the state of women’s healthcare. Kate’s story, which my hon. Friend the Member for Hastings and Rye shared, is testament to that state.
Wera Hobhouse
I do not mean to be pompous, but the Minister did not mention me—it was me who mentioned the online harm.
Wera Hobhouse
May I ask whether the Minister would meet the eating disorders APPG to talk about online harm, particularly in relation to sufferers of eating disorders?
Ashley Dalton
I thank the hon. Member for her intervention, and I will get there and mention her. I am more than happy to have that conversation with her.
For the benefit of the shadow Minister, the hon. Member for Hinckley and Bosworth (Dr Evans), I would like to clear something up and dispel some misinformation. We have not scrapped the women’s health strategy, nor have we abandoned women’s health hubs—far from it. We are using women’s health hubs to beat the backlog. The future funding decisions around those health hubs will be taken in due course. I can also confirm for the shadow Minister that Baroness Merron is the Minister with responsibility for women’s health, and she regularly meets Dame Lesley, the women’s health ambassador. Dame Lesley attended the 10-year plan round- table in January, which was chaired by Baroness Merron. I can reassure the hon. Gentleman on that.
When we came into government, we inherited an appalling legacy of nearly 600,000 women on gynaecology waiting lists. That is why the Prime Minister kicked off 2025 with our elective reform plan. The plan states our commitment to offer women gynaecological care closer to home, an approach that has been pioneered by those women’s health hubs. As of December, nine in 10 integrated care boards had at least one women’s health hub, and some have more.
Alice Macdonald
In Norfolk we had a virtual health hub. When we look at whether the health hubs are working and share best practice, can we talk about whether that is the best format for a health hub or whether a physical one would be better?
Ashley Dalton
That is something that we will take on board and consider as we move forward.
We have heard a lot about menopause and peri- menopause from many Members, including my hon. Friend the Member for Broxtowe (Juliet Campbell). We are supporting women through the whole menopause process. Menopause and perimenopause symptoms can be wide-ranging and debilitating. NHS England is developing a range of tools and interventions to help upskill more GPs in menopause care, including awareness of mental health symptoms during menopause, and developing a menopause workforce support package for employees. I can also confirm that we are using community diagnostic centres to pilot pathways for women who suffer from post-menopausal bleeding.
Ashley Dalton
I will come back to the hon. Gentleman on that, but I thank him for raising the issue.
We have also talked a lot about what underpins this topic: research and innovation, and my hon. Friend the Member for Stafford raised that point in particular. We are taking strides in vital research. By the spring, the NIHR expects to launch its sex and gender policy, which will ensure that research is designed, conducted and reported in a way that accounts for sex and gender—a point raised by the hon. Member for Canterbury. That will support our understanding of how women might be impacted differently by health conditions.
The hon. Member for Bath (Wera Hobhouse) talked about eating disorders and also about breast cancer, which a number of people raised. As I am sure the hon. Lady appreciates, that issue is important to me, as I was diagnosed with a breast cancer when I was under the age of 42. It is an important issue.
Health in the workplace continues to be an important issue for us, and we are dealing with that through our make work pay strategy and the Employment Rights Bill, which will set out some of those steps, including support for women experiencing menopause in the workplace.
On sodium valproate and pelvic mesh, the Cumberlege review made nine recommendations, of which the then Government accepted seven. I can confirm that the national pause remains in place.
Oral Answers to Questions
Ashley Dalton Excerpts(1 year ago)
Commons ChamberRead Full debate Read Hansard Text Watch Debate Read Debate Ministerial Extracts
The Parliamentary Under-Secretary of State for Health and Social Care (Ashley Dalton)
I thank my hon. Friend for his continued support for people with Parkinson’s disease, a condition that I know is close to his family. This Government inherited long waits for neurology services, with only 53.4% of patients, including those with Parkinson’s, waiting less than 18 weeks for a referral in June. Our elective reform plan will free up over 1 million appointments each year for those who really need them, including patients with Parkinson’s, and NHS England’s Getting It Right First Time programme continues to work with 27 specialised centres in England, including at University Hospitals of North Midlands.
Adam Jogee
I thank the Minister for her answer and congratulate her on her appointment. Will she join me in paying tribute to my constituent Julie Hibbs, from Bradwell in Newcastle-under-Lyme, who has long campaigned for support for people with Parkinson’s, like her? Will the Minister meet me and Julie to discuss the merits of adding Parkinson’s to the medical exemption list, and to discuss how we ensure that those with Parkinson’s get the support they need and deserve?
Ashley Dalton
I am happy to meet my hon. Friend and his constituent to discuss all of those matters of concern—I look forward to doing so as soon as my diary will allow.
Shockat Adam (Leicester South) (Ind)
The eyes are not only the windows to the soul, but a window to our health. Last week I had the pleasure of meeting the team at Moorfields eye hospital who, alongside a team at University College London, have done some work on a simple retinal scan that can detect Parkinson’s disease seven years prior to any symptoms. Does the Minister agree that optometry, eye care and eye health should be at the forefront of NHS England’s plan for integrated care, and that we should bring forward a national eye health strategy?
Ashley Dalton
Yes, I would be more than happy to support that. That is part and parcel of this Government’s aim to shift the NHS from hospitals to community.
Munira Wilson (Twickenham) (LD)
Debbie Abrahams (Oldham East and Saddleworth) (Lab)
The Parliamentary Under-Secretary of State for Health and Social Care (Ashley Dalton)
Lord Darzi’s report laid bare the shocking health inequalities in our country. It is completely unacceptable that in Britain in 2025, maternal mortality rates for black women are more than double those of white women and life expectancy at birth for females in Blackpool is eight years less than in Kensington and Chelsea. Reducing inequalities in elective care was identified as a key priority in the planning guidance and mandate that the NHS published last month, and further measures to address these inequalities in our country will be at the heart of our 10-year health plan, which will be published in the spring.
Debbie Abrahams
In 2013, the then coalition Government reduced the health inequalities weighting in the NHS formula, with the result that less money went to deprived areas. That was despite evidence that between 2001 and 2011, every £10 million invested in such areas resulted in four fewer men and two fewer women dying early. Can my hon. Friend reassure Government Members that that health inequalities weighting will be reinstated so that we can ensure that deprived areas get the funding they need and that lives are saved?
Ashley Dalton
The Government mandate to NHS England was published on 30 January and makes the importance of tackling health inequalities clear. NHS England has an existing programme that targets the most deprived 20% of the population, with the aim of reducing health inequalities. I can reassure my hon. Friend, who has been a determined campaigner on inequalities, that the health inequalities weighting has not been withdrawn. The funding in question, which amounted to £200 million, has been incorporated into the main integrated care board allocation. The weighting of that health inequalities adjustment has been increased from 10% to 10.2%, so that the ICBs still benefit from that extra investment, with funding redistributed to areas with the poorest health outcomes, based on measures of avoidable mortality provided by the Office for National Statistics.
Sir Alec Shelbrooke (Wetherby and Easingwold) (Con)
I welcome the hon. Lady to her position. She may be unaware of the number of debates that I have led into women’s health and endometriosis and pelvic mesh, and there is an inequality in the health service with how women are treated. Many women are deeply concerned by the announcements and statements about how the concentration on women’s health has been reduced. Will the Minister speak to the president of the Royal College of Obstetricians and Gynaecologists? Following that meeting, will she speak to the Secretary of State, who rightly says that he recognises when mistakes have been made, about reconsidering the approach to women’s health taken in the statement the other week?
Ashley Dalton
The Darzi review highlighted that there were too many targets set for the NHS, which made it hard for local systems to prioritise actions. There has been no reduction in women’s health services. The Government are committed to prioritising women’s health as we build an NHS that is fit for the future, and women’s equality will be at the heart of our missions. Women’s health hubs, which provide integrated women’s health services in the community, have a key role in tackling the inequalities faced by women. The Department has invested £25 million over 2023-24 and 2024-25 to support the establishment of at least one pilot women’s health hub in every integrated care system.
Connor Naismith (Crewe and Nantwich) (Lab)
Matthew Patrick (Wirral West) (Lab)
The Parliamentary Under-Secretary of State for Health and Social Care (Ashley Dalton)
Increasing HIV testing is a vital step towards meeting our goal, and it will be a core element of our new HIV action plan, which will be published later in the year. We are investing more than £4.5 million in delivering a national prevention programme, and, with backing of an extra £1.5 million, we will extend the programme for a further year, until March 2026.
Christine Jardine (Edinburgh West) (LD)