Tag: Maria Caulfield

The statement made by Maria Caulfield, the Parliamentary Under-Secretary of State at the Department of Health and Social Care, in the House of Commons on 19 December 2022.

I thank the hon. Lady for her question. I know families are concerned about the recent outbreak of strep A in children. Although the vast majority of strep A cases are mild and can easily be treated with antibiotics, a small number of children have gone on to develop serious infections.

The UK Health Security Agency has already declared a national enhanced incident to co-ordinate our public response. Increased demand has led to some temporary supply issues, but I reassure Members on both sides of the House that we have stock of antibiotics and have taken a number of steps to deal with some of the supply issues.

First, we have worked at pace to help to ensure that there are supplies of vital medicines to meet the increased demand. Earlier this month, we convened roundtables with manufacturers of the preferred treatment, penicillin V, and with major UK wholesalers. We continue to work with manufacturers and wholesalers to boost supply to meet demand. The key issue is getting stock to pharmacies across the country. We have brought forward stock to make sure it gets to where it is needed, and we are expediting deliveries. Deliveries to wholesalers and pharmacies continues to be made, with more expected in the coming days and weeks.

Secondly, we have issued eight serious shortage protocols to allow pharmacists to supply not only alternative forms of penicillin, but alternative antibiotics. This will make things easier for pharmacists, general practitioners and, of course, patients. We have also added a number of antibiotics to our list of medicines that cannot be exported or hoarded.

Finally, we have updated advice across the board. Further guidance was given to GPs and pharmacists on Friday as part of the new SSPs. My Department has provided advice to colleagues in primary and secondary care on the management of the current supply issues. We have also held a cross-party briefing for MPs, and a “Dear Colleague” letter will go out later today.

I know this is a worrying time for families across the country, but I reassure them and people across the healthcare sector that we are managing the higher-than-normal number of strep A cases this winter and we have a range of medicines available.

The statement made by Maria Caulfield, the Parliamentary Under-Secretary of State for Health and Social Care, in the House of Commons on 15 December 2022.

On 16 December 2021, the Government published their response to the findings of the inquiry into the issues raised by disgraced surgeon, Ian Paterson. We reiterated the apologies of the Government to the patients affected and those close to them and committed to ensuring we did more to protect patients in the future.

In line with this commitment, the Government accepted the overwhelming majority of the recommendations made by the inquiry and set out an implementation plan of 40 actions to put those recommendations into effect. Finally, we committed to providing a further update on the progress of this implementation plan in 12-months’ time. I am happy to be able to publish this report fulfilling that commitment today.

All the relevant bodies within the health sector have been united in understanding that these changes are essential. We all agree that patients cannot be failed in the same way again. On behalf of the Government, I want to thank every organisation that has engaged in this process for their commitment to making improvements. I would especially like to thank the representatives of patient groups impacted by Ian Paterson, who have campaigned tirelessly to ensure their experiences do not go unheeded. They have continued to be a source of inspiration and expertise throughout the implementation period.

I am pleased to report that good progress has been made across the implementation plan which we set out in December 2021. The report published today provides full details of this progress against the four themes of the Government’s response as laid out in the implementation plan. In this statement, I will highlight some of the most important developments under each of these themes.

Patient-centred information

Patients now have more access to information relevant to their treatment than they did during Ian Paterson’s time practising. This includes access to information about the performance of consultants working for independent sector healthcare providers, and specialties in the NHS. These continue to be added to, so patients will have more, and better, access to independent information before choosing a consultant. NHS England (NHSE) will work with the professions so that meaningful consultant-level information on the numbers and types of procedures performed should be made publicly available. If patients choose to be treated in the independent sector, there is now more information about what to expect, with further information to be made available over the coming year.

Patients now have the right to access their treatment records and clinicians are aware of the need to write to patients directly following a consultation or treatment, rather than only writing to their GP. This information gives patients a record of their condition, and test results to reflect on, or to seek a second opinion if required. This is reinforced by ensuring patients gets the time they need to consider treatment options and have access to a range of new resources to help them consider their options; options that patients will also be able to discuss with medical professionals who are equipped to handle these conversations.

Making challenge heard

Doctors across more specialties now have independent data on their practice available and will be required to use this as part of their appraisal and revalidation processes. This will help to identify issues and fix them. Staff in the health system also have more opportunities to make their voices heard about a patient’s care, including through clarified guidance and assessment of multidisciplinary team use as a forum.

Care Quality Commission (CQC) updated its guidance on complaints processes in early 2022. It is now easier for patients to raise concerns about treatment they receive and access independent resolution of their complaint if they are unsatisfied with the provider’s handling. As part of the implementation of the NHS patient safety strategy, NHSE has introduced measures to advance safety and the response to harm. The Government have appointed the first ever patient safety commissioner for England, Dr Henrietta Hughes OBE.

Ensuring accountability

CQC published the new single assessment framework in July 2022, which sets out what good care looks like, and National Quality Board published national guidance on system quality groups, setting out the requirements for quality governance in integrated care systems.

Alongside this, we have seen significant culture change in the independent sector, now leaving no doubt that independent providers must take responsibility for maintaining high standards of care in their facilities, irrespective of how the medical professionals involved are engaged by them (through employment or practising privileges). This has been supported by Independent Healthcare Providers Network’s refresh of the medical practitioners assurance framework in September 2022. NHS Resolution launched new exclusion guidance in April 2022.

Putting things right

Patients who are impacted by potential issues with their care will be reviewed through recall processes which are now better informed of how to put patients at the centre of their focus. The new national recall framework was published in June 2022 to facilitate this.

Patients will continue to receive apologies from healthcare professionals and providers for potential issues with their care when appropriate. Enhanced training and resources are now available to clinicians to ensure these apologies are delivered effectively and meaningfully.

The Government are working to ensure that any future changes to indemnity and insurance arrangements will be made using the best evidence base available. This includes a thorough assessment of the impact on patients, healthcare professionals, providers, and the wider market; with the aim of improving the position for patients when receiving treatment from any regulated healthcare professional, regardless of the setting. The Government’s ambition is that when this work concludes, patients have confidence that they can access appropriate compensation if harmed while receiving care, including when harm arises from criminal/intentional acts or omissions. The summary of responses to the consultation on appropriate clinical negligence cover for regulated healthcare professionals will be published alongside this implementation update on 15 December 2022.

The Government will be continuing to ensure this work is built upon, as part of our wider commitment to ensuring patient safety and high standards of care across the health system. We understand that there is no room for complacency when it comes to patient safety and, together with the patient safety commissioner, will make sure this is one building block towards a health system in which patients and those close to them can have the maximum possible confidence.

The speech made by Maria Caulfield, the Parliamentary Under-Secretary of State for Health and Social Care, in the House of Commons on 13 December 2022.

I thank my hon. Friend the Member for North West Leicestershire (Andrew Bridgen) for securing the debate. It is important that all Members get to discuss and debate such issues, and they are entitled to their opinion.

I have to say that I strongly disagree with my hon. Friend, not only in the content of his speech, but in the way he derided doctors, scientists and nurses. Many of us worked through the pandemic and saw at first hand the devastation that covid caused. There is no doubt in my mind that, despite the personal protective equipment, social distancing and infection control, the thing that made the biggest difference in combating covid was the introduction of the vaccine.

Safe and effective vaccines have underpinned our strategy for living with covid. Covid has not gone away, but we are living with it in a way that was not possible this time last year. Vaccines have saved thousands of lives, reduced the pressure on the NHS, and allowed the economy and society to reopen, not just in this country but in countries across the world. In countries with lower vaccination rates, their ability to open up, move on and live with covid was reduced.

Across the piece—not just for covid—vaccines remain our biggest line of defence, particularly during a challenging winter period. We see with our seasonal flu vaccine roll-out and our covid programme that getting the most vulnerable people vaccinated—

Andrew Bridgen

Will the Minister give way on that point?

Maria Caulfield

I will not. I have just three minutes to respond to the many points that my hon. Friend made.

It is important to put on the record that all the vaccines used in the UK are safe, and we have some of the highest safety standards in the world, with the MHRA globally recognised for requiring high standards of safety. I have worked in clinical research, and I can say categorically that the data is not hidden from the public or the MHRA; it is inspected rigorously and can be reinspected at any time.

Each of our covid vaccine candidates is assessed by a team of scientists and clinicians on a case-by-case basis, and it is only once a potential vaccine has met robust standards of effectiveness, safety and quality that it is approved for use. That is the case for all medicines, not just covid vaccines. Extensive data shows that the vaccine is safe and highly effective in reducing the deaths that we sadly saw during the pandemic. That does not end when the vaccine is approved; surveillance of vaccines continues, as it does with any medicine, and any adverse reaction is recorded on a regular basis. That does not stop following approval.

My hon. Friend talked about the yellow card reports. Those have been in place for many years. Anyone who has a side effect from any medicine can make a yellow card report. When I was first starting out in nursing, that was a physical yellow card; it is now online. Anyone can submit any suspected adverse drug reaction. The MHRA will collate and review them, and it has in the past gone on to suspend the licence of a medicine if it has concerns. That is something that it can do for any vaccine, including any covid vaccine.

The nature of the yellow card reporting system means that some reported events are not always proven side effects. A side effect can be reported; the MHRA will then go and look to see whether it is actually related to that medicine, and there is a list of probabilities of how likely it is that the side effect is related to that medicine. There is comprehensive surveillance to alert us to any unforeseen adverse reactions to vaccines and to enable us to act swiftly when required.

We know that there are some circumstances where individuals have sadly experienced harm with a possible link to a vaccination. I recognise how difficult that is for those individuals and their families. We have put measures in place to monitor any possible side effects and to commission further research that will help us better understand how to diagnose and treat those who have suffered or continue to suffer any ill effects from a covid-19 vaccine. That is the case for any medicine—even with a simple medicine such as paracetamol, people can get side effects—and that is why every medicine that is prescribed and dispensed has a patient safety information sheet listing the most likely side effects and encouraging people to report any that may not be included.

Danny Kruger

Will the Minister give way?

Maria Caulfield

I will give way quickly, because I have only a couple of minutes.

Danny Kruger

I am grateful. The Minister’s predecessor had asked the Joint Committee on Vaccination and Immunisation to review the evidence behind the decision to roll out the vaccine to children. Can she update the House or write to us to explain where that review has got to? Does she agree that the JCVI should be looking at the vaccination of children?

Maria Caulfield

I will write to my hon. Friend with an update on that report. It was touched on that the MHRA has licensed the vaccine for babies, but that has not yet been approved by the JCVI, so that is just a licence rather than a recommendation to roll out. However, I am happy to send him the details of that report.

I want to put on the record that the covid vaccines have saved tens of thousands of lives and prevented hundreds of thousands of people from being hospitalised. I completely disagree with my hon. Friend the Member for North West Leicestershire that there is a whole conspiracy of doctors, nurses and scientists—they have done nothing but work hard to get us through the pandemic.

Andrew Bridgen rose—

Maria Caulfield

I will give way for one brief point.

Andrew Bridgen

I thank the Minister for giving way on that important point. The claims about the number of lives saved worldwide by the vaccination are sponsored by vested interests. The modelling is the lowest form of scientific evidence—in fact, it is more science fiction than science fact.

Maria Caulfield

I completely disagree. I worked on the covid wards with patients who were dying from that virus. We had infection control measures, antibiotics, dexamethasone—a steroid—and every known facility available, and the only thing that made a difference was when those vaccines were introduced. They do not necessary stop people from getting the virus, but they certainly reduce its intensity and the likelihood of someone dying from it.

I completely debunk the conspiracy theories about a whole group of people benefiting financially from the roll-out of the vaccine and would gently say to my hon. Friend that if he has evidence, there are mechanisms in place for raising concerns, as we have seen with other drugs. Only today, I was before the Health and Social Care Committee talking about sodium valproate—we also had an Adjournment debate on that last week—where there are genuine safety concerns. The MHRA is taking that extremely seriously. It is not worried about pharma concerns; its first priority is patients, and it is exactly the same with the covid vaccine. So if there is evidence—I am not saying that there is not—it absolutely must go through the proper channels so that it can be evaluated.

We have launched a nationwide campaign to encourage people to come forward this winter to get their booster. I recommend that people do that safe in the knowledge that the vaccine is safe for people to have.

The speech made by Maria Caulfield, the Parliamentary Under-Secretary of State for Health and Social Care, in the House of Commons on 7 December 2022.

I congratulate my right hon. Friend the Member for Romsey and Southampton North (Caroline Nokes) on securing this important debate on fatalities relating to foetal valproate spectrum disorder. We all know the devastating effect that the drug can have during pregnancy, which is why we took seriously the recommendation in Baroness Cumberlege’s report. I have met the campaigners, Janet and Emma, when I was previously a Minister and since being reappointed—I can confirm that they are definitely not blacklisted by the Department. I look forward to meeting them again shortly to hear the concerns that they still have, which my right hon. Friend set out well this evening.

To reaffirm what the hon. Member for Lancaster and Fleetwood (Cat Smith) said, we all know that sodium valproate can be a highly effective drug that is used to manage and treat epilepsy as well as other disorders, such as bipolar disorder and migraines, often when many other medications do not work or have stopped working. It is absolutely right to say that if a woman is on sodium valproate, it is crucial that they do not stop that medication suddenly but discuss it with their GP.

We know that there are teratogenic side effects that mean that, if taken during pregnancy, sodium valproate can have harmful effects on a foetus and increase the risk of a child being born with physical defects and neurodevelopmental disorders. In relation to the point made by my right hon. Friend the Member for Romsey and Southampton North about possible death, I do not know about that specific case but I am happy to ask officials to go away and look at it, because that would be an important development.

The risk of birth defects following the use of sodium valproate is about 11%, but with a high maternal dose, the risk can increase to 24%. There are significant risks of taking that drug and effects on babies once they are born.

Cat Smith

I thank the Minister for the time that she makes available for the subject, which is much appreciated. While she is on the topic of the percentage risk of harm to the unborn baby, at that stage in pregnancy, many women and couples have a very much wanted pregnancy, which is perhaps planned for and longed for, but are suddenly advised by a doctor to terminate it. Does she agree that that tragedy needs to end? We need to come together to ensure that pregnancy prevention plans really work.

Maria Caulfield

I absolutely agree with the hon. Lady, and I will come on to some of the changes that are being made on that point. When I have met Janet and Emma, they have very much represented women who feel that those risks were not explained and that if they had known, they would have been on contraception or spoken to their team about stopping the medication before getting pregnant. Often, those are women with complex epilepsy for whom pregnancy is a difficult enough decision in the first place.

We have known for a long time that the drug should not be used by any woman or girl who can have children, unless they are in the proper pregnancy prevention programme. That is why, in 2018, the programme was introduced to reduce and prevent the number of pregnancies, which was high at the time, in women taking the drug. Being part of the programme means that women are supposed to have an annual review by a specialist, but I have concerns and have heard from campaigners that that does not always happen and is not always the case. There is also the valproate registry, which has now been created so that we can track every woman who is taking that medicine and ensure that the records of when they are prescribed it, when it is dispensed and what is happening to them are followed through, which has never happened before.

The programme is designed to make sure that, each year, those women have a discussion with their health team, so should they wish to become pregnant, they can get that advice there and then. When I was in this post previously, I had concerns about the overview of the register, the annual checks and some of the other safeguards around the dispensing and packaging of the drug, which have been touched on. That is why we have reviewed the programme.

I have met the MHRA, which has taken both campaigners’ and my concerns very seriously. It is looking at the programme, and it will be making an announcement shortly on stronger advice to GPs, but also to pharmacists, about some of the technical issues with dispensing medication, and on some safeguards we need in place so that women—once again, whether they mean to get pregnant or happen to get pregnant—have the advice they need and the reminder on the packaging when they pick up their medication.

The registry tracks all women in England who are taking the prescribed valproate, and it identifies if they become pregnant are accessing care for pregnancy. We can track pretty accurately when pregnancy happens, so we have a handle on how many women are getting pregnant while on the medication. I can reassure the House that the numbers are falling. They are still too high in my view, but they are falling. In the six-month period from April to September 2018 68 women prescribed valproate became pregnant, and from October 2021 to March 2022 that number fell to 17 women. That is still 17 women too many, although we are making progress in reducing that number of pregnancies, but that is why the MHRA is looking at further safeguards for prescribing and dispensing such medicine. It will be making that announcement fairly soon.

A national clinical audit is being undertaken by all community pharmacy contractors, as agreed with NHS England and the Pharmaceutical Services Negotiating Committee, which will measure adherence to current MHRA regulations. The audit will look at whether all patients are provided with a patient card and a patient guide every time the medicine is dispensed. It will also look at whether patients who are supposed to be getting a review every 12 months actually are, and what then happens to them if they are being signposted for additional advice.

I am appearing before the Health and Social Care Committee next week to go through the Cumberlege review on its anniversary and follow up on the progress that has been made. This week, I have met the new patient safety commissioner, Henrietta Hughes, who has also met Janet and Emma, and the issue of valproate is one of her key priorities in her first few weeks in post. I have discussed with her my concerns about its dispensing and packaging, and about the monitoring of women, including whether they are getting the advice they need for a planned pregnancy or, if they are not planning to get pregnant, whether they have had reliable advice and discussion about contraception. I plan to meet the patient safety commissioner on a regular basis to make sure that the measures in place are actually reducing the number of those pregnancies and providing women with the support and information they need.

The Department and the MHRA are consulting on a proposal that medicines containing sodium valproate should always be dispensed in the original manufacturer’s packaging. This would ensure that patients, particularly women and girls of child-bearing age, always receive the patient information leaflet about the medicine they are taking. We will shortly publish a response to that consultation, and we will keep Members updated.

To touch on the issue of redress, it was not one of the recommendations accepted in the original response to Baroness Cumberlege’s report. However, last year I was concerned about the issues, which my right hon. Friend the Member for Romsey and Southampton North raised, for women seeking legal advice and taking on the huge challenge of getting compensation. What we have done as an interim measure is to work with NHS Resolution to launch a claims gateway, so that individual women can go to NHS Resolution and get their individual case looked at and be provided with support if they want to make a claim, without having to go independently to solicitors and lawyers. That has only just started, and we are looking at how effective it is in helping women get access to some of the compensation they feel they need. However, in my conversations with the patient safety commissioner I have asked her to look at what a potential redress scheme could look like. I am not going to make commitments on that from the Dispatch Box because it is not necessarily my decision to make—that would have to be in discussion with the Chancellor—but I am keen to look at what a redress scheme would look like, and I will follow up on that with the patient safety commissioner and see what is possible. I hope I have been able to reassure colleagues.

Cat Smith

Will the Minister commit on the Floor of the House this evening that after she has had conversations with the commissioner about the possibilities of the scheme she will talk to the Chancellor or someone from his team about the recommendations and how they might be implemented?

Maria Caulfield

I have had those discussions about what a scheme could look like with the patient safety commissioner only this week. I will need to see the details, but I hope that reassures the House that I am listening to the concerns of parliamentarians and campaigners such as Emma and Janet, who represent a huge number of affected women. I understand the situation they are facing: they have lifetime costs for their children through no fault of the women or the children. They took that medication not realising the effect it could have. We now have that information, but we did not know it at the time. My commitment is that I am exploring options and will update the House on that later.

I want to reassure the House once again that we take very seriously the safety issues around this drug. It is an important drug in the management of epilepsy, and for some women it is the only way of managing their condition, but we need to make sure that women are aware of the implications of taking such a drug during pregnancy, that they are monitored annually to make sure those discussions are ongoing, and that every time their medicine is prescribed and dispensed that message is reinforced. We are reducing the numbers involved, which is great news, but we need to make sure they go even lower, and we need to look at how we support women who have been affected through no fault of their own.

We will be giving evidence at the Health and Social Care Committee next week. I think I am also meeting the hon. Member for Lancaster and Fleetwood shortly, and I am sure other parliamentary colleagues too. I just want to say that I want to support women who have been affected by taking sodium valproate and that we are in listening mode on what more we can do to support them and make sure the help they need and the support for their children are at the forefront of our minds.

The statement made by Maria Caulfield, the Parliamentary Under-Secretary of State for Health and Social Care, in the House of Commons on 23 November 2022.

Yesterday, NHS England announced an independent review will be taking place regarding the unacceptable incidents that took place at the Greater Manchester Mental Health Trust this year. It will focus on how these incidents were able to happen and why the failings were not picked up.

The abhorrent treatment of vulnerable people at the Edenfield Centre shown in the Panorama episode was completely unacceptable. Every patient has the right to be treated with dignity and respect, in a caring and therapeutic environment where their rights are upheld, their needs are met, and they feel supported and listened to.

This is why I welcome the steps taken by colleagues in the NHS to investigate those events. As the Minister of State, Department of Health and Social Care, my hon. Friend the Member for Colchester (Will Quince), stated in Parliament on 13 October 2022, this should not have happened. Therefore, it is vital that we get to the bottom of what went wrong so that we can make sure we do better in the future. As I said at the Dispatch Box, I have also instructed my officials to consider what is needed on wider issues for mental health inpatient care, separately to this independent review. I will give an update on this in due course.