Social Care Funding

Anne Marie Morris Excerpts

Tuesday 1st October 2019 Westminster Hall

[Anne Marie Morris (Newton Abbot) (Con)]

Today, we are looking at a question that is certainly as vexing as that faced by Nye Bevan when he looked at how we would fund health. As has been said, the need for social care is increasing across our population—for older people, younger people, working people and retired people. It is a good thing that we live longer, but we have to recognise that that fundamentally changes how we as a society might address that need. The answer, in my view, is not simply to throw money at it. Money is clearly part of the solution, but this is a complex puzzle, and when we consider that our system has remained largely unchanged for 50 years, I think it is time for another Nye Bevan moment.

We therefore need to identify the true scope of the issue. There is much hidden need, particularly in isolated rural areas such as mine in Devon. What is the best way of delivering? I chair a national inquiry into rural health and care. It is taking two years to deliver, and it is clear that there are issues with different geographies that can be dealt with more efficiently and effectively with different methodologies. We need to look at how technology can be better used. We should look at how we might train and motivate people across both health and social care, and there has to be parity of esteem between the two.

We need to look also at how the community can be engaged. That is not, in this case, just about money. Sometimes, it is not about money but about a willingness to be part of that community. North Devon was cut off during the extreme winter two years ago, but people survived because they pulled together as a community. That is the sort of resilience that we have to build in.

We have to find something efficient and effective. We have to be honest about the cost. I agree that we need to help society to understand that, and we therefore need to understand what the right contribution is from the individual, family, community and taxpayer. We talk about integrating health and social care, but right now the challenge is that we have two systems that are funded in very different ways. The five reports that we have had so far have looked only at the social care problem, but it is naive to think that we can look at it in isolation. What we need now is a report on integrating both the provision and commissioning of health and care. That we have not done.

Dilnot looked at one side of the problem, and we have had other inquiries looking at integrating commissioning and provision, but that is not enough. It seems to me that we need to commission an integration report across health and social care. We need to deliver parity of esteem. We need to identify the barriers to integrating those systems, and remove them. Duplication of regulators and organisations does not work. What is the true cost? What is the best way to share that burden? How do we look at insurance, savings and taxation? But that will take time, and I support the view that in the short term we need to look at domiciliary care. I believe that we could integrate that into primary care and that it should be free, whether it is funded through tax, savings or some other mechanism.

Oral Answers to Questions

Anne Marie Morris Excerpts

Tuesday 23rd July 2019 Commons Chamber

[Stephen Hammond]

I met the hon. Gentleman recently to talk about ambulance provision in his constituency and the Morecambe bay area, and I hope he is now satisfied with the progress we are making on that. I will look into the individual case he mentions and respond to him.

[Anne Marie Morris (Newton Abbot) (Con)]

3. What steps his Department is taking to ensure the accessibility of health services for rural populations.

[The Minister for Health (Stephen Hammond)]

The long-term plan that the Department published in January commits to delivering fully integrated community-based healthcare in primary and community hubs. It confirms that the standard model of delivery will be developed for use in smaller acute hospitals that serve rural populations.

[Anne Marie Morris]

I thank the Minister for his answer, but some rural villages, including some in Devon, have no ambulance service at all—a fact masked by high-level statistical reporting. Will the Government work with me and the National Centre for Rural Health and Care to expose the real rural healthcare deficit, which is so masked, and work with us to rectify the situation and provide the appropriate care and medical support necessary by putting in place a robust and accountable rural health and care strategy and plan?

[Stephen Hammond]

I know that my hon. Friend has worked with the National Centre for Rural Health and Care and chairs the all-party group on rural health and social care. She is right to mention the fact that there are particular challenges in the delivery of the best-quality healthcare that we want to see in rural areas. I would be delighted to work with her and the all-party group on the matter.

Children and Mental Health Services

Anne Marie Morris Excerpts

Tuesday 16th July 2019 Westminster Hall

[Andrew Griffiths]

My hon. Friend is absolutely right, not only about the impact on schools—I will say more later about what we can do in schools—but about the pressure on CAMHS and the massive importance of getting children seen as soon as possible. Just imagine if one of us were having a mental health episode and were told that we could see someone in 12 months who would then refer us for treatment. CAMHS are not the doctors or the psychiatrists who see the patient. They are not the help; they are the doorkeepers to getting help—the triage, as it were. Even when someone gets through the CAMHS door and jumps over the very high bar for getting treatment, it could be many months before they receive it.

It is a great challenge. I know that the Government take it seriously; their 2017 Green Paper “Transforming Children and Young People’s Mental Health Provision” outlined their ambitious new plans for delivering mental health support in schools, and the announcement this week of the mental health services trailblazers is a welcome part of that strategy. I am delighted that my area, Burton, is to be in the second phase of those trailblazers, which I genuinely believe will make a difference. However, figures from the Children’s Society suggest there has been little expansion in the provision available in schools since 2015, so we are starting from a low base. In particular, the figures point to a worrying lack of awareness among parents about the counselling offered in their children’s schools: just under a third are not aware of what is available at all.

I am pleased that the Government have announced that every school, college and alternative provision across England will be offered training as part of the £9.3 million mental health services and schools and colleges link. However, even though my area is one of the trailblazers, priority access to mental health training for schools and colleges will not be available in my constituency until next year. It is clearly needed now. There are so many MPs, constituencies and constituents who want access, so how can we roll it on quicker? To use my “Oliver!” analogy again—

[Anne Marie Morris (Newton Abbot) (Con)]

My hon. Friend is making an excellent speech. May I ask him to reflect for a minute on the particular issues for rural communities, including the distances? The lack of broadband means that the opportunities for dealing with those distances are missed. It seems to me—perhaps we will hear more from the Minister about this—that the Government could use technology more effectively in rural areas. We will certainly not get the help we need in time otherwise. My schools will not be getting help under the new scheme any time soon—we are not even one of the pilots. My teachers are very concerned that they will have more burdens, rather than an added resource.

[Andrew Griffiths]

My hon. Friend, who is always a champion for rural communities, makes an important point about rural isolation. We have known for a long time about the mental health challenges of farmers and rural communities, but it is all the more difficult for young people who are isolated from their friends. We talk about the social media pressure on young people with Facebook, Twitter and so on, but it is even more difficult for kids in isolated rural communities, because they are even more separated. That social media connection is often their only chance to talk to their friends.

--- Later in debate ---

[Andrew Griffiths]

The hon. Lady is absolutely right. Trauma in young people’s lives is often the trigger, whether it is sexual abuse, domestic abuse, violence perpetrated by other young people, or bereavement. All those triggers set off a train of deterioration in young people’s mental health that is often lifelong. It is so important that they get the access they need.

Several hon. Members have mentioned waiting times for CAMHS. I have certainly found that my constituents cannot get on Facebook quick enough to tell me about their CAMHS experiences. I do not want to denigrate CAMHS, which have great people doing great work; the problem is that there are just not enough of them and they are under too much pressure. As the hon. Member for York Central (Rachael Maskell) noted, CAMHS are turning away nearly a quarter of children who are referred to them. In 2017-18, they turned away 24.2%, meaning that at least 55,800 children were not accepted for treatment. Of those who were referred, the average waiting time was 34 days for an initial assessment and 60 days for treatment—significantly longer than the four-week standard set out in the Government’s Green Paper. We can all point to examples of much longer waiting times in our constituencies.

One constituent contacted me to say that her son had been self-harming for years. It took them months to get an appointment with CAMHS, and when the appointment happened, her son suffered a meltdown. That is not unusual, due to the pressures that those appointments put on young people. Because he is 15, their GP cannot prescribe anything for him. My constituent has had to watch her son throughout the night to make sure he does not do any permanent damage to himself. Another parent told me how her daughter was discharged from CAMHS, with it saying there was nothing more it could do to help with her anxiety.

Young people have told mental health charity Mind—I am very lucky to have Burton and District Mind in my constituency, which does a great job—that the wait for support is one of the most difficult issues they face. They say that sometimes, they find that their mental health deteriorates while they are waiting; the wait actually makes it worse. In England as a whole, half of those accepted for treatment during 2017-18 were still waiting for treatment at the year’s end. That proportion was lower in my area, east Staffordshire, where it was just over one third. However, that is still a substantial figure.

A school counsellor from my constituency contacted me to say that the waiting lists for referrals to child services outside of school can be months long. She believes that when it is established that a child needs help, a counselling session needs to happen within 48 hours. She goes on to say that too much red tape is preventing children from getting the help they need. I think we all recognise, as the Government have done, that support in school, delivered in a way that is accessible to young people—they feel comfortable asking for it, and know of other young people who have accessed it—is a real help.

One parent told me that she decided to fight to get her son’s care commissioned outside of the county they lived in because of her disappointment with the support she had received. She says that early intervention is key, and that there have been too many endless reports and not enough action has been taken. Another parent in my constituency said that she took her daughter to the GP two years ago. She was referred to That Place in Burton, which is a fantastic facility; she took her for assessment, only to be told that her daughter was not old enough to be accepted. Yet another constituent told me that after a referral for her daughter, aged nine, it took three years for them to see a psychiatrist. That kind of wait is difficult, and all the time, the young people are getting worse.

There is also a problem with the transition from childhood to adulthood. According to the British Psychological Society, about one in six 17 to 19-year olds have a mental health disorder; according to the Children’s Society, 16 to 17-year-olds are the biggest service users of mental health services. However, young people often face barriers to accessing support, and end up falling through the cracks of adult and children’s services as they transition. Some young people who are discharged from children and young people’s mental health services at 18 find it can be very difficult to get a referral to adult mental health services at all, and can end up completely isolated. In some circumstances, young people are not accepted into either children and young people’s or adult mental health services, due to them falling between the gaps.

Again and again, I hear that CAMHS discharges young people on their 18th birthday, and that there is no provision at all for them. The challenges those young people are facing do not magically disappear when they become adults. Just last Friday, I met with a constituent who was getting ready to leave CAMHS and had been left to organise her future on her own. She was not automatically transferred to adult services, and had to organise a private therapist in order to get the ongoing treatment that she needs.

One of my constituents sums the problem up better than I could:

“All the time the kids are getting no support, becoming suicidal, becoming adults with even more complex issues, families are breaking up because of the pressure, parents quitting work to do the job of education/social care/health, and all of this causes more and worse financial pressure later on. No one sees the bigger picture because they can’t afford to. No one sees long term because that’s too expensive. Early interventions are crucial but they aren’t funded. We will reap the whirlwind then wring our hands and say ‘how could we have prevented this’”.

That is absolutely pertinent.

The Government have set a five-year forward view for mental health, which is for one in three children and adolescents with a mental health disorder to access NHS mental health community services by 2020-21. In the new long-term plan, they have set a target that 100% of children and young people who need specialist care will be able to access it by 2028-29. However, that is so far down the track.

[Anne Marie Morris]

I totally agree with my hon. Friend: it is so far down the track. Does it not further concern him that in that same 10-year plan, the NHS talks about “parity of esteem”, but that is in 10 years’ time, and it is very unclear what will be done about the timelines for getting there? As my hon. Friend has said, 10 years is much too long to solve the problems we have today.

[Andrew Griffiths]

My hon. Friend is absolutely right. During that time, babies become children, children become adults, and the problem gets worse and worse. I do not deny the Government’s commitment and determination in this, but it is just not happening quickly enough.

The other thing we need to bear in mind is that, although we have heard about CAMHS and the pressures on the workforce, a huge number of brilliant voluntary sector organisations are also delivering these services. I am very lucky to have in my constituency an organisation called Youth Emotional Support Services, which delivers in schools in Uttoxeter, as well as Burton and District Mind. There are so many great organisations. However, even in my own patch, I have heard that a tendering process is currently going on in which the bar is so high, the requirements so difficult and the boxes to tick so numerous that third sector organisations simply feel unable to compete. The challenge is that the tender to provide the facilities goes to a private company, and the experience, dedication and benefits of those voluntary sector organisations are lost.

I was staggered to learn that some of the children’s mental health charities operating in my constituency are providing 85p of frontline services for every pound they receive. That is tremendous value, representing help for young people, and few businesses could get anywhere near matching that. However, the tender process that we go through makes it impossible for voluntary sector organisations to compete. I hope the Minister will look into that; I will be raising with her my particular issue in Staffordshire.

I think the Minister recognises that in this place, we are simply voicing the real concerns and fears of parents up and down the country. Like a snowball coming down a hill, young people’s mental health is under greater pressure than ever before, and as a result they are self-harming, committing suicide, or getting themselves into a situation in which they will, in future years, suffer from greater mental health disorders, addiction, and so many other long-term problems. I hope that the Minister will go away feeling that she has great support across this House for her campaign to get even more resources and focus on mental health services, particularly for children, because quite frankly our children’s lives depend on it.

Human Medicines (Amendment) Regulations

Anne Marie Morris Excerpts

Monday 18th March 2019 Commons Chamber

[Jonathan Ashworth]

My hon. Friend raises a very important point. There have indeed been reports of shortages in certain medicines. In recent weeks, we have heard of shortages of Naproxen, an arthritis medicine, with similar reports about EpiPens a few weeks ago. I have heard from some community pharmacists, directly themselves, that there is even an shortage of aspirin. I emphasise that these are anecdotal reports rather than information based on any national reporting that I have seen—this is what community pharmacists have told me when I have been in their pharmacies discussing this with them—but yes, there are shortages now as a result of the uncertainty in the pharmaceutical market.

Diabetes UK has warned that

“despite reaching out directly to the Department of Health and Social Care in December, we still have not seen the concrete detail needed to reassure us—or people with diabetes—that the UK Government’s plans are robust enough to guarantee no impact on insulin and medicine supplies in the event of a no-deal Brexit.”.

It was a similar story from the epilepsy bodies, who said:

“We do not have confidence in the current arrangements to ensure the continuity of life-saving medications for people with epilepsy.”

The Government have sought to reassure patients that their contingency plans are failsafe, but the report in The Lancet that I referenced earlier also said that

“stockpiling arrangements cannot cope for more than a few weeks.”

It also noted that some affected products, such as radioisotopes needed for treating some types of cancer, simply cannot be stockpiled. This chimes with the Royal College of Radiologists, which last month issued staggering concerns about the supply of medical isotopes, spelling out how the expected disruption would force clinicians to alter treatment plans and mean the prioritisation of some cancer patients over others. That is why the Government are proposing the serious shortages protocol contained in this statutory instrument and effectively using Henry VIII powers to enable Ministers to issue a protocol to pharmacies for them to follow.

As I said, this is an extraordinary power grab. It will effectively mean that a GP’s prescription can be changed by a pharmacist. No longer would a medicine be prescribed by a doctor who knows the medical history of the patient but instead by a pharmacist acting in accordance with a protocol drawn up by the Government. That is why these emergency measures have, quite rightly, raised alarm among various patient groups—because these changes could cause real problems for people with long- term conditions.

[Anne Marie Morris (Newton Abbot) (Con)]

Does the hon. Gentleman accept that it would be sensible if there was a sunset clause, because clearly giving that much power to a pharmacist as opposed to a physician who knows the patient is very dangerous if it is to be used for the long term or perpetually and not just to deal with the current crisis?

[Jonathan Ashworth]

The hon. Lady makes an entirely reasonable observation. I trust that the Minister took note of it and look forward to her reply to that point.

--- Later in debate ---

[Jonathan Ashworth]

My hon. Friend is right. That is exactly the point that community pharmacists put to me in Loughborough about three weeks ago when I visited them to discuss this. Echoing her point, the BMA has said that it does not support a “blanket approach” to allowing pharmacists to provide therapeutic equivalents where a prescribed drug is not available. The National AIDS Trust has said:

“The only person qualified to safely alter the medication prescribed to a person living with HIV is that person’s HIV consultant.”

SUDEP Action, alongside a broader coalition of epilepsy charities, is particularly worried about these proposals.

After facing pressure from those groups, the Government accepted that replacement drugs were unsuitable for epilepsy patients, but they have left it open to pharmacists to reduce the strength or dosage of epilepsy medication. I am not convinced that that will eliminate the big risks faced by these patients. As the right hon. Member for North Norfolk (Norman Lamb) said, many patients with epilepsy—especially the elderly—are on other medications, and any changes require careful management because of the interaction between different medicines. Up to 90% of people with epilepsy state that even a deterioration in their mood can have a negative effect on seizure control. Anti-epileptic medications have more significant interactions than any other group of drugs.

There are situations where the specific brand, type, form or strength of a treatment must be carefully tailored to the individual based on their responses, which is done by the prescriber and the patient over time. If that is changed by a professional who does not know the patient or their individual risks, some have warned that the consequences could be a loss of control of the condition, failed treatment and an unnecessary emergency, with very serious consequences indeed.

[Anne Marie Morris]

The hon. Gentleman is making a first-class point. This puts patients at risk, and it is not appropriate for the pharmacist to make that decision. People think that generics are the same thing as branded drugs, but they are not. For some, a particular brand is crucial. I commend him for what he is doing.

[Jonathan Ashworth]

I am flattered to receive such commendation from the Conservative Benches, and I commend the hon. Lady for her extremely well-made point, with which I agree entirely. I hope that the Minister will respond to the second good point that the hon. Lady has made.

The stakes are too high to get this wrong, yet there has been no impact assessment or risk assessment undertaken on serious shortage protocols for this statutory instrument. This is an unacceptable risk to anyone with a long-term condition and should be recognised by anyone making contingency plans. I was particularly horrified to read in the explanatory memorandum for this SI—it is quite shocking:

“The main benefits of the protocol would be the NHS cost savings associated with GP time.”

In the same breath, it casually goes on to say:

“There may be some risks to patients”.

That is in the Government’s own paperwork. It is astonishing. How can the Government seriously prioritise NHS cost savings over patients’ lives and allow an explanatory memorandum to go out with that sort of wording in it? I hope that the Minister can explain how that got in there and at least reassure us that it is not the Government’s position. If it is the Government’s position that there may be some risks to patients, that suggests that the Government should have come to the House sooner to explain why they are making this regulatory change and not left it to the official Opposition to table a prayer motion to get this debate.

I would like clarity from the Government on a few things. It is not entirely clear from the legislation exactly when these powers would be used. I would like to hear from the Minister whether these powers will be introduced in a no-deal Brexit scenario only or whether we can expect them to be more permanent. I am also concerned that there will only be a review of new powers one year after a serious shortage protocol is issued by Ministers. This speaks to the point made by the hon. Member for Newton Abbot (Anne Marie Morris). One year is too long to wait if this causes serious problems for patients and the wider sector.

Considering that the stakes are so high, it is be essential that the Government deliver extensive communication and training to GPs, pharmacists, other healthcare professionals and the public, to help them understand any new protocols and manage expectations and any dissatisfaction. I would be grateful if the Minister outlined the Government’s plans. I talk and listen to frontline NHS staff all the time, and I know that there is a well-founded fear about the implications of a no-deal Brexit for hundreds of thousands of people in need of life-saving medicines. I am interested to hear from the Minister what information about these protocols has been shared with the health sector and professionals involved.

When the Secretary of State gave evidence to the Health and Social Care Committee a few weeks ago, he informed it that he will prioritise medicines over food. That glib assertion from the Secretary of State hardly offered the reassurance that patients deserve. Brexit should not compromise patient safety in any way. It is up to the Minister to allay the widespread concerns, but if she is not able to do so, we will test the opinion of the House. I commend our motion.

[The Parliamentary Under-Secretary of State for Health and Social Care (Jackie Doyle-Price)]

I am grateful for the opportunity to address the House and reassure Members on both sides of the House about the purposes of the regulations. I have been asked a number of questions, and I will try to answer all of them as best I can.

I want to start by saying that there is considerable misinformation out there about these regulations, which are designed to most efficiently manage the supply of medicines in the event of a shortage. I should also make clear to the House that this is not just a Brexit regulation; it will apply in any case, not just in the case of no deal, not least because recent events have shown the challenge in managing medicines. The regulations on how pharmacists will be able to apply this protocol are designed to minimise not only the demand on GPs but the risk to patients, because pharmacists will only be able to use their powers under these regulations according to very clear criteria, and we will still encourage them to speak to prescribers where there is any element of doubt.

[Anne Marie Morris]

Will the Minister give us some details about what those criteria will be, so that clear decisions can be made by pharmacists and so that when a particular brand is really important for a patient, there is no possibility that a generic will be substituted?

[Jackie Doyle-Price]

The circumstances will be different from protocol to protocol, which is not a very clear answer—but we would have to look at each incident. The hon. Member for Leicester South (Jonathan Ashworth) mentioned HIV medicine. Another example is antipsychotic medicines, where there is a clear relationship with the patient: obviously, it would not be appropriate to unilaterally change those items of medication.

When a prescription is issued, the pharmacist has to dispense that medicine according to strict instructions under the terms of the prescription. For example, if the prescription was for packets of 200 mg tablets and there was a shortage of those, they could be substituted with a different measurement. All those issues would be dealt with from protocol to protocol, having been considered by a pharmacy panel who can properly and rigorously challenge what an appropriate substitute would be in the event of a shortage of any medicine.

[Anne Marie Morris]

Is the Minister not concerned about the challenge that, however qualified the pharmacist, they do not have the patient’s notes? She has referred to an amount, and I understand how having two smaller pills will equal what should have been prescribed, but when it is a generic versus a specific branded medicine, that is a very difficult and challenging decision to make.

[Jackie Doyle-Price]

I come back to what I said to my hon. Friend earlier. The terms under which pharmacists will be able to exercise their discretion will be clearly set out in each protocol, and there will be full consultation by an expert panel, with ministerial approval in such an event.

--- Later in debate ---

[Jackie Doyle-Price]

We are talking about a protocol that can deal with an immediate shortage, but we would not expect that shortage to continue indefinitely. It enables us to manage the shortage, while trying to secure the ongoing supply.

Reference has been made to EpiPens, and that is exactly what happened in that context: we knew that we had a shortage and that there was a supply coming, so steps were taken to manage the supply so that everybody who needed EpiPens had a supply of two, with dispensaries managing that supply. We would expect the same to happen. Where we issue a protocol, we would expect prescribers to go back to their normal supply of medication once we had corrected the supply problem, and this is to get us through that period. It is also to encourage people not to stockpile medicines in the event of worries about a shortage. This is about giving people the reassurance that we will manage such shortages effectively.

The hon. Member for Leicester South mentioned that there had been criticism about a lack of consultation. It is worth noting that the Government have been challenged by the Good Law Project on a number of grounds, but it is also worth telling the House that the High Court decided last week that permission for judicial review would not be granted on the issue of lack of consultation.

I want to clarify the purpose of the regulations. First, they implement the EU falsified medicines legislation on certain safety features on the packaging of medicines. They also extend the exemption for the supply of naloxone hydrochloride, so that drug treatment services can supply all dosage forms of that medicine; at the moment, we can only supply injectables, but we now know that nasal administration is more efficient. In addition, and this is obviously the main crux of the debate today, they enable retail pharmacies, where appropriate, to supply against a serious shortage protocol, instead of against prescriptions, if such a protocol has been issued.

Not implementing this statutory instrument would have dire consequences. Not only would the Government lose this tool to manage shortages of medicines, but we would also deny drug treatment services the ability to supply all dosage forms of naloxone hydrochloride. Without this SI, we would not be able to introduce UK-specific flexibilities for the falsified medicines safety features scheme, meaning that a disproportionate burden would be put on the supply chain.

On the safety features, I would like to say that we are committed to stopping falsified medicines from reaching patients. Our No. 1 priority is safe access to medicines in the most efficient way. I can also say that we want to retain a close working partnership with the EU on medicines regulation, for all the reasons the hon. Gentleman outlined, and we wish to ensure that patients continue to have timely access to safe medicines and medical innovations.

The new safety features measures under the EU delegated safety features regulation are directly applicable, and they already require UK manufacturers to place a unique identifier and tamper-evident features on packaging for almost all prescription-only medicines. These medicines need to be scanned on supply to the patient to verify their authenticity. Our position is clear that, as a member state, we were obliged to implement these requirements. We worked extensively with stakeholders to understand the detail and to develop the best approach on the flexibilities and enforcement specifically for the UK, and this was tested through a formal consultation process.

It is worth noting that the UK has a very complex supply chain. Without the national flexibilities in this statutory instrument, the burden on industry would be disproportionate and it would risk patients not getting timely access to medicines; nor would we be able to enforce the requirements already in place. The reputation of UK medicines, the UK pharmaceutical industry and regulators could be seriously undermined. I have already mentioned the issue of naloxone hydrochloride. It is administered in the event of a heroin overdose, so we clearly want to make that available in the most efficient way possible.

To come back to the serious shortage protocol provisions, these will provide the Government with an additional tool to deal with a shortage of medicines. Over 2.5 million prescription items are dispensed in primary care in England alone every day, and the vast majority are not subject to supply problems. However, we must have a robust system in place for when they are. We work closely with the Medicines and Healthcare Products Regulatory Agency, the pharmaceutical industry and NHS England in operating and managing the supply chain to help prevent shortages, and to ensure that the risks to patients are minimised when shortages do arise.

The issue of EpiPens is a very good example. Last autumn, we faced a serious international shortage of EpiPens. That shortage had a knock-on effect on other adrenaline auto-injectors and, despite efforts by the Department and the industry, there was not enough supply to meet the demand in the country. We were therefore forced to ration the available injectors so that the available supply could be spread out across all patients who needed them until more stock became available. To be able to do that, we put in place a dispensing protocol.

The protocol required pharmacists to check with patients how many adrenaline injectors, including expired ones, they had so that pharmacists could decide on the number of injectors to supply. Patients below a certain weight had to be referred back to their prescriber. Again, another risk management tool that we would apply in issuing a protocol would be to make sure that pharmacists were referring people back to their prescriber if there was such a question. This ensured that, throughout the duration of the shortage, we managed the available stock in such a way that each patient had access to at least two injectors. It was this incident with the adrenaline injectors, as well as our EU exit preparations, that led the Government to formalise that what was done in the EpiPen situation should be put in place to manage other serious shortages, should they arise.

I say again that this is not the Government’s plan for dealing with medicine shortages in a no-deal exit. That is simply not the case at all. We wanted to introduce these provisions before 29 March so that we would have the option of issuing protocols, but only as part of our multi-layered approach to minimise any supply disruption in a no-deal exit. We are confident that our other management plans will deal with that. These include securing additional roll-on roll-off freight capacity for goods; buffer stocks and stockpiling; extra warehouse space; and space on aeroplanes for products with a short shelf life or specific storage conditions. The questions raised about radioisotopes are clearly relevant to that. These regulations will ensure that companies can continue to sell their products in the UK. They will strengthen the process and resources used to deal with shortages in the event, despite everyone’s best efforts, that they do occur.

[Anne Marie Morris]

The Minister is being generous with her time. Will she explain what currently happens when there is a shortage? Of course I realise that patients need medicines, but why do we need this specific piece of legislation when, so far, the Government have dealt with many other shortages reasonably adequately, I should have thought?

[Jackie Doyle-Price]

As I explained, it was the issues regarding EpiPens that brought home to us the need to have a suitable protocol in place.

Hon. Members have expressed concern about the role of pharmacists in the system. At the moment, where the prescriber has prescribed a specific medicine, including a specific strength and quantity, the retail pharmacist must supply exactly what is on the prescription and cannot deviate from that. The pharmacist has no flexibility if the exact order cannot be supplied, for example, because of supply issues. The pharmacist has to send the patient back to their GP. Clearly that would not be an efficient use of GPs’ time if we could put in place a protocol that would enable the application of alternative medicines.

The serious shortage protocol enables retail pharmacists to supply in accordance with a strict protocol for a specific prescription-only medicine, rather than against a prescription, without going back to the prescriber. That will be done only in exceptional circumstances, in the event of a serious shortage of a medicine, when all other mitigation measures have been exhausted or would be likely to be ineffective, and all the clinical community think it is appropriate to issue such a protocol. The protocol may prescribe one of the following options: an alternative quantity, an alternative pharmaceutical form, an alternative strength, a therapeutic equivalent or a generic equivalent. However, as I said, each case will be considered on its merits, and of course the risk of various health conditions. We believe that therapeutic substitution will be extremely rare. It would need to be clinically appropriate, and a sufficient stock of any alternative would be required.

As I have said, any serious shortage protocol will be developed with clinician input. Which clinicians are involved will depend on the expertise required, but we would involve, for example, the relevant royal colleges and societies. We would also work closely with patient representative groups, as we did in the EpiPen shortage. Each protocol would clearly set out what action can be taken by the retail pharmacy, in what circumstances, for which patients, and during which period. I re-emphasise that this is not about pharmacists acquiring prescribing rights by the back door. It is entirely about ensuring that patients have access to the medicine they need by making the best possible use of highly qualified pharmacists and freeing up GP time for patients who need to see their GP. If a pharmacist is in any doubt about what they are prescribing, they can always exercise their professional judgment to refer an individual patient back to the GP, and if patients do not want the alternative under the protocol, they can always go back to their prescriber.

Let me be very clear: patients will not be given alternative medicines where this is not medically appropriate. This includes patients with complex medication regimes or conditions such as epilepsy or HIV. However, that does not mean that they are exempt from the protocols. For example, a protocol for a reduced quantity of anti-epilepsy medication could be issued, as we did for EpiPen. That would have to be considered against a backdrop of all the available stock being spread out across all patients, and there being time for patients to see their prescriber if the supply issues become long- term. Without the protocol, some patients would receive the medicines prescribed to them, but some would leave the pharmacy empty-handed. Clearly, we need to make sure that all patients have timely access to their medicines.

In the event of a serious shortage of any medicine, it is vital that patients continue to receive the treatment they need. The introduction of strict protocols, developed with specialist doctors, is a sensible step that will, in exceptional circumstances, allow highly trained pharmacists to provide an appropriate alternative or quantity, as set out in the protocol, to reduce the impact on patients. This ensures a co-ordinated response to a shortage and timely access to medicines.

Of course, I hope that we never have to introduce a serious shortage protocol, but there may be times when we have no other options, because all other measures have been exhausted or are likely to be ineffective. Not implementing the statutory instrument would put patients’ timely access to medicines at risk, first, by not enabling drug treatment services to supply all dosage forms of naloxone hydrochloride; secondly, by imposing much more burdensome implementation of safety features of packs of medicines with flexibilities to accommodate the specific characteristics of the UK supply chain; and thirdly, by denying the Government an important tool to manage shortages of medicines and to ensure that patients continue to get the right medicines in a timely manner. I hope that the motion is defeated.

Orkambi

Anne Marie Morris Excerpts

Monday 4th February 2019 Commons Chamber

[Bill Wiggin]

I tragically allowed the hon. Gentleman’s intervention one sentence too early. I was about to say that Crown use licensing would make the drug available to cystic fibrosis sufferers at a reduced price on the NHS, so I absolutely agree.

Those are just a few examples of how Crown use licensing can set the ball rolling on increasing public access to precision medicine. The UK Government have a powerful policy mechanism already behind them. They are now in a position to make a huge difference to many people’s lives. A bio-generic version of Orkambi manufactured at a lower price would save our NHS time, money and resources. The majority of medicines already in use by the NHS are generic versions of originator products.

I have a daughter whom I love unconditionally. Putting myself in the shoes of my constituent, I can only imagine the anguish that he faces, let alone the suffering of his daughter. We know that young children stand to gain the most from access to Orkambi, and I am sure that the Minister wants to give the taxpayer the opportunity to access this drug under the NHS and NICE.

[Anne Marie Morris (Newton Abbot) (Con)]

Has my hon. Friend looked at the cost and time delay involved in producing the generic alternative that he describes? Has he factored into his argument the potential cost of litigation, which I assume Vertex would pursue? I wonder whether his proposal might actually be less cost-effective and speed-effective than trying to put a bomb under the two parties to reach agreement.

[Bill Wiggin]

I have. This drug would cost £104,000 if bought from Vertex and about £5,000 if it were made generically, so there is a huge saving.

Health Technology Assessment Charges

Anne Marie Morris Excerpts

Tuesday 4th December 2018 Commons Chamber

[Anne Marie Morris (Newton Abbot) (Con)]

I rise to speak about health technology assessment charges in England. I am sad to see that there is not more interest in this debate, even at this very interesting early hour of the morning.

The Government are proposing to charge for technology appraisals undertaken by the National Institute for Health and Care Excellence. The House should understand that for a drug to be fully marketed, it has to go through three stages: it is required to be licensed, to go through NICE and then to go through the formulary. Licensing enables the drug to be certified as doing, in effect, what it says on the tin. The NICE process ensures that it offers good value for money and is something the NHS is prepared to make generally available. The formulary is all about endeavouring to ensure that the drug is available locally.

It is not common in other markets for technology appraisals to be charged for. It is not unheard of, as I am sure the Minister will tell me, but in the grand scheme of things, these pharmaceutical companies or life sciences businesses have already put billions of pounds into these particular drugs. As hon. Members will appreciate, there is quite a high failure rate at the first stage for licensing, but by and large, those that get to NICE are fit for purpose and are good value for money, and most of them are eventually passed.

Given the billions that the drug companies have already spent, to ask them to pay for this approval process, which is for the benefit of the NHS, seems a little churlish. Hon. Members may ask, given that the amount to be raised will be £10 million—with the cost for a single technology appraisal at £126,000 and a highly specialised appraisal of the same amount—whether this really matters. The answer is yes, it does. This is not a comment on NICE. NICE is incredibly well respected. It is a global leader in what it does. It makes very high-quality decisions, and it is absolutely clear that if we want to ensure something is fit for purpose and safe, NICE is where we want to go. Indeed, we need more NICE, not less NICE: we need more drugs to be available to patients.

The trouble with what is being proposed is that, while there is undoubtedly a need to look at the cost issues, it sends the wrong message, and that wrong measure will be far more damaging and costly to UK plc and to patients than the £10 million. The balance of risk between the taxpayer and the life sciences or pharmaceutical companies will change, albeit ever so slightly, but that message says that this is not something that we, UK plc, should be incentivising. That is wrong: it goes against the life sciences industrial strategy and against any recognition of the competition out there.

There is huge competition. The United Kingdom has some of the best brains in the world, but increasingly, because of the challenge of getting the drugs to market, competitors are looking at incubating in the UK, where we have the expertise, but when marketing and taking a drug to a competitive position, going to the USA or Japan, and failing that, Germany or France. What might seem a small figure is sending out the message, “Don’t invest here”.

Following Brexit, that is absolutely the wrong message. The sector could—and should—be a real source of this country’s growth post Brexit. It needs to grow: it can and must grow. We must send a strong message that we want people and businesses to invest in the UK to develop the medicines that we need and, most importantly, to ensure that the UK citizen has the best access to the best drugs in the world.

We then have to examine the NHS’s duties when it considers approvals for drugs. It has at least four duties. The first is to provide equal access to NHS facilities, irrespective of cost. The second is to promote research. The third is to take account of research and development costs when making decisions. The final duty is the family test to ensure that its actions respect the impact on the whole family of approving or not approving a drug.

The challenge with equal access is that the unmet need is for often expensive therapies and pharmaceuticals for very small patient groups. Increasingly, those new therapies are being developed by start-ups—new companies that focus on one particular disease area. Doubtless the Minister will say, “What if those small companies were offered a reduced rate, cut by 25%?” Frankly, that is the proverbial drop in the ocean. The negative message is still there. I am sure that the Minister will remind me that those small companies can phase payment. The problem is that that is front-loaded. The Minister will then no doubt say that there is the potential—as, when and if NICE decides not to proceed—of reimbursement. However, by that stage, most of the money—the equivalent of the £126,000—will have already been spent. It is a nice idea, but it does not work in practice.

The NHS has committed to promoting research, but as I have already mentioned, there is huge competition from America, Japan, Germany, France and many others. Not only will those who incubate here go to those countries to commercialise, develop and market that product, but in those countries, it is quicker, cheaper and easier to get to market. We are talking about businesses—those are business decisions—so why would they not do that? Sadly, we are no longer the first choice of place to commercialise, then sell and market drugs. We are often the second, third and even fourth choice. We cannot afford to lose pharmaceutical companies and investment. Compared with that, the £10 million the Government are looking to gain is a drop in the ocean. Post Brexit, we must do everything we can, in the interests of patients and our life sciences industry, to support our companies and ensure that they can continue to grow.

We must look at taking into account R&D costs. They are going up, not down. It is not clear from the regulations how many times the fee has to be paid, because there are several parts to those processes and there are also appeals processes. The other peculiar part of the way in which this has been shaped is that the charge applies only to medicines. It does not apply to medical devices and diagnostics, so it does not apply across all the possible cures that go through NICE. Are the pharmaceutical companies supposed to pick up the costs for medical devices and diagnostics, too? That does not seem right or fair.

Finally, there is the family test. The family will obviously be impacted by what happens to a member of it. If one member is suffering from something very acute, very rare and very debilitating, that will have a huge impact on the family members and the carers of that individual. The win in sorting this out is much greater than just that individual.

I propose to the Minister that none of the tests, to which the NHS has committed, has been met. Clearly, I would be with the Minister and the Government in saying that costs are an issue, but that is not the answer. Clearly we must look at ways of finding the money to produce more for less, but there are many other ways of doing that. Let us look instead at removing bureaucracy, improving efficiency and avoiding the duplication we see because of the three-part process of getting drugs licensed so they do what they say on the tin, going through the NICE process to see whether the Government and the NHS are prepared to ensure that they are readily available and, finally, going through the formulary process.

I submit that what we need to do is look at licensing, the NICE process, baseline commissioning and formulary decisions in the round. Let us look across those processes and cut out the duplication which other countries have achieved so successfully. I submit that we should not, in the best interests of patients and the country particularly post Brexit, introduce the regulations in April next year. We should look again at the broader issue and at all the processes in the round, and instead make this part of the NICE methodology review, which is due next year. Let us consult on efficiency and effectiveness, not just cost reduction.

We want more drugs assessed, not fewer. We want it done faster. We want it to be more efficient. We want it to be more effective and we want to make sure that UK patients get the benefit of lifesaving medicines more quickly than others. We need to strengthen the life sciences sector. We need to encourage investment in the UK. I say to the Minister, “Do not introduce the regulations. Think again.”

[The Parliamentary Under-Secretary of State for Health and Social Care (Steve Brine)]

Mr Speaker, you are remarkable for sitting here for all this time. I share the admiration for you, if not your football team after Sunday afternoon. Less said about that the better. I cannot even believe I have raised it. I know that you will have been there and will have enjoyed it. I just have to take my hat off to the 4-2 score. The return leg will come.

I am disappointed that only you, Mr Speaker, my Parliamentary Private Secretary, the Whip and my hon. Friend the Member for Newton Abbot (Anne Marie Morris), who introduced the debate, and I are here. An Adjournment debate without the hon. Member for Strangford (Jim Shannon) is a rare thing. I can only feel that he will come running in at any time.

I have been asked to reply to the debate on behalf of the Under-Secretary of State for Health, Lord O’Shaughnessy, who sits in the other place and has responsibility for this policy area. I take a keen interest in it, as he knows. My hon. Friend the Member for Newton Abbot has a keen interest in this matter, both on behalf of her constituents and in her capacity as chair of the all-party group on access to medicines and medical devices, which I know she chairs with aplomb.

The main thrust of my hon. Friend’s remarks was about the charging process the NICE has proposed, but let me reiterate to the House that the Government are committed to ensuring that patients can benefit from rapid, consistent access to effective new treatments. It is always important to say that in these debates. NICE plays a key role in this aim, through its technology appraisal and highly specialised technologies programmes. Through both programmes, NICE produces authoritative evidence-based guidance on whether drugs and other treatments should be funded by our NHS. Where NICE recommends a treatment as value for money, the NHS is required to make funding available, so that the treatment can be provided when it is clinically appropriate for a patient. That is reflected in the NHS constitution as a right to NICE-approved treatments, as it should be. Since it was established, NICE has recommended around 80% of the drugs that it has assessed. Many thousands of our constituents have benefited from access to effective new treatments as a direct result of its guidance.

Over almost 20 years, NICE has gained a firm reputation as a world leader in its field, and I was pleased to hear my hon. Friend talk about us wanting more NICE. When I travel around—at the G20 last month, for instance—and talk to fellow Ministers, they are always respectful about and look with some envy at what NICE achieves as an organisation. If we did not have it, we would have to invent it, so it is crucial that the methods and processes for making recommendations continue to evolve and develop to meet new challenges. I totally take my hon. Friend’s point about the NICE methodology review next year. These issues will be talked about within that process, of course.

My hon. Friend talked at length about charging. We think it extremely important that we have a system such as NICE in place to ensure that the NHS spends its money—public money, our constituents’ money—in the most effective way possible. It is critical that NICE’s work operates on a sustainable footing in a way that enables it to continue to be responsive to developments in the all-important—I completely agree with what my hon. Friend said—life sciences sector.

To date, NICE’s technology appraisal and highly specialised technology programmes have been funded through the resources that it receives from Government. However, in common with all Government bodies, it is right that NICE considers how to operate with maximum efficiency, as well as who stands to benefit from the services that it provides. My hon. Friend is absolutely right to talk about the robustness of how it spends money and looking at efficiencies across the board. As she rightly points out, that is why it will be doing its methodology review and why it does that regularly. It is also essential for us that NICE continues to be able to respond to continuous change in the global life sciences market—it is a global market, of course—whether with the ever-growing movement towards personalised medicine or an increasing number of medical devices and digital products.

For that reason, the Government and NICE believe that the most appropriate and sustainable method for NICE’s appraisal programmes in future is for NICE to charge the companies that benefit directly from its recommendations. This is not without comment and controversy, as we have heard this evening, but it also has support. To this end, the Government carried out a public consultation between 10 August and 14 September on proposed changes to regulations that would enable NICE to charge companies for the cost of making technology appraisal and HST recommendations. The consultation followed extensive engagement by NICE with the life sciences industry on a possible charging model. During that engagement, NICE heard clearly from companies that it would be important to ensure that there was some mechanism for minimising the impact of charges on small companies—my hon. Friend rightly referred to that—wanting the NHS to invest in their innovative and effective new products.

The Government are committed to ensuring that there is appropriate support for small businesses—I do not know whether my hon. Friend saw my speech before the debate, but she seemed to know a lot of what was in it—and she is right that this was reflected in the Government’s recent consultation that proposed a small discount for small companies and provision for small companies to pay by instalments. That was in there, too. We are especially keen in the response to pitch this right as we move from the consultation to the Government response. That is probably as much as I can say about that, but I repeat: we are keen to pitch that right for small companies and have listened to responses, including from my hon. Friend, to that consultation. It also gave a clear commitment to reviewing the charging mechanisms over time to ensure that they are fit for purpose and respond to developments in the life sciences sector.

We received 78 responses to the consultation from a range of audiences, including the life sciences sector, the NHS, patient groups and professional groups, as well as my hon. Friend through the all-party group. A range of issues were raised in response to the consultation, such as NICE’s impartiality and the impact on drugs for rare diseases, as well as potential impacts on small companies. I was over the road at the Britain Against Cancer conference today talking, for instance, to Cancer52, which represents people with rarer cancers, so that is very important to me as the cancer Minister.

It would not be appropriate for me to pre-empt the Government’s response to the consultation, and I do not intend to do that this morning, but I can assure the House that the Government have been carefully considering all the issues raised and agree that any charging mechanism must include appropriate support for the small companies, while protecting the impartiality and benefit of NICE’s work to patients and, as my hon. Friend rightly says, the global nature of this business and the great opportunities in this sector from Brexit.

We will publish our response to the consultation very shortly. The Under-Secretary of State for Health, Lord O’Shaughnessy, has invited my hon. Friend to meet to go through these proposals in detail and discuss her response to the consultation. As chance would have it, I understand that the appointment went in the diary today—just before today’s debate. Who would have thought it? That is happening this Thursday.

[Anne Marie Morris]

Would it be right to say that the consultation assumed there would be a charging mechanism and that it was not about whether but about how?

[Steve Brine]

Yes, the consultation was about how, but we are listening very carefully to the “how”.

As my hon. Friend said, Members have expressed concern that the introduction of the charging mechanism will make us a less attractive country in which to invest. We are committed to ensuring that the UK is an attractive environment for the life sciences sector. Sir John Bell’s life sciences industrial strategy published last year set out the sector’s vision for how we will do that, and we fully support the strategy’s vision. We have committed £500 million of Government money, and that has been backed by significant investment from 25 different organisations across the sector. Strong progress has been made on that sector deal, therefore, and one year on we are working with partners to agree the second sector deal with the new measures to secure our lead in the areas of global opportunity.

[Anne Marie Morris]

I thank the Minister for answering my last intervention so honestly. Given that the last consultation was not about the “whether” but about the “how”, may I ask if there was ever a consultation on whether this was the most appropriate way to ensure better value and more money for NICE to develop more medicines more efficiently?

[Steve Brine]

Not to the best of my knowledge, but this will of course continue through the NICE review process next year, and I have no doubt that my hon. Friend will be able to discuss this at great length with Lord O’Shaughnessy on Thursday.

I stress that the Government share the views that we have heard today about the vital importance of NICE’s work and about protecting the UK’s place in this important sector, which a lot of people work in and which—more importantly—a lot of patients rely on. That is why we want to ensure that NICE can continue to develop its recommendations with the same authority, transparency and impartiality that have been the backbone of what is a world-leading organisation with a world-class reputation.

Question put and agreed to.

Access to Orkambi

Anne Marie Morris Excerpts

Tuesday 17th July 2018 Commons Chamber

[Mr Lewis]

The right hon. Gentleman speaks for everybody present this evening and probably many who are not.

There is inevitably sadness, but there should be real anger because this situation is causing human misery to many people who have enough challenges in their lives without not being able to resolve this situation. It would not be right for any of us to pretend that these decisions are easy. NICE does a good job in very challenging circumstances, on the whole. In no way should we or do we seek to undermine its work.

[Anne Marie Morris (Newton Abbot) (Con)]

The hon. Gentleman is being very generous in giving way. As he is reflecting on NICE and its process, does he agree that there should be a change in the way it measures or calculates quality of life when it comes to rare rather than ultra-rare diseases? If the condition was classed as ultra-rare, we may well have got the go-ahead.

[Mr Lewis]

I think that most people would accept that now is the time for a review of the criteria that are applied and the processes that are undertaken. Any organisation needs to be continually improving. We do not condemn NICE. In fact, we acknowledge that it has got many difficult decisions right, but it has also got some wrong. Time and again, the reason that it has got those decisions wrong—arguably—is that the criteria it is applying and the criteria it has been given by the Department of Health are out of date and flawed. I think we would all want to see a review of NICE’s remit and the way in which it carries out its work over a reasonable period of time. It would be helpful if the Minister would respond to that point when he concludes the debate.

Oral Answers to Questions

Anne Marie Morris Excerpts

Tuesday 8th May 2018 Commons Chamber

[Jackie Doyle-Price]

I do not accept what the hon. Lady is saying. We are investing in new mother and baby units and making sure we have sufficiently good provision geographically so that mothers and babies can access them. We are also investing in more support in the community. I am pleased that the programme we are delivering, which is £365 million of additional support, will deliver early intervention for young mothers and babies.

[Anne Marie Morris (Newton Abbot) (Con)]

8. Whether he has made a comparative assessment of the health and social care needs of rural and urban communities.

[The Parliamentary Under-Secretary of State for Health and Social Care (Jackie Doyle-Price)]

The diverse health and social care needs of local communities are considered in this Government’s policy and implementation. We are actively supporting local areas, including through Public Health England’s joint work with the Local Government Association, providing evidence-based recommendations to tackle the different needs of rural communities.

[Anne Marie Morris]

Would the Minister find it helpful to ask the national centre for rural health and care, shortly to be launched, to identify the specific challenges facing the providers of health and care in rural areas?

[Jackie Doyle-Price]

The centre has already engaged with stakeholders to identify the issues and responses to the challenge of providing health and care in rural settings. The centre will focus on four areas—data; research; technology; and workforce and learning—and will work with partners to identify, scale up and promote the adoption of its activities across the public and private health sector to reduce health inequalities and improve the quality of life for all rural people.