NICE-Approved Products: Patient Access

Debate between Jim Shannon and Anne Marie Morris

Tuesday 30th November 2021 Commons Chamber

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

I rise to address the challenging issue of access for patients to medicines and medical devices. We all believe absolutely passionately that we should have access to doctors and nurses, good hospitals and operating theatres, but I think the pandemic has shown beyond question that access to medicines and medical devices goes hand in hand, and without that we do not have the NHS that I think we all believe everyone deserves.

What is the problem? The problem, I shall explain, is as follows. When a medicine is approved, it goes through two processes: first, with the Medicines and Healthcare products Regulatory Agency, which checks whether or not a drug is actually safe and does effectively what it says on the tin; and then it goes to a separate process run by the National Institute for Health and Care Excellence, which looks at cost-effectiveness and value for money. The theory goes that, once those two hurdles have been passed, the medicine is then accessible to anyone. It is very clear in the NHS constitution, which explains that there is a legal right for people to have NHS NICE-approved drugs if it is right for their particular circumstances. Indeed, the NICE guidelines say that there should be automatic adoption, if clinically appropriate and relevant, within 90 days of approval. So where is the problem?

The problem is partly in the system and partly in the words. The words in the constitution are effectively caveated: people can have a medicine if it is right for their particular circumstances. Likewise, according to the NICE guidelines, it will be automatically adopted if clinically appropriate and relevant. The challenge is that, in the current system, NICE will approve medicines for the condition for which they are most cost-effective, so in this country we do not have the ability to approve a medicine for multiple conditions—multiple indications, in the jargon. It is what is most cost-effective that gets approved, and others do not, and there is not a system, either than paying privately, to ensure that the medicine that has been approved for the condition for which it is most cost-effective is available to those with other conditions, but that medicine may in fact still be the only possible solution.

Assuming we get over that hurdle, there is a second hurdle, because not only must NICE have approved the drug, but it has to go on the approved list of drugs locally in the local health authorities—now integrated care systems. The problem is that to get on those formularies, somebody has to put it on those formularies. Currently, while in theory under the NHS NICE guidelines there is a system, it does not actually happen. There is currently a drug for multiple sclerosis, and research shows that people are still waiting after 150 days for it to go on the formularies in something like 25% of the local health systems across the country. So the system, fundamentally, does not work.

What does this result in? It results in a postcode lottery. If someone has type 1 diabetes, it is absolutely crucial that they monitor their condition. There is a device, a flash monitor, that is state of the art, and research shows that the uptake across the country varies between 16% and 65%. What is most worrying is that those parts of the country with the greatest levels of deprivation have the lowest levels of uptake. We all think we have access to medicines for cancer given that we now have the highly innovative and very welcome cancer drugs fund. However, that drugs fund is only relevant when the particular drug is approved for a particular type of cancer. So there will be some drugs—Avastin, for example—which those with the appropriate cancer can get through the CDF, but those with a different type of cancer or who do not fit the profile again have to pay for it privately, costing £252 to £1,088 per cycle, which is every three months.

Sadly, NICE does not approve much for those with skin conditions. For those with mastocytosis—blotches on the skin and boils causing vomiting and diarrhoea—the only solution is usually NICE-approved food allergy drugs, but they are approved for NICE allergies not skin conditions so they have to be paid for privately. For cystinosis, the accumulation of amino acids, which gives rise to kidney problems and kidney damage, the drug Procysbi has been approved by NICE but, bizarrely, there seems to be no uptake of that to date at all. That is important because that drug is, unlike the existing drug, a slow-release drug and therefore mums and dads do not have to keep waking up their kids in the middle of the night to give them the next dose, which, as we can imagine, takes a real toll on family life.

For those with an obesity problem there is a good solution in Saxenda, but that is approved for diabetes. So those whose obesity does not give rise to diabetes will not get access except by case-by-case approval. I am pleased to say that Imperial has finally accepted and approved.

How are we going to resolve some of these issues to make sure there is no longer a postcode lottery? First, let us look at the simple case of those drugs that are deemed to give the most health benefit and are therefore in theory approved and people can get hold of them. What can we do to make sure they do actually finally appear on those formularies and how can we then make sure the system for take-up is actually in place? One of the problems is that there is nobody sitting in these health bodies who monitors NICE drugs coming up, and therefore no one who looks to see whether in their health community they may be of benefit.

[Jim Shannon (Strangford) (DUP)]

I congratulate the hon. Lady on securing a debate on this topic. As she says, this is about NICE-approved products as well as drugs. One of those products is cognitive rehabilitation therapy, an important intervention for those with dementia, enabling them to live independently for longer. However, despite being listed in the NICE recommendations there is a barrier to delivery. Occupational therapists and other staff in memory clinics do not have the capacity to deliver programmes that are National Institute for Health Research and Alzheimer’s Society-funded. Does the hon. Lady agree that the NICE recommendations must address not just drugs but also products?

[Anne Marie Morris]

I could not agree more. It is crucial to realise we are talking not just about medicines and drugs but also devices and, as the hon. Gentleman says, the processes, which are often the connection between the medicine, the device and the patient.

Within these health bodies, there is no training and nobody specifically focused on monitoring innovation, and there is no obligation to prescribe. Even more peculiarly, for these drugs there is an agreement between the industry and the NHS, the voluntary payment scheme or VPAS, under which manufacturers that are members of the scheme effectively agree with Government when the medicine or device is approved that it will be supplied at a well-discounted price. In addition, there is an agreement that sets a cap so that if, as it happens, more prescriptions are written for that particular drug, it is agreed that the extra cost that the NHS has incurred will be reimbursed by the manufacturer.

So if there is excessive prescribing—we assume that is why there is an attempt to limit how much goes on to formularies—why is that a problem when we have the VPAS scheme? It is a problem because the scheme does not the pass the benefit, other than the reduced price, down to the local health authority. The money is put into a separate pot, and that pot is then used generally to support the NHS writ broadly; it is not ringfenced, either for medicines or to be used, as it could be, to support local health authorities—integrated care systems—when their budgets are put under pressure, which is why they do not want too many things on their formularies. This would help them pay the price.

It seems to me, Minister, that there are some solutions here. You will be aware that I raised three of them in proceedings on the Health and Care Bill. To deal with the imperfections of the current arrangements, if those drugs that were approved by NICE—we are talking about the most cost-effective drugs—were mandated to be on formularies within 28 days automatically, so no one had to decide whether they went on or not, that would be a good system. It would also ensure that the decision was in the hands of the clinician and not of the bureaucracy of the health authority.

It seems to me, Minister, that the second suggestion I made—

Fly-tipping in Rural Areas

Debate between Jim Shannon and Anne Marie Morris

Tuesday 21st November 2017 Commons Chamber

[Anne Marie Morris]

My hon. Friend is absolutely right. Central Government and local authorities are effectively contributing to the cost—there is a contribution from the taxpayer through central Government—but there is a burden on individual landowners and a requirement for them to clear up the land, and they get absolutely no contribution towards doing that. This is absolutely something that we need to look at because, as he says, it is not fair. What we want is, in the Government’s words, for the polluter to pay. It seems to me that the victims are paying, not the polluters. Fly-tipping is definitely on the increase. Most of it involves household waste, and to be fair, most of it is tipped on the highway, but an increasing amount is tipped on farmland and in woodland.

[Jim Shannon (Strangford) (DUP)]

I thank the hon. Lady for giving way; I have sought her permission to intervene on her. The role of local councils is an important one, and it is positive when they encourage people to recycle. Does she agree that they must always ensure that there is an avenue for people to dispose of their waste in recycling centres, because if there is not, they may be tempted to do something illegal, if only because it is handy to do so?

[Anne Marie Morris]

The hon. Gentleman is absolutely right. There is a real challenge to incentivise people in this regard, and we need to use carrots rather than sticks to ensure that they dispose of their waste carefully and responsibly.

Clearly, we should recognise the environmental damage that waste causes. It is absolutely right that we as a country have taken on board the European waste framework directive, which led to our Environmental Protection Act 1990. The legislation rightly dictated that we should reduce landfill and increase recycling, but there is a cost to that. The challenge is to determine who should bear that cost.

Planning (Community Right of Appeal)

Debate between Jim Shannon and Anne Marie Morris

Tuesday 20th January 2015 Westminster Hall

[Anne Marie Morris]

I strongly support that suggestion and it would be an excellent addition to the list of things that might be considered.

If the appeal mechanism is to be effective, it must be easy to use, low in bureaucracy and cheap. However, it cannot be beyond the wit of the Government to come up with a set of forms and a formula that will make it accessible to communities. I also believe that there are communities, community groups and charities out there that will be more than happy to put forward proposals for support.

[Jim Shannon (Strangford) (DUP)]

rose—

[Jim Shannon]

I will be very quick. The hon. Lady mentioned the figure—the number of people—that would trigger an appeal. In every case, the number of people living in an area who are impacted by a development might vary. There would be occasions when the impact of a development would be great, but the number of people living in the area impacted would be small. So I just wondered what the trigger figure would be.

[Anne Marie Morris]

Again, the devil would clearly be in the detail. However, the challenge is to create a relatively simple system. If we make things too complicated, including the definition of the “group” or “community”, this system will never be established. So, while I take the hon. Gentleman’s point, we must look at how we would make the system work in practice.

The appeal would need to be an appeal to the inspector, to give communities a right equivalent to the one that developers now have. In the same way, it is right that the council would have to pay a penalty if it refuses an application but the developer then succeeds in overturning that decision. Similarly, if the community succeeds on appeal, having initially been refused, the council would have to pay a penalty.

The benefits of this process would be that the community would at last see some fairness; that developers would be encouraged in a proactive way to better engage with communities; that local authorities would have to think long and hard, and not only about the community infrastructure levy, when making their decisions; and that in the future we would create communities rather than blocks of houses.

I commend the Government for what they have done in dealing with our housing issues and problems. However, I hope that the Minister will recognise and accept that there is a challenge here, and that communities feel aggrieved at their lack of engagement in the planning process. I also hope that he will agree to give this issue some proper attention, and will consider whether or not such an appeal is workable. Clearly, the matter would have to go out to proper consultation and I appreciate that this close to an election it may be more of a manifesto issue, rather than something to be done today.

Nevertheless, this is not just a case of amending existing legislation, and it would not be an adequate response to say, “We have done a great job.” We have; the Government have done a good job. And—dare I say it?—if the Opposition’s view held sway instead, communities would have no rights or say in where housing was located. However, we need to take this issue seriously and come up with some positive proposals. So I ask the Minister—through you, Chairman—to acknowledge that there is an issue and to agree to take some concrete steps.

Independent Retailers

Debate between Jim Shannon and Anne Marie Morris

Wednesday 24th November 2010 Westminster Hall

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

After such a bravura performance by my hon. and learned Friend the Member for Torridge and West Devon (Mr Cox), it is with some trepidation that I contribute to the debate. This is a very worthwhile topic, and I would like to contribute my view that the solution is a matter not just of what local authorities can do or what the Government can do—as has been said, many of these issues are within the hands not of the Minister, but of a number of his colleagues. The solution is also in the hands of people. In that respect, we can look at the role that the big society can play for small business, because I think it has a place.

In the south-west, we have a high number of small businesses; indeed, 91% of businesses employ fewer than five people. This debate about the small retailer is therefore crucial to us. Unlike my hon. and learned Friend, I will include the small villages in my constituency —there are 30 of them alongside the four towns—because these problems also exist in those villages. Small retailers, particularly in those small villages, are the lifeblood of their communities. They can be like the local pub, which is too often long gone. They can also be like the local post office, which is, again, too often long gone. I am therefore pleased that local residents in Stokeinteignhead have come together to found and now run a volunteer system to keep the local shop in their community. That helps elderly residents, who will come in—perhaps a little confused—to do their shopping. The shop also produces newsletters. It does all sorts of things that mean that that small retailer is at the core of the community. I reinforce the points that have been made about colour, diversity and, indeed, identity, which we need to retain not only on the high street, but in villages. That is a key issue.

The Independent Retailers Confederation has looked at the issue and come up with a number of thoughts, which I can perhaps share with the Minister. The confederation represents 100,000 small businesses, which is no small number. It has categorised its findings into five key areas. I will not spend a lot of time on each area, because hon. Members have already covered a lot of these points very well. In fact, there are six areas, and I want to explain what they are. They include planning, which we have touched on; skills training, which we have not touched on, and which I will come back to; regulation, which we have touched on in part; crime, which we have also touched on in part; and access to finance. To that list of five, I would add taxation. Business rates must, of course, be key. I will go briefly over each of those subjects.

On planning, there is clearly an issue about the power of the supermarket. There is also the issue of charity shops, which has been well rehearsed. When the Secretary of State for Communities and Local Government begins to look at the overall shape of planning, I want him to consider localism and the power that he intends to give to local communities to make proposals for plans and for what they should look like. I would encourage him to ensure that the plans consider not only housing, but businesses. We will help to shape the planning of our communities if those plans look at businesses as well as residential. If they do that, they will say, “We want one supermarket here, not two.” In one town in my constituency, Dawlish, we have an ongoing battle between Tesco and Sainsbury’s, which is a waste of taxpayers’ money and deeply frustrating for local residents.

I would also commend the greater use in our communities of the community land trusts. We look at them just as vehicles for residential, but they are equally appropriate in this context. I would encourage the Government to market such things better and to explain to local communities what they can already do.

On parking, which, if I may, I will envelope within planning, there are a number of very good schemes in other parts of the country—I regret that they are outside Devon—that combine the idea of a loyalty card with the idea of sharing parking. I absolutely take on board the point that local authorities will often use parking as a milch cow. However, there are schemes that allow shops, working with the local authorities, to increase the revenue and put some of it back into the local community. I commend those ideas.

[Jim Shannon (Strangford) (DUP)]

Does the hon. Lady agree that of all the six critical factors that she is speaking about, parking is the most important, because it shapes what happens in the town? There is not a one-hat-fits-all approach, whether we are talking about out-of-town, out-of-town-centre, in-town-centre or off-town-centre parking. The chamber of trade must be involved in these issues. There is also the issue of the connection between the centre of the town and the edge of town and the issue of regeneration. There are many things to be done, and the same hat does not fit everything when it comes to planning.

[Anne Marie Morris]

I thank the hon. Gentleman for his contribution. I think that that is an issue, but it is not the most important one, as I will explain.

The second issue is Training Access to training for retail skills is pretty rare. I am pleased that South Devon college, which is in my constituency, has a course on retail skills, and I would like the Government to encourage more such courses.

Let me move swiftly on to the third issue, which is regulation. As I am sure many Members are aware, it is estimated that it takes the average retailer seven hours a week just to deal with regulation, and that can cost them anything from £100 to £10,000 a year. This is about not just employment regulation, which is clearly one of the most onerous issues, or health and safety, but issues such as the minimum wage and how pension schemes will change. We need to look at the perhaps unintended consequences of the new shape that regulations will take when the Government put them forward.

The fourth area is crime. This is probably a well-known statistic, but crime and theft cost the retail sector £2 billion a year nationally. Two issues have been raised by the Independent Retailers Confederation: one is antisocial behaviour, which has been covered by the hon. Member for Vale of Clwyd (Chris Ruane); the other is theft. The challenge in dealing with the problem is that a theft does not happen until the culprit leaves the premises. How many small shopkeepers wait until the individual has left the shop to apprehend them? The answer is that they do not. They keep the individual there and call the police. The result is that there is no prosecution and police time is not particularly well used. There must be a better reporting method, and it must be possible to find a legal approach that is a better deterrent than the system we have now.

I am saddened that only two of the large banks are making significant progress with the lending guarantee scheme, and I look to the Minister to encourage more on that front. However, something that the banks suggested, which I think is very helpful, would be the introduction of a new mentoring system that would ultimately replace, in a way, much of what Business Link, which is being phased out, used to provide. That would provide excellent support for the retail sector. I suggest that such mentoring should be something we can see—the big society for small business in action. In my constituency I have considered getting local businesses together and asking them to help each other. Business surgeries are being set up, and local business men and women, as well as local banks and others, will be involved.

We are also setting up a group of individuals who will act as one-on-one mentors—not expensive, paid-for, qualified mentors, but local business men next door to other local business men. For example, the other day a business man wanted to become VAT deregistered and did not know how to go about it; a colleague had the answer. There are all sorts of things that we can do, and politicians can play a role in our communities. I am pleased to say that I have a great deal of support from my local chambers of commerce.