National Health Service Funding

Philippa Whitford Excerpts

Tuesday 22nd November 2016 Commons Chamber

[Madam Deputy Speaker (Natascha Engel)]

Order. Before I call the SNP spokesperson, I must inform hon. Members that, including her speech, we have calculated, generously, that every speaker will have five minutes, but we will probably have to go down to four minutes at some point.

[Dr Philippa Whitford (Central Ayrshire) (SNP)]

Does that include five minutes for me also?

[Madam Deputy Speaker]

Obviously the hon. Lady has no speech limit, but the speech limit has been calculated with her mind. I am just saying that the longer someone speaks for, the less time everyone else will have.

[Dr Philippa Whitford (Central Ayrshire) (SNP)]

Okay, well that is fairly disappointing, given what I have prepared.

UK-wide, the NHS faces sustainability issues. One of the key issues is the increase in demand from an ageing population and the increasing complexity of those demands. The way to tackle that demand is through public health and social care that ensures that those people do not end up in the most expensive place. Secondly, we have a lack of staff, both nurses and doctors. The lack of training nurses has been referred to. We also face the threat of losing some of our staff from the EU. The third threat to sustainability is money, but the money is the one we can fix, because money is a decision; the others will take a decade each to fix—by training more nurses and doctors, preventing illness and finding better ways to look after an ageing population.

As I have said in the Chamber before, I welcome the idea of STPs, because they should mean a return to place-based planning and integration and a move away from fragmentation and competition. The problem is, however, that they have to be based on patient-centred care, whereas, according to what is leaking out, they are being discussed on the basis of budget-centred care. We heard in the Health Committee that the STP groups were being given a figure that they had to meet by 2021 and then were working back from that. That will never work.

If we want to decrease inefficiency and increase efficiency we need to target the inefficiencies in the system, not just take an axe to the whole thing. When hospitals or GPs run out of money and take urgent action, it will be poorly thought out and immediate-survival action. We need to look at where the fat is and at the natural inefficiencies in the system, and some of that comes down to the lack of integration. STPs are a great opportunity but an opportunity we will look back on as missed if we do not do it properly.

The Secretary of State says that there is no privatisation in the NHS, but there certainly is marketisation and outsourcing. I graduated in 1982, so I have lived through every single iteration from both sides and three Governments. In 1982, we were just skimped. Basically, the NHS got 5% of GDP and it dropped to 4.5% over the ’80s. Instead of increasing that to where it is now, what we had was constant redesign.

The first was the internal market and GP purchasing. A GP would refer to our clinic, but if I decided the patient was not surgical and I referred them to gynaecology, the GP would refuse to pay. What started to happen? Surgeons and clinicians began sending the patient back to the GPs, so that they would refer them. Of course patients fell through the cracks; some never got that second referral and things were missed.

After the purchaser-provider split, we started to change the whole shape. We went from 100 health authorities to 300 primary care trusts, even though the leaders of the PCTs earned the same money as the leaders of the health authorities. People were made redundant and transitional change was hugely expensive. In the mid-2000s, we went from 300 PCTs to 150—again with redundancy and transition. As we move on, we start to see the private finance initiatives. As has been said, the NHS has paid over £60 billion for £11 billion-worth of buildings. That was not an effective thing to do.

Eventually, of course, we come to the Health and Social Care Act 2012, which got rid of the 150 PCTs and replaced them with 211 clinical commissioning groups. This is described as “putting power in the hands of the GPs”, but following a freedom of information request I know that less than 18% of CCGs have a GP majority on them. Some 47% of CCGs do not even have a clinical majority, so the idea that CCGs give power back to primary care is, I am afraid, a complete fallacy.

What we have seen, I am afraid, has come from all Governments. It was the Labour Government who took the purchaser-provider split and introduced independent treatment centres, giving them block grants. All the talk about patient choice was not really patient choice at all: the GP had to send the patient to the ITCs for their hips, because it had already been paid for. To try to counteract that, we have seen payment by results, which was the forerunner of the tariff. What that did was increase activity, so it helped with waiting lists and waiting times, but what we now have is activity that is just growing and growing. Hospitals get paid for activity, not for whether that activity is right.

In Scotland, we abandoned trusts in 2004, and we abandoned primary care trusts in 2009. Let us look at our costs book, which publishes the costs of administration. This is not just the costs of the market; it deals with all the administration of the NHS. Ours has fallen from 7.6% in 2006-07 to 6.7% in 2015-16. When it comes to the Department of Health or NHS England, no one has any idea. A piece of work was done for the Department of Health in 2005, which estimated admin costs at that time as 14%. I suggest that the current market is an awful lot more complex than it was then.

I think some things can be done around procurement. In Scotland, our national procurement gives hospitals a choice of 9,000 items. The supply chain in England has 600,000 items. It is not limiting; it is not national procurement. Our logistics division, which delivers that, will pick items per ward and deliver them all the way from a central depot to that ward. That allows us to cut some of the costs, as suggested in the Carter review.

We absolutely need to keep agency prices down. It is important to try to keep staff on a staff bank rather than get them through agencies. Why are we not asking the bigger question? Why are nurses choosing to work for an agency rather than the NHS? Is it that they earn more money? Is it flexibility? Is it family-friendliness? Would it not be better to look at how we let them work, so that they work for us rather than feeling that they have to go and work in an agency? From the point of view of job quality and job satisfaction, they would all rather be in one place than be in a different place every week.

There are things that could be done. There could be a better use of community pharmacies, and a better use of community hospitals for “step up” and “step down” services. It is crucial that we fund social care so that elderly people are looked after in their own homes. I think that STPs have potential. However, I ask the Secretary of State not to go on and on with marketisation, given that no cost-benefit analysis has ever been carried out and there is no evidence of benefit from it. The NHS could save an amount that is estimated conservatively at £5 billion a year, and that would have a significant impact on the debt.

The right hon. Member for Surrey Heath (Michael Gove) suggested that we needed to bring solutions. I am offering the ones that I can think of from Scotland, and I recommend them to the Secretary of State.

Oral Answers to Questions

Philippa Whitford Excerpts

Tuesday 15th November 2016 Commons Chamber

[Mr Dunne]

My hon. Friend will be aware that the sustainability and transformation plans discussed earlier today are designed to bring closer integration of health providers and commissioners within a health system area, such as the east midlands. The ambition is to integrate better health and social care provision to avoid some of the challenges he identifies.

[Dr Philippa Whitford (Central Ayrshire) (SNP)]

The A&E target the Minister mentions is actually a measure of the entire acute system. Important in that is the flow of patients from admission through treatment to discharge. In Scotland, delayed discharges have fallen 9% since health and social care were integrated. In England, they have gone up 30%. Does the Minister accept the need to fund social care properly to relieve the back pressure on A&E?

[Mr Dunne]

I listen with great interest to what the hon. Lady says, but I gently remind her of two things. First, as the result of the generosity of the Barnett formula, Scotland receives £1,500 per capita more to spend on health than England. Secondly, the Auditor General for Scotland recently reported that NHS Scotland was failing to meet seven out of eight key targets, including waiting times for A&E.

[Dr Whitford]

I wonder how many targets are being missed in England. The Royal College of Emergency Medicine report demonstrates that in the 176 emergency departments in England there are only enough consultants to provide the cover of one for 16 hours a day. On top of that, rota gaps among junior doctors are causing safety concerns. What exactly is the Minister going to do this winter and will he agree to lift his ban on locum agency staff to help to keep A&Es functioning?

[Mr Dunne]

We recognise that there have been pressures on emergency departments for some years, which is why we have put particular effort into recruiting more consultants. There are, I believe, 50% more consultants working in emergency departments in England than there were in 2010, and 25% more doctors.

Health Service Medical Supplies (Costs) Bill (Second sitting)

Philippa Whitford Excerpts

Committee Debate: 2nd sitting: House of Commons
Tuesday 15th November 2016 Public Bill Committees

[Mr Dunne]

The Department of Health receives income from a number of different sources. It mostly deals with expenditure but also receives income from activities conducted through the NHS. One source of income is the rebate through these schemes, which forms part of the funding available to the Department. We have committed that funds available out of the scheme will go into the NHS. The hon. Gentleman raised the issue of the £10 billion. I gently remind him that, in 2014-15, the funds available to the NHS from the Department of Health were £98.1 billion, and by 2021 that figure will be £119.9 billion, which in cash terms is a £20 billion increase and in real terms is a £10 billion increase.

[Dr Philippa Whitford (Central Ayrshire) (SNP)]

As the hon. Member for Burnley said, the system functions quite differently in Scotland. We have a new medicines and rare diseases fund, rather than a cancer drugs fund, which means that the use of funding to access new medicines is not limited to one cohort of patients. Our fund is £90 million, which, given that we are less than 10% of the UK population, means it is proportionately almost three times the size of the cancer drugs fund. As was mentioned, this is very much funded by the PPRS. It is committed to that. The pharmaceutical industry expects the rebates to be used to enable access to new medicines. One problem here is that the rebate goes into base funding, which means it disappears like water in the sand.

We have so many debates in this House about patients who are struggling to access new treatments. Amendment 46 talks about innovation and research, which we support in Scotland. We are quite a research-oriented country. Our research funding to our universities is 30% higher, in proportion to our population. The NHS in Scotland commissions research, particularly on things like informatics and data management around health and social care, which are the big challenges we face in the future.

The Scottish Medicines Consortium, which makes our decisions in the same way as NICE, was reformed in 2013. Since then, we have had a 40% increase in drugs being passed. What we see in England is that even if a drug is passed at the level of NICE, it sometimes does not come into use in the NHS, because the funding is simply not earmarked to make it available.

--- Later in debate ---

[Mr Dunne]

I do not have complete recollection of what the Secretary of State said, but he may have been referring to things such as the over-prescription of antibiotics, which we know is a problem globally. A great deal of work is being undertaken right across the NHS and with other health bodies around the world to reduce the scale of antibiotic prescription.

[Dr Whitford]

Is it not the case, however, that we seem to be developing this additional rationing system between NICE and patients of the NHS? I am talking about NICE’s recommendations being accepted but not funded. The hepatitis C drugs are basically being rationed to a certain number of patients per month, even though they have been passed by NICE and trying to eliminate the viral load in the community can be more effective in the long term.

[Mr Dunne]

Inevitably, some decisions have to be taken when introducing new drugs as to the extent to which they are applicable. Those are clinically-led decisions. There is not a completely bottomless funding pot for the prescription of medicine, so those decisions have to be taken by ordinary clinicians within their practices and within the infrastructure of approvals, which is entirely independent and led by NICE in England.

[Dr Whitford]

With respect to the Minister, that is not what I am hearing from clinicians who work in the field of HIV and hepatitis C. They are being told, “You can have”—for example—“50 patients a month,” and they are having to pick who gets the drugs and who does not.

[Mr Dunne]

I will not be drawn into the detail on a specific drug, because the hon. Lady may have access to information that I do not, but in relation to hepatitis C, as she has raised it, there has been a discussion between the trust and NICE. As I understand it, the trust is continuing to work with NHS England collaboratively to discuss the issue of access to the new hepatitis C drugs. We will always have some discussions about applicability when a new treatment is introduced, to see whether it is appropriate for all conditions; it may be that only some benefit from the drug. I think that that is as far as I can go on this issue.

To return to the Government’s view of the amendment, we are concerned that it would in effect circumvent the critical system of checks and balances around clinicians’ prescribing freedoms. That would present a danger to patients and the sustainability of the NHS. It is also not the purpose of the Bill to address matters other than the cost of medicines and medical supplies.

Treatments that do not demonstrate efficacy, safety and value for money should not be routinely available on the NHS. The National Institute for Health and Care Excellence, an internationally respected organisation that provides evidence-based guidance to the NHS, ensures that the treatments recommended for patients deliver value for money and improved patient outcomes. NICE’s recommendations are developed free from political interference and help NHS organisations to design services that are in line with the best available evidence and that meet the needs of their local populations.

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[Mr Dunne]

Then I will continue.

Certain companies appear to have made it their business model to buy the marketing authorisations for medicines without any patents outstanding. They then de-brand the medicines and abuse the existing freedom of pricing for unbranded generic medicines. Although the practice is not widespread, it must be addressed, which is the reason for the clause.

Currently, our only recourse is to refer such cases to the Competition and Markets Authority, as I mentioned. When the CMA investigates, we must wait for the outcome, and in the meantime the NHS continues to have to pay high prices. The Department consulted on the issue as part of the consultation on the statutory scheme that was launched in December 2015. The Department has been working closely with the Competition and Markets Authority and has referred cases to it. The CMA is about to issue a decision in a case on a high-priced unbranded generic medicine. As I have just said, it has also recently opened another investigation.

The powers under section 262 of the 2006 Act to limit prices of health service medicines can be exercised through directions or regulations. The Government’s intent is to work with directions, which will enable us to limit the price of a specific medicine from a specific manufacturer. The Government are obliged to consult the industry representative body when we want to direct the price of a medicine. In the case of high-priced generics it would be the representative body of the unbranded industry—currently the British Generic Manufacturers Association, which appeared before the Committee last week.

The Government would of course also engage with the company involved before issuing a direction that limited the price of a medicine. As I have indicated, there may be good reasons for a price increase, and it is important that the Government understand the reason behind a price increase before issuing a direction. As I said, the new information powers will help us with that.

My officials have initiated talks with the unbranded generic medicines industry representative body and the CMA to explore how in practice we would determine what should be considered a reasonable price. Any decision by the CMA in the cases that I highlighted earlier could help set a useful precedent. I can reassure the Committee that companies charging unreasonably high prices for unbranded generic medicines is not a common practice. The Government do not intend to use the power where competition in the market for unbranded generic medicines is working. However, the Government need the right legislative tool to be able to address unreasonably high prices of unbranded generic medicines. The clause will give us that tool, and I ask the Committee to agree to it.

[Dr Whitford]

Basically, we welcome the measures in clause 2 to try to close the specific loophole whereby companies that are part of the PPRS voluntary scheme and that also produce generic medicines are able to increase the prices of generic medicines. However, the Minister talked about the British Generic Manufacturers Association—largely companies that focus on generic medicines—which would be more to do with clause 3. My understanding is that the change will close the specific loophole relating to large pharmaceutical companies that also produce generic medicines, rather than companies that focus only on generic medicines, which we will come on to in clause 3. We welcome the closing of that loophole, but those two things are quite different and we should therefore not conflate them. It is not the competition authority that would tackle them. That is much more related to purely generic companies.

[Mr Dunne]

We will obviously come on to clause 3 shortly. The primary intent behind clause 3 is to modernise the statutory scheme, rather than to address the difference between one type of company that produces only generics and another that produces generics and branded medicines. I am not sure that I agree with the hon. Lady’s distinction.

[Dr Whitford]

My point is just that what the Minister has described applies more to clause 3, on companies that produce purely generic medicines, so the attempt would be to strengthen the statutory scheme that they might be part of. It is the production of generics by the group of companies under the PPRS scheme, the big pharmaceutical companies, that is getting under the wire. That is covered by clause 2(2). The Minister was talking about the Competition and Markets Authority and the British Generic Manufacturers Association, and I think clause 3 is more relevant to that. Clause 2 is more of a surgical change, which we absolutely support.

[The Chair]

The Minister can respond either now or later.

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[Julie Cooper]

I beg to move amendment 43, in clause 3, page 2, line 27, at end insert—

‘(2A) An amount calculated under subsection (2) may only be calculated using the same methodology as an amount payable by any member of a scheme made under Section 261 of the National Health Service Act 2006 (voluntary schemes for controlling the cost of health service medicines) is calculated.”

We support clause 3 in principle and the amendment aims to clarify that. Under the current system, following the National Health Service Act 2006, two schemes operate to control prices of medicines: the statutory scheme and the PPRS voluntary scheme. It is important to align those two schemes, because since 2014 there has been a significant movement of companies deciding to shift from the PPRS scheme to the statutory scheme to reduce the level of rebate payable. That has reduced savings to the NHS, so it requires urgent revision.

We agree with the principles of the Bill on ensuring that both schemes achieve the same level of savings and that the system is not open to abuse. We are concerned, however, that the Bill is not specific about how payments would be calculated under the statutory scheme. We agree with the Secretary of State that the purpose of the Bill is to clarify and modernise provisions to control the cost of health service medicines.

The amendment seeks to clarify beyond doubt that the Bill is in line with the stated aim of achieving equivalence between the two price-control schemes, by ensuring that under the statutory scheme members' rebates are calculated using the same methodology as for PPRS members. We commend the amendment, but will not push it to a Division. I am interested to hear the Minister’s comments.

[Dr Whitford]

One issue arises because the statutory scheme was based on prices in December 2013. The further on in time we are, the less proportional the return. Whether it is the same or a similar mechanism, we should avoid having a price rebate to the NHS stuck in time, which might be five years ago, and does not reflect the actual costs of the drugs.

[Mr Dunne]

The voluntary schemes are introduced and refreshed every five years. The current scheme was negotiated in 2014, so we are two years into that. One reason for having a time limit on the scheme, from the Government and NHS perspective, is that companies like to find ways during the course of time to adjust their commercial behaviour for their benefit. Having the opportunity to renegotiate the voluntary scheme every few years enables us to try to avoid the circumstances referred to by the hon. Lady.

[Dr Whitford]

If I could clarify, the voluntary scheme runs for five years but what I was talking about, with regard to clause 3, is the statutory scheme and the price rebate related to a requirement for a percentage reduction from the price in December 2013. That is how the rebate in the statutory scheme is defined. The further one gets away from that date point, the less one gains. It is the statutory scheme I am talking about rather than the voluntary one.

[Mr Dunne]

My understanding is that under the statutory scheme, the percentage applies based on sales achieved in the previous year. Therefore, the percentage reduction that we seek for the statutory scheme can be adjusted year by year. That is the intent of what we seek to do. I will seek further inspiration to ensure that I have exactly addressed the point that the hon. Lady makes.

Amendment 43 would have the effect of linking the payment mechanisms of the statutory and voluntary schemes. I understand why that might appear a desirable objective, so I understand the intention behind the amendment. We think there is merit in aligning the two schemes in some respects. However, to require them to be the same is inappropriate, because it removes some flexibility that the Government have, and from which the NHS benefits, in being able to negotiate the voluntary scheme on a periodic basis. The voluntary scheme has other aspects beyond pure price. Aligning the two in what will become a statutory scheme would restrict the scope for the two schemes to operate in a complementary manner.

The voluntary scheme is a matter for negotiation with industry on a periodic basis. As such, there is scope to include a range of measures. Those measures may change with each iteration of the scheme, to reflect the priorities of each side at the time of renegotiation. To illustrate that, the current voluntary scheme includes a range of provisions developed through negotiation with industry that sit alongside the payment mechanism. That includes price modulation, which enables companies to put prices up and down as long as the overall effect across their portfolio is neutral. That may have benefits for them, not only for their sales to the NHS but in the pricing references used by selling to the NHS in jurisdictions in other countries. That is of potential commercial value to companies, which may be willing to accept a higher payment percentage as a result—in other words, a higher discount to the NHS.

There are also provisions on the uptake of new medicines by the NHS, such as making NICE-approved medicines available within 90 days of a NICE decision. We are keen to encourage that. By contrast, the statutory scheme is intended to be a more straightforward approach. As such, the payment percentage applied may be slightly different from that applied to any voluntary scheme, in order to achieve a broadly similar level of savings once all elements of the schemes are taken into account.

As we heard in oral evidence last week, the freedom to negotiate the voluntary scheme is greatly valued by both industry and Government. We intend that any future voluntary scheme should be established through such negotiation, but linking the payment mechanisms would inevitably restrict that flexibility and freedom for both sides. In addition, while the Government welcome the collaborative approach of a voluntary scheme, we cannot guarantee that Government will always want two schemes in future. The amendment would constrain the Government’s discretion to run a single scheme if they and the House thought it best to do so. For those reasons, I urge the hon. Member for Burnley to withdraw her amendment.

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[Mr Dunne]

The clause amends the provisions relating to statutory schemes in section 263 of the National Health Service Act 2006, which describes the purposes for which the Secretary of State can make statutory schemes. The amendments make it clear that a statutory scheme may require companies to make payments to the Government, based on their health service sales. For those companies not in the voluntary scheme, the Government operate a statutory scheme. That is currently based on a cut to the list price of products, rather than a payment mechanism on company sales, as in the voluntary scheme. The cut to the list price has delivered fewer savings to date than the payment mechanism under the voluntary scheme.

[Dr Whitford]

That was the point I was trying to make earlier. One is a percentage return on sales and profits, and the other is a cut in price. The further we are from the time set, which was December 2013, the less value we have from that in proportion to current prices.

[Mr Dunne]

I am grateful to the hon. Lady for making that clear to the Committee. The different approaches to price control between the voluntary and statutory schemes have led to some companies making commercial decisions to divest products from the voluntary scheme and sell them through the statutory scheme, thereby reducing the effectiveness of the voluntary scheme and savings to the NHS. The introduction of a payment mechanism in the statutory scheme would save the health services across the UK an estimated £90 million a year, as set out in the impact assessment.

In response to the Government’s consultation on introducing a payment mechanism in the statutory scheme, the pharmaceutical industry queried whether the Government had the powers to introduce a statutory payment system. The clause clarifies the existing powers to make it clear that the Government have the power to introduce a payment mechanism in the statutory scheme. The ability to make the statutory scheme by way of regulations rather than setting out the detail in primary legislation provides us with the flexibility to respond to changes in the wider economy, the medicines market and patient needs. We have provided illustrative regulations to support scrutiny of this delegated power.

The clause makes a further amendment to section 263 of the National Health Service Act 2006. Currently, the power to make a statutory scheme cannot be applied to members of a voluntary scheme, which means that if the Government introduced a statutory scheme for unbranded generic medicines—although we have no current plans to do so—we would be unable to apply the scheme to manufacturers of unbranded generic medicines that have a mixed portfolio of branded and unbranded generic medicines, and are members of the voluntary scheme. The clause therefore amends the Act in such a way that the power to make a statutory scheme cannot be applied to products covered by the voluntary scheme rather than member companies of the voluntary schemes.

The Government’s view is that, for the most part, competition works well to keep down the price of unbranded generic medicines. Should that situation change, this amendment would enable the Government to use their clause 2 powers to take action beyond individual products or companies. I hope that is clear to the Committee. If so, I ask the Committee to agree that clause 3 should stand part of the Bill.

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[Mr Dunne]

No, I mean the Home Secretary.

We believe that competition is the best way to drive prices of medicines down for the NHS, and generally speaking that works well. In the case of the specific unbranded generics where there is a single supplier, we have seen that there is an opportunity for market abuse, and I agree with my hon. Friend the Member for South West Bedfordshire that the clauses are designed to use the device of price controls to avoid excess profit abuse by individuals in British companies, which we have seen.

I gently remind the hon. Member for Wolverhampton South West that successive Governments since 1957, including the Government whom he proudly supported for many years, had price controls in place for the cost of medicines.

[Dr Whitford]

The Minister was obviously not happy with the amendment on aligning the two schemes, but he talks about a mechanism of price control under clause 4. Will he give us even the broad principle of what he thinks the price control mechanism in the statutory scheme will be?

[Mr Dunne]

The mechanism in the statutory scheme will be to allow the discount to be changed periodically. That will be determined through consultation with industry in the same way as applies in the voluntary scheme.

[Dr Whitford]

To clarify, therefore will the situation continue to be that the statutory scheme is based on a price reduction as opposed to a percentage above a mark being returned to the NHS, as in the voluntary scheme? Will it be a similar mechanism to what we have today?

[Mr Dunne]

I believe that that is the case, but if I have misunderstood the hon. Lady’s question I shall clarify that later in the sitting, if I may. Our intention is to consult on the matter, so the precise mechanism has not yet been finalised; hence there is some uncertainty.

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[Mr Dunne]

I can help the hon. Gentleman directly with a specific example. The Secretary of State already has those powers under the 2006 Act, which the hon. Gentleman’s Government enacted.

Question put and agreed to.

Clause 4 accordingly ordered to stand part of the Bill.

Clause 5

Control of maximum price of other medical supplies

[Dr Whitford]

I beg to move amendment 47, in clause 5, page 3, line 39, at end insert—

‘(7) Before making regulations under Clause 5 the Secretary of State must conduct a consultation on the potential effect of this clause on the maintenance of quality of those medical supplies, and seek representations from manufactures, suppliers and distributors of medical supplies as part of the consultation.”.

This is a probing amendment on an issue of concern. The Secretary of State has obviously had powers since 2006, and perhaps earlier, to seek to control the price of medical supplies. That power has not really been utilised, and neither have the informatics of that. When controlling the price of drugs, the quality of those drugs is controlled by the Medicines and Healthcare Products Regulatory Agency so that pushing down the price does not result in loss of quality.

My concern is that, beyond a kitemark or a CE mark, we do not have anything in the United Kingdom that controls quality, particularly of consumables such as swabs and gloves. As a surgeon for 30-odd years, I can tell the Committee that the range in quality of things such as surgical gloves can be immense. A surgeon might use two or three pairs of gloves during an operation. If there is a leak in those gloves that is not visible, it might be only when the surgeon washes their hands afterwards that they see they have blood on their finger, which means that staff are exposed to blood contamination. Poor-quality swabs might result in thread or fluff coming off inside a patient, which can contribute to sepsis. There is no quality controller specific to medical supplies, so if we just drive down the price, we may drive down the quality.

We use a lot of central procurement in Scotland, and NHS National Procurement has helped us to control our prices for everything from consumables through to major machine purchases, which is already saving money for the NHS in Scotland. If there were a reduction in quality, our concern is that it would be UK-wide. It would be something that producers were doing, which would in turn undermine what the devolved Government were trying to do. Procurement remains devolved, but if the quality started to drop overall, that would affect all the devolved health services, as well as NHS England.

The amendment calls for consultation and for consideration of some form of quality regulation or control that would mean those items having to be way above the very basic CE level, at a point considered high enough quality for NHS use.

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[Mr Dunne]

Rather unusually, I start by thanking the hon. Lady for proposing the amendment. She has raised an issue for which we have considerable sympathy. She touched on the way in which medical products are procured in Scotland. I can confirm that we are looking to introduce more centralised purchasing across the NHS under the efficiency proposals made by Lord Carter in the other place. One of the areas of focus was the variability, in purchasing terms, of standard commodity items. She mentioned surgical gloves—I will not go into detail on those with her, because she has obviously used them considerably more than I can conceive of and is therefore very experienced when it comes to the variability not just in price but in quality of such commodity products. We are looking to introduce closer central purchasing—I think 12 items are currently being trialled or introduced in parts of NHS England.

We recognise that, as currently drafted, the Bill does not explicitly state in relation to section 260 that the Government are obliged to consult industry. I am aware that the 2006 Act, in relation to controlling the cost of medicines, does explicitly state that there is an obligation on the Government to consult. The hon. Lady’s amendment is appropriate in its intent. I invite her to withdraw it at this stage, but I undertake to work with her. My officials will consider how to amend the amendment to give it the effect that she seeks, but in a way that works in the context of the Bill. There are technical drafting issues with the amendment that mean that it would give us some unintended difficulties. That is the Government’s position on the amendment; I hope she is happy with that.

The hon. Lady referred to the effect of any pricing controls for medical supplies on the maintenance of those products’ quality. I can assure the Committee that the Government will take into account all relevant factors, including any concerns raised by industry about the quality of medical supplies, when making and consulting on price controls if they were to apply to medical supplies. The Government would not be in favour of putting any of those many factors in the Bill, because it may unnecessarily constrain the conduct of future Governments or the NHS.

[Dr Whitford]

If there is a move to more central procurement, will the Minister consider some form of quality control regulation or power at that point, so that central procurement is not just driven to accept the lowest price and there is some safety mechanism, in the same way we have the MHRA for drugs?

[Mr Dunne]

We will consult with industry on the impact of the Bill on medical supplies. Although I am not going to give the hon. Lady an absolute assurance that we can introduce a threshold for quality, which is quite hard to prescribe given the immense variety of supplies we are talking about, there is a clear intent that, if we are centralising procurement of equipment, that equipment has to meet a quality threshold in order to be acceptable to the clinician. I understand the point she makes. The intent is not to buy substandard equipment to treat patients, but to remove variability in pricing for the same equipment depending on different purchasers, which is inappropriate and means effectively the taxpayer is the funder of all these different entities.

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[Mr Dunne]

Yes, I think that is the correct answer. We do have those powers under the 2006 Act, but they have not been used, partly because generally speaking medical supplies is a competitive market. We have not seen the kind of abusive price behaviour that we are trying to address elsewhere in the Bill.

[Dr Whitford]

Will the Minister give way?

[Mr Dunne]

I am about to conclude but I will happily give way.

[Dr Whitford]

I would like to clarify the reason for introducing this, if there has not been a problem in the market, as we have seen with the price hikes in generics, and it is much harder to do. Why are the Government extending a power they have had for 10 years but never used?

[Mr Dunne]

In essence, we are trying to bring the regimes for medical supplies and drugs into the same environment, so that we are able in future to use the powers, which we are introducing for the first time for drugs, for medical supplies on the same basis, so that we do not have to treat one thing under one Act and the other under another. I hope that is clear.

[Mr Dunne]

I am not aware of any particular examples of medical supplies that we are concerned about at this point. However, I am sure that, if there are people outside watching who have good examples, they will let the Committee know before we conclude our deliberations.

Reverting to the hon. Lady’s amendment 47, we understand the intent behind it. We are not fully convinced that the current drafting would have precisely the effect that she is hoping. I invite her to work with me and my officials between now and Report. The Government will be happy to consider how we could best introduce the requirement to consult in relation to section 260. On that basis, I invite her to withdraw the amendment.

[Dr Whitford]

I beg to ask leave to withdraw the amendment.

Amendment, by leave, withdrawn.

Question proposed, That the clause stand part of the Bill.

[Mr Dunne]

Clause 5 amends section 260 of the 2006 Act, which enables the Secretary of State to control the maximum prices of medical supplies other than health service medicines. As we have just discussed, the Government have powers to control prices of medical supplies and we are not currently using those powers. It is important that we continue to have those powers, should we decide it is necessary to control prices of medical supplies in the event of market abuse.

With an increasing spend on healthcare products, the Government need the tools to be able to control prices, if there is any indication that medical suppliers do not provide value for money to the NHS and the taxpayer. The measures would ensure that the same enforcement and territorial extent provisions apply to controlling the cost of medical supplies and health service medicines.

Existing enforcement provisions in relation to medical supplies are draconian compared with those for medicines. Currently, a contravention or a failure to comply is in fact a criminal offence in relation to medical supplies, whereas it is not in relation to medicines. We are aligning the enforcement provisions to those for medicines and making them much more proportionate. That is done through clause 7, through consequential amendments. On that basis, I ask the Committee to agree that clause 5 stand part of the Bill.

Health Service Medical Supplies (Costs) Bill (Third sitting)

Philippa Whitford Excerpts

Committee Debate: 3rd sitting: House of Commons
Tuesday 15th November 2016 Public Bill Committees

[The Chair]

I think later would be helpful, thank you, Minister.

[Dr Philippa Whitford (Central Ayrshire) (SNP)]

I want to raise a small, perhaps technical, issue on amendment 11, which it seems would insert the rules and definitions with respect to excepted persons for Scotland, Northern Ireland and Wales under a new subsection defining health service products for England. It seems out of place, and there is no definition of English excepted persons.

The amendment would insert new subsection (8A) into new section 264A, which clause 6 inserts into the National Health Service Act 2006. It seems out of place because the provision would deal with English health service products, then the definition of the excepted persons in the devolved nations, and then Scottish, Irish and Welsh health service products. It may just be a technical issue, but I wanted to raise it.

--- Later in debate ---

[The Chair]

I am sure that the hon. Lady knows, but if she wants to speak to amendment 48 now, she can do so.

[Dr Whitford]

My colleague will speak to that amendment.

[Martyn Day (Linlithgow and East Falkirk) (SNP)]

It is a pleasure to serve under your chairmanship today, Mr Pritchard. I am somewhat reassured by many of the Minister’s comments, and I thank him for his explanations. Much of this stuff is technical, and I hope he sees amendment 48 in a similar light. I think it would improve and strengthen the measure.

The clause does not currently set out a mechanism for the disclosure of information to devolved Administrations or bodies. For example, how will the information be disclosed, and by what means? Will it be only the Secretary of State who can disclose? In short, will the devolved Administrations be able to get the information when they want and need it, so that it ties in with the figures and statistics they are seeing and they can see patterns? It is about flexibility.

The amendment is fairly straightforward and we think it would help to strengthen and improve the Bill. I hope that the Minister agrees. We would like him to clarify whether the Government intend to leave disclosure to the discretion of the Secretary of State, on an ad hoc basis. Otherwise, what would the terms of disclosure be?

--- Later in debate ---

[Mr Dunne]

First, in relation to amendment 11 and what the hon. Member for Central Ayrshire said, I think she made a perfectly reasonable point. As a lay reader of parliamentary drafting, if I may say so, it would be easy to be perplexed by the sequencing that she highlighted and brought to the attention of the Committee. I am advised, however, that the purpose of the amendment is to ensure that the UK Government collect information from English pharmacies and GP practices, but not from pharmacies in the areas of the devolved Administrations. Therefore, the reference to “Excepted person” includes pharmacies and GP practices in the devolved Administrations, but specifically does not include those in England, because their information is already collected by the UK Government. The terminology relates to where the GPs and pharmacies are and who is doing the collecting. I hope that helps.

[Dr Whitford]

I understand that, but I could not find reference to that in the National Health Service Act 2006, and I thought that the aim was to bring everything together in this Bill, so it seemed odd that there was no mention of English excepted persons. That is fine—that information is already being collected—but the Bill still separates the definition of English health service products from the definition of the health service products of the devolved nations. It seems an odd place to insert the amendment; it seems it is being attached to the definition of English health service products.

I totally accept that I am a complete novice, so there may be something I am not understanding, but to me, reading it logically, it does not seem to make total sense, and I thought that the aim of the Bill was to bring all the powers into one place. It seemed odd for there to be no definition of English excepted persons, even from an old Act, because what is happening here is that different things are being brought from the 2006 Act and from the Scotland Act 1978 into one place.

[Mr Dunne]

I thank the hon. Lady for that clarification. I hope that inspiration will arrive before I sit down.

To address the specific point made by the hon. Member for Ellesmere Port and Neston on devolution to Manchester, it is an interesting idea, which reflects some of the challenges arising from the increasing use of devolution of powers across our country. I can see why he might seek to secure a carve-out of income for Manchester. I would say, “Nice try”, but at present the funding arrangements for Manchester and other devolved areas in England are agreed via NHS England. That applies to the totality of funding available for health provision within the Manchester area, so the allocation already includes income derived from the voluntary scheme, and it will not be ring-fenced as a subset of the funds, because there chaos would lie.

--- Later in debate ---

[Mr Dunne]

Each year, when NHS England agrees its commissioning budgets and tariffs with providers, an allocation is made. That is based on the overall sum received by NHS England. Increases in revenues that derive from the Bill will help to swell that pot relatively modestly, although every penny counts, and that will therefore be taken into account when determining allocations to all CCGs, including those in Manchester.

I will give the Government’s response in relation to amendment 48; I do not have many comments to make. I sincerely hope that, before I reach the end of these remarks, I will be able to address the further point, on English exclusion, made by the hon. Member for Central Ayrshire.

Proposed new section 264B in clause 6 enables the Secretary of State to disclose the information collected to a range of bodies, which includes Government bodies such as NHS England, special health authorities, NHS Digital, other Departments and the devolved Administrations. It also enables the Secretary of State to prescribe representative bodies, or other persons in prescribed regulations, to whom he can disclose information in the future. For example, that might include certain information going to trade associations or other bodies that it might be appropriate to provide information to in future, with respect to the operations of the Bill.

The effect of the amendment tabled by the hon. Members for Central Ayrshire and for Linlithgow and East Falkirk would be that any of those bodies could in future access any information that the Government have collected. We do not believe that it would be right for representative bodies to be able to access information that the Secretary of State collects, primarily for purposes of commercial confidentiality. There are examples in other legislation in which we have taken specific steps to protect commercially sensitive information. I am not suggesting that one company would directly get access to information on another company’s profitability, but third-party advisers, for example, might get access to that information.

We do not want to provide opportunities for risking breaches of commercial confidentiality, because that would undermine confidence in the information gathering for all the companies, which includes major multinational companies. We think that the amendment might open us up to criticism from the major suppliers that there was greater risk of that intervention, which we would not want to see.

[Dr Whitford]

If the Minister looks at our amendment, which is incredibly short, he will see that all it says is “at that person’s request.” We do not want to widen the list in any way at all; we are not looking to add to the list. All we are saying is that, if it is accepted that a devolved Government should be able to access this information, it should be at the request of that devolved Government. It should not be, “We will tell you every April how you’re doing.” If a devolved country sees a pattern emerging, it should be able to say, “Can we request our data?” The issue is that data are to be collected centrally but not belong to the devolved nations to which they pertain. We are not trying to add anyone; we are just trying to give the devolved countries the power to request.

[Mr Dunne]

I completely understand that that is the intent of the hon. Lady’s amendment, and I think I have another way of addressing it, which I am now going to come on to. We think it entirely appropriate that at some point the devolved Administration might wish to change their information requirements. They might wish to add requests for information that they are not initially getting, which is a reasonable request.

We think that the right way to address that, rather than putting something in the Bill that might inadvertently allow other representative bodies access to information—I am sure the hon. Lady agrees that that might not be appropriate—is for a memorandum of understanding to be agreed between the Department of Health and each of the devolved Administrations that would allow requests for information to be submitted and dealt with in a manner agreeable to both parties. In the consultation process that will follow, we intend to enter into a memorandum of understanding that will include the procedures for requesting and sharing information.

I assure the Committee that the Government intend to continue to work constructively with the devolved Administrations to ensure that they have access to the relevant information collected in a format convenient to both sides, so that we do not end up with special data sets that are hard for an Administration to create because the data are not readily available from the information provided. Aside from that, we would honour the reasonable requests of any devolved Administration to be able to get access to the data, which I acknowledge the Administration may not own if the information has been gathered by the Department of Health.

On that basis, I hope that the hon. Lady and the hon. Member for Linlithgow and East Falkirk will not press their amendment.

--- Later in debate ---

[Mr Dunne]

Before I go into the clause as a whole, I would like to respond in further detail to the hon. Member for Central Ayrshire about excepted persons. Clause 6 will add a new section to the National Health Service Act 2006. It brings together information collection practices, both statutory and voluntary. The Secretary of State collects information from a sample group in England from time to time, but not from GPs and pharmacies in the devolved Administrations. Therefore, the definition of “excepted persons” covers those persons whom the Secretary of State does not intend to collect information from directly, because he would be relying on the devolved Administrations to do so. The terminology used in proposed new section 264B is new; it is not based on the 2006 Act, which the hon. Lady has read so diligently. I thank her for bringing the matter to the Committee’s attention and I hope that that explanation meets her concern.

[Dr Whitford]

To clarify, is there a rational reason for the positioning of the section as between English health service products and the other health service products? I am sorry if, as a novice, I am creating extra work.

[Mr Dunne]

I think that is to do with parliamentary drafting on which I stand to become an expert; I look forward to seeing whether there is a clear explanation for that, which I can give to the hon. Lady as we debate the clause.

The clause enables the Secretary of State to make regulations that require any person who manufactures, distributes or supplies health service products, which includes health service medicines, medical supplies and other related products, to keep, record and provide on request information on prices and costs.

The clause brings together and consolidates existing information requirements related to controlling the costs of health service medicines, as well as medical supplies, in one place in the Act, as we discussed this morning. It also allows the information to be used for the purposes set out in the clause.

The clause also expands and strengthens our information collection. It enables the Government to make regulations to put current voluntary information provision arrangements on a statutory footing. For example, we collect information from manufacturers and wholesalers of unbranded generic medicines and specials to inform reimbursement arrangements for community pharmacies. The Bill will enable us to make regulations to get information on more products and from more companies. That is necessary to ensure that reimbursement prices for pharmacies reflect market prices of the whole market, rather than just of those companies that currently supply data to us. As in any industry, there are new market entrants and participants leave the market; this is a dynamic market and we need the flexibility to bring in new products from new companies.

The clause will also enable the Government to collect information to assure us that adequate supplies of health service products are available, and that the terms on which they are available represent value for money. If we were to have concerns about the supply chain or parts of it, or about specific products, we could obtain information from companies in the supply chain to assure us that the products, or the supply chain, provided value for money to the NHS and the taxpayer. Although the Government are generally not the purchaser of health service products, they do pay for them and therefore transparency and value for money of the supply chain are important. For example, if we were to consider limiting the price of a high-priced generic, the power to obtain information would be crucial to determine whether excess profits were being made. We could obtain information from a manufacturer, which would help us to determine whether the price it was charging the NHS was unreasonably high. That information would also inform our decision on what the right price should be.

The purposes for which the Government can collect information are limited and involve three areas: cost and pricing schemes, reimbursement of pharmacies and GPs, and assessing value for money. The clause provides the Secretary of State with the power to request any information for the purposes set out in the Bill. It also provides an indicative list of the type of information that the Secretary of State may request. Most of the types of information listed are already collected by the Government under statutory or voluntary arrangements.

The clause will also enable the Government to share information with a range of bodies, including Ministers in the devolved Administrations, the NHS, other Departments and persons providing services to those prescribed bodies.

--- Later in debate ---

[Justin Madders]

I beg to move, That the clause be read a Second time.

As is explained in the explanatory note, the new clause would put a duty on the Secretary of State to place before Parliament an annual report on the impact of the Act and, in particular, on the pricing and availability of medicines and other medical supplies, research and development, and the NHS’s legal duty to promote innovation. I think we all agree that there are examples of unreasonable behaviour, but there may be occasions when there is a difference of opinion as to what amounts to unreasonable pricing practices, not least between the producers and the NHS.

We would be more assured if the consultation on the regulations had been completed by this stage. We are obviously not going to be in a position to know what that consultation has to say for some considerable time, so we believe the implementation of such a requirement would allow Parliament to scrutinise the impact of the legislation.

There has been some unease in the sector about the impact of the legislation and there is a certain amount of uncertainty, particularly around the future of the European Medicines Agency and the medium-term implications of Brexit not only for that agency, but for the research and development sector and the pharmaceutical industry as a whole.

We are one of the foremost countries in the world for drugs development, and our share of sales of the top 100 prescription medicines is 14%. The UK pharma industry employs 73,000 people, with very high-quality jobs in academia and science, but we cannot be complacent about the state of UK pharma, particularly as investment decisions are often made by parent companies in other parts of the world. That concern is compounded by the small volume of sales in the UK compared with other countries. We face increasing competition from emerging economies for R and D investment, with rapid growth in areas such as Brazil and China. That is not a new problem.

A report for the Secretary of State for Health by Professor Sir Mike Richards in 2010 on the extent and causes of international variations in drug usage explored levels of medicines uptake for 14 categories of drug in 14 high-income countries during 2008-09. The study showed that the UK ranked eighth out of the 14 countries. A follow-up study by the Office of Health Economics updated the quantitative analyses and ranked the UK ninth across all the medicines studied.

Apart from disadvantaging patients, the relatively low take-up of new medicines may put at threat R and D investment in the UK. We need some assurance on that and an ability to monitor and engage with the Government on it. We know many other countries are queuing up to take the European Medicines Agency off our hands, and there are real concerns about the knock-on impact of that.

The impact assessment for the Bill says there will be a reduction in revenue for the pharma sector, unsurprisingly. It also says:

“Reduced pharmaceutical company revenues are also expected to lead to a reduction in investment in research and development… and consequent losses of spill-over benefits for the UK economy, valued at £1.0m pa.”

While we agree that it is vital that those who abuse the system to drive obscene profits for themselves are dealt with, we do not wish to find the UK becoming a less attractive place for research and investment because other countries have made themselves more attractive.

We ask that the report become an annual feature of the Secretary of State’s duties to ensure that we can judge the effectiveness of the Bill. The converse point is that if we continue to see price increases, we want to be assured that the regulations are effective in driving best value for the NHS.

[Dr Whitford]

I rise to echo some of the points raised. We have discussed a lot of issues around the decision to leave the EU, including the loss of the EMA. As well as possibly losing international and multinational pharmaceutical companies—particularly those from the London area, which have based themselves here because of the EMA—it is clear that drugs may end up going through a licensing process for the UK later than is currently the case. They are likely to go through the American market and then the EU market, which will still have 450 million people, and we are likely to slide down to be more like Canada and some other countries. This is a very unstable time for research, because of the loss of Horizon 2020 and the EMA, and for our pharmaceutical industry, which is a major player in the UK. It is incumbent upon Government to ensure that the Bill has no unintended consequences that exacerbate that.

--- Later in debate ---

[Dr Whitford]

I beg to move, That the clause be read a Second time.

The point of the new clause is to explore a particular problem with what the Minister referred to earlier as “specials”. They are unlicensed preparations, often topical medicines, often used for severe skin conditions such as hard-to-control psoriasis. The British Association of Dermatologists reports that patients in England, Wales and Northern Ireland are struggling to get them prescribed, because the costs have spiralled out of control.

In Scotland, until last September, three quotes had to be obtained and one of them had to be from an NHS manufacturer. That has been streamlined, and a single quote, provided it is from an NHS manufacturer, is now acceptable. The British Association of Dermatologists looked at the 12 top specials that its members prescribe and estimated that if an NHS manufacturer had been used, instead of £845,000, the cost would have been £162,000. The association also reported that several private manufacturers are keeping two price lists—one for Scotland and one for England—and some of the dermatology items in England are eight times the price in Scotland.

That is literally holding people to ransom, and the result, because CCGs are hard pressed for cash, is that they are not comfortable funding specials and GPs are not allowed to prescribe them. Anyone who has ever had a dermatological condition of any kind, or knows someone who has, knows how unpleasant and utterly dominating of one’s life it can be. It is awful that patients, in particular in England, are not able to access such medicines. The new clause is looking at whether specials will be covered and whether enough attention is to be paid to them. The number of patients is small—hence the top 12 still come to less than £1 million—but for those patients this is a major issue.

[Mr Dunne]

Again, I am grateful to the hon. Lady for drawing the Committee’s attention to the issue. I confirm, for the benefit of the Committee, what the specials are—she has characterised them well.

From our perspective, unlicensed medicines or specials can be manufactured or imported to meet a patient’s individual needs when no licensed product is available. By their nature, specials are bespoke, and costs need to be balanced against the availability of treatment for an individual. I am aware of concerns that some specials, especially those not listed in the drug tariff, are not being prescribed because of their cost—the hon. Lady highlighted those for dermatological treatment. It must be recognised, however, that with specials, because of their bespoke nature, there are few if any economies of scale and they can be expensive to manufacture.

Under section 262 of the 2006 Act, the Government have the power to limit the price of any health service medicine, as long as the manufacturer is not in the voluntary scheme. Manufacturers or importers of specials are generally not in the voluntary scheme. Specials are health service medicines and we can therefore limit their prices. At the moment, the Government do not use their power to control the prices of specials. The hon. Lady gave an example, without naming the product, of a significant price differential between Scotland and England; if she is willing to write me a note after the Committee, I am interested in exploring why we have chosen not to take advantage of the power that we already have in that case, because on the face of it, it would appear to be an example of where the power perhaps ought to be used.

[Dr Whitford]

While there are not major economies of scale, if national health manufacturers are used, it is possible at least on a regional basis to pool some together. As things are at the moment, a pharmacy can simply approach its sister or mother company and ask for a price, which creates a vested interest in making the price high. I think that things can be done, which seem to be working in Scotland, so they are worth trying.

[Mr Dunne]

Again, I am grateful to the hon. Lady—

--- Later in debate ---

[Mr Dunne]

As we broke—literally, I was saved by the bell—I was describing how setting prices as suggested by the new clause could have unintended consequences. We are concerned that it may lead to manufacturers stopping the production of some specials if they are no longer profitable and patients facing adverse consequences.

By setting reimbursement prices in the drug tariff in primary care, the Government encourage pharmacy contractors to source specials as cheaply as possibly, which in turn creates competition in the market and, as a result, reimbursement prices decrease. For those specials not listed in the drug tariff, pharmacy contractors have no incentive to lower the list price. Currently, less than 1% of the total expenditure on medicines in primary care is on specials. Nevertheless, I believe those products, like all other products destined for the health service, should provide value for money to the NHS and the taxpayer. The information power in the Bill will help the Government to determine whether the products provide value for money and the illustrative regulations include an obligation to review those provisions.

The new clause would require the Secretary of State to commission a review of the adequacy of existing powers to control prices of specials, including the enactment and enforcement of those powers. The Government keep their power to control prices under review all the time; it was a review of those powers that led to the Bill in the first place. The Government believe that we have sufficient powers to limit the prices of specials if need be. The hon. Member for Central Ayrshire appears to have evidence of specials being priced to Scotland materially more advantageously than to England. If she would be willing to make that information available to us, we would be delighted to consider it.

[Dr Whitford]

I wonder whether the Government have given any consideration to having NHS manufacturers provide these products or to including some of the topical specials in the drug tariff, so that the price is kept down. Otherwise, despite the Bill, these drugs will be left outside its provisions. They are going to be too expensive and patients will suffer from that.

[Mr Dunne]

For the reasons that I have said, we have the power to look at the pricing of the specials already and we have not had evidence that the pricing has been abusive. We already have that power. We will keep prices and specific drugs under review. The best way to take that forward is to leave the powers as they are and not to proceed with the new clause, but to invite hon. Members to highlight specific examples that they are aware of.

--- Later in debate ---

[Rob Marris]

I thank the Minister; that is helpful. He is on top of his brief, as ever, and needed no inspiration to tell me that. It is helpful. The power does exist. I would like to ask the hon. Member for Central Ayrshire, because she has considerable expertise in the field. My expertise, such as it is, is as a lawyer. I see in her new clause the words

“ unlicensed medicinal products for human use”.

She may be able to tell me, because it is her new clause and she may have been looking at this issue. Where in the 2006 Act, or indeed in the Bill, although I think not, can we find what that phrase means? It may well be understood by medics—the topicals, the specials and so on—but it may not be understood by judges, for example. Can she help me on that when she winds up this debate? Otherwise, it seems to me as a layperson that the phrase

“ unlicensed medicinal products for human use”

could cover homeopathic so-called remedies. I do not think that the Secretary of State should be reviewing the pricing of homeopathic remedies.

To make my position clear, I think that homeopathy is bad science and a load of nonsense except for the placebo effect, but I use it as an example of unlicensed products that claim to be medicinal. I suspect that the hon. Member for Central Ayrshire would agree with my broad characterisation of homeopathic so-called medicines, apart from the placebo effect. What does that phrase in her new clause mean, and is it defined anywhere in law, or is it so obvious to medics that they and everybody in the pharmaceuticals business know what it means?

[Dr Whitford]

The phrase is the standard definition of specials. I cannot remember off the top of my head where exactly it comes from, but it is the recognised definition. It would not usually mean things such as homeopathic medicines. It is often things that are quite old and that have been around a long time that are not worth licensing, because they are not new and nobody will make any money out of them. We have a lot of products like that, but they are recognised within the practice of medicine. They are particularly common within dermatology, because of different topicals and the need to make different strengths of topical depending on the condition being treated.

I wanted to try to draw attention to this matter. The Minister has said that the Government have had the power all of this time and not used it. In part it is about bringing powers into line and creating consistency. I call on him to use those powers. Even though only a relatively small percentage of drugs are affected, the impact on patients from not being able to access them is significant. I beg to ask leave to withdraw the motion.

Clause, by leave, withdrawn.

New Clause 4

Review of extending provisions to repurposed off-patent drugs

‘(1) Within six months of the passing of this Act, the Secretary of State shall commission a review on whether the provisions of this Act shall extend to the regulation of the prices of repurposed off-patent drugs and shall lay the report of the review before the House of Commons.’—(Dr Whitford.)

Brought up, and read the First time.

[Dr Whitford]

I beg to move, That the clause be read a Second time.

The new clause seeks to explore one of the other anomalies that was challenged through a private Member’s Bill last November but unfortunately was talked out by the Minister at that time: repurposed off-patent drugs. Those are drugs designed for a particular use that, often during their use for that condition, contribute in relation to another condition.

Today, we have had considerable talk about the need to support pharmaceutical industries and encourage research and development, but the finding of a new purpose for a drug rarely comes from the pharmaceutical industry; it is usually done at a clinical or academic level through noticing patterns in clinical practice and following those up with trials. It is therefore not really something for which the pharmaceutical industry should receive a major award financially, although naturally if more of a company’s drugs sell and it is still producing them, it will see a benefit, which is totally fair enough.

One of the concerns is that, for a medic under the General Medical Council, there is a hierarchy of what we can prescribe, and at the top of that is licensed drugs for the purpose of the licence. Below that come repurposed drugs, which are therefore not licensed for that purpose. It is specifically stated that “they do the same” is not a sufficient excuse for using an off-patent generic drug.

With some of the drugs we have, new purposes are being discovered. Some statins can reduce brain atrophy in progressive multiple sclerosis. We have, as was referred to earlier, the use of bisphosphonates to prevent metastatic breast cancer and the use of tamoxifen to try to prevent breast cancer. That Bill was partly about trying to promote the use of those drugs, because they are off-patent and cheap, but one of the concerns among the medical profession is about a drug company buying a drug, tweaking it ever so slightly and then suddenly re-releasing it as a drug for multiple sclerosis at 10 grand a day instead of sixpence. What I do not see in this Bill is a recognition of the ability of people to come back and license a drug and totally change the price or to manufacture that drug simply as a generic with a massive price.

There was a case with the drug Lyrica, which is also known as pregabalin. The commonest use of that is for neuropathic pain: people who have had nerve damage from surgery or trauma and have difficult-to-control pain. The drug was originally designed for epilepsy, and Pfizer, which makes it, managed to get a court order saying that the patent on its use for neuropathic pain would continue to 2017 and that it would sue general practitioners who prescribed it as generic. That case has run for quite a long time, and I am proud to say that GPs basically ignored that order and have used the generic, but the advice of NHS England, which still sits on the website, says that GPs must prescribe Lyrica as Lyrica, which is obviously much more expensive. Therefore, over the last year GPs have had to be sitting out there exposed, open to the threat of litigation.

That is a real concern with repurposed drugs. That profit has been earned not by pharma’s research but by the research of other people usually in the public sphere: academics and in the NHS. Again, the new clause is to raise an issue that is not covered in the Bill and to see whether it has been considered at all by the Government.

[Mr Dunne]

I am grateful to the hon. Lady for raising this issue by tabling her new clause, because it gives us an opportunity to discuss an issue of considerable interest across the House. I am delighted to be able to inform the Committee that we do not believe we need to review whether the Bill’s provisions should be extended to repurposed off-patent drugs, because they will apply to those drugs whether they are licensed branded medicines or generic medicines. The new clause is therefore not necessary, because those drugs are already included.

Any licensed branded medicines that are developed may be included in either the voluntary or statutory scheme and be subject to all the provisions of those schemes. Unbranded generic medicines are subject to competition in the market, which keeps prices competitive and secures value for money. As we know, and have already debated today, there are examples of unscrupulous companies making unjustified price hikes for unbranded generic medicines when there is no competition in the market. As we have said, both today and on Second Reading, the Bill provides the Secretary of State with powers to intervene in such cases, in addition to the powers that the Competition and Markets Authority can exercise.

Having once again explained the specifics of how repurposed medicines will be affected by the Bill’s provisions, it might be helpful if I outline for the Committee some of the progress that has recently been made in supporting repurposing. For the reasons the hon. Lady identified, repurposing has benefits for patients in allowing drugs to be introduced as quickly as possible to provide alternative treatments to those originally intended by their manufacturers, where there is robust clinical evidence for new uses of existing medicines. Since November last year, a range of organisations have come together to work collaboratively to examine the issues at play in drug repurposing and to develop positive ways of handling those issues to ensure that patients benefit from robust research outcomes.

Officials in the Department have been working on the issue with the Association of Medical Research Charities and many of its members, as well as with NHS England, NICE, the publishers of the “British National Formulary” and the Medicines and Healthcare Products Regulatory Agency. All are committed to taking non-legislative measures to make sure that there is a clear and accessible pathway to ensuring that robust evidence showing new uses for existing drugs can be brought more systematically into clinical practice to benefit patients. That working group has made significant progress, and I would like to thank the organisations that have come together in a true spirit of co-operation to achieve rapid progress.

The General Medical Council has provided better advice for doctors about prescribing drugs outside their licensed indications, when that is clinically indicated. The “British National Formulary” has introduced new processes to ensure that information about repurposed drugs is captured more systematically and is therefore much more readily available for the clinical prescribers whom the hon. Lady referred to as the people at the forefront of this innovation. The Committee has heard from Dr Keith Ridge about the role that regional medicines optimisation committees will be asked to take in supporting prescribers to take up and use new evidence, particularly about unlicensed medicine use. Significant work has also been done on the development of a pathway that maps the routes from research result into clinical practice, which will help researchers and clinicians ensure safe and timely implementation.

NICE has published more than 50 evidence summaries for unlicensed and off-label uses of medicines. Although I said I did not want to go into detail, there are a couple of examples that the hon. Lady will be familiar with but other members of the Committee might be less so. NICE has made recommendations and guidelines on the use of tamoxifen to prevent familial breast cancer, and on the use of antidepressants—selective serotonin reuptake inhibitors—to treat irritable bowel syndrome.

I hope that with that explanation, hon. Members will agree not only that repurposed medicines are included within the Bill’s provisions, but that robust action is being taken by the Department and across the medical establishment to support repurposing for the benefit of patients. I ask the hon. Lady to withdraw her new clause.

[Dr Whitford]

I welcome the Minister’s explanation of what has been happening behind the scenes since the Off-patent Drugs Bill last year. The Bill Committee, of which I was a member, had a lot of discussion about the need to have a system for recognising the drugs, giving doctors and other prescribers the reassurance they needed to use them, and using the “British National Formulary” as a tool. We have heard nothing for a long time, so I really welcome the update that the issue is being taken forward. Prescribers are not all doctors now, and it is important that everyone who prescribes has the reassurance of knowing that they can safely prescribe and not be open either to making an error or to litigation. I beg to ask leave to withdraw the motion.

Clause, by leave, withdrawn.

New Clause 5

Extending price control to other medical supplies

‘In section 260(5) of the National Health Service Act 2006, after first “includes” insert “, but is not limited to, investigative,”’—(Rob Marris.)

This new clause is to ensure that the Bill’s provisions on price control apply to other capital equipment such as MRI scanners by including such items within the definition of “medical supplies”.

Brought up, and read the First time.

[Rob Marris]

I beg to move, That the clause be read a Second time.

I am glad that the Committee has generously left me sufficient time to deal with the new clause, which involves a tweak in the wording of the Bill. Clause 6 inserts section 264A into the 2006 Act, and section 264A(9) states:

“‘Medical supplies’ is to be read in accordance with section 260(5)”

of that Act. There is a synopsis of the subsection in paragraph 66 on page 14 of the explanatory notes, which hon. Members may have in front of them.

Page 162 of the 2006 Act states, in section 260(5):

“In this section and Schedule 22—

‘medical supplies’ includes surgical, dental and optical materials and equipment…and ‘equipment’ includes any machinery, apparatus or appliance whether fixed or not, and any vehicle.”

That definition is fairly clear but not sufficiently wide, hence my new clause, which would clarify it. Regarding medical supplies, there are, to my mind, three adjectives there qualifying two nouns, the three adjectives being “surgical”, “dental” and “optical”, and the two nouns being “materials” and “equipment”. There is considerable NHS expenditure on equipment—and materials, but particularly on equipment—that is not, as I understand it, surgical, dental or optical. A particularly expensive form of such equipment, as I outline in the explanatory note, which is helpfully on the amendment paper, is MRI scanners. They vary, obviously, but in round terms they cost about £2 million a throw and the NHS, understandably, has an awful lot of them—they are a magnificent diagnostic tool. There may well be other pieces of equipment that are perhaps not quite as expensive but which would not come under the rubric of surgical, dental or optical.

It seems, therefore, that there is a gap in the 2006 Act, and the new clause, which I am sure the Government will accept, is intended to plug that gap by indicating that those three adjectives are descriptive of the two nouns, but other adjectives could also be applied. For example, “investigative” is included in the new clause. The new clause would therefore simply ensure that there is no misunderstanding of the intent of section 260(5) of the 2006 Act. It is a helpful clarification to the Government.

Community Pharmacies

Philippa Whitford Excerpts

Wednesday 2nd November 2016 Commons Chamber

[Dr Philippa Whitford (Central Ayrshire) (SNP)]

The Minister kindly referred to the system in Scotland, which has been running for 10 years since we passed the Smoking, Health and Social Care (Scotland) Act 2005. It took time to introduce the new system, but now all pharmacies in Scotland are community pharmacies, meaning that they all provide services. They do not get a big payment merely for existing—they receive a quite tiny £1,730—but they do get payments based on needs that reflect a population’s age, vulnerability and deprivation, so those things are taken into account in their global funding. That funding is due to go up 1.2% in Scotland while there is talk of a reduction of 4% here.

The services provided have been referred to as the minor ailment scheme. Many pharmacies in England make provision under that scheme, but it is not a national system. In Scotland, the scheme is national and such services must be provided. One issue is that the pharmacies have to invest. They have to build a consulting room and change their building so that people can be seen privately when their minor ailment is diagnosed. They work to protocol for a whole list of ailments that they can diagnose and have the ability to treat. The ailments are minor things that many people would experience, and the approach avoids their having to go to a GP.

[Stephen Pound (Ealing North) (Lab)]

The hon. Lady makes an incredibly important point. People who go into a community pharmacy today will see a special treatment room where they can get phlebotomy, advice on blood pressure and all sorts of other things. Is it not perverse, cruel and utterly irrational to say to a group of professionals, who have done all this work to change the way they deliver their services, “Now we are finished with you. Out you go. You’ve done your bit. We are going to put you out and close down your pharmacy”?

[Dr Whitford]

I agree with the Government about looking for more services, but this is not the way to work with the profession, given that they want those in it to do more work and to work differently. Sadly, during my time in the House, we have repeatedly seen the Government not sitting down with a profession and saying, “Why not look for where savings can be made?”, but simply making a cut.

[Karin Smyth (Bristol South) (Lab)]

I was going to intervene on the Minister to follow up the point made by the Chair of the Health Committee. We are looking at bottom-up planning in England for the first time for a number of years with the sustainability and transformation plan process, so this is completely the wrong time to be making these irrational and random cuts.

[Dr Whitford]

We recently debated STPs and the potential they provide. The danger is that at the moment we are seeing finance-centred care, instead of patient-centred care. Going back to place-based planning, which is what we have kept in Scotland, where we still have health boards, means that we can look at integrating services, and pharmacies definitely need to be part of that. They have the potential to be a significant front-line player.

[Maria Caulfield (Lewes) (Con)]

I am interested in the experience in Scotland, although we do not have the same system in England. What does the hon. Lady think about moving pharmacists into GP surgeries? I think that it is a mistake. I would much prefer the approach that is being taken in Scotland, where pharmacies are expanding by having consulting rooms of their own.

[Dr Whitford]

Scotland actually has both. We do have pharmacists who are in a consulting room within a practice, and our Government have put £85 million into taking on an additional 140 pharmacists who work in primary care with GPs. We are not, as has been done in the past, saying, “Everyone on drug A must change to drug B because it is cheaper,” without giving any thought to how that affects the patient. We are consulting patients, who are often on 10 or 15 medications, all of which interact and have different side effects, and then rationalising that and giving the patient advice. We are therefore providing a clinical service rather than just a changeover service.

Our community pharmacy system has been running for 10 years, so it is quite mature. Patients register with a pharmacist in the same way as they register with a GP. The aim is for all people to be registered with whomever they consider their local pharmacist to be, as that means that they can access minor ailment treatment. It also means that people who are on chronic medication have a chronic medication service, with their prescription sent electronically to the pharmacy, which then keeps track of when it is due and therefore ensures that patients do not run out of medication. The pharmacies also provide an acute medication service for people who have not signed up to the other service but suddenly find they have no tablets, as they had not thought to re-order them with their GP. If they are regulars at the pharmacy, a single round of drugs can be prescribed for them there so that they do not have a gap in their treatment. The important thing is that our vision is to have all our pharmacists as prescribers by 2023, and to have our public registered with pharmacists by 2020.

[Mr Jim Cunningham (Coventry South) (Lab)]

The hon. Lady makes two important points: this move is cuts-led, rather than well planned; and just as communities rely on their doctor, they rely on the facilities at their pharmacy. That is particularly true of elderly people and those with disabilities, who may have to travel miles, depending on where the pharmacy is.

[Dr Whitford]

It is crucial that the service covers all areas, including those that are deprived and those that do not have good public transport. Distance is not everything; this is also about how people travel that distance. In many places, the distance involved might not be that great, but there simply may not be a bus going in the required direction.

[Catherine McKinnell]

I wanted to make this point to the Minister: the closure of community pharmacies will clearly lead to a poorer service, a loss of patient choice and poorer health outcomes for those in more deprived parts of the country. Is this not just another example of Government short-term cuts that will cost us more in the long term?

[Dr Whitford]

If this is introduced badly, the cost will be greater in the long term. When the Minister talks about a more service-based approach, I think that he aspires to something more like the Scottish model, which I would commend. I just feel that this is being done “backside forward”.

[Anna Turley (Redcar) (Lab/Co-op)]

rose—

[Dr Whitford]

I need to make a bit of progress.

We need to design the services with the people who work in them. Some 18% of Scotland’s population—nearly 1 million people—are registered with and do access the minor ailment service, which takes pressure off accident and emergency, because there is availability out of hours, and GPs. The fourth service that we have is the public health service, with 70% of all smoking cessation work in primary care being carried out in our community pharmacies. These four services together—minor ailments, chronic medication, acute medication and public health—represent a huge breadth of service for a community. It is important that pharmacies in England that are currently just retail and dispensing pharmacies are encouraged to go in that direction, because it brings benefit for the NHS.

My biggest concern is the random nature of how this process might develop. If the Government simply cut and let the dice fall where they will, the problem is that they will not end up with an integrated service. Scotland still has health boards, so if a community pharmacy is to open there, an application needs to be made to the health board. When the project started, the boards decided which places got to become community pharmacies, and they decide whether there is a need to open a new community pharmacy. The biggest mistake in this scheme is its randomness.

One issue raised by the hon. Member for South West Wiltshire (Dr Murrison) was the profits made when drugs are sold on. The Government could look at the vertically integrated wholesalers—the big chains. In the mid-2000s, they were not considered. The Government do not know how much profit they make or where that profit is made, and the system is totally unregulated. These chains control about 40% of the pharmacy market. One of the biggest chains, Walgreens Boots Alliance, has declared profits of almost £1 billion, yet it has somehow been able to reduce its tax bill by more than £1 billion in this country. We are talking about people who are make almost half their profit from taxpayers yet do not pay their full share of tax. I absolutely agree that under this proposal the big chains will survive and the small, independent, very community-based pharmacies will be lost.

[Neil Coyle]

The Minister accused those who highlight concerns of “scaremongering”. Atul, who runs St George’s pharmacy at the Elephant and Castle in my constituency, says:

“We may survive the first set of”—

in-year—

“cuts by compromising on our services. But the second set of cuts next April will most definitely place us at a real risk of closure.”

Does the hon. Lady agree with Atul that it is right for us to highlight our concerns, especially in constituencies such as mine, where we face losing 18 community pharmacies?

[Dr Whitford]

Losing that many pharmacies in any area would be a disaster. This is a bit like groundhog day, because this is our third discussion on this topic in as many weeks. The Minister said that there absolutely would be protection, but the pharmacy access scheme still largely comes down to the amount of dispensing that is done and the distances. It does not take account of which pharmacies are providing a good service, which ones are set up to provide a good service and how to encourage others to develop. This is what is completely wrong in the Government’s approach. They are just slicing money off and leaving individual businesses to decide whether they think they will be profitable. The danger would be that we get a whole lot of pharmacies deciding to sell out and walk, instead of someone saying for a particular area, “Eighteen is too many”—especially if they are all around one town square—“so which ones are best able to develop a service? Let them bid for it and let them be inspected, and let’s see how they take it forward.”

The Government could make a lot of savings by addressing the wholesalers. In Scotland, we have margin sharing, which means that a price control group looks at the profit that is made at various stages, and some of it has to be shared back. We do have people who are trading on the open market and moving drugs around, especially in the big chains. As we heard earlier, we would get a better result by sitting down with the profession and designing a service. STPs could provide the model within which to look at how many community pharmacies there should be and where they should be, and then it would be a case of working backwards.

The danger of the Government’s approach is that it is the wrong way round. Just calling something an “efficiency cut” does not make it efficient, and the danger is that we just slash something and it falls over. The pharmacy access scheme is not enough of a protection or of an intervention. There needs to be planning. I commend the idea of a proper services-based pharmacy system, but the aspiration should be not just that a few pharmacies choose to do it and others do not. It should be that a patient who walks into a community pharmacy will know what services they can get, and we should aim to have that right across the country.

[Several hon. Members rose—]

--- Later in debate ---

[Oliver Dowden]

I thank my hon. Friend for that intervention. Equally, many such pharmacies do not provide any of the wider community health benefits. In essence, they are just dispensing services.

[Dr Philippa Whitford]

Is it not estimated, however, that those will be the ones that survive, purely because they are big, while the small, high-service pharmacies in communities are more vulnerable?

[Oliver Dowden]

That is precisely the point that I am coming to. As we proceed with these reforms, hon. Members need to recognise that we will need further savings in this area. I am not attacking large retailers because of their size; it is because of the lack of such wider provisions. We need to look at ways of securing further savings from them which we can plough back into the community pharmacies that are providing the services on which all our constituents rely. I completely accept that pharmacies that are purely dispensing services are very inefficient as such. They are highly labour-intensive; it is just a very expensive way of delivering drugs. We need to identify ways in which we can bifurcate the two different types of providers.

I pay tribute to what the Minister has announced so far. He clearly demonstrates an understanding of the situation, as we have seen in relation to the protection of key local pharmacies through the community access scheme. For example, in my constituency, the services in places such as Elstree and Shenley, where we have small, rural communities, often with an elderly population, will be protected. Equally, the quality payment scheme recognises some of these wider community benefits.

However, I urge the Minister to do more in that area. Let me make two brief suggestions. First, we need more detailed recording of the sorts of services that are provided by pharmacies which take pressure off the NHS. As I understand it, there is no systematic way in which these additional benefits are recorded, and we are all working on the basis of estimates. We could have a system whereby the community pharmacies systematically recorded the benefit that they provided, and then they could be better rewarded for those benefits. At the same time, there would be a means by which we could penalise, or find further cuts from, the pharmacies that did not provide those additional services.

Secondly, the hon. Member for Central Ayrshire (Dr Whitford) rightly commented on the common ailments scheme that operates in Scotland. The Minister indicated that the Government are moving down that route. I urge the Government to go further on this. There is absolutely no reason why patients suffering from things such as common cold and flu symptoms or head lice could not be referred directly from their GPs to pharmacies, thereby saving money for GPs and providing additional income for those pharmacies.

I support the overall direction of reform, but as the Government proceed with these reforms, they could do with engaging more in looking at ways of supporting what is best in community pharmacies while providing further savings from the services that do not provide them.

--- Later in debate ---

[Maggie Throup (Erewash) (Con)]

As many hon. Members have already described, our community pharmacies play a vital role in all our communities. When my mum was seriously ill and housebound, her local pharmacist and all his staff were amazing. Nothing was too much trouble, whether it was changing her medicines at the last minute and delivering them to her home, or offering to deliver things like toothpaste and loo rolls at the same time. That is what community pharmacists are all about—being at the centre of the community, wherever they are.

Being part of the local community is even more important in rural areas, especially for the elderly who are often housebound, or have limited access to cars and so rely on public transport. That is why I welcome the pharmacy access scheme that the Minister has put in place. It should safeguard those pharmacies that are more than a mile apart and, more importantly, protect their patients. The Minister has gone further by adding in areas with high health needs. That must be welcomed, but I would like more specific information to help to reassure pharmacies in my constituency.

We all know that pharmacists can and want to do more. It is imperative that every community pharmacy across the country plays its part in providing first-class healthcare outside the hospital setting. Pharmacists are highly trained professionals with a wealth of knowledge that must be used to its fullest. As we hear time and again, our GPs are under a great deal of pressure. Our pharmacists are a group of professionals who can and do shoulder some of that workload. To name just a few of the services they can provide, they can give flu jabs, test cholesterol, monitor warfarin and check blood pressure. There is no reason why they cannot carry out other simple tests, such as point of care C-reactive protein tests to distinguish between viral and bacterial infections, and so play their role in combating antimicrobial resistance.

I have a request for the Minister. He should be more ambitious with the timescale for roll-out of the minor ailments service. We have already heard from the hon. Member for Central Ayrshire (Dr Whitford) about just how successful that service is in Scotland. We must combat any barriers that the CCGs put forward, as my hon. Friend the Member for Amber Valley (Nigel Mills) suggested.

The 18% increase in the number of pharmacies over the past 10 years has in many instances led to clusters of three or more pharmacies within just one location. Each gets a guaranteed payment of £25,000 every year regardless of the quality of service they offer, the number of prescriptions they process or whether increased capacity in the area was needed when they actually opened. I am sure many of my constituents will think that is wrong and wonder whether it is the right way to spend taxpayers’ money.

[Dr Philippa Whitford]

Does the hon. Lady recognise that pharmacies were allowed to open simply because they were willing to be open for 100 hours? The growth was random, and my concern is that this cut is random. Planning is the issue.

[Maggie Throup]

I completely agree that growth has not been controlled. We need to go back a number of years to learn from what happened and ensure it does not happen again. We also need to ensure that we put the right reforms in place now.

It is important that the £25,000, just for opening the doors, is not offered to other retail stores on the high street. It is vital we get the best possible deal for the taxpayer and the patient. The patient must be at the heart of everything. We must also remember that every pound saved by these changes will be invested back into the NHS. We need to get the important message out that, whether it is for cancer treatment or other life-saving treatment, every penny counts.

If the proposed reforms reward quality, pay pharmacists for their value added services and fully embed community pharmacists into the urgent care pathway, they will be welcome. However, we need to ensure they do what they are intended to do, and that we do not, as the hon. Member for Central Ayrshire said, end up with what we have now.

Health Service Medical Supplies (Costs) Bill

Philippa Whitford Excerpts

2nd reading: House of Commons & Programme motion: House of Commons
Monday 24th October 2016 Commons Chamber

[Dr Philippa Whitford (Central Ayrshire) (SNP)]

Like the right hon. Member for Chelmsford (Sir Simon Burns), I pay tribute to some of the research and development that has been done by the pharmaceutical industry. Europe has become the biggest research network in the world, and the biggest beneficiary of that has been the United Kingdom, through Horizon 2020 funding, in collaboration with others, and the European Medicines Agency. As others have said, however, both of those are going to change, so the pharmaceutical industry in this country will be rather nervous and anxious about its future.

Obviously, every new drug that the industry discovers creates an additional cost pressure for the NHS, hence the reason for the pharmaceutical price regulation scheme, which has existed since the 1950s. The current scheme has been in existence since 2014 and has brought significant benefits, as the shadow Minister, the hon. Member for Ellesmere Port and Neston (Justin Madders), has said. In Scotland it directly funds our new medicines and rare diseases fund. Ours is not a cancer drugs fund, so it gives us greater flexibility to treat very rare diseases. The patient’s condition does not need to be cancer, so we are giving Sofosbuvir for hepatitis C and Everolimus for tuberous sclerosis.

It is necessary, however, to have some form of management over the cost pressure, so the Scottish Government and my colleagues welcome the way in which the Bill tidies up the situation by closing some of the loopholes faced by the NHS. We have heard in particular about those who have a monopoly over generic medicines, whereby companies that are part of the PPRS can charge what they like for them. There needs to be much greater alignment and it needs to apply to all drugs, not just all companies.

The Secretary of State also mentioned the collection of data. As someone who has worked in the NHS, I have to say that it has struggled with that, and I have concerns about how it will work across the entire NHS, the entire pharmaceutical industry and medical technology and other supplies. We need to make sure that data collection is relatively simple and straightforward, and I also hope that we will bring together and use data that have already been collected.

I speak as a representative of one of the devolved nations and it is important that our Government are able to access those data easily. The Bill states clearly that the data gathered will be shared with Scottish Ministers, but on what basis? Will it be down to Scottish and Welsh Ministers to request data when they want them, or will they have to wait for an annual return, which might not happen when they want it to happen?

The Secretary of State said that there had been consultation, but I hope that that will continue, because the devil will be in the detail when it comes to the extension to all medical supplies. Scotland already uses a lot of central procurement to keep costs down, so it is important that the Bill enables, rather than interferes with, that.

[Rob Marris]

The hon. Lady is making a powerful speech, as ever. May I pick her medical brains, as it were, on the question of medical supplies? They are defined by the National Health Service Act 2006 as

“surgical, dental and optical materials and equipment”.

Would she, as a clinician and a surgeon, include a CAT or an MRI scanner, as a piece of surgical equipment? It is certainly not dental or optical. It seems to me, as a layperson, albeit a lawyer, that it is not surgical equipment, but investigative equipment, and MRI scanners, as she and many other Members will know, start at about 2 million quid.

[Dr Whitford]

That is an area that needs to be looked at. A narrow definition that covers only blades and swabs and that does not take into account our hugely expensive infrastructure would not make sense. When we buy those kinds of machines in Scotland, we tend to consider central procurement and assessment, which opens up the potential for massive savings. A lot more work will have to be done in Committee and then in regulation to make the process function in the way that everyone wants it to function.

We need something much more radical. That aspiration may not happen with this Bill, so it will have to come later. Patients in the UK face a delay of about five years to access new medicines. If we compare cancer survival rates, we will see that we are often ahead when it comes to patients with early disease. We are one of the earliest nations doing population screening for breast cancer. However, we start to fall behind when it comes to people with more aggressive or advanced disease. I think that that is where our poorer outcomes and survival rates by comparison with European countries come from, because it is palpable on the ground. Part of that is sometimes the eye-watering initial prices of new drugs. Yes, we can set methods to try to control that, but a lot of those drugs do not get through the system introduced by the National Institute for Health and Care Excellence because they are expensive. In my interactions with some of the major pharmaceutical players since I have been in the House, I have discovered an appetite for a different way of doing it. Prices could be much lower but there could be a guaranteed number of patients before a drug became generic. We might need to look at risk sharing, because at the beginning we often do not know whether a drug will really be as good as it is cracked up to be. If the price starts, like some cancer drugs, at £100,000, we will struggle to get it through any of our pricing systems.

Something else we have to deal with is the question of how we expect pharmaceutical companies to make a profit on drugs that we never intend to use. We need new antibiotics, but any brand-new class of antibiotics—we have not had such a class for 30 years—will have to be left on the shelf. The existing system will simply not fund research for such a drug. While the Bill tidies up some of the issues that we face now, we need to do much more blue-skies thinking on equipment, drugs and the way in which we develop different things. Otherwise we will have interminable debates, such as those in which I have participated in Westminster Hall: in one debate, we say that we want more research on, for example, brain tumours, but the next week we have a debate on the fact that we cannot access a brand new drug that has been developed by the pharmaceutical industry in the UK.

[Jo Churchill (Bury St Edmunds) (Con)]

The hon. Lady is making an informed and impassioned speech. Does she agree that we are entering a new landscape, and some drugs that have been discovered can be used for multiple treatments for different cancers, or even for other diseases? We therefore need an even more flexible approach so that we can benefit from those drugs and optimise patient outcomes.

[Dr Whitford]

Absolutely. We have entered the realms of using immunotherapies such as Herceptin for cancer. Equally, in the mid-2000s, people went to court to try to access that drug, which halves the risk of metastatic disease—and we end up spending much more on patients with that stage of the disease. We give Sofosbuvir in Scotland for hepatitis C because it is almost curative, so we have fewer new hepatitis C patients. We need a much more rounded way of looking at the costs and benefits of new drugs. The genetic drugs that we are likely to use in future will be even more eye-wateringly expensive, but then again, they may have a bigger impact.

The Bill tidies up loopholes, but I have concerns about the involvement of the devolved Administrations in the design of the schemes, access to data and ensuring that the funding for PPRS, which we use for our new drugs fund, is maintained. There is a call for us to do something much bigger and much more blue skies in future.

--- Later in debate ---

[Norman Lamb (North Norfolk) (LD)]

This is an uncontroversial set of measures and I confirm my support for the Bill as it stands. The great strides in medical science over the past decade and beyond are obviously to be celebrated, with cutting-edge new treatments for life-threatening and life-shortening conditions, including a number of rare diseases and cancers, offering many people the hope of improved health, longer life and a quality of life that in the past would not have been possible. As well as the enormous benefits it brings to patients, the life sciences industry makes an incredibly valuable contribution to the UK, and it is only right that we acknowledge that today. However, there is an inevitable cost attached to the triumph of modern medicine, and the challenge is to ensure patient access to new treatments as quickly as possible, while ensuring value for money for the NHS.

The Bill seeks to address some of the shortcomings. It addresses clear abuses of the current system and I think that it will bring greater consistency to the existing arrangements for controlling the cost of medicines new and old. As I have said, I find myself in agreement with the proposals.

It is good that so many companies recognise their responsibility for keeping the branded medicines bill in check by signing up to the pharmaceutical price regulation scheme. Under the scheme, manufacturers pay a rebate to the Department of Health to cover expenditure on branded medicines above agreed limits. It is a responsible approach, helping to ensure that patients can benefit from access to novel drugs in a way that is sustainable for the taxpayer. However, I agree with the Secretary of State on the need to address the current disparity whereby the statutory medicines pricing scheme delivers lower savings than the voluntary scheme. Those differences are expected to widen, which is clearly not in keeping with the spirit of either arrangement, so it makes sense that they should be more closely aligned. As he said, we have to remove the incentive to shift from one scheme to another.

I particularly welcome the proposals to strengthen the authority of the Secretary of State to intervene where unbranded medicines are priced excessively. The NHS and patients benefit immensely from medicines, which were once available only at great public expense, becoming available far more cheaply after the patent expires and generic products come on to the market. We should recognise the great value that the competitive market brings, saving the NHS more than £13 billion every year, according to the British Generic Manufacturers Association, but we also know that the overall cost of generic items is increasing at a faster rate than branded items, and that there have been some outrageous increases, to which other hon. Members have referred, in the price of some individual generic drugs in recent years when there is only a single company producing that drug. It looks like a clear case of profiteering, where the NHS is being ripped off.

Let us be clear what the implications are when a particular company makes an excessive profit from increasing the price of a drug in that way. It means that other NHS patients, particularly those in more marginal areas that do not get the attention that they deserve, lose out. There is less money to spend on, for example, teenagers with mental health problems or learning disabilities. There is a price to be paid for that excessive profiteering. It is utterly unethical behaviour. I hope that the Competition and Markets Authority can find a way to take action against these companies, which appear to have constructed a business model to exploit the loophole.

As hon. Members have said, a number of generic medicines increased in price by more than 2,000% in the last decade. The most horrific example I have come across is a medicine that increased in price from £13.98 in 2005 to £632.96 in 2015, a rise of more than £600 per item dispensed. It is utterly despicable for any private company to think that it can do that. The Government are right to take action to end that outrageous practice.

Generics account for three quarters of prescription items dispensed in the community. In those cases where competition fails to deliver value for money, it is important that there are measures at our disposal to control prices and to tackle abuses that could place intolerable pressure on NHS budgets. It makes little sense that generic medicines can be controlled through the statutory scheme, but that the Government are currently prevented from stepping in when a company’s branded products are regulated through the PPRS. It seems clear that we should remove that anomaly. I should add that, in using these powers to introduce price controls, the Government should of course exercise caution and guard against any unintended consequences that may impact on the viability of smaller companies. I am sure that the Government will be alert to that.

The aims and provisions of the Bill are admirable, but it is only part of a much wider debate about how we can sustain access to groundbreaking new treatments when the NHS is in the middle of the longest financial squeeze in its history. One intervention from a Government Member on the Secretary of State drew attention to the fact that the total bill for drugs is rising at an unsustainable rate. The right hon. Member for Chelmsford (Sir Simon Burns) also raised this question, and we have to address that because the NHS will not be sustainable at the current rate of increase in cost.

It is no secret that the NHS has struggled to adapt to modern medicines, particularly those that carry a large budgetary impact. Both NICE and NHS England have had great difficulty in figuring out which medicines to approve and how those medicines are to be afforded and brought to patients. Recently, NHS England has delayed funding for the new hepatitis C treatment, so I was interested in the points made by the SNP representative, the hon. Member for Central Ayrshire (Dr Whitford).

We also have the ongoing and deeply unsavoury case of the PrEP, or pre-exposure prophylaxis treatment. Not only is NHS England taking its legal challenge to the bitter end to avoid having to pay for the drug, but there have been reports of it pitting patient groups against each other by saying that patients could miss out on vital treatments for cancer or rare diseases for children should PrEP be funded. We do not want to get into comparing the rights and interests of one group of patients against those of another in that way.

Earlier this month, NHS England and NICE launched a consultation on proposals to change the way some drugs are funded when there is a high cost involved. NHS England and clinical commissioning groups are legally required to fund drugs recommended by NICE as being clinically and cost-effective, normally within three months of the guidance being issued, barring unique circumstances. Under the new proposals, if NICE recommends a drug that will bring an estimated cost to the NHS above a certain amount—£20 million is the suggested figure—NHS England can go back to NICE and ask it for longer to roll out the medicine if it is unable to agree a lower price with the manufacturer. Surely that is precisely the opposite of what we ought to be trying to achieve as regards speedier access to new drugs that are coming on stream. Ignoring questions about how that somewhat arbitrary cost threshold was arrived at, there is a concern that this is a creeping step towards the rationing of approved treatments in the NHS. It seems to me to be an admission that the NHS cannot afford to pay even for the drugs that are found to be cost-effective by NICE; similar concerns have been raised by Nicholas Timmins, that highly respected observer who is a senior fellow at the King’s Fund.

The great worry is that opening up the debate on how quickly or slowly approved treatments can be adopted will put us on a slippery slope to a new discussion about whether approved treatments should be adopted at all, and at the very least UK patients will be further disadvantaged—the SNP spokesperson has already made the point that we compare very badly with other countries —and there will be more delays in getting access to new cost-effective treatments.

[Dr Philippa Whitford]

Does the right hon. Gentleman recognise that we are one of a tiny handful of OECD countries that allow that opening price to be set completely by the pharmaceutical industry and to be set as high as it likes?

[Norman Lamb]

I note that point. I suppose my overall point is that given the unsustainable increase in the total drugs bill and given the actions that NHS England and NICE appear now to be taking, it seems that we will be in a more difficult position in getting speedy access to new drugs that can be life-saving. The Government need to reflect on that. The hon. Member for Central Ayrshire made the point in her speech that this Bill tidies up things that have to be tidied up, but there is a much bigger debate about how on earth the NHS can afford vital treatments that in other countries patients are getting access to much sooner.

If we are approaching a situation in which we are unable to cope with new treatments that have been judged by an arm’s length expert body, NICE, to be clinically effective for patients and cost-effective for the NHS, it is yet more evidence that the NHS needs more resources, and I repeat again to the Minister—he will be sick of hearing me say it—that at some point the Government must recognise that they are simply drifting towards a crash with the NHS. We face an existential challenge that this evening’s debate has highlighted and that has to be confronted at some point. I urge the Government again to consider a cross-party approach so that we can ultimately achieve, in discussion with the public, a long-term and sustainable settlement for the NHS and care that recognises both this dramatic increase in the cost of drugs and that all our loved ones want to have access to those drugs in their hour of need.

We should also be mindful of the potential impact of Brexit on the life sciences industry and the additional challenges we face in keeping the NHS medicines bill under control. If trade between the UK and other EU countries becomes subject to customs duties, import VAT and border controls, thereby increasing costs to the life sciences industry, that might in turn drive up the costs of new medicines to the NHS, and impact on access for UK patients to the most innovative new treatments.

Finally, we also need to make sure that evaluation processes and methodologies are fit for purpose. Traditional appraisal methods and notions of cost-effectiveness are unsuitable for many modern medicines, especially for drugs of immense scientific innovation that target just a small number of patients, but the NHS has been slow to respond to that. The Cancer Drugs Fund is a case in point—established as a sticking plaster after a cluster of promising drugs were judged not to be cost-effective. While it is almost certainly the case that many of those treatments came with too high a price to be routinely funded, few would deny that they were being evaluated under outdated processes that could not fully capture their value. Many rare disease treatments suffer from the same problem.

Companies have a duty to ensure that their medicines are fairly priced, but NHS England and NICE also have a duty to make sure that their evaluation processes and decision-making criteria are fit for purpose, so that new medicines are given a fair hearing without some of the excessive delays we have seen in the recent past. We owe it to patients to make sure that happens.

I support this tidying-up measure and, in particular, the ending of the outrageous practice of a number of companies profiteering at the expense of NHS patients, but this debate has also raised a much bigger issue about how we in this country afford groundbreaking treatments that keep our loved ones alive.

--- Later in debate ---

[Jo Churchill (Bury St Edmunds) (Con)]

It is a pleasure to follow my hon. Friend the Member for Erewash (Maggie Throup).

We all know the background and I will not waste everybody’s time by going over it again. We know about the ageing population and about bearing down on the costs, to which my hon. Friend the Member for Salisbury (John Glen) and the right hon. Member for North Norfolk (Norman Lamb) alluded earlier. We know that advances in science are going faster than we can legislate. One of my local clinical commissioning groups, Ipswich and East Suffolk, suffered an exorbitant increase in Epanutin capsules two years ago and had to find another £600,000 in six months. Looking at drugs more widely, as my hon. Friend the Member for South Suffolk (James Cartlidge) mentioned earlier, not prescribing paracetamol in that particular CCG would save £1 million a year.

The measures in the Bill aim to manage the cost of drugs. The measure on efficient data collection, so that we start to have good decision making based on evidence, is also most welcome. Last autumn, the Secretary of State consulted publicly on how to address the problem of excessively priced unbranded generic medicines, and the industry and others fed back. They were glad of the dialogue. As I said, drug costs are unsustainable. A saving of some £90 million per health area was identified. My own CCG area could save £1 million per annum from unused repeat prescriptions. Nationally, it would mean that more than 12,000 more community nurses could be employed. We need to start making these decisions about where we want to be spending our money. With the pressure on social care, something alluded to by the right hon. Member for North Norfolk, these are decisions we are going to have to make as a Government and as patients.

The current system allows for some to be inside and others to be outside the system. That limits its robustness. It is for this reason that I support the Bill wholeheartedly. The system does not target those who do not play fair and we need to stamp down on them. It is better patient outcomes that I am passionate about. We all play a part, including the pharma industry, due in no small part to the unique infrastructure in this country. This industry is important to us. As my right hon. Friend the Member for Chelmsford (Sir Simon Burns), my hon. Friend the Member for South West Bedfordshire (Andrew Selous) and my right hon. Friend the Member for Cities of London and Westminster (Mark Field) have all alluded to, we need to be supportive of those companies that work positively for patients and engage in trying to find solutions. Indeed, the Association of the British Pharmaceutical Industry supports the Government increasing their powers where market failure has occurred. There is a balance to be had to ensure that new drugs are developed.

That brings me to the matter of repurposed and off-label drugs, those that have another use than that for which they were originally formulated, for example Everolimus, Rituximab, Cycloserine, Viagra and Thalidomide. As the hon. Member for Wolverhampton South West (Rob Marris) said, Thalidomide was originally developed for morning sickness. Lately, it has been found to be very beneficial for the treatment of some cancers and skin conditions. We need to understand new uses for approved drugs for the speediest of transitions from bench to bedside. As they have not gone through new trials, we need to be mindful that they are not new drugs; and just because the target is, for example, prostate cancer and not breast cancer, these drugs should still be costed accordingly.

[Dr Philippa Whitford]

I wonder whether the hon. Lady remembers the time we spent in the House last November debating the Off-patent Drugs Bill. I flagged up the concern that a doctor prescribing a drug with a licence for a use takes precedence over an off-patent drug that may actually be the same. With the sort of gaming we have seen, there is a real concern that drug companies will tweak a drug in the slightest manner and then start selling it to the NHS at hundreds and thousands of pounds, when in actual fact an off-patent drug would do the same job. That has still not been dealt with.

[Jo Churchill]

I thank the hon. Lady for making the point so succinctly. I am also grateful to the Secretary of State for his clarification and the comments that have been made about the medical technologies industry, which I believe needs looking at. I would be grateful if we could know whether the savings made are likely to be reinvested in patients, particularly given my position as chair of the all-party group on personalised medicine, and in the latest medicines and treatments.

The Bill is designed to stop individuals making vast sums of money and taking advantage of a loophole. I back the Government’s aim of value for money and fair prices for optimum patient outcomes. I am heartened by the cross-party support for the Bill and look forward to it making positive progress.

NHS Provision (Brighton and Hove)

Philippa Whitford Excerpts

Monday 24th October 2016 Commons Chamber

[Caroline Lucas]

I am grateful to the hon. Gentleman for his contribution and I entirely agree. When I have talked to staff of the CCG, they have acknowledged that they are using an off-the-peg contract that is not suitable for such a service, and that there have therefore been problems in the system as well as with the company, which is not providing the service that people in our city deserve.

[Dr Philippa Whitford (Central Ayrshire) (SNP)]

I can see that in this case due diligence was not done in the contract, but is there not an underlying principle that when a piece of NHS service is outsourced the NHS version ceases to exist? Therefore, at some future date, if the service is not good enough or other circumstances change, it is not possible simply to take it back in-house.

[Caroline Lucas]

I thank the hon. Lady for her intervention—someone who knows a great deal about these issues. I absolutely agree. Once the service has been outsourced, the ability to do a convenient U-turn is taken away. That is failing patients in Brighton and Hove.

The Department has said that allegations of ambulances operating illegally warrant investigation by the CQC. I have written to the Department of Health to demand that that happens and I have written to the CQC as well. Will the Minister go further tonight than admitting the severity of the problem, and let us know what he thinks he can do about it? Specifically, will he provide assurances that the Department of Health is no longer content to leave patient safety in the hands of private companies such as Coperforma, and that it intends to step in, bring the service back in-house and at the very least check that the sub-contractors’ contracts meet the requirements?

--- Later in debate ---

[Caroline Lucas]

I am going to make some progress, because I want to finish making my case about funding.

Last week the Prime Minister claimed that NHS funding was being increased by £10 billion. In doing so, she ignored a plea from the respected Chair of the Health Committee, the hon. Member for Totnes (Dr Wollaston), for Ministers to stop using such a misleading figure, when the correct figure is less than half the amount claimed.

The chief economist of the Nuffield Trust argues that even that is overstating the case, highlighting King’s Fund research that found that NHS-specific inflation means that the real increase is about £1 billion—about a 10th of the figure that the Secretary of State and others repeatedly use. It is certainly not £350 million a week. I would be very surprised if any Ministers repeated that blatant lie again, but anyone who claims that the investment is £10 billion is playing hard and fast with the truth. Indeed, the NHS chief executive admitted to the Health Committee that the spending review settlement would actually deliver

“negative per person NHS funding growth”

in 2018-19, with “very modest” increases in the other years.

On top of that, Ministers expect the NHS to find £22 billion in efficiency savings by 2020-21. No one with expertise thinks that that is possible. In a scathing report in March, the Public Accounts Committee found that a significant number of acute hospital trusts are in

“serious and persistent financial distress”.

It said that there is a “spiralling” trend of increased deficits and that the current payment system is “not fit for purpose”. That is perhaps most starkly demonstrated by our beleaguered social care provision, the funding of which all three Care Quality Commission inspectorates agree is seriously affecting the NHS. The Committee goes on to warn that it must be funded sustainably as a priority.

Yes, we have the better care fund, intended to advance the integration of health and social care services, but the majority of that comes directly from the NHS budget, resulting in what the King’s Fund describes as

“a sharp and sudden reduction in hospital revenues.”

In other words, the Government are robbing Peter to pay Paul, while local authority social care budgets are slashed and people are having to sell their homes to pay for care or are not getting it.

Nor is the Government’s secretive sustainability and transformation programme the solution. Many constituents are worried that plans are being conducted behind closed doors and that vital NHS services could be cut as a result. We urgently need clarity on what STPs will mean in practice for both patients and staff. The Sussex and East Surrey STP area, which includes Brighton and Hove, faces a financial funding gap of literally hundreds of millions of pounds by 2021, and it is not at all clear how our STP will bridge that financial gap or whether acute services will be cut.

[Dr Philippa Whitford]

Does the hon. Lady agree that the principle of STPs going back to place-based planning could actually help reintegrate the NHS, but that, if it is done on the basis of budget-centred care instead of quality and patient-centred care, we will get the wrong answer?

[Caroline Lucas]

I am grateful to the hon. Lady for her intervention. I agree that place-based planning is potentially a very useful tool, but I fear that it is being used as a back-door way of making yet more cuts. I am also worried that that is happening in an untransparent way, which is giving rise to concerns among my constituents about exactly what is being set out. Winter is coming and the crisis already playing out in Brighton and Hove is likely only to get worse if the NHS continues down the path on which the Government have put it.

Specifically, we spend 2.5% less of our GDP on health than countries such as France and Germany. I am prepared to say what few others will say, which is that, if we want an NHS that meets our complex health and social care needs, we do not need privatisation and competition; we need those who can afford it to pay more in tax. This is something we can put a price on, whereas the cost of the worry, misery, pain and sheer uncertainty for many of my constituents is incalculable. Whole families have to live with the agonising wait for a loved one’s treatment. It often falls to them to act as carers during that time. The knock-on effect of NHS delays cannot and should not be dismissed. Concerns about delays and cancellations at our digestive diseases unit, for example, come up repeatedly. Operations are repeatedly cancelled, with patients in distress. There is the amazing mum fighting tooth and nail for adequate care and support for her severely disabled son. For her, the system is a battleground. She has to co-ordinate equipment in four different places and put up with repeated delays. She told me:

“It’s this that pushes people beyond despair and to breaking point.”

Breaking point is exactly where we are. A perfect storm caused by decades of chronic underfunding and privatisation has met the consequences of fragmentation and ramped-up marketisation. Terms and policies manifest themselves in grave and very real problems of the kind that I described when I opened this debate. Those problems are not unique to my constituency or city, but Brighton and Hove has an unusual demographic profile, with many younger people, as I have said, with complex needs, mental health problems, drugs and alcohol addiction, homelessness and long-term conditions. It also has some very elderly people.

That means that the array of services to support people using the NHS may need to become more complex, more tailored and more multi-agency, including police, voluntary agencies and so on. We need an ecosystem of healthcare, in which each part complements other parts as well as the whole, and which is achievable locally and nationally if we strip back the unnecessary, ineffective and damaging complexity that currently infects the NHS; if we reinstate the basic principle of a publicly funded and provided national health service that is free at the point of access; and if we give patients, staff and the public a voice from the outset and not just as part of a box-ticking exercise. I believe that is the way to bring us back from the brink.

I have raised a number of questions, and I will repeat them for the Minister before I give the floor to him for his response. Will the Department of Health step in to bring back accountability and stability to the non-emergency transport system in Brighton and Hove? Will it bring that service back into the public sector as a matter of urgency and pick up the Coperforma bill? Can the Minister promise that the STP plans will not mean cuts to services and closures? Will our hospital trust and mental health trust get the money that they need to address the staffing and other crises that they face without having to impose cuts dressed up as efficiency savings?

Will the Minister and other Ministers stop using inaccurate figures when they talk about investment in the NHS and use the autumn statement to announce a genuine step change when it comes to funding social care via local authorities and NHS services in the round, taking full account of NHS-specific inflation? Will he petition the Home Secretary to immediately guarantee EU workers the right to remain and protect the NHS from yet further instability and uncertainty? Finally, will he take a really honest look at the knock-on effects and inefficiencies of a healthcare model that is jeopardising accountability, transparency, standards and patient care?

Community Pharmacy in 2016-17 and Beyond

Philippa Whitford Excerpts

1st reading: House of Commons
Thursday 20th October 2016 Commons Chamber

[Mr Speaker]

My apologies to the hon. Lady; I call Dr Philippa Whitford.

[Dr Philippa Whitford (Central Ayrshire) (SNP)]

Thank you, Mr Speaker.

We discussed this on Monday and, as I pointed out, Scotland has had a national minor ailments service, a chronic medicine service and public health prevention for many years within community pharmacies, and we have found them to be very effective. Research showed they could cut 10% of the pressure on GPs and 5% on accident and emergency.

The problem with the Government’s proposal is that it is going to be a bit random; pharmacies are just going to be shutting on the basis that they cannot survive. Should there not be a planned system, to look at and discuss where they should be? It is not just a question of rural or deprived. It is also about transport; a mile away may be a real problem for those who are elderly and frail and for whom there is not a bus going in that direction. I welcome England taking forward these services, but my concern is the way in which it is going to be done; if it is just done due to cuts, it might not give England the answer it really wants.

[David Mowat]

I thank the hon. Lady for her point. She mentioned Scotland’s minor ailments programme. The announcement I made on that about a week ago was in many ways modelled on the Scottish model, because we know that pharmacies can do much more on minor ailments than at present. That will be commissioned separately from the other things we are talking about today, and paid for separately from the integration fund. We are a little behind Scotland in that regard, and we are going to catch up.

Community Pharmacies

Philippa Whitford Excerpts

Monday 17th October 2016 Commons Chamber

[David Mowat]

It will not surprise the House to learn that I agree. Last Thursday night, I announced to over 1,000 pharmacists at their annual dinner that we are moving ahead with an urgent access scheme. From the beginning of December, all 111 calls for repeat prescriptions will go directly to pharmacists, not to the out-of-hours GP service. That is a tangible difference. We will do just the same with a minor ailments scheme, which will be commissioned right across the country so that, by April 2018, pharmacists will be paid—over and above any money that comes out of this settlement—for minor ailments work on things such as earache and so on. Those are exactly the sort of sensible steps that need to be taken to integrate pharmacy more closely into GP practice, and that is what we are doing.

[Dr Philippa Whitford (Central Ayrshire) (SNP)]

In Scotland, we already have a national minor ailments scheme within our community pharmacies, and it has had a huge impact. The Scottish Pharmacy Board estimated at the beginning of the project that 10% of those making GP visits and 5% of those making A&E visits could be seen in community pharmacies, so our investment has been in completely the opposite direction—in that of developing and strengthening such pharmacies. On top of minor ailments, one of the big areas that has made a difference is in chronic disease management. For people on repeat prescriptions, the pharmacist requests their next prescription and has it ready, while for housebound people, they deliver it, as they do with blister packs.

The concern about these changes is that pharmacists are afraid it will be a case of cutting and then seeing who survives. If it is felt that there are too many pharmacies in one place, reducing their number needs to be done in a planned way, otherwise rural and deprived areas will end up without one. The Government should be making sure that community pharmacy is a real part of the NHS, not slashing it.

[David Mowat]

The hon. Lady made several points. On her last point, the access scheme on which we are currently consulting will protect pharmacies in rural and deprived areas. That is precisely the point of the scheme.

The hon. Lady’s first point was that Scotland has moved ahead on minor ailments, and we agree. I am on the record as saying that the pharmacy first scheme in Scotland is a good model. We want the profession to move away from just dispensing towards more value-added activities, such as services. That is precisely why we are putting into effect the minor ailments scheme that has been piloted. It will be implemented right across the UK—right across England, I should say—from April 2018.

European Medicines Agency

Philippa Whitford Excerpts

Wednesday 12th October 2016 Westminster Hall

[Jim Shannon]

I thank my hon. Friend for his comment. I was not aware until seeing the briefing pack that there had been a decrease in the pharmaceutical business over the past few years; I actually thought we were holding our own and moving forward. Brexit will give us the opportunity to move forward, so we should look positively upon where we are.

This debate is not simply an opportunity for remainers to highlight something that may be difficult to negotiate, with no desire other than to prove their opinion on Europe. There is nothing wrong with that—people have different opinions—but let us work together to ensure that we deliver.

[Dr Philippa Whitford (Central Ayrshire) (SNP)]

Is it not possible that part of the reason why the pharmaceutical industry has gone down is that the clinical trials directive of 2001 was very bureaucratic? Following that, we had a fall of one quarter in trial research in the UK, particularly in oncology. That directive is due to be replaced in 2018 with the EMA’s new regulation, which will streamline it.

[Jim Shannon]

I thank the hon. Lady for her intervention and the knowledge she brings to this Chamber and the House. I hope that we can improve on what she refers to when we get into the Brexit negotiations, and through our negotiations outside Europe when article 50 is triggered next year.

Let us work together to allow the EMA and the MHRA to come to an arrangement to continue what has been a great partnership to date and has achieved many results. According to the Financial Times, the EMA outsources up to a third of its work to the MHRA, and that work is responsible for a third of the MHRA’s income. A report in The BMJ states that that work makes the UK an attractive location to carry out clinical trials. The hon. Lady outlined that in her intervention, and I know that the Minister will respond and the shadow Front-Bench spokesman will add his comments.

That relationship, which has been proven to work, does not have to die because the EMA may—I emphasise “may”—move its headquarters. Work must be undertaken to underline the fact that although we will not be in the EU, we will remain the best in Europe at this type of clinical work. We have many things to be thankful for in our experience of it. We all understand the red tape in Europe, and I find it very hard to believe that the only reason why the work was outsourced to the MHRA was the location of the EMA.

--- Later in debate ---

[Dr Philippa Whitford (Central Ayrshire) (SNP)]

It is a pleasure to serve under you, Mr McCabe. I, too, pay tribute to the hon. Member for Cambridge (Daniel Zeichner) for obtaining the debate and for such an excellent opening speech, which laid out many of the key issues that we face.

In my constituency there is GlaxoSmithKline, which produces the largest amount of one of the key antibiotics used across the world. It is natural that there are concerns in my constituency and in that business. It is slightly tragic that we are having both of the debates on this issue today, instead of prior to the June referendum. Perhaps a little more airing of what we gain from the EU might have been helpful. Forty years of describing the EU in terms of straight bananas and bureaucracy has not been helpful.

In health, we have had nothing but gains. The two canards that were raised during the debate—people ahead of you in the queue to see the GP and £350 million a week on the side of a bus—have evaporated. Someone is much more likely to be treated by an EU national than to be squeezed out of an appointment in a hospital.

We have had nothing but health gains. The EMA is typical of everything the EU has done in many areas. Before 1995—prior to expansion, so we would be talking about 12 countries—we faced regulation in multiple languages across multiple countries. What we have seen in the EU is the development of harmonisation of regulation to the point where we have a single agency. Having one agency means, as the hon. Member for Cambridge said, that drugs get from research bench to patients much more quickly. The EMA monitors safety throughout Europe so that we can more easily pick it up when, in real-life use, there turns out to be a problem with a drug. It also helps to direct research into the big challenges that the population of the EU faces.

There has been a lot of discussion about the MHRA. It is clear that there would need to be significant investment in it. Even if we are still in the EEA or in a position to be part of the EMA, we will not have any influence. The MHRA does not just provide briefs and reviews. It was massive in influencing the structure and principles of the EMA, and such influence will be lost. The loss of influence over pharmaceutical firms that are here has been talked about. The chief executive of the Association of the British Pharmaceutical Industry has said that he foresees a major loss of inward investment in this country because of the loss of the EMA headquarters in London and because of our possible exit from the EMA.

Many such examples will come up in different sectors with regard to Brexit, but the EMA encapsulates all of it. It is not a separate bureaucracy telling us what to do. Twenty-eight countries were working together to find the slickest way to encourage quicker research and to bring it to some benefit. Research is a big part of this. It has been possible for the EMA to direct research on the challenges that the whole of Europe faces, such as antimicrobial resistance or modern plagues such as Ebola. As was mentioned, it supports research into rare diseases. One pharmaceutical firm or one academic unit would not access enough patients to ever get an answer. Across a population of 500 million, we have the real potential—we are already seeing that potential come through—to find answers to some of the horrific illnesses suffered by small groups in a population. “Suffering” is the right word, and we will lose the potential to find solutions.

Lots of drug companies do not bother trialling drugs in children because it is just too much hassle. The EMA has been able to push and say, “We need to have paediatric trials. We need to have trials in children.” That dovetails with the business of research across the EU, which has the biggest research network in the world. It is much bigger than in China and the US. The UK has led in benefiting from that. We put in £5.5 billion and get £8.8 billion out. The biggest share of research of all types through Horizon 2020 and framework 7 has been done in this country, and we are in danger of losing that.

The reason we lead in pharmaceuticals is not just because the headquarters is here; it is because of the dovetailing between academia, pharmaceuticals and universities, and the ability of researchers to move around. We have gained because English has become the language of research and science, because of America. So that has been a benefit that we have had. Of course that is a benefit that we will keep, but we are in danger of sitting out on a little rock all by ourselves.

There may be a delay if pharmaceutical firms have to go through a separate process with the MHRA, but what about British firms? What about the innovative medicines initiative, which encourages small and medium-sized enterprises and often works on the biological aspects of new medicines? They will face an absolute nightmare trying to sell their drugs in Europe. That is something that we are not giving remotely enough attention to.

I was a remainer. I am still a remainer and my population were remainers. Obviously, we are not happy with the idea of being taken out of Europe and of being taken towards such a hard Brexit, as the rhetoric has suggested in the past month. We need to realise what we may lose. We still have everything to fight for. What “Brexit means Brexit” actually means can still make a huge difference to what we manage to hang on to from the EU and what we lose completely. We need to ensure that the people who are at the table take account of this.

I worry because we are describing the EU as a shop. We are talking only about the single market and whether we will get access. Sometimes people mean that as a shorthand for everything else we have gained, but that allows us to be mentally sloppy and therefore allows someone to say, “Oh, good. We are like Canada. We have got access to the single market. Job done.” But it is not job done. The EMA was an example of Europe coming together, streamlining itself and finding a better way forward.

It has been recognised that the clinical trials directive of 2001 made it very difficult for the UK because the system became quite bureaucratic. The EMA has responded to that. The vastly streamlined clinical trials regulation starts in 2018. In fact, the EMA and the EU in this sector are getting rid of bureaucracy and making it easier for our companies and our academics to do research throughout Europe. Some 80% of all the top flight research of all kinds is international and multinational. If we do not allow the researchers to easily work with each other, we are cutting our noses off to spite our faces. We need to recognise that Europe has not just been about burning orchards or straight bananas. It has brought us huge gains in health and safety, in research and in getting drugs to patients. I call on the Minister to ensure that that message is brought home to the core Brexit team as strongly as he can manage.

--- Later in debate ---

[The Parliamentary Under-Secretary of State for Health (David Mowat)]

It is a pleasure to serve under your chairmanship today, Mr McCabe. I congratulate the hon. Member for Cambridge (Daniel Zeichner) and all the other hon. Members who have brought their experience to bear in the debate. I am sorry to disappoint everyone by not being from the Brexit Department. I will pass that on to those who are in it, but as has been noted, they are otherwise engaged in the main Chamber.

One reason why I am particularly pleased that we have had this debate today—I regret that all the answers may not be clear in 11 minutes’ time—is that often when there is talk in the media about the Brexit negotiations we are about to have, we hear a great deal about the importance of financial services, the City and passporting, and of the need to get those things right and the terrible effect it will have on our economy if we do not. The fact that we have had this debate, and that the hon. Gentleman and others have talked about how important the medicines industry is to our economy—not just in Cambridge, Cheshire or Scotland, but right across the country—is a reminder of the importance of this issue and has rightly put it on the agenda. I am sure the hon. Gentleman will keep it on the agenda, as will Ministers from the Department of Health.

At the start of the debate, the hon. Gentleman quoted the Prime Minister, who said:

“It is hard to think of an industry of greater strategic importance to Britain than its pharmaceutical industry”.

That is on the cover of a report, which I recommend everyone reads, on the structure and future of the life sciences industry post-Brexit. In a moment, I will talk a bit more about the work that the Office for Life Sciences is doing in that area. The pharmaceuticals industry is right at the centre point of where we need to be as a country in development work. It is an area that we are world-class in—an area of advanced manufacturing, which we need to be doing more of. We are leveraging the expertise and brilliant work in universities to actually make money, in a way that we do not do in all industries at all times. It is vital that we do not lose that.

I will repeat fairly quickly some of the statistics that we have heard on the structure of the industry. There are nearly 6,000 companies in the industry in the UK, and two of the major companies are GSK—located in many parts of the country, including Ayrshire—and AstraZeneca, which is located in Cambridge in particular. I have made the point earlier that a larger part of it was located in Cheshire a couple of years ago. Those are major, world-beating organisations, and for us to have an industrial future and a future as a country, we have to nurture them. In fairness, the thought that we would not do that is a nonsense. A fair challenge is to make sure that we do it right and keep it on the agenda, and I will try to address that today.

However, this is not a European industry, it is a global industry. AstraZeneca and GSK also have massive facilities in places such as Sweden and Philadelphia—all over the world. Of course it is absolutely essential that we get our relationship with the EU right. I think the point was made earlier that we have 3% of the EU market in terms of sales, although we are a lot bigger than that in terms of drug production and the importance of the pharmaceutical industry—it is probably more like 10%. GSK’s recent announcement of an £800 million investment in biologic and bioelectronic activity is to be welcomed.

The EMA was formed, as was generously mentioned, in 1995. There are 890 staff, the majority of whom are not from the UK; I think that only something like 60 are UK-based. The hon. Member for Heywood and Middleton (Liz McInnes) made the fair point that those people have families and futures, and asked how they are to be protected. The Prime Minister has said that we hope and expect that all EU nationals who work in the UK will stay here into the future. I have not heard any leader of any other country in Europe make the reciprocal point. I do not know if that is on the Labour party’s list of 171 questions, but it would be reasonable if it were. Having the EMA in the UK is of benefit to us not just because of those jobs but because, as Members have said, it is natural that people like to be close to their regulators. It would be reasonable to suppose that, although that might not be a decisive factor in many investment decisions, it would be a factor.

We also have the UK agencies: the MHRA, which covers medicines, and the Veterinary Medicines Directorate, which covers veterinary medical activities. They have 1,200 staff and 160 staff respectively. The point was made today that their activities are commingled with those of the EMA. Many of the EMA’s major committees are chaired by people from the UK, including from the MHRA and VMD. Equally importantly, the hon. Member for Central Ayrshire (Dr Whitford) made the point that 30% of its activities are done by the MHRA. The figure I have is 20%, but nevertheless, a significant amount of work done for the EMA is done in the UK. That is not just because of location—it is not just because the people who do that work are down the road. It is because they have the expertise, the science base and the people that are needed. Of course, with Brexit, all of that is up for discussion.

We have touched on the university sector, and I will not say a great deal about that. I have already made the point that the industry is an example of us successfully taking a sector with world-class, world-beating innovation and turning that into world-class, world-beating companies, in a way that we do not everywhere. It is of paramount importance that the sort of research that goes on in our universities continues. The Government intend to make sure that happens and, indeed, to increase it.

I have set out the regulatory and industry structure, but we are just about to impose Brexit on all of that. That is where we get into the territory of speculation and conjecture, and I apologise that I cannot be more definitive. Many of the questions that have legitimately been raised, in particular by the Labour spokesman, the hon. Member for Ellesmere Port and Neston (Justin Madders), will be central to any negotiation that the Government take part in. It is not possible for a Minister to address the House of Commons and say, “This is our position, these are our red lines, these are the things we are going to give a bit on and these are the things that really matter to us.” That would be nonsense. That is not how any of the commercial companies located in Cambridge or other places would deal with things. What we have to do—this is the role of Members here today—is make sure that the issues are raised with and understood by the negotiating team, because there will be trade-offs in any negotiation.

With respect to some of the Members who have spoken, I have to say that we do pay £20 billion a year to the EU. We may all vary in our view of how much value for money that provides, but the fact is the £350 million on the side of the bus was not an entirely made-up number. That did not influence how I voted in the referendum, but it was not an entirely made-up number. We pay £20 billion a year for the things that we get from the EU, one of which is the EMA and the activity around it. There is a dialogue to be had both on that amount of money and on issues such as the location of the EMA and all that goes with it. Of course, its location is one point to be discussed, and I have no idea how that will end up. The point has been made that it regulates not just for the EU but for Liechtenstein and Norway—I think there was another country as well, but I have not written it down. The UK could be another such country. For me to say it is an absolute line in the sand that the EMA must stay in the UK would be a nonsense.

A number of Members have asked what we are doing to prepare for the negotiations that will happen. That question can be divided into two parts: what are the agencies—the VMD and the MHRA—doing, and what are the Government doing? The agencies have set up groups looking at the opportunities and at how regulation might carry on into the future. A number of Members have made the point that there might be a time lag in medicines coming to the UK if they have to be regulated by more than one body, or if in the future the EMA does it separately from how we do it in the UK. That is really a decision for the UK. It is about how we choose to regulate, and that decision has not yet been made. It would be disappointing if that happened, and many of us will be working hard to ensure that it does not.

The Government have set out fairly clearly that we intend to underwrite EU payments to academic projects even after we have left the EU, to protect the important activity of research programmes. Through the Office for Life Sciences, we have set up a steering group charged with informing how we make the transition. The group is chaired by the Secretary of State, Sir Andrew Witty and Pascal Soriot from AstraZeneca, and over the next few months it will be responsible for informing our negotiating position.

I do not know how many colleagues know about the report, “Maintaining and growing the UK’s world leading Life Sciences sector in the context of leaving the EU”. I think it was put together by PricewaterhouseCoopers. It is a good start in setting out a number of issues we have heard about today and the importance of getting the process right. I very much recommend it. It does not answer all the questions, but it sets out the issues in areas such as trade, people, research, funding and regulation.

A whole string of points were made in Members’ contributions this afternoon. I do not want to spend too long on them, but the hon. Member for Cambridge mentioned that not being part of the EMA’s marketing authorisation might cause delays. That depends on how we set up regulation in this country, and there are a lot of choices. A lot of other countries, including Switzerland and Japan, regulate in different ways, and it would be premature for me to say too much about it. The hon. Gentleman also made the valid point that the EMA and the MHRA are completely intermingled, and that both benefit from the current arrangements. It is not just about the EMA contracting and hiring the MHRA. We do a lot of the work that leads to that top-level and highly professional European legislation.

The hon. Member for Strangford (Jim Shannon) reminded us that whatever we think, the country has voted and we are going to leave the EU. There is no ambiguity about that, and we have to make the most of it. That is a mature reflection, because it forces us to address the negotiations, and not to continue to go over what was on the side of the bus and all the rest of it. We are where we are, and we need to make the situation the best that it can be.

The hon. Member for Heywood and Middleton used her experience and knowledge as a research scientist to make a good speech. She made a point about people, which I tried to answer by reflecting on other EU states. She mentioned the Nobel prize winners’ remarks. I heard those remarks as well and thought that there was a slight irony in that they were asking us to remain in the EU and so on from the University of Chicago. That shows that we live in the world, not just in Europe, and we must reflect on that.

[Dr Philippa Whitford]

Those Nobel prize winners represent the last time we had a major brain drain, when, in the ’80s, we lost some of the best minds from the UK. That is one of the dangers: the people who want to be at the cutting edge will not see this as the place to be.

[David Mowat]

That is a fair point. It could be a danger. The point I was making was that they made the plea to remain in the EU from the United States, which is the leader in many aspects of science. I think we can agree that science is international—it operates in Japan, the US, the UK, Germany, France and elsewhere—and that, however we achieve Brexit, we should do what we can to avoid creating barriers to internationalisation.