Read Bill Ministerial Extracts
Julie Cooper
Main Page: Julie Cooper (Labour - Burnley)(8 years, 1 month ago)
Public Bill CommitteesQ Do you think there would have to be another body to take quality further, in the way the MHRA does with drugs, if this were going to come in, to avoid people going down to bare-minimum quality?
Philip Kennedy: As I say, we have an extremely productive dialogue with Lord Carter and the Department of Health on the forthcoming review of the procurement landscape. Huge efficiencies can be gained in restructuring that. We would prefer to look at that work in terms of assessing quality versus price, value, lifetime ownership and pathway design, as I mentioned earlier, where more significant savings could be realised for the NHS. Indeed, it would be good for industry to continue to develop products that have a higher quality threshold. Perhaps they cost more, but they would save significantly more than focusing on data that just look at existing product and existing price.
Medical device development is a very iterative process, unlike pharmaceuticals, which perhaps have a 25-year patent that protects something. One of our members has 80% of its revenues in products that only came to market in the last two years. That is where the efficiency, the quality and the cost-saving argument comes through. We surely want to encourage that as an economy.
Q This question is probably to Mr Smith. Generic supplies to the NHS in the UK provide some of the cheapest medicines in the developed world. Do you think that the approach to control the cost of generics is the right one, given that it is a minority of individual items that have come to the public’s attention because profits have soared significantly?
Warwick Smith: I am on record as saying it is the least worst system in Europe. There is no perfect system. What we have found, comparing what we have in the UK and elsewhere in Europe, is that competition is a much better way of controlling price than intervention. We produce lower prices in the UK than in the rest of Europe. We have had an issue, as you say. I think fewer than 2% of our products have made the front page of The Times. We agree that there should be data available to investigate whether those prices have a justification or not, and intervention perhaps by the Secretary of State or, at the end of the day, by the competition authorities. However, for the majority of products, as the Secretary of State said on Second Reading, the system works extremely well. We have spent time trying to come up with better systems and we cannot.
Q This is a question for Dr Ridge about the analytical capacity of the Department to look at the extra data you are going to be collecting. I was a little worried that, in The Times investigation, given some of the emails and responses from officials, they did not really appear to be on top of what was happening in terms of prices. My question is to seek reassurance as to the capability within NHS England sensibly and intelligently to analyse the extra data that will be collected under the Bill to know what is going on.
Dr Ridge: I am glad you make the point that I am from NHS England as opposed to the Department of Health. However, I am aware that the Department of Health has an analytical team in a particular bit of the Department that focuses entirely on issues associated with medicines and reimbursement. Indeed, the reimbursement policy responsibility sits with the Department of Health. Having been associated with that team for a number of years, and having previously been the Department of Health’s chief pharmaceutical officer, I am fully aware of the capability of that team. It is substantial, although I am sure that the head of that team—I can see him in my head now—will be considering whether he needs more resources to deliver what is required.
On the issue of price gouging and the 2% figure quoted by Warwick, it seems to me that at some point someone has to intervene in these things when you are into several thousand per cent. price rises. Although the intention would never be to do that first off—I am sure there would continue to be competition—there has to be a mechanism to do that.
Warwick Smith: To add to that, it is important to realise that the officials who were named in The Times were not part of that team. They were performing a more mechanical function to do with producing lists. The Bill ensures that the team reporting to the Secretary of State has powers of investigation and intervention. As Dr Ridge said, that is necessary and we agree that it is necessary.
Health Service Medical Supplies (Costs) Bill (Second sitting) Debate
Full Debate: Read Full DebateJulie Cooper
Main Page: Julie Cooper (Labour - Burnley)Department Debates - View all Julie Cooper's debates with the Department of Health and Social Care
(8 years, 1 month ago)
Public Bill CommitteesToday we begin line-by-line consideration of the Health Service Medical Supplies (Costs) Bill. Before we begin, if Members wish to remove their jackets, they may do so. Even though it is winter, it is very warm in here, so I have asked for the windows to be opened at some point. I want people to feel comfortable and relaxed. Will Members and, indeed, members of the public make sure that their mobiles are switched to silent, so that we are not disturbed during our proceedings?
On the table to my left, the selection list of today’s amendments—the order of business—is available for colleagues. It shows how the selected amendments have been grouped together for debate. Grouped amendments are generally on the same or a similar issue, as colleagues know, and the Member who puts his or her name to the lead amendment in a group is called first. Other Members are then free to catch my eye—to do so, please will you rise from your chair by more than one inch? That would be helpful. If called, Members may speak on any of the amendments in the group. A Member may speak more than once in a single debate.
I will work on the assumption that the Minister wishes the Committee to reach a decision on all Government amendments. Please note that decisions on amendments do not necessarily take place in the order in which they are debated; they take place in the order in which they appear on the amendment paper. In other words, debate occurs according to the selection and grouping list, but decisions are taken when we come to the clause that the amendment affects. I hope that that explanation is helpful to Members. I will use my discretion to decide whether to allow a separate stand part debate on individual clauses and schedules following the debate on the relevant amendments.
Clause 1
Voluntary schemes
I beg to move amendment 44, in clause 1, page 1, line 14, at end insert—
“for the purpose of investing in access to new and innovative medicines and treatments.”
With this it will be convenient to discuss amendment 46, in clause 4, page 3, line 22, at end insert—
“(c) the NHS’s duty to promote innovation.”
This amendment would introduce a requirement for the Secretary of State to take account of the NHS’s legal duty to promote innovation, as set out in the Health and Social Care Act 2012.
It is a pleasure to serve under your chairmanship, Mr Pritchard.
I will begin by outlining our overall priority for the Bill and, in particular, this clause. Our priority is to ensure that the Bill effectively controls the cost of medicines and medical supplies to the national health service while ensuring the best possible patient access to existing products and to new and innovative treatments. In that spirit, I would like to make some observations in support of amendments 44 and 46.
The clause will amend section 261 of the National Health Service Act 2006 and it is concerned with the powers related to the control of voluntary schemes. The stated aim of the clause is to give the Government new powers to require manufacturers or suppliers to pay the Secretary of State an amount that will be calculated on the basis of sales or estimated sales. The Opposition support the move to curtail excessive profits, thereby ensuring that the NHS achieves maximum value for money. Having said that we welcome saving vital NHS funds, we also wish to ensure that those funds are retained within the portion of the health budget that relates specifically to the supply of medicines and medical supplies. We do not wish to see the savings lost in an NHS deficit black hole.
On Second Reading, the Secretary of State confirmed that £1.24 billion had been returned to the Department of Health through the rebate scheme. That is a considerable amount of money, and the figure will increase when this Bill is enacted. However, we were not reassured by his vague statement that the money returned to the Department would be reinvested in the NHS.
Also on Second Reading, the Secretary of State mentioned the considerable pressures facing the NHS and he suggested that one consequence of the Bill would be to transfer funding from the drugs bill to the frontline. I hope that the Minister present recognises that medication is often the frontline and that ensuring the timely access of appropriate medication often prevents hospitalisation and thus saves the NHS money. It is very much a case of a stitch in time.
In addition, it is a fact that community pharmacists the length and breadth of the country have offered to work with the Government to eradicate waste and to cut costs. As the experts on all medication matters, they are best placed to work with GPs and patients to achieve maximum efficiency. Sadly, the Government have responded by taking steps that are likely to lead to a reduction in the number of community pharmacies. This is a missed opportunity and that is regrettable.
Amendment 44 would provide assurance by ensuring that rebates reclaimed against purchases of medicines were reinvested specifically in improving patient access to medicines. In Scotland, rebates collected by means of the voluntary prescription pricing regulation scheme are already specifically earmarked to fund new medicines. In essence, the Bill, which we support in principle, is to ensure that the NHS can procure medicines and medical supplies cost-effectively. I am sure that the intention is not to reduce funding to the NHS, so we cannot have a situation in which every pound repaid from the suppliers and manufacturers equates to £1 less of Treasury funding allocated to the NHS. We are concerned that, too often, budget constraints limit access to new and innovative medicines and treatments.
Recently, I have devoted a lot of time to supporting the campaign to achieve treatment for children suffering from the potentially life-threatening genetic condition of tuberous sclerosis. It is extremely distressing for parents to be informed that their child has been diagnosed with that incurable condition; it is even more distressing to learn that an effective pharmaceutical drug has been developed and licensed—Everolimus, marketed as Votubia —but is not available from the NHS for children in England. The drug is able to shrink the multitude of benign tumours that characterise that serious condition, thereby saving lives, improving quality of life for those affected and often removing the necessity for potentially damaging surgery.
That is one example, and there are many others. James Barrow from the Cystic Fibrosis Trust, speaking in support of the new medicine fund in Scotland, has said that using any reclaimed moneys in that way provides improved access and much needed transparency. Labour’s amendment to the clause would introduce a duty to reinvest any rebates to improve access to new and innovative medicines and treatments, as I have outlined.
Further to that, amendment 46 refers specifically to the duty of the NHS to promote innovation under the Health and Social Care Act 2012. The UK is a world leader in the field of life sciences, and the British pharmaceutical industry is at the forefront of global research and development. In 2014, 20% of all the world’s research and development into new medicines was carried out in the UK.
We have hitherto enjoyed significant benefits from European Union research funding. Given the outcome of the referendum, that is now at risk, and it is essential to ensure that we maintain our dominance in the sector, not least because the pharmaceutical industry employs close to 75,000 people. The promotion of innovation in the field is important not only for the health of the British people, but for the health needs of people worldwide. It is extremely important to the British economy, so it is vital that we do not take our eye off the ball. We need to put on record our continued commitment to research and to develop new treatments.
We face competition not only in Europe, but from emerging nations such as Brazil and China. We also need to ensure that the NHS does not trail in the take-up of those new drugs. Worryingly, the Office of Health Economics studied 14 high-income countries and found that the UK ranked ninth out of 14 across all the medicines studied. Successive studies have demonstrated relatively low take-up of new medicines in the UK compared with other countries. That is bad for patients and bad for our pharmaceutical industry.
The Bill therefore needs to achieve a balance. We need to ensure the best possible patient access to medication at the fairest price, and we need to encourage the pharmaceutical industry to continue to invest in research and development. Therefore, it is right that the Bill should outline our commitment to promote innovation. We look forward to hearing the Minister’s comments, but we are minded to press amendment 44 to a Division.
Mr Pritchard, thank you for calling me and, more particularly, for taking time out of your schedule to chair this important sitting.
On amendment 44, I was interested in the comments of the hon. Lady about the motivation behind it, with which I have some sympathy. I hope that what I say will reassure her that her amendment is unnecessary.
The amendment would require income from the pharmaceutical price regulation scheme and the statutory scheme to be ring-fenced to fund and increase access to new and innovative medicines and treatments. As a Government, we are committed to ensuring that patients have faster access to new and innovative medicines and treatments—I mention briefly the accelerated access scheme that we have introduced.
The hon. Lady touched on the compelling and sometimes tragic cases of individual constituents, friends and relatives seeking to get access to innovative drugs, in particular once those drugs have become authorised. Between 1 March 2000 and 30 June 2016, NICE, the National Institute for Health and Care Excellence, made individual recommendations for 646 separate propositions, 81% of which were recommended or optimised, so there is a steady track record of introducing innovative treatments and, in particular, drugs into our health service. That is done, properly, through the independent NICE structure. I am sure we will talk more about that in Committee.
As the hon. Gentleman knows, decisions to allocate spending across the responsibilities of the Health Department were determined as a result of the spending review last year. The decisions within the NHS that I am talking about, on treatments, rather than preventive public health, are determined by clinicians.
Separate to the Bill, Government are taking action to secure the UK’s future as an attractive place for the life sciences sector and to support faster patient access to medical innovations. For example, the recently published accelerated access review sets out ways to increase the speed at which 21st century innovations in medicines, medical technologies and digital products get to NHS patients and their families. Recommendations included bringing together organisations from across the system in an accelerated access partnership and creating a strategic commercial unit within NHS England that can work with industry to develop commercial access arrangements. We are considering those recommendations with partners and will respond in due course.
NHS England and NICE are jointly consulting on a number of proposed changes to NICE standard technology appraisals and highly specialised technology appraisals, including around speeding up the appraisal process. The Department of Health continues to work closely with NHS England and other stakeholders to improve uptake of new medicines. A key element of that is the innovation scorecard, published quarterly. It is designed to help users—clinicians, patients, commissioning groups, Government and other stakeholders—to understand and monitor the uptake of innovations in the NHS and should ultimately be used to promote an equitable spread of clinically effective, cost-effective innovations.
I hope that having heard in particular what I said about the way in which income from these schemes does not rise in a continuum but fluctuates, the hon. Member for Burnley will recognise that the amendment could have the adverse consequence of leading to a reduction in funding available for medicines.
Is the Minister aware of problems with the administration of the scheme in Scotland? Is he aware of what the experience has been in Scotland?
Fortunately, the Committee has the benefit of the Scottish National party’s spokesperson on health, the hon. Member for Central Ayrshire, who I am sure would be happy to give us her experience. The fact is that we have had some experience in England of fluctuating income from these schemes, which is the primary basis for our position.
We have the privilege of having two shadow Ministers. I do not know whether either of them wants to respond on amendment 44 or amendment 46, or whether the hon. Lady wants to press amendment 44.
I am grateful to the Minister for his comments, but I am still keen to press amendment 44 to a Division. The lack of transparency in what is currently available is unacceptable, and there is a danger that the Bill will be contrary to what I am sure is its real intention and cut funding to front-line medication. The amendment would prevent that.
I take the Minister’s point about fluctuation in funding, but I am sure he will agree that if this can be made to work in Scotland, it can be made to work here. I do not want us to fall behind on that. We are all aware of the massive deficit within the NHS. It is very important that funding recouped from pharmaceutical profits is not lost for the NHS and for the real purpose of providing new medicines, and that people in England do not lose because of the Bill. I thank the Minister for his comments, but I will press the amendment to a Division.
Question put, That the amendment be made.
I beg to move amendment 45, in clause 1, page 1, line 14, at end insert—
“(2A) After subsection (1) insert—
‘(1A) In exercising functions in relation to the controls on the costs of health service medicines, the Secretary of State must ensure that any medicine covered by a voluntary or statutory scheme that requires payments calculated by reference to sales of that medicine shall be made available to all NHS patients if recommended by a qualified NHS clinician.’”
The amendment continues in the vein of amendment 44, given our concern to ensure the best access to medicines. We are very much aware of the barriers that exist and are keen that every piece of legislation takes the opportunity to remove those barriers and make medicines more accessible to patients. It is important that the Bill does not inadvertently become a way of restricting that access. Where a clinician deems medicines necessary and desirable, patients should have access to them.
I was worried on Second Reading to hear the Secretary of State’s comment that the prescribing of some medicines is “not strictly necessary”. That questioning of the clinical judgment of the medical profession is not just inappropriate but could be suggestive of a dangerous precedent. We must never reach a stage where politicians decide which medication is appropriate and when. I assume that that was not the Secretary of State’s intention, but we would like to ensure that drugs approved by the National Institute for Health and Care Excellence are made available to patients if so desired by a qualified NHS practitioner.
There is already an agreed fixed limit on NHS spend on branded medicines, with any additional expenditure above that level paid for by the pharmaceutical companies via the clawback by the Department of Health. Currently, NICE assesses new medicines for cost-effectiveness, which provides a further restraint on pricing. There is therefore no reason for the NHS to deny patients any treatment covered by the scheme. We would like the Minister to look favourably on the amendment. We will not press it to a Division, but we are very concerned about the issues I have outlined.
Again, I understand the hon. Lady’s intent. I was a little confused by her interpretation of the Secretary of State’s remarks on Second Reading as meaning that politicians are involved in making decisions on prescribing. I assure her that, although I have been in the Department for a short amount of time, there has been no suggestion at any point that any politician should get involved in making decisions about which drugs should be prescribed.
I thought it inappropriate that the Secretary of State for Health expressed an opinion on which medications are necessary and which are not. I question his qualification to make that comment.
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.
From time to time, local circumstances may mean that clinicians do not have access to the drugs. They may be newly innovated, and given the scale of the NHS in this country, not all clinicians will get the information they need to provide new drugs as rapidly as some patients may like. It can take time to introduce a new drug, as the hon. Gentleman will understand. I recognise that it is the role of clinicians to prescribe in the best interests of their patients, and I know that local or national commissioning policies or technology assessments by NICE will mean that in some cases patients are unable to access the treatment that their clinician has recommended, but it is important to recognise that local and national scrutiny and the independent assessments of NICE are essential to promote evidence-based prescribing, protect patients and secure value for money. Undermining that system of checks and balances, as I am afraid the amendment tabled by the hon. Member for Burnley would, could endanger patients and result in significant variation in prescribing practices. I ask her to withdraw the amendment, since she has indicated that she does not intend to press it to a vote.
I beg to ask leave to withdraw the amendment.
Amendment, by leave, withdrawn.
Question proposed, That the clause stand part of the Bill.
Clause 1 will amend the powers relating to voluntary schemes in section 261 of the National Health Service Act 2006. The voluntary scheme referred to in that section is the pharmaceutical price regulation scheme. Although the scheme itself is voluntary, there are statutory powers that can be used in relation to its operation. Other than with respect to the entry and exit mechanisms, the Government do not currently use those powers for the 2014 PPRS, but we wish to retain the option of making regulations or directions with respect to those powers in future. The Government do not intend the amendments to the 2006 Act to affect the operation of the current 2014 voluntary scheme.
The amendments to the 2006 Act will put it beyond doubt that the Secretary of State’s existing powers can apply for the purposes of operating a voluntary scheme that includes only a payment system. They are part of our policy to align the powers relating to voluntary and statutory schemes, which we will come on to when we consider later clauses of the Bill. They will also ensure that when a company leaves the voluntary scheme, it is still able to make payments covering the period in which it was a member. That will clarify the requirements and ensure that there will be no loophole that companies can exploit to avoid making payments that are due after they have left the scheme.
It may also be helpful if I clarify a point that arose on Second Reading. In response to a question from my hon. Friend the Member for South West Wiltshire (Dr Murrison), the Secretary of State inadvertently indicated that the Bill would prevent companies that are part of the current voluntary pharmaceutical price regulation scheme from parallel importing of medicines. I would like to clarify that statement, because it did not completely accurately reflect our intent. Parallel imports made in accordance with the EU single market rules are a legitimate part of the medicines market, and the Government have no intention of taking action to prevent such trade. The Bill does not exclude the possibility of parallel import prices being controlled; they could be covered through regulation at a later date if the evidence warranted action. I hope that helps the Committee in its consideration. I commend the clause to the Committee.
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.
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.
I beg to ask leave to withdraw the amendment.
Amendment, by leave, withdrawn.
Question proposed, That the clause stand part of the Bill.
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.
Health Service Medical Supplies (Costs) Bill (Third sitting) Debate
Full Debate: Read Full DebateJulie Cooper
Main Page: Julie Cooper (Labour - Burnley)Department Debates - View all Julie Cooper's debates with the Department of Health and Social Care
(8 years, 1 month ago)
Public Bill CommitteesRare praise indeed from the hon. Gentleman. That is definitely going to go down in the annals of the Wolverhampton Echo, which I am sure will attribute an appropriate front page to that praise for the Government from the Member of Parliament.
To revert to where I had got to, I am sure hon. Members appreciate that there is clearly a limit to the level of detail we are able to publish, and I am sure that hon. Members appreciate that. Any information that we publish will be at a consolidated level, protecting suppliers’ confidentiality, which I have touched on several times, but will allow the Secretary of State to be clear on the basis of the conclusions to his review. We will, of course, be able to use supporting information to evidence our conclusions.
Turning for a moment to the detail of the proposed new clause, while the requirements set out in it reflect the duties placed on the Secretary of State in the Bill, I must be clear that the content of such a report should not be restricted. It must be able to address key issues arising during the course of the year, in the case of the annual report, and during the seven-year duration of the information regulations, in the event that such implications might have an impact on the operation of the schemes. Flexibility is at the heart of our proposals to address the issue through regulations. It would not be appropriate for such a report to address matters relating to the NHS duty to promote innovation. That is the one point of more substantive difference that we have with the drafting proposed by the hon. Member for Ellesmere Port and Neston.
We have already discussed the Government’s position on innovation. We are very clear that we are for it, as is the hon. Gentleman. However, we do not think it is appropriate to link measures in the Bill to that issue, which is a wholly different and much more wide-ranging issue than the narrower one of pricing and the cost of the medicines and medical supplies.
Does the Minister agree that there is a direct connection between control of the price of medicines and innovation, and that, if we do not achieve the correct balance, pharmaceutical companies will lack the motivation to invest in the extensive research and development that we all want to see?
I do not actually agree that there is a direct link. There is no question but that, in order to stimulate continued investment in R and D, it is appropriate for the industry to see a stable marketplace in a country as significant and important as the UK, and throughout the nations of the UK, for medicines and medical supplies. We are a large market. We spend more than £15 billion a year on pharmaceutical products, and we are also acknowledged by those companies to be a reference market for many other countries that do not have such a large or well-organised supply chain as we do. I accept that, in principle, it might be rather different if this were an emergent market.
Individual drugs are emerging through R and D programmes, but I do not think that is the same as the measures we are introducing, which are primarily designed to limit excessive abuses of pricing position, in which a company may be a monopoly supplier, in the case of the unbranded generics. For the branded products, we have a long-established procedure for recognising the recovery of R and D costs through the pricing mechanisms, and while we may not like paying for some of those branded products at the rate that we have to, we recognise that it is a competitive marketplace and, because of the cost of innovation—the cost of conducting clinical trials and so on—it is necessary to stimulate that innovation to ensure that those companies make a reasonable profit.
Promoting innovation is a high priority, not only for the Government and the NHS but for many other stakeholders in the industry. In our view, it would not be possible to quantify the contribution of the schemes in the Bill to that endeavour, for the reasons I have discussed. Trying to assess the impact on innovation is a much wider endeavour that does not just rely on price. For those reasons, I urge members of the Committee to reject the new clause.