Health Technology Assessment Charges

Anne Marie Morris Excerpts

Tuesday 4th December 2018 Commons Chamber

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

[Anne Marie Morris]

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

[Steve Brine]

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

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

[Anne Marie Morris]

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

[Steve Brine]

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

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

Question put and agreed to.

Access to Orkambi

Anne Marie Morris Excerpts

Tuesday 17th July 2018 Commons Chamber

[Mr Lewis]

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

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

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

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

[Mr Lewis]

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

Oral Answers to Questions

Anne Marie Morris Excerpts

Tuesday 8th May 2018 Commons Chamber

[Jackie Doyle-Price]

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

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

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

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

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

[Anne Marie Morris]

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

[Jackie Doyle-Price]

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

Health and Social Care Budgets

Anne Marie Morris Excerpts

Tuesday 14th March 2017 Westminster Hall

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

I shall be brief, Mr Bailey.

Our NHS is the envy of the world; our social care system, frankly, is not. Much has changed since the war years, and that has not yet been reflected or accepted. The health budget of £120 billion sounds a lot, but it is inadequate. It assumes that demand is falling; it is not, it is rising. Even NHS England has admitted that it is not enough. It is not sustainable—that is what the Public Accounts Committee report has set out. Trusts are still in deficit. Clinical commissioning groups have a very varied outcome, financially. The GP triaging offer is welcome, but it is a drop in a proverbial ocean.

The move to sustainability and transformation plans is absolutely right; the problem is that it is not properly funded and we are considering implementing models of care that are untried, untested and uncosted. That cannot be right. There is no transition funding and, although I welcome the capital funding for the project, £325 million is, I am afraid, not enough, Minister. Social care represents a third of local authority spending. We currently spend £14.4 billion. Unlike with the NHS, it is means-tested. Again, demand is going up but the funding is going down.

The funding to local government is inadequate. The 3% precept is helpful, but those of us in rural areas clearly have to pay more because we pay more council tax overall, compared with input from the state. The £2 billion is very welcome, but as my neighbour, my hon. Friend the Member for Totnes (Dr Wollaston), explained, it is a little bit but not enough and we need a proper review. We must also ensure that that money does not get stuck with our local authorities. That has happened before and I would not be happy with its happening again.

On the big picture, we do not really measure the system. We do not look at, or measure, need. We do not look at the people who do not even ask for help. Until we start measuring input, output and outcomes across the whole of health and social care, we will not solve the problem. The Green Paper is extremely welcome, and I agree with my hon. Friend the Member for Totnes that it must cover both health and social care. It would be better than a commission, but it must look at the whole system. It must look at the free/means-tested issue. It must look at integration, joint commissioning and a joint budget and accept some structural changes. We have had Sutherland, Wanless, Dilnot and Barker; the issue really is not that simple.

The Government must face up to the problem, but the public also must play their part. We have to accept change, and that is not easy. We must, as others have said, look at general tax, hypothecated tax, insurance, compulsory saving and much more, but the issue is not about just money, but models of care. While we are at it, Minister, please could we have some fair funding for rural areas? We have a disproportionate number of over-85s and rural sparsity that is not properly dealt with. Please Minister, can we have honest acceptance of the problem and the will to face up to it?

Health and Social Care

Anne Marie Morris Excerpts

Monday 27th February 2017 Commons Chamber

[Dr Wollaston]

I say to the hon. Lady that, genuinely, these plans offer us an opportunity to produce a transformative process, but they are being undermined by a number of critical points, and we should address them.

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

Does my hon. Friend agree that one of the key pieces missing from the STP plans is the bit that enables that double running, so that we can move from the existing system to the new system? There is no money anywhere for any transition and double running.

[Dr Wollaston]

I absolutely agree with my hon. Friend and neighbour. As she will know, in our area, we are seeing not only the closure of four much-loved community hospitals, but, on top of those 44 beds lost from community hospitals, the local trust wanting to cut 32 acute beds, at a time when its bed occupancy is already running between 92% to 94%. Unless we have that double running and the communities can genuinely see the change, those plans will be seriously undermined. Too often, the NHS plans for hoped-for demand, rather than actual demand.

--- Later in debate ---

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

Let us be clear: estimates are a serious business; they must be realistic. Every year, Parliament votes on how much can be spent. If excess is needed, Departments have to go back to the House, so getting estimates right is mission-critical.

The challenge I have with these estimates is that I have little faith that the assumptions they are based on are realistic. As my hon. Friend the Member for Totnes (Dr Wollaston) said, there is an assumption that demand will go down. As the population increases, and as immigration increases, that seems a very unrealistic view to take. The Government need to look long and hard at the assumptions they have made, because I for one am not convinced that they have got them right.

We also need to look at what these estimates assume in terms of the negatives. They assume we can keep on course if we reduce public health spending. If we start reducing that spending, which prevents the need for NHS intervention—the most expensive form of intervention—will we really save money? It seems to me that we will not. The other assumption made in these estimates is that central administration will be cut. We should bear in mind the complexity of what is going on at the moment, with 44 STPs coming on board, as we all hope they will, and I agree with my hon. Friend that they are a good concept, although I have some real concerns about delivery. Overall, I am concerned that these estimates are not based on realistic assumptions, and Ministers will need to seriously address that.

As the hon. Member for Hackney South and Shoreditch (Meg Hillier), who leads the Public Accounts Committee, and my hon. Friend have said, the estimates must take into account what we need for health and social care. If we cut spending on social care, or do not adequately fund it, we will increase spending in the NHS.

However, underpinning all of that is the need to have measurements in place across the whole system, as my hon. Friend indicated, so that we know what the full scope of the demand is. We must measure the results achieved by the resource we put in and the outcomes for the population as a whole. We all talk about measures around A&E and the NHS. We all talk about waiting times, and the targets that are set are all around waiting times. However, nobody is looking at what impact that has on primary care—on our GPs—or on social care. If an estimate is to be right, therefore, we need to look at the whole system of measurement.

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

My hon. Friend is making powerful points. At my local district general hospital, West Suffolk, winter preparedness plans included a 5% uplift in demand—this is exactly the point she is making—but there was a 20% increase. I have exactly the same thing in social care, where my social care providers tell me people are older and more poorly. We have increased demand across the piece for that reason.

[Anne Marie Morris]

I thank my hon. Friend for that helpful example. She is absolutely right.

If we look at the whole measurement system—this was acknowledged in one of our Public Accounts Committee sessions by the Department of Health—we see that there is limited measurement, and that there probably should be more. When I challenged the individual concerned on whether the Government would be looking at that, he stood from one foot to the other and could not give us much of an answer. These estimates have to be based on proper measurement of need, on what is operationally put into practice, and on the outcome for patients, but that simply is not the case.

We need to look at the differences between the NHS and social care as regards how the money is allocated. In the NHS, we have some ring-fencing, while in social care we do not, but because the two are inextricably linked, unless we look at the way in which each of those pots is managed, never mind how much is in them, we give rise to problems for the future. Social care is not ring-fenced. I am sure we are all grateful for the additional moneys that have been provided, but frankly they do not go far enough. The first chunk of money might cover the living wage, and the ability of local authorities to increase the precept by 3% is welcome, but as the Chair of the Public Accounts Committee said, that is taxpayers’ money.

[Dr Murrison]

My hon. Friend is making a very good speech. Does she share my concern about the 3% precept, as shifting the cost of health and social care away from general taxation on to a property-based tax has obvious problems—not least, that it will disadvantage communities that are less well off?

[Anne Marie Morris]

My hon. Friend makes a fair point. I have one of those constituencies where communities are not very well off. Many of the facilities that are there to provide social care are failing because we do not have the more affluent individuals who can ensure that some of our care homes, particularly nursing care homes, are alive and well. I am now down to just three for a very large constituency, and that is completely inadequate.

[Tim Loughton (East Worthing and Shoreham) (Con)]

My hon. Friend and I both have constituencies with a large proportion of elderly people. Indeed, Worthing has the highest proportion of over-85s in the whole country. This is a double whammy, because people who are over 85 tend to require a great deal more healthcare, stay in hospital for longer, and have multiple problems in hospital that cost more—we are looking after them well and need to look after them better—and the social care side when they do come out of hospital, too often delayed, is costly as well. Those are the growing pressures that the estimates appear not to take proper account of.

[Anne Marie Morris]

My hon. Friend makes an extremely good point. He is right that the cost of ageing is not adequately taken into account. The way the Government measure health outcomes is predicated on the number of births and looking at the lifespan of the population. Because people live longer in areas like my constituency in Devon, it is assumed that we therefore have better health outcomes, but that does not allow for the fact that we have a low number of live births. Many people move into our lovely area when they are much older, and so the level of improvement is small. There are some basic, fundamental flaws in the way the Government—not just this Government; it has gone on for years—estimate the need in an area. As my hon. Friend rightly says, one of the biggest challenges is age.

Integration is expected somehow to be the solution to all our problems, but there is no transition funding to allow for double running, and there are, as far as I am aware, not many pooled budgets. As we have heard, these plans make certain assumptions about the recruitment of individuals, but we cannot recruit at the level we need now, never mind what we will need for the future. There is also a lack of training in the specialisms that we are going to need. Specifically in some of our more rural areas—we have talked about the ageing population—we need more specialist generalists. That is agreed by most of the royal colleges, but it is not being put into practice. So many issues will impact on the effectiveness of integration that I doubt that it is really going to be a way forward in reducing costs. I am concerned that the integration model, while very welcome, has not been fully thought through. The barrier to its being successful is that there will be unbudgeted costs. There is no evidence for the assumption that demand will decrease, and so no evidence that integration will deliver savings. It therefore seems to me that these estimates cannot really be sound. Real cost estimates are needed.

We have failed to address the element of social care that is paid for privately. I refer here to the Dilnot report and the Care Act 2014. We are talking about how the Government’s money—the taxpayer’s money—is to be shared out between the two systems, but we should never forget that social care is means-tested as opposed to the NHS, which is free at the point of delivery. If we do not try to ensure that the necessary savings are made by individuals taking responsibility, with or without the Government stepping in, we will find that the demand on the NHS is simply too great for the system to succeed and for these estimates to be valid.

Oral Answers to Questions

Anne Marie Morris Excerpts

Tuesday 15th November 2016 Commons Chamber

[Mr Dunne]

The hon. Gentleman should know that, according to figures for the most recent month available, 90.6% of A&E attendances were seen within the four hours. We are aware that the system remains under pressure, and are putting efforts into identifying steps through the A&E improvement plan, with five specific measures to improve front-door streaming, back-door discharge and patient pathways through hospitals to improve that performance.

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

19. Rural areas have high demand for primary and social care that increases the pressure on A&E if it is not met. Given the relationship between primary, secondary, A&E and social care, does the Minister also measure waiting times in primary and social care in the same way? That would give him a fuller picture of the demands on the system that need addressing.

[Mr Dunne]

The short answer is that at present we do not record waiting times in the same way. Tests are being undertaken in relation to waiting times for GPs, but at this point I do not have access to the data.

Healthcare (Devon)

Anne Marie Morris Excerpts

Tuesday 18th October 2016 Westminster Hall

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

Devon shares a challenge with many other rural parts of the country. We can safely say that the things we are asking and lobbying for have a general application. From the Minister’s perspective, something that has a more general application will be much more acceptable.

We have an above average number of over-85s with complex co-morbidities, as do many other rural areas, because people like to retire to such places. We know that travel distances in Devon are particularly acute. We have been compared to Denmark in terms of the numbers of roads that we have.

It is absolutely right to raise the recruitment challenge, but it is not a simple question of not being able to get people; there simply are not enough people to get. Previous Governments have inadequately provided for training. In addition, we have the challenge of attracting people to work in a rural location. Rural locations are fine if someone is retiring there; young individuals want to live in cities; and that is the challenge. On top of that, the cost of living also makes a post in a rural area unattractive.

Perhaps the most difficult problem is the one-size-fits-all approach that previous Governments have focused on. The model for funding and for structures is built around an urban model where there are numbers and therefore productivity. The challenge we have is the lack of footfall, except in tourist times. We need to tick the box not only for the funding formula but for the new integrated models of care that look at integrating vertically and horizontally across primary and secondary care. The multi-specialty community provider and primary and acute care systems will simply not work where we are, which means that we cannot use the same solutions as other areas.

Devon is a prime example of all these problems. We have three different reviews going on. We have the success regime in north Devon; the consultation on primary care, which last year took place in south Devon and is now taking place in Northern, Eastern and Western Devon; and the sustainability and transformation plans, which have been relatively recently brought into play. As has already been mentioned, Angela Pedder, the leader of our STP, will look at combining all the reviews.

The real challenge that we face is the speed at which implementation of the changes is being considered. As other hon. Members have said, it makes it almost impossible to put in place the needed care in the community. Of more concern to me is the fact that nowhere have we really addressed the need for a proper strategy for rural healthcare. I have read the five-year plan, and the word “rural” appears three times. I have been frustrated, when I have written to the Minister’s predecessors to ask about a rural strategy, because they have told me that there is one, when the truth is that there is not. There is an urgent need for a proper review of examples from around the world—Australia and New Zealand. There are plenty of examples. Even China has a proper strategy, and other countries think about such things in a very different way. That, to me, is crucial.

The other day I attended a workshop with the Nuffield Trust, the ambulance service and a number of hospital trusts, looking at what is happening and what we need to do. In rural areas things are at crisis point. Care homes are closing and are not being replaced with new ones—at least not in rural areas. They tend to be developed in city areas. The result will be a change in the population mix in rural areas, which will lead to economic deprivation and then social deprivation. We need to accept that rural communities are different. They need to be supported; otherwise, the consequences will not be as simple as whether we lose a hospital. The taxes raised in this country are generated predominantly in the city, but we accept that they should be spent across the country; equally, that is how we should deal with our rural communities.

We should review and amend the funding formula. I am pleased to hear of the changes in allocation which are coming shortly. However, the issue is more fundamental than the funding formula. One of our challenges is the fact that the needs are different in each rural area, but training regimes have become increasingly specialised. There are many individuals who specialise, in a number of different specialisms; the current regime structure requires a certain number of specialists, in each of those specialisms, to get a tick in the box to say that an area is safe. We need more generalists, not more specialists. Several royal colleges are already considering the generalising of training, but we need conversations to happen not just within those royal colleges but between them, and Government should sponsor and support that. We also need to get acceptance within the trusts that recruit the individuals. If they will not accept the new generalists, we shall have a problem.

We need more generalists and we need more geriatricians. We also need to think carefully about how to deliver urgent care. Urgent care and accident and emergency are not entirely the same. Some of the models used in other parts of the world, such as Australia, are very interesting. It is wrong to say that if there cannot be an A & E department the hospital must go. There are many different ways to provide what we need, and we must look at that. We must also review the regulatory criteria. Regulators say, “You need a person with this job description and this expertise and training.” At the moment regulators will not allow an organisation to accept someone with the right skill mix but without the specific tick-the-box qualifications. That needs to change.

As to the care home sector, we clearly need hard measures, but we need soft measures too. The human side of social care is as important as the technical side. A challenge with respect to the agenda for integrating health and social care is to scrutinise the commissioning of social care in the same way as the commissioning of NHS care. At the moment that is not happening. I do not think I am wrong if I say that there is now a bit of a lottery, based on where people live, for how much money is allocated and therefore how good the care is.

My final plea is about the long-term plan. With increasing development and population—whatever happens about immigration—we need to ensure that we plan. At the moment, the NHS is not a statutory consultee in the planning process; and that needs to be rectified.

Access to Medical Treatments (Innovation) Bill

Anne Marie Morris Excerpts

Friday 29th January 2016 Commons Chamber

Debate resumed—

[Anne Marie Morris]

I shall resume my comments on amendment 2, which would remove clause 3. The argument goes that innovation has fallen in recent years owing to the legal complexities and doctors fearing a negligence claim against them if something goes wrong. There is no evidence of this, according to the Medical Protection Society, the Medical Defence Union, the General Medical Council or various other medical bodies that have spoken out on the issue. They claim that the Bill needs to be completely rethought and that no amount of amendment would make it acceptable. I would like to think that the work that my hon. Friend the Member for Daventry (Chris Heaton-Harris) has done will go some way to meet the concerns expressed before Committee stage.

Those most likely to benefit from innovative medicine are likely to be those most in desperation. Those who have nowhere else to turn will often be allured by the carrot on the end of the proverbial stick, but we must make sure that the treatment is right for that particular person. The UK has a proud history of research through universities, research institutes, the private sector and, of course, the NHS. According to the UK Clinical Trials Gateway, there are currently 3,754 trials recruiting, and that does not include the innovation that goes on day to day in the NHS.

According to the Association of the British Pharmaceutical Industry, it can take over 12 years to develop a new medicine to the standards of quality, efficacy and safety that are laid down in legislation. It will typically cost £1.15 billion to do all the research and development necessary before a new medicine can be licensed for use. For every successful medicine, 25,000 compounds are tested, 25 of these in clinical trials, with five receiving approval for marketing. The pharmaceutical industry invests more in research and development than any other industry—£11.2 million is spent every day—and employs around 23,000 people in R and D. My hon. Friend the Minister for Life Sciences stated in September last year:

“Research and innovation in the NHS are critical for addressing ...challenges.”

I agree and therefore wholeheartedly support amendment 2.

Amendment 3, which would remove clause 4, was tabled by my hon. Friend the Member for Daventry, with the support of the hon. Member for Central Ayrshire (Dr Whitford) and my hon. Friend and neighbour the Member for Totnes (Dr Wollaston). It is important to address the legal aspects of the Bill and medical negligence. The common law test, which is the main test for medical negligence, has been around since 1957 and derives from the case of Bolam v Friern Hospital Management Committee. The Bolam test states that if a doctor reaches the standard of a responsible body of medical opinion, he is not negligent. This rule has served us well over the past 55 years and I believe it will continue to serve us well. However, if it needs to be amended, our judges are in a suitable position to do that. The 1997 case of Bolitho v City and Hackney Health Authority, where the courts refined the Bolam test, is a great example of our common law in action.

Although I am sure some will point out that the Bill does not explicitly change the Bolam test and clause 4(3) appears to address the concerns that were expressed about the Saatchi Bill, I worry that lawyers would still find a way around this. Why tempt fate to change something that is not broken? Judges and lawyers know where they stand with the common law, so maintaining the status quo will give both doctors and patients the protection they need from negligent treatment. If the removal of clause 3 is agreed to, it is right that clause 4 should also be removed as it would no longer be necessary, and the common law of negligence and the Bolam test can continue to operate effectively, as they have done for 55 years. I therefore support amendment 3.

[Heidi Alexander]

This group of amendments, and in particular those which leave out clauses 3 and 4, are very welcome and have my full support. I appreciate that making such extensive changes to a Bill at this stage is not easy, but the hon. Member for Daventry (Chris Heaton-Harris) has been true to his word, and has rightly decided not to proceed with these clauses in the face of strong opposition.

Members who were present on Second Reading will have heard some of the grave concerns expressed by medical royal colleges, research charities and patient groups. I think it would be fair to the hon. Gentleman if I say that those concerns, which I shared, were more about the unintended consequences of clauses 3 and 4, than about the stated aim of his Bill. However, the effect of these amendments, if they are passed, is that the sole purpose of this Bill is now to give the Secretary of State the power to establish a database. The hon. Gentleman knows that on Second Reading, along with many other hon. Members, I said that I believed the Secretary of State already had this power.

The Association of Medical Research Charities has said that primary legislation is not required to set up a database of innovative medical treatments. According to the House of Commons Library, section 254 of the Health and Social Care Act 2012 gives the Secretary of State power to direct the Health and Social Care Information Centre to establish a system for the collection or analysis of information. Indeed, in Committee, the Minister signalled his intention to introduce such a database, regardless of whether this Bill becomes law. He said at that time:

“If the Bill does not, for whatever reason, reach the statute book, I would happily proceed towards establishing such a database”.––[Official Report, Access to Medical Treatments (Innovation) Public Bill Committee, 16 December 2015; c. 22.]

With that in mind, I have to question whether what is left of this Bill is needed at all.

There also seems to be some confusion, even in the Minister’s own mind, about the purpose of the Bill. The Daily Telegraph claimed on 22 January that the Minister had told it that changes in the reworked Bill could help to cut the length of time it took to bring a new drug to market by a third, from 15 years to 10 years. Yet when my hon. Friend the Member for Ellesmere Port and Neston (Justin Madders) received a written answer to a question on this very subject on 28 January, the Minister’s reply was:

“The Bill is not specifically designed to reduce the length of time it takes to bring a new drug to market”.

I would be grateful if the Minister clarified the apparent contradiction in those remarks. Having said all that, I support all the amendments in this group. Indeed, they represent a positive step forward in terms of the overall Bill.

--- Later in debate ---

[Heidi Alexander]

Setting aside the fact that I question whether what is left of the Bill is necessary, if the database is to be created, it is important that we get its design right. The Association of Medical Research Charities has expressed concern that the database might adversely impact patients and medical research. For such a database to be effective, it will need to be appropriately regulated and quality controlled. I believe that it can command the confidence of the medical profession only if it is developed in consultation with it. With that in mind, amendments 8 and 9 deal with the bodies that the Secretary of State must consult and get approval from before introducing regulations establishing a database of innovative treatments.

As the Bill stands—this is set out in clause 2(1)—to make those regulations the Secretary of State need only consult the Health and Social Care Information Centre. Restricting the statutory consultees to only one organisation seems highly restrictive and is inconsistent with the Bill’s explanatory notes, which state:

“The detailed design of the database would be consulted upon with professional bodies and organisations.”

Amendments 8 and 9 would make the legislation clearer on which bodies should be consulted.

I note that the Minister was unable to support similar amendments tabled in Committee because he felt that the list was “not exhaustive”. Indeed, he went on to say:

“Although it represents a helpful list of consultees, such a provision would need to include many more organisations. While I understand the intention behind the amendment, restricting the process would not be helpful”.

The hon. Member for Daventry (Chris Heaton-Harris) then said:

“I know from my consultation on the Bill with stakeholders that we would need longer lists than those in the amendments.”––[Official Report, Access to Medical Treatments (Innovation) Public Bill Committee, 16 December 2015; c. 22-23.]

With those constructive comments in mind, I have included in the list a provision allowing the Secretary of State to consult

“any other body or individual that the Secretary of State considers it appropriate to consult.”

I know that there were concerns that the list of specified organisations could become out of date. However, given that these regulation-making powers would likely be used only once—to create the database—I do not believe that concern is wholly justified. Indeed, if the Minister, or any hon. Member, believes that an inappropriate organisation is on the list set out in my amendments, I would be keen to know which organisation they feel should not have a say in the creation of the database.

I hope that these important amendments will address the concerns raised in Committee and that hon. Members will now be able to support them, because they will ensure that we get the design of the database right.

[Anne Marie Morris]

I will speak first to amendments 8 and 9 and then turn my attention to amendment 15. As the hon. Member for Lewisham East (Heidi Alexander) explained, amendments 8 and 9 would add a whole host of bodies—I think that I counted eight—that the Secretary of State must consult before making regulations under subsection (1). This relates to the conferring of functions on the Health and Social Care Information Centre in connection with the establishment, maintenance and operation of a database. The hon. Lady has talked articulately about why the two amendments should be made, but I have some concerns.

My main concern, despite everything the hon. Lady said, is that adding all these organisations that the Secretary of State must consult will just add to the complication of the database. The amendments not only ask the Secretary of State to consult, but ask that all these organisations approve the regulations. Adding these extra organisations will just add to the confusion about who is policing the system. Is the consent of all those organisations needed before a treatment can be removed, or can it be removed just by the Health and Social Care Information Centre? If a complaint is made about what is on the database, does it go to the Secretary of State, the NHS or the Health and Social Care Information Centre, or does it have to be put in front of all those organisations again?

I understand that the hon. Lady might not have all the answers to my questions and that these issues go deeper than just her amendments, but I do not think that adding extra layers of consultation will help to simplify the Bill or make it any easier to implement the database, which, if put together correctly, could do much good and help many people across the country and, potentially, the world. I do not support amendments 8 and 9, because I believe that they will add unnecessary complications to the database and impede the good work that it could well achieve.

Amendment 15 has been tabled by the Minister, who has spoken eloquently throughout these debates. Including references to treatments carried out for the purposes of medical research will enhance the database, because it will allow the inclusion of clinical trials and other forms of medical research. Including medical research in the Bill will hopefully help to address the UK DUETS database. Mr Deputy Speaker, you will be glad to hear that that is not a database of UK singers who perform together; it is the database of uncertainties about the effects of treatment. It publishes treatment uncertainties from a wide range of people, including patients, clinicians and research recommendations, among others. By including medical research on the database, hopefully we can remove a few more treatment uncertainties from the database or, on the flip side, identify treatment uncertainties with greater ease and therefore tackle them head-on.

Clinical trials are vital if we are to put our NHS resources into the right treatments. They can help find out how to prevent illnesses, detect and diagnose illnesses or treat illnesses. The earlier we can do that, the more lives we can save, so I support any move to increase clinical trials, which I believe this amendment will do. It is my belief—I am sure that my hon. Friend the Minister will correct me if I am wrong—that his amendment will also increase knowledge of clinical trials among clinicians by adding them to the database. Sir Francis Bacon said that “knowledge is power”, and I do not believe that is any less true when it comes to medicine and saving lives. I fully support the Minister’s amendment.

[Oliver Colvile (Plymouth, Sutton and Devonport) (Con)]

I congratulate my hon. Friend the Member for Daventry (Chris Heaton-Harris) on introducing this Bill. Let us hope that it has a successful outcome later. I should remind you, Mr Deputy Speaker, that I am the Government’s pharmacy champion and vice-chairman of the all-party pharmacy group. Consequently, the majority of my comments will be based very much on pharmacists as dispensers of medicines that will include off-label ones.

I enter into the debate with some trepidation having listened to the hon. Member for Central Ayrshire (Dr Whitford), who was incredibly well-informed and very persuasive. I hope that my comments will be practical and constructive. I want to concentrate on the data-sharing of summary care records, as well as information to do with these medicines, and the decriminalisation of pharmacists for dispensing errors. I hope that the Minister can clarify his position on some of this stuff when he winds up.

--- Later in debate ---

[Chris Heaton-Harris]

I thank the hon. Lady, and I completely concur. I can foresee great benefits for those in the outer reaches of the NHS who do not necessarily come across information about many of the trials that are taking place. One of the biggest criticisms of the original formulation of my Bill was the fear in connection with getting people on to clinical trials. I would like to think that we have not just overcome that issue, with the amendments we are discussing and the latest version of the Bill, but have gone some way along the line to help improve the ability of registered medical practitioners to have knowledge of such trials. I completely concur with the hon. Lady’s point. We have innovation everywhere, so there is a real purpose behind having a database, regardless of whether the Minister has had the ability to set one up before now.

On research, Lord Winston made a very important point particularly well in the other place on Second Reading of the Mesothelioma Bill. He stated:

“There is no question that in the field of treatment there is a great deal of research.”

He had a list of a number of chemotherapeutic agents that were being looked at, saying:

“In recent years I can count at least 10 or 11”.

He then went on to name them. They are impossible for me to pronounce, so I will not do so here today. He said that,

“there are various combinations of those therapies with other well-known mitotoxic agents. These have included trials”.

He went on to say:

“Other treatments have been researched: of course there is surgery…and there are now attempts to try to reduce the tumour inside the lung membranes.”

He spoke about three trials that Cancer Research UK is conducting to emphasise the wide range of “stuff”, as he put it, that is going on.

“One is some work with HSV1716, which is a virus that acts against dividing cancer cells. It comes from the herpes virus…a very good example of where we might make a breakthrough in treatment. Then there is a different strand of research with ADI-PEG 20, which in combination with other drugs such as cisplatin affects a particular amino acid in the chain of cell division”—

which could prevent cancer cells from multiplying.

“That has been specifically targeted for the treatment of mesothelioma. A compound, GSK3052230, developed by GSK, is I think about to enter phase 3 trials very shortly. That attacks the FGFR1 gene, and therefore stops cancer cells growing.”

This is where he makes the point exactly:

“There is now an increasing emphasis on understanding that, if we are going to improve outcomes for patients with a variety of different cancers, and other chronic long-term conditions, we need to move away from a generalised approach to managing disease towards personalised, precision medicine”.—[Official Report, House of Lords, 20 November 2015; Vol. 767, c. 395-7.]

Medicine is going to change. Research is going to change. Spreading the information about that across our NHS, and how quickly we can do that and learn from success and failure in our NHS, is a very, very important matter.

[Anne Marie Morris]

Does my hon. Friend believe that personalised medicine should become a reality over the next little while and not a research project, and that unless we have freedoms within the database we will never have the knowledge to find out that we can truly have personalised medicine?

[Chris Heaton-Harris]

I truly believe that personalised medicine will become a reality. I would like to think that a database would aid the spread of knowledge about how individual medicines are being used and who they might affect in different ways, so yes, I nearly completely agree with my hon. Friend.

--- Later in debate ---

[Anne Marie Morris]

I once again congratulate my hon. Friend the Member for Daventry (Chris Heaton-Harris) on bringing forward the Bill. I am sure I will not be the first to tell him what a feat it is to get a Bill through this House, with all its complexities, to Third Reading. Clauses 1 and 2 will give many people throughout the country hope that there is a cure for many well-known and not so well-known diseases. The database will make it much easier for clinicians up and down the country to find them and provide a better quality of life for many people.

I commend my hon. Friend for the time he has put into the Bill, and the effort he has made to obtain cross-party support on a number of issues. His work with the hon. Member for Torfaen (Nick Thomas-Symonds) to include some of the provisions of his Off-patent Drugs Bill is to be commended. Although I did not support all the hon. Gentleman’s amendments, I do believe, as I stated on Report, that amendments 10 and 13 will help many people to live healthier and happier lives for years to come. I therefore congratulate him on his contribution to this Bill.

Some great medicines have been developed through the use of off-label treatment, and I believe that they will continue to be developed, even without the new clauses that the hon. Gentleman tabled. I do not profess to be an expert in the field of off-label treatment, but I know that drugs such as infliximab, adalimumab and methotrexate are now regularly used in the treatment of Crohn’s disease and ulcerative colitis, having previously been used to treat rheumatoid arthritis and cancer. The use of those treatments has come on leaps and bounds over the past 10 years, and that in an environment where, it is claimed, doctors are scared to innovate. As I have stated, I do not profess to be an expert in these matters, but I do know that many doctors communicate not just countrywide, but across the boundaries of diseases, and learn from each other. The database that the Bill establishes will allow that to be achieved with much greater ease.

A member of my office staff has been fortunate enough to benefit from the drugs that I have just mentioned. Indeed, he informs me that he was one of the first people, if not the first person, to be given the drug adalimumab to treat Crohn’s disease. He was prescribed it in Southampton back in 2007, when it was not licensed for use in children. Had the doctors not taken innovative steps to prescribe a medicine that had not yet been licensed, he would not have had such a fulfilling life—something that many of us take for granted. That is just one example, and I am sure that Members across the House have many more examples of doctors using innovative medicines to help out constituents and loved ones with all manner of diseases. I am therefore delighted to support the Bill on Third Reading and the great work my hon. Friend the Member for Daventry has done to get us here.

Access To Medical Treatments (Innovation) Bill

Anne Marie Morris Excerpts

Friday 29th January 2016 Commons Chamber

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

I rise to support new clauses 1 to 3, 5 and 6 and amendments 10 and 13. The only reason new clause 4 does not stand in my name is that it relates to NHS England, which is outwith my purview.

People are well aware of my objections to clauses 3 and 4. Many Members in this House and medical voices outside the House have real concerns about the danger to patients of doctors having to convince only one colleague before trying a completely unproven approach. As well as the danger to patients, I feel that there is a danger to our clinical trials system. Why would someone go through applications, a year of paperwork and phases 1, 2 and 3, when they could just cut to the chase?

I pay tribute to the hon. Member for Daventry (Chris Heaton-Harris) for being willing to sit around a table with the Members who were named by the hon. Member for Torfaen (Nick Thomas-Symonds) and the Minister, and to start with a blank sheet of paper and work out how we could do something useful. It has been a great procedure. I welcome the fact that later in the day the hon. Member for Daventry will propose the removal of the clauses on innovative practice and litigation.

Turning to the off-patent drugs proposals, 6 November was a very frustrating day in this House. Every single Member who spoke from the Back Benches spoke in favour of the Off-patent Drugs Bill, but the time ran away during the Minister’s response—not the Minister who is here today. That debate showed the appetite across the House to get something done on off-patent drugs.

The hon. Member for Bury St Edmunds (Jo Churchill) has explained most of what I was going to explain. There is still the issue that while specialists are steeped in the evidence and used to using drugs off label, those who are not are less sure. There is no automatic place where they can check a dose or an indication. Sometimes, it is the general practitioner who does not carry it through. We have had lots of discussions in this House about the changes in the NHS and the evolution to multidisciplinary teams out in the community. That means that there are far more non-medical prescribers. The further someone is from the expert prescriber, the less comfortable they are. They do not have easy access to somewhere they can check when they think, “Is that just my bad handwriting or is that really what I mean?” That is what new clause 6 on the BNF could achieve.

The BNF is used by everyone and is on every desk in the NHS. As the hon. Member for Bury St Edmunds said, people can either check a drug that they have had a letter about from the hospital or look something up when they think, “I don’t have anything for this. What exists?” We will also discuss that when we come to the database proposals. I welcome the fact that the database has been changed from being a registry of people doing their own thing to a place where information is shared.

On new clause 5, which I tabled, although the inclusion of off-patent drugs in the BNF will achieve the sharing of information and will, in a sense, give them a slightly informal kite mark, I feel that it is important to look eventually at providing a licence. The reason for my concern relates to the drug simvastatin, which is used all over the place to control people’s cholesterol and has been found to be useful in multiple sclerosis—a disease that plagues many people and causes a lot of suffering, and for which, frankly, we do not have a lot to offer. That drug is incredibly cheap, but if a company decides to tweak a little molecule of it, call it something else and put it out as a new wonder-drug for multiple sclerosis, we will be having debates in Westminster Hall about a drug that costs fifty grand and that the NHS cannot afford. Under General Medical Council rules, the cascade is still that a doctor must prescribe a licensed drug over an unlicensed or off-label one, regardless of cost. If a doctor was faced with fifty grand for simvastatin-new versus sixpence for the simvastatin we all know, they would have no choice, and we would be right back in the same position—relentlessly discussing the NHS’s access to drugs.

The drugs we are talking about are already safe. They have had a patent and been used for so long that they are now off patent, which means that they have been around for a decade. We know their side effects, the common dosages and what to look out for. They should not have to start at point zero of the licensing process. We need a short licensing system, so that patient groups, academics, charities and the British Generic Manufacturers Association can say, “We think there is something useful here.” We have put provisions in new clauses 2 and 3 for the NIHR and NICE to have capacity in their systems to provide a funnel for evidence on such drugs.

These drugs are not developed by big pharma, so there are not huge costs that have to be recouped. The purposes of them are usually found by academics and clinicians, so pharmaceutical companies should not make a massive profit out of them. The benefit should be that the NHS can afford them and patients can access them. We have many debates about access to medical treatments in the House, usually in Westminster Hall and usually about drugs that are eye-wateringly expensive. In this case we are talking about drugs that are proven and cheap. We need to come up with a system that makes them accessible to patients.

I commend the Minister for the time, that, as others have said, he has given the four of us around a few tables, hammering these provisions together. I hope that we will be supported in working them through and actually doing some good for the NHS and our patients.

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

It is with great pleasure that I rise to speak in support of this important Bill, introduced by my hon. Friend the Member for Daventry (Chris Heaton-Harris), and the amendments he has tabled. Specifically, I rise to support amendment 13. I am sure that the hon. Member for Torfaen (Nick Thomas-Symonds) will be disappointed that his private Member’s Bill did not make it to Committee stage, but I hope that he is happy to see some of it included in this Bill.

I had my reservations about the Bill as it stood originally, and I have reservations about some of the amendments, but I believe that amendment 13 will increase the use of off-label drugs in a safe and secure way. Those drugs can often be a cheaper and quicker way to tackle a disease, as they do not have to go through the rigmarole of being developed and licensed, which can take many years and many billions of pounds. NICE states that an unlicensed medicine is one that

“does not have a UK marketing authorisation and is not expected to do so in the next 2 years”,

whereas an off-label medicine is one

“with an existing UK marketing authorisation that is…used outside the terms of its marketing authorisation”,

and for which

“it is not expected that the existing UK marketing authorisation will be extended to cover this use in the next 2 years.”

The inclusion of off-label use classes in the database as innovative medical treatments will allow the medical profession to see where off-label use has been effective, even if it is at the other end of the country. However, we must be careful not to place off-label uses on a pedestal and allow people to cling on to false hope. They are the most vulnerable people in our society, often looking for any treatment that may help them, but we must ensure that any drug that is prescribed off label is used responsibly and ethically. I believe that the database will help by allowing doctors to see what is effectively a large sample trial that gives them more information on a particular treatment. I therefore support amendments 13 and 10.

[Mrs Flick Drummond (Portsmouth South) (Con)]

I thank my hon. Friend the Member for Daventry (Chris Heaton-Harris) for bringing this important private Member’s Bill before the House and for his work in ensuring that all parties agree with it. It seems that a lot of work has gone into it by Members throughout the House, and as someone who was not part of those discussions, I am grateful to them for doing that work for everybody else.

The NHS benefits from one of the most rigorous health technology assessment organisations in the world, which provides clear and robust evidence of the clinical benefits of new interventions. However, the introduction of innovative treatments is complex, not straightforward, and the difficulty for the life sciences industry in getting new treatments to the market means that UK patients are often the last to see the benefits of new innovations in their disease area.

--- Later in debate ---

[Chris Heaton-Harris]

The hon. Lady knows that I would obviously have preferred to retain clauses 3 and 4, but I have to agree with her: the body of opinion stands on her side of the argument, not mine, so the simple answer is yes.

I remind the House, though, that there was a decent and honourable purpose behind clauses 3 and 4. Dr John Hickey, the former head of a primary care trust, contacted me to say that,

“as a registered medical practitioner, a former NHS Trust Chairman and with 30 years’ experience in the field of legal medicine with the Medical Protection Society (last five years as Chief Executive), I believe I am adequately qualified to comment on your Bill.”

He went on to say:

“Over the last 30 years I have seen how doctors have increasingly practised defensive medicine…because of the fear of litigation and disciplinary action by their regulators; this defensiveness is not in patients’ best interests.”

In fact, it may interest Members to hear that, in reading the debates on the Bill introduced by the hon. Member for Torfaen (Nick Thomas-Symonds) and the recent debate on the Mesothelioma (Amendment) Bill, I have seen much stated that supports the action I wanted to take in clauses 3 and 4 to reassure doctors who fear litigation. For example, the British Medical Association’s parliamentary brief for the Second Reading of the Off-patent Drugs Bill stated that there were

“two barriers to the use of off-patent drugs in a new indication: 1) Clinicians’ confidence in prescribing: clinicians take on a personal and professional liability if they prescribe an off-patent drug in a new indication”,

and therefore they require reassurance. The brief goes on:

“GMC guidance also indicated a greater level of responsibility for the doctor prescribing off-label and therefore potential greater risk of liability which would be a disincentive for a doctor prescribing off-label drugs”.

That is a simple statement of the purpose of clauses 3 and 4: to give doctors a supplementary way to assure themselves that they are doing the right thing where they might want to do something they believe to be in their patients’ best interests, in a fully evidenced, responsible and honest way.

Similarly, the Multiple Sclerosis Society’s brief on the same subject states:

“Guidance from the General Medical Council is clear that a doctor takes on an extra level of personal liability when prescribing off-label, which would be a significant disincentive to prescribing”.

Breast Cancer Now says that, because of personal liability,

“doctors can be unwilling to prescribe drugs for new purposes, even where…clinical evidence is strong”.

As Lord Freyberg stated in the mesothelioma debate in the other place,

“The fastest way to save lives is to see if the drugs for common cancers work on the rarer ones as well, given the shared mechanism of disease across cancer. This is off-label research and until we fix the issue of liability, as advocated by the noble Lord, Lord Saatchi, we will continue to send thousands, like my sister, to an early grave.”—[Official Report, House of Lords, 20 November 2015; Vol. 767, c. 407.]

There was therefore plenty of reason and evidence to support clauses 3 and 4, but I guess politics is all about being pragmatic, and I believe that the provisions that we have already discussed are worthy in themselves of inclusion in a sensible Bill, because they will do some positive things. It is therefore with some reluctance, as I am sure the House will understand, that I have decided to table these amendments, which strike the elements relating to clinical negligence from my Bill.

[Anne Marie Morris]

I support my hon. Friend’s amendment 2, which would remove clause 3—the responsible innovation clause—from the Bill. I know that his heart was absolutely in the right place when he first put the Bill before the House; however, I am glad he has tabled the amendment, as I am sure the majority of us, if not all of us, are present in the Chamber to ensure that the rest of his Bill, particularly the provisions dealing with the database, gets through.

I have received briefings from all manner of medical bodies, as I am sure all colleagues have, stating that the Bill would do more harm than good for patients. A letter signed by nine different medical bodies, including the Academy of Medical Royal Colleges, the British Medical Association and the Patients Association, says that

“this Bill will actually harm good innovation by weakening patient protection, adding unnecessary bureaucracy and undermining good scientific practice.”

By removing clause 3, amendment 2, along with amendment 3, will allay those fears. There will no longer be any fears about doctors using quackery, as some people outside the Chamber have put it. Instead, there will merely be a database, set up by the Secretary of State, who may by regulation confer functions on the Health and Social Care Information Centre, although I note that the hon. Member for Lewisham East (Heidi Alexander) has tabled amendments seeking to change who the Secretary of State has to consult before making any regulations.

At a constituency level, a number of concerns have been raised with me by those in the healthcare sector who believe this Bill, or at least this clause, would do more damage than good. There was a misconception among some people that it remained a carbon copy of Lord Saatchi’s Medical Innovation Bill, which was introduced in the last Parliament. Although my hon. Friend’s Bill is indeed similar to Lord Saatchi’s, the amendments he has tabled will completely dispose of any similarity at all. Innovation sounds like such a good idea. To most people in the street, it sounds like a marvellous thing and therefore taking “innovation” out of the Bill must be a bad move. However, innovation must be achieved through the correct means and must not pose any danger to patients.

The argument goes that innovation has decreased in recent years owing to the legal complexities and doctors’ fears of negligence claims against them if something goes wrong. There is no evidence of that, according to the Medical Protection Society, the Medical Defence Union, the General Medical Council and various other medical—

Debate interrupted.

NHS and Social Care Commission

Anne Marie Morris Excerpts

Thursday 28th January 2016 Commons Chamber

[Norman Lamb]

The hon. Gentleman is absolutely right. Simon Stevens has made the point that if we cut social care, the £30 billion gap widens. There is no escaping from that. The brutal truth is that the whole system is under very substantial pressure. Analysis by the Office for Budget Responsibility, which is independent of Government, shows that between now and 2020, we are planning to spend a reducing percentage of our GDP on health. At a time when demand is increasing so dramatically, does that decision make any sense at all? Back in 2013, the OECD did an analysis of all OECD countries in the European Union. Only five were spending a lower proportion of their GDP on health than we do. The NHS is very good value for money, but it is under extraordinary pressure.

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

The right hon. Gentleman is being very generous with his time. The picture that he is painting is one of a very reactive approach to the growing problems. I entirely support his call for this review. As a responsible society, we need to have a holistic, forward-looking, proactive approach, particularly with regard to social care. The Barker commission made a number of good proposals, some of which I agreed with and some I did not. To what extent does he agree with me on that point?

[Norman Lamb]

I totally agree with the hon. Lady. In fact, I think that I have agreed with every intervention so far. We will probably all just agree with each other. She is absolutely right and it goes to my point about crisis management. We are at risk of lurching from crisis to crisis, as we prop up a system that is under unsustainable pressure. Of course we always end up spending money at the repair end of the spectrum, rather than on preventing ill health.

There are some great initiatives in the west country, where volunteers, working with GPs, try to address the problems of loneliness, and that is helping to keep people out of hospital. That sort of thinking needs to be much more widespread.