Off-patent Drugs Bill

Anne Marie Morris Excerpts

Friday 6th November 2015 Commons Chamber

[Nick Thomas-Symonds]

My point is precisely that it is about more than information.

A licence for off-patent drugs would make a big difference. The all-party parliamentary group on off-patent drugs, which I chair, met on 15 October and took evidence from experts across the board. Pan Pantziarka, a repurposing specialist, said that granting a new licence triggers a “whole cascade of things”: the British National Formulary gets updated, clinical commissioning groups and specialist bodies take note, and guidance is updated. He said that, without that, we are dependent on doctors reading the literature and prescribing off-label, and that that is not the solution we want.

Sir John Burn, professor of clinical genetics and a non-executive director of NHS England told our inquiry:

“The other problem is making decisions in a short time scale—we haven’t got time to look at the bundle of evidence presented. The whole point of the licensing process is to distil that for the physician”

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

Will the hon. Gentleman clarify something for me? Under his proposed scheme, when a drug gets relicensed, what will the impact be on pricing? When a drug goes off-patent, one benefit is that it effectively becomes cheaper because any company can manufacture it, which is clearly a benefit for the NHS. With relicensing, is there a risk that the company will effectively re-price, landing the NHS with extra costs?

[Nick Thomas-Symonds]

I do not accept that that is a risk of the Bill. As the hon. Lady knows, the drugs are available for pennies a day. Under the Bill, the Government would step in to address a market failure. The Bill will not have the impact that she believes it will have. She makes a reasonable point, but it is not one that will arise under the apparatus and structure proposed by the Bill.

The alternative to the Bill—I firmly believe that if this Government do not do this, a future Government will have to legislate—is to continue to encourage more off-label prescribing. Even if that were desirable, very little has happened. In a letter dated 2 November, the Royal College of Physicians states:

“As there has been no meaningful progress on a non-legislative solution to this issue, we believe that your Bill is an important first step towards expanding access to these vital drugs.”

The proposal was debated a year ago and we have had a year to see whether there is a non-legislative solution to the problem.

The Bill has incredibly wide support across the professional spheres. I apologise in advance for not naming every charity that supports it.

--- Later in debate ---

[Nick Thomas-Symonds]

The hon. Gentleman is absolutely right. The Bill could really assist people out there in the country, which is why it should proceed.

[Anne Marie Morris]

The hon. Gentleman has not talked about the consequences for off-label drugs. I do not think that anybody would disagree with using good drugs for alternative purposes. Most of the concerns I have heard about the Bill are around the methodology and the process and the impact on off-label drugs. At the moment, drugs not on the agreed list can be prescribed, and I would be concerned if there was any threat to the ability to do so.

[Nick Thomas-Symonds]

With respect, that is precisely what the Bill seeks to do. We are talking about drugs that have been on patent for a particular purpose and that have a licence in that indication, but which also have another purpose. At the moment, theoretically, they can be prescribed off label, but that simply does not happen consistently across different spheres of medicine or across the country. The letter I read out from the Royal College of Physicians, dated 2 November, made that exact point.

The Bill is a common-sense solution that commands support across parties, in different spheres of the medical profession and from other stakeholders, and I commend it to the House.

Care Homes (Regulation)

Anne Marie Morris Excerpts

Wednesday 4th November 2015 Westminster Hall

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

Thank you, Ms Vaz. I shall endeavour to speed through my comments. First, I commend my hon. Friend the Member for North Devon (Peter Heaton-Jones). We are both MPs from the south-west, and our constituencies have a significant number of elderly residents and therefore of care homes and nursing homes. The issue he raises is crucial, but perhaps I can take the opportunity to broaden the debate, because I believe that the problem is not as simple as just the CQC. Many of his points about the CQC were well put, but this is a broader challenge.

I shall start by explaining that nine statutory bodies—all independent and all accountable to Parliament—are overseen by the Professional Standards Authority for Health and Social Care, so it is a question of looking not just at the CQC, but at all those bodies together. You can appreciate, Ms Vaz, that nine bodies will inevitably have various sets of regulations, which will not necessarily be consistent and work well together. Indeed, the Professional Standards Authority report in 2015 made it clear that the regulatory framework was unfit for purpose.

However, this is not just about the regulatory framework; it is broader than that, too. Rules and regulations do not make people good. Regulation is about trying to ensure best practice and that those who default are made to sort the situation out. As my hon. Friend said, too much bureaucracy takes the care out of caring, and this is really about care. It should not be about bureaucracy —box-ticking. It should be about ensuring that elderly residents are properly respected and cared for.

The Professional Standards Authority has concluded—unsurprisingly, given its oversight of nine authorities—that less is actually more. It suggests that we need a new framework and that we should look at sharing objectives across all the regulators and sharing the theories of what works so that there is a consistent approach. Most importantly, we should rebuild the trust among the professionals, the public and the regulator, because at the moment there is an awful lot of mudslinging among the three and that is not helpful. What we need is a good system that works for our society. We also need proper risk assessment models to ensure that we are looking at the things that really matter and actually put residents at risk.

There are, inevitably and tragically, many cases that none of us want to be repeated. It almost goes without saying—my hon. Friend has already made it clear—that there are plenty of examples. Indeed, the statistics demonstrate that there is clearly something wrong. The report “The state of health care and adult social care in England 2014/15” showed that 60% of providers found to be inadequate were not improving, so there is clearly something not quite right. In Bedfordshire the Old Village School home managed to go from “good” to closure within six months; previously it had been excellent. There is clearly something at the root of this that is not just about regulation and bureaucracy, but is more fundamental.

Before I move to that broad picture, I have a couple more thoughts on the Care Quality Commission itself. I have met Andrea Sutcliffe on a number of occasions and I believe that she is cognisant of and takes seriously the concerns raised by my hon. Friend. However, there is a challenge, which is that the remit of the CQC was expanded to cover so much that in reality it is almost inconceivable that it could do the job properly, to the right standards, given how stretched it is. Indeed, in its own survey in 2014, 40% of CQC staff felt that they were not adequately trained. There is clearly a challenge—about regulation, about structure and about asking an organisation to do more than realistically it is capable of doing. If that is the case, we should not be surprised when things fall apart.

There was an interesting comment, however, from the National Audit Office. It said that the CQC does not know whether its model for predicting staff numbers is accurate enough. That, for me, goes to the heart of the matter. We can have as much regulation as we like, but if we do not have staffing right—if we do not have the right numbers or the budget to pay for them—inevitably, there will be huge problems.

I have looked at the care home reports for Teignbridge District Council in my constituency. The new regime and the five new tests came into play April this year, and the new tests are absolutely on point: the home must be safe, efficient, caring, responsive and well led. That is absolutely right. Twenty-one of the 70 care homes in the area have been inspected and 10 have been found to be good. I share my colleague’s concerns about the homes that were not found to be good, but I took to reading the reports to find out what they actually said. Although the reports covered 10 or 15 different areas, if I dug down to the root causes I found that they were really about staff and the adequacy of both numbers and training.

I meet people from my care homes regularly, every three months, and they tell me that if hon. Members do as I did, they will reach a similar conclusion—that it is a real challenge to find the managers needed to run the homes. Without those managers, the homes are found wanting but they have no ability to resolve the problem. There is a similar challenge in the shortage of nurses. Being a nurse in the care home sector is much more challenging, I think, than being a nurse in the NHS. Care home nurses often work on their own at night, whereas a nurse in an NHS hospital will be surrounded by lots of colleagues. In the care home sector, nurses often work with difficult individuals who have complex problems, often including dementia, with all its attendant behavioural complexities.

The feedback from those responsible for care homes in my constituency conveys much frustration. They understand the role of the CQC, but they feel deeply frustrated that they cannot always put right the things that are found to be wrong. That must be incredibly frustrating. They feel that there needs to be a new balance between scrutiny and support. Although they feel it is right that they are properly scrutinised, they also feel that there is a lack of support. I had the pleasure of talking to the Minister only yesterday, and he was at pains to tell me that the CQC was indeed endeavouring to provide such support. I said to him then, and I will repeat it today, “They don’t see it and they don’t feel it.”

In the old days, under the CQC’s predecessor, care homes received guidance as well as criticism. Because of the desire to separate the two, which I can understand conceptually, they now feel as though they are left on their own. I am proud of our Devon homes, because we have produced our own kitemark for dementia care, as a result of which the homes work together, peer review each other and provide their own training schemes. I think that that is a good way forward.

For me, the big question is: are we looking at everything that impacts the system that endeavours to provide care in care homes and nursing homes? I do not think that we are. There is a big piece missing—the commissioning. At the moment, we review and scrutinise the provision of care, but we do not scrutinise the commissioning done by local authorities and unitaries. If they do not get the commissioning right and ensure that the right providers are providing what is needed, the system will fall down. I have, for example, seen individuals placed in care homes who should be in nursing homes because they have needs that are well beyond the capabilities of a non-nursing care home. That is something that must be critically and urgently addressed.

I am also concerned that we should look in a fair and balanced way at what we are paying our providers. At the moment, commissioners are not in any way held to account for what they pay providers. There is no standard review of the pricing across the country. If pricing is worked out on an ad hoc basis, the amount of money that local authorities pay their providers will vary across the country. At the end of the day, however, although there will be minimal differences in some staffing costs, by and large the costs will not be as diverse as the pricing structure indicates. There needs to be a proper analysis of the prices paid and what we are getting for the money. Are we getting tin tacks, or are we getting platinum? Is the situation as diverse as I fear it is? As a civilised society, we need to determine what we should be giving our citizens, and we need to ensure that that is delivered consistently across the country. The failure to do so will give rise to safeguarding issues.

My final point on commissioning is that we should separate commissioning and provision. At the moment, a local authority can do both, so there is a potential conflict of interest. I am conscious of the fact that time is not in my favour and you would like me to move on, Ms Vaz. I have made most of the points that I wanted to make, so I will just say that dealing with that is a key issue. Regulation is only part of the problem. As the sun slowly comes out, we need to start to fix the roof, and this has to be a key part of that process. We need a proper system of care, not merely compliance. It needs to be properly funded, and staff need to be properly trained.