Off-patent Drugs Bill

Debate between Kit Malthouse and Philippa Whitford

Friday 6th November 2015 Commons Chamber

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

I was interested to hear the hon. Member for Torfaen (Nick Thomas-Symonds) mention the research into zoledronic acid. I took part in the AZURE study, which indeed means that this bisphosphonate, which strengthens bone, will help bone to avoid getting invaded in the first place. We already use it in breast cancer for patients who have bone metastasis, but it provides a perfect example of where a second use can be found.

The hon. Member for Newton Abbot (Anne Marie Morris) expressed concern about prices going back up, but that simply does not apply. These drugs have been through the whole process, so we know about their safety and their side-effects; they are now cheap and generic. They are made by lots of different companies, and the reason they do not get licences is that it is simply not worth while because the companies cannot put the price back up. If a formulation is changed—if it was a tablet and is now an injection, or if it was an injection and is now a tablet—it is possible to apply for a new patent. If it is exactly the same drug, even with a new use, the company cannot get a new patent. It is not willing to spend the money on sponsoring it.

I have heard people say, “It is in the guidelines”—and believe me, many of these drugs are in NICE guidelines. NICE guidelines say exactly what was said at the beginning of the debate, which is that tamoxifen should be made available to patients who are at high risk of breast cancer. However, it is not licensed for them.

I am a breast cancer surgeon, and in my practice we carry out an operation called sentinel node biopsy. Instead of taking all the lymph nodes out of a woman’s axilla and giving her lymphedema—which some Members will have seen, either in their families or in their constituents—we try to remove only one or two, and we use dyes to target them. One is a blue dye called patent blue dye. It is so old that it is not even made in this country any more, and it literally costs pennies, but it is unlicensed. One of its possible side-effects is anaphylactic shock. That is very rare, thank goodness, but there it is. According to all the UK guidelines, that is the approach that must be taken to breast cancer patients.

I used to have to sign a form before every case that I handled, stating that I accepted personal financial liability if the patient suffered. Eventually I said, “Wait a minute: I am not putting my house on a piece of paper for every case when I would be in trouble if I did not handle that case.” Thankfully, my health board was eventually willing to underwrite it.

The idea that guidelines give us protection is unfortunately not true. When guidelines were introduced, the medical profession was reassured that they did not handcuff a clinician, and if a patient was treated off-guidelines, because patients do not fit in cubbyholes, there would not be an issue. Similarly, following guidelines slavishly does not give any protection. Doctors carry legal responsibility for any drug that they prescribe. So the specialists will prescribe off-patent drugs, and we will be using them.

[Kit Malthouse]

I am slightly confused. Doctors are absolutely responsible for what they prescribe, but only if they do so negligently. The hon. Lady would not expose herself to litigation if she had, for instance, used the dye on a patient who then suffered from anaphylactic shock if that had been an appropriate and responsible thing to do given the patient’s condition at the time.

Dementia Care Services

Debate between Kit Malthouse and Philippa Whitford

Wednesday 9th September 2015 Westminster Hall

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

I commend the hon. Member for Charnwood (Edward Argar) for securing this debate on what is probably one of the biggest challenges we will face over the coming decades. There is no easy answer, north or south of the border or on either side of the House. I think we all fear it. Previous generations have feared other illnesses and avoided them. They talked about consumption instead of TB, or about “the big C” instead of cancer. Most of our generation are less afraid of cancer than of Alzheimer’s. We are afraid of disappearing, or of being married to someone who simply is not who they used to be. That is a fear we all live with.

The Scottish National party welcomed the then Government’s introduction of a national dementia strategy in 2009. The Scottish strategy came in 2010. We set out clinical standards the following year and updated our strategy in 2013. We reached the 64% diagnosis target in 2013, when England was diagnosing 48% of those with dementia. I commend the fact that that has now risen to 59%, although there is obviously more work to do. Northern Ireland was diagnosing 63% of sufferers. What happens to someone when they are diagnosed? Think of the fear that we all have, and then imagine the bombshell that diagnosis is.

There is no easy answer, but we have done a few things in Scotland that we feel have worked. All our health boards now have a linked member of staff, like the cancer nurse specialists we have for breast cancer, which was my specialty. Since 2012, we have had the older persons’ acute care plan, which looks at secondary care and modern hospitals. I welcome the talk about dementia-friendly towns and villages—I will go home and throw down that challenge to my area, because that is not something I have come across.

In the past 18 months, our hospital has been completely redesigned, with colour zones and images of what everything is, instead of just words. Toilets, beds, kitchens—how to find one’s way around is all visual. We also have champions in every single ward. All that has really changed things. We have reduced length of stay from 22 days to eight days; we have reduced falls by half, and we have reduced returns to A&E from 26% to 8%. These relatively cheap, simple changes actually save a lot of money.

We obviously need more research and development, because at the end of the day families want a treatment to make early diagnosis worth while. Otherwise, what is the point? We have to be able to intervene. We can slow things down, but we want a drug that will stop dementia and reverse it. At some point further down the line, we will face the challenge of drug companies coming to us with an expensive drug that will do that. It will be important for the National Institute for Health and Care Excellence and other agencies to weigh up the sheer scale of dementia that we face and the money that could be saved by using even quite an expensive drug.

[Kit Malthouse]

One of the interesting developments over the past couple of years, which was looked at by Dennis Gillings, the international dementia envoy appointed by the G8, has been the question of whether the financial equation around the development of a drug could be changed by negotiating an international exception for its patent life, extending it by, for instance, five or 10 years. That might propel investment into research to find a cure and also make it cheaper when it does emerge, because the time for commercially exploiting it would be extended. Would the hon. Lady support such a proposal?

[Dr Whitford]

I absolutely would. In my previous life as a breast cancer surgeon, when I was also doing breast cancer immunology research, I watched what became Herceptin go from its development on the bench-top into common use. That took 21 years. This is something we often do not recognise when we moan about big pharmaceutical companies: they are investing in something that may turn out to be a mirage. The more that we can look at supported or shared R and D, the cheaper the drug will be when it finally comes to market. I would commend something like that.

The current problem is that most patients face living with dementia, and we must think about how we help them and their families to do that. We should be challenging ourselves to make dementia-friendly our surroundings and all the agencies that sufferers may interact with, whether through visual aids, through other people recognising them or, as the hon. Member for Stockport (Ann Coffey) said, through technology. The eHealth programme in Scotland is working on that, including devices in patients’ homes that it can interact with and establish whether the person is okay. Much of the care that people receive is the 15 minutes that the hon. Lady mentioned. How can we improve that? How can we ensure that the faces are not different every day? Some patients and families report 100 carers in a year. We should look at how we organise the care and remember who the real carers are: the family.

It is predicted that one in three of us will be carers for someone with dementia. We have a vested interest in ensuring that we look after them. The carer’s allowance is currently £60 a week, which does not even match jobseeker’s allowance, for a job that could be 164 hours a week, so we need to think of how we support carers and the work that they do. In Scotland, things are slightly different as we have free personal care, so the family does not pay for the carer who comes into the home. If that person has to go into a care home or nursing home, they do not pay for the personal care. The system has been expanded and deepened and actually allows us to keep more people at home for longer.

One problem is that care jobs attract lower earners. How can we motivate people and attract high-quality candidates if they are being paid the lowest possible amount?