Off-patent Drugs Bill

Philippa Whitford Excerpts

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.

[Joanna Cherry (Edinburgh South West) (SNP)]

There is a risk.

[Dr Whitford]

There is indeed a risk, as my QC expert has muttered. Part of the case would be that the doctor had prescribed an off-licence drug.

Experts in the field will prescribe many drugs that are off-patent for the treatment of secondary cancers. We are aware of the evidence, and we will use such drugs when we have the experience, but general practitioners will not. If a drug is not in the British National Formulary, they cannot check the dose, which might be different from the dose for the other usage.

We are seeing more and more non-doctor prescribers. We are seeing nurse prescribers and physio prescribers. We do not want to limit the use of future drugs that may be discovered by not sorting out the present position. It should not be beyond the wit of man. The NHS is surrounded by organisations, such as quangos, that could surely be used to deal with it.

[The Minister for Community and Social Care (Alistair Burt)]

Given the hon. Lady’s experience in this area, her presence in the House provides me with an opportunity that is too good to miss. Let me ask a question that goes to the heart of the reason for the Government’s concern about the Bill.

If I understand the hon. Lady correctly, it is not impossible to prescribe off-label if there is an indication that, say, the prevention of breast cancer may be aided by the use of tamoxifen. There is nothing to preclude that, although it may be difficult in the circumstances that she has described because of possible considerations of liability. Is she arguing that there should be no off-label prescribing because everything should be licensed, or not? I do not know whether it should be one or the other—[Interruption.] It is not a stupid question. We believe that if it is possible to prescribe off-label, the Bill is not necessary, but if it is not possible because of the difficulties that the hon. Lady has identified, perhaps that should not happen. Her experience is vital in this regard.

[Dr Whitford]

As I was trying to suggest, someone who is an absolute expert in a field will be comfortable prescribing off-label, because they are using the drug every day, and they know exactly what it does and how to use it. But our patients spend the majority of their time in primary care, and a GP, who is unable to look up and check the dose or indication, will be a little more uncomfortable. People who are non-consultants—those at staff grades, who are at other grades—will be less comfortable. We see that exactly in the prevention of breast cancer; this drug has not come on stream at the speed that would have been expected, because people are uncomfortable. There is certainly not enough protection to mean that nurses are going to prescribe a drug that is not licensed, and the vast majority of drugs do not have guidelines, so what the Minister describes is not a protection.

[Alistair Burt]

I just want to be sure about this. If I understand the hon. Lady correctly, that hesitation could apply to any off-label prescribing now, but off-label prescribing goes on—doctors and GPs do find the information and do it. I would not want to take the implication from her that off-label prescribing is wrong. It just needs the appropriate amount of information to make sure that it is right—otherwise, we do have to license everything.

[Dr Whitford]

When a drug is proven and is going to be in common usage, it should be licensed—otherwise, we are suggesting, “Why bother with licensing any drug?” We are talking about drugs that could make a big impact, but they will do that only if they are in common usage. Expecting doctors to face any potential that they are signing away their mortgage on their house by prescribing something is simply bizarre. Of course there is off-label prescribing as a drug develops, but once we have something with rock-solid evidence behind it, which we expect everybody of every grade and every profession within the NHS to use, we should give them the reassurance of licensing.

[Joanna Cherry]

My hon. Friend speaks knowledgeably about the treatment of breast cancer, but a number of my constituents who are living with multiple sclerosis have also written to me about this Bill. Scotland has one of the highest incidences of multiple sclerosis in the world. Can she confirm that the Bill will be of particular benefit to patients with multiple sclerosis in Scotland?

[Dr Whitford]

Yes, absolutely; a drug called simvastatin is simply used for lowering cholesterol but it has been shown significantly to reduce brain atrophy in patients with a certain type of MS.

We do not know what is in the future. Other drugs will be found to have a second use, so why would we not take this very practical Bill through and allow ourselves to deal with a bizarre anomaly? As I say, this is not beyond the wit of man. Let us pick one of the quangos around the NHS and get this job done.

--- Later in debate ---

[Alistair Burt]

Because if the message that goes out from this debate is that there is only one way to get these drugs, and if people feel that they cannot get them because of what has been said here, that would be darkness indeed. That is not the truth. That is not the position.

[Dr Whitford]

I find it bizarre that the right hon. Gentleman says that we must not bring in this change because it would undermine access to other drugs, because that tends to suggest that we should not have any licensing at all. Why is he happy to have drugs licensed but also feels that we should have unlicensed drugs?

[Alistair Burt]

Because current medical practice appears to be that drugs are available on licence for indications that are already there, but it may then become clear that some drugs are also useful for things that were not previously indicated. If the patent position is as we have discussed, then no licence process is put forward and people can prescribe off-label, as they do in many cases. Accordingly, the system works with both. The Government’s worry about this Bill is that, because of the attention paid to what is being said, it will be suggested that there is some sort of prevention mechanism that does not enable people to get the treatment they need. I am very anxious to state that that is not the case, as I think the hon. Member for Central Ayrshire also said. These drugs can indeed be prescribed. That has to be the message.

[Dr Whitford]

rose—

[Alistair Burt]

I will give way, but then I want to set out what the position is rather than what it is believed to be.

[Dr Whitford]

As I said, there is still an implied risk to people, and those who are distant from the research will not do this. The only reason these drugs are not licensed is that it is not worth the company’s while. Surely letting the Bill go into Committee would allow us to iron out all the issues to the satisfaction of the Government.

[Alistair Burt]

The issue about licensing could apply to any off-label prescribing. What we are talking about for some would, in theory, have to apply to all, because there is a risk to everything. That suggests a provision of licensing for all, which is not where we are going. This matter is not closed—let us be quite clear about that. If this measure does not go through today, the matter is not closed.

--- Later in debate ---

[Alistair Burt]

In that case, I am more than happy to again let the message go out from the Chamber today that these drugs are available and can be prescribed. Where it is clinically appropriate, they should be prescribed. Seeking this legislation will not change that availability.

Members of the House are doing a highly effective job of bringing their constituents’ concerns to the attention of Ministers and asking our help to resolve this issue. We are not aware of colleagues bringing examples of people who have been refused treatment. It is vital to know if there is evidence of people being refused treatment. As I said, the clinician’s letter that the hon. Member for Torfaen read out was wrong. Unless there is a clinical reason for not supplying the drug, there is nothing to prevent the doctor from doing so.

[Dr Philippa Whitford]

I simply make the point that we are now not just talking about doctors prescribing. It is unrealistic to expect physiotherapists and nurses to prescribe drugs off licence. It just will not happen.