Off-patent Drugs Bill

Kit Malthouse Excerpts

Friday 6th November 2015 Commons Chamber

[Marcus Fysh]

That is a good point and one I will come to in a moment.

One of my Yeovil constituents, Heather Moore, wrote to me this July, asking me to vote in favour of the Bill. She wishes it to become law not only because it would give patients wider access to the benefits of new treatment options, but because it would give financial advantage to the NHS by providing some very low-cost treatments. At this time of pressure on health services from demography and budget pressure, the improvements in cost-effectiveness that could stem from the Bill are essential.

A similar private Member’s Bill, sponsored by the previous Member for Cardiff North in the last Parliament, made it to Second Reading but was regrettably stopped short of becoming law. I believe that today’s Bill outlines an even more compelling case for approval, since it specifies the need for the Government to seek licences for off-patent drugs in new indications.

[Kit Malthouse (North West Hampshire) (Con)]

Like my hon. Friend, I am extremely supportive of the Bill—it is a very sensible measure—but there is a difference between what is being proposed and what is already available. I am patron of the Andover and Rural District branch of the Multiple Sclerosis Society. As I understand it, these cheaper generic drugs are already available for prescription off label. I think the Bill is trying to make the point that that is not being advertised enough to the clinical community and that the addition of a licence for particular treatments would promulgate their effectiveness much more widely. If I have missed the point of the Bill, please forgive me, but it seems to be as much about information as the ability to prescribe. The two are not mutually exclusive. We can provide more information to clinicians and provide licences at the same time.

[Marcus Fysh]

My hon. Friend makes a good point. The General Medical Council says that, traditionally, doctors have been reluctant to do that, partly because they may be wary of prescribing drugs for new uses owing to the increased level of personal liability that they may encounter.

Providing a way to overcome this reluctance, where efficacy has been demonstrated through licensing, deals with the argument made by the Under-Secretary of State for Life Sciences, my hon. Friend the Member for Mid Norfolk (George Freeman), in the debate on the previous Bill that the current law best meets the individual clinical needs of patients. The flexibility clinicians currently have to prescribe medicines, which my hon. Friend described, is fine, and it is each doctor’s solemn prerogative, but it should not be used as a structural excuse not to pursue new treatments where they have been shown to be effective for non-clinical reasons. In practice, that can encourage a lack of consistency and assurance for the patient because of the lack of NICE approval in the form of a technology appraisal. NICE is, in fact, in a very good position to conduct studies that test efficacy on particular subsets of patients, with their consent.

A partnership in my constituency between Yeovil District Hospital NHS Foundation Trust, Somerset clinical commissioning group, South Somerset GP federation and Somerset County Council was selected this March by a rigorous NHS England process to be one of 29 partnerships spearheading new ways of working—a vanguard project in finding new models of care. This partnership, called Symphony, is looking in particular at the integration of health and social care, bringing together GPs, hospitals, community hospitals, mental health and social services, and is focused on joint commissioning based on outcomes for patients. The intention is for the lessons learned in implementing this new model to be taken on board in replicating the integration process across Somerset and beyond. We need to learn the lessons and move forward together—fast.

I believe that this vanguard, which is led by very committed and talented people in each partner organisation—I congratulate and encourage them today—could act as a leader not only in developing this new care model, but in working with NICE in its role under the Bill to conduct technology appraisals for new uses of off-patent drugs.

This has particular application to one of the most difficult issues of our time—the fact that our population is ageing rapidly. There are areas of Somerset, as elsewhere in the country, where a majority of people are of retirement age—and that is likely to increase dramatically over coming years. The management of conditions that are becoming more prevalent as our population ages must be taken forward with every tool available to us.

A report written by the governors at Yeovil district hospital in October last year shows that there has been an increase in the number of local patients with suspected cancer. Indeed, Somerset has one of the highest proportions of cancer prevalence in England. This may come as no surprise, as it is a very attractive place to live and work, and it has attracted many people moving from other parts of Britain, with many choosing to retire in the area.

I strongly support the new cancer drug fund that this Government have implemented, which has given more cutting edge treatment options to those with cancer, but we can go further by increasing access to new treatments through off-patent drugs, which can be much cheaper.

--- Later in debate ---

[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.