Off-patent Drugs Bill — House of Commons, 2015-11-06
Topic: Health
Philippa Whitford (Scottish National Party, Centre-left): 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.