Today is the second reading of the Off-Patent Drugs Bill, a Private Member’s Bill being introduced in Parliament. Its aim is to simplify the procedures that currently exist around re-purposing existing drugs – that is, to allow them to be used for the treatment of something other than that which they were created for.
This Bill could have exceptionally important repercussions for the prevention of breast cancer if it is given Government backing. One in 10 women in the UK will get breast cancer in their lifetime, yet finding ways to lower this figure is a complex balance of many things, including using drugs as a preventative measure. As we invest more and more in research, we’re finding new ways of using drugs that could help reduce risk in many of these women.
Current restrictions around the reclassification of drugs mean that it is very difficult to persuade bodies such as NICE and the MHRA to give the green light when it comes to using an existing drug for a new purpose. It requires drugs companies to submit to very expensive and time consuming measures to re-test the medicines – something which they are therefore disinclined to do.
An example is Tamoxifen, which was approved for the prevention of breast cancer by NICE last year after being used as a drug for the treatment of the disease for many years. Clinical trials had shown that it was effective at reducing the chance of developing breast cancer in high and moderate risk women. While it might seem like the obvious next step to start giving it to women with high or moderate risk as a preventative measure, the reality is that there are mounds of red tape to navigate before we even come close to that. In the intervening years, countless women who could have seen their risk lowered by taking the drug will have been given a diagnosis of breast cancer.
We’re currently facing the same battle with Anastrozole, which when taken as a preventative measure can reduce risk by up to 53 per cent, yet is currently only available as a treatment for breast cancer.
Of course, the Bill doesn’t only apply to breast cancer. If approved, this could change the face of medicine in the UK. We’ll all be watching and reading carefully to see what happens next.