Off-patent Drugs Bill

Graeme Morrice Excerpts

Friday 7th November 2014 Commons Chamber

[Jonathan Evans]

Invariably, such drugs have been licensed for other uses, but it transpires that they are being researched, as I will outline in my further remarks, and that research is showing that they can be used effectively in another way. The kernel of the problem that I am seeking to highlight is that, without licensing, they are not being used in that way.

A licence gives a clear indication to GPs that a drug is both safe and effective, so it is preferable that indications that could achieve such a licence are supported. We face an unacceptable situation where cost-effective drugs are not made routinely available for new and proven effective uses. Although a small number of people might be fortunate enough to get the drug, a far greater number with exactly the same condition, in exactly the same clinical circumstances but with a different GP, will not. That is the worst form of inequality.

I want to highlight one scandalous example of the failure, red tape and bureaucracy of our current licensing system. The passive approach to the flaw that I have highlighted has meant that, for all of 15 years, the chemoprevention drug tamoxifen was routinely available to women in the United States of America to prevent the development of breast cancer but not to thousands of women at risk here in the UK, not because the research evidence is any different in the United States of America and the UK but because under our licensing system there is just no one to request that this treatment should become routinely available. So for 15 long years nothing whatsoever happened, and thousands of women here in Britain were denied treatment that it has been clinically proven could have prevented the development of breast cancer in many cases.

It was not until 2013 that the National Institute for Health and Care Excellence—NICE—eventually recommended the use of tamoxifen in the UK in its guidelines on the management of familial breast cancer, but that still stopped short of licensing, because of the flaw to which I have referred. As a result, the NICE guidance has proved insufficient to ensure equal access and there is no evidence that it has significantly changed clinical practice. The uptake of these treatments is lower and less uniform than if the drug were licensed. Furthermore, owing to the infrequency with which NICE guidelines are updated and their impact, this mechanism could not be widely employed to make off-patent drugs available, and I believe that the example of tamoxifen starkly confirms this.

[Graeme Morrice (Livingston) (Lab)]

I entirely agree with what the hon. Gentleman has said so far. Indeed, I want to lend my personal support to his private Member’s Bill and wish him well on its Second Reading. Several dozen of my constituents have contacted me in support of the Bill and specifically asked me to come along today to represent them in the Chamber and to vote for the Bill on Second Reading if, indeed, there is a vote. I certainly hope that his Bill is not talked out.

[Jonathan Evans]

I am grateful to the hon. Gentleman for that contribution. If he will forgive me, I will not go further down the path of responding because of the point that he made at the end.

Sadly, all existing off-patent drugs that reduce the risk of people developing breast cancer fall into this category. The leading proven chemoprevention drugs are tamoxifen and raloxifene. These drugs, which reduce the risk of breast cancer developing in high-risk women by around a third, are not licensed for this purpose. With nearly half a million women in England and Wales eligible for these low-cost treatments, there is an urgent need to address the barriers to chemoprevention drugs being prescribed. The cost of tamoxifen is 6p a day; the cost of raloxifene is 61p a day. A third chemoprevention drug, anastrozole, originally developed as a hormone therapy, has been shown to reduce the risk of breast cancer developing by a half, and with fewer side effects. The evidence is there, but what action can be taken to ensure the routine availability of these treatments? The answer is none, or very little.