Off-patent Drugs Bill

Part of the debate – in the House of Commons at 11:18 am on 7th November 2014.

Alert me about debates like this

Photo of Jonathan Evans Jonathan Evans Conservative, Cardiff North 11:18 am, 7th November 2014

My hon. Friend, yet again, anticipates another part of my remarks. The second part of my Bill is about giving a certain responsibility to the Secretary of State to encourage NICE to promote technology appraisals. I will deal with that in a little more detail in due course. He is quite right, but not exclusively: licensing is the major problem.

Major new research will be published in the next few months that provides evidence that bisphosphonates—drugs that were originally licensed for the treatment of bone fractures in adults with advanced cancer—are effective in the early stages of breast cancer in reducing the risk of the disease spreading to the bone in post-menopausal women. That analysis of phase 3 clinical trials is likely to show that, in post-menopausal women with early breast cancer, this therapy reduces the 10-year risk of breast cancer spreading to the bone by 34% and the risk of dying from breast cancer by 17%.

I should like us to reflect on that for a moment: a 17% reduction in the risk of women dying from breast cancer. What would be the cost of any new treatment that could deliver such results? It would probably be tens of thousands of pounds, and we would want to pay that for such impressive results. However, zoledronic acid, a type of bisphosphonate drug, can be given to post-menopausal women every six months for three to five years, and that can reduce the risk of breast cancer spreading to the bone by a third and the risk of death from breast cancer by a sixth, and it would cost less than 5p a day.

Yet bisphosphonates are off-patent drugs that are produced relatively cheaply by numerous pharmaceutical companies as generic drugs, as my hon. Friend Bob Stewart mentioned earlier. It is therefore pretty certain that under the current flawed licensing system no organisation would seek a licence to use that treatment in preventing secondary breast cancer, even when the evidence is published, so the drugs will not be routinely available to the women who clearly need them.

I want to pay tribute to the distinguished breast cancer clinicians and researchers who have been speaking out about this issue for years. Sixteen of them wrote to The Times on the day of the Bill’s First Reading, stating:

“For some time it has been clear that there is a real barrier to licensing old drugs for new purposes, even when there is evidence that they are effective. This means that treatments which could bring real benefit to the lives of people and in some cases be life-saving, with minimal cost, are not routinely available”.

It is not just access to cancer treatments at stake; the current system will fail us for any medical condition in future if we do not correct the flaw. The Multiple Sclerosis Society makes it clear that strong preliminary evidence has shown that a number of repurposed medicines could be effective in the treatment of multiple sclerosis, but the UK currently lacks a system by which old drugs can be relicensed. In the past week the society wrote directly to the Minister in support of my Bill, in a letter co-signed by Professor Sue Pavitt, chair of the UK’s MS clinical trials network, and other leading specialists in the field. They cited the example of simvastatin, a drug originally licensed for treating high cholesterol that has been shown to be effective in slowing brain atrophy in secondary progressive MS by over 40%. Although final evidence from a phase 3 clinical trial is required to confirm those results, if successful that drug would address a significant unmet need, as there is currently no treatment that can slow or stop the deterioration seen in progressive MS.

The MS Society has pointed out that, given that simvastatin’s patent has expired, the treatment would require a licence in order to be made widely available on the NHS to people with multiple sclerosis, and it argues that the mechanism to achieve that just does not exist, despite the repurposing of previously licensed drugs being a fast and cost-effective way to provide new treatments. Those eminent clinicians and the MS Society strongly support my Bill and the mechanism it would create to provide access to medicines that could help tens of thousands of people with untreatable multiple sclerosis.

The treatment of Parkinson’s disease could greatly benefit from the Bill. I know that Tom Isaacs, president and co-founder of the Cure Parkinson’s Trust, has written to the Minister in the past week to point out clearly the charity’s full support for the Bill. Tom has said:

“Parkinson’s may not be a death sentence, but at the moment it is a life sentence. There is increasing evidence that a number of off-patent drugs have the ability to slow, stop or reverse our condition. Under these circumstances, the ability for patients to have a clearly defined way to make these medications accessible is now imperative.”

I think that it is now appropriate to turn to the detail of the Bill, given that the Minister might do so, Madam Deputy Speaker. To address the anomaly I have outlined, the Bill introduces a new advocate—the Secretary of State or a body appointed by him—for off-patent, repurposed drugs in the existing UK licensing system. The advocate would have to act in the public interest, and in circumstances where no other body had taken on the role of seeking a licence. The level of evidence required to trigger the advocate to seek a licence for an off-patent drug in a new indication would have to be significant. The treatments referred under the mechanism would be required to meet exactly the same standards for a licence for any other treatment, so nobody is lowering the bar in the licensing process. The Bill does not seek to make any unproven treatments available to patients; it simply seeks to address a clear market failure in the current system and to allow proven drugs to be considered for a licence after their patents have expired.

Clinicians have also suggested the supplementary provision in the Bill for NICE to appraise off-patent drugs in new indications where these are unlicensed—the point made earlier by my hon. Friend the Member for Beckenham, who sadly is no longer in his place. It is anticipated that that exceptional route would be used rarely. Regulations would outline the specific and significant standards that would need to be met before the provision was triggered. Although it may already be possible under existing legislation for NICE to appraise drugs for an unlicensed indication, the Bill would simply place a duty on the Secretary of State to direct NICE to conduct a technology appraisal for an off-patent drug in a new indication that satisfies the evidence threshold.

The Minister has stated publicly:

“The Government firmly believe that cost-effective, clinically appropriate drugs and devices should be routinely available to NHS patients.”—[Hansard, 1 September 2014; Vol. 585, c. 141.]

I recognise and applaud the admirable steps that this Government have taken to improve access to new cancer treatments. The cancer drugs fund has been established for England and now has a budget of £280 million a year. It is an incredible scheme that has improved access to treatments for thousands of patients in England, and I have seen for myself the disadvantages that my constituents have faced by not having an equivalent fund in Wales.

On the CDF, we are currently spending millions on new treatments, so why not improve access to treatments that cost just pennies but that we know can save or improve lives? In future there will be drugs for other conditions, including Parkinson’s, multiple sclerosis, breast cancer and Alzheimer’s, that could benefit from the Bill. We cannot wait 15 years longer than other countries for our constituents to get these treatments, as happened with tamoxifen, and then tolerate a postcode lottery in their availability to our constituents.