Off-patent Drugs Bill

Jonathan Evans Excerpts

Friday 7th November 2014 Commons Chamber

[Jonathan Evans (Cardiff North) (Con)]

I beg to move, That the Bill be now read a Second time.

Only a handful of MPs are ever successful in the private Members’ Bill ballot, so I am delighted and honoured that, 22 years after I was first elected to the House, and now in my final year of parliamentary service, I have at long last joined this rather select group and have the opportunity to promote a Bill on such an important matter.

First, let me thank the Bill’s sponsors, and MPs from all parts of the House, who have shown such support and interest in my Bill. The passionate welcome it has received has been truly amazing, although not surprising given the challenges it addresses.

Just yesterday, the letter page of The Times led with a joint appeal to the Minister and the Government in favour of the Bill from the Association of Medical Research Charities, the Breast Cancer Campaign, Leukaemia and Lymphoma Research, Breakthrough Breast Cancer, the Alzheimer’s Society, the Multiple Sclerosis Society, Leukaemia Care, Breast Cancer Care and the Cure Parkinson’s Trust. I should particularly like to thank Jenny Goodare and Mia Rosenblatt of the Breast Cancer Campaign for all the help they have given me in introducing my Bill.

Why question access to off-patent drugs? The problem goes back many years and is caused by a gap in the licensing system. The system is set up on the basis that a pharmaceutical company that wants to market any new drug acts as the drug’s sponsor throughout the process. That is fine and clearly understandable when the company anticipates many years of patent protection for its new product, but the essence of the problem that my Bill addresses is that no mechanism is in place to ensure the routine availability of existing drugs where patent protection has expired and where the drugs may be clearly shown later to be clinically effective but in a new way and for a new purpose.

Every time previously licensed drugs are shown to be effective for a new purpose, a new licence is needed to certify the drug’s safety at whatever the dose may be and for that purpose, and it must then be authorised to be marketed for such use. However, if a drug is no longer patent protected, no organisation or individual will take on the role of seeking any necessary licence for that treatment, because, after the patent has expired, other drug companies can produce and market generic versions of the drug, so the price of the product is driven down through the simple expedient of competition. It follows that the incentive for any pharmaceutical company to act as an advocate or sponsor for an off-patent drug and apply for a new licence is lost.

The outcome of all this is that off-patent drugs that should be routinely available at extremely low cost effectively have no sponsor. Without a change in the system, no one is ever likely to make licence applications for off-patent drugs, even when they may be effective for new purposes. In fact, it remains illegal to advertise and sell such drugs for such purposes if the drug is not licensed. What this all boils down to is that off-patent, repurposed drugs are not routinely available on the NHS, despite minimal costs to the taxpayer and the clear, clinically proven health benefits.

We may hear mention today of the ability of general practitioners to prescribe a drug outside the terms defined by the licence, which is known as off-label prescribing—in fact, Madam Deputy Speaker, given our earlier experience today, we may hear a lot about that—but the reality in clinical practice is much more complex and there are many disincentives to prescribing off label. A small number of clinicians may well be comfortable prescribing drugs off label in certain limited circumstances, but we know from the chemoprevention example, which the Minister quoted in the earlier debate, that this is not happening on any substantial scale. We also know that the absence of a licence is deterring many clinicians and GPs from prescribing these life-saving drugs in their new indications. Medical charities and senior distinguished clinicians have said that it is just not good enough to rely on the promotion of better information about off-label indications between clinicians.

[Bob Stewart (Beckenham) (Con)]

Are off-patent drugs likely to be found in a chemist’s shop? Do chemists keep stores of these drugs?

[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.

[Bob Stewart]

Without trying to talk out anything, may I say that I totally support what my hon. Friend is trying to do? Could NICE not do this sort of thing?

[Jonathan Evans]

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 the Member for Beckenham (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.”—[Official Report, 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.

[Mr Christopher Chope (Christchurch) (Con)]

I congratulate my hon. Friend on bringing forward this brilliant Bill. If it does not succeed today, it will certainly succeed in future, because it seems to be based on unanswerable logic. Can he explain why he thinks the Government are against it?

[Jonathan Evans]

It will be for my hon. Friend the Minister to make the Government’s case, although I certainly hope that he will not be lengthier than I am being in endeavouring to make my case.

It is simply not acceptable to sit back and hope for the best: we will let our constituents down by taking such a stance. I have heard it said that the Bill is not necessary and that better information for GPs and clinicians may be the answer, but the reality is that addressing the licensing flaw in the current system, as I have outlined, is the only way to tackle the issue effectively.

I say to colleagues, let us take this opportunity to act and deliver real change for those affected by cancer, multiple sclerosis, Alzheimer’s, Parkinson’s and so many other conditions. That is what the charities supporting them, and the senior clinicians specialising in treating them, are asking for. If we take forward this Bill, we can save and improve lives. If we tinker at the margins, we will not. For those who really want change, who really want people in this country to have access to the best treatments available, the answer is before us and it is clear. A legislative solution is necessary. By passing this Bill, we have an opportunity to change and save our constituents’ lives. I hope that we take it.

--- Later in debate ---

[George Freeman]

I am not clear which particular drugs my hon. Friend is referring to, but let me answer in a generic way. I would like us to become a place where, instead of it taking 10 or 15 years and $1 billion to bring innovative drugs to market, we use the NIHR platform and our investment in genomics to become a country where for some cancers we could be getting drugs to the most needy patients through the early access to medicine scheme that I have been championing and that the Department launched earlier this year. Potentially, we could be getting drugs to patients five, six, seven or eight years earlier than would normally be the case through the traditional model of phase one, two, three, four.

[Jonathan Evans]

The drugs the Minister is talking about are new drugs. They are not a mechanism for using existing licensed drugs for which the patent has expired, which, under current circumstances, are not being prescribed to people who need them. That is what this debate is about.

[George Freeman]

I well understand that. The off-patent is a distraction; it is the question of off-label. The truth is that clinicians are free today to do it. My hon. Friend’s point about timing is very well made. I would merely say that at this stage, with the working party I am putting together and the strategy I would like us to launch—I would very much appreciate his input—I think we should be looking at setting some very clear goals and targets for speeding up that use. In particular, we should ensure that where there is evidence of an innovative and new use for an existing drug off label and there is good evidence to suggest it, we roll it out across the system. It is both the speed of first adoption and the speed of roll-out across the system.

This offers the prospect of a more appropriate and sustainable approach that can apply to a range of different drugs. We can use it to tackle this problem much more quickly and to get new drugs into use much more effectively. More specifically, we are looking to gather further evidence around potential barriers by focusing first on NICE’s updated guidelines on familial breast cancer, through the NICE associates network, and asking it further to promote its implementation. I will also ask NICE whether it would be prepared to use one of the patient decision aids it is piloting for further support.

To draw all the strands together and look at the issues at national level, we plan to arrange a national round table of the key stakeholders to be co-hosted by my Department with NHS England and NICE. We intend to use the initial meeting to identify what the various participant stakeholders might usefully do to help to address the cultural and clinical leadership issues and what other practical steps might help. The request I make to those who support the Bill is that we review the need for any further guidance or legislation in the light of that work when it has been completed. I am delighted to extend an invitation to my hon. Friend to be a part of that.

In conclusion, I very much appreciate the points that have been made today. I recognise the very real concerns that have led to the drafting of the Bill. I am absolutely committed to investigating and getting to the bottom of the reasons why new evidence is not being picked up and implemented consistently, as well as why some clinicians may be reluctant to prescribe in this way, and, crucially, the important role of NICE in supporting that with updated guidance. I am committed to doing so with the involvement of all interested parties.

The Government remain firmly of the view that improvement in this area can best be achieved through a combination of measures, and that resorting to legislation to demand regulatory measures is not a magic bullet. It will not solve the issues we believe are actually responsible for this problem, and it carries the risk of some serious and unintended consequences. It is for those reasons that the Government cannot support the Bill. However, I reiterate that we support the intention of promoting greater use of off-label medicines. We are committed to looking seriously at this and to launching a strategy and a work plan, with specific targets for increasing the rate of use of off-label medicines, with all the key agencies and to invite stakeholders in the sector, in particular medical research charities and the AMRC, to help us with that. New uses for existing drugs is something we actively support. The truth is that, as much as we would love to, we could not and should not go down the slippery road of starting to legislate for the use of medicines that should be, and are rightly, a matter for clinicians.

[Jonathan Evans]

I thank all who have contributed to the debate, including the Minister. In fact, other than the Minister everybody has spoken in favour of the proposition contained in the Bill. I am especially grateful to my hon. Friend the Member for Bury North (Mr Nuttall), who has been involved from the inception in supporting the Bill. I am grateful for the intervention of my hon. Friend the Member for Christchurch (Mr Chope), who has been such a source of great support in this process, which, even after 22 years, is relatively new to me. He, of course, is something of a Friday expert. I am also grateful to my hon. Friend the Member for Beckenham (Bob Stewart) for his interventions and his clear articulation of support for the Bill. Let me also thank the shadow Minister and those on the Labour Benches who have made it clear to me and to the charities their complete support.

The problem is that the Government take one view on the Bill, whereas charities, clinicians and others are saying that the current situation is unacceptable. It is not good enough to argue against going down the road of legislation, given that we already have a legislative process for licensing. For instance, it is the law that if a drug has not had a licence, it cannot be effectively marketed in the UK. The reason GPs often do not routinely prescribe life-saving medicines is that the rules in essence make it illegal to market them in that way. It is not surprising, therefore, that GPs, given that legislative background and the litigious world of the medical and legal profession, decide to avoid something unless it is licensed. It is not as though the charities sector has not provided the Department with a welter of information on why GPs are not doing it. The lack of licensing is at the core of it.

As the Minister knows, I respect him and his background career, and we have had several conversations about the Bill, but the proposition that passing the Bill would damage the current situation is simply laughable. I do not know who wrote that line for the Minister, but that proposition needs to be re-examined. Nothing in my Bill would cause a GP to say, “Well, actually, I was going to prescribe something, but I’m not going to now.” With due respect to him, that was the weakest of his arguments.

We heard earlier from the Labour Benches that several colleagues have received representations on the Bill from a wide coalition of charities covering a range of medical conditions. Yesterday, I spoke to several of my colleagues on a day trip to a constituency in southern England, and everyone spoke of having 50 or 60 constituents urging them to support the Bill and of being pleased to have received a response saying that the Government were speaking to me as the Bill’s promoter. Many people interpreted that to mean that the Government would be broadly supportive of the Bill.

For that reason, I am deeply disappointed to hear now that the Government are opposed to the principle of the Bill. I do not need to rearticulate its provision—it is a very simple Bill—but it says that in the absence of somebody applying for a licence, the Secretary of State has the duty to make that application or to appoint another public body to do it. Thereafter, the Bill makes provision for the drafting of regulations that present widespread opportunities for the Minister to address his concerns.

[George Freeman]

To clarify, we agree with the objective of the Bill, which, as I understand it, is to get greater off-label use of medicines for new indications, but we disagree about the mechanism. The Bill is very clear on the mechanism: it is to pass legislation to require the MHRA to issue licences. We believe that this is the wrong solution, but we are in alignment on the problem that needs to be solved.

[Jonathan Evans]

That is very helpful. I have always understood that a Second Reading debate is on the principle of the Bill; we then deal with the detail in Committee, and then we proceed to Report. Ever since I was first elected 22 years ago, that is how I have understood it to work. If my hon. Friend is saying, “We are not against the principle, but against the mechanism”, that is a reason to support the Bill on Second Reading and then to debate in Committee how we adjust it to take into account his concerns.

[George Freeman]

I congratulate my hon. Friend on making an extremely eloquent argument, but I cannot let that go. The point is that the principle to which we object is the passing of legislation to require the MHRA to issue licences. That is more than a vague guiding philosophy; it is the mechanism suggested, and that is why we are opposed to it. I genuinely believe we will make more progress in the next few months using my office and the organisations for which I am responsible, working with the supporters of the Bill, to drive forward these measures.

[Jonathan Evans]

So we are back to the Government being opposed to the principle of the Bill. It might have helped if Ministers had said, in response to those Members who wrote to them saying they were aware of my Bill, that they were opposed to the principle, as we have just heard from the Minister. Members were led to believe that the Government were not against the principle but were discussing these matters and that we might ultimately reach an accommodation. Now we understand that the Government are opposed to the principle.

The principle is one advanced by the clinician community and the AMRC and supported by editorials in leading newspapers in the UK this week. It is not surprising that almost every leading newspaper has urged the Government to pay attention to the arguments. The hon. Member for Copeland (Mr Reed) highlighted how people outside the House look at what we do here. As I said in my opening remarks, it is important that we pay attention to the clinician community and the AMRC. For that reason, I hope the House will support the Bill.

Question put, That the Bill be now read a Second time.