Off-patent Drugs Bill

Nick Thomas-Symonds Excerpts

Friday 6th November 2015 Commons Chamber

[Nick Thomas-Symonds (Torfaen) (Lab)]

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

It is an honour to be drawn in the ballot and to bring forward a private Member’s Bill on such a key issue. My grandmother, who inspired me to go into politics, died of breast cancer, and it is poignant for me that this Second Reading debate takes place in the week that would have been her birthday.

I am grateful to those who have sponsored this Bill, and to Members from across the House who have supported it. I thank the former hon. Member for Cardiff North, Jonathan Evans, whose Off-patent Drugs Bill was debated last year, and his successor, the hon. Member for Cardiff North (Craig Williams), for his support for this slightly refined version of the Bill. I thank my constituents for all their support, and I also thank Jenny Goodare from Breast Cancer Now for her help in preparing the Bill.

The Bill is a UK-wide Bill that creates a duty on the Government to make cheap drugs available when pharmaceutical companies have no incentive to do so. There is a problem: if a drug is shown to be useful for a new purpose after its original patent has expired, there is no financial incentive for a pharmaceutical company to sponsor that off-patent treatment through the processes that are normally used to licence it, and to ensure its adoption on the NHS.

Such off-patent treatments are usually available at low cost, but the current system is not set up to make them routinely available when they have been repurposed. Put simply, without a licence to act as a kitemark of safety, and a cost-effectiveness appraisal to give the NHS a mandate to provide it, there are multiple disincentives to treatments being prescribed, meaning that they are not routinely made available.

I have a letter from a clinician dated 15 October 2015 that I have permission to read out—the personal details have been redacted. He says he was contacted by a lady because she was advised that she had a high risk of breast cancer, and that raloxifene, which is an example of a drug that would benefit from the Bill, could be prescribed to help to prevent it. The key passage in the letter states:

“Unfortunately, I am unable to prescribe this as it is not licensed with this indication.”

[Interruption.] The Minister shakes his head, but I am quoting directly from a letter written by a clinician only in the past few weeks. That affects real people and has had a great impact on somebody’s life.

The Bill proposes a Government responsibility to step in and address that market failure in the public interest. Part 1 of the Bill introduces the duty of the Secretary of State to seek licences for off-patent drugs in new indications. The idea is to make those cheap, off-patent drugs routinely available. The president of the Royal College of Surgeons of Edinburgh recently said that, at the moment, there is significant variation, leading to variation of access across the UK.

There are barriers to the drugs being regularly available. Lack of awareness is a problem, but it is not all about that. General Medical Council guidance states that licensed treatment should be considered before an off-label or unlicensed treatment. In addition, GMC guidance is clear that a doctor takes on an extra level of personal liability when prescribing off-label.

[Carolyn Harris (Swansea East) (Lab)]

A Government spokesman was quoted in The Independent this week saying that the only thing general practitioners need is more information. Does my hon. Friend agree that that was both unhelpful and ill-informed? Deluging GPs with yet more information is certainly not productive.

[Nick Thomas-Symonds]

My point is precisely that it is about more than information.

A licence for off-patent drugs would make a big difference. The all-party parliamentary group on off-patent drugs, which I chair, met on 15 October and took evidence from experts across the board. Pan Pantziarka, a repurposing specialist, said that granting a new licence triggers a “whole cascade of things”: the British National Formulary gets updated, clinical commissioning groups and specialist bodies take note, and guidance is updated. He said that, without that, we are dependent on doctors reading the literature and prescribing off-label, and that that is not the solution we want.

Sir John Burn, professor of clinical genetics and a non-executive director of NHS England told our inquiry:

“The other problem is making decisions in a short time scale—we haven’t got time to look at the bundle of evidence presented. The whole point of the licensing process is to distil that for the physician”

[Anne Marie Morris (Newton Abbot) (Con)]

Will the hon. Gentleman clarify something for me? Under his proposed scheme, when a drug gets relicensed, what will the impact be on pricing? When a drug goes off-patent, one benefit is that it effectively becomes cheaper because any company can manufacture it, which is clearly a benefit for the NHS. With relicensing, is there a risk that the company will effectively re-price, landing the NHS with extra costs?

[Nick Thomas-Symonds]

I do not accept that that is a risk of the Bill. As the hon. Lady knows, the drugs are available for pennies a day. Under the Bill, the Government would step in to address a market failure. The Bill will not have the impact that she believes it will have. She makes a reasonable point, but it is not one that will arise under the apparatus and structure proposed by the Bill.

The alternative to the Bill—I firmly believe that if this Government do not do this, a future Government will have to legislate—is to continue to encourage more off-label prescribing. Even if that were desirable, very little has happened. In a letter dated 2 November, the Royal College of Physicians states:

“As there has been no meaningful progress on a non-legislative solution to this issue, we believe that your Bill is an important first step towards expanding access to these vital drugs.”

The proposal was debated a year ago and we have had a year to see whether there is a non-legislative solution to the problem.

The Bill has incredibly wide support across the professional spheres. I apologise in advance for not naming every charity that supports it.

[Christina Rees (Neath) (Lab)]

The Bill has the support of a huge number of medical research charities, which lead the way in research on the use of repurposed drugs. Currently, there is no route to market for off-patent drugs in new indications. Does my hon. Friend agree that the Bill will fix that anomaly?

[Nick Thomas-Symonds]

I agree entirely with my hon. Friend. Twelve medical research charities back the Bill; the NHS clinical commissioners in England back the Bill; and the British Medical Association backs the Bill. More than 10,000 members of the public have written to their MP in support of it. That is in addition to the 20,000 who wrote last year to the former Member for Cardiff North. Four of the medical royal colleges support the Bill. Forty eminent clinicians wrote in recent weeks to The Daily Telegraph to support the Bill. It has incredibly wide support across parties and among the professions.

[Albert Owen (Ynys Môn) (Lab)]

I congratulate my hon. Friend on the Bill and pay tribute to Jonathan Evans, a thoughtful Member of Parliament who introduced a Bill in the previous Parliament. In addition to the long list of experts that my hon. Friend has quoted, I am sure he has had other lobbying letters. I had one from a multiple sclerosis sufferer. He eloquently put his case and said: “Please be there to give us hope.” Does my hon. Friend agree that the Bill will give us hope for cures for the future?

[Nick Thomas-Symonds]

I agree entirely with my hon. Friend.

[Liz McInnes (Heywood and Middleton) (Lab)]

We are talking about people who support the Bill. The Association Of the British Pharmaceutical Industry says that it supports the principle of the Bill, but that it is concerned that it could discourage the development of new medicines. Does my hon. Friend agree that the Bill in no way precludes the normal process of research and development for the manufacture and discovery of new drugs?

[Nick Thomas-Symonds]

I agree entirely with my hon. Friend. Repurposing is becoming increasingly common. Approximately 10% of the Brain Tumour Research portfolio is in repurposed drugs. For the Cure Parkinson’s Trust, the figure is 50%, and for the Alzheimer’s Society it is 13.6%. My hon. Friend makes a powerful point.

[Liz Saville Roberts (Dwyfor Meirionnydd) (PC)]

The debate is poignant for me. Breast Cancer Now is very supportive of the Bill, and my best friend and the mother of my goddaughter is currently in hospital recovering from her second treatment for breast cancer in 10 years. I should like to take the opportunity to say this. Christine Lennon, the most organised, capable and scary of my friends: we all want you home as soon as possible. [Hon. Members: “Hear, hear.”]

Some 850,000 people suffer from dementia, and that number is likely to increase to 1 million in 10 years’ time. The matter raised by the Bill is relevant to 20% of the drugs that the Alzheimer’s Society support, and it claims that the Bill will enable it to work on off-patent drugs. Does he agree that that is very significant, given that the disease affects so many people?

[Nick Thomas-Symonds]

On the second part of the hon. Lady’s intervention, I entirely agree that it would assist the Alzheimer’s Society. On the first part, I am sure the whole House wishes her best friend a speedy recovery.

Given the time restraints, I will touch on just one benefit that the Bill would have. zoledronic acid, a type of bisphosphonate, was originally used to treat bone fractures in advanced cancer and osteoporosis, but it can also reduce by 28% the risk of breast cancer spreading to the bone in post-menopausal women. If it were routinely available to 34,000 women, it could save 1,000 lives a year, at the cost of about 5p per day per patient. That is precisely the kind of benefit the Bill could bring.

[Dr Rupa Huq (Ealing Central and Acton) (Lab)]

My hon. Friend talked about cost. Does he agree with my constituent, Elena, of west Ealing, who wrote to me on this subject to say that it would help MS sufferers in particular and that

“it is crucial that affordable treatments are used to their full potential particularly at a time when NHS resources are stretched. The Bill will tackle this issue head on and stand to benefit hundreds of thousands of people in Ealing and beyond.”?

[Nick Thomas-Symonds]

I agree entirely with my hon. Friend. It is precisely that kind of benefit that the Bill would bring.

[Rachael Maskell (York Central) (Lab/Co-op)]

Today, a constituent of mine, Mark Hamilton, is laying to rest the ashes of his father, who lost his life very suddenly in September. Had these drugs been available then, he might well be with us today. Is that not why it is so important that the Bill proceeds to its next stage?

[Nick Thomas-Symonds]

I am grateful for that intervention, because the Bill could have a positive impact on the lives of many people. That is why it should move forward.

This is a common-sense solution to an acknowledged problem. There is even a precedent for it. The Secretary of State, who is not in his place, but whom I am sure will be ably represented by the Minister, is the licence holder for a chemotherapy drug called Erwinase. It is manufactured by a state-owned pharmaceutical company called Porton Biopharma Ltd, which was established in July and in which the Secretary of State is the sole shareholder. There is, therefore, a precedent for the type of intervention I am talking about to deal with this market failure. The Bill will bring enormous benefits to people. It is a sensible solution to the problem.

[Chris Stephens (Glasgow South West) (SNP)]

I congratulate the hon. Gentleman on bringing the Bill before the House. A constituent of mine, Tracey Hardie, is a cancer survivor, but this is not just about her; it is about other people, and those who have survived cancer are very supportive of the Bill.

[Nick Thomas-Symonds]

The hon. Gentleman is absolutely right. The Bill could really assist people out there in the country, which is why it should proceed.

[Anne Marie Morris]

The hon. Gentleman has not talked about the consequences for off-label drugs. I do not think that anybody would disagree with using good drugs for alternative purposes. Most of the concerns I have heard about the Bill are around the methodology and the process and the impact on off-label drugs. At the moment, drugs not on the agreed list can be prescribed, and I would be concerned if there was any threat to the ability to do so.

[Nick Thomas-Symonds]

With respect, that is precisely what the Bill seeks to do. We are talking about drugs that have been on patent for a particular purpose and that have a licence in that indication, but which also have another purpose. At the moment, theoretically, they can be prescribed off label, but that simply does not happen consistently across different spheres of medicine or across the country. The letter I read out from the Royal College of Physicians, dated 2 November, made that exact point.

The Bill is a common-sense solution that commands support across parties, in different spheres of the medical profession and from other stakeholders, and I commend it to the House.

--- Later in debate ---

[Alistair Burt]

I will take interventions, but it is only fair to the House that I respond to the debate and answer some of the charges that have been made—[Interruption.] It is not disgraceful; it is the right answer.

[Nick Thomas-Symonds]

Will the right hon. Gentleman accept two points? First, he made clear his objections to the Bill, and they were firmly answered by the expertise of the hon. Member for Central Ayrshire (Dr Whitford). Secondly, the Government have had a chance to put forward a non-legislative solution to the problem in the past year, but they have completely failed to do so, so why is he still refusing to allow the Bill to proceed to Committee?

[Alistair Burt]

After I have dealt with the other interventions, I will deal with the actions since last year’s Bill.

--- Later in debate ---

[Alistair Burt]

I am happy to be corrected in relation to procedure. The procedure of the House allows the Minister to speak until 2.30 pm. [Interruption.] I am not obliged to do so—that is correct—but I am choosing to do so because I believe that I would not be performing my duty if I were to allow a Bill that I think is wrong and potentially harmful to go through.

[Nick Thomas-Symonds]

rose—

[Alistair Burt]

I am not going to take any further interventions; otherwise, I will take it that the House does not want to hear from me. I have to make some progress.

--- Later in debate ---

[Alistair Burt]

Not at the moment, because this point is absolutely crucial to put on the record.

Prescribing in that way is part and parcel of normal, everyday clinical practice, as the hon. Member for Central Ayrshire confirmed. It is very common in prescribing for children and in treating some forms of pain. Most doctors, particularly GPs, will do it every day in their clinical practice. That has already been covered in relation to tamoxifen and raloxifene for the prevention of familial breast cancer. As was rightly identified by the hon. Member for Torfaen, the issue is compounded when drugs come off patent and new evidence suggests that they would be appropriate in the treatment of new indications.

The hon. Gentleman has gathered a lot of support for the Bill, but it does give the impression that such drugs are not being made available to patients. It also suggests that licensing is required to make these drugs available for patients, and that a NICE technology appraisal is required as well.

[Nick Thomas-Symonds]

I did not say that.

[Alistair Burt]

If the hon. Gentleman is happy to say that that is not the impression given, I am pleased to correct what I said.

[Nick Thomas-Symonds]

I never said that the drugs were not available. I said that they could theoretically be prescribed, but that it did not happen consistently by sector or across the country. That is what I said. It is on the record.

[Alistair Burt]

In that case, I am more than happy to again let the message go out from the Chamber today that these drugs are available and can be prescribed. Where it is clinically appropriate, they should be prescribed. Seeking this legislation will not change that availability.

Members of the House are doing a highly effective job of bringing their constituents’ concerns to the attention of Ministers and asking our help to resolve this issue. We are not aware of colleagues bringing examples of people who have been refused treatment. It is vital to know if there is evidence of people being refused treatment. As I said, the clinician’s letter that the hon. Member for Torfaen read out was wrong. Unless there is a clinical reason for not supplying the drug, there is nothing to prevent the doctor from doing so.

--- Later in debate ---

[Alistair Burt]

I certainly did myself a disservice with a silly, offhand remark. I entirely accept that. It is not like me and I apologise.

The stance that I am taking as the Minister representing the Government is that I do not believe this is the right vehicle to achieve what Members want. I am also concerned—

[Nick Thomas-Symonds]

On a point of order, Madam Deputy Speaker. With the greatest of respect to the Minister, he has had a bit more time since the last point of order and it is quite clear that he has run out of arguments and is now talking to the clock. I beg to move that the Question on closure be put.

[Hon. Members]

Hear, hear!