Surgical Mesh Implants

Carolyn Harris Excerpts

Wednesday 18th October 2017 Westminster Hall

[Carolyn Harris (Swansea East) (Lab)]

It is a pleasure to serve under your excellent chairmanship, Mr Owen. I congratulate my hon. Friend the Member for Kingston upon Hull West and Hessle (Emma Hardy) on securing this important debate. I pay tribute to my hon. Friend the Member for Pontypridd (Owen Smith) for taking the lead on this important issue and for establishing the all-party parliamentary group on surgical mesh implants, of which I am proud to be an officer.

When one in 15 women fitted with the most common type of mesh will require surgery to extract it, it is clear that the issue needs to be addressed nationally. The figures are staggering and the situation is like Russian roulette. Mesh is resulting in women being unable to walk, go to work, go about their everyday lives or enjoy a fulfilling sex life. More than 800 women in the UK are taking legal action against the manufacturers of the product, so it is clear that the problem is not just going to go away.

The NHS tells us that insufficient reporting and under-published data are contributing to the problem. A basic requirement should be a register of women who have had the implants, so that we can truly assess the potential impact. Regulators around the world have been demanding more testing to ensure that the mesh is as effective for treating prolapses as it is for other conditions. We cannot just sit on the fence; the problem is ongoing. We cannot just sit around waiting for the guidance to be published, whether that is next year or not. With so many people affected, there must be an immediate inquiry. We cannot wait—too many women are experiencing severe pain and discomfort because of these products. Now is the time for the Government to carry out a full audit, establish a register and look to find a way to eliminate the damage and destruction to women’s lives that the mesh has caused. Now is the time to sling the mesh.

Land Registry

Carolyn Harris Excerpts

Thursday 30th June 2016 Commons Chamber

[Carolyn Harris (Swansea East) (Lab)]

I declare an interest. I am proud to say that the Land Registry has its largest UK facility in my constituency.

The Land Registry provides a substantial number of jobs to Swansea East and plays a very important socioeconomic role, not just in my constituency, but in the surrounding areas. In July 2014 the coalition Government shelved plans to sell the well-respected 150-year-old service. That was after only 5% of respondents to a consultation felt that privatisation would make the Land Registry a more effective and efficient service. The consultation produced an overwhelming response:

“Overall, across virtually all respondents, it was suggested that a case for change had not been made.”

Despite this, fewer than two years later, the Government are yet again reviewing plans to privatise the Land Registry. That is being driven by the Treasury’s demand to make cuts, with the short-term aim of cutting the national debt.

[Lilian Greenwood]

My hon. Friend is making a passionate case on behalf of the people she represents. Is she aware of the report from the New Economics Foundation, which concluded that future funds from the Land Registry would outweigh the cash cost of a one-off sale after 25 years? The plan fails on the Government’s own terms.

[Carolyn Harris]

I am aware of that and I will come to it later in my speech.

The consultation on moving Land Registry operations to the private sector was launched on 24 March 2016. Ludicrously, it closed two days later. I would argue that it was deliberately timed so that MPs would not notice the announcement, because we were all heading home for the Easter recess—I was actually on a train to Swansea, and I read of the plan on a Twitter post. Like many colleagues, I was furious at the way the announcement was made.

Currently, the Land Registry is entirely self-funding and no drain whatever on the Government purse. Furthermore, the service makes a surplus year on year. That is passed on to the public by way of reduced costs for using the service. It also provides the Treasury with a significant income.

A report from the New Economics Foundation shows that selling off the Land Registry would harm Government finances in the long term. It suggests that the Land Registry and other assets under threat of privatisation or part-privatisation are clearly able to innovate and deliver a profit without needing to be in the private sector.

The sale of the Land Registry will hardly put a dent in the national deficit finger—[Laughter.] We can all point the finger at the Government. At the same time, we will be giving up valuable assets and forgoing long-term revenue streams. Land Registry jobs are also well paid and, more importantly, well respected. It is important that we retain them as part of a well-mixed economy to give job opportunities and a way forward to people from all sorts of backgrounds.

Only an in-house Land Registry can continue to deliver a quality, trusted and impartial public service.

[Chris Elmore (Ogmore) (Lab/Co-op)]

My hon. Friend is making a key point, and I completely agree with her. The public outcry about the privatisation of the Land Registry is unprecedented. People trust the service, and they want it to remain. Fundamentally, it is also profitable. Why the Government are considering privatising it is beyond most Opposition Members and several Government Members as well.

[Carolyn Harris]

I entirely agree, but, unfortunately, public demands do not always fall on receptive ears, to quote the Women Against State Pension Inequality Campaign.

If privatised, the Land Registry would no longer be subject to the Freedom of Information Act, so it would be easier to conceal who owns land and to prevent the publication of datasets such as those that identified the properties in London owned by the non-domiciles in the Panama papers.

I am distressed to see jobs disappear in my constituency. Swansea East is already suffering enough job losses—Royal Mail, HSBC, Virgin Media and Tata Steel. We cannot afford to lose any more jobs. In the last Parliament I tabled an early-day motion calling for the Government to abandon plans for privatisation, and I am glad to say that it received a lot of support. It has been retabled this month, and it is again gathering support.

Many feel that this proposal is just another get-cash-quick scheme from the Government, but in reality it jeopardises jobs, brings economic uncertainty and threatens to remove the transparency that allows us to have confidence in the fight against corruption and illegal accounting.

I implore the Minister to realise that this plan is ill-thought-out and that it will be challenged by the unions, legal and property professionals, the public and Opposition Members. The Land Registry is value for money, and it is an efficient and trusted service.

Access To Medical Treatments (Innovation) Bill

Carolyn Harris Excerpts

Friday 29th January 2016 Commons Chamber

[Nick Thomas-Symonds]

These new clauses and amendments, which I support, relate to off-patent drugs. I think it would be useful for me briefly to set out the context in which they arise. The Off-patent Drugs Bill, a private Member’s Bill that I introduced—it was debated on Second Reading on 6 November—is a UK-wide Bill that would create a duty on the Government to make cheap drugs available when pharmaceutical companies had no incentive to do so. The problem, put simply, is that if a drug is shown to be useful for a new purpose after its original patent has expired, a pharmaceutical company has no financial incentive to sponsor that off-patent treatment through the processes normally used to license it and ensure its adoption on the NHS. Those off-patent or off-label treatments are certainly available at low cost. The issue is simply that although clinicians can of course prescribe them, they tend not to be prescribed consistently across the medical sector, or indeed geographically.

The Off-patent Drugs Bill ran out of time that day, but I think it is accurate to say that the Government supported its aims but not the mechanism it proposed. None the less, in recognising that there is a problem, and with a shared position on both sides of the House on the need to encourage greater consistency in off-label prescribing, a lot of work has since been done, and on a cross-party basis. I am proud that new clause 1 stands in the name of Members from no fewer than eight political parties. The concept of encouraging greater use of off-patent drugs, and indeed my Bill, have significant support across the House and outside. I pay tribute to Jonathan Evans, the former Member for Cardiff North, who first introduced such a Bill in 2014. His successor, the current Member for Cardiff North (Craig Williams), has also supported my Bill.

[Carolyn Harris (Swansea East) (Lab)]

I congratulate my hon. Friend on the excellent work he has done on the Off-patent Drugs Bill. Given the consensus across the House, does he agree that now is the time for a firm commitment from the Government on that Bill?

[Nick Thomas-Symonds]

I am grateful to my hon. Friend for that intervention. I hope to hear such a commitment today, so I look forward to what the Minister for Life Sciences has to say in that regard.

That wide support for my Bill was shared by medical research charities, NHS clinical commissioners in England, the British Medical Association, thousands of members of the public who wrote in, and four medical royal colleges. Indeed, 40 eminent clinicians wrote to The Daily Telegraph in support of my Bill.

Since then, I am pleased to say that there have been good attempts on both sides of the House to build on that good will in relation to off-patent drugs. I want to thank the hon. Member for Daventry (Chris Heaton-Harris) for the highly constructive and pragmatic way in which he has been willing to take the off-patent agenda forward when speaking about his private Member’s Bill. I thank the hon. Member for Bury St Edmunds (Jo Churchill), who brings a strong personal perspective to the debate. Her sense of what is good for patients has been highly constructive in the debates we have had over the winter months. The hon. Member for Central Ayrshire (Dr Whitford), who used to be a breast cancer surgeon—in fact, she still practises—has brought a great level of expertise and experience in recent months, for which we are extraordinarily grateful. I also pay tribute to the Minister, who has been extraordinarily generous with his time and that of his officials in order to try and take this agenda forward, and for that I am extremely grateful.

I want first to make a point about clauses 3 and 4. While there is something of a consensus around responsible innovation, I had strong concerns about those clauses, as did many across the medical profession who thought that they might encourage a more dangerous type of experimentation, if I may put it that way. Looking at the amendments tabled by the hon. Member for Daventry, I can see that his intention is to remove clauses 3 and 4 altogether, which would be a very welcome step. That would mean that the principal remaining part of the Bill relates to the database of innovative medical treatments. The hon. Gentleman’s amendments 10 and 13 would bring the off-patent concept firmly into the purpose of this Bill, and therefore into the database. A lack of data was one of the barriers identified to more consistent prescribing of off-label treatments. The amendments would be an extremely welcome step forward, because they would not only enshrine in law the off-label aspect, but bring the data into the database so that it became more widely and readily available, assisting clinicians on the frontline. I sincerely hope that the amendments will be positively received by the Minister.

New clause 1 sets out an action plan for developing a pathway for off-patent repurposed drugs where strong evidence of their effectiveness in a new indication exists, with the aim of securing routine use. Put simply, this is an action plan with clear timeframes for progress. Again, this would be a welcome step forward.

New clause 2 would require the National Institute for Health Research to develop a mechanism for gathering and recording evidence on off-patent repurposed drugs, including clinical trials evidence, and passing it to the relevant bodies. The NIHR already has a dedicated horizon-scanning centre, but this would set up a dedicated stream for off-patent repurposed drugs to speed up getting them to the frontline and into routine use.

New clause 3 proposes that where there is strong evidence of effectiveness in a new indication, the National Institute for Health and Care Excellence should be directed to conduct a technology appraisal, including a cost-effectiveness analysis. While these drugs are extraordinarily cheap, some level of cost-effectiveness analysis would none the less be desirable, since to achieve routine commissioning, in England for a start, a persuasive business case clearly needs to be put to local hospitals and clinical commissioning groups.

New clause 4 is about having a national commissioning policy for off-patent drugs. It also requests that the Minister work with the devolved nations to produce something that is genuinely UK-wide. This has already happened in the case of NHS England working with Prostate Cancer UK to produce a commissioning policy for an off-patent repurposed drug called Docetaxel.

New clause 5 would make the licensing process more accessible. What would that mean in a practical sense? For example, an initial meeting where there is a discussion of the case and the likelihood of successful treatment could be free, a representative of patient organisations could be designated within the Medicines and Healthcare Products Regulatory Agency for patient organisations, and there could be a guidance document for non-pharmaceutical applicants.

Off-patent Drugs Bill

Carolyn Harris 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”

Post Office Horizon System

Carolyn Harris Excerpts

Monday 29th June 2015 Commons Chamber

[George Freeman]

I will come to the quality of the system. It is difficult on the face of it to characterise either the training or the helpline as having been inadequate. The vast majority of people who use or have used the Horizon system since it was introduced 15 years ago have in fact done so successfully. However, there is always room for improvement and the Post Office has implemented a business support programme to that end, including improvements to training, with both classroom and new online training available 24/7; improvements to the Post Office’s support helpline, including new ways of identifying and proactively supporting branches in difficulty; and new processes to help sub-postmasters manage their branch and protect against fraud.

I now come to some of the points that have been made about the Horizon IT system. It is used by tens of thousands of people working in the post office network, performing more than 6 million transactions every working day in branches up and down the country, so it is essential that it functions correctly. Like any large IT system, it is subject to rigorous testing, independent audit and industry accreditation. Nevertheless, in the light of the concerns raised about serious glitches in the Horizon system, the Post Office commissioned an independent firm of forensic accountants, Second Sight, to investigate.

Second Sight produced two independent reports—one in 2013 and the other earlier this year—both of which found there was no evidence of systemic flaws in the system. That is an important point that I would like to reiterate in response to the shadow Minister’s point: there is no evidence of systemic flaws in the system. Second Sight’s reports have, rightly, pointed out some areas where the Post Office could have improved how it operates, particularly on the training and support that it provided in some individual cases. As I said earlier, the Post Office is acting on those points.

The general secretary of the National Federation of SubPostmasters, George Thomson, told the Business, Innovation and Skills Committee in the last Parliament that the NFSP

“represent 7,000 sub-postmasters…If there was a systemic problem…we would be absolutely inundated.”

He went on to say:

“Over the 15 years, the Horizon system has been fantastically robust.”

As well as improvements to training and support, the Post Office also launched a mediation scheme so that any current or former sub-postmaster who felt they had problems with the Horizon system could bring forward an application. They would have their cases thoroughly reinvestigated both by the Post Office and by Second Sight, and, if appropriate, proceed to mediation to seek to resolve any issues.

It is important to understand that the mediation scheme is independent of the Government. That is the right approach for something that is a contractual matter between two independent businesses, and we should remember that sub-postmasters are independent businesspeople who have contracts with Post Office Ltd.

Mediation is, of course, a voluntary process. Both parties need to consent to it, and for it to be successful there needs to be a reasonable chance of coming to a common understanding. Sometimes mediation will not be appropriate or will not succeed, but it is important to note that mediation cannot overturn a criminal conviction. I will come back to that point.

My hon. Friend the Member for North West Leicestershire and others have been critical of the mediation scheme and how it is progressing. He mentioned that 90% of cases are being excluded from mediation, but that statistic is not borne out by the information provided by the Centre for Effective Dispute Resolution, which oversees the mediation scheme and is independent.

[Carolyn Harris (Swansea East) (Lab)]

Given the number of postmasters and postmistresses who have been attending MPs’ surgeries to discuss this matter, does not the Minister agree that one miscarriage of justice is one too many and that the Post Office has to be accountable for this system?

[George Freeman]

I absolutely accept that the Post Office must be accountable for any miscarriages and I will make a suggestion at the end about how we might address that.

My hon. Friend the Member for North West Leicestershire raised the case of his constituent Mr Rudkin. As he will understand, I cannot comment on that or any other individual case, because their details are rightly confidential, but I reiterate an offer that has been made to all hon. Members who have a constituent in the scheme: Post Office Ltd has offered to meet to discuss individual cases in detail, provided the applicant gives their consent. I am aware that Post Office Ltd has repeated that offer to my hon. Friend in the last fortnight, and I hope that he and others will take up that offer. I would be delighted to convene the meeting in my office in the Department if that helps.

I will move on to the points that my hon. Friend made about whether there may have been miscarriages of justice where sub-postmasters have been prosecuted and convicted. The Post Office handles large amounts of public money every day and operates a trusted role in communities, so it is vital that it has processes in place to protect that money and guard against fraud or theft. The Post Office can bring prosecutions against an individual, but it is down to the courts to determine whether they are guilty.

If an individual has been convicted and feels that their conviction is unsafe, they should explore the legal avenues open to them. They should seek advice on whether they can appeal their conviction, or raise their case with the Criminal Cases Review Commission. That is the correct way to deal with these issues if people believe there have been miscarriages of justice. The House cannot overturn a court ruling; nor, indeed, can mediation.