William Mead: 111 Helpline

Greg Mulholland Excerpts

Tuesday 26th January 2016 Commons Chamber

[Mr Hunt]

We will certainly look at whether we need to have more clinicians in 111. We do have clinicians available in 111. My own view is that it is the separation of the out-of-hours services and the 111 service that is at the heart of the problem that we are looking to deal with, but as part of the review we will look at the availability of clinicians in 111.

[Greg Mulholland (Leeds North West) (LD)]

I, too, add my condolences to the Mead family. I can only imagine their anguish at having been told “not to worry” and that this was “nothing serious”. There was a catalogue of failures, not just with 111. Is consideration being given to the decision by GPs not to take William’s heart rate, as clearly should have happened? Is there in any sense a reluctance to refer young patients to the acute sector? If that is the case, advice to GPs needs to be changed.

[Mr Hunt]

I can reassure the hon. Gentleman that we are looking at all these things. As with the issue of the prescribing of antibiotics raised by my hon. Friend the Member for Thirsk and Malton (Kevin Hollinrake), of course we want GPs to avoid inappropriate referrals to secondary care, but it is vital that where a referral is needed, it happens. We see this not just in cases of sepsis, but in cases of cancer. It is vital that we get better at catching cancers earlier if there is to be a successful outcome to the treatment, so the hon. Gentleman is absolutely right. That will be looked at.

Oral Answers to Questions

Greg Mulholland Excerpts

Tuesday 5th January 2016 Commons Chamber

[Jane Ellison]

I know that my colleague, the Under-Secretary of State for Life Sciences, is working very hard on that matter, and is hoping to make an announcement soon. I am sure that, at that point, he will be able to update my right hon. Friend.

[Greg Mulholland (Leeds North West) (LD)]

With regard to ultra-rare diseases, I will be joining the family of seven-year-old Sam Brown on 23 January to celebrate the funding of Vimizim. I thank all those involved in that decision, including those in the Department. As well as an update on Translarna, can we also have an update on the possibility of funding another drug that we have been campaigning for, which is Everolimus for tuberous sclerosis?

[Jane Ellison]

I thank the hon. Gentleman for his words, as does my hon. Friend the Under-Secretary of State for Life Sciences. With regard to the matter that he just mentioned, I know that it is something that NHS England is reviewing and it will come forward with a view in due course.

Junior Doctors Contract

Greg Mulholland Excerpts

Monday 30th November 2015 Commons Chamber

[Mr Hunt]

My hon. Friend is absolutely right: we have had some very unfortunate megaphone diplomacy over recent months, but I hope we can now put that behind us and that lessons will be learned. As he rightly says, we have never wanted to do anything other than what I think is good for doctors, as well as what is good for patients, and that is what the proposals were about.

[Greg Mulholland (Leeds North West) (LD)]

It should not have come to this and, of course, there will be a cost implication as a result. I welcome the involvement of ACAS to get to this stage and I hope the strike will be averted. Could the Secretary of State assure me that the specific concerns of anaesthetists are taken into consideration, given that they are on site all the time and are essential in making sure that hospitals are safe?

[Mr Hunt]

Anaesthetists have an absolutely vital role to play in providing proper seven-day services. In the highest-risk operations it is obviously very important for consultant anaesthetists also to be present, to give their very important judgments. I absolutely give the hon. Gentleman that assurance.

Oral Answers to Questions

Greg Mulholland Excerpts

Tuesday 13th October 2015 Commons Chamber

[Alistair Burt]

It is not possible for me to talk about what may emerge from the spending round and settlement, but I can say to the hon. Lady that local authorities were given extra finance to implement the Care Act 2014. Some £5.3 billion is available to local authorities to work through the new integrated social care and NHS budget. So we are very conscious of the pressures on local authorities, which need the resources to provide the social care we all expect.

[Greg Mulholland (Leeds North West) (LD)]

The coalition Government agreed a policy of a cap on care costs, and the Conservative manifesto in May said that no one would have to sell their homes to pay for care. Some £100 million has been wasted on this delay, which has betrayed our older people and has simply ducked one of the biggest crises facing this country. Will the Minister and the Department now apologise?

[Alistair Burt]

There was a consultation on the coalition proposals, which began at the beginning of this year and ran through the election period. The consultation included a very strong representation from the Local Government Association, which said that it did not want to implement the care cap now and wanted extra time. Therefore, the decision has been taken not to cancel, but to delay. It is of course a change from the position we set out. I fully accept that, but we listened to stakeholders and we are now going to use the extra time, at the request of the LGA and others, to find a way through to implement the policy and to use the time for extra financial products.

Oral Answers to Questions

Greg Mulholland Excerpts

Tuesday 7th July 2015 Commons Chamber

[Mr Speaker]

Emulating Strangford brevity, perhaps, I call Mr Greg Mulholland.

[Greg Mulholland (Leeds North West) (LD)]

Thank you, Mr Speaker. On 22 June, the Life Sciences Minister said in a written answer:

“The decision on the interim funding of Vimizim…will be made by NHS England by the end of June 2015.”

The families involved, and also families affected by Duchenne muscular dystrophy and tuberous sclerosis, were then told that there would be a decision on 30 June and 1 July—

[Mr Speaker]

Order. The hon. Gentleman will resume his seat. It is a discourtesy to the House to be long-winded, especially when exhorted not to be. The hon. Gentleman has got—[Interruption.] Order. Do not argue the toss with the Chair, Mr Mulholland. Don’t shake your head, mate. I am telling you what the position is: you were too long. [Interruption.] Leave, that is fine—we can manage without you. [Interruption.] You were too long and you need to learn. That is the end of it. I call Mr Peter Bone.

Drugs: Ultra-rare Diseases

Greg Mulholland Excerpts

Tuesday 16th June 2015 Westminster Hall

[Mr David Crausby (in the Chair)]

The Speaker’s Commission on Digital Democracy recently recommended the use of regular digital public discussion forums to inform debates held in Westminster Hall. A digital debate has taken place on Twitter ahead of today’s debate on access to drugs for ultra-rare diseases. For this reason, Mr Speaker has agreed that for this debate members of the public can use hand-held electronic devices in the Public Gallery. Photos, however, must not be taken. I encourage Members who wish to refer to the Twitter debate to call it the rare diseases Twitter debate, rather than using people’s individual Twitter names.

[Greg Mulholland (Leeds North West) (LD)]

I beg to move,

That this House has considered access to drugs for ultra-rare diseases.

I am delighted to have the chance to speak on this important topic today. I was also delighted to lead and take part in the historic Twitter debate yesterday, which was a great success. On top of the very strong show of support from Members of all parties, the fact that nearly 1 million people took part in the debate yesterday shows how important the issue is.

I got involved in the issue because Katy and Simon, the parents of Sam Brown, a six-year-old boy in my constituency, came to see me. In 2009, when Sam was 16 months old, he was diagnosed with Morquio syndrome, an ultra-rare disease that 88 people in the United Kingdom have. It is a degenerative life-limiting condition with a typical life expectancy of around 25 years. It limits considerably what those suffering from it can do. All of us here can only imagine what it must feel like as a parent to receive the devastating news that your child will deteriorate before your eyes, not live to an old age, and may not even see much, if any, of their adulthood. Imagine how it feels when a nurse rings up and says, “There might be a treatment, but it is only a trial.” Of course, on hearing such news, what parent would not want to sign up for a trial for the drug Vimizim, supplied by the drug company BioMarin? That is exactly what Katy and Simon did: they signed up Sam to the trial without hesitating.

For the past three years, Sam has been doing a 100-mile trip from Otley to Manchester every Thursday to get Vimizim, his enzyme replacement therapy. Without it, Sam would see his growth stunted more than it already is, with further skeletal deformities and possible heart and vision problems. With Vimizim, Sam’s parents, and, even more importantly, Sam’s medical team, say that he is clearly physically more capable and stronger, with more stamina than ever before. To quote Katy, his mother:

“The drug has given him the freedom to be a child again.”

I ask right hon. and hon. Members to take the opportunity to share the single, “There is a Boy”, produced by the Keep Sam Smiling campaign and produced at his primary school, the Whartons in Otley, where they have shown huge support to an ordinary little lad who wants to be an ordinary boy and an ordinary man. The video for the single shows Sam being a fireman, a doctor and an astronaut, the kinds of things that he has the right to hope one day to be, but he can have that hope only if he gets treatment and is able to continue to take Vimizim.

We are here today because, after three and a half years, in just nine days’ time, Sam’s access to Vimizim looks set to be cut off.

[Jon Trickett (Hemsworth) (Lab)]

The hon. Gentleman knows that I represent the grandmother of Sam Brown. This debate is important. As the hon. Gentleman has said, the mother has already testified to how Sam is stronger and fitter as a result of taking the medication. NICE has said that it is

“likely to provide valuable clinical benefits for certain aspects of the condition”.

Even if it does not provide a full cure, how can the treatment for that wonderful young boy be axed?

[Greg Mulholland]

The recommendation from NICE is strange—I will come on to that—given that, clearly, the drug is effective.

Sam and other children and adults with Morquio disease are not the only people being let down. There are other conditions. I have been working with Members and organisations on the mutation of Duchenne muscular dystrophy and tuberous sclerosis. We have come together to campaign as one to say that we need a better way of approving drugs for ultra-rare conditions. At the moment we have a system in this country where people with ultra-rare diseases are discriminated against, and that must stop.

[Rehman Chishti (Gillingham and Rainham) (Con)]

I pay tribute to the hon. Gentleman for the work that he has done and for securing this debate. On other rare conditions, I have a very sick two-year-old in my constituency who suffers from neuroblastoma, a rare form of cancer that only 100 children suffer from each year. It is difficult to accept that my constituent has to raise money and travel to the United States to get treatment. We should ensure that children or anyone suffering from rare conditions, such as Ruby Young and those in the hon. Gentleman’s constituency, get the treatment they need at the first port of call in their own country.

[Greg Mulholland]

The hon. Gentleman is right to say there are other such conditions. I will not be able to mention them all today, but other Members may wish to do so. I will concentrate on the three conditions that I have been working on: Morquio, Duchenne and tuberous sclerosis. Some 180 people suffer from those conditions. I am sorry to say that all those people and their families have been hugely let down by the repeated failure of process by NHS England and by the thick wall of bureaucracy and utter lack of accountability.

[Mark Tami (Alyn and Deeside) (Lab)]

Like the hon. Gentleman, I have been involved in the issue of Morquio. The correspondence that we have had seems to want to blame the company; the company says it has not had the information; and patients suffer. This matter has been drawn out, and we now have the news from NICE.

--- Later in debate ---

[Greg Mulholland]

I thank the hon. Gentleman for his intervention. It has been a pleasure working with him and others. We must continue to do so. That leads me on to the fiasco of the decision-making process. The leadership of NHS England should hang their heads in shame over the way they have handled this. There is also a responsibility on the shoulders of the Minister, who I know cares about this, but he needs to get a grip of NHS England and the way that it has failed families. Part of the problem goes back to the passing of the Health and Social Care Act 2012, which led to the disbanding of the advisory group for national specialised services in April 2013. That advisory group was the expert body that advised on specialist treatments and services, and it was respected by many rare disease charities.

[Mr Jim Cunningham (Coventry South) (Lab)]

I congratulate the hon. Gentleman on securing this debate. There are muscular dystrophy treatments in Europe that have suddenly been halted in this country. I hope the Minister can give us a good answer on that because people are suffering while there are delays. In some instances, it could shorten their lives.

[Greg Mulholland]

I hope that we get answers today and a real promise of intervention from the Minister.

[Mrs Cheryl Gillan (Chesham and Amersham) (Con)]

I pay tribute to the hon. Gentleman’s work on this issue. I joined this campaign because of Archie Hill, a constituent of mine aged 10 who has Duchenne muscular dystrophy. No matter what the Minister says about drugs such as Translarna and the process that the hon. Gentleman is about to outline, which has been disgraceful, that drug is available in other European countries and we have still not cleared it for patients in the UK.

[Greg Mulholland]

Indeed. It was a pleasure to meet the right hon. Lady’s constituent, Archie, and his parents. These young people are inspiring us to campaign. She is absolutely right. We are debating the European Union Referendum Bill today in the Chamber. Other EU countries, and some non-EU countries, regard these treatments as effective and affordable, yet we do not.

I will fast-forward from the scrapping of the previous body to October 2014, when NHS England came out with the scorecard system. That is despite one of the clinicians involved, Dr Chris Hendriksz, saying on 22 October in an email:

“I would suggest the scoring is not used at all for decision making this round and I would rather have people acknowledging that they are making random decisions than to try and give some credibility to a process that was deeply flawed.”

That is from one of the senior clinicians.

NHS England none the less went ahead with the scorecard system to decide which funding should be prioritised. Suzanne Mallah and her 10-year-old boy Kamal, who has Morquio and is another inspiring young person whom I have been delighted to meet, saw that that was not only haphazard but discriminatory. With the help of the MPS Society, they threatened legal action on 28 November against NHS England on the basis that the scorecard was clearly discriminatory, that there was no policy explaining it and that there had been no public consultation on its use. Just one week after that, on 2 December, NHS England announced that it was suspending use of the scorecard because the MPS Society and Kamal were right and it was wrong.

[Mr David Anderson (Blaydon) (Lab)]

The hon. Gentleman makes a good case. Is it not also the case that clinicians have not been listened to all the way through this, in the same way that they were not listened to when the Health and Social Care Act went through? That is what has led us to where we are. I have been the chairman of the all-party group on muscular dystrophy for 10 years. We had a very good working relationship with the specialised commissioning groups, which were effective in getting medication of this type to people, but the bureaucracy created by the Act was against clinicians’ wishes, which is why we are here today. NHS England has a lot to answer for. The Government’s decision to ignore the voice of professionals has put us in this position.

[Greg Mulholland]

It has been a pleasure to work with the hon. Gentleman and the APPG on muscular dystrophy on the Translarna part of the campaign. He is absolutely right. We want not only an acknowledgment from the Minister that the current processes are not fit for purpose and not fair on those with ultra-rare diseases, but a drive to overhaul them.

[Mary Glindon (North Tyneside) (Lab)]

I congratulate the hon. Gentleman on securing the debate. Does he agree that one of the best ways to help people suffering from ultra-rare diseases is Muscular Dystrophy UK’s suggestion of a fund to ring-fence money for these rare diseases?

[Greg Mulholland]

That is a powerful suggestion, as is using the surplus from the tariffs that drug companies are expected to pay to form part of a fund. There certainly needs to be an overhaul.

[Sir Gerald Howarth (Aldershot) (Con)]

Will the hon. Gentleman give way?

[Greg Mulholland]

I will give way, but I am conscious that I have not gone through the process yet.

[Sir Gerald Howarth]

We are all extremely grateful that the hon. Gentleman has been so generous in giving way. Like him, I was at Downing Street last week, supporting my constituent Harry Barnley, who suffers from Duchenne muscular dystrophy. The headquarters of the Batten Disease Family Association are in Farnborough in my constituency. The hon. Member for North Tyneside (Mary Glindon) referred to ring fencing. Part of the problem is that there is a very small number of these cases and they are very expensive to treat. I wonder whether we should either ring-fence some funding or introduce a surcharge on prescription charges generally paid by the public, so that the funding issue is taken out of it. There are two issues: the clinical issue and the funding. If we remove the funding issue, we can concentrate on the clinical issue.

[Greg Mulholland]

I thank the hon. Gentleman for his contribution. I am sure the Minister will want to consider that in his drive for an appropriate system.

After NHS England suspended the use of the scorecard on 2 December, a meeting of the NHS England clinical priorities advisory group on 15 December was called off. That is when we started campaigning for an interim process while NHS England went back to the drawing board. NHS England refused to do that, which I am sorry to say left all these families in the dark, with no idea what would happen next or in what timescale. NHS England then launched a consultation on 27 January, with a new process for deciding which drugs to fund that closed on 27 April. We still have not heard the decision. We have been told that there may be a decision on 25 June, although that has not been confirmed in writing. I hope that the Minister will give confirmation today.

Linked to that are the recent NICE recommendations, and particularly those on Vimizim. Even though we were clearly told by NHS England that its decision on 25 June would not be dependent on NICE, it now says that it will not approve Vimizim because NICE will not do so in the short term. The whole thing is a fiasco and an embarrassment. I understand the Minister’s argument that we cannot have political interference. However, the Secretary of State for Health made clear when he appeared before the Public Administration Committee in the previous Parliament that he accepts that the buck stops with him. When things are wrong and when bureaucrats are failing, it comes to his desk and to the Life Sciences Minister’s desk. I urge the Minister to take that up.

I pay tribute to the MPS Society for its amazing campaigning, and particularly to the chief executive Christine Lavery, whose son Simon had Morquio and died in 1982 aged just seven. Her passion and her colleagues’ passion have inspired me and others, and we will continue to work with them. The enzyme replacement therapy produced by BioMarin, Vimizim, is currently supplied on a free trial by BioMarin to 34 patients around the country out of a total of 88 patients, so more people with Morquio are not getting Vimizim than are.

The list price for Vimizim is £395,000 per person per year. In October, BioMarin proposed a fixed-term arrangement with NHS England to supply the drug at a lower price for a number of years. After BioMarin’s offer in October, NHS England did not even reply, despite repeated follow-ups, forcing BioMarin to announce in February that it would cease to supply the drug after 11 May; that date was then extended to 25 June. Having heard nothing, BioMarin said that it would have to withdraw the drug.

[Mark Tami]

Gracie Mellalieu in my constituency, fortunately being in Wales, will get the drug until October, but there is still that cut-off point. Is the hon. Gentleman amazed, as I was, at the total lack of engagement from NHS England, even when that offer was made?

[Greg Mulholland]

It is absolutely disgraceful and I urge the Minister to properly take that up. We have not had answers or justifications, although there can be no justification for NHS England behaving in that way. NICE’s decision not to recommend approving Vimizim in the short term has already been deemed to be flawed by those involved, including the MPS Society and clinicians, because it fails to consider BioMarin’s offer and has assumed that the cost of the drug will be the original £395,000. How has that happened? NICE also took months to put together the interim guidance, but has given only until next Tuesday to receive the extra evidence that it has asked for. Surely that is an unfair timeline for response.

As of 28 April 2015—which, incidentally, is a year after Vimizim was approved by the European Medicines Agency, meaning that it is approved in 20 European countries, including France, Germany and the Czech Republic—the drug was still not available in the UK, because NHS England has failed to put in place arrangements for funding it. Does the Minister not share the sense of frustration, anger and disbelief that the NHS refuses to fund the drug when so many of our neighbours do? More fundamentally, Earl Howe gave patients an assurance that their access to the drugs that they need would not depend on the cost per quality-adjusted life year measure. Can the Minister tell us why his Department has gone back on that assurance? That is exactly what it appears to have done.

I appreciate that the Minister has taken the time to meet us, but I remind him of the 11-page letter that he asked the organisations to send him some 11 weeks ago. We expected him to respond to that, as it was a complaint about NHS England’s handling of the matter, yet he simply passed it on for NHS England to respond to. That is not what we asked him to do, and the response does not address the points that we made to him, at his request, about how NHS England has failed people. I ask him again to reply directly and properly, and to investigate the mishandling of the situation by NHS England.

Duchenne muscular dystrophy has been mentioned. Again, I highlight the campaigning of organisations such as Muscular Dystrophy UK, Joining Jack, Action Duchenne, the Duchenne Family Support Group, the Duchenne Children’s Trust, Alex’s Wish and the Harrisons Fund. Those groups share the MPS Society’s frustration at the process. As many hon. Members know, Duchenne muscular dystrophy is a condition affecting only boys, and numerous potential treatments are in late clinical trial. Translarna, in particular, received conditional approval funding in the EU in August 2014. This clearly effective drug is being funded in a number of countries, including Greece, even given its economic situation, yet we are still no closer to hearing whether it will be funded here. I hope to hear positive news on that drug today.

I pay tribute to the Tuberous Sclerosis Association and the work of Jayne Spink and her colleagues. For those who do not know, tuberous sclerosis is a condition that causes the growth of tumours in organs, including the brain, eyes, heart, kidneys, skin and lungs, and a range of associated health problems, including epilepsy, learning difficulties and behavioural problems. The drug everolimus has been found to be effective in shrinking the tumours, extending life and improving quality of life, but although it was licensed for use in patients with tuberous sclerosis in February 2013, NHS England has failed to draw up a prescribing policy. At least two people have already died since the drug was licensed; Chris Kingswood, a consultant nephrologist, said that Julie Brooker’s death in January 2013 was “absolutely preventable” if she had been given access to everolimus.

[Jo Churchill (Bury St Edmunds) (Con)]

My constituent William needs that drug. The issue for his family is the timeline, which the hon. Gentleman mentioned. They have waited two years and been told that it may be another year, but they have said to me that William might not have that much time and that, like the woman the hon. Gentleman just mentioned, he might no longer be with them by then. Those parents are fighting for their son.

[Greg Mulholland]

The hon. Lady is right: none of these children or families has time. All those conditions deteriorate irreversibly. She is right that it has been 28 months since the drug was approved, yet patients are no closer to accessing it. What will the Minister do to speed up a commissioning policy for everolimus?

I turn to Batten disease, another condition already mentioned. I pay tribute to the Batten Disease Family Association. Batten disease is another condition that I had not heard of until I was approached by my constituents Duncan and Lynsey Brownnutt. I have been pleased to join Duncan to support some of his amazing fundraising efforts. This summer, he is off on a wonderful cycling trip to the Arctic Circle with his friend Rod to raise money, but the day after the general election, his six-year-old daughter Ellie Mae passed away from Batten disease.

Batten disease is another condition currently without any cure. It includes increasing visual impairment, complex epilepsy with severe seizures, decline of speech, language and swallowing skills, deterioration of motor skills resulting in loss of mobility and ultimately death. Potential treatment for Batten disease is not even being considered for 25 June. If the situation of the other conditions is still unclear and their drugs have been turned down, when will action be taken on treatment for Batten disease?

[Mrs Flick Drummond (Portsmouth South) (Con)]

May I just point out that BioMarin is also developing a treatment to alleviate some of the symptoms of Batten disease?

[Greg Mulholland]

The Batten Disease Family Association explained that to me when I met with representatives, but unfortunately that is not even in the consideration for 25 June. That is why we need an overhaul.

We have a five-year Parliament. I hope that the Minister will serve as the Life Sciences Minister for a considerable time, if not for the whole Parliament. His challenge as the Life Sciences Minister, as well as dealing with the accountability deficit that clearly exists in NHS England’s decision making, must now be to initiate a proper process for the approval of drugs for rare conditions. Of course there are cost implications, and of course drugs must be effective, but the situation is that there are effective drugs that this country is not funding, while other countries with less strong economies are finding the money in their health services to fund them.

[Rehman Chishti]

The hon. Gentleman talks about funding, but one aspect that precedes funding is awareness of such diseases. For example, the Government’s “Be Clear on Cancer” campaign does not take into account rare conditions and cancers such as neuroblastoma, from which my constituent, who is near death, is suffering. The Government must ensure that rare conditions are part of the bigger campaign, so that the people suffering from them get the help that they need as well.

--- Later in debate ---

[Greg Mulholland]

The hon. Gentleman is right. I am afraid to say that politically, particularly at election time, there is not enough focus on rare conditions and too much focus on more common conditions in order to appeal to a broader group of people. We cannot allow that to lead to discrimination against people with ultra-rare conditions.

I will finish with two quotes. The first is from the framework agreement with NHS England, which clearly lays out that the Minister and the Secretary of State can and should intervene. Paragraph 4.11.3 says:

“If the Secretary of State considers that NHS England is significantly failing in its duties and functions, he is able to intervene and issue directions to NHS England. This also applies where he or she considers NHS England has failed to act in the interests of the health service.”

Clearly, that is what NHS England has done, and he must now act and get a grip of this process.

I will leave the final word today to Katy Brown, the amazingly courageous mother of six-year-old Sam, because we can imagine the devastation that she felt after the flawed NICE decision not to recommend approving the drug for the time being, knowing full well that NHS England will just use that decision as its cue to say no on or before 25 June. Katy has said that, if that is the case,

“Sam is being handed a death sentence…He is being denied his freedom, his independence and his future.”

That is not something that any of us should allow when we have a drug that is affordable if we have a system such as that in other European nations and that is clearly clinically effective. We need major change and, Minister, we need it quickly.

Oral Answers to Questions

Greg Mulholland Excerpts

Tuesday 2nd June 2015 Commons Chamber

[Ben Gummer]

I thank the hon. Gentleman for his question. In relation to posteriors, it is good to see his in its rightful place. I have heard of his constituent’s case, which is as distressing as that of Jagger and of all those suffering from Duchenne muscular dystrophy. It is a terrible disease that causes lasting pain to the sufferers and their families. That is precisely why we are pushing hard for a decision from NHS England by the end of this month—it could not have come as quick as he had hoped—and for interim NICE guidance by the end of this year. I am pushing officials to move as quickly as they can on this.

[Greg Mulholland (Leeds North West) (LD)]

The reality is that NHS England has failed to respond to letters or to turn up for meetings, and it has behaved in an utterly unaccountable manner in regard not only to Translarna but to Vimizim, which is used to treat Morquio syndrome. We have still not had confirmation that an interim decision will be made on 25 June, but we are now being told that there will be a decision from NICE on 5 June. Will Ministers finally get a grip on this and give the families affected by these various conditions some sense of when they might get the treatment that could improve their quality of life?

[Ben Gummer]

I am sorry to hear that the hon. Gentleman has had that experience with NHS England. My hon. Friend the Minister for Life Sciences will want to speak to him about that; if it is the case, it is clearly unacceptable. As the hon. Gentleman will have heard from my previous answer, we are hoping to get quick decisions from NHS England on the interim commissioning guidance this month, and I am pushing hard for a decision from NICE as soon as possible this year, so that we can get interim guidance from it.

Jimmy Savile (NHS Investigations)

Greg Mulholland Excerpts

Thursday 26th February 2015 Commons Chamber

[Mr Hunt]

We have already paid compensation claims. Initially, those claims will be taken from the Savile estate and the money left in the Savile charities, but if those funds prove not to be enough we would pay from the NHS Litigation Authority. The report is not able to confirm the extent to which senior management knew or did not know about the allegations, so it is difficult to make progress on the specific points, but that does not stop people being able to make a claim and receive compensation.

[Greg Mulholland (Leeds North West) (LD)]

I echo the Secretary of State’s praise from those involved in this meticulous investigation and report, but does he acknowledge the concern that the cases of many victims of sexual abuse in other organisations and institutions have not involved a celebrity? I have in my possession a letter from 1993 sent from a Barnardo’s project worker in Leeds to Leeds city council, which blames a constituent of mine for her own rape. Nothing was done to protect her. The abuse continued, and that offence was not reported to the police. Clearly, that would not happen now, but there are still victims whose cases are not being looked at and are not getting justice. What can be done about that?

[Mr Hunt]

A lot of things, and that is what this morning is all about. Mandatory reporting so that the reporting of incidents becomes the norm and not the exception is clearly an area where culture has to change. We have to find the right way to do that. Also, if we get this culture right, we should be able—this must be the ultimate objective of all this work—to stop such incidents happening in the first place. If people had acted earlier on their suspicions about Savile, a lot of victims would have been spared the torment that they subsequently had to endure. The biggest tragedy of all this is that it happened over decades and nothing was done. That is what we need to make sure never happens again.

Epilepsy

Greg Mulholland Excerpts

Thursday 26th February 2015 Commons Chamber

[Greg Mulholland (Leeds North West) (LD)]

I start by congratulating my hon. Friend the Member for South Thanet (Laura Sandys) and my right hon. Friend the Member for Chesham and Amersham (Mrs Gillan) on securing this important debate and giving us all the opportunity to contribute on behalf of our constituents. I particularly thank my hon. Friend for bringing her experience and for what she has done during her time here, and I echo the sentiment that it is a shame she will not be coming back to carry that on. Other people will have to do that, and I am sure right hon. and hon. Members will do that here.

It is important to start by saying that my right hon. Friend the Minister of State, Department of Health has taken a real interest in epilepsy and that he and his colleagues have introduced significant improvements in this Parliament. Equally, the NHS Commissioning Board’s decision to introduce a national clinical director for neurological conditions, Dr David Bateman, has been positive in ensuring that epilepsy is on the agenda at the most senior level in the NHS.

In February 2013 we saw the publication of the NICE new quality standards for children and adults with epilepsy. I also welcome cross-departmental working, and the fact that the Department for Education is looking at better support for pupils in school diagnosed with epilepsy. There is still a lot to do, and still too much of a sense that care is good in some areas and poor in others; that has to be a priority for the next Government.

I am proud that Epilepsy Action, an excellent organisation, is based in Leeds. Its headquarters are in Yeadon, an area that I represent. The office is about 100 yards over the border in the constituency of my hon. Friend the Member for Pudsey (Stuart Andrew). We share Yeadon, but we are both proud that this wonderful national charity is based in Yeadon in north Leeds. I will not repeat the findings of its powerful survey, except to reiterate one figure. Of the clinical commissioning groups that responded, 70% said that they had not produced and had no plans to develop a written needs assessment of the health and social care needs for epilepsy. That is simply not good enough and it has to change, and quickly. I urge my hon. Friend the Minister in the time that he has remaining to make it clear that that is not acceptable and must change.

Every health and wellbeing board must know how many people in their area have epilepsy and develop an epilepsy section for their joint strategic needs assessment, and that should include information about current local provision and services and future needs. Health and wellbeing boards must also work with their local CCGs to ensure that adults and children in their area experience a joined-up approach to their epilepsy health care needs. Every local authority scrutiny board with responsibility for health must consider whether their JSNA adequately meets the needs of adults and children with epilepsy in their local area.

I am delighted to tell my right hon. Friend the Minister that the Leeds Teaching Hospitals NHS trust—this is not me saying it, but my constituents and practitioners tell me—is one of the best trusts in the country for supporting those who have epilepsy. We are proud of that. The trust has a team providing specialist epilepsy care and advice for people in Leeds and the wider Yorkshire region, and as well as the medical treatment of epilepsy it runs an epilepsy surgery pathway for people with difficult-to-treat epilepsy. It has specialist brain tumour and vagal nerve stimulation clinics. I hope that my right hon. Friend will join me in recognising that Leeds is a centre of excellence for epilepsy. If, in the remaining five weeks while he is definitely in this particular job he has the time to come and visit to meet some of the people involved, I would find time in my diary to join him.

Like many other Members, I have learned from my constituents about epilepsy. My constituent Dominic Ware and his parents Vic and Carol have given me their permission to pass on some of what I have learned from them. My constituent Andy Cavadino also has epilepsy. They have enabled me to see both the good and the issues that need dealing with.

Andy Cavadino’s epilepsy developed over 10 years after a serious head injury. The two main issues affecting him relate to driving and to medication. As a teacher, he finds it frustrating that he is allowed to drive a people carrier but not a minibus. He wants there to be a much more transparent discussion about what vehicles can and should be driven by people with epilepsy. The second issue that he raises has already been covered by other hon. Members. People have an attitude to those with epilepsy; they are often nervous and on edge around people with epilepsy. As Andy told me, people sometimes say, “Take it easy.” We need to raise awareness that people with epilepsy are generally on medication, if they need to be, and that that is helpful. We must do more to fight the sense of concern, paranoia and stigma that is attached to people such as Andy.

Dominic Ware’s epilepsy has been a huge part of his life and that of his parents, Vic and Carol. It is something that they have to cope with. The care that Dominic has received in Leeds has saved his life and now enables him to lead a normal life, which is precisely what needs to happen. However, they and especially Vic, who is a passionate campaigner, know that for too many people, that is not the case. During the debate, we have heard of people who, unlike Dominic, have been failed, often with devastating effects, and that is simply not acceptable. Will my right hon. Friend the Minister support Vic’s call that whoever forms the next Government should appoint an epilepsy champion in the Department of Health to bring things together so that there is a single, strong voice in government to push the issue forward?

[Madam Deputy Speaker (Dame Dawn Primarolo)]

Order.

Drugs (Ultra-rare Diseases)

Greg Mulholland Excerpts

Tuesday 20th January 2015 Westminster Hall

[Greg Mulholland (Leeds North West) (LD)]

I am delighted to have the opportunity to raise this hugely important issue, which affects a number of children across the country represented here today by a good number of right hon. and hon. Members. Although the debate is scheduled for only half an hour, I will take interventions from Members who wish to raise constituency cases. I am happy to do so because this is an important issue that affects families across the country. At the moment, 88 children in the United Kingdom have Morquio. There are 2,500 people with Duchenne muscular dystrophy, but 50 have a nonsense mutation, which falls into the category of an ultra-rare disease. We are talking about 138 people, 111 of whom are currently on treatment trials with the two drugs that are relevant to this debate.

I am delighted that there was a powerful lobby last week on behalf of the group with the nonsense mutation of Duchenne muscular dystrophy. Families from across the country gathered in Portcullis House and then presented a 24,000-strong petition calling for Translarna. I was with the hon. Member for Blaydon (Mr Anderson), who chairs the all-party group on muscular dystrophy, and the right hon. Member for Chesham and Amersham (Mrs Gillan), who was there with her constituent Archie Hill. We were joined by Liam and Saul, two other boys with the condition. We were all delighted that the hon. Member for Blaydon managed to ask a question at Prime Minister’s Question Time, and the answer gave hope to all those children because the Prime Minister gave a very personal answer comparing his own son to Archie—he had a picture of Archie playing football. The Prime Minister came to speak to us, and he said that he would personally do what he could, which echoes the Minister’s work. I thank the Minister for his personal assistance, which has been extremely helpful. I have met him twice, and I know he is very engaged on this matter, which I appreciate.

[Mrs Cheryl Gillan (Chesham and Amersham) (Con)]

I am grateful to the hon. Gentleman for giving way. I pay tribute to him for his work on this subject, which is second to none. I also thank him for mentioning my constituent Archie Hill and his parents, who have campaigned tirelessly for Translarna for their son. Does the hon. Gentleman agree that it is important that NHS England takes on board what the Prime Minister said to us, and to the families whom we represented, at Downing street last week by introducing a plan that enables Translarna to be available to those children who could benefit now, rather than waiting for the bureaucracy that is tying the drug up in knots? It could be available for those children now.

[Greg Mulholland]

Absolutely. It is a pleasure to be working on this issue with the right hon. Lady and other right hon. and hon. Members from both sides of the House. This is a personal issue for me, too. My attention was drawn to the issue when Simon and Katy Brown came to see me with their son, Sam, in 2012. Sam was then four, and he is now six. Sam is receiving Vimizim, which is the only drug that clinically works for Morquio. Both drugs have been shown to have a very significant impact on the health of these individuals, changing what they are able to do with their lives, which is crucial.

[David Simpson (Upper Bann) (DUP)]

I thank the hon. Gentleman for giving way. I congratulate him on securing this debate. Is the supply of drugs purely down to finances, or is it totally bureaucracy? What is it? Why is there a hold-up on such an important issue?

[Greg Mulholland]

That is a good question, and it is the nub of the issue. It is not finances. Finances are clearly an issue, but it is important to get the message out that they are not the cause of the hold-up. There is an element of bureaucracy in the process, which I will address. I know that the Minister is seeking to ensure that we have a proper process, but ultimately we have to make decisions based on the effectiveness of the drugs. In this case, both drugs have been shown to work and are licensed and used by health systems in other countries.

[Caroline Nokes (Romsey and Southampton North) (Con)]

I thank my hon. Friend for giving way, and I congratulate him on securing this debate. On effectiveness, would he agree—I hope the Minister also concurs—that it is about timing, particularly with Translarna? The drug will extend the ability of young boys to maintain their mobility and to keep out of a wheelchair, which is why it is so critical that the bureaucracy is speeded up for individuals such as my constituent Jagger Curtis and his dad, James. They need the drug now, not in six, 12 or 18 months’ time. It comes down to ensuring that the drug is available when it will be effective.

[Greg Mulholland]

Absolutely. That is very much the case with Morquio, too. Simon and Katy Brown have told me that the drug is having a huge impact now. I met Sam and saw him running around when he visited my surgery. When there is deterioration in such conditions, the clock can never be turned back, which is why we are urging the Minister to address the situation. I am delighted that we had meetings with him. All the organisations involved, the MPS Society, the Muscular Dystrophy Campaign, Action Duchenne and Joining Jack, are urging the Minister and NHS England to find a way to ensure that all these children, not only the 111 who are currently on the trials—some of whom are, of course, receiving placebos—but all 138 children with these conditions, are able to access the drugs now. We have asked for a decision on that by the end of January.

We are in this situation because a decision was supposed to have been taken by NHS England on 15 December 2014, but a letter was sent by the MPS Society and a young man with Morquio syndrome, Kamal—I am delighted that his family are visiting Parliament today—and on receipt of that letter NHS England, realising that its process was potentially discriminating against people with ultra-rare conditions, pulled the entire process, leaving all these families in limbo. NHS England has a responsibility to put another proper, robust process in place.

[Alec Shelbrooke (Elmet and Rothwell) (Con)]

I am grateful to my hon. Friend for giving way. I will be meeting my constituent Angela Paton on Friday afternoon. She was part of the trial, which helped her immensely, but she is worried that the drug may now be withdrawn. Would my hon. Friend like me to report to him after that meeting on Friday?

[Greg Mulholland]

Absolutely. It is critical that we all work together on this issue. Indeed, I would like to hear from the MPs for all these families across the country so that we can have one voice to say to NHS England and the Minister, who has been very helpful, that we need a solution and that we need to hear some news by the end of January.

NHS England is now consulting on a new process, and it has said that it will take 90 days. That may seem a reasonable time to come up with a process, but considering that the old process was flawed, there needs to be something to fill the gap that enables all these children to access the drugs now. At the moment, the drugs in this case are being supplied through the good will of the drug companies: BioMarin in the case of Vimizim and PTC in the case of Translarna. Both companies are engaged in the process, both have a part to play and both are involved in dialogue with the Minister and NHS England.

I will briefly explain the two conditions so that people understand. Morquio is caused by the lack of an enzyme needed to break down certain chains of sugar molecules used in building bones, cartilage, tendons and other bodily tissues. Those unbroken molecules are stored in parts of cells called lysosomes, which become swollen, disrupt cell functions and cause progressive damage. Babies with the syndrome grow normally, but growth slows significantly after 18 months. Those severely affected stop growing at about age eight, and their final height may be three or four feet, which has many effects on their quality of life. There is no cure for Morquio, but the enzyme replacement therapy Vimizim, for which clinical trials are ongoing at the moment, has been shown to be effective. As we have said, any delay with the drug will cause damage that cannot then be reversed.

[Kerry McCarthy (Bristol East) (Lab)]

Before I came in, I was speaking to my hon. Friend the Member for Alyn and Deeside (Mark Tami), who would have liked to be here but who has a meeting and sends his apologies. When reading the testimonies from the MPS Society UK, I was struck by how significant a difference the drug makes to children’s energy levels. Obviously, clinical trials and other formal assessments are important, but the personal testimonies from the families about the changes that they have seen in the children and how much energy the drug gives them are far more compelling than any scientific assessment could be. Does the hon. Gentleman agree that listening to the families is important?

[Greg Mulholland]

It is crucial, but that also tallies with the medical evidence. It has been shown that that particular treatment stabilises symptoms, slows deterioration and has a hugely positive impact on quality of life. Children can do more and lead more normal lives; they have more energy and stamina. People with Morquio can live full lives and go on to education and employment, but childhood is their only opportunity to take a drug to slow the effects of the disease.

Duchenne muscular dystrophy, also caused by a mutation, affects young boys specifically. It also has no cure and gets worse over time. It begins by affecting a particular group of muscles and then muscles more widely, leading to difficulty walking, running, jumping, standing up and climbing stairs. Children with Duchenne muscular dystrophy may end up in a wheelchair fairly young, and are certainly predicted to become wheelchair-bound between the ages of eight and 14 as their muscles weaken and they lose their ability to walk.

[Mrs Gillan]

The thing that came home to me was that those children need to access such drugs quickly, while they are still walking. Is that not why the time scale is so urgent? As soon as the child is no longer ambulatory, the drug will not have an effect. That is why we must have a speeded-up timetable and access to personal budgets for such drugs.

[Greg Mulholland]

The right hon. Lady is absolutely right. Without such drugs, boys with Duchenne and children with Morquio are deteriorating now while waiting. They were expecting a decision on 15 December about whether they would be able to access those two drugs.

Translarna changes the natural course of the mutation in Duchenne muscular dystrophy, slows the decline in physical functioning and can therefore also play an important role in reducing the burden that the condition places not only on the boys who have it but on their families. They can do more, lead normal lives and see their boys do normal things with their siblings.

The number of people affected by the nonsense mutation in Duchenne is very small: there are only 50, 34 of whom are currently in the Translarna trial. The number expected to be eligible for Translarna is about 80 to 90 people, so we are not talking about huge numbers. Some of those people, incidentally, are not yet diagnosed; it is believed that that is the largest potential figure. Vimizim is already licensed in various countries: more than 20 European countries have access to it outside clinical trials, including France, Germany, Italy, Denmark and the Czech Republic. Translarna has been given conditional approval by the European Medicines Agency to treat boys with the nonsense mutation. Data gathered from clinical trials of Translarna indicates that the drug, as well as being effective, is safe. Results of the phase 2B trial were encouraging. Boys who received a low dose of Translarna could walk an average of 31 metres farther than boys receiving the placebo. Translarna is already available in Italy, Germany, Spain and France.

The clear message from all the families and organisations representing people with both those conditions is that we cannot wait for the drugs. NHS England has a responsibility, but so does the Department of Health, because the abolition of the previous highly specialised commissioning service led to an unfit-for-purpose process that had to be scrapped in the face of the pre-action. There is a moral and potentially a legal responsibility to find a way to make that decision. We are now already more than a month past the day when those families were expecting a decision that could literally be life-changing for them.

We understand, of course, that NHS England must put in place a proper process, but I urge the Minister to carry on doing what he is doing and the Prime Minister, who has taken a personal interest in the issue, to find a way to allow all those children to access these two drugs, which have been shown to be effective and to have a hugely transformative effect on their lives and those of their families. I will carry on working with the Minister and the two drug companies, but I urge him to listen to this message. We cannot wait 90 days. We need an interim solution, and I hope that we can have that by the end of January, soon as that is. I will carry on working with him and colleagues throughout the House until we get that news.

--- Later in debate ---

[George Freeman]

I understand; my right hon. Friend makes an important point. In fact, I raised it this morning in my meeting with NHS England. My understanding is that NHS England will continue to consider individual applications for Translarna through its individual funding request process from patients who may be exceptional. However, my understanding is that such cases really do have to be exceptional. In reality, the members of the whole group that we are considering are more or less suffering from the same condition and therefore they may not qualify under those criteria. I merely share that with my right hon. Friend because I myself raised that point this morning with NHS England.

[Greg Mulholland]

I stress to my hon. Friend the Minister that we are discussing two conditions and two drugs, Translarna and Vimazim. I also have to say to him again that we understand that NHS England has to put a process in place; of course it does, because the process it had put in place was not fit for purpose. Does he accept that NHS England has a legal, as well as a moral, responsibility in this regard? It certainly has a moral responsibility. Having said that the decision will be made on 15 December, NHS England cannot now hide behind saying, “There needs to be a new process,” when this situation is its fault in the first place. We are now a month on from that initial deadline, and there needs to be an interim solution to somehow allow these 138 children to access the two drugs in the meantime, and before that process is complete.

[George Freeman]

I certainly accept the moral case; I think that everyone would accept that there is a moral duty to get this matter right and to try to make these decisions on the right basis and on the basis of the right evidence. The legal position, given the legal challenge, is more complicated, and it has triggered a formal process of reappraisal. As I have said, I will meet NHS England officials to urge them to try to expedite that process as best they can. However, I must stress that I do not want to get into a situation where we compromise due process and inadvertently undermine a case. What I want to see is a NICE decision being made as quickly as possible, and I will urge NICE to expedite that process in every way it can, so that we get the right decision that we all want.