Accelerated Access Review

Debate between Mark Durkan and Sharon Hodgson

Tuesday 13th December 2016 Westminster Hall

[Mrs Sharon Hodgson (Washington and Sunderland West) (Lab)]

It is an honour to serve under your chairmanship, Sir Alan. I thank my hon. Friend the Member for Dudley North (Ian Austin) for securing this important debate. I note that as he said, it is just over a year since he first brought to the House a debate on cystic fibrosis.

I appreciate all hon. Members who have attended and spoken in this debate to show their support for the cause; it is one that we must urgently get right. Members have shared many moving cases involving their constituents whose lives Orkambi could save and would certainly transform. My hon. Friend the Member for Dudley North mentioned Carly Jeavons and Sam and Rob, the parents of Daisy. The hon. Member for Strangford (Jim Shannon) spoke about Evie-May, and my hon. Friend the Member for Bristol East (Kerry McCarthy) mentioned her niece Maisie. My right hon. Friend the Member for Leigh (Andy Burnham) spoke about his office manager Karen Aspinall and her son, as well as Philip and his sister Melissa, who sadly died. Philip believes that Orkambi would have helped his sister and would certainly help him, as he also suffers from cystic fibrosis. Those people believe that their lives would be transformed by Orkambi. I believe that too, and the evidence supports it, as we have heard in detail.

I thank all hon. Members who have spoken in this debate, including the hon. Member for St Ives (Derek Thomas), the hon. Member for Bath (Ben Howlett) and my hon. Friend the Member for Cambridge (Daniel Zeichner), for their excellent contributions, as well as the many others who have made valuable interventions. I also thank the Cystic Fibrosis Trust for its dedicated campaigning on the issue, and the 20,000 people who have been involved in its survey, in the digital debate here in Parliament, and in petitions and e-action. The concerns and the need for action are clear, and it is up to the Minister to give all those people beyond this place the answers that they need.

In my contribution, I will set out why the Opposition want to see the Government do more on innovative drugs, through case studies involving Orkambi. I will touch on issues of access to Orkambi and other drugs for those living with cystic fibrosis and expand into the recommendations of the accelerated access review, which can do much to address many of the issues involving access to new drugs.

Although it is welcome that the prescription drug Kalydeco was given the go-ahead by NHS England last week for two to five-year-olds as part of re-prioritisation, Orkambi remains an issue. There is currently a deadlock in negotiations between the pharmaceutical company Vertex, the Government and NHS England for the drug to be accessible to the 2,700 people who stand to benefit from it. As we have heard in detail today, that is all down to rejection of the drug under NICE’s appraisal system because there is a lack of long-term data. Although it is welcome that NICE recognises the treatment as effective in managing cystic fibrosis, it is clear that we desperately need a new system under which drugs can be better accessed, especially those that show that they can benefit patients. We have also heard about new data that NICE did not take into account and that would have showed 42% effectiveness.

Orkambi has been shown to halve the amount of hospitalisation of cystic fibrosis sufferers, and 96-week data published recently showed that it can help to slow lung function decline by 42%. The data are also backed up by anecdotal evidence from people who have accessed Orkambi through the compassionate use programme and are beginning to report transformations in their health—some are reporting enough improvement to come off the lung transplant list. That information is all positive. It should be made better available for consideration as part of the appraisal process; it should also form part of the negotiations between Vertex, the Government and NHS England. However, when we see a deadlock, all of that information is for naught. Thousands of people are suffering irreversible lung damage that could be stopped if the current impasse between those around the negotiating table was broken. Those who will suffer the most are stuck in the middle.

It is up to the Government to facilitate the end of the deadlock so that people can access Orkambi and see their lives transformed. One way to do that is to begin the job of implementing the recommendations set out in the accelerated access review, which the Opposition welcome. The goal of speeding up access to drugs by cutting four years off the time needed to bring new medicines to patients is something that we should all welcome; we need to see whether it can be achieved. The review has the potential to change the philosophy of the NHS in line with the five-year forward view, but also to help to maintain our global lead in life sciences. The recommendations set out in its final report have the potential to transform how we provide drugs and treatments, ensuring that we see innovation in drugs, diagnostic tools and healthcare developments. However, there still remain issues around thresholds for new drugs, which NICE and NHS England are currently consulting on. I understand that some associations and charities have raised concerns about that, and I hope that the Minister will update us on some of those discussions.

[Mark Durkan (Foyle) (SDLP)]

My hon. Friend is right to be so positive about many aspects of the accelerated access review. However, as she has mentioned, there are concerns that new definitional ruts could be created by some of the terms of the review, which could lead to some patients and some promising drugs being trapped in exactly the sort of deadlock that she has described.

[Mrs Hodgson]

My hon. Friend is right to raise those concerns. We do not want to move into a new system that will create new unintended consequences. Perhaps the Minister will touch on that in his speech.

Although some are calling for interim solutions to help people who are stuck waiting for the accelerated access review’s recommendations to be implemented, it is also important that the Government get on with implementing those changes. The review was announced more than a year ago and was published two months ago now. It is important to remember that the transformation that we all want to see will not happen straight away, but it is still right that we keep up the pressure for the recommendations to be implemented. There are many such recommendations, and I hope that the Minister will be able to update us today on the progress on each of them. There are two in particular that illustrate what can be done to resolve the deadlock around Orkambi—the immediate establishment of an accelerated access partnership and the setting up of a new flexible strategic commercial unit.

The accelerated access partnership is one way in which, through co-ordination and collaboration across the system, we could see drugs brought on to the market more quickly to benefit patients who need access to them. I would be interested to hear from the Minister what progress has been made on its creation, especially in conjunction with the issues surrounding the deadlock on Orkambi.

It is clear that the strategic commercial unit could help to benefit those who wish to see Orkambi offered on the NHS. The unit could work with those involved in this dispute to end the current deadlock through facilitation of the flexibility and transformational change promised by the accelerated access review. That would go some way towards helping to access data on drugs such as Orkambi and getting them out to patients. There is a willingness out there for that flexibility to be brought into the system; for example, the Cystic Fibrosis Trust has offered to use the UK cystic fibrosis registry to help to provide essential data that can help to prove how effective drugs can be and what more needs to be done. We have already heard how substantial that registry is; it includes 99% of sufferers. I understand that the trust’s offer has been welcomed by all sides in the negotiations but is blocked due to the lack of progress in implementing the changes set out in the review. I hope that the Minister will give us some clarity on when the unit will be created and when we can see a culture shift within the system that will allow for flexibility to accept data and information that show how much effect these drugs have on people’s lives.

Contaminated Blood and Blood Products

Debate between Mark Durkan and Sharon Hodgson

Thursday 24th November 2016 Commons Chamber

[Mrs Sharon Hodgson (Washington and Sunderland West) (Lab)]

It is a pleasure to speak in such an important debate. I want, first and foremost, to thoroughly thank my hon. Friend the Member for Kingston upon Hull North (Diana Johnson), who for many years now has championed and pushed on this vital matter. Her work cannot and must not go unnoticed or unrecognised. I am sure people across the country, and indeed across the House, will want to join in thanking her.

The experiences of those men and women affected by this awful scandal should never be out of our minds as we continue to do all that we can to support them. Doing all we can for them is paramount, knowing full well that whatever we do will not be enough to give them back their life or a life without suffering or pain. HIV and hepatitis are terrible conditions. Someone living with HIV or hepatitis will face fears of developing other conditions and have to face the stigma that comes with these conditions. This debate is welcome, as it is the first time the House has had the chance to debate the new scheme since it was announced and to continue to hold the Government to account to do more. It is important that we now have the chance to discuss that in a considered and comprehensive manner.

In my contribution, I want to touch upon three areas: first, the current funding system in England; secondly, the involvement of private companies to administer support to beneficiaries; and, thirdly, the need for an independent Hillsborough-style panel to recognise the failures of the system that these people have had to live with.

It was announced earlier in the year that a new financial arrangements system would be introduced, and a public consultation was conducted to get views and opinions on how that would take shape. Although there has been a welcome, if somewhat modest, increase in the annual payment to people with HIV, hepatitis C at stage 2 and those who are co-infected, as well as the first guaranteed ongoing payments for people with stage 1 hepatitis C, it is concerning that these payments fall short of what has been drawn up in Scotland.

Also, the current English system makes no mention of support for people who have been cleared of hepatitis C prior to the chronic stage but who, despite fighting off the disease, may still exhibit symptoms ranging from fatigue to mental health issues and even diabetes. These people have never been entitled to any support, and continue to get none. The scheme does not include support for those infected with other viruses, such as hepatitis B, D or E, and for those people it has meant continuous monitoring of their liver function. It is estimated that that group is extremely small and, according to the Haemophilia Society, would be a minimal cost to the Department of Health.

We find that the new scheme does little or nothing for bereaved partners, parents or children of those who have sadly died from diseases contracted through the contaminated blood scandal. The new system should have gone a long way to supporting those various groups within the affected community. I hope that the Minister can give us some reassurance that those concerns have been noted, and that she will go away and look into what more can be done to help the people I have just mentioned.

There are also concerns regarding the discretionary payments, which, thankfully, were saved, despite it being announced in the consultation earlier this year that they could be scrapped. That should be welcomed, but there is a clear concern that the discretionary support will not go far enough to improve the support on offer for those with HIV or those who are co-infected. The Government need to consider that impact and what more they plan to do. It is worrying that the Government have yet to make clear the minimum and maximum discretionary support that people will be able to receive.

I understand that the Reference Group on Infected Blood is currently considering that policy and that we will hear more from it in the new year, but would it not be worth while for the Minister to give us some indication now, so that those who will depend on this money in the years to come can have some reassurance, especially as we enter the festive period? There are many questions to be answered. That is why I hope that in the time allowed the Minister will give us in the House and those who will be watching the debate the reassurances that they need.

The new scheme will replace the current system so that the five trusts across the country that administer the payments are amalgamated into one, and I know that that has been welcomed. However, there is one very concerning point that was so eloquently put by my hon. Friend the Member for Kingston upon Hull North when she opened the debate and which needs to be addressed by the Minister. I refer to the potential involvement of a private sector company, such as Atos or Capita, which both bid in the tender process. The Minister no doubt expects me to make the typical party political point, but I am not going to do that.

That potential involvement was never included in any talks with the all-party parliamentary group on haemophilia and blood contamination, no consultation was held with the affected community, and there was no mention of it in the Department’s response to the survey, yet we see it happening now. The concern here is that the many thousands of people affected by the mistake—which, it must be remembered, was often made by US private companies—feel aggrieved at the potential involvement of a profit-making private company. That resentment is justified, especially as it was the mistake of a private company that put them in their current situation. There should be no profit making when it comes to compensating for the failures of the private sector. That was highlighted well by my hon. Friend in her speech and was also touched on by the former Health Minister, the right hon. Member for North East Bedfordshire (Alistair Burt).

The issue was highlighted too by the APPG’s survey of nearly 1,000 people affected by the scandal, who clearly had concerns about the involvement of a profit-making private company. It is important that those affected have their say in the administration of the payments and support. I would therefore be interested to hear the Minister’s thoughts on their involvement, as we have seen in Scotland, where there has been an alternative scheme operator which includes beneficiary involvement. Perhaps the Minister can tell us why private involvement is now being considered, but was never consulted upon.

My final point is about co-ordinating an independent panel, such as in the case of Hillsborough. The Prime Minister promised in September that she would keep an open mind about an independent panel, but she has, sadly, quashed the idea. The rationale given is that we have had two public inquiries into this matter already, by Lord Archer and Lord Penrose. That may be the case, but it is important that we consider the approach to helping people to get the justice they deserve, especially as it is clear that neither of the inquiries met the needs of the affected community. The two inquiries were narrow in their focus and were not about apportioning blame. The affected community is not calling for that. What it is calling for, which is strongly supported by the Opposition, is a truth and reconciliation process and public disclosure of the failures, which those affected rightly deserve.

[Mark Durkan]

On the need for some vehicle of inquiry into the background, in an intervention I pointed out that, in the Irish Republic, the right to compensation was established in 1995. There was an Act in 1997, but it was following a tribunal of inquiry that the state admitted liability, so there was further legislation in 2002. The liability of the Irish state rested on the fact that the tribunal found that the state knew that there was a risk and carried it because the UK and others were prepared to carry the same risk.

[Mrs Hodgson]

I am grateful for that important intervention, which emphasises why we need an inquiry into issues such as the one that the hon. Gentleman has raised.

I am sure the Minister can understand the concerns across the House and out in the community among the people affected and their families. Before she replies, I ask her not to adopt the same language as that used by the Prime Minister, who attributed the lack of support for an independent panel to the delay in the introduction of a support system. An independent panel with clearly defined terms of reference would not impede the development and implementation of the new system. I hope the Minister will keep that in mind when she responds, and recognise how important it is for those affected to get the reconciliation for which they have fought so long.

The Government must be committed for reforming the system and listening—must be commended, rather, for reforming the system and listening. I know they are committed to that. However, this is such an important issue that we must get it right, and once more I thank my hon. Friend the Member for Kingston upon Hull North for her steadfast campaigning on this issue over many years. I am sure the community will also recognise that fact. Those people who have had their lives marked so significantly by the failures of the past should rightly be compensated and respected. Those who have died because of that serious mistake, those who are still living with the repercussions of the mistake, and those who have thankfully fought it off but still live with the impact of it all deserve respect and dignity, and I hope that in her reply the Minister will give them just that.