Rare Diseases Strategy

Daniel Zeichner Excerpts

Tuesday 28th March 2017 Westminster Hall

[Daniel Zeichner (Cambridge) (Lab)]

It is a pleasure to serve under your chairmanship, Mr Pritchard. I congratulate the hon. Member for Bath (Ben Howlett) on securing this debate and on his excellent work as chair of the all-party group.

My interest in this subject has been stimulated by visiting a number of key research sites in and around Cambridge, where vital work is being done to develop new treatments. The Sanger Institute has the world-famous and world-leading 100,000 Genomes Project and works closely with the adjoining European Bioinformatics Institute. Because of Brexit, both institutes face major problems with retaining key staff and ensuring data flows, although that is a debate for another day. We also have the National Institute for Health Research’s biomedical research centre, which is led by Dr John Bradley and based at Addenbrooke’s hospital.

I recently joined Dr Bradley and Professor Lucy Raymond, professor of medical genetics at Cambridge, to celebrate Rare Disease Day at an illuminating roundtable with patients and practitioners. We heard case studies that highlighted some of the very difficult challenges that patients with rare diseases face, including practical difficulties with the benefits system. I was particularly struck by meeting a patient who suffered from lupus. She explained that she had good days and bad days—something that the welfare system just cannot cope with, making her already difficult life even harder. The message that I came away with—apart from the important links to the genetic sequencing work being done at the Sanger and the need to identify the right people to test—was that research into rare diseases not only helps with those diseases, but leads to discoveries with a much wider application.

I will focus my comments on new treatments and on how to ensure ready access to them. As we have heard, this debate is very timely because it comes hot on the heels of recent NICE guidance that introduces a financial cap for access to new medicines. NICE is proposing an upper limit for costs per quality-adjusted life year, above which it will not recommend funding for highly specialised technology treatments. That decision could have a profound impact on people affected by rare diseases in the UK. On Thursday, when I asked the Leader of the House for a debate on the matter, he replied that

“decisions about individual medicines are taken by a body such as NICE, where clinical judgment is to the fore, rather than being subject to political pressure”.—[Official Report, 23 March 2017; Vol. 623, c. 966.]

None the less, I am glad to have the opportunity to raise the matter today. I agree that it should be for NICE to decide, but this is a significant change from medical efficacy to financial rationing. Such a highly political change should be debated here, not outsourced.

We must listen to what charities such as Alzheimer’s Research UK and Cancer Research UK are saying. They warn that lives will be lost because of this new rationing system. I was particularly struck by the words of the MPS Society, which provides support to people affected by mucopolysaccharide diseases. It said that the decision by NICE and NHS England

“will affect the most vulnerable in UK Society and confirms that children and young adults with ultra-rare diseases going forward are economic pawns in a failing NHS and cheaper dead than alive.”

Those are very strong words. They are not mine, but they show how people feel, and I am sure that the Minister will have noted them.

Genetic Alliance UK said:

“NICE, in close collaboration with NHS England, are sending a clear message that they are unwilling to fund new innovative treatments for rare diseases. This is a real slap in the face for patients and families with rare diseases, and contrary to the founding principles of the NHS.”

It has also suggested that, as we have already heard, none of the four rare disease medicines that have so far been approved would have been approved under the new proposals, which it believes will cause a

“drastic reduction in access to innovative treatments for very rare diseases in England”.

It is also worth mentioning that the guidance will have an impact not only on people affected by rare diseases, by closing off their access to innovative treatments, but on the UK’s vital life sciences sector more broadly, as it risks curtailing investment in new medicines. As the BioIndustry Association says, it sends

“an immediate, stark, negative signal to the global life science investors and companies that the UK needs to attract in the Brexit era.”

The reaction from patient groups, as well as from industry, demonstrates the broad concern about the adverse impact that NICE and NHS England’s decision will have on patients. The UK strategy for rare diseases published in 2013 has the laudable aims of raising awareness of rare diseases and improving diagnosis, research and access to services for people affected, but there is a real risk that those aims will be undermined by the new guidance.

I echo the calls from the hon. Member for Bath and other hon. Members for the Department of Health to publish an implementation plan for the UK strategy for rare diseases, because until we see a coherent plan, progress on the strategy’s objectives will continue to stall. As the all-party group has rightly summarised:

“An implementation plan…is a tool for delivery, coordination, collaboration, communication and monitoring.”

Such a plan would also enable stakeholder groups to have a clear idea of which institutions they could work with to influence the implementation of the strategy.

We have already heard today that the Minister responsible for public health and innovation, the hon. Member for Oxford West and Abingdon (Nicola Blackwood), has made a personal commitment that the UK rare diseases strategy should be translated into an implementation plan. I applaud her for that commitment, but I hope the Minister will confirm that the Department will follow through on it, because last year the then Health Minister, the hon. Member for Mid Norfolk (George Freeman), stated in a written answer:

“There are no plans to consult on the implementation plan”.

The Government have described the UK strategy for rare diseases as

“a long term strategic vision for improving the lives of all those with rare diseases and conditions”

and have committed

“to ensuring that patients with rare and ultra-rare diseases in England are able to access effective treatments.”

I fear that recent decisions will mean that access to those effective treatments will be shut off. The Government must act urgently if they want their strategy to move beyond paper and reach the patients and people it aims to help.

Health Service Medical Supplies (Costs) Bill

Daniel Zeichner Excerpts

Ping Pong: House of Commons
Wednesday 15th March 2017 Commons Chamber

[Justin Madders (Ellesmere Port and Neston) (Lab)]

I support the Lords amendments. I believe that they will improve the Bill significantly, and that they draw on many of the points that Opposition Members made during its earlier stages.

When I was asked to lead the debate for the Opposition—it was the first time that I had done so on a Government Bill—I was assured by my colleagues that this Bill was relatively short, but by comparison with the legislation that we passed on Monday, it strikes me as something of an epic. I only hope that we have more success today than we did on Monday with the amendments that were passed in the other place. As with that other Bill, however, the length of this Bill should not in any way detract from its importance. The exploitation of loopholes by a small number of unscrupulous companies left the Government with no option but to act, and we agree with the thrust of the Bill. We welcome the Lords amendments, both those that the Government are supporting today and the amendment relating to a duty to have regard to the life sciences sector and access to new medical treatments.

Let me first deal with the matters on which there is agreement. Lords amendments 1 and 2 relate to special medicinal products. They will do much to improve the reimbursement for specials, given that the current arrangements are in many cases failing to secure value for money for the taxpayer. As the Minister will know, there is a significant price variation between hospital and community care, with the result that many patients are currently denied access to some specials. The amendments could lead to significant savings throughout the NHS by introducing a more cost-effective whole- market procurement system, as well as having the potential to improve access to treatments. I am pleased that there now appears to be cross-party consensus that action is needed. However, I would welcome confirmation from the Minister that any savings made as a result of the amendment will be used to improve access to specials and other new treatments, rather than simply being returned to general budgets.

We also support Lords amendments 4 to 7, which relate to medical supplies. They add a much needed duty to consult before introducing secondary legislation to control the prices of medical supplies. That goes some way to addressing widespread concerns throughout the sector about the failure to engage before measures relating to medical supplies were introduced in the Bill. Lords amendment 7 would subject the first order to control the prices of medical supplies to the affirmative procedure. That means that if the Government wanted to introduce a new pricing scheme, they would have to convince Parliament that there was a case for doing so.

When we last debated these issues, concerns were expressed that the Government were asking us to give them powers in respect of medical supplies, but were not in a position to tell us how they might be used. The amendment does much to allay those concerns by giving a further opportunity for challenge should Ministers wish to exercise those powers. We are pleased that the Government have given some ground in that regard.

We also welcome Lords amendments 8 to 10, which introduce a trigger mechanism for information-gathering powers. These amendments make it clear that the Government would be required to issue an information notice before they could collect certain types of information. Amendment 9 sets out in detail what information would need to be provided, as well as the related form, manner and timings. Importantly, it would also introduce a right of appeal for those served with an information notice. This again goes some way towards resolving the concerns that we set out in this place about the potentially onerous effect of the new information-gathering powers.

Lords amendments 11 to 14 relate to the provision of information to Welsh Ministers and stem from the recommendations of the Delegated Powers and Regulatory Reform Committee in the other place. We welcome these measures, which I understand also have the support of the Welsh Assembly. We also support the remaining amendments, which are consequential.

That leaves us with amendment 3, which would introduce a duty on the Government when implementing the legislation to have regard to the life sciences sector and access to new medicines and treatments. This measure received cross-party support in the other place and I am disappointed that the Government intend to oppose it today.

We strongly support the core of the Bill, which seeks to close loopholes and to secure better value for money for the NHS from its negotiations with the pharmaceutical sector. However, if amendment 3 does not form part of the final legislation, the Bill will be looked upon as a missed opportunity.

The likely departure of the European Medicines Agency raises extremely worrying questions about the future of the life sciences and the pharmaceutical industry in this country. It is reported that up to 20 other countries are now queuing up to host it after it leaves these shores. That shows just what an attractive proposition it is for those looking to say to the sector, “This is a place to invest in.”

We have the strategic disaster of the EMA going against a backdrop of the sector’s investment in R and D already falling in recent years. Between 2003 and 2011 there was significant growth in spending in this area, eventually reaching a peak of £5 billion. However, by 2014 that had fallen to £4 billion, a reduction of 20% in just three years. We are extremely concerned that the potential loss of the EMA could see this figure fall back even further.

Over the last six years, we have ended up with the worst of all worlds: falling investment in R and D by the pharmaceutical industry and appalling rationing of treatments, leaving patients unable to access a range of medicines and treatments unless they have the means to pay for them privately. Members on both sides are beginning to find it ever more frustrating that when increasingly crude and arbitrary rationing is raised, the response from the Minister is often to agree with the concern, but simply to say that it is a matter for the individual clinical commissioning group in question. How many more times will Ministers sit and listen to huge concerns from every area of the country about treatment being denied to people in desperate situations before they finally accept that the unprecedented levels of rationing are not the consequence of a series of decisions that are unconnected and remote from Government, but a direct result of the systematic underfunding of the health service for the past seven years?

[Daniel Zeichner (Cambridge) (Lab)]

Does my hon. Friend agree that some of the debates in Westminster Hall and the concerns expressed by Members across the House have been prompted by the fact that the resources for new treatments have not become available in the way that was expected because, as the Secretary of State admitted, although the large amount of rebate from the pharmaceutical sector goes to the NHS, it is not being used specifically for new treatments?

[Justin Madders]

My hon. Friend is right to express that concern. We do not really know where this rebate has ended up, but all Members know from their personal experiences and our debates that across the board rationing is reaching unprecedented levels, particularly for new and innovative treatments. This is not just a manifestation of the financial straitjacket the health service currently operates in, nor is it just a disaster for individual patients, nor is it just an abrogation of the Minister’s responsibility to uphold the fundamental principles of the NHS; it is also a direct threat to the future prosperity of our life sciences industry. In answer to the Minister’s question about whether we are on the side of patients, I say we absolutely are. Proposed new clause 3(b) makes it very clear that we are on the side of patients, and in particular their ability to access new and innovative treatments.

It is impossible to look at the health of the pharmaceutical sector in this country without considering the central issue of access to treatments. The UK is home to about 4,800 life sciences companies and it continues to have the largest pipeline of new discoveries anywhere in Europe. We are all rightly proud of that. However, the fruits of this innovation are increasingly being enjoyed by patients in other parts of the world before NHS patients can benefit. For every 100 European patients who can access new medicines in the first year they are available, just 15 UK patients have the same access. How can anyone look at that and not say that something is going badly wrong?

As I set out in previous debates on the Bill, a recent report by Breast Cancer Now and Prostate Cancer UK showed that NHS cancer patients are missing out on innovative treatments that are available in any other comparable country to the UK. That should surely shame us all, and it looks as though the situation will get worse. A number of cancer charities estimate that the proposals by NICE to introduce a budget impact threshold could affect one in five new treatments. With one of the options available being a longer period for a phased introduction, the worry is that more patients will be denied access to those critical treatments. I thought that this Bill was meant to be the mechanism by which the cost of drugs would be controlled. Can the Minister explain the flaws in the proposed new pharmaceutical price regulation scheme that make this extra method of cost control necessary?

A debate in this place a few weeks ago drew attention to a number of breast cancer drugs, including Kadcyla, Palbociclib and Perjeta, that might no longer be funded due to changes to the cancer drugs fund. Those are but three examples. Media analysis by the King’s Fund found that there were 225 stories relating to rationing of services in 2016, compared with 144 in 2015 and 86 in 2011. There is clearly a trend developing and we need to reverse it.

We do not have much time today, so I shall draw my remarks to a close by reminding the House that this debate touches on many important issues that are all interlinked—three of them in particular. The first involves securing better value for the NHS; the second involves ensuring full and rapid access to treatments for NHS patients; and the third involves the need to support and promote our life sciences sector. The Government will not achieve any of those aims unless they adopt the right approach to all three. The Bill aims to put in place a system that will deal with the first of those aims, which we support. The amendment that we support today seeks to send a clear message to patients and to industry that the Government consider the other two elements equally important. That is why we are so disappointed that they are not prepared to listen to the overwhelming view expressed in the other place and support that amendment. I urge the Minister to reconsider.

Mental Health and NHS Performance

Daniel Zeichner Excerpts

Monday 9th January 2017 Commons Chamber

[Mr Hunt]

The way to deal with those kinds of terrible problems is to have a strong economy that allows us to support people through difficult periods in their life. We have one of the strongest economies—in fact, I think we will be the strongest economy in the G7 this year. That allows us to do things such as invest in our health and social care system. It is the Conservative party that can deliver that.

[Daniel Zeichner (Cambridge) (Lab)]

I have spoken before about the staggering rise in the number of patients presenting at A&E at Addenbrooke’s in Cambridge, and the hospital confirmed to me this morning that it continues to see more than 300 people each day, with high levels of delayed transfers of care. The impact was brought home to me by a constituent, Ann, who told me that on Thursday last week the facilities were so overcrowded that an adjacent seminar room was pressed into use. Bloods were being taken in the room, and she was treated there behind a makeshift curtain, reclining on a standard chair. Those are awful conditions in which to be treated, and in which to have to work. The Secretary of State says that it is not about funding; if it is not, will he come to Cambridgeshire and sit down with his Conservative colleagues on the county council and tell them where they are going wrong?

[Mr Hunt]

I went to Addenbrooke’s in the autumn and saw at first hand how hard the staff there are working. That is another trust that is in special measures, but it has made huge progress in trying to turn things around. I met several staff in the emergency department as well, and I pay tribute to them for their very hard work. I have never said that it is not about funding; what I say is that it is not just about funding. There is huge variation. In parts of the country, emergency departments avoid precisely the kind of overcrowding that the hon. Gentleman described at Addenbrooke’s. Hospitals that do that very successfully include Luton and Dunstable. We need all hospitals to adopt what the best hospitals do.

Oral Answers to Questions

Daniel Zeichner Excerpts

Tuesday 20th December 2016 Commons Chamber

[Nicola Blackwood]

The hon. Lady is right to identify the scale of the challenge, which is why we have put AMR on our national risk register, and she is also right to point out that no one country can tackle AMR alone. The United Kingdom has played a global leadership role. We co-sponsored the World Health Organisation’s 2015 global health plan and created the £265 million Fleming fund so that we could specifically help poor countries to tackle drug resistance, and we will continue to play that global leadership role.

[Daniel Zeichner (Cambridge) (Lab)]

The O’Neill report was published some six months ago and included recommendations for national Governments. What practical progress have the Government made so far?

[Nicola Blackwood]

On 19 September we published our comprehensive response to the report, which describes a range of actions that we will take on each of Lord O’Neill’s recommendations. The most practical progress that I can report is the fact that the prescribing of antibiotics has fallen for the first time since records began. I think that we can all be proud of that progress.

Accelerated Access Review

Daniel Zeichner Excerpts

Tuesday 13th December 2016 Westminster Hall

[Daniel Zeichner (Cambridge) (Lab)]

It is a pleasure to serve under your chairmanship, Sir Alan. I congratulate my hon. Friend the Member for Dudley North (Ian Austin) on leading this important debate. We have long needed to address the fact that the UK is trailing behind on patient access to new medicine. A.A. Gill who, just three days ago, sadly died of cancer, wrote:

“The NHS represents everything we think is best about us.”

But in his final column, he revealed that he was denied immunotherapy that might have helped him to live longer. He said that NICE,

“the quango that acts as the quartermaster for the health service, won’t pay.”

His experiences are striking, but they are a symptom that is all too common of a system that is struggling to cope. When Labour established NICE it soon became a world leader in approaching the profound and challenging question of how to allocate scarce resources fairly. Although the question remains the same, the times have changed and the pace of innovation has increased, as has the cost.

We were all pleased when the Government’s long-awaited and much-delayed accelerated access review was finally published. Simply put, we need innovative new drugs to reach patients quickly at a price that the NHS can afford, but it is not clear that the accelerated access review has solved the conundrum. There are already signs, since publication, that yet more problems are emerging. NHS England’s sudden and unexpected consultation on the QALY—quality-adjusted life years—threshold for highly specialised technologies risks running counter to the spirit of the AAR and introducing yet another gatekeeper.

The AAR recommends a fully funded early access to medicines scheme, but we need a positive response from both the Government and NHS England because the danger is that, with other countries having funded early access companies, we risk seeing clinical development work moving away from the UK.

As we have heard, the Cystic Fibrosis Trust has suggested that the AAR made several recommendations that could enable access to drugs such as Orkambi through flexible pricing arrangements and the gathering of real-world data to prove the drug’s effectiveness. Does the Minister agree that those recommendations will make a difference to people affected by cystic fibrosis? If so, will he commit to implementing the recommendations?

Other hon. Members have told us of real-world examples, and I will quote my constituent Julian Wheel:

“My youngest daughter, a local Cambridge primary school teacher for over 15 years, recently had a new daughter, diagnosed with cystic fibrosis. It imposes major changes on her and her partner’s lives in caring for her—time, difficult nutritional choices and the fear of recurrent infection, not to mention the additional and regular workloads imposed on the NHS staff at Addenbrooke’s, the local GP practice in Harston and healthcare visitors.”

He says that their family receive terrific support from the cystic fibrosis clinic and local surgery practice, but this new drug could relieve the suffering and improve their quality of life. He says it could offer “real hope.”

New drugs are expensive, but incentivising innovation should be a priority. The Government must ensure there are effective mechanisms that can help to address the affordability challenges that new treatments are likely to present. A balance will need to be struck between setting a price that rewards and incentivises innovative research and setting a price that is also affordable to the NHS. Will the Minister establish a strategic commercial unit in NHS England to consider flexible pricing models?

Recommendations such as a fully funded early access to medicines scheme could make real inroads, but of course that depends on the Government supporting their implementation. The BioIndustry Association points out that innovation is impaired because the current early access to medicines scheme is not funded, and the lack of funding poses a barrier to many small biotech companies engaging with the scheme.

Across the board, organisations have called for a strong response from the Government to the accelerated access review. I am not sure we yet have that. Will we have one today?

Social Care Funding

Daniel Zeichner Excerpts

Monday 12th December 2016 Commons Chamber

[David Mowat]

Cities do have issues with delivering social care, but so do rural areas, which quite often have a very high proportion of older people. That, in itself, can absorb a great deal of cost. The truth is that, as I have acknowledged, the whole system is under pressure, including in Bristol. We acknowledge that, and we are increasing the total spend by 5% during this Parliament.

[Daniel Zeichner (Cambridge) (Lab)]

We have heard from my hon. Friends about the failings of the social care precept model to address this issue, but what of councils such as Cambridgeshire, which chose not even to take the meagre resources available? Offered 4%, the council took just 2% this year, leaving the local hospital with 100 over-85-year-olds with nowhere to go. When are the Government going to stand up for older people in Cambridgeshire?

[David Mowat]

That was a decision made by Cambridgeshire County Council, and a number of other councils, such as Hammersmith and Fulham, made the same choice not to increase the precept. Presumably, they did not feel as though they needed to use that money for adult social care. That is a choice that those councils have, and it is a choice that they must take to their voters.

NHS Funding

Daniel Zeichner Excerpts

Monday 31st October 2016 Commons Chamber

[Mr Hunt]

I congratulate my hon. Friend on her excellent question. I absolutely agree with her, as someone who worked in healthcare before she came to this House, that it is vital to nurture the links between the health and social care systems if we are to deal with some of the issues that concern Members on both sides of the House. There are some very good examples of where this is working well, but it is not happening in as many places as it needs to, and we all must focus on that.

[Daniel Zeichner (Cambridge) (Lab)]

The Secretary of State was in Cambridge on Friday. Did he have an opportunity to notice that at Addenbrooke’s, the hospital that serves Cambridge, the number of over-85s coming into A&E has risen by almost 12% year on year, and on Friday there were 100 over-85s in that hospital who should have been out in the community? Does he agree that that is proof perfect of the failure of this Government’s policies on social care, which are the root cause of the problems in our NHS?

[Mr Hunt]

The hon. Gentleman is looking at the record of this Government: we have 1,200 more doctors in our A&E departments, who are treating within four hours 2,500 more people every single day. We are also putting more money into the NHS and into the social care system. Addenbrooke’s is a hospital under great pressure, but it is determined to co me out of special measures and do its best for patients, and I salute all the staff, whom I much enjoyed meeting there on Friday. The one thing they would not want is the NHS budget to be cut from current levels.

Health Service Medical Supplies (Costs) Bill

Daniel Zeichner Excerpts

2nd reading: House of Commons & Programme motion: House of Commons
Monday 24th October 2016 Commons Chamber

[Mr Hunt]

The hon. Gentleman makes an important point. It will be for this House and the Government to reflect prior to 2019 on whether it is worth carrying on with two schemes, which has been the arrangement for many years. Successive PPRS voluntary agreements have covered the vast majority of sales to the NHS and the statutory scheme has been a back-up for people who do not want to participate in the voluntary scheme. Recently, however, there has been an element of gaming the system whereby more and more firms have been moving from the voluntary scheme into the statutory scheme. The Bill will remove the incentives for them to switch between schemes and will make the benefits to the NHS essentially the same whichever scheme people choose. It will be for this House to reflect on and for the Government to consider whether the dual structure is right going forward.

[Daniel Zeichner (Cambridge) (Lab)]

The Secretary of State tells us that £1.24 billion has come back through the rebate, but many are puzzled about where that money has been spent. Can the Secretary of State tell us?

[Mr Hunt]

Absolutely. The money comes back to the Department of Health and is invested in the NHS. Indeed, it would be wonderful if it was more than £1.24 billion, because there is an awful lot of need on the NHS frontline right now; the funds are much needed. Our concern is that companies have been exploiting the differences between the voluntary and statutory schemes, particularly the loophole, which the Bill seeks to close, that if companies have drugs in both schemes, we are unable to regulate at all the prices of the drugs that would ordinarily fall under the statutory scheme. That is why the Bill is so important.

European Medicines Agency

Daniel Zeichner Excerpts

Wednesday 12th October 2016 Westminster Hall

[Daniel Zeichner (Cambridge) (Lab)]

I beg to move,

That this House has considered the future of the European Medicines Agency.

It is a pleasure to serve under your chairmanship, Mr McCabe. I am grateful for the opportunity to secure the debate, which I called with the expectation of being answered by a Minister from the Department for Exiting the European Union. It is unclear to me why that is not happening; perhaps that could be No. 171 on our list of questions about Brexit. None the less, I am sure we can expect a robust and helpful response from the Under-Secretary of State for Health, the hon. Member for Warrington South (David Mowat), who perhaps can explain that to us.

I start by laying my cards on the table. I am old enough to remember the John Major Government and the Maastricht treaty; I was perhaps one of the few at that time who actually read it. I also remember the troubles that the then Prime Minister had. Despite those difficult times, one of his major achievements was to secure the location of the European Medicines Agency in the United Kingdom. More than 20 years on, that success by a Conservative Prime Minister is being put at risk by the foolish path being pursued by the Conservative Government today. John Major famously referred to some of his colleagues—I apologise for this, Mr McCabe— as “bastards”; now they are running the show.

Last week, the Chancellor wryly commented that no one voted for Brexit to make us poorer. I wonder how many knew about the potential impact on one of our key industries, the future of which we are discussing today. My guess is that very few knew and that very few were voting to destroy British jobs and to do reckless damage to one of our great success stories. The area of the country I represent is a world leader in pharmaceuticals and life sciences. The Cambridge biomedical campus is at the pinnacle of international research, with, just a few years ago, AstraZeneca choosing Cambridge as its location rather than elsewhere in the world—but that was before 23 June.

Given that the vast majority know nothing of all this, let us set out some of the details about the European Medicines Agency and the significant role it has played over the past two decades in providing a harmonised approach to medicines regulation throughout the European Union. It was set up in 1995 from predecessor organisations, is a decentralised agency of the European Union and is located in London. Its mission is

“to foster scientific excellence in the evaluation and supervision of medicines, for the benefit of public and animal health in the European Union”.

Responsible for the scientific evaluation of human and veterinary medicines developed by pharmaceutical companies for use in the European Union, it can grant marketing authorisations for medicines that allow for their use across the 28 EU member states, as well as the countries of the European economic area—Iceland, Liechtenstein and Norway.

The EMA describes its four main functions as to facilitate development and access to medicines, to evaluate applications for marketing authorisation, to monitor the safety of medicines across their life cycle and to provide information to healthcare professionals and patients. Essentially, it is tasked with ensuring all medicines available on the EU market are safe, effective and of high quality, and it seeks to harmonise the work of existing national medicine regulatory bodies, such as the UK’s Medicines and Healthcare Products Regulatory Agency. It serves a market of more than 500 million people living in the European Union and covers a market of 25% of global pharmaceutical sales, of which the UK constitutes just 3%.

We should understand the EMA in the context of the growing global pharmaceutical market and the UK’s world-leading life sciences sector. The Prime Minister herself said in July:

“It is hard to think of an industry of greater strategic importance to Britain than its pharmaceutical industry”.

Indeed, the life sciences sector in our country has a turnover of more than £60 billion per year and generates exports worth £30 billion. In 2014 it invested £4 billion in research and development—more than any other sector. It employs 220,000 people in our country and 25% of the world’s top prescription medicines were discovered and developed in the United Kingdom. In my constituency of Cambridge alone, there are more than 160 life science companies reinforcing the strong local knowledge economy, and contributing to the economy well outside my region as well.

In passing, it is perhaps worth noting that Cambridge is one of just a handful of UK cities making a net contribution to the UK Treasury, thanks in no small part to its vibrant life sciences industry. Thus, the Cambridge view on how we secure future prosperity may perhaps be worth listening to. Cambridge, and those in this key sector, are most certainly unhappy with the current route being taken for a range of reasons and the future of the EMA is a good example. What will be its future, post-Brexit? What will be the impact on the future of our country’s life sciences industry more generally? What will be the real impact on the NHS—the real impact, not the bus slogan? The head of NHS England, Simon Stevens, has rightly insisted that the regulation of medicines and devices must be considered during the Brexit negotiations.

What are the options? As I have noted, countries inside the European economic area are included within the EMA’s centralised marketing authorisation procedure, which means that, if the UK remains part of the economic area, the process for regulating and supplying medicines in our country might see little change, which could bring stability for the sector.

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

It is a pleasure to serve under your chairmanship, Mr McCabe. My concern is that, outside the European Union, we will be in a position in which pharmaceutical companies will have to go to the EMA to go through the process to make the drugs available, and subsequently have to do the same thing for the purposes of UK law, which will cause delay. Does my hon. Friend agree that it is important that we have parallel processes so that there is no disadvantage to patients in this country?

--- Later in debate ---

[Daniel Zeichner]

My hon. Friend pre-empts the points that I will move on to. The issue of delay is really important.

I was talking about the option of staying within the European economic area. Sadly, from what we are hearing, and from what is possibly happening in the Chamber at this very moment, that is an option the Government do not seem to be entertaining. If we do not, pharmaceutical companies might have to apply separately to the UK’s MHRA if they want to supply a drug in the UK, as my hon. Friend has pointed out. Most commentators predict that that is likely to lead to a slower, less efficient regulatory process.

The Association of Medical Research Charities has pointed out that the strong and aligned medicines regulation across the EU, underpinned by science, is essential to bringing new medicines to patients in a way that minimises delay and costs. At the weekend, the chief executive of AstraZeneca made exactly that point—that, without the EMA, NHS patients would get new drugs more slowly and drug costs to the NHS would rise, meaning less money for the NHS; not quite what was written on the bus. Perhaps the Minister will confirm that the Government believe that people voted for less money for the NHS. That is certainly not the general understanding.

There is also an associated worry that smaller biotech companies, the lifeblood of our future prosperity, which in many cases are pioneering revolutionary treatments, will lack the capacity to file multiple applications at once and to handle all the associated paperwork. Some will struggle on, and we wish them every success, but I fear others will go elsewhere, to our detriment.

The MHRA finds itself in a potentially difficult place. It has commented, carefully, in response to the referendum result:

“We will continue to work to the highest levels of excellence and quality, working with and supporting our customers, partners and stakeholders to protect health and improve lives. Working closely with government, we will consider the implications for the work of the Agency. We will continue to make a major contribution globally to improving public health through the effective regulation of medicines and medical devices, underpinned by science and research.”

Those words, and the intention behind them, are encouraging, if unsurprising, but the MHRA has been put in a difficult and uncertain position. No major member state has left the EU before, so there is no model to follow for disentangling the UK’s medicines and life science industry from the EMA. The EMA and the MHRA work symbiotically and their separation is likely to be complex. The MHRA may be left with a bigger workload, and pharmaceutical developers may well prioritise the much larger EU market and delay securing regulatory approval in the UK. Indeed, US and Japanese companies already file in their home markets first before seeking approval in the European economic area. The UK, with its much smaller market, will be in danger of being at the back of the queue.

As we have heard, the EMA has allowed UK patients faster access to new treatments. It is worth noting that, in Australia and Canada, where medicines are licensed nationally, patients have slower access. On average, new medicines come to market six to 12 months later than in the US and the European Union. It seems likely we will be in the same position. Is that really what people voted for—longer delays in getting life-saving treatments? Again, I seek the Minister’s view.

The damage is not only done to us. The BioIndustry Association warns that, without Britain, the European Medicines Agency could also end up losing out. It would sorely miss the MHRA’s strengths in patient safety regulation. The Association of the British Pharmaceutical Industry has said that European colleagues are desperate for the MHRA to be retained as part of the regulatory process, owing to the high regard in which it is held. Both the ABPI and the Association of Medical Research Charities advocate ongoing regulatory co-operation between the EMA and the MHRA. The ABPI suggests that there is a strong rationale for seeking regulatory co-operation on the basis of the public health benefits to patients. The organisation says that strong, globally aligned medicines regulation has proven effective in bringing new medicines to patients quickly, without the additional costs of multiple regulatory systems. I believe we should do all we can to safeguard that.

The Government wrote in July that their renegotiation on the new European Union-United Kingdom relationship includes looking at the relationship between the UK and the EU medicines regulatory framework. I would appreciate an update on what they now believe that new relationship might look like and whether regulatory co-operation might still be possible.

[Dr Sarah Wollaston (Totnes) (Con)]

The hon. Gentleman is making a powerful case. These points were raised with the Select Committee on Health in the run-up to the referendum. Will he join me in calling for people to submit further evidence to the Health Committee, now that we have launched our inquiry into what the Government’s priorities should be during their negotiations on the terms of our withdrawal?

[Daniel Zeichner]

I thank the Chair of the Health Committee for her intervention. I certainly encourage those in my area and others to take up that offer. We will be doing so.

Let me come to the most tangible issue of all: the future physical location of the European Medicines Agency. Just last month, the Government said in a written answer to my hon. Friend the Member for Denton and Reddish (Andrew Gwynne):

“The future arrangements which apply in relation to European Union institutions based in the United Kingdom should be determined once the United Kingdom has left the EU. It is too early to speculate on the future location of the European Medicines Agency.”

Early or not, speculation is intense, and others are moving fast to gain advantage. The EMA stated in July that it

“welcomes the interest expressed by some Member States to host the Agency in future”,

while stressing that the decision will be taken

“by common agreement among the representatives of the Member States.”

Various member states are already vying to host the EMA. The Danish Prime Minister has said he is looking at it. The Irish Health Minister has said that attracting the EMA to Dublin is one of the “more interesting” opportunities afforded by Brexit. Italy, Sweden and Spain are also reportedly expressing an interest.

The EMA employs some 900 people. What will happen to their jobs? Will those people move with the agency? Inevitably, there is concern that, should the EMA relocate outside the UK, there will be a knock-on effect on the wider pharmaceuticals and life sciences industries. When they next decide where to locate and invest, does losing the EMA hinder or help? In my view, the answer is fairly clear, but I would welcome the Minister’s view.

We risk losing jobs. We risk losing influence. On a practical level, any company that sells to the European economic area has to have a qualified person for pharmacovigilance—an experienced, senior person based in the European economic area. If we are outside that area, QPPVs would have to move out of the UK or lose their jobs. There are 1,299 QPPVs currently in the UK. That is another potential loss, and of course, every highly-skilled job lost has a multiplier effect.

Perhaps the Minister can give us an estimate of how much all this will cost us. When I asked the Secretary of State for Exiting the European Union that question in the House on Monday, he had no answer. I appreciate that the Minister, following the lead given by the Brexit Ministers, is unlikely to be able to provide detailed, concrete information at this stage. I have some sympathy; if you do not have a plan, it is probably best to say as little as possible. However, I hope that the Government understand just how important it is for the UK to retain the closest relationship possible with the European Medicines Agency. It is important for patients. It is important for businesses. It is important for innovation, and it is important for our economy as a whole.

--- Later in debate ---

[Daniel Zeichner]

I thank all hon. Members who have taken part today. As so often in these Westminster Hall debates, we have had a much more constructive, collaborative discussion than we might have had in the other Chamber.

The hon. Member for Strangford (Jim Shannon) said that the die is cast. This morning I was described on my local radio station, BBC Radio Cambridgeshire, as a “remoaner” by one of the more constructive UK Independence party MEPs. I was not sure whether to be insulted or flattered, but my retort was that I think I am a realist. Today’s debate has shown a realistic understanding of the challenges and options that lie ahead. I am encouraged, perhaps more than is helpful for the Minister with regard to his ministerial friends in the Brexit Department, by the suggestion that the European economic area option is the best one for this sector. Many of us will be making that case, and I suspect that the debate will continue. It is right to highlight the importance of the sector, and I am thankful for the opportunity to do so today.

Question put and agreed to.

Resolved,

That this House has considered the future of the European Medicines Agency.

NHS Bursaries

Daniel Zeichner Excerpts

Wednesday 4th May 2016 Commons Chamber

[Daniel Zeichner (Cambridge) (Lab)]

I congratulate the shadow Health team on securing this debate.

Just a few weeks ago, I found myself in a packed lecture theatre in Cambridge. I had been invited there by Giovanna Mead. She is a student nurse, and the room was packed full of her colleagues. They were angry—not for themselves, but for those in the years ahead who should be following in their footsteps. They were absolutely convinced and absolutely sure that if the Government’s changes go ahead, people like them would not be doing as they had done. They would not be embarking on the training that is so essential to the future of our NHS.

Those people are rightly furious that there seems to be a complete misunderstanding about just how different they are as a cohort from other students, and just how different their course is from other courses. There has been a complete failure to understand how their course involves being at work and sometimes, as they explained, going way beyond the call of duty. Being at work is different from just being on a course. The testimonies of these nurses and those of others across the country speak volumes. I pay tribute to the Royal College of Nursing for pulling together hundreds and hundreds of these stories. What makes the Minister so sure that he knows so much better than all these people, who are actually doing nursing and who know and understand the choices that people in their situation are likely to make?

Before I was elected here, I worked for Unison and met many student nurses, so I know that the Government fail to understand the simple truth that nursing, midwifery and allied health professional students are not like other students. One important and fundamental difference lies in the requirement that healthcare students spend a significant proportion of their studies on clinical placements. As the Royal College of Nursing points out, and as others have said,

“student nurses aren’t like other students. 50 per cent of their time is spent in clinical practice working directly with patients and their families and they have a longer academic year.”

Indeed, student nurses must spend a minimum of 2,300 hours on clinical placement during their studies—working, providing care and making a vital contribution to the health service. This often includes early shifts, night shifts and weekend shifts. In practice, the funding changes being driven through will charge students to go to work and to do a job that is desperately needed.

Furthermore, it is clear that these changes are being rushed through without proper consideration of their consequences. The Government say that they will create 10,000 new nursing, midwifery and allied health degree places, which would be welcome if it were to happen—particularly at a time when agency staff are plugging the staffing gap and draining NHS finances. It has not been made at all clear, however, that the resources are in place to support an influx of new students in clinical settings. Put simply, do the placements exist?

This concern is linked to a wider issue about the uncoupling of education commissioning and workforce planning. The potential consequences of a disconnection between university recruitment and NHS workforce planning must be addressed, and I would welcome the Minister’s comments on the risk this uncoupling poses to the ability of the NHS to best assess and plan workforce requirements.

[Wes Streeting]

One of the more interesting aspects of the Government’s proposals is to increase routes through non-degree courses. In view of the report of The Lancet in February 2014, does my hon. Friend agree that the Government should tread carefully here? Based on data across nine European countries, it suggested that every 10% increase in the number of Bachelor degree-educated nurses in a hospital is associated with a 7% decline in patient mortality. Even on the more positive aspects of the proposals, does my hon. Friend agree that the Government should tread much more carefully than they are?

[Daniel Zeichner]

My hon. Friend has made an interesting point, and I hope it is one that the Minister will address.

There are other ways in which student nurses, midwives and allied health professionals are different. As we know, they are more likely to be older, to be women, to come from black and minority ethnic backgrounds, to have children, and to have first degrees already. The average age of a new nurse is 28. Those characteristics matter, because they increase the likelihood that the changes in funding for healthcare degree places will be a disincentive to the undertaking of degrees. According to the Royal College of Midwives, the removal of NHS bursaries means that

“Women with children and those who already have a first degree will be particularly hit hard…many of these women already make up a large proportion of our current midwifery student base.”

Many students take up healthcare studies as a second degree course. Already saddled with repayments of undergraduate debt, they are hardly likely to be enthusiastic about the prospect of taking on an additional debt of £51,600. The starting salary for nurses is only £21,692, and replacing NHS bursaries with loans will mean an average pay cut of more than £900 a year for a nurse, midwife or allied health professional, given current salary levels. We know that debt particularly deters poorer students, single parents and BME students—those who are more likely to be found entering nursing and midwifery.

I think that the people who can best explain what the Government’s decision will mean are those who will be most directly affected. The Royal College of Nursing has collected their testimonials in a huge big blue book, which I have waved around hopefully during a number of Question Time sessions over the last few weeks, and which I commend to the Minister.

Let me end by returning to that packed room in Cambridge, and give some of those students a voice. Sarah from Cambridge says:

“I would not have survived without my bursary. The nurse’s salary is poor and to have debt on top is terrible.”

Amanda says:

“I am an adult learner with a husband and two children. I had my children young so was unable to fulfil a degree at the usual time… If I was to have a mountain of debt at the end it would not have been worth my while! I fear it will put off adult learners entering into the degree programme, which will mean the NHS losing out on valuable, decent people who would make fantastic nurses!”

Maria says:

“By stopping the bursary we are in danger of preventing mature students from entering training as those who already have financial commitments will struggle. This will mean that the NHS loses the chance of recruiting a great resource of potential nurses.”

Another Sarah says:

“I am really disappointed by this change, and nursing is not like any other profession so should be treated uniquely. It is really tough being a nursing student and I think that the proposed bursary changes should be considered carefully to respect the work, commitment and enthusiasm of student nurses.”

She puts it very well. If the Government will not listen to me, perhaps they will at least listen to her.