Health: Innovative Medicine

Lord Hunt of Kings Heath Excerpts

Tuesday 1st April 2014 Lords Chamber

[Lord Hunt of Kings Heath (Lab)]

My Lords, I declare my interests as chair of an NHS foundation trust, president of GS1 and a consultant and trainer with Cumberlege Connections.

I, too, congratulate the noble Baroness, Lady Thomas, on securing this debate on this vital subject. I welcome the Government’s announcement about the early access to medicines scheme. However, like the noble Lord, Lord Kakkar, I would like some assurance about the scheme being operated equitably. Will the Minister assure me that it will not apply just to patients being treated by specialist centres where research or clinical trials have been undertaken? I would also like to pick up the point made implicitly by the noble Baroness, Lady Grey-Thompson, which is that patients must be able to make an informed choice about whether to consent to the treatment being offered.

I also believe that this question raises much wider issues about the NHS approach to innovative medicines. It is a critical issue for NHS patients but is also critical in terms of the health of UK pharma and the contribution that it makes to our economy. I have long been troubled by the UK approach to innovative medicine. We have a hugely strong science base and a strong pharma R&D presence that cannot be taken for granted, yet traditionally we have been very slow on the general uptake of proven new medicines and treatments. Within the NHS, it is remarkable that drug costs are treated as a disturbing cost pressure to be held down, if they can be, whereas increased spending on clinical staff and medical equipment is seen as a good thing, per se.

The noble Earl and I have been debating these issues for many years. We debated the introduction of NICE. He will recall that NICE was introduced as a way of speeding up the introduction of new, innovative, proven treatments, but we know that we have some way to go. We also know that there are still some concerns about the conduct of medical trials in this country, which has a direct bearing on our approach to innovative new medicines and treatments. I refer the noble Earl to an interview given by the director of the Wellcome Trust, in which he expresses real concern about the continuing delay in medical trial approvals. He recommends generic protocols preapproved by ethic committees and institutions at a national level. I know the noble Earl has a particular responsibility in this area, and I would be very interested if he were able to comment on it.

We also know that, as the noble Lord, Lord Walton, suggested, there are gaps in the NICE methodology. The cancer drugs fund is an example of one government response to gaps in the methodology. This early-access scheme is another. The noble Baroness, Lady Thomas, and the noble Lord, Lord Walton, discussed orphan drugs. That is another area where, left to itself, the market will not enable them to be brought to market at an affordable cost. As the noble Lord, Lord Walton, said, NICE is working on a value-based approach. It is clearly early days, but if the noble Earl were able to comment on the extent to which he thinks that would enable NICE to produce new methodologies that would cover these areas, that would be very welcome. The alternative is that government is simply going to have to fund and top-slice various little funds to meet gaps in the NICE approach. At some point, that will call into question the whole NICE approach. I think we have recognised for some years that, while overall the NICE approach is lauded internationally, there are gaps that we have to find a way of filling.

My final question for the noble Earl is about clinical commissioning groups. One of the issues about innovative medicines is the decisions now being taken by these new organisations. The noble Earl will be aware of research in the past few months that shows that in relation to technology appraisals, there can be up to a twentyfold variance in uptake in different parts of the country. He needs no reminding that there is a legal requirement on clinical commissioning groups to fund NICE technology appraisals. I am concerned that clinical commissioning groups are ignoring their statutory responsibilities. This is the other end of the whole approach to innovation. If we are unable to guarantee to patients that these innovative treatments are going to be introduced in the NHS, we are letting patients down. I hope the noble Earl will be able to give us some reassurance on this.

NHS: Bed Capacity

Lord Hunt of Kings Heath Excerpts

Thursday 20th March 2014 Lords Chamber

Asked by

[Lord Hunt of Kings Heath]

To ask Her Majesty’s Government what action they are taking to prevent hospital patients being moved in the middle of the night to relieve pressure on beds.

[Lord Hunt of Kings Heath (Lab)]

My Lords, I beg leave to ask the Question standing in my name on the Order Paper, and refer noble Lords to my health interests.

[The Parliamentary Under-Secretary of State, Department of Health (Earl Howe) (Con)]

My Lords, moving patients between wards overnight should happen only for good clinical reasons, because it can be a distressing experience for them and their families. We have asked NHS England’s medical director, Sir Bruce Keogh, to write to all hospital trusts requesting that they minimise transfers that are not aimed at improving patient care. As the Government’s response to the Francis inquiry highlighted, listening to and learning from patients to improve care is a top government priority.

[Lord Hunt of Kings Heath]

My Lords, it is all very well the Minister’s telling the NHS not to do it any more, but does he agree that the real problem here is the pressure on hospital services, particularly on A&E services, which then leads to a desperate search for beds, which then causes patients to be moved in the night time, as this survey has reported? Do Ministers have a response to the more general issue of the acute pressures on our acute hospitals at the moment?

[Earl Howe]

My Lords, many hospitals have been under pressure, particularly during winter, as they always are. It is telling that if one looks at the tell-tale signs of pressure, such as bed occupancy, the rates have remained stable for a number of years. In fact we have more clinical staff on the front line, particularly in A&E, than we had a few years ago. There is no doubt that there are times when hospitals feel acutely under pressure. However, despite rising demand, average waits for assessment in A&E are around 30 minutes at the moment, compared with over 70 minutes in 2009-10.

--- Later in debate ---

[Earl Howe]

I am not aware that it is mandatory. It is certainly good practice for hospitals to inform families, just as they should inform patients. Every decision taken about the patient should be explained to that person.

[Lord Hunt of Kings Heath]

My Lords, can I come back to the point raised by my noble friend? The noble Earl will know that Monitor is requiring foundation trusts to make five-year plans ahead. My understanding is that almost all such plans made by acute trusts are predicated on reducing bed capacity in order to keep within the budgets that they are likely to have over that period. Can he assure me that as those bed numbers are reduced, community care and social care provision will increase in order to enable patients to be discharged appropriately?

[Earl Howe]

It is for that very reason that we are setting up the Better Care Fund as from April 2015, so that health and social care are more joined up, people are kept out of hospital and we can therefore safely reduce the number of beds. We have to take an all-systems approach to this; it is no good looking at one part of the system—health and social care have to be looked at together.

Health: Local Healthwatch Funding

Lord Hunt of Kings Heath Excerpts

Wednesday 19th March 2014 Lords Chamber

[Earl Howe]

I agree with the noble Baroness that, in the normal course of events, expenses should be reimbursed, but I say again that it is not the role of Ministers to second-guess the judgments of local authorities. We believe in local autonomy. There are plenty of other ways in which many local authorities are supporting voluntary groups in their areas apart from Healthwatch, and making a difference in that way.

[Lord Hunt of Kings Heath (Lab)]

My Lords, I refer noble Lords to my health interests. I can hardly believe what I am hearing. Of course I understand why the noble Earl’s department does not want to tell local authorities what to do, but surely this is a question of upholding propriety in the use of public money. His department allocated more than £43 million to the DCLG to distribute to local authorities for Healthwatch. Somewhere along the line, either in the DCLG or in local authorities, someone has nicked £10 million. Does the department not want its money back?

[Earl Howe]

I do not believe that anybody has nicked £10 million, my Lords. The issue here is the one raised by the noble Lord, Lord Harris, and others: the absence of ring-fencing should not be seen as something negative. It has enabled councils to take a strategic approach to allocating their resources, in line with local needs and priorities. It has given them freedom to deploy their resources across the piece to achieve value for money. It is now, as I said earlier, up to local communities, but also local Healthwatch itself, to hold their local authority to account and thereby to demonstrate the impact that they are having, and make the case for more money if they feel that they merit it.

Mental Health: Funding

Lord Hunt of Kings Heath Excerpts

Tuesday 18th March 2014 Lords Chamber

[Earl Howe]

My Lords, the Government are committed to the principle of transparency in these areas. I can tell the noble Lord that last month NHS England published expenditure data from its programme budgeting data set for 2012-13 which show that expenditure on mental health in that year was £11.28 billion.

[Lord Hunt of Kings Heath (Lab)]

My Lords, the noble Earl cannot escape his own responsibility and that of his ministerial colleagues. He sets the mandate for NHS England. NHS England has specified that for the next financial year mental health trusts are to be discriminated against as compared to acute trusts. Ministers cannot evade their responsibilities. Why do they not intervene?

[Earl Howe]

My Lords, we have intervened. I have already referred to the action my honourable friend Norman Lamb has taken, making it very clear that not only would there be ministerial oversight of clinical commissioning group plans but that we would ensure that every decision made by a clinical commissioning group with regard to its mental health patients could be justified.

Alcohol: Calorie Labelling

Lord Hunt of Kings Heath Excerpts

Thursday 13th March 2014 Lords Chamber

[Earl Howe]

My Lords, this area is currently under scrutiny by my ministerial colleagues in the Treasury.

[Lord Hunt of Kings Heath (Lab)]

My Lords, the noble Earl mentioned the Chief Medical Officer. Did he see her comment last week that the Government ought to consider a sugar tax? What response have the Government made to their own Chief Medical Officer?

[Earl Howe]

My Lords, as I have just indicated to the noble Lord, Lord Harrison, taxation is always an instrument that Governments consider. We continue to keep the international evidence on that under review, but we think that for now the voluntary action we have put in place is delivering results. We will keep a close eye on progress but taxation is always an instrument that Governments can deploy.

Regenerative Medicine: S&T Committee Report

Lord Hunt of Kings Heath Excerpts

Thursday 13th March 2014 Lords Chamber

[Lord Hunt of Kings Heath (Lab)]

My Lords, I very much welcome the debate and I congratulate the noble Lord, Lord Patel, on securing it and commend him, the noble Lord, Lord Krebs, and the committee members for the quality of the report itself. I declare my interests as chair of an NHS foundation trust, president of GS1 and consultant and trainer with Cumberlege Connections.

This subject is of considerable interest to me. I am sure that the noble Earl, Lord Howe, will remember our great debate on the order allowing the extension of embryonic stem cell research over 10 years ago, when your Lordships’ House debated the matter for over seven hours. We agreed to it subject to the establishment of a Select Committee. I think that we played our part in laying some of the foundations for the progress that has subsequently been made.

The report itself is a powerful one. It very helpfully points out the many strengths the UK has in regenerative medicine—strengths we always hoped we would be able to take advantage of—but it also points out some of the issues around private investment, regulation, translation and how we are to take forward developments that look particularly promising as far as patient treatments are concerned.

Overall I welcome the Government’s response, which has been positive. However, it leaves four specific questions, which I will put to the noble Earl. They concern: regulation; the funding of research and development; and manufacturing capacity. I will then look a little further down the line towards the role of the National Health Service and the uptake of such new medicines and developments.

Both the noble Lords, Lord Willis and Lord Turnberg, spoke particularly eloquently about the issue of regulations and the problem we may have because of the number of regulatory bodies involved in regulation. The committee itself wanted to give a stronger role to the HRA; that is an important point on which we look forward to a perhaps more considered response from the Government. However, I was particularly interested in the point raised by my noble friend Lord Turnberg about the issue of clinical trials and the approach of the MHRA as compared to regulators in Japan and the US. That is the issue in Japan, for example. My noble friend cited that approval can be based around phase 2 trials and that what is needed is the adoption of what my noble friend called an adaptive licensing system. I am well aware of that issue.

I believe that the MHRA is a very good agency that does very good work. However, I am not yet convinced that it sufficiently recognises the urgency of making changes to its own approach. I understand that this is difficult, and I have no doubt that it has to work within the context of European directives in that area. However, can the noble Earl give us some assurance that the MHRA and the other regulatory bodies recognise that this country has a big stake in regenerative medicine? We cannot allow overbureaucratic regulatory procedures to get in the way of that.

I know that we have debated regulation on many occasions, and I wonder whether the noble Earl might consider taking a more proactive role himself—because I think he has responsibility in this area—to knock heads together between the different regulatory bodies. We have huge potential here; it would be a very great pity to lose it because our regulatory bodies were not able to keep up with the science.

Can the noble Earl respond to the issue of research investment? We will never be able to match the kind of investment that the US makes. However, we have clearly shown that we can produce very good results with investment at UK levels. Hearing the sums—the noble Baroness, Lady Sharp, very helpfully went through them—I think that they are pitiful compared to the kind of sums that need to be invested. I would like to hear some more about how the Government think that they, the medical charities and other sources can increase our effort in this area.

Manufacturing capacity has been raised as an issue. I welcome the Regenerative Medicine Expert Group, but I saw no reference in the work streams to the issue of manufacturing capacity. Can the noble Earl say a little more about how the Government think they ought to be able to encourage more manufacturing capacity in the UK?

Finally, I will ask the noble Earl about uptake by the National Health Service, which again is an issue that we have debated and which will become a big problem in the future. We know that the NHS, wonderful though it is, is very conservative as regards uptake of new medicines and treatments. The reason NICE was created was to encourage the NHS to do better. Yet in a recent report, as regards technology appraisals, which clinical commissioning groups are by law duty-bound to fund, it is clear that the take-up varies 20-fold for some important new technologies in England. We cannot allow the caution of the NHS over the uptake of new medicines to get in the way of making the most of regenerative medicines. I would be interested in the Minister’s view of how we can get the NHS to play a much stronger role.

The Regenerative Medicine Expert Group is very much to be welcomed. All of us respect highly Sir Mike Rawlins, who is an excellent choice as chairman, and I note that the group is expected to conclude its work by the end of 2014. It would be very helpful to the House if the Minister could be clear with us that the Government will take the report seriously and, on the back of it, will be prepared to reconsider some of the points that they have made in answer to the excellent report of your Lordships’ House.

Medical Act 1983 (Amendment) (Knowledge of English) Order 2014

Lord Hunt of Kings Heath Excerpts

Tuesday 11th March 2014 Grand Committee

[Lord Hunt of Kings Heath (Lab)]

My Lords, I, too, welcome the order. It comes, of course, from a report which followed the death of David Gray in 2008 after he received medical treatment from Doctor Ubani, a German national working his first shift as an out-of-hours doctor. Doctor Ubani gave David Gray an overdose of diamorphine which was 10 times the recommended maximum dose. A Select Committee investigation followed, looking at the use of overseas doctors in providing out-of-hours services, which was published on 8 April 2010. This recommended that the Government make the necessary changes to legislation that would allow the GMC to language-test those applying for registration. The order follows that and we welcome it. I commend the GMC and the noble Earl’s officials for their work in this area.

A number of points have been raised. I was interested in the BMA briefing on this matter which encapsulates some of the issues to which noble Lords have referred. It particularly concerns the area of fitness to practise. I agree with the noble Lord, Lord Kakkar, that the fact that the order covers the fitness to practise of doctors who are practising rather than those who are wishing to practise is a significant advance.

The BMA is right to ask for safeguards to ensure that testing for language competency is not abused. As it points out, a doctor’s language competence may not be a cause for concern but may be used as a conduit to prevent a doctor working where an employer may have more general concerns. One can recognise the circumstances in which this could be used. I would be interested to know what safeguards the GMC proposes in this area. Clearly, careful differentiation is required between situations when language is the main cause of concern and when there are other underlying problems such as professional or personal issues.

The BMA also states that an assumption has been made in these proposals that if someone is found not to hold a sufficient standard of English following a fitness-to-practise investigation, the situation is remedial and language competence could then be improved sufficiently over time to allow the doctor to continue to work in the UK. The BMA points out that while this may indeed be the case, it is concerned that the quality of English tuition may be very variable and that some responsibility might need to be taken by the GMC to signpost doctors to expert language training.

My next point was raised by both the noble Baroness, Lady Finlay, and the noble Baroness, Lady Brinton—namely that language competence is not the sole area which determines the likelihood of a doctor not trained in the UK experiencing difficulties. Effective communication is far broader and, indeed, has been highlighted by the GMC’s programme for doctors new to the UK, which looks at professional and ethical standards along with the importance of effective communication. I agree that it is essential that those new to the UK understand and apply the ethical and professional standards expected of them. That reinforces the point made by my noble friend Lord Turnberg that in the case of specialists from other countries, we sometimes do not know what we are getting.

I refer the noble Earl to a further briefing from the General Medical Council which stated that, by January 2016, the Government will have the opportunity to implement into UK law the new language requirements in directive 2013/55/EU on the recognition of professional qualifications. These clarify that competent authorities throughout Europe, such as the GMC, should have explicit powers to assess the language competence of all health professionals after their qualifications have been recognised but before they are allowed to practise.

The GMC considers that at that point we should be able to produce a more comprehensive scheme for language controls before doctors are given a licence to practise in the UK. Will the noble Earl confirm the GMC’s interpretation and can he say anything more about the timelines for this country implementing directive 2013/55/EU in the UK? Will he also confirm that, in so doing, we will be able to meet the point raised by the noble Viscount, Lord Bridgeman, in relation to other health professions? The point he raised about nurses is very well taken, particularly in view of the fact that they are very mobile in terms of where they work. It would be good if the noble Earl could confirm that as well.

Contracting Out (Local Authorities Social Services Functions) (England) Order 2014

Lord Hunt of Kings Heath Excerpts

Tuesday 11th March 2014 Grand Committee

[Baroness Brinton (LD)]

My Lords, it is encouraging that the results from the social work practices pilots are very positive. Phrases like “innovative”, “flexible” and “less bureaucratic” are very important to begin to change the culture in the way people work. It is also as important that the real personalisation of services is balanced by the job satisfaction of staff.

The Explanatory Notes that accompany the order are almost entirely positive. I picked up a slight nuance in the Minister’s comments. I wonder if there were any identifiable less positive or concerning features about which it might also be worth advising local authorities in how they are going to be commissioning work in the future. Apart from that, it is inevitably unfortunate that there is a short notice period that this is intended to cover, before the Care Bill comes in. At least there will not be a gap now, which is to be praised.

[Lord Hunt of Kings Heath (Lab)]

My Lords, I should have declared on the previous order—and do on this order—my chairmanship of the Heart of England NHS Foundation Trust and that I am president of GS1 and a consultant and trainer with Cumberlege Connections. I am happy to support this order. I think it is the third time the noble Earl has been before the Committee to present such an order and, as I understand it, it is an interim measure until the Care Bill is enacted; the noble Earl has said that that is expected to be on 1 April 2015.

To pick up the point raised by the noble Baroness, Lady Brinton, I suppose it would have been helpful if we could have seen the draft of the final evaluation report at this point—it is now not going to be published until April. The noble Earl referred to some of the main findings of the draft final evaluation report from King’s College. He said that it was mainly positive although there were clearly some issues, which are identified in paragraph 7.6. Perhaps he might like to say a little more about that.

Perhaps I could also ask the noble Earl about right to control. This was considered in the previous order, and in this order a reference is made to the fact that decisions on the future of the right to control pilot scheme have yet to be made and hence no provisions are included in the new order in this regard. When we debated this on 20 November 2012, the noble Earl referred to the interim evaluation of the right to control programme, published in February 2012, which showed that disabled people were benefiting but there simply was not enough evidence to make a decision on a wider rollout. He went on to say:

“Clearly, an extension of the kind that we seek will give us more evidence. The early signs are positive but that does not provide the basis for a robust decision on permanent arrangements”.—[Official Report, 20/11/2012; col. GC 150.]

Has the department now given this further consideration? Can the noble Earl say why no decisions on the future of right to control have yet been made and when he thinks such decisions will be made?

[Earl Howe]

My Lords, I am grateful to both noble Lords for their comments and questions. They both asked whether in the draft report from King’s we found any negative advice about the results from the pilots. I think the answer is no but it is worth repeating what I alluded to in my initial remarks—that King’s commented that the success of the pilots critically depended on the quality of the contract and the relationship with the local authority. The pilots that worked best were those where those two things had been got right. However, there was nothing to negate our general policy intention to roll out the right of delegation more widely. When the evaluation is published—I, too, have not had the opportunity to have sight of it yet—I am confident that it will be helpful to local authorities looking to delegate functions and I am sure we can be grateful to the team who put the report together for a very thorough piece of work.

The noble Lord, Lord Hunt, asked me about the right to control pilots. As he will have noticed, the order before us does not cover the right to control them. The pilot finished in December 2013. It was considered that there was no need to continue the pilot, which is currently being evaluated. Unfortunately, I cannot tell him when an announcement will be made on that issue but as soon as I am made aware of the date I will be happy to inform him of it. However, we were clear that the order before the Committee today need confine itself only to the matters to which I have already referred.

Health: Midwives

Lord Hunt of Kings Heath Excerpts

Wednesday 5th March 2014 Lords Chamber

[Earl Howe]

My Lords, I hesitate to correct my noble friend but Independent Midwives UK submitted a business proposal to the department which would require the Government to provide a £10 million grant to support the inception of an insurance scheme for its members to provide full maternity care. We have considered two options, either of which would deliver that result. The creation of any government scheme specifically for Independent Midwives UK would effectively position the Government as the underwriter of the independent sector. That is something that we have hitherto found difficult to consider.

[Lord Hunt of Kings Heath (Lab)]

My Lords, I refer noble Lords to my health interests. It sounds to me as though the Government are perhaps going to come up with a positive outcome. Why have independent midwives been excluded from the NHS Litigation Authority’s clinical negligence scheme for trusts? Would that not be a very straightforward way of allowing independent midwives to continue and to be regulated? Clearly, one of the big issues at stake is that, without cover, it is likely that they will not receive proper registration in the future.

[Earl Howe]

Yes, my Lords, that would be a very simple solution but it was rejected by Independent Midwives UK when it was put to it.

NHS: NICE-appraised Medicines

Lord Hunt of Kings Heath Excerpts

Thursday 27th February 2014 Lords Chamber

Asked by

[Lord Hunt of Kings Heath]

To ask Her Majesty’s Government what is their response to the report of the NHS Information Centre for Health and Social Care, Use of NICE appraised medicines in the NHS in England-2012, experimental statistics, which showed extensive variation in patients’ access to new innovative medicines.

[Lord Hunt of Kings Heath (Lab)]

My Lords, I beg leave to ask the Question standing in my name on the Order Paper and I refer noble Lords to my health interests.

[The Parliamentary Under-Secretary of State, Department of Health (Earl Howe) (Con)]

My Lords, patients have a right to drugs and treatments that have been approved by the National Institute for Health and Care Excellence that their doctor decides are appropriate for them. There can be many reasons for variation in use but we are determined to tackle unjustified variation where it exists.

[Lord Hunt of Kings Heath]

My Lords, I am grateful to the noble Earl for that response. Does he agree that one of the conclusions of the report is that there can be a tenfold variation in the take-up of innovative new medicines that have been approved under the NICE technology appraisal programme? Given that it is a legal requirement for clinical commissioning groups to fund those treatments, as I understand it, what sanctions can be taken against commissioning groups which do not fund those treatments? What can patients do in each area if they are refused such treatments? Is there a process of appeal that they can take their concerns to?

[Earl Howe]

My Lords, there is a process of appeal. Patients can go to their clinical commissioning group or, indeed, to NHS England and ask for the matter to be specially looked at. However, it is important to understand what these figures are and what they are not. They are not intended to be, and do not claim to be, a statement of whether certain drugs are being underprescribed or overprescribed in a particular area. One has to drill down into the reasons. In fact, when one does that, for most of the groups of medicines where it was possible to compare observed and predicted use, the report shows that use has increased over time, and we are introducing additional tools to allow the NHS to get to the heart of the reasons for variations in local areas.