Health and Care Bill

Debate between Lord Warner and Baroness Walmsley

Lords Hansard - Part 1 & Report stage
Thursday 3rd March 2022 Lords Chamber

[Lord Warner (CB)]

My Lords, I rise even more briefly to support Amendment 116. It is worth reminding the Minister and the House that the Government Statistical Service is independent. It was made so by the Blair Government so that Ministers could not withhold, distort or delay the publication of uncomfortable statistics. Rebukes on dodgy statistics secure public reprimands of Ministers and departments.

The logic of this position is that you do not put the collection or publication of health statistics in the hands of an operational arm’s-length body, particularly because there could be a conflict of interest. That point has already been made. These functions should be left in the hands of an independent non-operational body, which is what the amendment in the name of the noble Lord, Lord Hunt, does. Can the Minister explain why the Government are making this change? My instinct is to be mightily suspicious.

[Baroness Walmsley (LD)]

My Lords, I simply rise to say that I agree with all noble Lords who have spoken and look forward to the Minister’s reply.

Health and Care Bill

Debate between Lord Warner and Baroness Walmsley

Lords Hansard - Part 2 & Committee stage
Wednesday 26th January 2022 Lords Chamber

[Lord Warner (CB)]

My Lords, it is a delight to follow the noble Lords, Lord Lansley and Lord Hunt, on this set of amendments, with which I totally agree. I want to dilate for a few moments on the realpolitik of being a Minister in the great, august organisation called the Department of Health and Social Care. I can say some things that the noble Lord, Lord Lansley, as a former elected Minister, possibly cannot.

When I ceased to be a Parliamentary Secretary and was promoted to work with the big boys and girls as a Minister of State, and had to deal with issues such as reconfiguration, poor performance and so forth, I became used to regularly meeting elected MPs who wanted to tell me about the errors of their ways in decisions that had been taken in the public interest. There was a steady flow of them, which, if I may say, tended to get bigger the nearer you got to an election. If people wanted to go through the archives, I would refer them to the history of Lewisham Hospital and of Chase Farm Hospital, to name but two.

Very often in these situations, it is not about closing a whole hospital but about re-engineering—we will come to some of this in the next group. I give the example of stroke services in London. It is re-engineering a particular set of services, which the local MP is then put up for trying to ensure that change does not happen. That is where you need to help Ministers do the right thing, when it is in the public interest to make changes. The amendments from the noble Lord, Lord Hunt, help Ministers do the right thing.

The point the noble Lord, Lord Lansley, made is absolutely valid. In many of these circumstances, it becomes very difficult if you are an elected Minister—as distinct from an appointed Minister, who does not have to face the electorate—to resist some of the local pressures to avoid change which would be disadvantageous to a local hospital. For those realpolitik reasons, I think the noble Lord, Lord Hunt, is on the right track and we should support the amendments.

[Baroness Walmsley (LD)]

My Lords, I support the noble Lord, Lord Lansley. Clauses 39 and 64 give the widest possible powers of intervention to the Secretary of State and even the power to delegate that power to someone else. The noble Lord, Lord Hunt, and other noble Lords clearly believe that the Government are going too far, hence the large number of amendments in this and the next group.

I believe that the Clause 39 powers could justifiably be used only in the case of some cataclysmic failure of the NHS. There are four questions to ask. Is it possible that the Secretary of State would ever need these powers of intervention at an operational level, given that he already has the mandate? Does the Secretary of State have any other powers which could be used prior to this atomic bomb of a power? Has the NHS survived well enough over the last 10 years without the Secretary of State having such powers? Does Clause 39 upset the balance between the Secretary of State and the autonomy of NHS England? I think the answers are no, yes, yes and yes—your Lordships can work it out.

The Health and Social Care Act 2012 removed the Secretary of State from this sort of meddling. I thought at the time that it might also avoid him or her taking the blame for failure, but that was just me being cynical and there has actually been no failure of political accountability over the last 10 years. The ninth report of the House of Lords Constitution Committee refers to this issue. It notes that, in 2011, it

“raised concerns that that Bill could erode ministerial responsibility due to the proposed duty on the Secretary of State to promote autonomy for persons exercising functions in relation to the health service. What is now section 5 of the Health and Social Care Act 2012 was amended, such that the Secretary of State instead must have regard to the desirability of securing autonomy. This helps ensure a balance between enabling those providing health care services to deliver services in a manner that they consider appropriate, whilst ensuring ministerial responsibility.”

The Constitution Committee believes that, in combination with Clause 64, the powers taken for the Secretary of State by Clause 39 would undermine that autonomy and upset the balance. They also risk

“undermining accountability by making it more difficult to understand which body is responsible for a particular function of the NHS.”

The fact is that the Secretary of State already has the power to change the mandate of NHS England—as the noble Lord, Lord Lansley, pointed out—to adjust its funding or to bring political pressure upon it to behave in certain ways, without the need for the powers in this clause. Indeed, I think it would be very unwise to use these powers, and he or she will certainly get the blame if it all goes pear-shaped. The Bill, as has already been pointed out in some detail by noble Lords, the DPRRC and the Constitution Committee, gives the Government considerable regulatory and guidance powers, about half of which allow no parliamentary scrutiny at all. Does that not give the Secretary of State enough ability to ensure things are done in the way the Government wish? The Secretary of State already wants to be Henry VIII; does he also want to be King Herod?

Health and Care Bill

Debate between Lord Warner and Baroness Walmsley

Lords Hansard - Part 3 & Committee stage
Wednesday 26th January 2022 Lords Chamber

[Lord Warner (CB)]

My Lords, I want to briefly make clear my support for this group of amendments and try to be consistent with what I said on the previous group. The only amendment which causes me to have pause for thought is Amendment 183. The NHS, perfect in every form of course, has been known to have its arteries fur up occasionally. Sometimes there is a need for scale in some services. I want to mention three or four services where scale, after clinical consideration, is important. Pathology is a good example, where we need to have more scale than many of the local pathology departments. Another one, which the Royal College of Surgeons has advocated, is elective surgery hubs, which may mean taking stuff away from a particular local hospital. Another good example is the issue of stroke specialisation, which is beneficial for patients. I have given you three examples where we do not want to totally neutralise the Secretary of State. Sometimes Ministers have a use; it may be few and far between, but occasionally they have some use. We do not want to say that you cannot ever be a catalyst for change. That seems a bit drastic in Amendment 183, and I ask the noble Baroness, Lady Cumberlege, to think about that, because sometimes scale is important, with clinical advice for the benefit of patients.

[Baroness Walmsley (LD)]

My Lords, I am in favour of surgical excision. I oppose the powers of the Secretary of State in Clause 40 and Schedule 6 to intervene in decisions on reconfiguration of health services. Far be it from me to want to protect Conservative Secretaries of State for Health from themselves, but I warn that if they use these powers they will eventually get the blame.

The noble Lord, Lord Stevens, gave a number of very good reasons why this clause should be deleted from the Bill. My reason is somewhat different. I think these powers are very dangerous. We have recently seen how the Government’s powers to provide or withdraw funding from a proposal, let us say, to build a new school or improve infrastructure in a particular constituency have got them into trouble. We have heard allegations made against Government Whips by Members of Parliament of actions which could be criminal offences of bribery. It is alleged that, in seeking to ensure support for their leader, they are threatening Members of Parliament that funding for their projects, which have already been declared to be in the public interest of their constituents, will be withdrawn unless they behave in a certain way, so political considerations would trump public interests.

Like the former Member of Parliament to whom the noble Lord, Lord Hunt, referred, all politicians know that the provision of a new hospital or clinic or, on the contrary, the closing of a healthcare setting are very sensitive considerations in elections. All parties ensure that the voters know their views on these matters at election time and in between elections. The Prime Minister knows this. Why else would he put such emphasis on his promise of 40 so-called new hospitals by 2030 if this were not the case? It makes a good headline, even if we know that some of them are not new and some of them are not hospitals.

The powers of reconfiguration sought by the Secretary of State in Clause 40 would give the Government the ability to change the decisions of those put in place locally and well qualified to make them in a non-partisan and needs-based way, thus allowing the Government to wield unwarranted political power. It is probable that this Government would not be able to resist doing so, for the wrong reasons, and it is incumbent on all parties to stop them by deleting Clause 40 from the Bill. Indeed, I do not think that I would be in favour of giving these powers to any Government of any political party; they are just too liable to be misused.

Health and Care Bill

Debate between Lord Warner and Baroness Walmsley

Committee stage
Thursday 20th January 2022 Lords Chamber

[Lord Warner (CB)]

Before the Minister responds to that, can I amplify what is being refused here by the Government? As I understand it, he is trying to rely on the Care Act to get local government to co-operate and integrate care with the great elephant, the NHS. This is asking a minor player to take on a major player with far more resources. Amendment 89, tabled by the noble Baroness, Lady Hollins, makes the NHS come back every two years about the outcomes. That is a fairly modest challenge to the NHS and I fail to understand why the Government cannot simply accept that in principle and then negotiate the drafting.

[Baroness Walmsley (LD)]

I am so sorry to delay the Minister again, but briefly. After we have pushed this Bill through Parliament, we will have an integration Bill and a White Paper and legislation on social care. When we have had this, those and those, can we come back to this?

Health Service Medical Supplies (Costs) Bill

Debate between Lord Warner and Baroness Walmsley

Wednesday 5th April 2017 Lords Chamber

[Lord Warner (CB)]

My Lords, the amendment removes the requirement on the Government in the original amendment passed by this House to have “full regard” to the considerations relating to life sciences and access to NICE-approved medicines and treatments. Instead, it requires the Government to “take account of” those considerations in discharging its responsibilities under the Act. This responds to the Government’s concerns that the original wording was too inflexible to respond to all the situations with which they might be confronted in controlling the price of medicines and medical supplies. I suggest that the revised wording gives them the flexibility they seek while retaining some requirement to pause to consider the impact and implications of a price cut to NHS-purchased medicines and medical supplies on the UK’s important life sciences sector and on patient access to NICE-approved medicines.

We passed the original amendment and placed it at the front of the Bill because of our central concern that the legislation seemed overpreoccupied with driving down the price of drugs and medical supplies to the NHS and was in serious danger of losing sight of the importance of the life sciences sector to UK plc, despite the Minister’s protestations—and, together with that, the related issue of ensuring that patients have speedy access to the most cost-effective therapies.

Delaying patients’ and NHS access to new proven therapies will only drive life sciences away from the UK at a time when pharmaceutical investment here is already on a downward trajectory, and at the very time when we need this investment to be increasing under the Government’s own industrial strategy post Brexit, as the Minister has rightly said. But the money is going down from big pharma investing in this country and the Bill has not helped reverse that trend. Delaying patients’ and NHS access to new proven therapies will only make things worse.

The danger of this Bill passing without a pausing mechanism of the kind I am suggesting is that the Act will become yet another example of the short-termism that is criticised in this House’s Select Committee report on NHS sustainability, published today. I recommend that noble Lords read that report about the short-term focus of much of the action taking place in the NHS today. I declare an interest as a member of that Committee.

The Bill has made the ABPI and the pharmaceutical industry worried that it signals the end of the voluntary PPRS system for settling the price of research-based medicines in this country. Only this week the ABHI published a report on a strategy for a thriving med-tech industry outside the EU, calling for the NICE technology appraisal programme to be expanded to assist NHS take-up of new technology. Little did it know that it was this very week, as the Minister recognised, that the Government, through the agency of NHS England, had introduced a new “budget impact test” for NICE-assessed products. That is yet another hurdle to be jumped by British science and research and before NHS patients can benefit.

I have been probing this new system which in plain English is a new affordability test grafted on to the NICE appraisal process following discussions between NHS England and NICE, under, I suggest, a good deal of pressure from the Department of Health. I tabled a Question on this on 14 March, to which the Minister answered on 28 March. I still have concerns about that Answer, which I am pursuing through further Questions. But I want briefly to share those concerns with the House because they are relevant to why we should send the Bill back to the Commons with a new amendment.

First, there is the very real issue of how big a part NICE-approved medicines actually played in the 20% rise in the drugs bill between 2010-11 and 2015-16 that the Government are so concerned about. Were these appraisals the villains or were there other explanations for that increase in the drugs bill? We do not know. Nor do we know whether the costs of these appraisals were actually offset by savings derived from the new treatments. The danger is that an unexplained rise in the NHS drugs bill can cause a panic reaction in the department, which will then use this new legislation to curb access to new drugs.

My second concern is over the actual legality of this new system and the damage being done by it to NICE’s reputation for independence. As I understand the 2013 regulations governing NICE functions, they impose a three-month period for NHS implementation of NICE-approved technology appraisals. It is only NICE that can extend the period of implementation, not the Secretary of State and not NHS England. So we are going to see a system being developed under which NICE is regularly put under pressure by the Department of Health or NHS England to extend the three-month implementation period.

I welcome any light that the Minister can throw on these concerns, but it is not just me or this House that he needs to satisfy—or even industry. He also has to convince patient interest groups such as Breast Cancer Now, Prostate Cancer UK and Diabetes UK, which are all very concerned about the budget impact test and what it means for patients’ speedy access to new proven therapies and their rights under the NHS constitution. I am not convinced that what the Minister has said this afternoon will convince them that they should not be suspicious of these changes.

The more events unfold, the more this looks like a piece of legislation originally designed legitimately to tackle a major NHS rip-off from a generic scam which was then rapidly expanded in scope to give the Government more powers to drive down NHS prices for medicines and medical supplies. From our earlier consideration at different stages of the Bill, I suggest that there has been a lack of proper consultation with many interested parties, and the measure provides powers whose exercise could well have some highly undesirable outcomes. The budget impact test could well illustrate what we might expect without some counter-influence; my Amendment A1 strives to do that but without over-restricting the Government’s legitimate freedom of action when there are outrageous increases in drug prices to the NHS. I beg to move.

[Baroness Walmsley (LD)]

My Lords, I support the noble Lord, Lord Warner, in his amendment. I thank the Minister for how he has worked with your Lordships’ House on all sides to improve this Bill; it is unfortunate that we remain with one point of disagreement. We certainly support the policy objective of the Bill in general and very much welcome the list of actions in the Minister’s introduction to promote research and drug development in this country. But in listening to his outline of his particular responsibilities, it occurred to me that no policy area is ever an island; they always impact on other things. The Minister’s responsibility to achieve best value for the NHS actually impacts on other responsibilities that he and his department have—in particular, in relation to this amendment, on the thriving life sciences sector, on which we all depend, and the access of patients to cutting-edge medicines.

Both those things are suffering from particular threats at the moment. One is Brexit, which I shall not go into now; we have discussed it on many occasions. The other is the recent £20 million affordability test that the Government are introducing. Although £20 million sounds like a very large amount of money, if it is applied to medicines where the population of those needing the medicines is very large, such as some of those mentioned by the noble Lord, Lord Warner—diabetes, breast cancer and other things—the individual cost to an individual patient does not need to be very high to be caught up by the affordability test. The Minister used the word “only”; he said that it would affect only one in five of medicines, but I think that that is an awful lot of medicines, and we should be very concerned about it. That is why we feel that it is important to press the Minister on this issue.

I congratulate the noble Lord, Lord Warner, on offering the Government a compromise, which I hope would avoid what the Minister is clearly worried about: being taken to judicial review by a pharmaceutical company about efforts to push down the price of a medicine. I draw the Minister’s attention to the word “sector” in paragraph (a) of the proposed new clause, which asks the Government to take account of the need to,

“promote and support a growing life sciences sector”.

The word “sector” makes it unlikely that any pharmaceutical company trying to take the Government to judicial review would succeed if the Government had, in all other respects, promoted a thriving life sciences sector in this country. It is highly unlikely that they would do so.

I therefore hope that the Minister will think again and not resist this amendment. It is essential, given the current threats to patients in this country—and very large populations of patients too, in particular those coming towards the end of life—to pharmaceuticals, to treatments and access to medicines. I therefore hope that the Minister will reconsider, and, if the noble Lord, Lord Warner, wishes to test the opinion of the House, he will have the support of these Benches.

Health Service Medical Supplies (Costs) Bill

Debate between Lord Warner and Baroness Walmsley

3rd reading (Minutes of Proceedings): House of Lords
Thursday 23rd February 2017 Lords Chamber

[Baroness Walmsley (LD)]

My Lords, we on these Benches are also happy to support the amendments. Like the noble Lord, Lord Lansley, I have no intention of detaining the House with long-winded thanks. However, I want to voice my recognition that the Minister, in his new role, has both understood and responded to the issues raised on the Opposition and Cross Benches about the shortcomings of the Bill, which had been through the House of Commons without anybody noticing or trying to amend its unintended consequences, rather like the Article 50 Bill that we debated in this House on Monday and Tuesday.

[Lord Warner (CB)]

My Lords, I thank the Minister for listening so intently during the proceedings and for his response. I am also grateful to those on the Front Benches opposite for their co-operative approach—they are a shining example to their colleagues in the Commons of how to be effective in persuading the Government to change their mind. I hope the Minister’s emollient approach will continue when the Bill leaves this place in relation to the new clause that we have put in at the front of the Bill, despite the advice he was given. I hope that good will will continue to operate as the Bill completes its passage through both Houses of Parliament.

Health Service Medical Supplies (Costs) Bill

Debate between Lord Warner and Baroness Walmsley

Report stage (Hansard): House of Lords
Tuesday 7th February 2017 Lords Chamber

[Lord Warner (CB)]

My Lords, Amendment 3, in my name and those of the noble Lords, Lord Patel and Lord Hunt of Kings Heath, and the noble Baroness, Lady Walmsley, is very straightforward. At the start of the Bill, it would lay a clear duty on the Government, in discharging the Bill’s provisions, to have full regard to promoting and supporting a growing UK life sciences sector and to ensuring patients have rapid clinical access to new medicines approved by NICE through its technical appraisal process.

This is to ensure that the Bill does not just focus on driving down the price of NHS drugs regardless of other considerations—which, in my view, there is a clear danger of given the way the Bill is framed. I made absolutely clear at Second Reading and in Committee that I fully support the Government acting through the Bill to prevent the NHS being blatantly ripped off under the statutory scheme when a branded drug comes off patent, as happened with Flynn Pharma when a Pfizer anti-epilepsy drug came off patent. The ABPI has never challenged actions in cases of this kind. However, the broad wording of the Bill goes well beyond closing this particular loophole. The Bill gives the Government the power, in the statutory scheme, to replace a list-price discount system with one in which a company repays the Government a percentage of net sales, with as yet no clear indication of what this level will be.

That might well be an acceptable approach if the system was applied solely to the statutory scheme, but not if it is then used in the voluntary PPRS. The industry’s concern is that this statutory scheme provision will create a precedent that could be applied later by the Government to the voluntary PPRS. My reading of the Bill is the same as that of the ABPI, namely that the legal precedent could enable a future Government to try unilaterally to apply the same approach to the voluntary scheme when a PPRS period ends, whatever assurances the current Minister may give. This would effectively abort a negotiated system of settling NHS drugs prices and encouraging research and innovation that has worked well for industry, UK plc and successive Governments for over 50 years. Ministerial assurances that this will not happen have not convinced the pharmaceutical industry or me that this could not happen. We both believe that stronger legislative safeguards are needed.

I think I can speak with some authority on this issue, having been a Minister with responsibility for the pharmaceutical industry and NICE, and having had, perhaps unlike the Minister, to negotiate a PPRS settlement with the industry, which achieved a 7.5% price cut in branded drugs prices for the NHS. I do not think anybody in the industry would see me as a soft touch for big pharma, but I knew that my job, like the Minister’s, was to balance a number of factors and not just get the cheapest drugs for the NHS. These factors involve the safety and value for NHS money of new medicines, but they also involve helping the UK life sciences industry to grow and flourish and to secure speedy access for patients to new drugs approved by NICE.

The Government have not done a spectacularly good job with their consultations on the Bill in showing the industry that they understand this balancing act. They certainly have not convinced the industry, and suspicions have been raised by the inclusion of elements that were not in the 2015 consultation on the Bill. The effect has been to foster distrust within an industry that UK plc badly needs to nurture at this time of massive economic uncertainty. This has been made worse by a negotiation currently taking place with the industry to slow the introduction of NICE-approved drugs if they exceed a certain financial threshold. Why is this so important? Why should the Government not just focus on getting the cheapest drugs they can for the NHS at this time of financial constraint?

The pharmaceutical industry invests over £4 billion a year in R&D in the UK, more than any other sector. It employs 62,000 people with a geographical spread outside London and the south-east. Pharmaceutical manufacturing employees have the highest gross value added of any high-technology industry, at over £330,000 per employee. One in four of the world’s top prescription medicines was discovered and developed in the UK. All this will be put at serious risk by Brexit, as the Prime Minister seems to recognise in the new industrial strategy that she recently announced.

We know that through Brexit the UK will lose the European pharmaceutical regulator, the EMEA, but there are also many other threats to the UK life sciences industry from Brexit. We could lose market access for our innovative products and there could be a flight of researchers and research. At such a time, the last thing this highly successful UK sector needs is a rather indifferent piece of legislation proposing what are in my view unnecessary regulatory burdens and creating uncertainty about the future arrangements of settling NHS prices for new drugs.

The second leg of the amendment covers the issue of speedy patient access to new drugs approved by NICE. I will not detain the House on this issue because others will probably want to say more about it. However, I remind the House that we already have a poor record on the take-up of new NICE-approved medicines. For every 100 European patients who can access new medicines in the first year that they are available, just 15 UK patients have the same access. Even when NICE has approved drugs and treatments, the NHS take-up still lags behind what it should be, despite the legal obligations.

To be fair to the Government, they seem to recognise the threat to the UK life sciences industry that Brexit poses. In the industrial strategy they identify life sciences as one of the five world-leading sectors that they wish to cultivate, and they have asked Sir John Bell—I can describe him only as brilliant—to lead work on early deals in this sector. That only makes the timing of this rather scrappy piece of legislation all the more surprising. However, we are where we are. The best thing we can do is put a protective overarching duty at the beginning of the Bill, and that is what Amendment 3 does. I hope the Minister considers that the amendment is helpful to the Government’s industrial strategy and the work Sir John is doing, as well as being a reassurance to the life sciences sector. It also needs to be the first clause in the Bill. I beg to move.

[Baroness Walmsley]

My Lords, in supporting the amendment, I reiterate my support for the general purpose of the Bill, which is to ensure good value for the NHS. However, there is a danger that it could result in reduced access for UK patients to new drugs and treatments if badly handled by the Government in future. As usual, the devil is in the detail—and, in particular, how the Government use the powers given to them in the Bill. That is why I support the imposition of a duty to ensure the continued growth of the life sciences sector and to protect access for patients to new medicines and treatments.

I share the concerns of the noble Lord, Lord Warner, about the effect of Brexit, which I mentioned in my Second Reading speech. In the light of the hard Brexit on which the Prime Minister is intent—without a mandate—there are many hazards to this industry, on which we depend for a major contribution to our economy, and to the future of medicine in the UK, so it is vital that the Government have that in mind when operating the Bill when it becomes an Act.

I have in mind as an example the new biosimilar medicines that the noble Lord, Lord Carter, pointed out in his report have the potential to save the NHS a vast amount of money while providing the same or even better treatment. He said that one new biosimilar drug alone can save the NHS £60 million a year. These biologic drugs currently account for six out of the top 10 medicines by spend in the UK, and I gather that five out of the top seven biologics will come out of patent by 2020—so there will be enormous potential for the development of generic biosimilars for many diseases. These drugs cost about 100 times more to research and develop than other generic drugs, but the current pricing system does not take that into account. They are different and, because of their enormous cost-saving potential and the competitive environment in which they will be marketed, which could bring down the cost even further, I think that they need special consideration from the Government.

Amendment 7, tabled by the noble Lord, Lord Lansley, which I support, could achieve this if the Government were inclined to use it, but I think we need to go further and put at the heart of the Bill a duty on the Government to protect future cutting-edge medicines when they first come into the market. Unless that is done, UK patients could become the last in the developed world to get these medicines. We want to be first, not last.

A healthy, competitive market will deliver tremendous cost savings to the NHS in the long term, but this requires sufficient—not excessive but sufficient—financial returns to compensate for the high cost of R&D. Otherwise, we will not have enough companies prepared to compete over a long period. This will prevent the NHS benefiting from the potential savings offered by these medicines. For those reasons, I support the amendment.

Health Service Medical Supplies (Costs) Bill

Debate between Lord Warner and Baroness Walmsley

Committee: 2nd sitting (Hansard): House of Lords
Wednesday 25th January 2017 Grand Committee

[Lord Warner]

In response to the noble Baroness’s point, I would not claim to have actually considered the detail of what level of pricing we will use. My point in this amendment is to try to establish the principle of a trigger mechanism, and I am happy to be advised on ways of improving it.

[Baroness Walmsley (LD)]

My Lords, the noble Lord, Lord Warner, is right that we need to have a trigger mechanism. This is gold-plating, and not very effective gold-plating. As the noble Baroness, Lady Finlay, just said, it will produce an absolute mass of information. The question is how to find, among that mass of information, situations where there is malpractice, abuse or unwarranted price rises. It is the same sort of argument as we had when the police wanted to collect everybody’s internet information. Really, it is like looking for a needle in a haystack. It is much better to have it targeted, where there is a reason to believe that there is something going on.

How will the department identify from this mass of information those situations that it needs to investigate further? Will it apply some sort of algorithm to the information at any point along the production or distribution line when there is an increase of more than a certain percentage or a certain percentage related to the average—or what? How is it going to be done? These companies have quite enough to tackle with Brexit coming along the track and do not need a further burden such as this.

Health Service Medical Supplies (Costs) Bill

Debate between Lord Warner and Baroness Walmsley

Committee: 1st sitting (Hansard): House of Lords
Monday 23rd January 2017 Grand Committee

[Lord Warner (CB)]

My Lords, Amendment 1 is in my name and those of the noble Lord, Lord Hunt of Kings Heath, and the noble Baroness, Lady Walmsley. First, I welcome the Minister to his first health Bill as a Minister. I am sure that the noble Lord, Lord Hunt, will have a great deal of sympathy with his position of having copped the Committee stage of a Bill in which he had had no previous involvement, because I did exactly the same to him when I left office and left him with the Mental Health Bill—having made, of course, an extremely brilliant speech at Second Reading to introduce the Bill.

I sympathise with the Minister’s position, but that does not mean that we will not probe forcefully on a Bill that is definitely a curate’s egg which does not seem to have left the Commons in as improved a state as it might have done. I am afraid that earlier this morning I separated Amendment 1 from Amendments 2 and 4. I hope that that has not caused too much trouble. I wanted to focus in this amendment on life sciences and the PPRS scheme and on their importance.

Amendment 1 is very straightforward. At the start, the Bill lays a clear duty on the Secretary of State, in discharging the Bill’s provisions, to have regard to supporting a flourishing UK life sciences sector and ensuring that patients have speedy access to NICE-approved new medicines and treatments—a subject to which I think we will come back on a number of occasions. As I made clear at Second Reading, the Department of Health Minister with responsibility for the pharmaceutical industry does have to balance a number of factors, and not just get the cheapest drugs for the NHS. This is what I had to do when I had those responsibilities, and the position is the same today, as I understand it. These factors involve the safety and value for NHS money of medicines, but they also involve helping the UK life sciences industry to grow and flourish and securing speedy access for patients to new drugs that have been approved by NICE.

It is clear that the Government have not done a spectacularly good job with their consultation on the Bill in showing that they understand this balancing act. They certainly have not convinced the pharmaceutical industry—hence this amendment at the start of the Bill. Suspicions have understandably been raised by the inclusion of elements in the Bill that were not in the 2015 consultation on the Bill, including enforcement powers for future voluntary pricing schemes that operate outside the statutory scheme. There is also the issue that the range of products covered by the Bill seems to have been extended, along with the disproportionately bureaucratic information requirements that have now found their way into the Bill.

We will come to many of these issues later, but I will focus here on safeguarding life sciences and the PPRS. Why is this so important? I will start with the life sciences issue. The pharmaceutical industry invests more than £4 billion a year in R&D—more than any other sector. It employs 62,000 people, with a geographical spread that is well outside London and the south-east. Pharmaceutical manufacturing employees have the highest gross value added of any high technology industry, at more than £330,000 per employee. One in four of the world’s top prescription medicines was discovered and developed in the UK. It is a very important and powerful industry for this country.

All this will be put at serious risk by Brexit, as the Prime Minister seems to recognise in the new industrial strategy that she announced today. We know the UK will lose the EMEA through Brexit, but Brexit also poses many other risks to the UK life sciences industry, which could lose market access for its products and see a flight of researchers and research. At such a time the last thing the sector needs is a piece of ill-considered legislation imposing unnecessary regulatory burdens—again, something the Prime Minister said in her industrial strategy that she wants to reduce.

As I made clear at Second Reading, I am not saying that the Government should not act to prevent the NHS being blatantly ripped off under the statutory scheme when a branded good comes off patent, as happened with Flynn Pharma and a Pfizer anti-epilepsy drug. The ABPI has never challenged action in cases of this kind. However, the broad wording of the Bill goes well beyond closing this loophole. It gives the Government the power in the statutory scheme to replace a list-price discount system with one in which a company repays the Government a percentage of net sales, with as yet no clear indication of what this level will be. The industry’s concern is that this will create a precedent that could be easily applied to the voluntary PPRS scheme. Ministerial assurances that this will not happen are simply not the same as legislative safeguards. My reading of the Bill is the same as the ABPI’s, namely that this legal precedent could enable a future Government to unilaterally apply the same approach to the voluntary scheme when a PPRS period ends. This would end a negotiated way of setting prices and encouraging research and innovation that has worked well for industry and successive Governments for more than 50 years.

The second leg of Amendment 1 covers the issue of speedy patient access to new drugs. We will come to this matter later on other amendments so I will say little now, except to remind the Committee that we already have a poor record on the take-up of new approved medicines. 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. Even when NICE has approved drugs and treatments, NHS take-up still lags behind. The first page of Friday’s Times showed the sector’s concerns, with one-fifth of new drugs being rationed and drug companies now openly saying they will no longer launch new drugs early in the UK. Whatever we do with other parts of this Bill when we come to them, I urge the Government at this time of great uncertainty for UK life sciences to put at the beginning of this Bill a statement of intent and reassurance of the kind embodied in Amendment 1. I beg to move.

[Baroness Walmsley (LD)]

My Lords, I support this amendment and compliment the noble Lord, Lord Warner, on his comprehensive introduction of it. I have no intention of repeating everything he said. However, I have a few points. I, of course, support the Government’s intention to try to make sure that the health service is not ripped off, but point out that a very large fine has just been imposed on Pfizer by the competition law regulations in relation to the case mentioned by the noble Lord, Lord Warner—so even without this Bill, that is working and we must bear that in mind.

What I am particularly concerned about is the potential effect on the life sciences sector, particularly—as the noble Lord, Lord Warner, said—in the light of Brexit. There are dangers to our markets and to our researchers. Our research is going elsewhere and researchers from other EU countries coming to us are all in danger because of the Prime Minister’s determination to take us out of the single market and the customs union, which I do not believe is what the public voted for.

The particular issue that concerns me is that although we were told in some of the meetings we had that there had been consultation and there will be more consultation before elements of the Bill are implemented, parts of the industry tell us that they are very concerned that they were not consulted. They do not feel that the level of consultation before the Bill is implemented is anything like good enough. We have to support our life sciences industry. We are very good at life sciences. It is one of the things that we can lead—and have led—the world on, but we must make sure that it is not in danger.

The other point is on access to treatments—not just drugs but other treatments. I am told by GPs that rationing is already in place, either by these referral management companies—private companies—that are being placed between the GP and his or her recommendation and the consultant, or by the consultants having pressure put on them to refuse consultation over certain patients referred to them by GPs. We already have rationing and we need to make quite sure that we are not affecting our pharmaceutical industry. We must ensure that our industries involved in research, medical implements, treatments, machines and devices and all those things that we are so good at inventing are not damaged by the Bill. It is really important that we have a statement of intent in the Bill. It will place on the Government the responsibility to make sure that they consider this terribly important sector. I have not had a chance to read the industrial strategy yet, but I would be surprised if the money follows the intent. I do not think that we will be able to look to that for any comfort, so we need this amendment.

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[Baroness Walmsley]

My Lords, I am in favour of this group of amendments. The Government plan to introduce new regulations and duties on the industry at a very difficult time, so the Minister cannot be surprised that the industry is concerned and that parliamentarians would like to take the opportunity to hold the Government to account based on what happens after the Bill becomes an Act.

For some of the things that we have been talking about, I have been told that the Government already have powers but have not used them—they are just refining and clarifying them and making them more proportionate. Of course, that makes the industry worry that they are planning to use them, even though they are not saying so. We need to know what will happen to all these issues of availability, access, proper supply and cost to the NHS once the Bill has passed. In the interests of transparency and post-legislative scrutiny, will the Minister accept that the Government should report back to Parliament?

[Lord Warner]

My Lords, I have added my name to Amendment 14, but I also support in principle Amendments 9 and 10A in this group. Each of these amendments does something slightly different and they need some consolidation. They are, however, a reflection of a deep sense of unease over where the Bill is taking us and a strong wish to monitor its consequences. The Government are imposing a lot of requirements on the industry for information. The quid-pro-quo is that we would like a lot more information from the Government on how this has worked in practice.

There seem to be three features that that kind of reporting back should cover. The first is the scale of payments made; the second is the use to which the money has been put; and the third is the impact of the Bill on the access to new medicines of NHS patients. It would not be right to try to draft this off the tops of our heads, but it would be helpful if the Government would accept that there should be some kind of monitoring of key issues around the Bill that are then reported back to Parliament and the public on a regular basis—let us say annually—and if we could get together with the Government to help draft something for Report in this kind of territory.

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[Lord Warner]

My Lords, I too am sympathetic to this amendment. I have a linked amendment, Amendment 33, which is about introducing a trigger before information is required. Both amendments, I think, are intended to curb the enthusiasm of Secretaries of State to intervene in a market situation where things are working reasonably well. So I have every sympathy with the amendment of the noble Lord, Lord Lansley, and I hope that the Minister will consider it sympathetically.

[Baroness Walmsley]

I too have a great deal of sympathy with the amendment, but I just wonder what the definition would be of an “open and competitive” process—perhaps it would be defined in regulations. Does the noble Lord agree?

Children and Social Work Bill [HL]

Debate between Lord Warner and Baroness Walmsley

Wednesday 13th July 2016 Grand Committee

[Lord Warner]

What expertise does the DfE have in relation to the work and performance of social workers working with adults? The Minister has no responsibility for that. His officials have no knowledge or responsibility for this area. Where is the evidence? Does this come from the Department of Health? Where has it come from?

[Baroness Walmsley]

My Lords, I did not get an answer to my question about which Secretary of State it would be. Strangely enough, although Clause 21 refers to “Secretary of State” in the singular, in his response the Minister talked about Secretaries of State. Will he clarify whether we are talking about the Secretary of State for Education and the Secretary of State for Health in agreement? If so, what will happen if they do not agree?

Children and Social Work Bill [HL]

Debate between Lord Warner and Baroness Walmsley

Monday 11th July 2016 Grand Committee

[Lord Warner]

I will speak to Amendment 130 in my name and that of the noble Baroness, Lady Walmsley. I will also speak to the proposed deletion of Clause 15 from the Bill. Rather unusually, I would prefer that Clause 15 were removed from the Bill altogether than that the Government accept the amendment in my name and that of the noble Baroness.

Given the widespread concern outside this House that the noble Lord, Lord Watson, has already mentioned, we need to understand much better than we do at the moment why the Government are so keen to have this sweeping power in Clause 15. I find the underlying premises of Clause 15 extremely strange—even more so than when I spoke about the clause at Second Reading. First, the clause seems to presuppose that in some way legislation is blocking the delivery of good quality children’s services. There was an opportunity to explain these alleged blockages in the Minister’s latest document, Putting Children First but, on a quick read, I cannot see that that opportunity was taken except for some rather generalised remarks about testing “deregulatory approaches” and a quote from Professor Eileen Munro about “unnecessary legal rules”. But my understanding is that in her review of child protection, Professor Munro was not arguing for changes in primary or even secondary legislation, but for amendments to statutory guidance. Will the Minister clarify what the primary and secondary legislation blockages are, preferably in writing to all members of the Committee before Report?

To compound the confusion, I understand that the Government have already used existing statutory power to amend statutory guidance following the Munro review by issuing directions to particular local authorities. Ofsted’s annual report shows local authorities adopting innovative practice without the need for changes in legislation. Moreover, as the noble Lord, Lord Watson, mentioned, the Government’s very own Red Tape Challenge, as it was called in 2014, seems to have revealed very little to remove for children’s services. Again, will the Minister clarify that, preferably in writing? So far, the Government have produced no evidence that primary or secondary legislation is impeding innovation in children’s services. They already have plenty of scope for amending statutory guidance or issuing directions to particular local authorities without the wide-ranging power to repeal or modify children’s social care requirements in Clause 15 that would last, I understand, for at least six years.

One is entitled to be a little suspicious about what the Government are really up to with Clause 15. Of course, I am the sort of chap who takes for granted that Ministers are well intentioned when they bring measures before your Lordships’ House, but could it be that what lies behind this provision is a short-cut way of outsourcing whole chunks of services? Ofsted seems to be claiming that up to 25% of children’s services are inadequate. Rather than working with some external turnaround capacity to improve matters, is there a new-found enthusiasm within DfE for trying to get quicker results by removing legislative impediments to outsourcing?

Personally, I have no particular objections to outsourcing if that can be shown to have a beneficial effect for children after trialling. I have been trying to probe what the DfE is up to with the transfer of children’s services to trusts. On the answers that I have received, this is clearly an expensive process, it can be very time-consuming, accountability can become extremely blurred and at present there is no body of evidence to support it as a general remedy for failure. Moreover, the DfE has still to publish the report that it commissioned in 2014 from LaingBuisson into developing capacity and diversity in the provision of children’s services. I know from my involvement in that work that it did not suggest that creating a market in children’s services would be easy.

I turn briefly to Amendment 130, which would require the Secretary of State to set up an independent review panel to consider whether any exemptions or modifications under Clause 15(2) are likely adversely to affect the legislative safeguards or rights of children approved by Parliament and to consider the published advice of such a panel before acting. I consider this the least that we should do if the Government persist in proceeding with Clause 15. To sum up, we need much more transparency and clarification from the Minister on why the Government need Clause 15 and why they cannot use their existing powers of direction and statutory guidance to secure their espoused innovation objectives.

[Baroness Walmsley]

My Lords, I support the noble Lord, Lord Warner, in arguing for this amendment. If these clauses eventually remain in the Bill, which is in considerable doubt, although I will leave it to my colleagues to argue that case, it is vital that children’s rights and entitlements are not diminished in the process. These clauses, to my mind, fundamentally undermine rights that have been enshrined in children’s social care legislation following intensive debate in Parliament. They are to be removed at our peril. However, given that some local authorities have seen an 82% increase in the number of children in need between 2010 and 2015, at the same time as local authority budgets have continued to decrease, there is a danger that these new powers might be seen as a way to save money. However, undermining children’s basic rights should not be the penalty for innovation. Many local authorities have vastly improved the service that they give to vulnerable children by trying new things without seeking any exemptions from the children’s rights.

The noble Lord, Lord Warner, mentioned Professor Eileen Munro. He is quite right that she never suggested that we needed to repeal primary or secondary legislation; she just asked for less onerous guidance. Innovation has been done effectively through waiving statutory guidance in some authorities. Importantly, outcomes have been monitored and reported on and it is from such reports that lessons are learned. That is the way forward.

I question the necessity for this part of the Bill. In particular, I want to ensure that the Secretary of State can be assured by independent experts that the benefits to children’s rights will be greater than the risks. The key word here is independent because, according to the Bill, the only people who have to be consulted are the Chief Inspector of Schools and the Children’s Commissioner. I point out that both of them will already have been appointed by the Secretary of State. Although I have every respect for the current incumbents of those offices, we need more independence than that. That is why I support this amendment. Innovation should be encouraged within a framework of fundamental rights and entitlements within the law.

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[Baroness Walmsley]

Before the Minister replies, would he reflect on the fact that those of us who came to the meeting last Thursday were given what the noble Lord, Lord Hunt, is asking for—three examples of where local authorities would have liked exemptions—and that we were not convinced by any of them? In every case, we could think of another way in which that difficulty could have been got around by a creative local authority in order to produce better outcomes for children, and of course there is no other excuse for doing it. We really were not convinced.

[Lord Warner]

I really must help to reinforce this message to the Minister, because from what he has said so far he does not seem to get it. What we need, in writing, are the primary and secondary legislation blockages that are stopping innovation and why in those cases you cannot use the Secretary of State’s power of direction or an amendment to the statutory guidance. That is the issue, and he has not come anywhere near tackling that proposition.

Children and Social Work Bill [HL]

Debate between Lord Warner and Baroness Walmsley

Wednesday 29th June 2016 Grand Committee

[Baroness Walmsley (LD)]

My Lords, I have Amendment 18 in this group, which adds wording about protecting safety and providing stability in home lives, relationships and education or work. It is very similar to the wording in proposed new subsection (1)(f) in Amendment 1, moved by the noble Baroness, Lady Howe.

Coincidentally, I also submitted the same amendments as the noble Lord, Lord Ramsbotham, to remove “have regard to the need” and the other amendments he referred to that follow from that—so of course I have added my name to those.

I wholeheartedly agree with the noble Lord, Lord Bichard—who would have been able to speak for himself if we had met on Monday as originally planned—that the whole point of setting out the corporate parenting principles explicitly is to make the responsibility explicit. That is most likely to be achieved if the drafting is as clear as possible. The inclusion of “have regard to” detracts from that clarity. It also changes the nature of the duty: it is no longer to encourage people to do something but to “have regard to” encouraging people to do something. How pathetically weak and feeble. I could have regard to something but decide to do nothing as a consequence of my regard. That will not do.

We need a set of corporate parenting principles that protect all those things that contribute to the health, well-being and future opportunity of children in care and those leaving care. That is why my Amendment 18 adds the principle of protecting their safety and providing stability in their home lives, relationships and education or work.

Children in care who are abused will be damaged for ever if we are not very careful. That is why we need to keep them safe. Children who are moved around from one foster placement to another and have no stability feel insecure and cannot keep up those relationships that help them to know who they are and their place in the world. The people they value and who value them are so important to their sense of self-worth and their attainment in life.

The Education Select Committee found that health services are turning away children in care who do not meet diagnostic thresholds. Access to services is prohibited when children do not have a permanent address. They experience moves in care, moves from one foster parent to another—or, even worse, moves out of their area. Problems include registering with a GP and poor communication between local authorities and clinical commissioning groups.

Designated health professionals report that they have not been asked to contribute to the strategic planning of services for these children, and some others felt that there were no robust routes for contributing to commissioning processes and decision-making.

Stability at home, school and in relationships is vital for these children and should be included in the principles. It is very important that the legislation is clear, so that those affected are in no doubt what their responsibilities are. The only people who benefit from confused or over-elaborate drafting are the lawyers. As drafted, Clause 1 is confused, and we must try to clarify it during the course of our deliberations.

Many noble Lords are seeking to add important additional principles, including my noble friends Lady Tyler of Enfield and Lady Bakewell of Hardington Mandeville. Their amendments on mental health and poverty alleviation will come later, and I support them wholeheartedly. But the point I am making is that these amendments, and others, would be to no avail if the principles just had to be regarded and not strictly adhered to. So I say to the Government: if you really believe in these principles as drafted—and, I hope, as amended by several important additions from me and others—please accept that the words “have regard to the need” must go.

[Lord Warner (Non-Afl)]

My Lords, I am probably one of only three people in this room who has actually been a corporate parent. Having worked in a local authority, I know that if you put wording in a Bill that says “have regard to”, the chief officer, who may want to do the right and proper thing by these children, will be put in a spot of bother. If a local authority and its lawyers see “have regard to”, they will have a conversation with the chief officer which will start: “Do you really have to do this, if the financial situation is tough and bad?”.

Cities and Local Government Devolution Bill [HL]

Debate between Lord Warner and Baroness Walmsley

Tuesday 21st July 2015 Lords Chamber

[Lord Warner (Lab)]

My Lords, before speaking to this amendment tabled in my name and those of the noble Baroness, Lady Walmsley, and the noble Lord, Lord Patel, let me declare my interest as an adviser on health and care to Capsticks Solicitors.

This is the last time that the Minister will have to listen to me banging on about the NHS, which is no doubt a cause for celebration in DCLG. The amendment brings us back to the issue of safeguards for the devolution of NHS functions. Our earlier discussions on this issue have tended to generate more heat than light, and I think the problem lies in the fact that the Bill was never designed for the devolution of NHS functions. It is a Bill for devolving essentially local government functions away from central government. It is not designed for devolving functions from a 67 year-old iconic National Health Service, with a large number of statutory duties placed on a Minister, supported by a bevy of national bodies and requirements, and strong public expectations of adherence to national standards and rules. So far, the Government have struggled to come up with a formula that reconciles the centralised characteristics of the NHS, which is held in great public affection, with a move towards the greater devolution of the delivery of health services and health service functions that many of us would like to see.

Let me reiterate that I am not opposed to using the Bill for devolving NHS functions to properly accountable combined authorities or new public bodies. I just want the Bill to contain clear safeguards which recognise that some essential national characteristics of the NHS should continue to function. I do not think it sufficient, as many of us have tried to explain to the Minister, to use individual transfer of function orders to reserve certain functions to the Secretary of State. That pays insufficient attention to the statutory NHS duties placed on the Secretary of State for Health that he simply cannot offload on to other bodies. At the same time, as we have said before, it is an approach that is likely to fragment the national, cohesive nature of the NHS, leading to a ragbag of local devolution arrangements.

I have tried to distil from our earlier discussions a short clause setting out the three health service issues that have to retain national characteristics. First, the Health Secretary,

“must remain able to fulfil all the statutory duties placed on him under health service legislation”.

That has simply not been clear from the Government’s explanations. In framing this provision, I have been much helped by the contribution of the noble and learned Lord, Lord Mackay of Clashfern, in our previous discussions.

The second issue is to stop the transfer of,

“regulatory or supervisory functions vested in national bodies”.

This goes wider than the prohibition of transferring regulatory functions in Amendments 3 and 4 that the Government have now introduced. The natural character of the NHS means that there are bodies that can be both regulatory and supervisory. For example, Monitor is not just a regulator but a supervisor of failing trusts. CQC is both a regulator and, I would suggest, a service improvement agency. There are other national bodies that make NHS services safer for patients without being full-blown regulators within the terms of Amendments 3 and 4. If anyone thinks the NHS does not need national supervisory bodies, they should read yesterday’s Healthwatch report on hospital discharges.

The third prong of my amendment requires the Health Secretary to,

“ensure that … bodies to whom health service functions are transferred adhere to the national service standards and the national information and accountability obligations placed on all health service bodies”.

That is particularly important for patient access to information and exercising their freedom of choice over service access outside the area of a combined authority.

I am grateful to the clerks in the Public Bill Office for their technical help in framing this amendment, and to colleagues for their assistance in drafting it. I have also been assisted in pursuing this matter by briefings from the BMA—I often do not take credit for advice from the BMA—NHS providers and the specialist services commissioning group.

The Bill needs an override provision such as this if the essentially national character of the NHS is not to be lost. I hope the Minister agrees that it needs to be in the Bill as part of this House’s scrutiny of the Bill. I beg to move.

[Baroness Walmsley (LD)]

My Lords, I do not think that I need to say very much because this amendment has been very ably introduced by the noble Lord, Lord Warner, but I do support it. I thank the Minister for introducing Amendments 3 and 4 today because they address part of the concerns we have had. However, many concerns remain, regarding accountability, information service standards and, of course, supervision. There are many functions that would never be appropriate to devolve to a local authority, such as the duty to ensure a supply of appropriately trained personnel in the health service, a matter for which Public Health England—which is answerable to the Secretary of State—has responsibility. It would never be appropriate to devolve those functions, and there are many of them. The noble Lord, Lord Warner, has crafted a very clear statement of what is required. Although the noble Baroness did her very best on Report to assure us that the Government share this amendment’s intentions, we need the amendment on the face of the Bill. Legislation needs to be clear, and that is what this is.