Health Service Medical Supplies (Costs) Bill

Debate between Baroness Wheeler and Lord Warner

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

[Baroness Wheeler]

My Lords, this important group of amendments to Clauses 6 and 7 covering England and Wales is intended to reduce the scope of the burdensome information requirements under the Bill by excluding medical technology and supply sectors from its provisions. The Bill itself is inconsistent throughout on how it refers to this key part of the industry, variously referring to the producing of medical supplies, of health service supplies or of health service products. This gives fuel to the widespread assumption that the medical supplies parts of the Bill were a hastily drawn-up afterthought addition to its main purpose.

Our amendments in this group—excluding Amendment 19—remove all references to “health service products” in these clauses and substitute the “health services medicines” reference consistent with the other parts of the Bill applicable to the pharmaceutical industry. Despite extensive questioning and probing of Ministers by noble Lords and in the Commons and today’s explanation from the Minister in our earlier debates we have still to hear any evidence-based justification for these heavy-handed information and disclosure requirements. Both the ABPI and the ABHI have voiced strong concern at the onerous information requirements under the Bill and draft regulations and the potentially huge impact on SMEs across both sectors.

We were encouraged at Second Reading when the noble Lord, Lord Prior, in response to the widespread and deep concerns put forward, told us that,

“the last thing in the world we want to do is to build a bureaucratic edifice … or to gold-plate regulations, information requirements and the like … we are absolutely open to all ideas and suggestions on how we can reduce the regulatory and bureaucratic requirement on companies that supply the NHS”.—[Official Report, 21/12/16; col. 1685.]

Just to remind noble Lords—a point underlined earlier by my noble friend—the Bill currently requires,

“a person who manufactures, distributes or supplies any UK health service products”,

and in England it is applicable to,

“any medicinal products used to any extent for the purposes of the health service continued under”

proposed new Section 264A(1),

“and any other medical supplies, or other related products, required for the purposes of that health service”.

In other words, millions of products and thousands of small, medium, large and very large businesses.

Within Clause 6, information may be required on:

“the price charged or paid by the producer for products … the price charged or paid for delivery or other services in connection with the manufacturing, distribution or supply,”

of those products,

“the discounts or rebates or other payments given or received … in connection with the manufacturing, distribution or supply”,

of those products and,

“the revenue or profits accrued … in connection with the manufacturing, distribution or supply”,

of these products. These are the current draconian provisions and the only response so far to the Government’s insistence that they are open to ideas and suggestions is to promise to consult the medical supplies sector after the legislation has been passed.

We will not go into the issue of the dreaded Section 260 of the 2006 Act, which already contains powers to get price control and information powers over the companies concerned, but we have still to hear a convincing argument as to why it cannot be used as a basis for seeking any further information that is required. We are told that the new provisions clarify, modernise and streamline and now, in the noble Lord’s words, “make the provisions much clearer than they currently are in the 2006 Act”, but Ministers have still to explain exactly how this is the case.

To remind the Committee, the impact assessment makes the astonishing admission that the costs of these provisions have not been quantified for manufacturers, wholesalers and dispensers. Can the Minister tell the Committee whether any further work has been done on this? Surely proposals that stand to impact tens of thousands of businesses should be part of the evidence base before the Government decide to proceed with legislation? It is crucial that the Government accept our amendments and delete the medical supplies industry from the scope of Clauses 6 and 7; only then can they have the meaningful consultations with the industry that should have taken place before the introduction of the Bill. As noble Lords have underlined, it is not acceptable for Ministers to seek to change primary legislation to give the Government new information powers when the details and impact of the new powers will emerge only in future.

Finally, Amendment 19 in this group seeks to address the huge burden that the new information requirements will place on thousands of small businesses across the country. Bearing in mind that the Government have done no work on the potential impact on SMEs, this amendment would at least introduce a threshold limiting the businesses affected to those companies with a total workforce of more than 250 employees or with annual revenues of more than £50 million in each of the preceding three fiscal years prior to the information request. This is based on the EU threshold in relation to procurement. However, given our upcoming withdrawal from the EU, it seems sensible to specify a roughly equivalent amount in pounds. The value of the pound is, of course, currently subject to ongoing fluctuations. If the Government are inclined to act on this amendment, the Minister and his colleagues may wish to give some thought to an exact figure ahead of Report.

The potential impact of the proposed powers on SMEs is significant and could come with a significant unseen cost to domestic businesses and, as a result, to patients. A small firm such as Mediplus, with 55 employees and a turnover of approximately £6.5 million, already has to meet a range of requirements to demonstrate that it is providing value for money. The Bill would increase the time and cost of demonstrating compliance with regulations without any discernible improvement in final outcome. Increasing the bureaucratic burden on SMEs could force firms to consider how they bring products to market, which could have only a negative impact on the NHS and its patients.

The Government have indicated that they would exempt businesses with a turnover of approximately £5 million. The noble Lord will appreciate that, although that sum sounds large, it is very little in comparison with the revenues of the larger pharmaceutical firms which the Bill aims to regulate. The Government’s proposed exemption will still subject a company such as Mediplus to an increased regulatory burden. As noble Lords keep pointing out, all this is completely counterintuitive, given the Government’s supposed commitment to deregulation, and can only risk the viability and innovative streak of very small businesses, which we should be supporting in the current climate. I beg to move.

[Lord Warner]

My Lords, I have added my name to the set of amendments and strongly support what the noble Baroness, Lady Wheeler, said.

The Minister is new to this legislation. He has joined the party a little late on the Bill. I ask him to stand back and look at some of the terminology used in it. It skips lightly through about four different terms: health service medicines, medicinal products, medical supplies and health service products. It zigzags in and out of those terms throughout the Bill. It then gives a set of definitions at the end which, on the most generous interpretation, overlap with each other. So we are imposing new obligations on a whole set of people in and around the NHS and the pharmaceutical industry without being very clear which group of products we are most concerned about. We are taking powers in the Bill to put obligations on all suppliers of those products to keep a lot of information in case the Government should at some point in future call on them to provide it. That does not seem to me a sound basis on which to legislate when we are trying to reduce the regulatory burden on not just small but medium-sized companies. We always talk about the small companies, but Amendment 19 is useful because it involves reducing the burden on medium-sized companies as well.

The impact assessment then adds to the problem by giving no idea of the impact of these provisions on those companies. At least these amendments narrow the focus to where there is an acknowledged problem—medicinal products—which is where the Bill started. If you read the Long Title, it looks as though it started as a Bill about medicines to which someone has tacked on “and related issues”, or similar words. I suspect that the Bill started off trying to deal with a genuine problem but has grown just in case it might be helpful to have some other provisions. Then, to add unnecessary complexity, it has moved around on what products are to be covered to the point where we are putting obligations on a very large number of organisations in case the Government come calling for information.

That is why I shall return to this subject when we come to Amendment 33, which tries, at the very least, to put some obligation on the Secretary of State to show that he has good reason for requiring the information sought in this Bill. That is a debate for another day, but the Minister should look very carefully at whether the Bill has a confusing set of definitions and a use of words that is going to cause a lot of confusion for the world outside.

Care Bill [HL]

Debate between Baroness Wheeler and Lord Warner

Tuesday 16th July 2013 Lords Chamber

[Lord Warner]

My Lords, I rise briefly to support the amendment of my noble friend Lady Pitkeathley. As someone who has spent six years in the local authority salt mines, I say that one should never underestimate the capacity of any local authority, when times are hard, to scratch around for things by which they can raise some money—I say this with affection. If there is a scintilla of doubt in this legislation about the ability to charge carers for services, we should remove it immediately. Otherwise I would be willing to bet a reasonable sum of money that when there is a financial crisis in some part of the country at some point in the future, a bright spark in a local authority will light upon the chargeability of carers for particular services. I am not sure whether my noble friend’s wording is the right way of doing this, but her intention is absolutely right. I hope that the Government will take this issue away and make sure that this particular piece of legislation is totally fireproof in terms of the ability of local authorities to charge carers for services.

I also support the amendment of my noble friend, Lord Lipsey. Evidence was given repeatedly to the Dilnot commission about the distressed state that many people were in when they made key decisions about their family’s circumstances. I suspect that he is on to something important that affects quite a lot of people.

[Baroness Wheeler]

My Lords, these amendments under Clause 14 deal with the difficult area of charging for the care and support that we have established is required through assessment. The historic settlement of charging for social care but not for healthcare is being increasingly challenged and the obviously linked issue of funding for social care is ever present, as we have been reminded in today’s debates.

The common agreement about charges is that they should be fair and that the process for means testing should be as simple and as unintrusive as we can make it. Fairness in the eyes of the public means no postcode lottery, but the excellent work by my colleague Liz Kendall, our shadow Care Minister, has shown just how stark the variations are across local authorities today. This is something that we need this Bill to address. Why should charges for the same service be allowed to vary so much? This is seen as unfair and it is. I will be interested to hear from the Minister about this variability of charges and what actions the Government are taking to address it.

For many older people, claiming for any kind of help is hard. We need a system that is easy to use and we could do far more to integrate the various bureaucracies to minimise form filling and document checking and having to repeat the same information over and over again. We could use income information from the Inland Revenue, for example, and we could unify all assessment frameworks and use passporting of entitlement to minimise bureaucracy and administration costs. Much of the detail is for the future in the regulations, but this is our opportunity to remind ourselves of key principles, such as fairness and simplicity, that should shape those regulations. Can the Minister tell us when the draft regulations relating to Clause 14 and charging will be published?

When they are published, the regulations themselves will inevitably be complex and disputes are likely. Dispute through judicial review or the courts is not the way. Will the Minister explain why there appears to be no response to appeal or conflict resolution processes contained in this part of the Bill? Why do many of the decisions made under provisions in Part 1 seem not to have some mechanism of appeal attached to them? The appeals system should be fair, easy to access and independent. Does the Minister acknowledge that this is needed?

On the specific amendments in the group, my noble friend Lady Pitkeathley has provided an excellent explanation of the importance of her two amendments, Amendments 89A and 89B. As usual, it is very hard to find anything additional to say when it comes to carers and carers’ rights after she has spoken. It is right always to underline our support for the provisions in the Bill providing statutory rights for carers, but there are still areas of concern that need to be addressed relating to means testing and local authority care charges, and the widespread fear among carers about charges as local authorities become increasingly strapped for cash.

Health and Social Care Bill

Debate between Baroness Wheeler and Lord Warner

Tuesday 13th December 2011 Lords Chamber

[Lord Warner]

My Lords, I also support the amendment of the noble Baroness, Lady Greengross. I do so from the perspective of someone who as a special adviser was involved in the framing of the Human Rights Act in 1998. At that time, much of the thinking in the devising of that Act was on the basis that publicly funded services were pretty much synonymous with public delivery of those services. Much of the language around public functions and public authorities was based on that assumption. In fact, that was already out of date at that particular time. Since then, we have never really put this point beyond doubt in legislation. It is timely to do so now, when so many of the services in people’s own homes are contracted out by public bodies to voluntary and private providers. It is a lacuna in the arrangements, despite some of the assurances given by Governments of both persuasions since the Human Rights Act 1998.

[Baroness Wheeler]

I also support Amendment 295G from the noble Baroness, Lady Greengross, replacing the similar amendment from the noble Baroness and the noble Lord, Lord Low, both of whom have argued the case strongly and convincingly on this matter.

The importance of addressing current loopholes in the application of the Human Rights Act to publicly funded healthcare and home care services is underlined by the scale of the legal anomaly that the amendment seeks to address. As we have heard, almost 500,000 older people receive essential care in their own homes provided by the local authority. Some 84 per cent of them lack the protection of the Human Rights Act because their care is provided by private or third sector organisations, or independently by 150,000 self-employed personal assistants who care for people in their homes through the application of personal care budgets or direct payments.

The noble Baroness’s own work in highlighting the inadequacy of at least 50 per cent of the home personal care received by older people as part of her recent inquiry underlined the prevalence of human rights abuses in home care settings. The report makes painful reading for all who want dignified and appropriate standards of care for older people in their homes. The stark reality is that, if their human rights are violated through inappropriate standards of care, they at present have no direct legal redress against their care providers.

Of course, we need to make the caveat that good practice is often exemplified by the private and voluntary sector. As a carer, the care provided by the private sector agency to the person I care for at home is of good quality and the care support workers are committed and dedicated professionals, despite long hours and low pay. Their care for the person that I care for is not covered by the Human Rights Act but would be if he were in residential care. That is a serious anomaly. I hope that the Minister will be able to reassure us that the Government recognise that this is a major problem and will take the opportunity presented in the Bill to address the matter. With an increasing number of people receiving home care from a private or voluntary sector organisation rather than directly from their local authority, there is a vital need for certainty around the application of the Human Rights Act to these care providers.

I was going to comment on four other amendments but none of them was spoken to so I will leave it at that.