Health and Care Bill

Lord Sharkey Excerpts

Lords Hansard - Part 1 & Report stage
Monday 7th March 2022 Lords Chamber

Moved by

[Lord Sharkey]

126A: Clause 151, page 117, line 40, leave out subsection (3) and insert—
“(3) In section 1, omit “an EEA state or Switzerland” and insert “a relevant state or territory”.(4) In subsection 2(1)(b) omit “an EEA state or Switzerland” and insert “a relevant state or territory”.(5) In subsection 2(2) after (i) insert—“(j) make provision to make payment (otherwise than under a healthcare agreement) in respect of healthcare provided in a relevant country or territory, but only when the Secretary of State considers that exceptional circumstances justify the payment and has laid before Parliament the reasons for such consideration and the details of the payments;”.(5) Omit subsection 2(7).(6) After section 2 insert—“(2ZA) Regulations under section 2 may—(a) confer functions on a relevant public authority or a Scottish or Welsh health board (including discretions);(b) provide for the delegation of functions to a relevant public authority or a Scottish or Welsh health board.(2ZB) The Secretary of State may give directions to a person about the exercise of any functions exercisable by the person under regulations made by virtue of section 1 (and may vary or revoke any such directions).””

[Lord Sharkey (LD)]

I shall speak to all the amendments in this group. I am very grateful to the noble Baronesses, Lady Brinton and Lady Thornton, for their support. All the amendments in this group address Clause 151. The purpose of this clause is to enable the Secretary of State to implement reciprocal healthcare agreements with countries other than the EEA states and Switzerland, where we already have such agreements. These agreements were provided for by the Healthcare (European Economic Area and Switzerland Arrangements) Act 2019. This Act was the subject of intense debate as it passed through this House. Noble Lords approved the inclusion in the Act of explicit constraints on the powers of the Secretary of State to make such agreements. This ensured that wider and different purposes, such as privatisation, could not be included. I make it clear at this point that we strongly support the intention to extend the geographical range of reciprocal healthcare agreements.

--- Later in debate ---

[Lord Sharkey (LD)]

My Lords, I am very grateful to the Minister for the comprehensive way she addressed the various anxieties about Clause 151. I am reassured by her clear statement that the purpose of the 2019 Act, as amended in this Bill, is not to implement trade deals, and by her equally clear statement that reciprocal healthcare agreements do not relate to the commissioning and provision of services for the NHS. I heard the Minister say that Clause 151 actually narrows the power given under the 2019 Act and explained how this was so. I am grateful for that explanation too. I am even more grateful that all the regulations produced by Clause 151 will now made under the affirmative procedure. On that note, I beg leave to withdraw the amendment.

Amendment 126A withdrawn.

Health and Care Bill

Lord Sharkey Excerpts

Lords Hansard - Part 1 & Report stage
Tuesday 1st March 2022 Lords Chamber

[Lord Hunt of Kings Heath (Lab)]

My Lords, as this is my first contribution on Report, I declare my interests as a member of the GMC board and president of GS1, the British Fluoridation Society, the HCA and HCSA.

I welcome what the Minister said about research and its importance, and some of the tensions between practical work as a clinician and the crucial importance of clinicians engaged in research. The amendments that he introduced are very welcome, but like the noble Baroness, Lady McIntosh, I am disappointed that he has not brought similar amendments forward in relation to NICE. One suspects that it is something to do with money; he thinks that giving away amendments on research is cost-free, whereas there might be a resource implication when it comes to NICE. That is a pity.

The noble Baroness has talked about a postcode lottery in this country on the outcome of NICE judgments, but we also have a European postcode lottery. The fact is that NHS patients have much less access to modern new medicines and devices than those in many other countries. Stats that I have seen on medicines suggest that, for every hundred European patients who can access new medicines in the first year they are available, just 15 UK patients have the same access. We know that even when NICE has given its blessing to new medicines and treatments, take-up in the NHS still lags behind that in other countries.

I think that the noble Baroness, Lady McIntosh, and I were somewhat puzzled by the ministerial response in Committee in this area. We know that the NHS uses all sorts of rationing devices to prevent those new medicines and devices being allocated generally throughout the NHS, notwithstanding what NICE has to say—that is why I support the noble Baroness’s amendments. Essentially, my two amendments seek to build on the principles that she has referred to.

Amendment 171 relates to three issues which I think remain from Committee. The first relates to the links between licensing and reimbursement processes. Happily, the MHRA has established two new licensing pathways, ILAP— the Innovative Licensing and Access Pathway—and Project Orbis, for cancer medicines. This is very welcome; it is designed to speed up access.

However, the challenge with faster licensing decisions is that NHS reimbursement decisions need to speed up too, otherwise medicines can be placed on the market but cannot be made available to patients on the NHS. To its credit, the MHRA has designed this into ILAP, because NICE is directly involved in ILAP, and licensing and reimbursement decisions can be joined up. However, in respect of Project Orbis, there has been no such effort. Late last year, breast cancer patients faced the worrying situation where a drug, Trodelvy, which offered them hope, was licensed through Orbis but was not then available on the NHS. My amendment would therefore ensure that NICE acted to issue guidance on Project Orbis medicines as close to licensing as possible, as it does for ILAP.

Secondly, the amendment would clarify that NICE alone is responsible for determining its methods, as an independent body should be. In its recent methods and processes review, it concluded that

“there is an evidence-based case for changing the reference-case discount rate to 1.5% for costs and health effects. However, because of the wider policy and fiscal implications and interdependencies that are beyond the reach of this review, no change to the reference-case discount rate”

could be made. It further stated:

“Reducing the discount rate will make most technologies appear to be more cost effective.”


We are therefore in a situation where NICE wants to make a change to its methods, which would result in more medicines being made available to patients but is being stopped from doing so. That is not acceptable. NICE should be free to determine its methods, including the discount rate.

The final effect of the amendment would be to clarify the role that the current voluntary scheme, VPAS, and the statutory scheme play in reimbursement decisions. These schemes essentially cap the NHS’s expenditure on drugs, meaning the exposure of the taxpayer to spending on drugs is limited. The problem is that the health service then adds a whole host of other mechanisms to restrict access to medicines as well. My own view is that once we have VPAS and the statutory scheme in place, we do not need those other mechanisms.

Amendment 178 builds on this. I have already referred to the Project Orbis scheme. It has great potential, but unfortunately, as Gilead has pointed out, there is a lack of alignment across the system between government, the MHRA, NICE and NHS England, which has an impact on timelines for approval. This is particularly concerning in light of moves by other countries such as France to legislate to enable early access to innovative therapies prior to a cost-effectiveness assessment, with any difference in the final agreed price rebated by the company. We need an integrated access and funding pathway for medicines licensed by Orbis, prior to NICE approval, modelled on the French system, whereby companies rebate any difference in price following the decision by NICE.

The final point I will make is that we also need to deal with NICE capacity issues. In January 2022, NICE highlighted in its board papers that approximately 20 evaluations were paused in 2021-22 due to capacity constraints because of vacancies. This is despite increased industry fees paid for health technology assessments. While NICE’s vacancy rate has reduced, the same board papers note that:

“Organisational capacity continues to be the key risk for NICE ... strategy, and gaps in hard to fill specialist roles in a competitive global market.”


I would like the Minister to respond to this.

More generally, I hope that the Minister can give us some assurance that he and other Ministers recognise that all these initiatives to speed up access, excellent though they are, will come to very little unless they can sort out the NHS side of things and get rid of some of these rationing mechanisms which have been put in place.

[Lord Sharkey (LD)]

My Lords, like the noble Lords, Lord Patel and Lord Kakkar, I have added my name to the government amendments in this group. These amendments directly address the criticisms which we made in Committee that, as things stood, a duty to promote research lacked any real force. Since we made these criticisms, we have met with the Minister and his officials to try to strengthen this research duty and make it more meaningful and concrete. These amendments, and the others in the next group, are the result of our discussions.

The Minister has explained, and given some examples, how they would help. The importance lies on what new things the amendments put in place. They require the NHS to explain, in its business plans and annual report, how it proposes to discharge, or has discharged, its research obligations. They also require a performance assessment of ICBs, which includes how well they have discharged their research duty and their duty to facilitate and promote the use of evidence in research. I thank the Minister and his team for their extensive engagement on the question of research in the NHS. I am pleased that we have strengthened the research duties of the Secretary of State and the ICBs. I am particularly pleased that progress will now be formally reported and assessed.

I should also mention that, in his letter of yesterday, the Minister listed a number of non-legislative measures either being taken or developed for facilitating or fostering a culture of research within the NHS, and for holding to account the people responsible for delivering this.

Finally, the noble Lord, Lord Patel, has asked me to say how sorry he is that he cannot be here today. He wanted the House to know that he supports the Government’s research amendments and is grateful for their co-operation in generating more research in the NHS. As the noble Lord, Lord Kakkar, has said, he is at home recovering from Covid, and I am sure that the House wishes him a speedy recovery.

[Lord Kakkar (CB)]

My Lords, I remind noble Lords of my own declarations of interests made in Committee: I am chairman of the Office for Strategic Coordination of Health Research, chairman of the King’s Fund and chairman of King’s Health Partners. In so doing, I make particular reference to the King’s Fund, since the Minister, in closing the last group of amendments, indicated the contribution to discussion which the fund has made with regard to the questions of inequalities.

I strongly support the amendments on the question of research that have been put by Her Majesty’s Government, and so ably and thoughtfully presented and introduced to your Lordships’ House by the Minister. The noble Lord, Lord Sharkey, has summarised why this is so very important. Ultimately, a research culture needs to be promoted at the heart of the NHS, and these amendments go a long way to achieving that clear objective.

There is so much by way of other initiatives that Her Majesty’s Government promote on the funding of research and support to bring together different parties to drive the broader life sciences agenda. However, ultimately, this all depends upon an NHS which is strongly supportive of, and facilitated to deliver, that research. Without this commitment, there was a very real risk that, with the other priorities that the NHS is inevitably required to pay attention to, the need to promote and facilitate research would be lost.

In facilitating research, NHS organisations, the Secretary of State, the NHS board and integrated care boards will have to pay attention to not only the facilities provided but the attendant workforce questions, ensuring that a workforce is properly prepared and able to engage in the research agenda, that progress in that regard is properly reported and that the full benefits of a research culture and the output of research are available to patients throughout our country.

Health and Care Bill

Lord Sharkey Excerpts

Lords Hansard - Part 2 & Committee stage
Monday 31st January 2022 Lords Chamber

[Baroness Brinton (LD) [V]]

My Lords, along with the noble Baroness, Lady Thornton, and other noble Lords, I was involved in the passage of the Bill that started off life as the Healthcare (International Arrangements) Bill, and which, by the time it was passed, had been renamed the Healthcare (European Economic Area and Switzerland Arrangements) Bill—a name almost as long as the Bill itself, and after some of the worst Henry VIII powers had been removed, including the power of Ministers to sign international trade agreements that could include preferential access to NHS contracts without the formal scrutiny and decision-making powers in Parliament.

The frustration with the remote arrangements is that I am speaking before my noble friend Lord Sharkey. I know that he will speak about the delegated powers in Clause 136. I wish I could hear his contribution before I speak, but I want to say that it seems the Government have forgotten, in nearly three years, the roasting that they got from your Lordships’ House during the passage of the Healthcare (International Arrangements) Bill. The noble Lord, Lord Wilson of Dinton, said:

“The sweeping nature of the powers proposed in the Bill are in many ways offensive to the proper conduct of legislation. I accept that they are needed in the current situation in relation to the EU and Switzerland, but to go wider than that is wrong, I think. We have to insist on legislation being properly prepared, properly debated, properly scrutinised and properly consulted on.”—[Official Report, 12/3/19; col. 926.]


The then Health Minister, the noble Baroness, Lady Blackwood, when conceding on those Henry VIII powers later that day on Report, said:

“I want to be clear that the consequential Henry VIII powers were initially included as a future-proofing mechanism. They were never free-standing and we had envisaged using them in only a limited set of circumstances … we want to alleviate any fears that we are taking powers which are not absolutely necessary in this Bill. As such we are prepared to take the significant step of removing the entire Henry VIII consequential powers in Clauses 5(3) and (4).”—[Official Report, 12/3/19; col. 963.]


One of the reasons that your Lordships’ House is so concerned is that it looks as if the provisions in that Bill are being resurrected in Clause 136 of this Bill. I will give two brief examples: “2 Healthcare agreements and payments” on page 110 of the Bill, among other clauses, gives the Secretary of State the powers to make a healthcare agreement with another country and for Parliament to only comment on it by the negative resolution. For those of us who worked on a previous Bill, that sounds horribly familiar. It also gives the Secretary of State the power to give directions to a person about the exercise of any function, which is familiar not only from that Bill but from other parts of this one.

In “2B, regulations under Section 2A: consent requirements” on page 112, it says at (5) that the consent of the Secretary of State is required for a

“healthcare agreement”

which means

“an agreement or other commitment between the UK and either a country or territory outside the UK or an international organisation, concerning health provided anywhere in the world”.

Any type of “agreement” or “commitment” brings us full circle back to the Healthcare (International Arrangements) Bill as first drafted. This would include international treaties, as was planned back in 2019, to include that access to providing major parts of healthcare in the NHS, but without the consent or knowledge of Parliament, because the detail of the agreement would not need be seen before it was signed, including by the NHS, its stakeholders and the staff who work in the sector.

Lest we think that this is just words, the Chancellor of the Exchequer and the Secretary of State for Health and Social Care have both talked extensively in America to healthcare providers in recent months. What is different about this clause is the breadth of definition of a healthcare agreement, the powers that are held only by the Secretary of State, and the total lack or paucity of consultation or scrutiny by Parliament and other stakeholders before the Bill came to your Lordships’ House.

Why has Clause 136 reinstated some of the key elements of the Healthcare (International Arrangements) Bill that were removed because Ministers recognised that the scope was too wide, the Henry VIII powers were egregious, and Parliament, the NHS and other stakeholders were being totally disregarded?

Should my noble friend Lord Sharkey wish to propose on Report that the clause do not stand part, I will support him.

[Lord Sharkey (LD)]

My Lords, as the noble Baroness, Lady Brinton, said, I have given notice of my intention to oppose the Motion that Clause 136 stand part. This clause is yet another example of the Government’s abuse of delegated legislation and the avoidance of any meaningful parliamentary scrutiny. It is also a clear and obvious breach of an important constitutional convention.

Clause 136 amends the Healthcare (European Economic Area and Switzerland Arrangements) Act 2019, which started off life as the Healthcare (International Arrangements) Bill, as we just heard. It would enable the Government to implement healthcare agreements with countries outside the European Economic Area and Switzerland. The exercise of the powers in this clause is through regulations subject only to the negative procedure. The department points to the 2019 Act as for seeking these powers, despite what we just heard from the noble Baroness, Lady Brinton.

During the passage of the then Bill in 2018-19, the Government justified or tried to justify taking the relevant powers as the need for speed and flexibility in the extraordinary circumstances of the EU withdrawal process. Parliament did not accept the provisions in the original Bill that the powers should be geographically and temporarily unlimited. After interventions by Parliament, the powers ended up being confined to the EEA and Switzerland and being sunsetted.

The department may be correct to state that the Secretary of State currently lacks the necessary powers to implement reciprocal healthcare agreements with countries outside the European Economic Area and Switzerland. However, this does not mean that there is currently no way to implement such agreements. They could and should be implemented by primary legislation. This would be in keeping with a long-standing constitutional convention that, outside the exceptional case of making provision for EU law, international legal agreements that make changes to UK law are given domestic force by an Act of Parliament. This ensures proper parliamentary scrutiny.

Our committees have pointed out breaches of this convention to the Government on several recent occasions. The last occasion was the proceedings of what was originally the Healthcare (International Arrangements) Bill, as I have just mentioned. Before that, the DPRRC commented on the breaches of this convention in the Professional Qualifications Bill in May 2021 and the Private International Law (Implementation of Agreements) Bill in March 2020. The Constitution Committee commented on the same Bill in its May 2020 report and concluded that:

“It is inappropriate for a whole category of international agreements to be made purely by delegated legislation.”


This is exactly what the Government are proposing in Clause 136.

The department does not address why such international healthcare agreements could not be implemented by primary legislation. We could try to remedy this abuse of delegated powers and breach of convention, as we did with the 2019 Act, by limiting their application and by sunsetting provisions. But, without a clearer understanding—or indeed any understanding—of exactly what agreements the department intends to use these powers for, it is not really possible to limit the power as we did then. The powers could also be sunsetted, as per that Act, but it is clear this would be inappropriate, given there is no longer a pressing time constraint on their use, unlike the then imminent departure from the EU. A better solution would be for the Government to abide by the constitutional convention and bring forward the appropriate primary legislation. That is the only way in which to enable any meaningful parliamentary scrutiny of these important reciprocal arrangements.

I look forward to the Minister’s explanation of why it is necessary to bypass Parliament and breach the constitutional convention in the manner proposed. I understand why it may be convenient, but cannot see why it is necessary or proper. We will certainly return to this issue as the Bill progresses.

[Baroness Finlay of Llandaff (CB)]

My Lords, I am most grateful to the noble Lord, Lord Sharkey, for that completely comprehensive overview of the problem with this clause. I simply have some questions relating to it. We have devolved powers in the devolved nations of the United Kingdom and, to my understanding, this clause does not oblige the Government to have undertaken a comprehensive consultation with them before entering into such an agreement. It does not seem to require legislative competence before such legislation is proposed, and that legislation certainly would not come before this Parliament anyway.

Health and Care Bill

Lord Sharkey Excerpts

Lords Hansard - Part 1 & Committee stage
Wednesday 26th January 2022 Lords Chamber

Moved by

[Lord Sharkey]

106: Clause 20, page 20, leave out lines 20 to 43

[Lord Sharkey (LD)]

My Lords, Amendment 106 is in my name and those of my noble friend Lady Walmsley and the noble Baroness, Lady Thornton. I am very grateful for their support.

Two months ago, two of our Select Committees, the DPRRC and the SLSC, published simultaneous and collaborative reports. The DPRRC report is entitled Democracy Denied? The urgent need to rebalance power between Parliament and the Executive, and the SLSC report is called Government by Diktat: A call to return power to Parliament. It would be very hard to exaggerate the importance of these reports, and I congratulate both committees on a very timely and disturbing reminder of the Government’s habit of trying to bypass Parliament and avoid effective scrutiny, as they do again in this Bill.

Both the reports focused on the long-standing abuse of the use of delegated powers legislation, and the DPRRC concluded:

“The abuse of delegated powers is in effect an abuse of Parliament and an abuse of democracy, and this report will, we hope, be a prompt to strengthen Parliament in the coming years.”


We can make a start on that hope with this Bill.

The DPRRC noted in its report of 15 December that the Bill contains 155 substantive provisions and 156 delegated powers. It concluded:

“The Health and Care Bill is a clear and disturbing illustration of how much disguised legislation a Bill can contain and offends against the democratic principles of parliamentary scrutiny.”


The report examines some of the Bill’s clauses in some detail, including the insertion via Clause 20 of a new Section 14Z48 into the National Health Service Act 2006. Essentially, the new section gives a Minister the power to make law by simply publishing “a document”. The department tries to justify the lack of any parliamentary procedure associated with the publication of a document on the grounds that the power is concerned with operational and administrative matters. However, the DPRRC goes on to say:

“Such a power is very unusual. If used in a context other than one involving public sector health bodies, it might give grave cause for concern and set an extraordinary precedent. Statutory liabilities should be imposed transparently, subject to clear legal conditions and parliamentary scrutiny.”


I should point out here the force of the word “unusual” in the committee’s comments. This is the highest form of disapprobation used by committees, and for good reason. This proposed new section is a blatant, transparent and disgraceful attempt to avoid any parliamentary scrutiny whatever.

The DPRRC’s conclusion is damning. It says:

“The power to impose a legal liability by merely publishing a document, without any parliamentary scrutiny, is a striking example of disguised legislation. We regard it as an inappropriate delegation of power, which should be removed from the Bill.”


In its report on the Bill of 7 January, the Constitution Committee agreed with the DPRRC’s recommendation to remove the new section from the Bill. I agree strongly, and that is what our amendment would do. I suggest to the Minister that if he wants to retain the powers set out in proposed new Section 14Z48, he rework them between now and Report so that they at least involve scrutiny by the affirmative procedure. If not, he can certainly expect us to return to this serious abuse of delegated powers on Report. I beg to move.

[The Lord Speaker (Lord McFall of Alcluith)]

My Lords, the noble Baroness, Lady Brinton, is taking part remotely and I invite her to speak.

--- Later in debate ---

[The Parliamentary Under-Secretary of State, Department of Health and Social Care (Lord Kamall) (Con)]

My Lords, I thank the noble Lord, Lord Sharkey, and the noble Baronesses, Lady Finlay and Lady Greengross, for bringing this group of amendments.

I understand the intention behind Amendment 106, on payment to providers, which is to remove new Section 14Z48 in its entirety, but the section will allow NHS England to specify the circumstances in which an ICB is liable to make payments to a provider for services commissioned by another ICB.

The Government are committed to ensuring that delegated powers in the Bill use the most appropriate procedure, so that Parliament has due oversight of their use. We recognise that the Bill contains a significant number of guidance-making powers and powers to publish documents. However, we believe that they are appropriate because, as the noble Baroness, Lady Walmsley, said, they reflect the often complex operational details and the importance of ensuring that the guidance keeps up with best practice, especially as the system flexes and evolves. I understand the noble Baroness’s point about Parliament, but the issue here is whether, every time the system flexes, Parliament has to have another debate. The ICBs will be reading the guidance, not Hansard, and the guidance should reflect that.

Nor is it our intention to interfere unduly in the financial affairs of ICBs. Instead, the intention is to resolve specific circumstances, such as emergency services. The legislation makes it clear that each ICB has to arrange for urgent care services to be available for all people physically present in the area, not just for the people who are its core responsibility by virtue of their GP registration. I am sure noble Lords will agree that it would be neither fair nor in the best interests of promoting an efficient health service for the ICB to both arrange and cover the cost of all additional emergency treatment brought by visitors to the area, particularly in areas with high visitor numbers. A number of noble Lords referred to that principle in debates last week.

Instead, this provision allows NHS England to mandate a different payment rule for those services, ensuring that, where necessary, the ICB where a patient is registered will pay, rather than the ICB where they receive treatment. This ensures that the financial impact is felt in the right commissioning organisation and eliminates the risk of some ICBs having unreasonable financial demands placed on them—for example, during the holiday season.

The wording of this provision replicates almost exactly the National Health Service Act 2006 as amended in 2012, but it is updated to reflect the new ICB structure. As my noble friend Lord Howe mentioned to me, we had a massive debate about this 10 years ago, but the provision seems to have worked effectively in the CCGs, and we wish to continue that with the ICBs.

Amendments 143 and 144, in the name of the noble Baroness, Lady Finlay, are about NHS England directing ICBs. I understand the interest in ensuring that NHS England has the necessary tools to intervene in ICBs where necessary. However, we believe that NHS England already has sufficient powers to direct ICBs. NHS England already has certain powers to direct an ICB under Section 14Z59(2), and powers to intervene over ICBs in order to prevent failure and to ensure that the lines of accountability from ICBs through NHS England to Parliament are strong.

However, this power has a threshold in that it can be used only if NHS England deems an ICB to be failing to discharge a function or at risk of failing to do so. The threshold removes the possibility of NHS England overdirecting the system while retaining the power for use if necessary. This balances the need to prevent failure and to support accountability with allowing ICBs the autonomy they need to operate effectively.

Amendments 133, 139 and 161 expressly require that ICB annual reports and NHS England performance assessments of ICBs include specific consideration of commissioned services, including NHS Continuing Healthcare, which noble Lords have spoken about, and that the CQC reviews of ICSs include specific consideration of that. We agree with the principle, but we believe that it is already covered in the Bill. NHS England already has a key role in overseeing ICBs. For example, the Bill requires NHS England to assess the performance of each ICB every year, and ICBs are required to provide NHS England with their annual report. These reports will include an assessment of ICB commissioning duties, which would encompass any arrangements for NHS Continuing Healthcare.

In addition, as noble Lords are aware, Clause 26 gives the CQC a duty to assess integrated care systems, including the provision of relevant healthcare and adult social care within the area of each ICB. This would include the provision of NHS Continuing Healthcare. We intend the CQC to pilot and develop its approach to these reviews in collaboration with NHS England, but also with other partners in the system. This should ensure that the methodology does not duplicate or conflict with any existing system oversight roles.

With this in mind, we believe that these amendments are not necessary, because commissioned services, which we would expect to encompass NHS Continuing Healthcare, are already included in these clauses. I hope that I have been able to somewhat reassure your Lordships. For these reasons, I ask noble Lords not to press their amendments.

[Lord Sharkey (LD)]

My Lords, it is clear that new Section 14Z48 is an unambiguous abuse of delegated powers. It provides for a law to be created by the simple issuing of a paper. There is no real possibility of a coherent defence of this procedure and the Minister did not provide one, relying as he did on special pleading and the extraordinary notion that Parliament cannot handle complexity.

As the Bill stands, Parliament is bypassed and scrutiny is avoided. I remind the Committee that the DPRRC and the Constitution Committee have recommended the removal of this section. I again suggest to the Minister that if he wants to retain the powers set out in Section 14Z48, he should rework them between now and Report at least to involve scrutiny by Parliament via the affirmative procedure. If he does not, we will return to this issue on Report. In the meantime, I beg leave to withdraw the amendment.

Amendment 106 withdrawn.

Health and Care Bill

Lord Sharkey Excerpts

Lords Hansard - Part 1 & Committee stage
Monday 24th January 2022 Lords Chamber

With these few remarks, I beg to move.

[Lord Sharkey (LD)]

My Lords, it is a pleasure to follow and to agree with the noble Baroness, Lady McIntosh. I will cover some of the same ground in my remarks.

I start by declaring my interests as chair of the Association of Medical Research Charities and of the Specialised Healthcare Alliance. The alliance campaigns on behalf of those 3.5 million of us who have rare or complex conditions. The members of the AMRC spend around £1.7 billion a year on medical research, mostly through universities in the United Kingdom. That is more than is spent by the Government via either the Medical Research Council or the National Institute for Health Research.

I will speak to Amendments 79 and 196 in my name and the names of the noble Lords, Lord Kakkar and Lord Patel, and the noble Baroness, Lady Blackwood. It is a privilege to have the support of such extremely distinguished and expert Members, and I am very grateful to them. The amendments also have the support of much of the medical research sector. Both amendments concern research within the NHS. This subject is a long-standing preoccupation of the medical research community, the NHS and the Government.

As long ago as 2011, the Academy of Medical Sciences published an influential paper setting out some key findings, prominent among which was the difficulty in attaining NHS permissions for research. In fact, this was identified as the single greatest barrier to health research. In 2017, the NHS and NIHR published a joint paper called 12 Actions to Support and Apply Research in the NHS. The NHS Long Term Plan, published in 2019, was generally received positively but actually had little to say about research. As your Lordships would expect, the NIHR did have something to say about research in its work of March last year, “Embedding a Research Culture”, which rehearsed the benefits of a research-intensive NHS. Three of the main actions called for were:

“Improving visibility and making research matter to the NHS … Making research more diverse and more relevant to the whole UK … Strengthening public, patient and service user involvement in research.”


These are obviously very important goals, but setting them out as clearly as the NIHR does makes it clear that the NHS’s performance in this vital area really does need improvement.

Also in March last year, the Government published a ministerial paper focused entirely on the delivery of UK clinical research. The paper set out the value of clinical research and our world-leading position. It made the assertion that

“research is the single most important way in which we improve our healthcare—by identifying new means to prevent, diagnose and treat disease.”

It concluded that that meant

“embedding clinical research at the heart of patient care and the NHS, making participation as easy as possible and ensuring all health and care staff feel empowered to support research.”

I strongly agree with both these assessments, and I am very glad to see them as firm policy goals. I welcome the clear and directive language and the signals of intent, which is why I was extremely disappointed to see such a very weak obligation as regards research in the Bill.

New Section 14Z40, inserted by Clause 20 on page 17, sets out what it describes as a duty in respect of research for ICBs. It simply says:

“Each integrated care board must, in the exercise of its functions, promote— (a) research on matters relevant to the health service, and (b) the use in the health service of evidence obtained from research.”


This is essentially the same kind of duty as imposed by the 2012 Act, and it is extraordinarily weak. The word “promote” is not really meaningful. What would satisfy this condition? Mere exhortation would probably qualify. Imposing a duty to actually do research would be much clearer, much simpler and more likely to have an effect. This would also be consistent with the Government’s view of the critical importance set out in the ministerial paper. That is what our Amendment 79 seeks to do. It is a “must actually do something” obligation rather than a “promote the doing of something” obligation. It requires that ICBs must ensure that those eligible organisations for which the ICB is responsible conduct research on matters relevant to improving patient outcomes and healthcare delivery and promote the use in health and care of evidence obtained by research.

The amendment has two additional parts. The first is to impose a requirement for ICBs to co-produce research aims with local place-based partnerships and to ensure diversity of participation. This acknowledges both the benefits and the necessity of place-centred research and close partnership in the production of research aims. The second additional part of our amendment is simply a requirement that the ICB publishes via its annual reports and joint forward plans the steps it has taken or plans to take to deliver clinical research.

Our Amendment 196 is also in this group. It deals with research directly in trusts and foundation trusts. As things stand, Schedule 4(16) of the 2006 Act says only that

“An NHS trust may undertake and commission research and make available staff and provide facilities for research by other persons.”


This is clearly permissive and not directive. Our Amendment 196 would remove this paragraph and replace it with a requirement for both trusts and foundation trusts to actually carry out research, as in Amendment 79. The amendment would also preserve, from the 2006 Act, making available staff and providing facilities for research by other persons.

I strongly believe that both amendments—all parts of them—are in keeping with the ministerial paper, Saving and Improving Lives: The Future of UK Clinical Research Delivery. I hope that the Minister will recognise the cross-party and not adversarial character of our proposals. We really agree with the Government about the paramount importance of research in the NHS—we just need to make it happen. I look forward to the Minister’s reply and to further discussions between now and Report.

[The Principal Deputy Chairman of Committees (The Earl of Kinnoull) (CB)]

The noble Lord, Lord Howarth of Newport, is participating remotely. I invite him to speak now.

Health and Care Bill

Lord Sharkey Excerpts

Lords Hansard - Part 2 & Committee stage
Monday 24th January 2022 Lords Chamber

[Lord Lansley (Con)]

My Lords, I am pleased to follow the noble Lord and I endorse the points he makes about the diversity of provision, which is certainly something that we should aim for; I am not sure how we will make sure it is in the Bill, but we will get to that later on. I will not dwell on the other amendments; I will simply explain why I oppose Clause 70 standing part. I was pleased to see that the noble Baroness, Lady Thornton, shares that view, although she may do so for different reasons.

This gives me an opportunity to explain something that I have been saying to Ministers—not necessarily these Ministers but their predecessors—for the last two or three years: if the NHS took the view that the structure of the procurement regime that was applied to it was a constraint, cumbersome and the various other words that it used, Ministers could do something about it very quickly because, in the legislation, they have the power to change the regulations. So why do they not do so? I also want to explain that the existing regulations do not impose some of the constraints that it is argued they do. That begs the question behind my opposition to the clause standing part: why are we legislating in this way in this clause, when the effect is to remove a power to make regulations relating to the procurement regime in order to then put into the Bill a power to do just that? It really does nothing much more than that.

Of course, in truth, we do not know what these new regulations will look like because they have not been published, as the noble Lord, Lord Hunt of Kings Heath, rightly said. The issue lies in the regulations because, as I will demonstrate, what mattered to the service, as it turned out, was not what was in Section 75 of the 2012 Act but what was in the subsequent 2013 procurement, choice and competition regulations. I am sorry, but this is going to take a few minutes.

Clause 70 does nothing much more than refer to the fact that there should be transparent and fair processes, that “managing conflicts of interest” should take place and that compliance should be verified—I do not know quite what that means but it is probably a good thing. It also makes reference to general procurement objectives. You might ask what those are, since they are not specified in Clause 70 itself.

If one goes back to the previous legislation, one gets to the point in the NHS (Procurement, Patient Choice and Competition) (No. 2) Regulations 2013, which are also revoked later in Clause 70. In the regulations, there is a paragraph that says what the procurement objectives are:

“for the purposes of the NHS … a relevant body must act with a view to … securing the needs of the people who use the services … improving the quality of the services, and … improving efficiency in the provision of the services”.

I rather hope that we are not yet encountering anything to which people would object. It then goes on to say:

“including through the services being provided in an integrated way (including with other health care services, health-related services, or social care services).”

Frankly, we have had years now of people explaining that the legislation did not allow them to do things in an integrated way. But when one looks back to 2013 and the regulations brought in, they say that the objective is to do things in an integrated way. I slightly wonder why the NHS did not do that, rather than complain that it could not.

Let me go on. When looking at the general requirements of procurement subsequently in that regulation, it includes the provision to

“act in a transparent and proportionate way, and … treat providers equally and in a non-discriminatory way”,

and wants projects delivered with “best value”. So far, again, there is nothing to which people object.

In Regulation 3(4) we hit something that people might object to. In defining what quality and efficiency look like, the regulations go on to say that the services should be

“provided in a more integrated way”—

which we have already heard about, and it repeats exactly that point—

“enabling providers to compete to provide the services”.

This may be where the objection came from, in which case my argument to Ministers is this: if that is what you do not like in the regulations, omit it from them. Ministers could have done it literally in a matter of weeks.

What is the other objection to the existing structure of the legislation? Section 75 of the Health and Social Care Act 2012, about the power and what it should be used to do, talked about good practice in procurement and the right to patient choice. I mentioned in a previous group the importance of, in my view, putting the right to patient choice into the provider selection regime, but we will come on to that again at a later stage.

Here is a third point, and something to which I think some people objected to, and have objected to subsequently; that providers

“do not engage in anti-competitive behaviour which is against the interests of people who use such services.”

I might say that if the anti-competitive behaviour is in the interests of the people who use those services, it is not necessarily objectionable. However, when one looks further, Regulation 10 of the subsequent regulations describes the circumstances in which anti-competitive behaviour might be justified:

“unless to do so is in the interests of people who use health care services … which may include … the services being provided in an integrated way”.

We keep coming back to this.

The other point I would make—she is not here, but the noble Baroness, Lady Blackwood, said it at Second Reading—is that the NHS objected to the fact that it was required to engage in compulsory competitive tendering. Section 75 of the 2012 legislation says that the regulations may

“impose requirements relating to … competitive tendering”,

as well as to the management of conflicts of interest, but it does not require the regulations to be made at all, and it certainly does not require the regulations to include compulsory competitive tendering, and nor do the subsequent regulations published in 2013 require that.

All of that leads me to the conclusion that Section 75 of the 2012 Act simply creates a power; it does not need to be changed for new regulations to have been made. Section 75 says that subsequent 2013 regulations may be objectionable to people in so far as they refer to qualified providers and to competitive tendering. If that was the problem, you should revise the regulations, publish them, take out the bits you object to and give the NHS a provider selection regime that fits their anticipated needs. The objectives are all there: quality, efficiency, best value, fairness, proportionality and an integrated service—and an integration, if that is what this Bill is all about, was already there in the 2012 legislation.

My question to my noble friend for before Report, and the question asked by the stand part debate, is: why are we doing what we are doing in Clause 70? Cannot we do it perhaps more simply and effectively by amending the existing legislation, rather than by trying to do wholesale repeals, introducing something that we will not know what it looks like until after this Bill has passed through this House?

[Lord Sharkey (LD)]

My Lords, Amendment 213 is in my name and that of the noble Baroness, Lady Thornton, and I am very grateful for her support. I can be briefer than I was expecting to be, given what the noble Lords, Lord Lansley and Lord Hunt, have said in the last few minutes.

My amendment addresses another instance of an attempt by the Government to bypass parliamentary scrutiny, and it proposes in response an enhanced form of parliamentary scrutiny. As the noble Lord, Lord Hunt, remarked, the DPRRC report on the Bill notes that the delegated powers memorandum says that, although initial consultation has been carried out by NHS England on the content of the procurement regime, full analysis has not been completed and there has not been time to produce a more developed proposal. Clause 70 gives the Minister the power to impose a new procurement regime, without giving any details of what it might be. This is the clearest possible example of the Government taking powers to make policy without specifying at all what that policy may be.

The DPRRC rejects the inclusion of regulation-making powers as a cover for inadequately developed, or undeveloped, policy. What is worse, the delegated powers memorandum says that a Cabinet Office procurement Bill will most likely follow this Bill, and it may require some amendments to the regulation-making powers that we are discussing in this Bill. The regulatory powers in question are to be subject to the negative procedure. I think we all, except for the Government Front Bench, would recognise that the negative procedure is emphatically not effective parliamentary scrutiny.

What we have here is a skeleton clause, with regulation-making powers of very broad scope. There is nothing in this clause, or in the Bill more generally, which would in practice constrain how broadly these powers could be used in constructing a procurement regime. It would probably be better, from the point of view of parliamentary scrutiny, to leave out Clause 70 entirely, as the noble Lord, Lord Lansley, my noble friend Lady Walmsley and the noble Baroness, Lady Thornton, propose, and wait for the full policy to be set out in the Bill, as promised to follow soon from the Cabinet Office.

If the Minister can advance compelling reasons why this Bill should be the vehicle for setting up the procurement regime by regulations, there is one route we could take, as set out in my amendment. This amendment imposes the super-affirmative procedure on the delegated powers proposal. The super-affirmative procedure is designed and used to deliver a measure of real scrutiny in circumstances that require it. In proceedings on the recent Medicines and Medical Devices Bill, the Minister very helpfully summarised the super-affirmative procedure as follows, saying that the

“procedure would require an initial draft of the regulations to be laid before Parliament alongside an explanatory statement and that a committee must be convened to report on those draft regulations within 30 days of publication. Only after a minimum of 30 days following the publication of the initial draft regulations may the Secretary of State lay regulations, accompanied by a further published statement on any changes to the regulations. They must then be debated as normal in both Houses and approved by resolution.”—[Official Report, 19/10/20; col. GC 376.]

According to the Library, the last recorded insertion in a Bill of a super-affirmative procedure was by the Government themselves, in October 2017, in what became the Financial Guidance and Claims Act.

I repeat that, if the Minister really can convince us that he has a compelling reason to have this new procurement regime set up by regulations in the Bill, my amendment would provide the opportunity for detailed parliamentary scrutiny. If he cannot accept that, then we would be wise to take out Clause 70 in its entirety.

--- Later in debate ---

[Lord Kamall (Con)]

May I explain about the point made by the noble Lord, Lord Lansley, on Clause 70—

[Lord Sharkey (LD)]

Before the Minister abandons Amendment 93 entirely, could he explain why it is necessary to have, in this Bill—when there is another one coming along—regulation-making powers that are unconstrained and non-specific?

[Lord Kamall (Con)]

We do not believe that they are, but clearly there is a difference of opinion about it.

I would like to turn, however, to the point made by my noble friend Lord Lansley on Clause 70. The regulations that we create under Clause 70 will have a broader scope than those currently created under Section 75. The provider selection regime will include public health services commissioned by local authorities, thereby recognising their role as part of joined-up health services delivered for the public. While we always want to act in the interests of people who use our services, our regime recognises the reality that in some cases integration, rather than competition, is the best way to achieve this for the health service. Finally, removing the section and creating a new bespoke regime, is—despite the scepticism of the noble Lord, Lord Warner—what the NHS has asked for. There is strong public and NHS support for scrapping Section 75 of the 2012 Act—

Health and Care Bill

Lord Sharkey Excerpts

2nd reading
Tuesday 7th December 2021 Lords Chamber

[Lord Sharkey (LD)]

Like other noble Lords, I welcome the noble Lord, Lord Stevens of Birmingham, and congratulate him on his frank and witty maiden speech. I declare an interest as chair of both the Association of Medical Research Charities and the Specialised Healthcare Alliance.

Last year, members of the Association of Medical Research Charities contributed £1.7 billion to medical research in the United Kingdom—more than either the NIHR or the MRC. The Specialised Healthcare Alliance’s 120-plus members campaign for those with less common and rare diseases, which affect some 3.5 million people in the United Kingdom. Both organisations bring the patient’s voice and interests to medical research in the UK. I will focus my remarks on medical research and rare diseases.

The Bill before us does not offer any significant differences in these areas from its predecessor, the 2012 Act. In Clause 20 on page 17, the Bill sets out a duty in respect of research for each ICB. As the noble Baroness, Lady Blackwood, explained, it says only that ICBs will have a duty to “promote” research. This is equivalent to the duties already existing in the 2012 Act. In the Commons, there were significant attempts to strengthen this and upgrade the duty to promote to a duty to conduct. We believe that the amendments proposed to achieve this—notably from Chris Skidmore, a former research and innovation Minister, and my colleague, Wera Hobhouse—had real merit. We will want to return to them in Committee.

We will also want to make sure that, to make a duty to conduct research effective, this duty will also extend to eligible organisations for which ICBs are responsible. The benefits of making it a duty to conduct, rather than just promote, research are well evidenced and wide-ranging. They include improved patient outcomes, improved job satisfaction among health workers and significant gross value added being generated. It is well evidenced that patients treated in research-active settings have lower mortality rates and increased confidence in the care they receive. There is an equally strong body of evidence that shows that engaging in research improves job satisfaction, boosts staff morale and can reduce burn-out. Research also presents the ideal opportunity for patient involvement.

I now turn to rare diseases and patients with complex conditions. The proposed structural changes in dealing with these areas would benefit from some additional safeguards and reassurances. The plan to delegate or transfer the commissioning of certain specialised services from NHS England to ICBs makes it vital that minimum national standards are strictly observed. I know from conversations with NHS England that that is its clear intention. However, we need more detail on how this is to be done, how it is to be monitored and how any corrective actions may take place. Also, what mechanisms will be in place to take advantage of learnings across ICBs and generate continuous improvement? It is especially important that we know what measures will be in place to prevent the fragmentation of the care for people with complex comorbidities. We shall want to ask how the interests of this group can be embedded in the ICB decision-making process.

Finally, I turn to the question of approvals. We want to see provision made in this Bill for establishing a new assessment route for medicines for people with rare and less common conditions, with better engagement with these patients and faster timescales—perhaps something analogous to the approach taken to the creation of the highly specialised technologies appraisal programme of 2012. We will want to discuss this issue in Committee.

The UK is already a medical research superpower, as recent events have demonstrated. If we are to maintain and profit from that position, as the Government wish, investment in research is absolutely critical. That investment does not only require proper funding; it requires collaboration between funders, especially between medical research charities, the NHS, our research universities and industry. It also requires recognition of the importance of listening to patients and patient groups and involving them in every step. I look forward to raising all these matters, as well as the Government’s bizarre and overenthusiastic use of delegated powers, in more detail as the Bill makes progress.

Medicines and Medical Devices Bill

Lord Sharkey Excerpts

3rd reading & 3rd reading (Hansard) & 3rd reading (Hansard): House of Lords
Thursday 21st January 2021 Lords Chamber

Moved by

[Lord Sharkey]

1: Clause 17, page 12, line 4, leave out from “subject” to end of line 8 and insert “to the super-affirmative procedure set out in section 51”
Member’s explanatory statement
This amendment is to correct the drafting.

[Lord Sharkey (LD) [V]]

My Lords, Amendments 1 to 8, in my name and that of my noble friend Lady Jolly, are to correct drafting. None of them, individually or collectively, alters the meaning or substance of the parts of the Bill that they would amend. I beg to move Amendment 1.

[The Parliamentary Under-Secretary of State, Department of Health and Social Care (Lord Bethell) (Con)]

The noble Lord, Lord Sharkey, made his points cogently on Report. We do not intend to oppose the amendments on the Marshalled List, as they are technical tidying amendments, consequential on those in the name of the noble Lord, Lord Sharkey, that were passed on Report.

[Lord Sharkey (LD) [V]]

I am very grateful to the Minister.

Amendment 1 agreed.

--- Later in debate ---

Moved by

[Lord Sharkey]

2: Clause 21, page 14, line 21, leave out from “subject” to end of line 25 and insert “to the super-affirmative procedure set out in section 51”
Member’s explanatory statement
This amendment is to correct the drafting.

--- Later in debate ---

Moved by

[Lord Sharkey]

3: Clause 52, page 34, line 32, leave out “section 11(1), section 17(1) and section 21(1)” and insert “and section 11(1)”
Member’s explanatory statement
This amendment is to correct the drafting.

Medicines and Medical Devices Bill

Lord Sharkey Excerpts

Report stage & Report stage (Hansard): House of Lords & Report: 1st sitting & Report: 1st sitting: House of Lords
Tuesday 12th January 2021 Lords Chamber

Moved by

[Lord Sharkey]

3: Clause 1, page 1, line 8, at end insert—
“( ) Regulations made under subsection (1) that introduce significant new policy or significant changes to existing policy are subject, in relation to regulations made by the Secretary of State, to the super-affirmative procedure set out in section (Super-affirmative procedure), in relation to regulations made by a Northern Ireland department, to section (Super-affirmative procedure: Northern Ireland), and, in relation to regulations of the Secretary of State and a Northern Ireland department acting jointly, to both.”

[Lord Sharkey (LD) [V]]

My Lords, the amendments in this group are in my name and the names of the noble Baroness, Lady Andrews, the noble Lord, Lord Forsyth of Drumlean, and the noble and learned Lord, Lord Judge. I am grateful for their support and regret that the noble Lord, Lord Forsyth, cannot be here today. He is currently chairing a meeting of the Economic Affairs Committee.

The purpose of the amendments is to replace the use of the affirmative SI procedure in Parts 1, 2 and 3 of the Bill with the super-affirmative procedure. This is to restore an element of meaningful parliamentary scrutiny to a Bill that so conspicuously lacks it. This is a skeleton Bill. Parts 1, 2 and 3 contain no policy detail and effectively give Ministers carte blanche to decide policy. They give the Minister almost unfettered power to remake our human medicines, our veterinary medicines and our medical devices regimes.

Our DPRR Committee and the Constitution Committee were extremely critical of this approach. On Second Reading, as the noble Baroness, Lady Thornton, has reminded us, the noble Lord, Lord Blencathra, chair of the DPRRC, and speaking for it, said that

“the structure of the Bill is absolutely atrocious and an affront to parliamentary democracy.”

He went on to say:

“Parliament is effectively bypassed; that is a sick joke of good law.”—[Official Report, 2/9/20; cols. 415-16.]


Parliament is bypassed largely because the affirmative SI procedure does not allow for real scrutiny. We cannot amend SIs, and the House has voted down affirmative SIs on just four occasions in the last 70 years.

The Constitution Committee was clear in its 2018 report, The Legislative Process: The Delegation of Powers, when it said:

“Without a genuine risk of defeat, and no amendment possible, Parliament is doing little more than rubber-stamping the Government’s secondary legislation. This is constitutionally unacceptable.”


The affirmative SI procedure does not constitute meaningful parliamentary scrutiny.

By contrast, the super-affirmative SI procedure is designed and used to deliver a measure of real scrutiny. Erskine May, in part 4, paragraph 31.14, characterises the procedure as follows:

“The super-affirmative procedure provides both Houses with opportunities to comment on proposals for secondary legislation and to recommend amendments before orders for affirmative approval are brought forward in their final form. (It should be noted that the power to amend the proposed instrument remains with the Minister: the two Houses and their committees can only recommend changes, not make them.)”


In Committee, I set out at some length the details of how our super-affirmative procedure could work. In her response, the Minister helpfully summarised that the

“procedure would require an initial draft of the regulations to be laid before Parliament alongside an explanatory statement and that a committee must be convened to report on those draft regulations within 30 days of publication. Only after a minimum of 30 days following the publication of the initial draft regulations may the Secretary of State lay regulations, accompanied by a further published statement on any changes to the regulations. They must then be debated as normal in both Houses and approved by resolution.”—[Official Report, 19/10/20; col. GC 376.]

According to the Library, the last recorded insertion in a Bill from a super-affirmative procedure was by the Government themselves, in October 2017, in what became the Financial Guidance and Claims Act. In Committee, I noted that when they are not doing it themselves, the Government traditionally object to the use of the super-affirmative on all or any of three grounds. The first is that it is unnecessary, because the affirmative procedure provides sufficient parliamentary scrutiny; the second is that it takes too long; and the third is that it is cumbersome. The Government did not depart from tradition. In Committee, they used all three objections.

The first objection, that the affirmative procedure provides sufficient scrutiny, is plainly and simply wrong, unless of course the Government regard no effective scrutiny as sufficient. The second objection, that it takes too long, is to misread its purpose. It is the case that the super-affirmative procedure takes longer, but that is because it contains provisions for real scrutiny, which necessarily takes time. This is not a negative; it is the merit of a procedure and the point of it. I should point out here that any emergency or urgent need will not trigger the super-affirmative procedure. The Bill now allows for the “made affirmative” procedure to be used in such cases.

The third objection raised by the Minister was that the super-affirmative procedure could be cumbersome and involve a disproportionate use of parliamentary time. She gave the example of the minor change to the Human Medicines Regulations 2012 to illustrate the point. This was a very helpful observation, and we are grateful for it. It would obviously be wrong to take up parliamentary time on minor changes, but, accordingly, we have revised our amendments since Committee to take account of this. The amendments now before us apply the super-affirmative procedure only to regulations that introduce what the Secretary of State considers to be either significant new policies or significant changes to existing policies. All other SIs can be dealt with as currently specified in the Bill.

This is a skeleton Bill. The noble Lord, Lord Hodgson of Astley Abbotts, chair of our Secondary Legislation Scrutiny Committee, had something to say about this type of Bill in a 4 January article in Prospect magazine:

“First and foremost, parliament should continue to be vigilant about the balance of power that is at the heart of our constitution. The right of the legislature (parliament) to resist any encroachment on its powers by the executive (government) is central to our democratic system. … parliament should continue to object to the use of ‘skeleton bills.’”


He proposes that the Government:

“Put the appropriate level of detail into primary legislation and avoid skeleton bills.”


It is obviously too late to do that with this Bill, which allows Ministers to take powers and make policy before they have decided what that policy is. Secondary legislation was never intended as a means of making policy. Using secondary legislation to do that, as the noble Lord, Lord Blencathra, so clearly put it, bypasses Parliament.

Our proposal restores a measure of parliamentary scrutiny where there are proposed significant new policies or significant changes to existing policies. It is activated only by significant policy changes. It amounts to meaningful scrutiny without removing the final decision from Ministers. It does not get in the way of emergencies or urgent need, but it does prevent Parliament being bypassed. This is an important test of the balance between the Executive and the legislature and an opportunity for Parliament to assert its right, and its duty, to scrutinise. Subject to the Minister’s response, I intend to test the opinion of the House. I beg to move.

[Lord Judge (CB) [V]]

My Lords, I apologise to the House; this is the first time I have spoken on this Bill and I have not been able to speak earlier in the proceedings, so I will try to be brief. I also assume that, notwithstanding the recent vote on sunset clauses, the Minister’s response during the debate indicates that the Government will not be very interested in leaving it in the legislation.

This Bill’s importance is obvious. It is hardly regulation light; to the contrary, in the modern way, it has a banquet of regulation-making powers which would, as the debate has shown, enable the Minister to extend policy and create policy by statutory instrument. For that purpose, I need simply refer to the observations of the noble Lord, Lord Patel, in the previous debate.

In the 30 December debate on the Bill on the trade agreement with the EU, I suggested that, now that all that was done finally, we in this House at any rate needed to focus on the sovereignty not of the Prime Minister or the Executive but of Parliament over the Executive, and proper parliamentary control over the legislative process. We are, as has been discussed, no longer bound to implement EU directives—hence, in part, this Bill. We should decide now—and if not now, when?—to brake, or at any rate better to control, the damaging, wide-ranging, regulation-making powers which now regularly come our way.

Time and again, the cross-party committees of the House have complained about, for example, skeleton Bills, Henry VIII powers and inappropriate delegated powers. Time and again, in Bill after Bill, the pleas—convincing, constitutional and persuasive—have been totally ignored. A cascade of regulation-making powers continues its unabated flood in every Bill that comes before the House, and this Bill is such an example.

That is not the end of it. The consequences are vividly described in the report of the Secondary Legislation Scrutiny Committee, dated 17 December 2020, just a few days before Christmas. It contains devastating criticisms of risks to proper scrutiny currently observed by that committee. I commend its reading to the whole House. In the first year of this Session, we had 901 statutory instruments. Of those relevant to this Bill, the number from the Department of Health alone was 126. No one in the report has suggested that the department’s work is exempt from its wide-ranging, broad criticism.

The wider use of the super-affirmative process would ensure better parliamentary scrutiny and control of the Executive, which for too long have simply ignored the constant urgings of the parliamentary committees in this House, in particular, as this Bill shows, the recently expressed concerns of the Constitution Committee and the Delegated Powers Committee. One day they will ask why they bother. They do so only in the hope that, one day, the Executive of the day will take notice.

As these pleas have been ignored and have failed, and, as is perfectly plain, as I indicated at the outset, the Minister’s reservations and distaste for consolidation and sunset clauses were absolutely manifest, this amendment will secure that, for this Bill and for this department, with these wide-ranging and important powers, the super-affirmative level of control should be exercised. The time to exercise it is now. It is time that the power is exercised more frequently.

--- Later in debate ---

I understand the arguments about parliamentary scrutiny. However, I strongly maintain that the Bill as amended in Committee strikes the right balance between effective challenge and scrutiny of our regulations, and is workable legislation. I hope the noble Lord has now received sufficient assurances, as well as understanding the challenges inherent in his proposed approach, and I hope that he will feel able to withdraw his amendment.

[Lord Sharkey (LD) [V]]

I am very grateful to all those who have spoken in support of these amendments. Skeleton Bills always limit parliamentary scrutiny, and this Bill is no exception. The Minister in his more than three-minute speech has exaggerated enormously the difficulties with the reach of our proposal. I disagree, for example, with the notion that our proposal blocks the use of the “made affirmative” procedure. It is clear that the Government are wedded to the idea of taking powers to make policy before they have decided what that policy is, and that is at the heart of the matter. This inevitably means bypassing Parliament and we should resist. I would like to test the opinion of the House.

--- Later in debate ---

[Baroness Thornton (Lab)]

As I said to the noble Lord and the Bill team yesterday, these are probing amendments and I do not have any intention of pressing them. That is because I accept that the Minister and the Bill team have done a very good job of making this part of the Bill work much better.

It is always worth rehearsing in the Chamber some of the arguments that we have had outside the Chamber, because people often go back to the Hansard record to ask why we changed words from this to this. That is why the noble Baroness, Lady Jolly, and I put down some of these amendments. We have had some extremely useful discussions outside the Chamber, as we should have done, so I hope the noble Lord understands that that is why these amendments are being put today.

Under my Amendment 5, the overarching objective in making regulations under Clause 1 must be safeguarding public health. This is a probing amendment on the difference between “public health” in the government amendment before us today and the “health and safety of the public”, which was the phrase used in the amendment introduced in Committee. It is worth explaining why we accept that that change was sensible.

It is my understanding that “public health” is a broader and more subjective concept that may encompass economic interests, or may relate to increased pharmaceutical investment and innovation, and other factors beyond health and safety, which may conflict with them in some circumstances. Does the Minister agree that we have to explain the less strong commitment that is included in the Bill? Safeguarding public health is also not the same as protecting the safety of medicines and medical devices. It is very important that we are clear about that in the powers given to the Secretary of State in determining what would contribute to safe- guarding public health.

I congratulate the drafters on changing “attractiveness” to “favourability” and “benefits” and “risks” in my Amendments 12, 34 and 48. These amendments seek to probe the criteria that determine whether benefits outweigh risks and require the assessment to be published. The government amendments in this group replace the consideration of UK attractiveness with reference to it being a “favourable” place in which to conduct clinical trials and manufacture and research new medicines, medical products and services. The theme that runs through the whole of this legislation, as has been mentioned by many noble Lords, is that that is the place we want to be in, and the country we want to be, as we move forward.

Proposed new subsection (3A) looks like an attempt to allay concerns, stating that, where regulations impact on safety, they may be made only if the benefits outweigh the risks. It is worth putting on the record the discussion that we had about benefits and risks. Risk and benefit analyses are a well-established feature of clinical trials regulations and ethics committees, but they normally have more well-defined parameters than simply a risk-benefit assessment, yet these are precisely the regulations that these powers will allow to be made. This is why we need to make sure that we are clear what we are talking about here. This comes back to scrutiny and the need for the ability to scrutinise the Government’s assessment of risks and benefits in making regulations. These arguments pertain to Clause 9 for veterinary medicine and Clause 14 for medical devices. That is why we wanted to have this discussion.

[Lord Sharkey (LD) [V]]

My Lords, I welcome the amendments in this group. They add clarity to the obligations laid on the Secretary of State in making regulations under Clause 1(1) and its counterparts.

I particularly welcome Amendment 12 in the names of the noble Baroness, Lady Thornton, and my noble friend Lady Jolly, as it seems particularly important. It requires the Secretary of State to publish the criteria used in determining the benefits and risks caused by regulation and to set out how they have been weighed against each other. This amendment touches on the whole issue of transparency in devising regulations. The level of transparency that Amendment 12 requires should certainly apply to the factors listed in the Minister’s Amendment 9. These factors, which the Secretary of State must have regard to, are the safety of human medicines, the availability of human medicines and the likelihood of the relevant part of the United Kingdom being seen as a favourable place in which to carry out research related to human medicines, conduct clinical trials, or manufacture or supply human medicines. These are all clearly important, and I am glad that the Minister has added manufacturing to this list, as I suggested in Committee.

The list contains three rather vague notions: “likelihood”, “favourable” and “being seen as”. For all these terms, we need to know what definitions will be used and what evidence will be required in support. For “being seen as”, the question arises: being seen as by whom? What weight will be given to different views from different sectors? If, for example, it turns out that academic researchers and pharma companies have different views about the favourability of the UK, how are they to be weighted? On “likelihood”, could the Minister say whether he considered the word “desirability” instead, which seems closer to what we want here?

I hope the Minister is able to give reassurance on the points I have raised and that he accepts the merits of Amendment 12 and its counterparts.

[Lord O'Shaughnessy (Con)]

My Lords, I will make three quick points about the government amendments in this group, which I broadly welcome. The first relates to Amendments 4 and 42, where the Minister has clearly listened carefully to the forceful arguments made by my noble friend Lord Lansley, the noble and learned Lord, Lord Woolf, the noble Baroness, Lady Jolly, and others in Committee. I am delighted that he has.

For those of us who have not been involved in the discussions, and following on from the points that the noble Baroness, Lady Thornton, made about why language from the European regulation has been adopted—“safeguarding public health”—it would be helpful if my noble friend could explain, on the record, why that language has been chosen. That is particularly the case given that he expressed some reluctance in Committee, bearing in mind that the regulations being referred to also had some relevance to operating the internal market, not simply medicines safety. It would be good to hear from him on that.

Secondly, on Amendments 8 and 44, unlike other noble Lords I did not believe that there was a suspect motivation behind the use of the word “attractive” by my noble friend and the Bill team, or any desire to reduce stringency to attract investment. But I would be grateful if my noble friend could confirm that the Government remain as determined as ever, if not more so, to grow the UK’s life sciences sector, and that it was never their intention to lower regulatory standards to achieve this.

Thirdly, on Amendments 9 and 45, I commend my noble friend on the subtle but important changes already referred to by the noble Lord, Lord Sharkey, in Clauses 1(3)(c) and 14(3)(c), especially the inclusion of manufacturing and broader medical research. The salience of these two parts of our overall supply chain has come to the fore during the pandemic, which has demonstrated our strengths in basic science but, unfortunately, exposed our weaknesses in manufacturing resilience. It seems right that this should be explicitly recognised in the Bill and I commend my noble friend for making those important changes and for demonstrating, once again, his ample appetite for listening and acting.

Medicines and Medical Devices Bill

Lord Sharkey Excerpts

Committee stage & Committee: 7th sitting (Hansard) & Committee: 7th sitting (Hansard): House of Lords
Thursday 19th November 2020 Grand Committee

[Baroness Bennett of Manor Castle (GP) [V]]

My Lords, I will speak briefly in favour of this amendment in the name of the noble Baroness, Lady Cumberlege. Like the preceding speaker, I am aiming to add extra angles and approaches rather than to repeat what has already been said—but I associate myself, essentially, with everything that has already been said.

As I was thinking about this amendment, I was reflecting on a session in the House—I believe it was this week, although it all blurs slightly if one looks at a screen for long enough—when the Minister, the noble Lord, Lord Bethell, was being questioned by one of his noble friends about why a whole series of Written Questions about Covid had not been answered. The fact is, of course, that all aspects of our health system are currently under enormous pressure. The proposition that I put—as I was arguing in another amendment to the Bill earlier this week—is that this is actually an amendment that makes the Government’s job easier. It carves off a recognisable, obvious piece of work that does not have to be done by already horribly overworked, stretched systems. It means that something can be done: something can be ticked off and said to be under control, managed and done, in a way that does not draw too heavily on that existing overstretched system. That is the first point I wanted to make.

The second point I want to make—and I feel that I need to apologise to the noble Baroness, Lady Cumberlege, for bringing this up—is that, as a former newspaper editor, when I was thinking about reports and what happens to reports, I had to go back to the Leveson inquiry, conducted by Lord Justice Leveson. I remember, when I first read that report, I thought about how it had been carefully structured to put aside some of the more difficult areas, particularly the issue of media ownership concentration. In the report Lord Justice Leveson had tried very hard to create something that was implementable and manageable, and that had some chance of being delivered. I think we all know that that is not what happened, so I can understand that anyone asked to take on a huge job of work, as the noble Baroness, Lady Cumberlege, did with this, must ask themselves the question, “If I devote so much time, energy and effort to this work, will it actually be delivered?”

I said before that the patient safety commissioner amendment was possibly the most important one. In some ways, this certainly vies with it. This is about delivery. We know that there are three reasons to call an inquiry. One might be to find information, one might be to reassure the public, and another might be to create a plan of action. Those are the three often-stated reasons, but sometimes there is a fourth reason—perhaps “sometimes” is not the right word; perhaps “often” might be a better word—to kick something into the long grass. It is crucial that the issues uncovered by the noble Baroness are not kicked into the long grass, and that the very clear, obvious and important recommendations are not lost. So I support this amendment and, should it need to go further, I will continue to support it.

[Lord Sharkey (LD) [V]]

My Lords, Amendment 121 is another recommendation, as we have heard, from the Cumberlege review. We would, within three months of the Bill being passed, set up a task force to implement the recommendations of the Independent Medicines and Medical Devices Safety Review. This particular recommendation, like the others in the review, received very widespread support at Second Reading, and a key element of the recommendation contained in this amendment is the appointment of an independent chair of the task force. It is absolutely critical that this independence is real, and perceived as being real. It should be clear to all that the chair is not an establishment place-person, and is an obviously safe pair of hands. It is vital that public confidence in the safety of medical devices be restored, and we very strongly support this amendment. This amendment is the means—and perhaps the only means currently available to us—of making the Cumberlege recommendations a reality. If the Minister is not inclined to accept this amendment, I hope that the noble Baroness, Lady Cumberlege, will bring it back on Report, so that we can test the opinion of the House.

[Baroness Thornton (Lab)]

My Lords, I will be very brief, as it must be clear to the Minister that there is unanimity across the Committee in support of setting up this safer care task force. My noble friend Lord Hunt was quite right that this is about whether the Government take this report seriously, and for me this is also an issue of accountability. Recommendation 9 of nine states:

“The Government should immediately set up a task force to implement this Review’s recommendations.”


I hope that the Minister will just say, “Yes, we’ve done it”, so that we can now be told what the timeline for the task force will be and who will be involved. That is my hope from the Minister’s remarks, but if that is not to be the case, I hope that it might be the case in two or three weeks’ time when we move to the next stage of the Bill.

--- Later in debate ---

I look to my noble friend the Minister to say that the Government will consider Amendment 123 and see what they can say in response to it in particular. That is for the Government to take away and continue the process of finding a basis for consultation on policy on the reform of redress. I know that it is nearly 14 years on, but I still think that a reduction in cost in the NHS Litigation Authority’s responsibilities is the main way of proceeding. We can pursue that through non-adversarial fact-finding and arbitration mechanisms to try to reduce the number of occasions on which people go to court to litigate for compensation to be provided.

[Lord Sharkey (LD) [V]]

My Lords, I can be very brief. Amendment 122, in the names of the noble Lord, Lord Hunt of Kings Heath, and the noble Baronesses, Lady Cumberlege and Lady Bennett of Manor Castle, would require the Secretary of State to bring proposals before Parliament to establish a redress agency for those harmed by medicines and medical devices.

The arguments advanced for this by the noble Lord, Lord Hunt, the noble Baroness, Lady Cumberlege, and others, seem completely and obviously convincing, and we strongly support this amendment. We have not spoken to its proposers about this, but we wonder whether this redress agency might be hosted by the patient safety commissioner. We also wonder whether the amendment perhaps ought to be reworked into a revised task force amendment for Report, as we discussed in the previous set of amendments.

I know that the Government are in resistance mode about the patient safety commissioner but, when he responds, could the Minister tell the Committee what coherent arrangements there currently are for NHS patient redress, and whether he believes these arrangements are satisfactory?

[Baroness Thornton (Lab)]

I think this has been one of those really rather good and unexpectedly deep House of Lords discussions, going back into the mists of time. Until the noble Baroness, Lady Cumberlege, mentioned the redress Act, I had completely forgotten about it—it all came flooding back.

We have two quite different amendments in this group, and my noble friend Lord Hunt said at the outset that his Amendment 122 was a probing amendment. This is about opening up the discussion, which it certainly did—a discussion that has long needed resolving. The noble Lords, Lord Lansley and Lord O’Shaughnessy, were quite right in that it is an issue of the future; this group has one probing amendment about the future—what it should look like and how you create an agency that can address the issue of those harmed by medicines and medical devices. It is a very legitimate discussion, which needs to be had.

The second amendment, in the name of the noble Baroness, Lady Cumberlege, is about the future, what happens now and what happens about the harms that were done—the avoidable harms, in the case of hormone pregnancy tests, sodium valproate and pelvic mesh. That is very important indeed, and the noble Baroness is right to say that those harms must be specifically addressed by the Government and to push that. I think that is what we would be looking for—how the Government would implement those recommendations. I see the noble Baroness, and the noble Baroness, Lady Bennett, whose comments we very much welcomed and valued, but I do not think that was the last word. I hope she will involve herself in the next stage of the Bill. In fact, I am depending on it.

The Government have to address Amendment 123 in particular, because that is urgent and needs to be done now. I look forward to hearing what the Minister has to say about that in particular.

--- Later in debate ---

Moved by

[Lord Sharkey]

145: Clause 44, leave out Clause 44 and insert the following new Clause—
“Commencement
This Act comes into force on the day on which it is passed.”

[Lord Sharkey (LD) [V]]

My Lords, this is a probing amendment; its purpose is to allow the Minister to explain why Clause 44 contains four different commencement provisions for different parts of the Bill. The Explanatory Memorandum is silent about the reasons for that. I would be grateful if the Minister could explain on what basis the paragraphs in subsection (1) were chosen, why the coming into force of the items in subsection (2) is delayed by two months, and, in subsection (3), why Chapters 3 and 4 of Part 3 come into force at the absolute discretion of the Secretary of State. I think that I may understand subsection (4), but it would be helpful if the Minister could explain that to us too for the record. I beg to move.

[Baroness Thornton (Lab)]

The only question I want to ask is the question the noble Lord, Lord Sharkey, has just asked. Can the Minister give a rational explanation about why certain parts of the Bill come into force at different times? The key question on commencement is whether the commencement schedule as drafted risks holding up any of the work that needs to be done or allows the Government to move too slowly on anything.

My colleagues in the Commons drew attention to this provision as essentially a means of saying, “at some point in the future”. Can the Minister give an indication of the timeframe in which the Government expect to get these regimes consulted on, regulated for and up and running? As the Bill is drafted, the timing is left rather open-ended.

--- Later in debate ---

[Lord Bethell (Con)]

My Lords, I will seek to provide an answer to my noble friend. Should it not be quite the right answer I will endeavour to write to him. It is my understanding that no substantive provision of an Act should be brought into operation earlier than two months after Royal Assent. However, some sections of the Act can be brought into force on Royal Assent, typically those setting out how the Act is to be cited and what the procedure is for making regulations or commencing them. It is under those arrangements that the sequencing which he describes can be undertaken.

[Lord Sharkey (LD) [V]]

I thank the noble Lord, Lord Lansley, for his intervention. I will read Hansard carefully tomorrow to make sure that I understand not only his question but the Minister’s reply. I thank the Minister for his explanations—they were useful—and for the brief preview of his next speech.

Amendment 145 withdrawn.

--- Later in debate ---

[Lord Patel (CB) [V]]

My Lords, I speak very briefly to support this amendment. The noble Baroness, Lady Thornton, and the noble Lord, Lord Hunt of Kings Heath, have covered the argument extremely well. As the noble Lord said just now, the guidance is produced by the Secretary of State but, when you look at it in practice, it says that the Secretary of State “must have regard to” the guidance—that is, can take note of it but does not have to follow it.

I am a doctor and am used to following guidelines. If I do not follow the guidelines, I am liable to be reported; if I do not follow them for any reason in the management of a patient, I am expected to write down as to why I did not follow them. I am not expected to take note of it or have regard to it—I am expected to follow it. The amendment proposed by the noble Baroness, Lady Thornton, addresses exactly that point: why is the Secretary of State not asked to follow the guidelines which he or she drafted?

[Lord Sharkey (LD) [V]]

We all know that the words “have regard to” create no real obligations, whereas the words “act in accordance with” do create real obligations. Clause 13 seems to contain important restrictions on the actions of the Secretary of State, but it does so via guidance. As the Bill stands, with its “have regard to” wording, that guidance has no statutory force. If the restrictions are to have any reality—and I assume that the Government would like them to, or they would not have written them into the Bill—we must replace “have regard to” with “act in accordance with” as the amendment proposes. We support the amendment.

[Lord Bethell (Con)]

My Lords, I thank the noble Baroness, Lady Thornton, for her amendment, which is designed to require that the Secretary of State must “act in accordance with” the guidance on the use of civil sanctions that he is required to publish under paragraph 13 of Schedule 1, as opposed to having regard to the guidance. Paragraph 13 requires the Secretary of State to prepare and publish guidance about the use of civil sanctions. More specifically, this guidance must cover the sanctions that may be imposed if a person commits an offence, the action the Secretary of State may take, and the circumstances in which action is likely to be taken.

I understand the intention behind Amendment 146 and recognise that it is crucial that civil sanctions are imposed in a transparent and consistent manner to ensure that the regime operates effectively. However, the current drafting of Schedule 1, including the obligation on the Secretary of State to publish and have regard to guidance on the civil sanctions regime, will ensure this transparency and consistency.

The guidance will be prepared after consultation with the devolved Administrations and others. The purpose of any guidance is to provide clarity to the civil sanctions regime and detail the circumstances in which different civil sanctions may be pursued. However, instances of non-compliance or criminal activity, where the medical device regulations are concerned, need to be dealt with on a case-by-case basis. The scale, complexity and severity of non-compliance can vary significantly. As such, any resultant enforcement activity needs to be proportionate, effective and commensurate with the non-compliance or criminal activity.

The amendment in the name of the noble Baroness, Lady Thornton, would bind the Secretary of State, acting through the MRHA, to act in accordance with guidance in every instance. This would limit the regulator’s ability to arrive at and undertake the most appropriate course of enforcement action commensurate to the multifaceted nature of the case at hand. The MHRA cannot set out every circumstance where it may be appropriate to impose civil sanctions. However, by preparing, consulting and publishing a clear set of guidance we can be clear on the framework and illustrate circumstances on how and why a civil sanction might be imposed without being exhaustive.

The regulator needs civil sanction guidance that is flexible enough to appropriately address all forms of non-compliance. To mandate following the guidance to the letter could potentially mean that no action can be taken if the MHRA encounters a new example of non-compliance that has not been explicitly catered for in the guidance but clearly warrants a civil sanction. Under such circumstances, the Secretary of State will, of course, comply with obligation to publish revised guidance as required in paragraph 13 of Schedule 1.

I remind noble Lords that recipients of civil sanctions can contest the imposition of a civil sanction before it takes effect by appealing to the First-tier Tribunal. It is also worth highlighting that, as currently provided, the guidance will be statutory guidance and the regulator must have regard to it when carrying out enforcement activity.

Furthermore, this type of provision is standard across the statute book. For instance, provisions requiring regulators and statutory bodies to “have regard” to statutory guidance can be found in a wide range of legislation, from Section 2 of the Higher Education and Research Act 2017 to Section 5 of the Business and Planning Act 2020. In a civil sanctions context, Section 63 of the Regulatory Enforcement and Sanctions Act 2008 provides that provisions conferring a power on a regulator to impose a civil sanction must also make provision relating to guidance—in particular, that the regulator “must publish guidance” about its use of a sanction and

“have regard to the guidance … in exercising its functions.”

The Ecodesign for Energy-Related Products Regulations 2010 has a similar civil sanctions regime. These regulations are concerned with the establishment of a framework for the setting of ecodesign requirements for energy-related products. In paragraph 28 of Schedule 5 to those regulations the market surveillance authority

“must have regard to guidance”

while exercising his or her functions with regard to the imposition of civil sanctions. I hope that the reassurance we seek is not unusual but in line with how civil sanction and, indeed, other regimes operate domestically. For that reason, I therefore ask the noble Baroness to withdraw Amendment 146.