Medicines and Medical Devices Bill

Lord Kakkar Excerpts

Committee stage & Committee: 1st sitting (Hansard) & Committee: 1st sitting (Hansard): House of Lords
Monday 19th October 2020 Grand Committee

[Lord Hunt of Kings Heath (Lab)]

My Lords, I have added my name to Amendments 1 and 140 tabled in the name of my noble friend Lady Thornton. As we are at the start of the Committee stage, perhaps I may remind the House of my membership of the board of the General Medical Council and my role as president of GS1 and the Health Care Supply Association.

I agree with my noble friend Lady Thornton about the clash between the first day of the Committee stage of this Bill and the Second Reading of the United Kingdom Internal Market Bill in the main Chamber. Today we are dealing with some of the most important debates in the whole Bill and when we come back on Report there will be a need to give more time to allow those people who could not be present today to make a full contribution to these debates. I hope that the usual channels will take that away. I am not quite sure about the procedure in these unusual circumstances, but in normal times I would have asked that the Committee stage procedure be used for these introductory debates on Report in order to allow for interventions. However, since interventions are now limited, that may not run well, although I think that noble Lords will understand what I am getting at.

This is an important Bill on patient safety and the health of our life sciences sector. It is striking in its brevity and in the extensive powers to be given to Ministers. The noble Lord, Lord Patel, has spelled out the wide range of delegated powers contained in the Bill, while a pungent analysis by my local university, the University of Birmingham, points out that, while delegated powers may be needed to ensure responsiveness in the EU exit transition period and to meet the challenges of technological change, they should not be used indefinitely or relied on to implement matters of policy. I am not going to repeat what the Delegated Powers Committee or the House of Lords Select Committee on the Constitution have said, but it is rare for two Select Committees to comment at the same time and in such a critical way about the skeletal nature of a Bill. It is to be hoped that the Government will listen carefully to what is being said.

At Second Reading, the Minister suggested that the sunset clause as proposed by my noble friend would emasculate legislation

“meant to give regulators the powers to be effective and to future-proof medical regulation in a fast-changing industry for many years to come. We must understand the impact on an industry that needs regulatory certainty or else, as many noble Lords have noted, will move elsewhere.”—[Official Report, 2/9/20; col. 433.]

I have to say to the Minister that most of the regulatory uncertainty has been caused by the Government’s failure to be clear about what regulatory regime they want for medicines and medical devices. They have now had four years to think about this and we are still nowhere near knowing what regulatory system they want to put in place. Are they going to go for alignment with the European Medicines Agency or do they want to strike out on their own? Do they want to ally with the US FDA? What on earth are the Government’s aims? The industry is at risk because of this huge uncertainty. The idea that we should allow the Government willy-nilly to get this Bill through and make whatever changes they want without the House treating it as primary legislation simply will not wash. I am absolutely convinced that the long-term regulatory system must be subject to detailed primary legislation. As far as I can see, the amendment to bring in a sunset clause is probably the most appropriate vehicle to ensure that that happens.

[Lord Kakkar (CB) [V]]

My Lords, in contributing to the first day in Committee on this Bill, I draw the attention of noble Lords to my registered interests, in particular to those as a professor of surgery at University College London and as the chairman of UCLPartners.

I support Amendments 50, 67 and 115 tabled in the name of my noble friend Lord Patel, to which I have added my name. The point has been well made by my noble friend that the ecosystem for the delivery of healthcare in our country and therefore the use of medicinal products, medical devices and veterinary medicines is a complex one that is attended by substantial legislation, much of which has been brought into force as a result of the European Communities Act 1972. It is therefore absolutely right, to echo a point made previously by the Minister, that there is a need for this Bill to ensure that such regulation can continue, so that we can continue to have a safe and effective healthcare system and take advantage of the essential requirement to avail ourselves of medicinal products and medical devices.

There is surely also an absolute obligation to ensure that regulation should avoid adding to the complexity that already exists. For those who have to labour under these regulations and ensure that they can present innovation and advances to benefit our fellow citizens within the context of the regulations, we should always be working to simplify them.

In this regard, we are all conscious of the fact that many different types of regulations touch on the healthcare system. There are those that pertain to ethics, and those that deal with the function and delivery of ethics committees and the evaluation of intervention at a local and national level. We have regulations that deal with the adoption and evaluation of innovation within the context of the MHRA, and with the evaluation of intervention and innovation pertaining to NICE. We have heard from the noble Lord, Lord Patel, about the medical device regulations enacted in 2002, which codify and implement various EU directives in this matter, and the substantial amendment attending medical device regulations in terms of the legislation passed as part of EU exit regulations in 2019.

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[Baroness Walmsley (LD) [V]]

My Lords, I support Amendment 5, which would insert the words

“objective of safeguarding public health by promoting the availability and supply of human medicines”.

While the purpose of the Bill is to bring some sort of order out of the chaos of Brexit, it is vital that we put those words up front. In the first words on page 1, before Clause 1, the purpose of the Bill is described as

“the protection of health and safety, in relation to medical devices”.

Why does it not say, “in relation to medicines and medical devices”? That is why we need Amendment 5.

Government Amendments 2 and 7 are weak, in my view. For example, the words “promote health and safety” in Amendment 2 and “considering whether they would” in Amendments 7 and 72 are well meaning and better than the original but, I dare to say, legally useless.

The word “promote” also appears in government Amendment 68. In contrast, the noble Lord, Lord Lansley, and the noble and learned Lord, Lord Woolf, use the much stronger word “safeguard” in their Amendment 70, which I support. I also support their probing amendment for clarification in Amendment 76 that therapeutic practice is also included. I will be interested to hear whether the Minister can explain whether this is needed or, perhaps, not.

[Lord Kakkar (CB) [V]]

My Lords, I support Amendments 5 and 70 in the names of the noble Lord, Lord Lansley, and the noble and learned Lord, Lord Woolf. I seek further clarification on the Government’s purpose regarding the amendments proposed by the Minister.

First, what is the rationale for moving away from the current basis on which regulations in this regard exist, which states the purpose of safeguarding public health? Why do the Government not think that appropriate as the basis for legislation for medicines and medical devices? It has been the basis on which regulations have previously existed in domestic legislation and it seems counterintuitive to move away from that purpose, as so clearly explained by the noble Lord, Lord Lansley.

Secondly, there is this question of whether there should be an objective or a subjective test attending the purpose of legislation, all parties having agreed that it is of benefit to move away from simply having a power to clearly defining a purpose. There has been considerable debate and discussion about what is considered the frequent use of judicial review now and how in some way it undermines the position of Parliament and is less than helpful more generally in our country. It seems therefore intuitive for a Government who have concerns about what is sometimes considered excessive use of judicial review to try to provide legislation that would make it less necessary and less frequently turned to.

The noble and learned Lord, Lord Woolf, made the point that clarity is essential. Surely an element of clarity would be to have in place an objective test—to safeguard public health—rather than, as currently, merely being “satisfied”. The need that the Secretary of State can make regulations if he is satisfied, as we have heard in this debate, is much more subjective and therefore must be open to much more frequent challenge.

[Lord Sharkey (LD) [V]]

My Lords, I have only just learned that if we do not pass the government amendments in this group, we put at risk the required legislative consent order for Northern Ireland. I had intended to oppose Amendments 2, 7 and 14; I did not understand why Amendment 2 was necessary or had any real force or meaning—in any case, I much preferred Amendment 5 —and Amendment 7 seemed downright confusing, since its net effect is to impose an obligation on the Minister to have regard to certain things when considering making regulations but no obligation to consider the specified things when actually making these regulations.

I have spoken to the Minister and will now not oppose the government amendments. However, I feel that we have been bounced. I first realised the Government’s intention to move when I read today’s Chair’s guidance and I understood that there was a Northern Ireland problem when I was given, about 40 minutes ago, a copy of the note from the noble Lord, Lord Bethell, to the noble Lord, Lord Lansley, from yesterday. We were not copied in on that note. I strongly feel that this is all very unsatisfactory.

The Minister has not really answered the question that I asked him in our impromptu interval of why we need to rush. Could he explain why delaying the start of the legislative consent order process until Report would be a problem? It is still not clear to me. I trust the Minister’s assessment but I do not understand how he arrived at it. In his note to the noble Lord, Lord Lansley, he says, for example, that the delay would mean that we could not meet some unspecified timing objective but he prays in aid the notion that the minimum interval between Committee and Report is a contributing factor. We can change that interval; we could choose. Could the Minister explain again why it is necessary to do this today?

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[Lord Kakkar (CB) [V]]

My Lords, I shall speak in support of the amendment in the name of the noble Lord, Lord Lansley, to which I have added my name. Important arguments have been made with regard to the need to ensure that we can move away from the clinical trials directive which is currently the basis for such legislation in our country, and to adopt the clinical trials regulation to which our regulatory authorities have made such an important contribution over recent years.

On previous occasions Her Majesty’s Government, with specific regard to the 2018 EU withdrawal agreement Bill and the 2018 Trade Bill, made clear commitments that we should implement the clinical trials regulation in full as part of a negotiated agreement incorporating its legislative and non-legislative provisions; or, in the event that no agreement can be reached, that an element of the regulation would be adopted to the greatest extent possible on a unilateral basis in domestic legislation. We have received further reassurances in terms of the withdrawal agreement Act that the Government would give priority to taking the necessary steps to bring into UK law without delay all the relevant parts of the EU clinical trials regulation that were within the control of the United Kingdom. With regard to the Trade Bill, in September 2018, the House was reassured in the strongest possible terms by Her Majesty’s Government that a commitment was being made to implementing the regulation. However, when the Bill before us was considered in the other place, no such commitment was made and therefore, this probing amendment is vital.

I know that arguments have been made that not all the elements of the regulation are within the power of Her Majesty’s Government to implement, but as we have heard from the noble Lord, Lord Lansley, there is the opportunity to deal with the clinical trials portal and information system in a different way and to design, as other amendments propose, a system that might be agreeable. Arguments have also been made that the clinical trials regulation itself, although a substantial improvement on the current directive, is not perfect, and that the GCP and ICH guidance to which the clinical trials regulation makes reference need themselves to be advanced. Work is being undertaken in that regard.

The European clinical trials regulation provides for referring to guidance on the operational delivery of clinical trials or other guidance, so that should not be seen as an impediment. The real concern here is that while, unfortunately, impediments and hurdles to the adoption of the clinical trials regulation may be identified, that would be the wrong thing to do. The regulation is important. The current clinical research legislation under which we labour in our country is not ideal, which is why we have this regulation. On many occasions, Her Majesty’s Government have committed to the adoption of the regulation, so can the Minister indicate why the opportunity provided by this Bill should not be taken to fulfil those undertakings and thus provide us with the greatest possible certainty regarding the conduct of clinical research in our country? This is vitally important to patients, to the economy and to sustaining a viable life sciences ecosystem.

[Lord Patel (CB) [V]]

My Lords, I support Amendment 38, in the name of the noble Baroness, Lady Thornton, to which I have added my name. I shall also speak to Amendment 39. I am grateful to the noble Lord, Lord Hunt, who has already spoken, for lending his support. I have listened carefully, and I support what has been said about the issues raised, particularly about whether we remain aligned with the EU trials mechanism or whether we are to be part of that mechanism.

During the EU withdrawal debate this issue was discussed at length. In fact, there was an earlier opportunity for the amendment to be put—as noble Lords may remember, it was widely supported—but I withdrew it, because the then Minister, the noble Lord, Lord Callanan, said that at an appropriate time, when legislation was brought in, the Government would address the issue. By that I supposed he meant that they would address the issue of remaining part of the EU clinical trials regime—but this Bill does not do that.

What options are available to the United Kingdom? One of them, of course, is to remain and participate in the EU clinical trials regime, if that is possible. An alternative is silent participation, as in the EEA model. That would mean that we could not vote, we could not lead projects and we could not raise objections. The third option is to be independent and aligned. The noble Lord, Lord Lansley, referred to that, and I agree with him that the important part of the EU clinical trials regime is its portal—a portal that the UK played a major part in developing—through which companies can apply for clinical trials.

The fourth option is to be independent and divergent: the UK would create a new clinical trials system. There is no time to do that by the end of 2020, but over time the UK could create a new system and build alliances. However, the risks need to be clearly understood, and balanced. Where will the companies go? Will they go where they have a bigger market, and a bigger opportunity, with larger numbers of patients for the trials, or will they conduct their trials in the United Kingdom?

There might be novel ways to approach this, and I understand that the MRHA is discussing and trying to develop a novel way of conducting clinical trials, which might be more attractive to companies. But of course, as we do not know what those are and we are not being told what they are, we cannot comment on them.

Currently, what looks like the best option is to be part of the EU clinical trials mechanism. With clinical trials for rare diseases, it is even more important for the UK to remain aligned with, or to be part of, the EU processes for rare diseases in relation to trials, to the data that will be available, and to medicines—for example, treatments developed for muscular dystrophy and metabolic disorders.

About 3.5 million people in the UK suffer at some point from one of the 7,000 or so rare diseases. The number for which treatment is available is small; hence the great need for collaborative research, data collection and the development of medicines, because a larger population is needed for clinical trials. Companies such as Silence Therapeutics, which the noble Baroness, Lady Thornton, mentioned, use gene silencing technologies for developing novel therapies for rare diseases. Others, such as Sarepta, use gene therapy for developing medicines. Companies such as Gilead Sciences are developing CAR T therapy; it was the first to introduce CAR T therapy for cancers in the United Kingdom. All those companies have said that they would wish to remain in the United Kingdom to do their trials, if the environment was right.

The treatments that will utilise innovative techniques, such as gene silencing, are often used to treat rare diseases that affect a limited number of people, as I said. The number of patients with a rare disease in an individual country such as the UK is likely to be low by definition. However, for clinical trials to work, they require large numbers. Unified and streamlined international processes are essential to ensure that the application authorisation processes of these clinical trials can continue to work both effectively and at pace.

By implementing the clinical trials regulation, the UK can remain eligible for access to the central EU portals and processes for clinical trials, which ensure that clinical trials can recruit enough patients for rare diseases and include submissions, reporting and authorisation requirements and, particularly importantly, inclusion in patient registries. Those were developed as part of the EU-wide MHRA initiative to develop registries for rare diseases.

The UK should also seek to maintain alignment with patient safety and pharmacovigilance standards, as mentioned by the noble Baroness, Lady Thornton, to give patients and clinicians confidence in trials that are conducted in the UK and to support the UK’s ability to host trials that need to take place in multiple countries. Without this level of alignment, it is likely that clinical trials, particularly for innovative treatments such as gene silencing, will not be able to go ahead in the United Kingdom, denying UK patients access to new treatment options at an early stage.

I will end by saying a few words in support of Amendment 125 in the name of the noble Baroness, Lady Jolly. Given the global nature of the Human Medicines Regulations, the UK should be a member of the ICH—the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use. Having recently joined as an observer on Project Orbis and the Access Consortium, the UK can work towards providing a leadership role on global regulatory standards, and it is more likely to do that if it is part of the EU clinical trials mechanism.

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[Lord Sharkey (LD) [V]]

My Lords, we strongly support Amendments 4, 42, 52 and 92 in this group.

The proposal in the Bill to create new criminal offences by statutory instrument is completely unacceptable. It is a matter of basic principle that the creation of new criminal offences requires proper parliamentary scrutiny. The delegated powers affirmative procedure does not provide this or anything like it. This ought not to be controversial. The Government’s own list of the areas in which it is appropriate to use delegated legislation does not include the creation of criminal offences.

Our Constitution Committee has made its position very clear. It considers the use of delegated legislation to formulate policy or create new criminal offences or public bodies constitutionally unacceptable. The Government propose to do the first two of those things in this Bill; it is dismaying that they should so directly and bluntly ignore the conclusion of the Constitution Committee.

The Government appear, however, to have felt the need to modify their initial position somewhat. Their amendments in this group preserve the power to create new criminal offences by statutory instrument, but now cap any sentence for breach at two years. That is a category error. Our objection is to the creation of criminal offences by delegated powers. The length of the sentence attached is completely irrelevant and I am amazed that the Government think that capping the sentence might make the creation of criminal offences proposal more acceptable.

There is an obvious and fundamental principle at stake here. Criminal offences, no matter what penalties are attached, should not be created without full parliamentary scrutiny. They should not be created by the use of delegated powers. I urge the Minister to think again and to remove the offending provisions from the Bill. If he is disinclined to do that, I hope that the House will insist on Report.

[Lord Kakkar (CB) [V]]

My Lords, I very much support what the noble Lord, Lord Sharkey, has just said. In so doing, I support Amendments 4, 42, 52, 63, 69 and 92 in this group.

It seems counterintuitive at the very least for a Government to come forward with proposals to give a Minister powers using a delegated provision to create new criminal offences and, when challenged, to justify the position by saying, “Well, we will limit the sanction to two years’ imprisonment.” This completely misses the point, as we heard from the noble Lord, Lord Sharkey. There is a clear principle at stake here, which has been well described by the Constitution Committee in its report on this legislation. Very simply, it offends liberty and the functioning of our democracy that a Government can propose to create criminal offences that would deny a citizen their liberty for one day, let alone a maximum of two years, and feel that there should not be proper parliamentary scrutiny in the accepted fashion for the creation of criminal offences. Her Majesty’s Government should think very carefully about what they propose to do here and bring their own amendments beyond the government amendments suggested in this group.

[Baroness Barker (LD)]

My Lords, I just want to add to what my noble friend Lord Sharkey said. This is a matter of principle; from the two reports by the two committees that have been cited and from the Second Reading debate, the Government can be in no doubt about the strength of feeling on it. In the light of those, the Government’s response in the government amendments in this group is, frankly, rather pathetic and not at all acceptable.

The Bill represents an enormous upheaval for one of the critical areas of our industry. The pharmaceutical industry is of immense importance to this country. Apart from anything else, to add criminal offences created through delegated powers by means of a Bill that is so spare and lacking in detail does a huge disservice to people who want to continue to pursue not just high-quality but ethical production of badly needed medicines in this country and within international frameworks. If the best the Government can do is to table the amendments in this group, they do the industry a great disservice.

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[Lord Sharkey (LD) [V]]

My Lords, Amendment 6 deals with human medicines. Amendments 53, 71 and 98 in the group make the same provisions as Amendment 6 but for veterinary medicines, medical devices and information systems. I will also speak to Amendments 143 and 144, which deal with the mechanisms that make Amendments 6, 53, 71 and 98 work. Our Amendments 135, 136 and 142 would replace the negative procedure in cases of urgency with the “made affirmative” procedure. I shall not speak to these because the Minister has more or less conceded the point in his new amendments.

Amendment 6 is in my name and those of the noble Lord, Lord Forsyth of Drumlean, the noble and learned Lord, Lord Judge, and the noble Baroness, Lady Andrews. I am immensely grateful for their support and regret that they cannot be present today because they are all speaking at the internal market Bill Second Reading in the Chamber. It is extremely unhelpful that the Government have scheduled two significant Bills for the same time slots. They should be decoupled to prevent future clashes.

Amendment 6 and its equivalents deal with the non-urgent scrutiny procedures currently set out in the Bill. They replace, in Parts 1, 2 and 3, the affirmative procedure for delegated powers with the super-affirmative procedure set out in Amendments 143 and 144 later in the Bill. The purpose of these amendments, taken as a whole, is to restore an element of parliamentary scrutiny to a Bill which so conspicuously lacks it.

This is a skeleton Bill. Parts 1, 2 and 3 contain no policy detail but give the Minister effective carte blanche. The Minister is given almost unfettered power to remake our human medicines, our veterinary medicines and our medical devices regimes. The reports of the DPRR Committee and the Constitution Committee were highly critical of this approach. At Second Reading, 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 that his committee was

“deeply concerned not only by the Government’s failure to provide sufficient justification for the adoption of a ‘skeleton bill’ approach—which would give Ministers sweeping powers to almost completely re-write the existing regulatory regimes … but also by their failure to acknowledge the breadth of the powers that the Bill would confer.”

He concluded:

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


Despite all this, it is likely that the Minister will choose to represent the proposed use of the affirmative procedure in this Bill as meaningful parliamentary scrutiny, but it is emphatically not that. Parliament cannot amend SIs and this House has voted down affirmative SIs just four times in the past 70 years. The Constitution Committee in its 2018 report The Legislative Process: the Delegation of Powers noted:

“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.”


Affirmative SIs do not constitute meaningful parliamentary scrutiny, and the Government’s promise of wide, but unspecified, consultation on the powers in the Bill does not somehow magically restore parliamentary scrutiny. Parliament is still bypassed.

There is a delegated legislation procedure that allows for significant parliamentary scrutiny. This procedure, which comes in several flavours, is known to the Government as “exceptional procedures” and to Erskine May, in Part 4 Chapter 31.14, as the “super-affirmative procedure”. This is what our amendments propose should replace the existing affirmative procedures written into Parts 1, 2 and 3. Erskine May characterises the super-affirmative 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 notes 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.”

Our amendments follow this pattern and are more generally based on the variant of the procedure used in the Public Bodies Act 2011. Amendments 143 and 144 set out the details and the stages. First, the Secretary of State must lay before Parliament a draft of the proposed regulations and a document explaining them; secondly, he or she must request a committee of either House whose remit includes health, science or technology to report on the draft regulations within 30 days; and thirdly, in proposing a draft statutory instrument containing the regulations, the Secretary of State must take account of any representations, any resolution of either House and any recommendations of the committee to which the draft was referred. After the expiry of the 30-day period, the Secretary of State may lay before Parliament regulations in terms of the original or a revised draft. The Secretary of State must also state what representations, recommendations or resolutions were made in the 30-day period and give details of any such. He or she must also explain any changes made in a revised draft. After that, the normal affirmative procedure continues.

The Library records that the last insertion in a Bill of the super-affirmative procedure was by the Government themselves in October 2017 in the Financial Claims and Guidance Bill. When they are not doing it themselves, the Government traditionally put forward any of or all three routine objections to the use of super-affirmatives. The first is that it is unnecessary because the use of the affirmative procedure provides sufficient parliamentary scrutiny. Sometimes, this objection is elaborated by praying in aid extensive consultation. I remind the Minister of the DPRRC’s remarks in paragraph 45 of its report on the Bill where it says that

“we are concerned at consultation being presented as a substitute for Parliamentary scrutiny.”

It is quite obviously untrue that the affirmative procedure allows any kind of effective scrutiny.

The second routine objection is that the super-affirmative procedure is cumbersome. I take this to mean only that this procedure is more elaborate than the affirmative procedure, which is, of course, the whole point. It is necessarily more elaborate because it provides for actual scrutiny where the affirmative procedure does not. The third routine objection is that it all takes too long. This has force only if there is some imminent deadline. The Minister may argue that there is such a deadline at midnight on 31 December. At this point, the Government lose the powers conferred by Section 2(2) of the European Communities Act to modify the regimes, but does this really present a deadline? I leave aside here the issue of whether this Bill will have been passed by then, given its very slow progress and the sparse future scheduling.

The impact assessment helpfully sets out, in Annexe B, the number of times the Section 2(2) powers have been used. Between 2013 and 2019 they generated a total of 11 SIs. In each of the last four years they have generated just one SI. This is not an avalanche. Nothing in these figures shows urgency. Nothing suggests we need to rush regime changes by excluding scrutiny provisions from the Bill. Nothing suggests that using the super-affirmative procedure would cause significant delay or disadvantage.

The impact assessment notes explicitly, on page 5:

“policy development is at an early stage”.

This was in June. If policy development has made progress since then, perhaps the Minister can now tell the Committee what policy changes he intends to propose, using the delegated powers in Parts 1, 2 and 3.

If policy development has not made progress, it is vital that when it does, and sees daylight in SIs, those SIs are scrutinised as fully as possible, as the super-affirmative procedure permits. In the event that a policy or technical change is required urgently, the provisions of this Bill, with the latest Government amendment, should allow the use of the “made affirmative” procedure.

This is a skeleton Bill. It is an attempt to bypass Parliamentary scrutiny. It contains no policy details and has no special claim to urgency as a reason for limiting scrutiny. The affirmative procedure is not meaningful scrutiny, as our Constitution Committee has pointed out—but the super-affirmative procedure is. That is what these amendments propose. Parliament should not be bypassed. I beg to move.

[Lord Kakkar (CB) [V]]

My Lords, I support the noble Lord, Lord Sharkey, and everything he has said in moving Amendment 6. These are clear matters of principle, and although one must accept that government Amendment 133 is an attempt to provide concessions on them, the noble Lord has set out clearly why adoption of even the affirmative procedure will not provide sufficient scope for appropriate scrutiny of what may turn out to be exceedingly important regulations.

The argument for adoption of the super-affirmative procedure has been well made, and I shall not repeat all the noble Lord’s arguments, save to say that in moving his amendment he also dealt with all the potential arguments that could be put against what is proposed in the amendments. In those circumstances, bearing in mind the importance of the issues that the legislation will cover, and the deep anxieties already expressed in Committee about the nature of the Bill, both in practical terms and in terms of its constitutional implications, Her Majesty’s Government should seriously consider accepting these important amendments.

[Lord Patel (CB) [V]]

My Lords, Amendments 137 and 138 in this group are in my name. They have partly been answered by government Amendment 133, and I shall speak about all three. My amendments are probing amendments, which would prevent regulation exercise in respect of Clauses 6 and 15 in relation to the disapplication of certain provisions in the medicines and medical devices regulations where there is a serious risk to public health. The reasons for this are the same as those set out earlier on the amendment tabled by the noble Baroness, Lady Thornton, and the noble Lord, Lord Hunt of Kings Heath.

The Government do not require the negative procedure to intervene swiftly in emergency scenarios, as the affirmative procedure is available, and safeguards parliamentary scrutiny. That is what the amendment is about. The Government have tried to respond to it, to some extent, through their Amendment 133, which removes subsections (3) to (9) of Clause 42 and inserts instead many new subsections, including a table detailing which specific provisions will be subject to the negative procedure, the “made affirmative” procedure and the draft affirmative procedure.

Covid-19 Update

Lord Kakkar Excerpts

Monday 21st September 2020 Lords Chamber

[Lord Bethell (Con)]

My Lords, the noble Baroness raises an important point about the rollout in the devolved Administrations. I do not have the details in my brief but I would be glad to write to her with them.

[Lord Kakkar (CB)]

My Lords, I draw the House’s attention to my registered interests. The Minister has alluded to the strategy, announced by Her Majesty’s Government earlier this month, of moving to mass population testing for citizens, regardless of symptoms. This is clearly predicated on having capacity for high-frequency testing, rapid reporting of results and a minimum threshold of accuracy for the test used. What assessment have the Government made of the threshold of accuracy in relation to sensitivity and specificity required to ensure that the mass testing strategy is successful—which is essential if we are to not only implement public health measures but save our economy?

[Lord Bethell (Con)]

My Lords, the user cases for different tests are being drafted and interrogated as we speak. The user case, for example, of an anaesthetist going into a delicate operation would be very different from the asymptomatic testing of a large school, or of people thinking about going to the pub in the evening. Matching the tests with the user cases is an important and necessary step. Once that is agreed with all relevant scientific committees, we will publish those user cases so that manufacturers can make the tests according to the required dimensions and specifications.

Covid-19: Rise of Positive Tests

Lord Kakkar Excerpts

Wednesday 9th September 2020 Lords Chamber

[Lord Bethell (Con)]

Testing arrangements for care homes have, as the noble Baroness, Lady Jolly, alluded to, risen dramatically. Testing is done in a large variety of ways. For large care homes, mobile testing facilities are put in place; for care staff, facilities at local NHS hospitals are in place; and we invite visitors to have tests in advance of visiting their loved ones. This is all overseen by the NHS Test and Trace programme, and the CQC remains the auditor of the care sector.

[Lord Kakkar (CB) [V]]

My Lords, I draw noble Lords’ attention to my registered interests, in particular my membership of your Lordships’ Science and Technology Committee. In his appearance before that committee in July, the Government’s Chief Scientific Adviser suggested that the higher the number of cases in circulation at the beginning of winter, the greater the likelihood of a significant peak of disease. What assessment have Her Majesty’s Government made of scientific evidence on the threshold at which the number of new cases might suggest that we can no longer be confident that the NHS will have sufficient capacity to deliver both its routine winter service and manage resurgent Covid-19 admissions?

[Lord Bethell (Con)]

My Lords, we are well within the threshold that the noble Lord, Lord Kakkar, alludes to, but we are concerned about winter. That is why we are putting in place new restrictions and new arrangements to stop the spread of this disease, protect the NHS and save lives.

Medicines and Medical Devices Bill

Lord Kakkar Excerpts

2nd reading & 2nd reading (Hansard) & 2nd reading (Hansard): House of Lords
Wednesday 2nd September 2020 Lords Chamber

[Lord Kakkar (CB)]

My Lords, I thank the Minister for introducing this Bill. In so doing, I remind noble Lords of my registered interests, particularly as professor of surgery at University College London and chairman of UCLPartners.

The Bill is important, as has been emphasised on so many occasions during this debate, because at its heart its purpose is to secure patient safety. Beyond that, it has the objective of ensuring a regulatory environment in which our life sciences industry can thrive. That is important because, beyond financial services, the life sciences are the second-largest contributor to our economy. However, patient safety comes first.

A number of issues in the Bill should have enjoyed detailed debate at Second Reading, but the way we are forced to conduct Second Readings at this time and the limited time we have to explore these issues make that impossible. However, I will identify and bring to your Lordships’ attention two specific issues that will need to be explored in Committee.

The first is the question of clinical trials. Twice in your Lordships’ House, Her Majesty’s Government have given very clear assurances that the clinical trials regulation that will at some point be adopted and implemented in the European Union would have its provisions reflected in UK legislation. It is regrettable that the new clinical trials regulation will not be in place by the time we leave the European Union and therefore not automatically become part of EU retained law.

The important issue here is that the trials regulation replaces the current clinical trials directive, which is defective. It seems unfortunate and unacceptable that, having lobbied so strongly in Europe to replace the current directive with the new regulation, our country, our patients and our researchers will be left with the defective current directive on the statute book. Why do Her Majesty’s Government not wish to use the current opportunity of this Bill to undertake implementation of the key improving provisions of the clinical trials regulation so that our research community and patients can benefit from an enhanced and much more effective clinical trials regulatory environment as we move forward?

The second issue is regulation of medical devices. We have heard much discussion about this problem during this debate. It is quite right that Clause 16 of the amended Bill, having completed its passage in the other place, provides for the opportunity to create registries to look at marketed device products to ensure that they can be traced and patients identified, but it does not deal with the important question of what level of evidence for the safety and efficacy of a device should be necessary before marketing authorisation is provided in the United Kingdom. This is vital.

There are trial methodologies beyond clinical, randomised trials which could be instituted that provide the opportunity for limited authorisation of new devices with patients included in prospective registries with very careful follow-up. The comparison of data from those patients with broader patients with similar diseases and conditions would allow for a proper safety evaluation of newly marketed devices and, ultimately, broader marketing once those initial data were made available. That would be the appropriate approach to patient safety. I hope Her Majesty’s Government will consider using the Bill to provide that kind of certainty.

Independent Medicines and Medical Devices Safety Review

Lord Kakkar Excerpts

Wednesday 15th July 2020 Lords Chamber

[Lord Bethell]

I thank the noble Lord for his searching questions. The role of the MHRA on both medical devices and medicines has been massively upgraded, and the review process for new medical devices has been improved. However, medical devices have different criteria from medicines.

One of the most important things that we have sought to do is to include a registry of the medical devices themselves and a registry of the medical devices inserted into individuals. Compliance with both procedures are the most important steps for clinicians embarking on new products.

[Lord Kakkar (CB) [V]]

My Lords, I thank the Minister for answering questions on this Statement and in so doing remind noble Lords of my registered interests. In her excellent report, the noble Baroness, Lady Cumberlege, identifies concerns about the lack of evidence that is required prior to the granting of marketing authorisation for many medical devices, where all that is often required is demonstration of equivalence to an already marketed product. The noble Baroness highlights the striking difference that exists with regard to the situation for medicinal products, where robust evidence of efficacy and safety is required before a medicinal product can be marketed. Are Her Majesty’s Government content with this situation—this difference between the level of evidence required before a product and a device can be marketed as regards patient safety? If there are concerns, what approach do Her Majesty’s Government propose to take with regard to ensuring that there is proper evidence of both the safety and efficacy of a device prior to its broad marketing and use in large populations of patients?

[Lord Bethell]

The noble Lord alludes to an extremely difficult balance that we have to seek to make. He is entirely right that medical devices and medicines operate on different criteria. The most important thing is that the MHRA resources for focusing on the approval of medical devices have been improved and the procedures enhanced. However, medical devices remain an important area of potential innovation, and we are concerned not to suffocate this area of potential improvement as it has been suffocated in other areas. At present, the Government believe that we have struck the right balance, but we remain keenly focused on it and it is under constant review.

Contraceptives and Hormone Replacement Therapy Drugs

Lord Kakkar Excerpts

Wednesday 18th March 2020 Lords Chamber

[Lord Bethell]

The noble Baroness is entirely right to express her frustration. It is enormously frustrating for those concerned and for our medicine supplies. Medicine production is a long-term business. There was a point when HRT consumption went down, but then demand grew exactly when some production facilities had backed off their supply. It was an incredibly unfortunate combination of events that has led to this situation, but I reassure the House that we are working extremely hard to provide alternatives and to replace those most favoured products that are in short supply at the moment.

[Lord Kakkar (CB)]

My Lords, I remind noble Lords of my declared interests. Has thought been given to whether novel therapies that might soon become available from research elsewhere in the world might be applied to the management of patients infected with coronavirus in our own country? Is the Minister content that the current regulations that govern the use of medicinal products in man are sufficiently flexible to allow for drugs that not only currently exist but might be repurposed for this, and for novel and innovative therapies, neither of which might be licensed for use in the United Kingdom at the current time, to be made available without further impediment if that was thought to be a useful intervention?

[Lord Bethell]

The noble Lord, Lord Kakkar, is entirely right to stress this point about regulation. I assure him and the House that we are working extremely closely with Public Health England and the MHRA to ensure that there will be no regulatory hurdle that prevents the swift introduction of proven, safe products into the UK market. This is a massive priority that has had great scrutiny from both the department and Downing Street. It is one that we are focused on and will continue to focus on.

Coronavirus

Lord Kakkar Excerpts

Monday 9th March 2020 Lords Chamber

[Lord Bethell]

The noble Baroness is absolutely right about the importance of guidance and I reassure her that an enormous amount of work is being done to draft clear guidance for employers, volunteer groups and all parts of society, which will include case studies, FAQs and detailed recommendations. That work is being guided by the CMO and senior officials at PHE.

As for 111, we look very closely at the metrics for the return of calls. Overall, the headline figures suggest that the 111 service is bearing up incredibly well under intense pressure, but I do not deny that there must be people who have had bad experiences. These pressures sometimes lead to poor results and we will keep a very careful eye on that.

[Lord Kakkar (CB)]

My Lords, I declare my registered interests. Clearly, the decision to move from the phase of containment to that of delay is essential to sustaining the ability of the health delivery system to deal with this problem.

What objective criteria will be used to determine how that decision is taken? How are the behaviour and natural history of this disease elsewhere in the world being used to inform when we should move from containment to delay?

[Lord Bethell]

The noble Lord asks an important question. The truth is that it is more of an art than a science. Efforts were made to look at clear metrics for triggering this result, but it is a complex situation and our understanding continues to develop. It is ultimately up to the judgment of the CMO and the confidence of the Secretary of State to make that call.

Queen’s Speech

Lord Kakkar Excerpts

Thursday 9th January 2020 Lords Chamber

[Lord Kakkar (CB)]

My Lords, I thank the Minister for the very thoughtful way in which she introduced this broadly based debate. She was able to reaffirm Her Majesty’s Government’s commitment to public services—none more than our National Health Service. She also demonstrated the very important government commitment to the area of science and innovation. In so doing, I remind noble Lords of my own registered interests, and in particular a new registration as chairman of the King’s Fund.

The issue of the provision of healthcare is critical to every citizen in our country. Not only is the provision of healthcare vital in terms of protecting our fellow citizens; it is critically important in ensuring that we have a healthy population who are able to contribute to the economy, and of course in ensuring that the vital investment that is made in the National Health Service and in the broader ecosystem that surrounds our National Health Service can be used to drive an important element of our economy: life sciences.

In the gracious Speech, Her Majesty’s Government outlined a number of important commitments to strengthen the provision of healthcare in our country in this coming Parliament, including: the area of the workforce, in terms of enhanced training, and the capacity to attract trained professionals from overseas to work and support our NHS through the provision of a new visa scheme; ensuring and enhancing patient safety through the introduction of a new investigatory mechanism, which needs to be thoughtfully introduced so as not to cut across the important regulators and the multiple mechanisms for investigation that already exist when there has been a mishap in the delivery of healthcare and where lessons need to be learned; and the commitment to enshrine in law the additional funding that is critically required to deliver the sustainability of our NHS.

I turn to two other important issues highlighted in the gracious Speech. The first is the capacity for integrated care, which will be critical if the additional funding provided is to be used in an appropriate way that will have a meaningful impact. Integrated care is of course the integration of primary with specialist care, the integration of care for physical and mental health, and the integration across the health and social care boundaries.

Her Majesty’s Government have received from NHS bodies some suggestions on legislative change that may be required to ensure that they can mobilise themselves effectively to deliver this important integrated care agenda. When do the Government propose to respond to suggestions that NHS England and NHS Improvement be merged, and that providers and commissioners of healthcare at a local level may form joint decision committees able to ensure a better integration of care, rather than having to have major legislative change to create new statutory bodies? It is critically important that, ahead of determining how this additional investment in the health service is to be spent, the structures in which the money will be applied are properly defined and the Government are absolutely content that they are fit for purpose to deliver the important objectives necessary for the long-term sustainability of the NHS.

It is also critically important to be clear that the voluntary joint decision-making committees, between commissioners and providers at local level, will be of sufficient authority to drive the changes in the delivery of care and working practices, and the construction of care environments, that will be necessary to ensure the successful application of this additional funding.

I turn finally to the question of innovation. Once again, Her Majesty’s Government, through the high-risk science fund—of which life sciences might represent an important component—seeks to demonstrate a broader commitment to the life sciences sector in our economy. The publication of the industrial strategy recognises the important contribution life sciences make to our economy—£74 billion per annum—and the 250,000 of our fellow citizens who are employed in the life sciences industry, to such great effect.

An important question remains about how that industry will interact in undertaking clinical research. The Government are committed to ensuring that our life sciences and healthcare economy become the most advanced and innovative in clinical research and the evaluation of innovation. How do the Government propose to do that in the context of still being able to participate effectively in the new clinical trials regulations that will exist for the rest of the health economy in Europe?

Queen’s Speech

Lord Kakkar Excerpts

Tuesday 22nd October 2019 Lords Chamber

[Lord Kakkar (CB)]

My Lords, I thank the Minister for introducing this debate and reminding your Lordships of the elements of the Queen’s Speech relating to healthcare provision and the science sector in our country. I remind noble Lords of my interests as professor of surgery at University College London and chairman of UCLPartners. It is a pleasure to follow the noble Baroness, Lady Walmsley.

I would like to pick up on some points made by my noble friend Lord Patel. I reiterate the tremendous regard and respect that all Members of this House, and I in particular, have for my noble friend Lady Emerton. She has made a remarkable contribution to your Lordships’ House and is one of its kindest and most thoughtful Members. It has been a great pleasure and privilege to come to know her since I was fortunate enough to join the House.

The Queen’s Speech rightly identified Her Majesty’s Government’s commitment to healthcare and the NHS. Clearly, safety is vital and the Government should be congratulated on introducing legislation to establish the health service safety investigations body. However, there are a number of potential concerns. A number of other organisations in the broad structure for the delivery of healthcare and other regulators already have a safety responsibility—NHS trusts, professional regulators, the Care Quality Commission, NHS Improvement and so on. All these bodies have statutory responsibilities. How will Her Majesty’s Government ensure that there is not regulatory overreach, which can have a detrimental effect on openness and transparency and impede the objective of ensuring that safety is at the heart of healthcare delivery? It is a very important question. Further regulation without consideration of what is already available could be very harmful.

There is also a clear commitment to ensuring that the additional funding already identified for the provision of healthcare in the NHS is appropriately applied. In this regard, are Her Majesty’s Government satisfied that the current landscape and the disposition of NHS England and NHS Improvement are appropriate, or do they present something of an impediment to the establishment of proper integrated care? This must ensure that the community base, rather than hospitals, is the focus for the management of chronic diseases, and that we have a system that facilitates the appropriate management of patients with established disease and ensures that prevention is at the heart of our ongoing healthcare strategy.

The adoption of innovation is also absolutely critical. The landscape, populated by many bodies, is particularly defined by the academic health science centres and health science networks. Are Her Majesty’s Government content that that structure is appropriate to facilitating the adoption of innovation at pace and scale, or is it necessary to look at those particular designations, and indeed other elements of the system, to ensure that they are better co-ordinated to deliver the adoption of innovation? Innovation will be critical to the sustainability of our NHS; we need innovation not only in novel therapies, medical devices and technologies but in how we develop the workforce to respond to the challenges of the next two decades.

We are also particularly privileged in our country to have a unique ecosystem defined by the National Health Service, our universities—we have four of the top 10 in the world for biosciences and life sciences—a remarkable pharma industry sector and, of course, a biotech and medtech sector. Those sectors commercially provide some £63.5 billion of turnover to the UK economy, employ more than 200,000 people and represent some 5,000 companies. That is of huge importance, not only for ensuring that innovation is established quickly, discovered and brought to bear to manage the diseases of our fellow citizens, but for its economic contribution. This has been well recognised by recent Governments, who have shown important commitments to this area.

However, in a report published in September, the Institute for Public Policy Research identified that whereas in 2011 our country enjoyed 10.5% of global spending on life sciences R&D, that figure fell to just 7% in 2016, despite an important commitment by the Government. The circumstances around Brexit have caused further uncertainty in the life sciences sector. It is a matter of deep regret that there might be further delay in delivering Brexit.

The implications of this are substantial for this important part of our economy, but they are also vital because if we fail to sustain the pace of innovation in life sciences, we will not deliver an NHS that can provide the most important benefits for our fellow citizens. That NHS will not be able to contribute to the growth of the economy and to increased wealth creation in our country because patients and individuals will be less healthy and less economically productive, and the broader benefits of this important sector will be lost to our country.

Academic Health Science Centres

Lord Kakkar Excerpts

Tuesday 2nd July 2019 Grand Committee

[Lord Kakkar (CB)]

My Lords, I also thank my noble friend Lord Butler of Brockwell for introducing this debate so thoughtfully. I declare my interest as chairman of University College London Partners, one of the designated AHSCs, and professor of surgery at University College London. As we have heard from the noble Lord, AHSCs were first designated some 10 years ago, following the review by the noble Lord, Lord Darzi of Denham, at the 60th anniversary of the NHS. Their clear purpose was to overcome the two translational gaps: the one between a discovery and establishing a therapy in man, and the one between that and ensuring it can be used more broadly across a relevant population. As we have also heard, there has been huge success in achieving the two objectives of overcoming translational gaps 1 and 2 with great effect on outcomes for individual patients, performance in broad health economies and opportunities for wealth creation in our country. It should be borne in mind that the life sciences represent, after financial services, the second most important part of our economy.

The nature and complexity of innovation and the broader questions attending health systems have changed over that 10-year period. We are faced with demographic change and important fiscal challenge and restraint in health economies. It is broadly accepted that the adoption of innovation is critical if health economies are to remain sustainable. Organisations such as academic health science centres therefore have a pivotal role. As we have heard, successive Governments have recognised not only the potential role of these centres, but the broader question of innovation in health economies through the creation of other designations, such as AHSNs, collaborations for applied research, biomedical research centres and so on. As we come to this third designation for academic health science centres, the question for Her Majesty’s Government is: what specific purpose do they see for AHSCs in the changed landscape for innovation in our health economies? Where do the AHSCs sit in terms of these other structures and designations, how are they to be co-ordinated, and how will we determine their success? We also have to try to understand whether the designation of academic health science centres in the future will be attended by contractual obligations, as we saw recently in the redesignation of the academic health science networks. To date, each of the AHSCs has been able to perform effectively, but driving its own agenda determined by its own local priorities and regional, national and global opportunities. Will that be the case in the future?

There remains also an outstanding question about how government and arm’s-length bodies in the NHS propose to facilitate the most important opportunity for academic health science centres: that is, their capacity to mobilise data across complex health economies and bring those to bear, not only on drug discovery but on changing the patterns and application of clinical care, development of the workforce, and of course the utilisation of vital resource most effectively. Do Her Majesty’s Government propose to deal with this particular question of mobilising the opportunity for health informatics in redesignation of academic health science centres? Finally, as we have heard, these designations come without any funding. Is it proposed that, at the time of redesignation, some funding is provided to the AHSCs?