Medicines and Medical Devices Bill

Lord Lexden Excerpts

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

[Lord O’Shaughnessy (Con)]

I shall speak to the amendments in reverse order, starting with Amendment 123 in the name of my noble friend Lady Cumberlege. As she said, these amendments deal with the here and now and with the future, and it is important that we start with the here and now. The perspective I bring to this is again informed by my work with valproate charities through the all-party group and by reflecting on the evidence compiled by charities such as INFACT and others and presented in my noble friend’s report. Historically, some 20,000 babies were exposed to valproate in the UK and half suffered harm. The disorder recognising those harms, foetal valproate spectrum disorder, was fully recognised only in 2019, although the drug was known for decades to have effects of that kind.

It must now be the case that for those families and others we put in place a proper redress scheme. They have had to battle to be recognised. They have had to battle to change clinical behaviour. They have had to battle red tape and a lack of understanding in personal impact payment schemes and in the education and health assessments carried out for young children. This is not only a historical problem; it is true today. We need a solution in the here and now. We do not need to spend huge amounts of time creating a new agency or anything else—I will come to that in a moment—but we need to address that and their harms today. I hope my noble friend will be sympathetic to that spirit.

Amendment 122 is in the name of the noble Lord, Lord Hunt. He is quite right to want to look at this structurally, given all the scandals over the years, including thalidomide, contaminated blood, which I dealt with briefly when I was a Minister, breast implants and many others. It was quite right that my noble friend Lady Cumberlege talked in her report about creating an agency and a proper redress scheme for clinical negligence. Indeed, she has been promoting such an idea since her work on maternity safety, where, as we know, are the largest financial claims and some of the most heart-breaking. I do not think any of us can deny that the system is currently broken. The noble Lord, Lord Hunt, talked about some of the data points from NHS Resolution’s annual report. The annual cost is now nearly £2.5 billion and there are total liabilities of £84 billion because of clinical negligence. A lot of that is the cost of care for people who have been harmed, but a lot of it is the frictional cost—the legal and other costs of going through the process—let alone the uncounted cost to families, especially as the average number of days to settle claims has been increasing over the past decade. There is a very strong case for acting in a big structural way to do something about this.

Having said all that, and having been responsible for this policy area as a Minister, it is a very complex situation. There is undoubtedly a case for moving to a less confrontational and swifter approach. This is not a new idea, as the noble Lord, Lord Hunt, pointed out. We have been thinking about this and legislating for this purpose for at least the past 15 years. There are good examples of no-fault compensation schemes that work in New Zealand and across Scandinavia, which generally satisfy all the participants and, importantly, change clinical behaviour, which is so important in reducing the cost. However, the truth is that this is tied up in broader tort reform, which I am definitely not expert enough to discuss, and in considerations attached to other legislation. A good example is Section 2(4) of Law Reform (Personal Injuries) Act 1948, which has been discussed in this House before and concerns the entitlements of people who have suffered from clinical negligence, but inevitably affects other people who have been harmed.

It is also true that these kinds of schemes do not necessarily save money. Indeed, the modelling I saw when I was a Minister suggested that they could end up being more expensive. That is the challenge and we have to be realistic. It might be deserved, but it is a challenge in moving from one scheme to another.

I am definitely a supporter of action on this front, and I would very much like to hear from my noble friend that work is going on. I worked closely with my noble and learned friend Lord Keen, when he was at the Ministry of Justice, on this programme, and I hope it has continued. I am not sure that this can be dealt with in the way suggested, with a clause dropped into the Bill, because of all the consequential changes and the very difficult issues that it raises, but it is unbelievably important. The cost—that liability of £80 billion—is two-thirds of annual spending on the NHS and we simply cannot go on taking on these liabilities to future tax- payers, let alone to those people who have been harmed. We need to see a more robust policy response from the Government in general on this.

[The Deputy Chairman of Committees (Lord Lexden) (Con)]

The next speaker on the list, the noble Baroness, Lady McIntosh of Pickering, has withdrawn, so I call the noble Lord, Lord Lansley.

[Lord Lansley (Con)]

My Lords, I am in the position that my noble friend Lord O’Shaughnessy was in earlier, as much of what needs to be said has been said, but I want to add a few remarks on the two amendments.

I echo what my noble friend Lord O’Shaughnessy said. In the light of the First Do No Harm report, we have to be careful to address ourselves to the issues before us and put in place schemes of redress on the three causes. I am not an expert on those, but when I was Secretary of State for Health I was only too aware, when dealing with the Thalidomide Trust or infected blood payments, for example, that when we reviewed and made payments that were more generous, we were working in what was, in effect, an administrative structure that did not necessarily have coherence or consistency. We were making what we thought were the right decisions at the time, but those who had been harmed all suffered, from their point of view, from two problems. The first was the relative lack of generosity of the payments, which were made to reflect specific needs but were not representative of the overall harm that had been done. Secondly, there was no admission of liability, which is always an issue. Liability matters. Those who are harmed want to see liability determined and accepted.

I am sympathetic to the view that not only should redress schemes be considered for the three causes in the report, but the Government should take the opportunity to think about what a redress scheme might look like more generally. My noble friend Lady Cumberlege and her colleagues looked carefully at a number or international examples. They might well have thought, with some justification, that the French scheme—I will not attempt its title in French, but it is a national office for indemnity in relation to medical accidents—is an interesting basis on which to examine the issue. We might include not only the redress schemes from previous years but the present schemes that need to be established. This is something that Ministers might want to say in relation to the continuing review into infected blood accidents.

Again, like my noble friend Lord O’Shaughnessy, I do not want to confuse what are related but distinct issues. The schemes relate to what are, in effect, systemic failures. Recommendation 3 of my noble friend Lady Cumberlege’s report appropriately says that the schemes are to provide redress in relation to avoidable harm resulting from systemic failures. There is a question, which is not entirely resolved in the report, about which test should be applied. The Government should look carefully at where liability genuinely lies. Where there is harm as a result of systemic failings, the Government have a responsibility. That is fairly straight- forward. However, that is not the same as assuming that such a scheme should encompass all the many other cases that give rise to most of the clinical negligence claims against the NHS, which result not from systemic failings but from the failings of medical practice in particular circumstances. Those are different and separate. This debate is not the right place to go on about that at length.

I was interested to hear the noble Lord, Lord Hunt of Kings Heath, talk about the NHS Redress Act 2006. The noble Baroness, Lady Thornton, will recall that in 2009 she was not able to bring that Act into force. I was the shadow Secretary of State during the passage of that Act and Secretary of State after 2010. One reason for not bringing it into force, to which my noble friend referred, was the Government’s intention to undertake tort law reform in general and this was a tort-based liability scheme.

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[Lord Bethell (Con)]

My Lords, I thank the noble Lord, Lord Hunt of Kings Heath, and the noble Baroness, Lady Bennett of Manor Castle—who indicated her interest in this along with my noble friend Lady Cumberlege—for raising the important issue of redress for those harmed by medicines and medical devices.

I share the review’s concern that patient voices were not heard, and I reiterate that we are committed to ensuring that the healthcare system does better at listening, learning and acting on patient concerns. Furthermore, we recognise that patients need to be at the centre of decision-making to ensure that their perspectives are built in.

Our focus is on improving the safety of medicines and medical devices so that in future there should be less need for redress. We are determined to increase patient safety and drive additional pre-market scrutiny and post-market surveillance of medical devices. For example, the yellow card scheme plays a vital role in providing an early warning that the safety of a product may require further investigation, and the MHRA is transforming and strengthening the system to make it easier for patients and healthcare professionals in the UK to directly report adverse incidents involving all medicines and medical devices. The UK has one of the safest medicines systems in the world and we will continue to make sure that patients and the public have access to the best and most innovative medicines.

Amendment 122, in the name of the noble Lord, Lord Hunt, would require the Secretary of State to bring forward proposals to establish a redress agency within 12 months of the Royal Assent of this Bill. Committing now to such an agency would short-cut the in-depth policy consideration that the review’s recommendation of a redress agency deserves, as a number of noble Lords have reasonably recognised. I understand that my noble friend Lady Cumberlege herself undertook substantial engagement with the affected patients and other parties as part of her review. Listening and consultation is a vital part of how we take forward any policy change, and it is even more important given the significance of this issue.

A redress agency would represent a significant addition to the current landscape for all stakeholders, and we need to give them time to contribute their perspectives and think through the implications for them. In particular, there is a need to work through what the determinations and parameters of such arrangements would be and how they would interface with current legal remedies—already complex—before we could agree to take forward this proposal. This would help us explore how that would affect the patient journey through different potential approaches, the costs and their value for money. We also need to be mindful of the potential impact on industry.

With regard to Amendment 123, tabled by my noble friend Lady Cumberlege, given that legal action is pending over hormone pregnancy tests, and as is usual when matters are sub judice, I am restricted in what I can say on this aspect of the amendment.

I know that the establishment of a specific redress scheme was my noble friend’s fourth recommendation in the report of the Independent Medicines and Medical Devices Safety Review. While I am very sympathetic to the desire of my noble friend and others to see the Government respond to her report and take forward her recommendations, I do not agree that policy should be made and deadlines set through primary legislation. Indeed, her report itself was sadly delayed during the current situation we find ourselves in.

I reassure the noble Lord, Lord Hunt, that we will respond to the issues raised in the amendment as part of our formal response to the Independent Medicines and Medical Devices Safety Review. The Government are considering all recommendations made in that review and will provide an update before the Christmas Recess. I hope that the noble Lord, Lord Hunt, has heard enough that is reassuring and feels able to withdraw Amendment 122, and that my noble friend Lady Cumberlege is similarly reassured not to move hers.

[The Deputy Chairman of Committees (Lord Lexden) (Con)]

My Lords, I have received no requests to speak after the Minister, so I call the noble Lord, Lord Hunt of Kings Heath, to conclude the debate on his amendment.

[Lord Hunt of Kings Heath (Lab) [V]]

My Lords, I think this has been an excellent debate. I fully accept, as my noble friend Lady Thornton said, that my Amendment 122 covers a much wider area than Amendment 123, which focuses on the specific issues relating to the report of the noble Baroness, Lady Cumberlege.

My Amendment 122 was definitely a probing amendment, because the current situation in relation to clinical negligence is wholly unsatisfactory. It combines the bureaucracy and slowness which the noble Baroness, Lady Bennett, referred to in relation to Windrush and she is absolutely right to draw parallels. It combines a hugely frustrating process for patients and their relatives with a system that increasingly becomes ever more expensive for the NHS. The noble Lord, Lord Bethell, was not going to be drawn on these wider considerations, but the noble Lords, Lord Lansley and Lord O’Shaughnessy, have both dealt with these—we know that it is a very complex issue, but surely, at the end of the day, we have to recognise that the current system simply is not working.

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Clauses 39 and 40 agreed.

[The Deputy Chairman of Committees (Lord Lexden) (Con)]

We now come to Amendment 126. I should inform the Committee that if this amendment is agreed to, I cannot call Amendments 127, 128 or 129.

Clause 41: Consultation

Amendment 126

Moved by

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Amendment 133 agreed.

[The Deputy Chairman of Committees (Lord Lexden) (Con)]

Amendments 134 to 138 have been pre-empted.

Amendments 134 to 138 not moved.

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Clause 43 agreed.

[The Deputy Chairman of Committees (Lord Lexden) (Con)]

We now come to Amendment 145. I remind noble Lords that anyone wishing to speak after the Minister should email the clerk during the debate.

Clause 44: Commencement

Amendment 145

Moved by

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[Lord Bethell (Con)]

My Lords, I thank the noble Baroness, Lady Thornton, for her amendment, which would require the Secretary of State to act in accordance with the guidance on the use of civil sanctions—I am sorry, I am on the wrong amendment.

Amendment 145, in the name of the noble Lord, Lord Sharkey, seeks to amend the commencement clause, Clause 44, so that all provisions would come into force on the day the Bill receives Royal Assent. I am confident that the amendment is not necessary. Clause 44(1) provides that the clauses needed to make emergency amending regulations will come into force the day the Bill receives Royal Assent.

Under Clause 44(2), a significant number of clauses come into force after the customary two-month commencement period. Chapters 3 and 4 of Part 3 come into force on a day the Secretary of State appoints which is specified in regulations. This combination of commencement provisions is for a good reason. Patients, stakeholders and Parliament must know what the law is before the law is made. The two-month commencement period allows the Government to continue to engage with industry and the relevant stakeholders properly before provisions come into force.

Importantly, Clause 44 provides for the necessary powers and provisions to come into force on Royal Assent should it be necessary, within that two-month period, to make regulations urgently in order to protect the public from an imminent risk of serious harm to health.

I understand that there may be concern about Clause 44(3), which allows the Secretary of State to determine when Chapters 3 and 4 of Part 3 come into force, but I assure the noble Lord that, again, this is for a good reason. Chapter 3 of Part 3 is concerned with enforcement and included in that is the introduction of a civil sanctions regime. Civil sanctions will act as a flexible, proportionate enforcement mechanism, enhancing the MHRA’s ability to incentivise compliance. The new civil sanctions regime requires supplementary regulations to be made under paragraph 9 of Schedule 1 before it can be fully operational. It is important that the MHRA engages with industry and stakeholders on these regulations and the accompanying guidance. Indeed, the Bill requires a consultation to be carried out before they are made. If these provisions came into force on the day the Bill achieved Royal Assent, we would have no time to make the necessary regulations. Our time to consult in advance on those regulations and the guidance would be severely condensed.

It is absolutely right that we consider the views of stakeholders and the public before making the supplementary regulations and bringing the new civil sanctions regime into force. I assure noble Lords that the Government are committed to bringing the enforcement and data and disclosure chapters into force as soon as is appropriate in order to enhance the safety of the medical devices regime. I hope the noble Lord, Lord Sharkey, understands the reasoning behind the clause and feels able to withdraw his amendment.

[The Deputy Chairman of Committees (Lord Lexden) (Con)]

My Lords, I have received no request to speak after the Minister, so I call Lord Sharkey—

[Lord Lansley (Con)]

I sent an email.

[The Deputy Chairman of Committees (Lord Lexden) (Con)]

With apologies to the noble Lord, Lord Lansley, who does wish to speak after the Minister, I now ask him to do so.

[Lord Lansley (Con)]

I thank the Deputy Chairman. I sent the email only about 30 seconds ago so I suppose, strictly speaking, that apologies on his part are not required. I should have anticipated the need to ask a question, but I am afraid I was prompted by listening to the noble Lord, Lord Sharkey, and the Minister’s reply. I want to ask one question: how can what will become Section 1 be brought into force without Section 2? I do not understand. If a power is to be used under Section 1, it must surely make provision about some of the long list of relevant areas in what will be Section 2. In the absence of Section 2 being in force, I cannot see how Section 1 works.

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[The Deputy Chairman of Committees (Lord Lexden) (Con)]

We now come to Amendment 146. I remind noble Lords that anyone wishing to speak after the Minister should email the clerk during the debate.

Schedule 1: Medical devices: civil sanctions

Amendment 146

Moved by

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[Baroness Thornton (Lab)]

My Lords, we have reached the final amendment so I will be as brief as I can. The first thing I need to clarify, and I do not know if other noble Lords have spotted this, is that my amendment is actually to page 32 not page 34, otherwise it makes no sense at all. It is to amend line 10 on page 32—of the Bill that I have in front of me, anyway. But maybe I have an old copy of the Bill. Paragraph 13(7) of Schedule 1 says:

“The Secretary of State must have regard to the guidance or revised guidance published under this paragraph in exercising functions under this Schedule.”


That is the point of this tightening-up amendment, which would require the Secretary of State to “act in accordance with” the guidance.

Amendment 146 is about the planned civil sanctions regime for medical devices. Part 5 of Schedule 1 provides that the Secretary of State must “prepare and publish guidance” on

“the sanctions that may be imposed on”

someone who commits an offence,

“the action that the Secretary of State may take”,

and the circumstances in which they may take such action. This could be, for example, when a penalty may or may not be imposed, the amount of such a penalty, what the Secretary of State will take into account in determining that amount and so on. Before publishing the guidance the Secretary of State will, of course, consult devolved Administrations and anyone else they consider appropriate. Where necessary, should changes be needed, the Secretary of State must revise the guidance and publish the revised version.

Once published, this guidance is the information that will be in the public domain on the operation of this regime. Yet after all that preparation, as currently drafted, the Bill says the Secretary of State must only “have regard to the guidance” when “exercising functions under this Schedule”. The amendment would simply tighten this up, so that the Secretary of State must “act in accordance with” the guidance. I look forward to the Minister’s response, and I hope we can locate it in the right place—I obviously have an old version of the Bill in front of me.

[The Deputy Chairman of Committees (Lord Lexden) (Con)]

The amendment proposed is to page 34, possibly corrected by the noble Baroness, Lady Thornton, to page 32.

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[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.

[The Deputy Chairman of Committees (Lord Lexden) (Con)]

My Lords, I think that I have received no requests to speak after the Minister so, hoping that I have not overlooked the noble Lord, Lord Lansley, once again, I call the noble Baroness, Lady Thornton, to conclude this debate.

[Baroness Thornton (Lab)]

First, I need to say that I do have an old version of the Bill which I picked up from my desk on my way here, so I apologise to the Committee for that. I will read the Minister’s comments, but if the schedule already has, as I understand it, the ability to be flexible written into it—I think the Minister said that it was there in Clause 13—it seems to mean that one does not need to have regard to it. One would need to act in accordance with it, because the Bill already has built into it the flexibility needed under the circumstances that he was describing. However, I will read his comments and reflect on them. I beg leave to withdraw the amendment.

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Bill reported with amendments.

[The Deputy Chairman of Committees (Lord Lexden) (Con)]

My Lords, that concludes the Committee’s proceedings on the Bill. I remind Members to wipe their desks and chairs before leaving the Room.

Committee adjourned at 4.56 pm.