Medicines and Medical Devices Bill

Lord Bethell Excerpts

Committee stage & Committee: 2nd sitting (Hansard) & Committee: 2nd sitting (Hansard): House of Lords
Monday 26th October 2020 Grand Committee

[The Deputy Chairman of Committees (Baroness McIntosh of Hudnall) (Lab)]

The noble and learned Lord, Lord Mackay of Clashfern, has withdrawn from the debate, so I call the noble Baroness, Lady Jolly. Is Baroness Jolly with us? I am going to call her one more time; then we will have to move on, I am afraid. Baroness Jolly? Apparently not, so I now call the Minister.

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

My Lords, I give profound thanks for the debate on this group and start by reassuring the Committee that safety is very much at the heart of the Bill. Doing what is right for patients is at the heart of it but I acknowledge the remarks alluded to by my noble friends Lord Lansley and Lord O’Shaughnessy: patients are also entitled to have conversations with their doctors about what is right for them. That sometimes goes beyond a conversation about safety. To have those balanced, personal conversations to offer them hope, with innovative new treatments or in a clinical trial, we need other considerations to work together; we need the full picture and I want to make a few remarks on getting that balance right.

Before I do, I acknowledge the very touching and moving human stories that a number of noble Lords remarked on in this debate. I always find this subject extremely moving, and it is entirely right for us to remember the tough anecdotes and testimony of those groups which have advocated on behalf of the victims of terrible misadventure and clinical mistakes in the past. I also acknowledge what the noble Lord, Lord Alton, referred to as misogyny and what the noble Baroness, Lady Thornton, referred to as being ignored by the clinical profession. These two aspects of the situation weigh most heavily on my mind.

Before I move on to the testimony of the noble Baroness, Lady Cumberlege, I thank her for the hard work that she and her team put into her report. I reassure her and others that there is no question of the report in any way being buried or overlooked, or not cared about. The report, which was delivered in late July, is being weighed up with seriousness and intent. I reassure all those who are part of this debate that the Minister for Patient Safety, Nadine Dorries, is working up a response to it which will be delivered thoughtfully and with impact when the time is right. I completely and utterly recognise the support from across the House and from patient groups for the report’s recommendations and import.

However, patient safety is not the only aspect of the Bill, which we think needs to get the balance right between different aspects. Perhaps I may flag to noble Lords our amendment on this, Amendment 2, which inserts on page 1 at line 6:

“The appropriate authority may only make regulations under subsection (1) if satisfied that they would promote the health and safety of the public.”


We think that Amendment 2, agreed last Monday, gets the proportionate and balanced approach correct and that we have practical regulation which can rise to the challenge of public health. I spoke last week to the reason for Amendment 2; it is a floor, not a ceiling. It means that the appropriate authority must be satisfied that regulatory changes promote public health, which is an important introduction to the Bill.

Whenever we reach this House, we deal with matters of nuance. We have discussed my noble friend’s amendments to change the way in which considerations apply, to one of an “objective”. With Amendments 8, 55 and 73 the noble Baroness, Lady Thornton, has proposed additional curbs. She has asked for regulations to be made that

“act with a view to ensuring”

that three considerations are met. I would expect to be asked under what circumstances regulations might be made that do not

“act with a view to ensuring”;

It would not be scrutiny by noble Lords if I did not. When we looked at this construction, it seemed likely that matters we might well wish to regulate on that were not specific to the considerations would fall out of scope. The burden of proof that those regulations met the bar the noble Baroness would set would be very high. “Ensuring” is the question here.

Government Amendment 2, which was passed last week, sets that threshold for regulation, where the authority must be satisfied that regulation would promote public health. I hoped that it would satisfy, but I am open to further conversation with the noble Baroness on this and, of course, other matters.

If the root of the issue is how the considerations will be applied by the appropriate authority, the noble Baroness will be aware that the Government have tabled amendments to Clause 41. Those amendments would change the way in which consultation is run. We would be obliged to include initial thinking on how the considerations have been applied to the development of regulatory change proposals so far.

The noble Lord, Lord Sharkey, has with Amendment 9 also suggested that an assessment of impact on these three considerations be published alongside draft regulations. He knows that an Explanatory Memorandum and an impact assessment must be produced when making a statutory instrument. While we are not there yet, I draw his attention to government Amendment 131, which would oblige the Secretary of State to report to Parliament every two years. That report must contain concerns raised during consultation, with that consultation informed by the Government’s initial assessment of the considerations. Parliament will therefore have the Government’s assessment but also the public’s assessment of the Government’s assessment. I hope that that is reassuring to the noble Lord.

I started this group by touching on the importance of patients and I am grateful to my noble friend Lady Cumberlege for her Amendment 10. She has support for it. I fully understand and support the rationale for wanting medicines and medical devices to be safe for patients. However, Amendment 10, placing the safety of medicines above all other considerations, could inadvertently put patients at risk.

The noble Lord, Lord O’Shaughnessy, alluded to availability, for example. During the pandemic, much has been done to ensure supplies of medicines—new experimental medicines, old medicines for different purposes or medicines that are at least available when others are in short supply. We have introduced a number of regulatory flexibilities, which have been widely welcomed by industry. They have helped to secure continued supply in a very challenging situation.

While patient safety underpins everything that the MHRA does, these changes were introduced for the primary purpose of ensuring continued supply. If we placed the safety of a medicine above all other considerations, we might put the safety and health of the patient and wider public at risk should they not receive the medicines that they need.

It would also potentially mean challenges in getting patients new medicines. A medicine that is novel or offers a great deal of hope might be inadvertently ruled out because of concerns regarding poor clinical practice or potential use in patients for whom it is not appropriate. We do not want to deny a potentially effective medicine to all patients in all circumstances. By placing safety as the primary consideration, clinical trials would also be almost impossible to conduct. By their very nature, they seek to test the safety of medicines.

I understand the noble Baroness’s concerns. She is deeply motivated by a desire to prevent what has happened before from happening again. I have spoken to patient groups. I am a father of daughters and a husband to a wife. I was deeply affected by the speeches made at Second Reading. However, I think that her objective—the safety of patients, not the safety specifically of medicines and medical devices—is protected by the government amendments that were passed last week. We will not be able to make regulations if we cannot be satisfied that they promote public health. That rules out deregulation for deregulation’s sake, for instance, but it allows, particularly in the case of an emergency, getting treatment to patients.

I hope that the noble Baroness will understand that we are aligned in intent, if not in delivery. We have designed that overarching test—that the appropriate authority is satisfied—to deliver on the safety of patients without preventing, for example, regulation in a pandemic. I know that she has spoken to my officials. I welcome ongoing conversations through the passage of the Bill, in Committee and beyond.

--- Later in debate ---

[Lord Hunt of Kings Heath (Lab)]

My Lords, I thank the Minister for his response. Could he say a little more about the Government’s overall patient safety strategy? He is saying essentially that the Bill is confined to medicines and medical devices regulation, yet underlying the concerns of the noble Baroness, Lady Cumberlege, is the fact that patient safety has not been gripped. In a sense, he has given a technical response. We will come to more specific amendments relating to, say, a patient safety commissioner, but at some point it would be interesting to get an insight into government thinking about patient safety more generally.

[Lord Bethell (Con)]

I will be candid with the noble Lord. The Cumberlege report has put patient safety absolutely at the top of the agenda. If it was not for Covid, it would be the primary issue of today in health matters and would lead all our thinking for the year ahead. The report is incredibly important and it has made its mark in a big way. However, it was delivered at the end of July and, if you take out August, that is only six or seven weeks ago. It takes a bit of time to respond to these reports. I know that the noble Baroness is chafing at the bit and wants a response—of course she does—but it has not been very long in report terms.

I cannot avoid the obvious, which is that we are in the middle of an epidemic. The Department of Health is completely overrun. We have nearly doubled in size in the past four weeks, but even so the capacity for response, in ministerial time and official time, simply is not there. I completely understand the keenness of noble Lords in this Room to get a clear response, but the sequencing is that this is a Bill on medicines and medical devices. We seek to take on board the lessons of the Cumberlege report and, where possible, specific items, but the Bill is not designed to be a vehicle for the implementation of the report recommendations. We will acknowledge and, where possible, accommodate the report’s insight, but the report needs a formal response from the Minister for Patient Safety and I am not that Minister and there has not been time for that response to arrive yet.

[The Deputy Chairman of Committees (Baroness McIntosh of Hudnall) (Lab)]

My Lords, I will have one more go to get the noble Baroness, Lady Jolly, to join us. Lady Jolly? It is rather sad calling into the void. I take it that she is not able to join us, so I call the noble Baroness, Lady Thornton.

--- Later in debate ---

Moved by

[Lord Bethell]

14: Clause 1, page 1, line 11, leave out paragraph (c) and insert—
“(c) the likelihood of the relevant part of the United Kingdom being seen as an attractive or favourable place in which to conduct clinical trials or supply human medicines.”Member’s explanatory statement
This amendment clarifies what was meant by the version of Clause 1(2)(c) in the Bill as brought from the House of Commons.

[Lord Bethell (Con)]

My Lords, in moving Amendment 14, I will also speak to Amendments 57 and 77 in my name. These all relate to clarification of the Government’s use of “attractiveness” in the Bill.

Our life sciences sector is critical to this country. It achieves great things. We have the RECOVERY trial. We have an industry that rose to the ventilator challenge issued earlier this year. It contributes to the economy and jobs; in turn, the Government have committed to ensuring that it continues to do so.

Our approach to regulation is a pivotal part of supporting that. I know that much was said at Second Reading as to how attractiveness might be defined. A number of amendments have been tabled to define it, all of which demonstrate the importance of this part of regulatory consideration. I look forward to hearing the debate on them.

To provide greater clarity on our meaning and intent of the “attractiveness” consideration in Clauses 1, 8 and 12, I have brought forward Amendments 14, 57 and 77. They set out that, as an integral part of the development of proposed regulatory changes, regard will be given to the favourability of the UK as a place to conduct critical medicine and device development, manufacturing and supply processes.

They also clarify our intent that Clauses 1(2)(c), 8(2)(c) and 12(2)(c) reflect that the Bill is a platform for us to continue to support increased investment in the UK to develop and supply medicines and devices, by ensuring that we make regulation that is sympathetic to that need. That is why the amendments strengthen the consideration regarding the likelihood of the relevant part of the UK to be seen as an attractive or favourable place in which to trial and supply human medicines or develop and supply veterinary medicines and medical devices.

I am pleased to see that this focus on favourability echoes language in amendments put forward by the noble Baroness, Lady Thornton, and the noble Lords, Lord Patel and Lord Hunt. Many of the proposed amendments on the definition of attractiveness provide an explicit list of specific elements that could underpin a consideration of favourability or attractiveness of the UK as a place to develop and supply medicines and devices, but I am confident that the current drafting already captures the multiple different stages that are inherent in seeing these goods placed on the market and supplied to patients.

The noble Baroness, Lady Thornton, and others have commented on the fact that this is a new term in legislation. Attractiveness means doing everything reasonable to be the first place where new treatments are identified, developed, rolled out and adopted, where investment in life sciences takes place and where the enrolment of patients in clinical trials is supported. It is neither necessary nor helpful to set out in the Bill all the different factors and stages of the development and supply landscape that will enhance the attractiveness and favourability of the UK. Providing a narrower definition limited to specific factors and elements of the current development and supply landscape risks excluding aspects of supply that are not yet in place. If we cannot currently predict the scale of innovation that these sectors may offer in future, can we accurately predict all the factors that will ensure that the UK is an attractive place to bring those innovations?

Government Amendments 14, 57 and 77 work together with government Amendments 2, 7, 51, 54, 56, 68 and 72. These place an obligation on the appropriate authority to be satisfied that the effect of the changes will be to promote the health and safety of the public or, in the context of veterinary medicines, that the regulations promote the health and welfare of animals, the health and safety of the public or the protection of the environment. It is part of that assessment into whether health and safety would be promoted that the appropriate authority must have regard to safety, availability and attractiveness.

In combination, I am firmly of the view that these amendments will ensure that appropriate rigour is given to how the key powers in Clauses 1, 8 and 12 are exercised. These amendments provide additional nuance. They clarify but they do not proscribe. They rule in rather than ruling out. I beg to move.

--- Later in debate ---

[Baroness Thornton (Lab)]

I thank all the speakers who supported our Amendment 20 and the amendments that follow on from it. I need to start by placing on the record that we do not agree with the Government’s amendments to this clause but we will not object to them. Were we not in the situation of basically having to agree to put these amendments in the Bill, this is a very good example of where we would need to have a different kind of debate. Looking specifically at the Government’s amendments, I think that adding the word “favourable” does not clarify the meaning or elucidate anything. Since we are not absolutely certain what “attractiveness” means, I am not sure we can be clear what “favourable” means either.

Our amendments, and others that noble Lords have tabled, would take the first stab at defining “attractiveness”. I am very attracted to the amendments that the noble Lord, Lord Sharkey, spoke to, because the idea of improvement is also very important. We are in the same territory and we will need to put further thought into this between now and the next stage of the Bill.

My noble friend Lord Hunt was completely correct when he spoke about the need to address how slow we are in this country in the uptake of new medicines and innovations. The noble Lord, Lord Patel, said that if we do not define “attractiveness” we might end up with the sort of undesirable trade-offs we discussed earlier today.

We have had a very interesting and useful discussion—the kind of discussion we should have in Grand Committee—where various points of view come together. We can see that we might end up with a completely new amendment at the next stage that will define “attractiveness” in the Bill and talk about the need for improvement and innovation. We will probably need to put our heads together between now and then.

[Lord Bethell (Con)]

My Lords, this has been an important discussion as to what attractiveness of the UK means. We have already moved on this issue with our amendments. We are still listening. I thank noble Lords for an instructive and wise discussion of this issue.

The noble Lord, Lord Sharkey, offers a definition in Amendment 15 that would include manufacturing. My noble friend Lord Lansley and the noble and learned Lord, Lord Woolf, suggest adding “medical innovation”. In Amendment 20, the noble Baroness, Lady Thornton, and others set out a number of additional aspects, such as

“favourability to the establishment of research, design or manufacture of medicinal products or related services”

I reassure all those noble Lords that it is our instinct that the consideration of “attractiveness” as written in the Bill is sufficiently broad. It contains multitudes. While processes such as the clinical investigation of devices are not specifically listed as a consideration in Clause 12, they are covered in the current wording. Manufacturing is of course a vital element of the supply chain. Any impact on manufacturing will be relevant when considering the attractiveness of the UK as a place to supply medicines.

I acknowledge that the term “attractiveness”, as noble Lords have remarked in conversation, is not ordinarily found in legislation. However, I believe it is largely one of common sense. We all wish to protect the ways in which the UK is attractive. In 2015, the ABPI estimated the value of the life sciences sector to be £30.4 billion. Some 482,000 jobs were supported by the sector. We wish to protect that and to be a place for both innovators and generic manufacturers.

That is why this test is essential. It is a reminder, but it does not need to be comprehensive in the legislation. It needs simply to rule in, not rule out. That is why manufacturing is not explicitly mentioned, nor the other factors, although it is covered. Were we to list all the various aspects of how medicines and devices are made, we might miss something. We might interpret this list as prescriptive, rather than illustrative, and not cover an equally important but novel aspect of the future.

I hope that the government amendments provide further clarity. While noble Lords have drawn attention to specific aspects of how the UK is attractive, which are very important, their amendments are unnecessary. However, if there are particular considerations that the noble Lords, Lord Hunt and Lord Patel, and the noble Baroness, Lady Thornton, have concerns about—I note words such as “procurement”, “scale up”, “adoption”, “take-up of innovation” and “data-driven technologies”—I ask them to write to me. If further reassurances can be provided on why we consider this to be the right construction, I will be happy to respond.

In this instance, I hope the noble Lord, Lord Sharkey, is therefore willing not to move Amendment 15, and that other noble Lords do not feel compelled to move their amendments.

Amendment 14 agreed.