Medicines and Medical Devices Bill Debate
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Baroness McIntosh of Hudnall
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Medicines and Medical Devices Bill
Baroness McIntosh of Hudnall ExcerptsMonday 26th October 2020
(3 years, 6 months ago)
Grand CommitteeRead Full debate Medicines and Medical Devices Act 2021 View all Medicines and Medical Devices Act 2021 Debates Read Hansard Text Read Debate Ministerial Extracts Amendment Paper: HL Bill 116-III(Rev) Revised third marshalled list for Grand Committee - (26 Oct 2020)
Baroness Sheehan (LD) [V]
My Lords, is a pleasure to follow the noble Lord, Lord Alton. I agree with every word of his contribution, which is no surprise; I am usually in agreement with him.
I wish to speak briefly in support of Amendment 8, in the names of the noble Baroness, Lady Thornton, and the noble Lord, Lord Hunt, and to add my voice to support other amendments in this group. Amendment 8 would amend the wording at the start of Clause 1(2) to read
“the appropriate authority must act with a view to ensuring”.
This offers greater purpose of intent on the part of the Government of the day than the existing
“the appropriate authority must have regard to”.
It would strengthen the Government’s responsibility to their citizens over the safety and availability of human medicines, as well as the attractiveness of parts of the UK for clinical trials, et cetera, however that attractiveness is defined. I look forward to the upcoming debate on that issue with interest. It would of course also strengthen the duty of the Government of the day to ensure fair access to medicines, as per Amendment 19, which will be debated later and is in my name and that of my noble friends Lady Jolly and Lord Sharkey, and the noble Lord, Lord Alton, who I always think of as a friend.
It goes without saying that I strongly support all amendments relating to the report of the noble Baroness, Lady Cumberlege. Finally, I lend my support to Amendment 59 in the name of the noble Baroness, Lady Bennett. Animals cannot speak for themselves yet they are sentient beings. Their welfare should be our concern.
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The noble and learned Lord, Lord Mackay of Clashfern, has withdrawn from the debate, so I call the noble Baroness, Lady Jolly.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.
The Deputy Chairman of Committees (Baroness McIntosh of Hudnall) (Lab)
My Lords, I have received one request to speak after the Minister, from the noble Lord, Lord Hunt of Kings Heath. Once we have heard from the noble Lord, I will try one more time to establish contact with the noble Baroness, Lady Jolly. However, I have to tell the Committee that so far we have not been successful.
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.
Baroness Thornton (Lab)
I thank the Minister for his reply and all noble Lords who took part in what has been a worthwhile, interesting and sometimes rather impassioned debate.
The Minister is probably being slightly optimistic in thinking that we will not attempt to implement as much of the report of the noble Baroness, Lady Cumberlege, in this legislation as we can, because we are not sure when the next Bill where we could do so will come along. He might think about that. A little while ago, we had a Bill that would have been perfect for this report’s purposes but, unfortunately, we never got any further than Second Reading.
I thank the noble Lord, Lord Sharkey, for his support as we have moved through slightly difficult times in the past few days. The noble Baroness, Lady Cumberlege, knows that she has our support for the recommendations in her amazing report. We will do everything that we can from this side of the House to make progress.
The noble Baroness, Lady Bennett, is quite right to remind us of the fact that we are dependent on animals for making sure that our medicines are safe. We should never forget that.
My noble friend Lord Hunt was quite correct when he said that patient safety needs to be central. In fact, my noble friend’s remarks reminded me of the time when I was number two to the noble Lord, Lord Darzi, when he was a Minister in the House. He was absolutely passionate about patient safety and how it could be implemented. He also made a coherent argument for the fact that you could ultimately save money if you got patient safety right from the broad GP level all the way through to the implementation of new drugs and so on.
The remarks from the noble Lord, Lord Patel, were a tour de force. They illustrated again to us, if we did not already know, that his experience and knowledge are of enormous use to the Committee.
The noble Lord, Lord O’Shaughnessy, was doing a balancing act, saying “Ooh, attractiveness, ooh, patient safety, how is that going to work out?” He started off by saying that there should not be a trade-off but I think that he might have come to the conclusion that there will be one.
Between them, the noble Lord, Lord Kakkar, and the noble Baroness, Lady Watkins, brought enormous wisdom to this discussion. Both of them were balanced in the way that they expressed the need to put patient safety at the centre of the Bill.
The Minister and my team and I need to discuss the difference between “having regard to” and “with a view to ensuring”. The two things are not the same; this is not just about semantics. We probably need to have that discussion between now and the next stage of the Bill. On that basis, I beg leave to withdraw the amendment.
The Deputy Chairman of Committees (Baroness McIntosh of Hudnall) (Lab)
We now come to the group beginning with Amendment 14. I remind noble Lords that anyone wishing to speak after the Minister should email the clerk during the debate.
Amendment 14
The Deputy Chairman of Committees (Baroness McIntosh of Hudnall) (Lab)
My Lords, the next speaker was to have been the noble Baroness, Lady Jolly. I am afraid we have not been able to establish a connection with her, so I call the next speaker, the noble Lord, Lord Lansley.
Lord Lansley (Con)
I want specifically to refer to Amendment 16 in this group, which is in my name and that of the noble and learned Lord, Lord Woolf. The purpose of that was prompted by looking at subsection (2)(c), and this question of attractiveness, or
“the attractiveness of the relevant part of the United Kingdom as a place in which to conduct clinical trials or supply human medicines.”
In this particular instance, we concluded that while one might think that the United Kingdom was, or was not, an attractive place to supply human medicines and derive certain conclusions from that, the process of medical innovation is not well captured by a simple reference to clinical trials. The process of medical innovation is a wider set of factors than clinical trials alone. In particular, I think that in our minds, in looking at the United Kingdom, one of the underlying strengths of the United Kingdom as a place in which to develop medicines is because of our strengths in discovery.
For example, I remember as a resident of and former Member of Parliament for South Cambridgeshire that my constituency included the Laboratory of Molecular Biology which, among its other attributes, is the single research institute with the largest number of Nobel prizes in the world. The strength of discovery is an absolutely central aspect of the fact that AstraZeneca, Cancer Research UK and Addenbrooke’s and Papworth hospitals are close by and the biomedical campus at Cambridge is bidding to become Europe’s single strongest location for life sciences. If you delved back over the last 50 years and asked what the distinguishing characteristic of that was, you might well say Cambridge University—and people would well understand that—but you might equally say the Medical Research Council’s Laboratory of Molecular Biology and all that went with it. This is not because the LMB does clinical trials; it is because it does discovery. I think our intention was to say that, if the medicines regulator is having regard to these factors, maybe it should have regard to discovery as well.
I entirely take the point that perhaps, where the medicines regulator is concerned, discovery is something that happens before it really gets involved. However, if it is thinking about the environment for life sciences, I find it very hard for it to think about it in parts, and not as a whole. That is what Amendment 16 is intended to explore.
There is another question conveyed by a number of these amendments, which, as my noble friend the Minister has quite rightly highlighted, is this interesting use of the word “attractiveness”. I may well have regard to the attractiveness of many things, but that does not necessarily mean I do anything about it. That the Minister has brought forward his own amendment to point to
“the likelihood of the relevant part … being seen as an attractive”
place is very interesting and takes us much closer to where we want to be. However, it still begs the question of what the medicines regulations should require the regulator to do about it, having had regard to this thing. There are other amendments which, I think, perfectly properly raise the question of whether the regulator should seek to enhance the attractiveness of the United Kingdom as a relevant place, et cetera. I think it raises a very interesting question. I get the impression that the Minister is trying very hard to move to the right place; I am just raising the question of whether we are quite there yet without something like the word “enhancing”.
The Deputy Chairman of Committees (Baroness McIntosh of Hudnall) (Lab)
My Lords, before I call the next speaker, I should just inform the Committee that we now know that the noble Baroness, Lady Jolly, is unwell, and will therefore be unable to take part in the remainder of today’s proceedings. In due course, no doubt, we will know who will take her place in subsequent groups. I call the next speaker, the noble Lord, Lord Hunt of Kings Heath.
Lord Hunt of Kings Heath (Lab)
Can I just follow the noble Lord, Lord Lansley? Clearly, we are going to continue teasing out “attractiveness”. I have no doubt that I want the UK to be attractive in terms of the development of medicines and medical devices, and I think the noble Lord, Lord Lansley, was absolutely right when he paid testimony to the underlying strength of our medical innovation and discovery, and indeed the life science sector as a whole. I think one of the questions we are going to consistently talk about is that we do have a problem with the attitude of the National Health Service to those very medical innovations that take place in this country. As I will touch a bit on procurement, I should declare an interest as president of the Health Care Supply Association, because clearly it is involved in procurement decisions.
As I think was discussed in the first day of Committee, the ABPI has reported that for every 100 European patients who can access new medicines in the first year, just 15 UK patients have the same access. It is a major problem that we are so slow to take advantage of developments in new medicines and devices, both in our country and globally. We are seeing in the NHS essentially an unprecedented level of rationing, both locally and nationally. My own view is that NICE has developed into more of a rationer than it was ever intended to be. Locally, clinical commissioning groups are making almost perverse decisions, ranging from cutting out health promotion programmes to being very restrictive on some operations or, again, on access to innovative drugs.
Of course I understand that the drugs budget cannot be open-ended, and the NHS must achieve value for money. But the fact is that we are at great risk of losing our place at the top table when it comes to medicines and medical devices innovation, despite the excellence of the people we have, which the noble Lord, Lord Lansley, referred to. At the moment, I think we have developed around 14% of the top 100 global medicines, but 20 years ago it was 25%, and the risk, of course, is that we go lower and lower.
Similarly, in relation to access to devices, we have a very innovative devices sector, but again it is utterly frustrated by the NHS’s record in adopting innovation. Its suppliers are forced to battle against a fragmented marketplace—they lack a clear route to market—budget silos that impact on buyers’ ability to release savings directly, and a short-term focus on cash-releasing savings at the expense of longer-term benefits. As an example, I was approached by the Urology Trade Association, which represents the suppliers of the majority of urology projects to the NHS, which pointed out that, in normal times, urinary tract infections are the greatest single cause of unplanned hospital admissions, so it has a big impact on quality and duration of life and on use of NHS resources. If we were prepared to invest in improved devices, it could have a major benefit. But essentially, whatever the Government say about procurement and value-based procurement, they always go for the lowest price, and I am afraid that we often buy the lowest-quality products.
The ABHI has told me of one company in the dialysis sector which now sees the UK as a second or third-tier sector, due to the prices it commands here. I know that on the first day of Committee the noble Lord said he cannot talk about reimbursement; the problem is that Ministers will never talk about reimbursement. It is interesting that, in general, if we are increasing staff—the numbers of doctors and nurses—I think Ministers tend to proclaim that as a good thing. However, increased budgets in devices and medicines is a shock, because the whole philosophy of his department and the NHS is to hold down the budget.
The problem is that, essentially, we do not invest in the great things that are happening. It is naive to think otherwise. There are a lot of things we can do to encourage the kinds of things that are happening in Cambridge—through tax incentives, for example, and schemes for faster access—but they relate only to a few selected medicines and devices. Overall, we are at great risk. I am afraid that the NHS has to face up to some responsibility for that, both in terms of the industry, and in terms of patients. Why should we in this country have to wait so long for medicines that in other European countries are available much sooner? This is a major issue which we need to tackle.
The Deputy Chairman of Committees (Baroness McIntosh of Hudnall) (Lab)
I call the next speaker, the noble Lord, Lord Patel. Lord Patel? Oh dear, we are not having a great afternoon. If we cannot establish contact with the noble Lord I will move on to the next speaker. Lord Patel, are you with us?
The Deputy Chairman of Committees (Baroness McIntosh of Hudnall) (Lab)
I am sorry. We could not hear you and we still cannot see you.
The Deputy Chairman of Committees (Baroness McIntosh of Hudnall) (Lab)
Ah! You are with us in all your glory. Please continue.
Lord Patel (CB) [V]
Not much glory, but thank you very much.
Before I talk about the amendments I intended to speak to, I want to comment on the amendment tabled by the noble Lord, Lord Lansley, and the comments that the noble Lord, Lord Hunt of Kings Heath, just made, which I absolutely agree with.
The noble Lord, Lord Lansley, is right about innovation. It should be part of the Bill, together with clinical trials. As he rightly said, we are a nation that excels, and has done for more than 20 years, in discovery science, particularly in biology and molecular biology. He mentioned Nobel prizes: the United Kingdom has won 29 Nobel prizes in medicine and physiology, and 29 in chemistry, two subjects often linked with discoveries in biology.
However, as the noble Lord, Lord Hunt, said, we are poor at taking the biology forward into innovations and drug development. We have some fantastic universities for drug development, but for that they require a strong allegiance with the NHS. The science base needs to be integrated with our NHS and its data, including patient data, to develop drugs. That is what we lack. He is absolutely right. I hope that we will have another opportunity to address this matter. Are our policies on how drugs are procured and assessed holding us back? That is a good debate to have, and it is a pity we are not having it today.
I have already said that I support Amendment 16, in the name of the noble Lord, Lord Lansley; I also support Amendment 20, in the name of the noble Baroness, Lady Thornton, to which I have added my name. I shall also speak to my own amendments—Amendments 21, 61 and 82—which are supported by the noble and learned Lord, Lord Mackay of Clashfern, who could not be with us because he is in the Chamber.
With regard to government Amendment 14, I have said before, and I repeat now, that the construction is open to the interpretation that the attractiveness of the UK is to be treated as part of what promotes public safety. If so, the amendment would not address—indeed, it would appear to prevent—the argument being made that attractiveness and the safety of medicines and medical devices can sometimes be in conflict. The consideration of attractiveness can undermine the consideration of safety. This is in line with the Government’s repeated assertion that attractiveness is never in conflict with safety.
The Deputy Chairman of Committees (Baroness McIntosh of Hudnall) (Lab)
My Lords, I understand that the noble and learned Lord, Lord Woolf, who was due to speak next, is not with us this afternoon. I am saying this very slowly in case he is, but I do not think so. In that case, I call the next speaker.
Baroness Watkins of Tavistock (CB) [V]
My Lords, I support Amendment 20 in the name of the noble Baroness, Lady Thornton, to which I have added my name. Its purpose, together with Amendment 21 in the name of my noble friend Lord Patel, who has just spoken so eloquently in favour of it, are to provide a definition of attractiveness for clarity and the primacy of safety, while maintaining an environment that promotes the UK as a centre for global life science research and innovative working with academic partners in all continents across the globe. In addition, Amendment 20 should ensure that the UK population has prompt access to new medicines once they have been approved in line with Her Majesty’s Government’s philosophy for the future.
The Deputy Chairman of Committees (Baroness McIntosh of Hudnall) (Lab)
That was commendably brief. I call the next speaker.
Baroness Masham of Ilton (CB) [V]
My Lords, in supporting Amendment 61 and the others in this group, I declare an interest as I have a farm and I often use vets, who supply veterinary products and medicines. I must say that vets have been exceedingly careful and all precautions have been taken that have been put in place for protection over Covid-19. The Veterinary Medicines Directorate protects animal and public health and the environment. This needs our support, which this amendment provides, as it ensures that safety remains a priority.
In recent years, over half the veterinary surgeons who register in the UK each year have qualified elsewhere in the EU and the EEA—38.5% from the UK, 52% from the EU and EEA, and 9.5% from other countries. Free movement of people has had an enormous impact on our veterinary workforce. Additional barriers to the movement of EEA-qualified vets to the UK will have significant consequences for animal health and welfare, public health and trade. If understaffing happens, it will become a safety issue. Some 95% of the veterinary workforce in abattoirs graduated overseas, mainly from the EU. This information comes from the British Veterinary Association. Does Regulation (EU) 2019/6 on veterinary medicinal products aim to make more medicines available in the EU to treat and prevent diseases in animals through simplifying our procedures for obtaining a marketing authorisation and reviewing incentives for breakthrough medicines? The Bill provides the means to make “corresponding or similar provision” to both regulations. Will the Minister give an assurance that that will happen? It is a safety issue and very important.
To make the UK an attractive place to do research and development, the much-needed bright people coming from abroad should feel wanted and safe. It is time that the UK realises that we cannot achieve the high standards that we want without help from others in veterinary science. We should be welcoming and kind to each other. I hope that the Minister will help to prioritise safety in this important Bill. I send my best wishes to the noble Baroness, Lady Jolly, and hope that she gets better soon.
The Deputy Chairman of Committees (Baroness McIntosh of Hudnall) (Lab)
My Lords, we now come to the group beginning with Amendment 17. I remind noble Lords that anyone wishing to speak after the Minister should email the clerk during the debate.
Amendment 17