Medicines and Medical Devices Bill

Debate between Lord Sharkey and Baroness Thornton

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

[Baroness Thornton (Lab)]

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

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

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

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

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

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

[Lord Sharkey (LD) [V]]

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

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

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

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

Medicines and Medical Devices Bill

Debate between Lord Sharkey and Baroness Thornton

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

[Lord Sharkey (LD) [V]]

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

[Baroness Thornton (Lab)]

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

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


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

--- Later in debate ---

[Lord Sharkey (LD) [V]]

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

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

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

[Baroness Thornton (Lab)]

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

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

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

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

--- Later in debate ---

[Lord Sharkey (LD) [V]]

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

[Baroness Thornton (Lab)]

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

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

Medicines and Medical Devices Bill

Debate between Lord Sharkey and Baroness Thornton

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

[Baroness Thornton (Lab)]

The amendment, in my name and that of my noble friend Lord Hunt, gives the Secretary of State a duty to act with a view to ensuring, rather than having regard to, safety, availability and UK attractiveness when exercising the powers in the Bill. The Bill states:

“the appropriate authority must have regard to … the attractiveness of the relevant part of the United Kingdom”,

and we want to change that. However, there is no definition of attractiveness in the Bill.

The Independent Medicines and Medical Devices Safety Review, led by the noble Baroness, Lady Cumberlege, published in July, focused on safety issues with just three medical interventions. Along with these, recent scandals such as those relating to metal-on-metal hips and PIP breast implants, show the need for strong regulatory oversight. Patient safety must be prioritised, including where there are competing considerations, such as the attractiveness of the UK as a place to conduct clinical trials and supply medicines and medical devices.

To address this, we believe that either the attractiveness clauses should be removed, or a statutory definition of attractiveness should be included in the Bill, along with a further provision that the appropriate authority should always prioritise safety. I beg to move.

[Lord Sharkey (LD) [V]]

I shall speak briefly to Amendments 9 and 13. I should start by saying that I enthusiastically support Amendment 8, moved by the noble Baroness, Lady Thornton. We all know that the phrase “have regard to” lacks any real force. Like her amendment, our Amendments 9 and 13 are intended to strengthen Clause 1(2), whose opening words read

“In making regulations under subsection (1), the appropriate authority must have regard to”,


followed by a list of the things to which it must have regard. Amendment 9 would change those opening words to read, “In making regulations under subsection (1), the appropriate authority must have regard to, and in the case of regulations not subject to section 42(6), (7) or (8), must publish with the draft regulations an assessment of their impact on,” and then the list of things to which regard must be had.

Clause 42(6), (7) and (8) are excluded because they contain urgency provisions and may now anyway make use of the “made affirmative” procedure. The purpose of the amendment is to ensure that there must be a full assessment of the impact of any regulation on the three specified areas. This applies to all three of the areas and is of particular importance in the assessment of safety and how it is to be prioritised, in subsection (2)(a).

Amendment 13 addresses the issue of assigning priority to the safety of human medicines, as do other amendments in this group. It would rewrite subsection (2)(a), so that instead of reading,

“the safety of human medicines”,

it would read “the priority of ensuring the safety of human medicines”. Other noble Lords have tabled amendments suggesting different ways of ensuring this priority and I look forward to hearing their contributions. But whatever the variations in approach, it is obvious that a strong, clear and unambiguous statement of the priority of the safety of human medicines needs to be inserted in the Bill.

--- Later in debate ---

[Lord Sharkey (LD) [V]]

My Lords, I will speak to Amendment 15, but I begin by supporting Amendment 16, in the names of the noble Lord, Lord Lansley, and the noble and learned Lord, Lord Woolf. I strongly agree about the importance of the UK being seen as an attractive place to promote medical innovation.

Amendment 15 is in my name and those of my noble friend Lady Jolly and the noble Baroness, Lady Finlay of Llandaff, and I am very grateful for their support. The amendment addresses Clause 1(2)(c). As we have just discussed in the previous group, subsection (2) lists what an appropriate authority must have regard to when making regulations under subsection (1). Subsection (2)(c) specifies that the appropriate authority must have regard to,

“the attractiveness of the relevant part of the United Kingdom as a place in which to conduct clinical trials or supply human medicines”.

But we have, in extraordinary circumstances, accepted the Minister’s Amendment 14, so that the text will now read,

“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”.

That is not a formulation that lends itself to easy measurement.

I listened very carefully to the Minister’s brief explanation of the merits of his amendment, but I was unable to see a clear and actionable distinction between his new version and the old one. It was all getting a little theological—“angels dancing on the head of a pin” sprang to mind. In any case, the new Government amendment shares two defects with the old version.

The first is that they are both completely unambitious. We should be looking at least to maintain, and preferably to increase, the attractiveness of the UK as a place to do clinical trials or supply human medicines. I spoke last Monday about the critical importance of clinical trials to the UK’s global leadership in the life sciences. I have already noted that the number and share of clinical trials has declined since 2016, and we now rank behind the US, Germany and Spain. Because of Covid, we have abandoned 1,500 trials and suspended 9,000 more. We need to do better than simply to have regard to the attractiveness or the likelihood of being seen to be attractive. We need explicitly to maintain or improve that attractiveness, as our amendment proposes.

The second defect in both the Minister’s first and second versions of subsection (2)(c) is that they fail to mention manufacturing. Why is the appropriate authority not required to have regard to maintaining or improving the attractiveness of the UK as a place to manufacture human medicines? The ABPI raised this issue in its briefing for Second Reading, saying that, in addition to having regard to the attractiveness of the relevant part of the UK to conduct clinical trials or supply human medicines, the ABPI would also value an assurance from the Government that secondary legislation will support the attractiveness of the UK as a destination to develop and manufacture human medicines.

The ABPI has a point. I raised this question, and the ABPI’s position, with the Minister in a meeting on 13 October. In that meeting, the Minister’s officials replied that they thought that manufacturing was covered in other regulations. Will the Minister confirm that and tell us which regulations explicitly require the appropriate authorities to have regard to the attractiveness of the UK as a place for developing or manufacturing human medicines? If, however, there is no such statutory requirement elsewhere, would the Minister consider adopting Amendment 15?

Amendments 58 and 78 would make the same provisions as Amendment 15 but for veterinary medicines and medical devices.

I should also say that there are obviously enough opposing or various views on the attractiveness issue to make it clear that we will want to return to this subject on Report, not only in the context of Amendment 14. I look forward to the Minister’s response to Amendment 15.

[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.