It is a pleasure to resume proceedings on the Bill. The exchanges in Committee were of a high quality in both content and tone, and I look forward to more of the same afternoon. I was proud to take the lead for the Opposition in Committee, as I am during the remaining stages of the Bill, and I thank my predecessor in the early rounds, my hon. Friend the Member for Washington and Sunderland West (Mrs Hodgson).
Let me turn to new clause 1. I am so pleased to see the Government introduce what we spoke of in Committee as a device registry, which is now called the information centre. Bad medicines and devices cause exceptional harm. The noble Baroness Cumberlege is looking at the impact of three of these: Primados, sodium valproate and surgical mesh. I pay tribute to the campaigners and their allies in this place for all their work to ensure that those who are suffering, or who have suffered, are not forgotten. Clearly there have been devices that, knowing what we know now, we would not have used. There is a risk of similar things happening in the future, and it is a risk that we cannot fully mitigate, so an information centre will at least put us in the strongest possible position to react quickly and clearly.
I am personally grateful to the Minister for the level of engagement from her and the Government in general. I and my colleagues in the other place are committed to continuing to develop the idea. I know that the hon. Member for Central Ayrshire (Dr Whitford)—who will be watching proceedings, and whose expertise and creativity are missed—is ready to do the same. I can tell from my inbox that there is considerable interest in the sector in making this work, and I hope the Minister will commit to full consultation with it.
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I want to take this opportunity to talk about the Cumberlege review. I had rather hoped that the remaining stages of the Bill might fall after the review reports on 8 July. That is important, because the report could have
a profound impact on how we view the Medicines and Healthcare Products Regulatory Agency and on how we view the past and what we need to do in the future. Presumably, proceedings in the other place will fall after that date, so I hope the Minister will at least be able to commit not only that the Government will engage seriously with that review—I am sure they will—but that crucially they will be willing to make amendments to this Bill or changes more generally to the MHRA through other legislation, regulations or in other ways to ensure that it is fit for the future and addresses the challenges that come up in that review.
Turning to the amendments in my name, this is a simple Bill and the sunset clause that amendment 20 would introduce reflects that. The Bill takes our current arrangements as governed by our previous membership of the European Union and transplants them into UK law—so far, so simple. It then hands the Secretary of State the power to amend those arrangements as they wish via secondary legislation. The Minister and I agree on a great deal of things—probably the vast majority of things—but our views diverge on whether that power is a downgrade from where we are. While I accept that the democratic deficit in the European Union is the face that launched a thousand undergraduate essay ships, there are nevertheless multiple independent stages across the Commission, the Parliament and the Council. Whether or not that is a good process is for the birds for us now, but if nothing else, there are lots of eyeballs to pick up mistakes.
Under the Bill, we will have a Secretary of State governing high-risk medicines and medical devices, with decisions essentially ratified by a Committee or occasionally, perhaps, on the Floor of the House, where the Secretary of State will have a majority come what may. I think in any terms that is a diminution, and the Government will need to be mindful of that.
All amendment 20 asks is that the Secretary of State returns to Parliament after having had the powers for three years and resets the arrangements, creating an holistic new status quo, as we are doing now. That is not to say that the status quo would then be locked in for ever—it would have to be a moving picture—but it would just give us an understanding in the round of all regulations and allow Parliament to have a full consideration, rather than doing it bit by bit. Given how much scrutiny will be coming out of the process, the measure is not onerous. Nevertheless, I accept that a sunset clause is an inelegant solution so I do not intend to press the amendment to a vote. It is the best we have as an Opposition, and I hope that the Government will bear it in mind in the other place.
Page 4 of the Government’s impact assessment says that before a medical device enters the UK market, the domestic notified body—for us, that is the MHRA—must sign it off and say it is safe. It must then be signed off by two other notified bodies from other member states. That is a triple lock. Under the Bill, it will be just the MHRA and the Minister. That is a high wire, and it leaves the potential for a lot of harm.
A sunset clause—I would probably rather characterise it as a reset clause—would allow us to consider or evaluate one particularly critical by-product of the Bill that I can guarantee every Member will hear about from their constituents, if they have not done so already. If colleagues comb the Bill or do a ctrl+f search looking
for the words “hub and spoke”, they will not find them. They can be found only on page 10 of the Government’s impact assessment at paragraph 42. Buried deep in there is the idea that the Government may—or do—plan to change the age-old principle that the pharmacy that dispenses is the pharmacy that distributes, either at the counter or via home delivery.
Paragraph 42 raises the idea that instead, mobile deliverers will be able to partner with dispensing pharmacies to deliver their prescriptions for them or, more likely, be able to dispense and deliver on their behalf, leaving pharmacists to pick up new clinical responsibilities. There are very strong valid arguments on both sides of the issue. I cannot tell the House with certainty how I would vote if asked to pick a side at this very moment. Some say that the measure will destroy community pharmacy and others say it will unleash community pharmacy into the brave new world.
I can tell the House this: it is the most profound reform to community pharmacy in our lifetimes. It is delicate and it is important. Our constituents care about it, as do our local businesses. The Bill opens it up. I would even say that the impact assessment pre-judges the matter, and it is not even on the face of the Bill. That is why the Bill needs a sunset clause. We know we have to support the Bill’s Third Reading, or we will not have a regulatory regime for medicines and medical devices, but how on earth did we get to the point where we are practically committing to an entire new model for pharmacy along the way? I cannot understand that, and I hope the Minister will respond to that in summing up and make a strong commitment to the broadest possible consultation on the matter, because we will have to tread very lightly indeed.
On amendments 21, 22, and 23, when Paul wrote to the Corinthians, 13:13, he spoke of three things you discover as you grow up. We are entering wedding season now—happily we are allowed to do that again—so Members will recognise this message:
“And now these three remain: faith, hope, and love; but the greatest of these is love.”
Similarly, on clause 1(2) of the Bill, there are three things when it comes to human medicines—or, in the case of my other amendments, veterinary medicines or medical devices: safety, availability and attractiveness of the UK market. Surely, the greatest of these is safety.
I know the Minister has a strong personal commitment to patient safety, so I still cannot quite understand why in the Bill it is seen as equal to the attractiveness of the UK as a driving force of the Secretary of State’s decision making. I reckon we could stand in Members’ Lobby all day without finding an hon. Member who would make attractiveness a coequal priority with patient safety. I am keen to hear what legal advice she has had on this point. Are we certain that there is not a vulnerability facing a future Secretary of State who is said to have prioritised patient safety over the attractiveness of the UK market for litigious and exceptionally powerful pharmaceutical companies? I do not intend to push this to a Division, but I would be keen to hear her reflections on this point and ask that it be considered in the other place.
Amendment 19, which stands in the name of my hon. Friend the Member for St Helens South and Whiston (Ms Rimmer), deals with an exceptionally important
issue. Again, there would be complete unanimity that human tissue harvested without consent is repulsive and that we in this country would want nothing to do with it—I have no doubt on that at all—but we also know that globally it is happening, and so it is incumbent on us all to make sure we are certain that such tissue does not enter the UK for the purposes we are discussing today. I listened carefully to what the Minister said in Committee. She provided a good deal of reassurance—and she has provided further reassurance this afternoon—but it is clear from correspondence from campaigners since that there might yet be gaps in the current arrangements and that we must act either today or in the other place.
Finally, I turn to the remaining Government amendments. As I said in Committee, I find it reassuring when there are Government amendments, because it means they are still reading their own Bill, which is a very good thing—I see it as a point of strength. I do not have any quarrel with these remaining amendments, but I want to make a final point about the use of secondary legislation powers, which the entire Bill is built on. This point is made clear on page 10 of the delegated powers memorandum. Not only is the Secretary of State reserving for himself significant powers via secondary legislation, but many are via the negative procedure. Examples include: labelling, prohibiting, advertising and the fees regime governing human medicine—an awful lot of very important things, and all at the stroke of a pen before Parliament has even said a word about it. I cannot help wondering whether the Government should be careful what they wish for. This is a high wire they have stepped out on to.
That summarises the Opposition’s views on the amendments. They are good amendments, both the Government and the Back-Bench ones, and I hope the Government will give the Opposition amendments strong consideration either today or at a later stage.