Power to make regulations about human medicines

Part of Medicines and Medical Devices Bill – in a Public Bill Committee am 11:30 am ar 8 Mehefin 2020.

Danfonwch hysbysiad imi am ddadleuon fel hyn

Photo of Alex Norris Alex Norris Shadow Minister (Health and Social Care) 11:30, 8 Mehefin 2020

I beg to move amendment 9, in clause 1, page 1, line 5, at end insert

“for a period of two years following Royal Assent.”

This amendment provides a sunset provision for the Bill requiring the Government to return with primary legislation.

It is a pleasure to serve under your chairship, Mr Davies. As the shadow Secretary of State for Health and Social Care said on Second Reading, we understand the need for, and urgency of, the Bill. We will therefore be supportive during its passage, but we will seek to improve it. These improvements will take three forms: a focus on patient safety, a focus on promoting greater transparency about the development and use of medicines and medical devices, and seeking to contain the massive and extraordinary powers the Secretary of State is securing for himself.

I am conscious, certainly in this first sitting, that we have an awful lot on. I hope that colleagues will be understanding if it feels like I am moving at pace, because there is quite a lot of ground to cover. However, I wanted to say how grateful I am to the Clerks for having helped me put these amendments together, and to the Minister and her officials for their constructive support so far. The tone of discussions about the Bill has been really good, and I am sure we will continue in this way.

Finally, a lot has happened since the First Reading of the Bill, not least the fact that I have taken over from my hon. Friend, the unstoppable Member for Washington and Sunderland West (Mrs Hodgson), as the Opposition public health lead. As I have been telling stakeholders, they will probably find me similar in approach—committed, but in good humour—but perhaps lacking the same colourful jackets.

This is an enabling Bill. It is a necessary Bill, but we cannot give the Government a blank cheque. We are talking about the power to decide critical, life-and-death matters involving medicines, devices, humans and animals, and we should not just wave that off to secondary legislation without understanding what that might mean and whether there might be a better way to do it. As such, amendment 9 seeks to put a limit on that power.

The proposed arrangements allow the Secretary of State and his successors to make hundreds or more individual decisions to change our current regulatory regime into a markedly different one, one statutory instrument at a time, which I do not think is desirable. Instead, this amendment offers the Secretary of State two years of that considerable power, but asks him to return in two years’ time with a comprehensive set of regulations across medicines for both humans and animals; for medical devices; and, critically, for the proposed new regime surrounding the Medicines and Healthcare Products Regulatory Agency.

That would provide a chance for proper consultation across the sector, including with patient groups, industry bodies and interested companies, as well as more parliamentary scrutiny to set up the regime that we all want—a safe one, an effective one and a world-class one. It would also give us two years of life outside the European Union and would really help us to land in that place and find out how different we intend to be, certainly in this sector. It would provide time for piecemeal change, but it would at least then reset things, and then I would be at the point where I would be much more relaxed about the use of secondary legislation to diverge from that as circumstances require, because we would have reset things in the full knowledge of Britain’s new place in the world.

There is a case to be made that the arrangements being proposed in the Bill reflect current arrangements; after all, we do not have parliamentary scrutiny over the regulations that have come traditionally in previous decades from the EU. However, that is a political argument—a very effective one—and we know that, outside the white-hot light of public debate around the EU, the EU works differently from that. That was a theme developed by the Member for Central Ayrshire on Second Reading.

Page 4 of the Government’s impact assessment of the Bill describes how a higher-risk medical device enters circulation in the UK for use, saying that for a high-risk medical device to enter the market “a Notified Body”—for us, that is the Medicines and Healthcare Products Regulatory Agency—has to “certify” it. So far, so similar—that is essentially what the Bill would allow, as well. However, at the moment the device would be checked by two further notified bodies from within EU structures and the European Commission, as it says on page 5. That is quite a protection; that is a triple lock. It is not just our own MHRA saying whether or not a device is safe; there are two other equivalent bodies saying that, too.

That system will go and instead we will have a Secretary of State, we will have a Department, and I am sure that NHS England will have a view, too, but fundamentally we will just have a Committee of the House—a statutory instrument Committee. That is quite a diminution. Surely we at least need to know that there will be adequate safeguards in place. If the Government do not accept the amendment, I would be very keen to know what can be done to protect that triple lock.

I will move on to tell a story about two page 10s. Paragraph 42 on page 10 of the impact assessment refers to the potential to move to “hub and spoke dispensing” for pharmacy. That is a very live debate in the field of pharmacy at the moment, I have to say. I have probably not checked this with the shadow Secretary of State, but I see some positive arguments for it, although I can also see significant risks. It is the sort of thing that I think parliamentarians from all parties will be very interested in. I think that we would form different views on it, and not on party lines, because we are basically saying that pharmacy changes—that it is less about dispensing and more clinical, and that bigger nationally based pharmacies, as it were, will instead provide an outsourced dispensing arm. I can see efficiencies in that system; we are doing an awful lot of that at the moment in the context of coronavirus. However, that would be a radical change for pharmacy. At the moment, paragraph 42 on page 10 of the impact assessment says it is a potential direction for where things will go for pharmacy.

If we look at the Bill, we do not see the words “hub and spoke” anywhere, which is very significant. I gently say to Back-Bench Members of the governing party: “You could be in a situation in a year’s time where you are in a statutory instrument Committee being asked, basically, to make the most significant change to pharmacy in decades, and one that you will get a lot of emails about from your local pharmacists, certainly in community pharmacy, and I really do not think that is the sort of power that the Bill is intended to give.”

I said that this was a story of two page 10s. Page 10 of the delegated powers memorandum refers to clause 1 of the Bill and justifies the use of delegated powers:

“The human medicines regulatory regime is ever-changing and requires technical changes in order to keep up to date. These are changes we cannot predict in advance and therefore would not be practical or appropriate for these amendments to be made through primary legislation each time an update is required.”

That is saying, “Something changes a little bit and we would not want a whole new law to keep pace.” Of course, I understand that. However, we are talking about something really significant here; I would argue that it is an entire model change for pharmacy. We know that this is of interest to the Government, because it is in their own impact assessment. They say that it is a possibility. We really need to square that.

I accept that the Secretary of State will need powers and will have to do things through secondary legislation to keep us up to pace with, or to diverge from, European regulations. However, I am not confident that this is a mandate to make really significant changes to something that is very important to us all. That is why I have moved amendment 9. It would say to the Secretary of State, “Go and have a look at this for a year-plus, and then develop legislation to reset that.” Let us have proper consultation with the sector and with citizens. Let us have proper parliamentary scrutiny. Then, if we come to the view that this is the best way to do it, by all means that is what we should do.

I hope that the Government are minded to accept the amendment, but I am sceptical of that chance, so I would be keen for the Minister to return to these two points. First, will this provision mean a diminution of protection, certainly when it comes to the triple lock on medical devices? Secondly, there needs to be at least an acceptance from Government that the liberty to make quite big and bold changes is not licence to make any changes that they want, bolstered by a Committee majority, because I do not think that that is in the spirit of the legislation or of this exercise, which is about getting us to a safe position following the end of the transition period.