Medicines and Medical Devices Bill

Lord Bates Excerpts

Committee stage & Committee: 1st sitting (Hansard) & Committee: 1st sitting (Hansard): House of Lords
Monday 19th October 2020 Grand Committee

I hope that the noble Baroness has heard enough to feel able to withdraw Amendment 3 and that other noble Lords with amendments in the group will not press theirs.

[The Deputy Chairman of Committees (Lord Bates) (Con)]

I have received a request to speak after the Minister from the noble Lord, Lord Patel.

[Lord Patel (CB) [V]]

My Lords, the Minister referred to the large number of trials that are started in the United Kingdom. Can he say how many phase 3 trials have been started here? He also referred to the platform that the MHRA has developed with regard to Covid that accelerated the delivery of drugs, which is correct. However, that is not the same as a platform for rare diseases.

I agree that the licensing that was done at speed, within six months, would normally have taken two years: for instance, the licensing of the use of Remdesivir, produced by Gilead Sciences for the treatment of Covid-19. However, that is not the same as the noble Lord’s implication that it could be used for rare diseases. Those require a larger database, which Covid had, because there is no shortage of Covid data. Furthermore, he said that the EU portal means that individual countries have to approve. That is correct, but the approval is a speedier process because it has gone through the portal, unlike before.

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Amendment 3 withdrawn.

[The Deputy Chairman of Committees (Lord Bates) (Con)]

We now come to the group beginning with Amendment 4. I remind noble Lords that anyone wishing to speak after the Minister should email the clerk during the course of the debate.

Amendment 4

Moved by

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[Baroness Penn (Con)]

My Lords, it is perhaps appropriate if I begin by speaking to the government amendments—Amendments 43, 44, 64 and 65 in the name of my noble friend Lord Bethell —in this group. In doing so, I thank my noble friend Lord Blencathra for his committee’s report. As previously noted, we have listened to that report, and the changes that we propose through these amendments are intended to address the specific concern in that report regarding penalties for existing criminal offences.

As drafted, Clause 5(1)(b) already provides a restriction limiting the maximum penalty to imprisonment for two years when creating a criminal offence. The DPRRC asked us to explain whether the penalties for existing offences could be amended when there was no maximum specified in the Bill. I want to be clear that we do not intend to increase the penalties for existing offences.

Amendments 43 and 44 would work together to amend Clause 5. They make it clear that, under Clause 1, we may not make regulations that provide for a criminal offence to be punishable by more than two years’ imprisonment. This will apply to both new and existing criminal offences. For veterinary medicines, Amendments 64 and 65 seek to achieve the same by amending Clause 10.

The government amendments will, I hope, remove any concern that powers in Clauses 1 or 8 could be used to make regulations extending sentences for existing offences beyond two years’ imprisonment.

I now turn to Amendment 4 and the other amendments in this group to which noble Lords have spoken. The ability to enforce breaches of the regime governing medicines is a power originally conferred on the Secretary of State in the interest of protecting public health. This was introduced by the Medicines Act 1968 and provisions around offences are found throughout the Human Medicines Regulations 2012. They are also contained in the Veterinary Medicines Regulations 2013.

Offences deter potentially harmful activity and make it possible to take punitive measures against those whose actions put people, animals and the environment at risk. As we make necessary updates to the regulatory requirements, we must be able to remain consistent with the current enforcement regime, which already imposes criminal sanctions. It would not be right that a person may face a criminal sanction for breaching current requirements but not for breaching new regulatory requirements, for example relating to novel technologies and medicines. As with other changes to provisions, making changes to offences will be subject to the draft affirmative procedure, and we will make offences proportionate and necessary. It is imperative that we are able to balance novel regulation with enforcement of that regulation.

It cannot be ignored that crime involving medicines is increasing. Furthermore, criminal activities adapt to new environments and technology. In recent months we have seen opportunistic criminals selling online unauthorised and unapproved medicines and devices for the treatment, prevention or diagnosis of Covid-19, including antimalarials, self-testing kits, “miracle cures” and “antiviral misting sprays”, which could cause harm and unnecessary stress to patients. Enforcement capabilities must be able to keep pace with criminal exploitation. Delegated powers afford us our continued ability to enforce the regulatory requirements for medicines and devices for public protection. To be effective, they must be enforceable.

The Veterinary Medicines Regulations 2013 contain numerous criminal offences for breaches of the regulations; again, this is for the purposes of enforcement. The Veterinary Medicines Directorate’s enforcement strategy is risk-based; it focuses on proportionality, consistency, transparency and targeting. The VMD works with businesses and individuals to assist them in complying with the legislation through the provision of advice and guidance. However, where necessary the VMD will use more formal means of enforcement to secure compliance. It is critical that we have the delegated powers to enforce this.

We have always been clear that we are trying to provide greater clarity on how to enforce the regulations on medical devices. The regulator’s ability to have teeth when we are looking to raise medical device safety standards in future is essential. The report from my noble friend Lady Cumberlege tells us that.

The Bill is also clear on the maximum time limit for imprisonment, which applies to any new criminal offence introduced. This limit matches the current system for devices, where criminal offences for medical devices are already punishable for up to six months. The devices regulations are in place to protect public health; breaches of those regulations put people at risk and can cause significant harm. It is only appropriate that there is a clear consequence for any such actions, including potential criminal prosecutions. We will of course have regulations subject to the duty to consult at Clause 41, which will mean the public have the opportunity to comment on the necessity and proportionality of the approach.

I hope the necessity of enforcing the new regulations, and the safeguards the government amendments have provided, persuade the noble Lord to withdraw his Amendment 4 and others not to move theirs.

[The Deputy Chairman of Committees (Lord Bates) (Con)]

I have received no requests to speak after the Minister, so I call the noble Lord, Lord Hunt of Kings Heath, to respond to the debate on his amendment.

[Lord Hunt of Kings Heath (Lab)]

I first thank my noble friend Lady Thornton for her words in support of the amendment and the noble Lord, Lord Patel, who was hoping to field an impressive cast list in this debate. I thought he did very well; I have always thought he would make a first-class lawyer—he should take that as a compliment.

At the heart of it, as he and the noble Lord, Lord Sharkey, said, this is a constitutional point: the advice we have had from a House of Lords Select Committee is that what the Government are proposing is constitutionally unacceptable. While the Minister’s amendments are always welcome, the fact remains that the Bill, after the Government’s amendments, would allow Ministers to create completely new criminal offences and make changes to existing offences. The Minister kindly explained this, but here we get to the heart of this Bill and the problem that many of us have with it. She talked about novel regulation and the need to keep pace with developments. I understand that.

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[The Deputy Chairman of Committees (Lord Bates) (Con)]

We now come to the group beginning with Amendment 6. I remind noble Lords that anyone wishing to speak after the Minister should email the clerk during the debate.

Amendment 6

Moved by

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[The Deputy Chairman of Committees (Lord Bates) (Con)]

My Lords, I have received one request to speak after the Minister. I call the noble Lord, Lord Patel.

[Lord Patel (CB) [V]]

I thank the Minister most sincerely for her extensive response. I understand some of the points she made. I am also grateful that she is going to write to me and other noble Lords about the definitions that I questioned in my speech.

I accept that at times the Government will need to have powers in emergencies, but some of the examples the Minister gave were not really emergencies. I made the point that in such situations government Amendment 133 and the table do not allow for parliamentary scrutiny. The fact that there is no sunset clause means that the Government will have power to make regulations under both the negative and the affirmative procedure for evermore. That cannot be right. Yes, there will be a learning process, but there should be more ability for Parliament to scrutinise.

[The Deputy Chairman of Committees (Lord Bates) (Con)]

I call the Minister to respond to the point made by the noble Lord, Lord Patel.

[Baroness Penn (Con)]

My Lords, I believe that the noble Lord’s comments reflect the themes that we are discussing throughout our scrutiny of the Bill. I certainly take them on board with regard to this group of amendments, I believe that we have discussed them before and will discuss them again on other groups of amendments.

[The Deputy Chairman of Committees (Lord Bates) (Con)]

Finally, I call the noble Lord, Lord Sharkey, to respond to the debate on his amendment.

[Lord Sharkey (LD) [V]]

I am grateful for the support of the noble Lord, Lord Kakkar, and the noble Baronesses, Lady Jolly and Lady Thornton, but I am disappointed that the Minister still seems to regard the affirmative procedure as constituting effective scrutiny. Let me briefly quote again the Constitution Committee, which says:

“Without a genuine risk of defeat, and no amendment possible, Parliament is doing little more than rubber-stamping the Government’s secondary legislation. This is constitutionally unacceptable.”


Neither the DPRRC nor the Constitution Committee agrees with the Government’s position on this, I think largely because it is obviously wrong. I am also disappointed that the Government seem to continue to believe that extensive consultation is equivalent to or a substitute for parliamentary scrutiny—another obviously wrong position, as the DPRRC makes clear.

As to the objection that the super-affirmative procedure is too cumbersome or lengthy, neither of these objections could have any weight unless there were some urgency. As I have explained, there is not; even if there were to be, the “made affirmative” procedure would kick in and take care of it.

As I remarked in the opening group this afternoon, at the root of all this is a desire by the Government to take powers to make policy before they have decided what that policy is. This is not only perverse but evades parliamentary scrutiny and bypasses Parliament. We will return to this issue on Report. In the meantime, I beg leave to withdraw my amendment.

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Amendment 7 agreed.

[The Deputy Chairman of Committees (Lord Bates) (Con)]

We now come to the group beginning with Amendment 8. I remind noble Lords that anyone wishing to speak after the Minister should email the clerk during the debate. I call the noble Baroness, Lady Thornton.

[Baroness Thornton (Lab)]

May I ask for some clarification? Normally in Committee—under normal life, as it were—we would not start another group that would take at least three-quarters of an hour or so if we knew we were going to rise at a set time. I want some guidance as to why we will start this group now, when we know that we will not finish it within the time allowed. We might get through my speech and the next one, but that will be it. I am looking for guidance, Lord Chair.

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[The Deputy Chairman of Committees (Lord Bates) (Con)]

Weighty matters of this nature are dealt with by the usual channels; the Government Whip will respond.

[Baroness Penn (Con)]

My Lords, I understand that the need to rise at a set time is part of the needs of the hybrid House. With other Grand Committees that have taken place in this circumstance, we have made progress on groups and had to adjourn mid-group. That is incredibly important in order to make progress on legislation when we are operating to time-constrained sessions.

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[Baroness Thornton (Lab)]

I think we should. This is an important debate and we need it as a whole debate. I would be very grateful if that could be considered. I promise to make a small speech when we restart.

[The Deputy Chairman of Committees (Lord Bates) (Con)]

That concludes the work of the Committee this afternoon. The Committee stands adjourned. I remind Members to sanitise their desks and chairs before leaving the Room.

Committee adjourned at 7.13 pm.