Medicines and Medical Devices Bill

Baroness Garden of Frognal Excerpts

Committee stage & Committee: 4th sitting (Hansard) & Committee: 4th sitting (Hansard): House of Lords
Wednesday 4th November 2020 Grand Committee

[Lord Patel (CB) [V]]

My Lords, I shall curtail my remarks, as time is limited and this is very much a probing amendment. It draws attention to the need to ensure that paediatric regulation-specific measures that preside over the licensing of medicines to better protect the health of children, are reflected in future legislation regarding clinical trials in the United Kingdom.

New medicines licensed in the EU are currently subject to an EU Parliament directive that requires research about new medicines to consider babies, children and young people. The directive means that standardised procedures are in place for sponsors to plan and conduct studies. To get new medicines intended for use by children licensed for marketing in the EU, sponsors must have in place a paediatric investigation plan that aims to ensure that the necessary data are obtained through studies in children. In short, new medicines applying to be licensed for use by children must be trialled by them. It is often the case that medicines trialled in adults are then given in lower doses to children.

New medicines trialled in the United Kingdom are currently subject to this regulation. Moving on, there are clear clinical reasons why it is important for babies, children and young people, as they may show differences from adults in their response to and tolerance of medicines. To ensure that new medicines are safe for their use, they must be involved in clinical trials. That is the important point of my modest amendment.

Furthermore, there is a commitment and a key pledge in the NHS long-term plan to raise to 50% by 2025 the involvement of children and young adults in clinical trials. If there is no regulation requiring that data be collected in clinical trials with children, we will not achieve this. So all I seek is an assurance from the Minister that the Government and the MHRA are well aware of this and that the paediatric regulation will be considered whenever the clinical trials regulations are drawn up by the MHRA. I beg to move.

[The Deputy Chairman of Committees (Baroness Garden of Frognal) (LD)]

My understanding is that the noble Lord, Lord Lansley, has withdrawn, so I call the noble Baroness, Lady Jolly.

[Baroness Jolly (LD) [V]]

My Lords, since March 2011, the European Medicines Agency made available information on clinical trials in children via a public interface, the European Union Clinical Trials Register. The register is based on the information stored in EudraCT, a European database that contains information on all clinical trials with at least a site in the EEA. Can the Minister clarify whether this information will be available to researchers and paediatricians in the UK? Can he confirm whether this point has been part of EU negotiations? Can he further clarify whether there is any difference with data from joint research projects operating across the island of Ireland? Are all data equally accessible? We support the amendment.

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Clause 5, as amended, agreed.

[The Deputy Chairman of Committees (Baroness Garden of Frognal) (LD)]

We now come to the group beginning with Amendment 46, and I remind noble Lords that anyone wishing to speak after the Minister should email the clerk during the debate.

Clause 6: Emergencies

Amendment 46

Moved by

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[Lord Patel (CB) [V]]

My Lords, I support these amendments. They touch on the issues and arguments returned to in respect of amendments to Clauses 15 and 42, which set out the procedures to be followed in exercising these powers, as was mentioned by the noble Lord, Lord Hunt of Kings Heath, its unjustified use of negative procedure and this case of protocols. Clauses 6 and 15 provide that the Secretary of State can disapply certain provisions of the medicines and medical devices regulations

“in circumstances which give rise to a need to protect the public from a risk of serious harm to health.”

Such provisions may be within the Human Medicines Regulations 2012, the Medicines for Human Use (Clinical Trials) Regulations 2004, and the Medical Devices Regulations 2002. However, they also may refer to those provisions that are still to be drafted at the current time and are thus unknown and not yet subject to scrutiny.

I recognise that it is necessary to be flexible in the face of an emergency situation as in the current pandemic. However, in its present form this is another example of broad-reaching powers falling outside of that which is reasonable and proportionate. While the disapplication of certain provisions using this power can be exercised to regulations under the affirmative procedure, they may also be passed in certain circumstances by the negative procedure, and, as in these amendments, by protocol. The use of a protocol, in particular, bypasses Parliament, and therefore is unnecessary. I support these amendments.

[The Deputy Chairman of Committees (Baroness Garden of Frognal) (LD)]

The noble Lord, Lord Blunkett, has withdrawn, so I call the noble Baroness, Lady Jolly.

[Baroness Jolly (LD) [V]]

My Lords, we support these amendments, which relate to the disapplication of regulatory provisions in an emergency. As the Bill stands, the Secretary of State may make regulations about these provisions. This can be subject either to

“conditions set out in the regulations”

or in

“a protocol published by the appropriate authority.”

As the protocol is not subject to parliamentary scrutiny, the amendment in the names of the noble Baroness, Lady Thornton, and the noble Lords, Lord Hunt of Kings Heath and Lord Patel, would remove this provision from the Bill so that, as the noble Baroness, Lady Wheeler, said, conditions would have to be set by regulations alone.

[Lord Bethell (Con)]

My Lords, the lockdown debate later this afternoon brings home the significance of an emergency like Covid. It requires swift, dramatic change to protect public health. Clauses 6 and 15 are essential. They would allow us to make provisions about the disapplication of a medicine or medical devices provision where there is a need to protect the public from a serious risk to health. We would need regulations to do this, because to act in breach of an otherwise applicable provision would be an offence.

Medicines is a highly regulated area. Regulations apply from development of medicines to delivery, right the way down to the pharmacy. It is a complex and overlapping system, designed to protect the end-user, the patient. But there are times when we need to switch off a circuit of the system to respond to an emergency. This is most vividly apparent when we speak of a Covid vaccine. This is end to end, from port arrival, to the logistics of its delivery, to who may administer it. We need to be able to pick this circuit out of the whole and isolate it. Otherwise, to disapply regulation without being highly specific is to disapply regulation not just from the vaccine but from other medicines as well.

This is the point of conditions that go alongside the disapplication. Where we know what the conditions will be, of course it should be in the regulations. But often we cannot know what the specific conditions are. That is where the protocol comes in that the noble Baroness, Lady Thornton, with her Amendments 46, 47, 93 and 94, would like to remove. I acknowledge that the Delegated Powers and Regulatory Reform Committee objected to the use of a protocol. I note that its condemnation was not limited to this Bill but was a broader point about other legislation as well. I hope that I can explain why such a protocol is necessary here.

Protocols are a last resort in any emergency that provides critical flexibility in highly regulated areas. They would be time limited to provide flexibility and administrative detail, tailored to the professional audience that requires it and in language which they are familiar with. A protocol will be used only where it is not be possible to determine all the necessary conditions of disapplication at the pace needed to deal with an urgent threat. The protocol allows for the finer details to be sketched in, while giving Parliament the structure of the regulations to consider. We can debate the principle of disapplying certain provisions of the regulations, without always having the specific names of medicines or vaccines in front of us.

There are existing provisions in the Human Medicines Regulations 2012 that allow for the disapplication of regulatory provisions on how prescription, pharmacy and over-the-counter medicines may lawfully be supplied. These are limited to circumstances in the event or anticipation of a pandemic disease. This formed part of the response to the swine flu pandemic in 2009. Six protocols were issued in relation to specific antivirals for the treatment of swine flu, enabling them to be supplied by authorised staff who would not normally be able to supply prescription-only medicines. This involved separate protocols for different strengths of oseltamivir, a demonstration of just how specific we would expect the protocols to be.

We have made an SI this month introducing provision for the use of protocols in relation to coronavirus and influenza vaccinations. That SI seeks to anticipate the certain flexibilities that might be needed but it is not possible to cover all eventualities. It anticipates the need for rapid supply and the potential mass administration of medicines, since the anticipated vaccine may be delivered by injection.

However, until we are presented with a vaccine, we cannot know how many injections are required, for example. That is a finer point of detail that has implications for the scale of operation required. The SI makes clear that the disapplication of existing regulatory provisions about supply and administration of medicines will be subject to conditions set out in the protocol. These conditions of disapplication will include specifics around the class of persons permitted to administer the vaccines, and the protocol would specify the process by which a person in that class is designated as a person authorised to do so. It will provide for supervision and recording requirements that must be met when the vaccine is administered. These requirements will change depending on the necessities of the specific vaccine. Parliament can debate the regulation, but until we know the detail of that vaccine, we simply cannot establish how this operation will run.

The emergency powers allow us to go broader in terms of disapplications than what is currently available, a reflection of the type of emergency we face. In the illustrative SI published on introduction we have provided some clarity on our intent. It gives an example of what might be needed to ensure the disapplication could be relied upon in response to other circumstances, including a spread of toxins, pathogenic agents, and so on, that give rise to the risk of serious harm to health. This too would operate alongside a protocol.

Amendments 93 and 97 in the name of the noble Baroness, Lady Thornton, relate to emergencies involving medical devices. Provisions already exist in the Medical Devices Regulations 2002. These provisions allow particular devices to be put into service without being subject to CE marking, following a duly justified request if the Secretary of State considers this to be in the interests of the protection of health.

The ventilator challenge allowed us to fulfil the clinical need for ventilators through a combination of CE-marked devices, and devices which were granted an exemption from the requirement. They were required to conform to bespoke technical specifications as a condition of the exemption being granted, and the technical specifications evolved as they needed to. That ensured that the only devices in service without a CE mark were those that met the highest possible standards.

Online publication will also support dissemination to the required audience, to whom it will be targeted, such as operators in the supply chain, enabling conditions to be quickly understood by those who must use them, referring to concepts, processes and so on that they are familiar with from their field.

Protocols are a last-resort power. Where we can anticipate what the conditions of disapplication will be, we will put these into regulations, but I cannot say now how many injections will be required for a Covid vaccine or how many staff will be needed to deliver it. Parliament has our intent, our plans and our proactive preparations now, but not technical specifications—nor do we. I commend the noble Baroness, Lady Thornton, and her team for all they do to hold us to account. It is right that they look at how we can write good legislation, although we need legislation that allows for practicality in a crisis. Therefore, I hope I have provided enough assurances for her to feel able to withdraw her amendment.

[The Deputy Chairman of Committees (Baroness Garden of Frognal) (LD)]

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

[Lord Patel (CB) [V]]

My Lords, I say respectfully to my friend the Minister that he is putting up smokescreens. As he mentioned, he already has the power under the 2012 Act to do much of what he wants to do. Furthermore, the arguments used all relate to the Covid emergency. He alluded to this afternoon’s debate and the measures that are about to be taken, but he already has those powers, otherwise he would not be able to do it. We have emergency legislation related to Covid, which includes immunisation through vaccines. By the way, how many doses would be required? It is not necessary to have that in legislation: it is a clinical decision based on the effectiveness of a vaccine. I do not require legislation to tell me how many tablets I should prescribe to my patients for any disease, so I fear that these are smokescreens. He already has powers of disapplication in an emergency, and I continue to support the amendment.

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Amendment 48 agreed.

[The Deputy Chairman of Committees (Baroness Garden of Frognal) (LD)]

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

Committee adjourned at 4.15 pm.