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 Jo Churchill Jo Churchill The Parliamentary Under-Secretary for Health and Social Care 11:30, 8 Mehefin 2020

It is a pleasure to serve under you, Mr Davies. I agree with the hon. Member for Nottingham North that we have worked on the Bill in a spirit of co-operation, and I would very much like that to continue, because sitting at its heart is the patient, and patient safety is what we are after here. I will come on to the two specific points, but I shall address now the sunset element and why, in our opinion, that is not the way to proceed, because of its time-limited nature.

As the hon. Gentleman said, the Bill is necessary because at the end of the transition period, we will lose the ability to update. I am grateful for his words saying that both he and the shadow Secretary of State for Health and Social Care understand what we are trying to do. We need to be able to amend the legislation that governs human medicines and medical devices and veterinary meds. This measure will enable us to update the regulations in the light of patient needs and in the light of changes and innovation. I am sure that the hon. Member for Nottingham North would agree that one challenge is the dynamic nature of how medical devices in particular, but also medicines, are changing—at the bedside, but also right across healthcare. Patients and their best interests are at the heart of the Bill, and that is where I want to start.

On amendment 9, what the hon. Gentleman says is important, but the explanatory statement, while giving clarity, still leaves us with the challenge of an overarching sunset clause for the Bill, such that two years after Royal Assent, the primary legislative framework would fall away and Parliament would have to re-legislate for the provisions in the Bill once again. I understand that the hon. Gentleman’s intention is to ensure that Parliament reconsiders, and those checks and balances are important —it is important that we think about the legislation that we are passing. One would hope that at that time, Parliament will be sitting under normal circumstances, but, to be frank, we are not sure. That said, I would like to set out specifically why this proposal would be unhelpful and cause a potential risk to patient safety.

The Bill, in the main, does not deliver any immediate change to the regulation of medicines and medical devices. It provides a framework of powers to ensure that regulatory change can be made as and when necessary. It does, as I hope all hon. Members will recognise when we reach the relevant clauses, increase the level of parliamentary scrutiny, and it is that that enables us to look before something goes forward. There is going to be more scrutiny, under the affirmative procedure, for us to look and understand what it is we are legislating for than we have had thus far. Use of the affirmative resolution is made near universal, other than in the event of an emergency and for very minor changes.

The Bill delivers clarification of the enforcement powers available to the MHRA in respect of medical devices by consolidating offences. It introduces civil sanctions as an alternative to prosecutions, and concentrates the MHRA’s various tools to ensure compliance with the medical devices regulations in one place. Such strengthening, and introducing a necessary power of disclosure of information, rights a wrong that has been in place for some time: the inability to share information throughout the NHS family if there is a concern about a medical device. I know we all welcome that. It is, arguably, an additional lock to what we currently have, because the data is shared.

If the Bill were to be sunsetted two years after Royal Assent, I cannot see what benefit that would bring because it would still be appropriate in relation to the powers in clauses 1, 8 and 12 to make changes to the regulatory regime through secondary legislation, which would necessarily require primary legislation to do it—that, again, would give assurance. To have the Act fall away after two years would run the serious risk that we would cease to have the legal powers we need available to us to make regulatory change to address a patient safety risk or to improve access to medicines and all innovative therapies that might be coming onstream at that point.

As we know, the passage of the Bill has taken some time and a hiatus would be extremely detrimental to patients. Also, we might not be able to deliver reforms such as the ones alluded to by the hon. Member for Nottingham North on community pharmacy. As he knows, we are already six months into the Bill and we are just beginning our consideration. It is entirely conceivable that in two years’ time, we might not be able to secure the necessary powers on the statute book in order to use them. I ask for his forbearance in not pushing this matter, because a sunset clause could lead to further unintended consequences. I therefore do not think it is necessary.

We will need to make changes to human medicines, veterinary medicines, clinical trials and medical device regulations. The changes range in nature from the very minor but important, such as the ability to have Braille printed on medicine packages, to updates to the marketing authorisation process. For example, innovative therapies have tailored manufacturing requirements that reflect the deterioration of specific short-life components, and we would want to do that if we knew that the lifespan of the component was compromised. The changes can be extremely specialised, and secondary legislation is the appropriate vehicle for such changes. Where the changes are critical to patient safety, it is absolutely right that we can make them quickly and not worry about the powers to do so falling away, which would leave us hobbled in our ability to care for the patient.

I understand the concern of the hon. Member for Nottingham North about delegated powers and their breadth, given the points raised in respect of other Bills. However, our substantial delegated powers memorandum sets out the limits and curbs on the powers available, and the safeguards applied to them. To further assist, we have published a draft of six illustrative statutory instruments as examples of how the delegated powers in the Bill may be used. That is in accordance with the recommendations in the Delegated Powers and Regulatory Reform Committee’s recent report. I very much want to reassure him about that.

It is necessary to regulate such matters through secondary legislation, as they are technical areas comprising a large body of law built over time that reflect a highly complex area where small changes may make a difference to good regulation. That is why it is important to have that flex. Small changes to the human medicines regulations might have a significant bearing on one element of the regulatory regime, but have no impact whatever on how medicines are supplied and so on. It would be unwieldy at best and dangerous at worst to rely on primary legislation for any change to the regulation of medicines, medical devices and clinical trials, given the necessity for speed when changes are needed. We might put ourselves in the position of continually needing to return to Parliament, potentially with emergency legislation every so often, to put something right that provides a material benefit but is of little consequence, which could be done via a statutory instrument, and putting off updating regulations until enough change is required that a Bill becomes paramount. Meanwhile, where changes were not made, there would be those who would obviously be affected because we would have failed to take action when it was needed for those individual patients.

I am sure that the hon. Member for Nottingham North would not want the UK’s regulatory regime to stagnate. I know that he supports a vibrant life sciences sector, as I do—particularly given the part of the country he represents, with its great university—where we can encourage innovation and access to innovative therapies, tempered with the need to protect our patients. Without the ability to update and amend regulations by secondary legislation, we run that risk.

The substantive powers in the Bill are necessary. There could be unintended consequences if the Act falls away and we have a gap, such as whether the MHRA would continue to have in its arsenal the necessary equipment to deal with serious harms, or whether there could be challenges in securing compliance.

The power to disclose within the NHS family is new. A combination of EU legislation, and the way it has been implemented in the UK, has prevented us from being able to, for example, tell one NHS trust that alerted the regulator to an issue that other trusts had raised similar points, so we do not build the picture of patient safety across trusts. I know that the hon. Member for Nottingham North has approached the Bill with patient safety in mind, as I have, because we have discussed it, and I have had conversations with the hon. Member for Central Ayrshire over the weekend, as has the hon. Gentleman.

We are all trying to get the Bill to a place where the patient is at the centre and their safety comes first. I hope that the hon. Gentleman and other hon. Members appreciate the significant benefits and coherence that the power would bring for patient protection. It ensures that information for patient safety travels through the system, and it provides another lock on the system to ensure that information is received rapidly for the protection of patients.

To that end, sunsetting the Bill would present more harms than it would address, but that would not be the true impact, however well intentioned. The impact would be by virtue of where the amendment falls in clause 1(1), on the ability to update and amend the law in relation to human medicines. The same arguments relating to why that would be unhelpful apply, but it is also unclear what the intent would be with respect to regulations already made under that clause. We would not wish inadvertently to undo change to the statute book, for good reasons and in the interests of Parliament, so that Parliament can return to the principles of the Bill on each occasion, rather than the specific changes necessary to improve the regulation of human medicine.

I understand that the aim is to ensure that Parliament can consider the matters thoroughly and that the amendment is about scrutiny. I hope that in our consideration we can address any material issues now, so that Parliament will not need to do so again.

On the hon. Gentleman’s concerns about pharmacy, which I will come to later, essentially it is about ensuring that community pharmacies are enabled. I am cognisant that we wish to empower small pharmacies to be able to use a hub and spoke model to secure their place on the high street and to ensure that, with appropriate training for technicians, the clinician can be freed to move forward, as per the pharmacy contract, to give advice to patients as part of the primary care team. That is what, in essence, lies behind the desire for pharmacy to be enabled, in order to deliver more for patients and for pharmacists, who are highly skilled and to whom I pay tribute. They have been a stalwart part of the entire system through the past 12 weeks. They have met patients in the high street and their doors have remained open. This legislation will enable them to be the fine clinicians that we know they are, and to use their high level of skill to benefit others.