Health and Care Bill

Debate between Lord Kakkar and Lord Lansley

Lords Hansard - Part 2 & Committee stage
Tuesday 18th January 2022 Lords Chamber

[Lord Kakkar (CB)]

My Lords, I rise to support the amendment in the name of my noble friend Mawson and others, and in so doing congratulate him on his thoughtful introduction. It is clear that one of the most important aspects, and the purpose, of this Bill is to ensure integration at a local level. But the purpose of that integration must surely be—as has been confirmed by the Minister—to improve health outcomes for the entire population. It is well recognised that that can happen only if the social determinants of health in local communities are addressed appropriately and effectively, in a way that our health system has not been able to do to date.

If we accept that to be the purpose, then local integration—that focus on and understanding of the social determinants of health—and responding to local needs must be secured in the organisation of the integrated care systems and their boards. As we have heard from the noble Lord, Lord Mawson, and others, to achieve that, one must not only understand, appreciate and hear the local voice, but be clear that the culture that is established in these systems is responsive to those voices and is determined to act on them and the understanding of the local situation—particularly those social determinants that extend far beyond what has been and can be delivered through healthcare alone—and focus on other issues such as housing, education and employment. It would be most helpful if the Minister, in answering this debate, could explain how that is going to be achieved in the proposed construction of the integrated care boards.

Of course, one recognises that Her Majesty’s Government are deeply committed to this agenda. But it is clear that if these boards are not constructed in such a way that they can change the culture and drive, in an effective and determined fashion, a recognition of those social determinants and create opportunities at a local level to address them, much of the purpose of this well meant and well accepted proposal for greater integrated care at a local level will fail.

[Lord Lansley (Con)]

My Lords, I did not originally intend to contribute to this debate. However, I would like to thank the noble Lord, Lord Mawson, for his Amendment 41A, which, although modest in scope, has initiated an extremely useful debate and raised a lot of important issues. I do not want to add a lot of material to the debate, but I want to focus on the questions that have emerged from it.

Medicines and Medical Devices Bill

Debate between Lord Kakkar and Lord Lansley

Committee stage & Committee: 2nd sitting (Hansard) & Committee: 2nd sitting (Hansard): House of Lords
Monday 26th October 2020 Grand Committee

[Lord Kakkar (CB) [V]]

Is the Minister able to indicate why there might be anxiety about giving priority to safety? Is it because methodology by way of clinical trials evaluation is not sufficiently well developed to make that a statutory principle for the availability of medicinal products or medical devices? Is it that there might be some basis for legal challenge that would make this ill-advised? If not, it appears that putting safety at the forefront is in the interests of patients, our healthcare system, clinicians and the standing of our country as a place to lead in the development of the life sciences.

[Lord Lansley (Con)]

My Lords, I am glad to have the opportunity to contribute to this important debate, to which I have very much appreciated listening. I want to talk about Amendments 10, 12, 74 and 75, in the name of my noble friend Lady Cumberlege, on which I think I very much follow and share the views of the noble Lord, Lord Kakkar.

We are all agreed about what we are trying to achieve at this stage; the issue is how we go about putting it into effect in this Bill. My first point is on patient safety. In the excellent report of my noble friend Lady Cumberlege and her colleagues, what I read is the imperative to minimise harm and to stop avoidable harm. It is clear in the report that stopping avoidable harm is what is being sought and I am assuming that that is what is meant by the proposition that we must make patient safety a prime consideration. In my view, we are all agreed that patient safety is a consideration above those of availability of medicines and the attractiveness of the United Kingdom as a place for life sciences. I do not object to that; I think that that must be true. Indeed, as a number of noble Lords have said, the achievement of a regulatory regime that properly prioritises the safety of patients is absolutely right.

However, when we think about how we translate that into law, we have to look at all the considerations for a medicines regulator. Let me take two angles on that. First, what do my noble friend Lady Cumberlege and her colleagues expect the MHRA to do? In their report, they say that they expect the MHRA to engage with patients and understand better patient-reported outcomes and patient-reported experiences in order better to be able to assess the benefits and risks of the medicines that it regulates—I emphasise “benefits and risks”, not just risks. In that sense, I want the legislation to tell the MHRA that that is indeed what it should be doing.

Secondly, we start with the medicines regulations that we have from the European Union. To some extent, as noble Lords will have gathered from my incorporation of the phrase “safeguard public health” into Amendment 5, which we debated last week, I think that that proposition enables that consideration by the regulator to be incorporated into its operations. It should be there. Otherwise, how can safeguarding public health be demonstrated if one is not properly assessing both the benefits and risks of new medicines?

Indeed, one of the early paragraphs of EU directive 2001/83/EC on medicines for human use says:

“The concepts of harmfulness and therapeutic efficacy can only be examined in relation to each other”.


The end of the paragraph says that applications for marketing authorisation for a medicinal product must

“demonstrate that potential risks are outweighed by the therapeutic efficacy of the product.”

For this reason I wanted to incorporate safety and therapeutic efficacy in an early draft of my Amendment 5, since both are essential. It is correct to prioritise safety over availability, attractiveness or other considerations, but to attach to patient safety the proposition that it is an overriding consideration seems wrong. It is not an overriding consideration; it is an essential one, alongside the therapeutic efficacy of the current or new intervention being examined, whether a device or medicine.

That is not reflected in the amendment’s language at this stage, entirely due to where we are in Committee: we should understand that and decide how to capture that thought. It might be that we have done it already by capturing the proposition of safeguarding public health—in my view we have. However, we should make safety not an overriding consideration but a primary consideration for the medicines regulator. That is a difference. Perhaps my noble friend Lady Cumberlege and the Minister might like to think hard about how we might reflect that.

Finally, I think Hippocrates would agree. “Do no harm” is of course not in the Hippocratic oath, but it derives from Of the Epidemics, in which he wrote,

“have two special objects in view with regard to disease, namely, to do good or to do no harm.”

The two must be together. The medicines regulatory system must ensure that we can do good through better outcomes for our medicines and devices, but also do no harm.