Medicines and Medical Devices Bill

Lord Lansley Excerpts

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

Therefore, I strongly urge Her Majesty’s Government to consider these amendments seriously. A three-year timeframe seems a perfectly reasonable one in which to move towards consolidated legislation. In addition to all the benefits that I have already laid out, there is an additional benefit: ultimately, this Parliament should be working towards improving legislation and the context in which it is presented to our fellow citizens. This is an ideal opportunity to address a vital area that touches on the lives of every citizen and to deal effectively with matters that have built up over a long period and do not necessarily sit well together, through the opportunities presented to us by coming out of the European Union and, therefore, the terms of the European Communities Act and all that has been enacted and codified as a result.

[Lord Lansley (Con)]

My Lords, I am grateful for the opportunity to speak on this group of amendments. May I, however, begin by seeking clarity about the grouping of the amendments? Amendment 116 is also to be found in the eighth group and is more appropriately to be found there. It is my amendment; I know where it should sit properly. It does not belong in this group and is not relevant to this subject. However, I think the Marshalled List should list Amendment 116 in the name of the noble Baroness, Lady Thornton, who raises what is effectively the sunset issue in that amendment. The noble Lord, Lord Patel, who I always think of as a friend, referred to his Amendment 141, which is not listed in the grouping but should be here; Amendment 142 is listed in group five and also should be here. With those two changes, I think that we are talking about the right group.

I could stop now, but I will be quick and refer to just two things. First, as a former Leader of the House of Commons, responsible for the legislative programme, I view with deep unhappiness the idea of attaching three-year sunset clauses to all the legislation we put through the House. If we start down that path, we will never introduce new legislation but will constantly be revisiting old legislation and trying to renew it. There is an argument about the nature of this Bill but it is an argument I am proposing to have when we debate the next group of amendments. It is skeletal, and there are things we can do to make the power not only clearer in its purposes but much more accountable if used. So, I am against the sunset clause.

My other point relates to Amendments 50, 67 and 115 in the names of the noble Lords, Lord Patel and Lord Kakkar. I have great sympathy with these. I think it was the noble Lord, Lord Patel, who referred to the consolidation of human medicines regulations in 2011 or 2012. There is a great deal to be said for the regular consolidation of legislation to make it more accessible. I do not regard consolidation as a purely technical legal exercise; it should always be used as an opportunity to simplify and clarify. It is not, in my view, sufficient to say, as I think Ministers might well reasonably do, “We consolidated human medicines legislation and we will continue to keep the regulations in as clear a form as we can”. From time to time, there is a purpose in coming back to primary legislation and looking for clarity and consolidation. That is often what we use the Law Commission to do, because it has particular expertise in this area. It may be inappropriate to do so at this stage for human medicines because of the necessity of making the regulations and of transposing former EU regulations and directives into UK law. It is perfectly reasonable for that to happen over some period of time, but I hope that Ministers will consider that.

Where medical devices are concerned, there may be a better argument. The noble Lord, Lord Patel, was quite right—navigating medical devices legislation is, if anything, harder than navigating human or veterinary medicines legislation. There is a lot to be said for finding the consolidation instrument for medical devices regulation, once we know what it looks like and we have brought it into force. My friends the noble Lords, Lord Patel and Kakkar, are on to something; I just do not think that new primary legislation within three years is the route. However, for Ministers to recognise the value of consolidating instruments including, from time to time, consolidating primary legislation is certainly desirable.

[Baroness Walmsley (LD) [V]]

My Lords, I support the attempts in this group to put a sunset clause into the Bill. I have a great deal of sympathy with the demands of the noble Lord, Lord Patel, for consolidation. It is vital that through these amendments and others to later clauses, we are able to review the use of the Bill’s powers by this failed Government, who have made so many mistakes. A Government who cannot even secure the free trade agreement that was supposed to be the easiest thing ever, who disastrously and expensively have not produced the promised world-beating test and trace system and who have presided over one of the worst rate of Covid-19 deaths in Europe due to their dithering and failure to put health first, must have their powers fettered. But, as has been said, this is a skeleton Bill and gives the Government extensive powers with little ability for Parliament to intervene.

A lot is changing. The Brexit transition phase is coming to an end in a couple of months. We have learned many lessons from Covid-19, which should be implemented. The NICE review is coming up, and every month new medicines and therapies are coming on to the market. It would be folly not to have a sunset clause in the Bill. I therefore support what was said by my noble friends Lady Jolly and Lady Thornton, and urge the Government to consider, in all humility, that in two or three years’ time they may not be in power, and the whole landscape will have changed. It is therefore essential that we have an opportunity to review how the powers in the Bill have been used to change things, especially if all has not gone well.

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[Lord Bethell (Con)]

My Lords, Amendments 2, 7, 51, 54, 56, 68 and 72 are a package intended to respond to the comments made at Second Reading and the consideration of the Bill by your Lordships’ Delegated Powers and Regulatory Reform Committee and the Constitution Committee.

I have said at both the Dispatch Box on Second Reading and in meetings with a number of noble Lords that I am listening and ready to make improvements to the Bill where they are necessary. I am ready to provide reassurance about how the powers are intended to be exercised. Amendments 2 and 68 would require that regulations may be made only if the appropriate authority is satisfied that the regulations promote the health and safety of the public. A number of noble Lords spoke in favour of clarity regarding how the considerations applied in making regulations and whether the first consideration—that of safety—had primacy. This was a point made by the noble Baronesses, Lady Barker, Lady Andrews and Lady Walmsley, and by the noble and learned Lord, Lord Woolf. Their remarks on how the Government could improve the nature of the framework Bill were ones that I paid particularly close attention to. In making legislation, there is a delicate balance between making it absolutely clear that regulatory change will not be made that is contrary to promoting the health of the public and not binding the Government so completely that necessary regulatory change that is not explicitly for the purpose of promoting the health of the public is not possible. This amendment seeks to provide that comfort: that the Government’s making of regulations must satisfy that obligation.

Amendment 51, on veterinary medicines, is drafted differently to reflect the specific circumstances of how veterinary medicines are made. For example, a medicine that might be suited to the health of an animal might unhelpfully contribute to antimicrobial resistance in humans. An overarching requirement to be satisfied that regulatory change promotes the safety of animals, without reflecting that we must also consider the safety of animals as food products in the food chain, would have inadvertent consequences. Amendments 7, 54, 56 and 72 are consequential to these.

I have considered carefully the alternative constructions tabled by your Lordships. I wanted to demonstrate our absolute commitment to patients’ health and safety that is at the heart of this Bill. My noble friend Lady Cumberlege’s report has highlighted the importance of this.

My amendments do not fetter our ability to make good regulations that will enable the development of new medicines and devices in the UK and ensure the availability of those medicines. But, in doing so, the requirement to be satisfied will protect against the inadvertent impact on the health of the public. This will answer the requirement to make it clear how the Bill is a framework Bill, as opposed to a skeleton Bill, providing that test against which regulations can be measured.

I hope that these amendments provide assurance not only to those in this House who sit on the Delegated Powers and Regulatory Reform Committee and the Constitution Committee but to others who are keen to see the Government reflect my noble friend’s recommendation that patient safety be put first. I beg to move.

[Lord Lansley (Con)]

My Lords, I am glad to have this opportunity to speak to my Amendment 5 and to Amendments 70 and 76 in this group. I am particularly grateful to the noble and learned Lord, Lord Woolf, and the noble Baroness, Lady Jolly, for putting their names to Amendment 5. As the Minister rightly said, he set out to respond in government Amendment 2 to the remarks of the Delegated Powers and Regulatory Reform Committee and the Constitution Committee. We discussed this a lot at Second Reading. The essence of the argument that I among other noble Lords made was that the Bill was a skeleton, the skeleton approach was criticised by the Delegated Powers Committee and we needed to move it from a skeleton to a framework by making it clear that the power to make regulations is for a purpose. The noble and learned Lord, Lord Woolf, and I set out to do that in our amendment: to express a purpose rather than have a power that essentially had no test other than whether the Secretary of State had had regard to certain factors—there was no objective test that could be examined, because it is very easy for Ministers to say that they have had regard to something.

Why did we have the objective of safeguarding public health? The relevant EU regulation, which is the EU human medicines directive 2001/83/EC, as amended, says at what is essentially its first article:

“The essential aim of any rules governing the production, distribution and use of medicinal products must be to safeguard public health.”


Therefore, rather than invent our own purpose, we thought that the starting point for the legislation should be to reflect the same objective as incorporated into the regulation-making power up to now. The Minister may well say, “But the EU regulation is not only based on the public health treaty objective but on the internal market objective”. However, Article 3 of the EU regulation, which follows that, is quite clear:

“However, this objective must be attained by means which will not hinder the development of the pharmaceutical industry or trade in medicinal products within the Community.”


Therefore, the other legal bases, if anything, tend to act alongside and be balanced with the original treaty objective, which is to safeguard public health. It seems that there is therefore nothing inherently wrong in our own power to set out the objective, which is to safeguard public health, and then to set alongside it in the subsequent subsection the other considerations to which the Secretary of State must have regard. We will go on to discuss those, but they include the safety of human medicines, the attractiveness of the UK as a place to conduct clinical trials, and so on.

This is the test: why are we moving from the current legislative basis to a new one? What is inherently better in saying that Ministers must be satisfied that they will promote the health and safety of the people and in what sense is that different from safeguarding public health? Noble Lords might well say, “You have won—you put your amendment down and the Minister has put government Amendment 2 down, and they say more or less the same thing”. We submit that they do not quite say the same thing, since the government amendment’s construction is that the Secretary of State “must be satisfied that”. Our construction is that it

“must have the objective of”.

I am not qualified to say any more about this matter; I will leave that to my noble friend in this regard, the noble and learned Lord, Lord Woolf. An objective test should be expressed in the legislation in objective terms, not in subjective terms of whether the Secretary of State is satisfied.

Amendment 70 does a similar thing in relation to medical devices. Amendment 76 begs the question: is the safety of a medical device to be assessed in the absence of knowing its therapeutic use? It may well be that the answer is that assessing the safety of a medical device must necessarily consist not only of the approval process but of understanding its use in therapeutic settings. If the answer is that that will necessarily be the case and if Clause 12 of the Bill means that anyway, I am perfectly happy to accept that. However, I am looking for an assurance from the Minister that that is what Clause 7 means: safety of a medical device is not simply through its approval processes but through understanding in the approval process how it will be used in therapeutic practice.

In conclusion, from what I have said we do not think that government Amendment 2 is better than our Amendment 5. However, government Amendment 2 is clearly better than what is in the Bill at the moment, because it gives us a purpose for which the regulation-making power is to be used. I make a plea to noble Lords. At this stage, in Committee, I would far rather change the Bill by accepting the government amendment and its sequelae, as we would say, and therefore send the Bill to Report in at least a form that one Front Bench agrees with than not change the Bill and have to have this same debate all over again on Report. We might have the same debate, but it would clarify for the benefit of noble Lords on Report if at least the Bill has moved from where it has been to show how the Government are seeking to meet the objectives set out at Second Reading and by the Delegated Powers Committee so that we can look at it again properly on Report. I of course reserve my position and that of my noble friends whose names are attached to this amendment, as we might well want to come back to the issue on Report and say that our formulation with an objective test is better than the subjective test that government Amendment 2 implies.

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[Lord Sharkey (LD) [V]]

Can you hear me now? Yes? Good. Noble Lords will be relieved to hear that I will not start again. I will speak to Amendments 34, 36 and 37.

Clause 4 deals with clinical trials, which delivered £1.5 billion in GVA and £335 million to the NHS in 2018-19. They are an absolutely critical part of UK life sciences and part of what makes the UK a global leader in medical research. Anything that reduces the number or share of clinical trials in the UK weakens that leadership and could delay access to new drugs or treatments.

In its briefing, the APBI points out that our share of clinical trial applications and patient recruits has fallen since 2016. As the noble Lord, Lord Hunt, said, we now rank behind the US, Germany and Spain for phase 3 trials—and Covid has had a dramatic effect. The University of Southampton has published research showing that 1,500 clinical trials of new drugs and treatments for cancers, heart disease and other serious illnesses have been permanently closed down in Britain, with a further 9,000 suspended.

The Government know all this and acknowledge the importance of clinical trials. Given that, Clause 4 is a surprisingly weak response. It does not require the Government to do anything at all. It simply says that they may regulate—it does not say how they may regulate—and lists the areas in which they may regulate. This is another example of the abuse of secondary legislation. It gives unspecified policy-changing powers to Ministers without saying what these policies might be, except that they should do no harm—not a very demanding qualification.

When questioned about this and asked which bits of the CTR they will carry across, the Government’s response is, “The elements that are in the UK’s best interests.” These best interests are to be identified after consultation with interested parties. This all seems unnecessarily feeble. Researchers, commercial and academic, need certainty and stability as soon as possible. Ideally, they would like the provisions of the new UK regime to incorporate all possible provisions of the CTR as they come into force. We know what these provisions are. We know all the thinking behind them. The UK played a central part in their construction in the first place. Our amendments try to give some clarity and certainty to the situation.

Amendment 34 would replace “may” with “must”. It would oblige the Government to do something and does not just give them the power to do something if they feel like it. Substituting “must” for “may” would mean that the Government must make provision corresponding or similar to provision in the CTR.

Amendment 36 would modify this requirement slightly to acknowledge that we cannot adopt certain provisions of the CTR. These are the provisions that relate to the EU clinical trials information system and the assessment model involving co-ordinated decision-making on multi-state trials. Amendment 36 would add “where possible” to the requirement to make provision corresponding to or similar to provision in the CTR to allow for this.

Amendment 37 specifies two features of the CTR that the Government must incorporate. These are specified because they are new and very important, and for the avoidance of doubt about the meaning of “corresponding to” or “similar”. The two new features are the new definition of clinical trials and the allowing of co-sponsorship. In its briefing, CRUK notes that the MHRA has had considerable input in the new definition of clinical trials. It notes in particular that the new definition expands the scope of low-risk trials and excludes altogether some studies, such as pure pharmacology studies that are focused on how medicines work rather than on the extent to which they do. The CTR also defines and allows co-sponsorship, where two or more sponsors across multiple countries may share responsibilities. CRUK regards this as a very positive move, allowing for more flexibility in trial set-up and helping to foster collaboration. We helped to design both these new features. We should ensure that they are incorporated into our new regulatory regime.

[Lord Lansley (Con)]

My Lords, I am glad to follow the noble Lord, Lord Sharkey, because he made some important points and it saves me having to make the same points less well.

The purpose of Amendment 35—in my name and that of the noble Lord, Lord Kakkar—is precisely to explore the issues that the noble Lords, Lord Sharkey and Lord Hunt, raised. I am concerned that, as it stands, the provision may mean that we do not align sufficiently with the clinical trials regulations as they exist in the European Union. That is a great pity because we have gone to an enormous amount of trouble to try to improve the clinical trials regulations in the European Union; indeed, we arrived at a point where they were significantly better than the previous regulations. To depart from them now seems a retrograde step.

We cannot be sure that we will stay aligned with those regulations for ever but having the objective of seeking to have our clinical trials regulations correspond to those in the European Union opens the option for us to be in the clinical trials information system. If we start to diverge from the EU clinical trials regulations, I am not sure how we can then be incorporated into that system. That automatically means significant difficulties in trying to manage multi-state clinical trials in Europe with a view to an authorisation process through the European Medicines Agency because the information system will, I think, be an essential pre-condition for marketing authorisation applications to the EMA. The purpose of Amendment 35 is precisely to explore this issue. What do the Government mean by “or similar”? Do they intend to diverge or not? If they intend not to diverge and to retain corresponding regulations, that is excellent. If they intend to do otherwise, that is not so good.

I do not intend to enter into the argument about aligning with the European Medicines Agency for the simple reason that we have been here before. We legislated in the Trade Bill in the last Session to align ourselves with the agency and to participate in its processes. Unfortunately, I do not think that that is going to be available to us, so legislating for it in the United Kingdom will be, I am afraid, without effect. I will focus on the Clinical Trials Information System because there is likely to be a willingness and interest on the part of our European partners to retain the United Kingdom in this process. I hope that is so, that we might be able to attain that, and that that will be the Government’s objective.