Medicines and Medical Devices Bill

Lord Mackay of Clashfern Excerpts

2nd reading & 2nd reading (Hansard) & 2nd reading (Hansard): House of Lords
Wednesday 2nd September 2020 Lords Chamber

[Lord Mackay of Clashfern (Con) [V]]

My Lords, first, I thank the Minister for the excellent way in which he introduced this Bill. Secondly, I want to say a word or two about the distinction made by the noble Lord, Lord Lansley, and the noble and learned Lord, Lord Woolf, between a skeleton Bill and a framework Bill. I understand that a framework Bill would be one in which the powers given under the Bill would have to be used for purposes specified in the Bill. Accordingly, if we are to make this a framework Bill, we will have to produce realistic purposes for which the powers must be used.

My second point is in relation to tissue. I strongly support all that has been said about that already.

My third point is that I am very concerned about the question of trials. It is very important that clinical trials are ready to be used over quite a large area of population, particularly, as has been mentioned, in specialist diseases.

My last point is about my noble friend Lady Cumberlege’s report. I fully support it in every aspect. I worked with my noble friend Lady Cumberlege long ago and I know how valuable her work is. The thing that worries me somewhat is how long this might take to implement. There is certainly the possibility of a task force, which was recommended in the report and mentioned today by the noble Lord, Lord Brennan. That strikes me as a signal that nothing much will happen for some time. I regard the present situation with regard to the people mentioned who have suffered so greatly as a very pressing situation, to be dealt with immediately. I would like this to be stopped as soon as possible.

The Bill requires Royal Assent by the end of the year and therefore there is a limited amount of time available. I suggest that a possible way to deal with this would be to set up a patient safety commissioner whose job is to hear from the public and treat that information as important and give it to the people who are responsible for the authorisation and use of various medicines and devices.

I think it would be possible to frame very quickly an amendment that could be used now to set up such a commissioner, with the responsibility to hear from the public and then bring the information that he gets from the public appropriately before the authorities responsible for carrying out the safety assessments in authorisation and use. That could be done now; then a task force would be able to look with slightly more leisure at what else could be added. That could be a Bill separate from, but associated with, what I am proposing.

Medicines and Medical Devices Bill

Lord Mackay of Clashfern Excerpts

Committee stage & Committee: 6th sitting (Hansard) & Committee: 6th sitting (Hansard): House of Lords
Tuesday 17th November 2020 Grand Committee

[Baroness Bennett of Manor Castle (GP) [V]]

Thank you. I will not go back to the beginning but I was speaking about the need for consistent data, which the Minister referred to in his earlier summing up. We have, of course, diverging systems and that is the point of devolution: it is for the devolved nations and Administrations to be able to go their own way and end up with quality, easily comparable data. It is obvious that there will need to be very tight consultation and working together. Amendments 105 and 132 would put this into the Bill, Amendment 105 being particularly important in terms of data.

I will also refer briefly to the other amendments in this group. As the noble Baroness, Lady Wheeler, said, government Amendment 126 is an improvement. Any kind of strengthening of consultation, as in the references to the public and devolved Administrations, is good but it is only partial. I can only commend Amendments 127 to 130 for pushing further on these issues. We know from the report of the noble Baroness, Lady Cumberlege, that so much needs to be done better. Transparency, openness and consultation are clearly key to all of that.

[Lord Mackay of Clashfern (Con) [V]]

My Lords, I join my noble friend Lady McIntosh of Pickering in apologising for having my name to amendments here while I have found myself in proceedings on another Bill which was fairly encompassing in the sense that it required a good deal of attention to understand what was going on. We were not able to achieve the result that the noble Baroness, Lady Finlay, managed of being in both places at once. However, I am glad to be here on this occasion and I am particularly interested in Amendment 117, which we may reach later.

In this group, I particularly support Amendment 127, which the noble Lord, Lord Patel, has carefully referred to already. I generally support all that has been said by others before me on this group of amendments, especially the reference of the noble Lord, Lord Sharkey, to the need to keep in mind the medical charities. I think particularly of Cancer Research, but it applies equally, as he said, to all of them.

I wondered whether the government amendment made unnecessary some of our amendments, but I really wonder about that, because a public consultation is not specifically targeted, and I think the groups that we have represented—particularly in relation to Amendment 127—require to be consulted more directly. I do not know how your Lordships feel about consultations, but I often find that I did not know that there was a consultation at all until the time allowed for it was well passed. That is no doubt due to my lack of efficiency, but I suspect that a lot of patients will not know that a public consultation is happening unless it is drawn specifically to their attention. It is important that the consultation, public as it is, has direction as well. Therefore, I think that Amendment 127 and the other specific amendments are well worth considering in relation to the new government amendment.

I am also extremely anxious that the devolved Administrations should be properly consulted. Of course, devolution and independence are different things, and we are talking about devolved institutions at present. This group of amendments is important, and I agree with most of what has been said about them. Therefore, I do not need to say any more on this occasion.

[Lord Hunt of Kings Heath (Lab) [V]]

My Lords, it is a great pleasure to follow the noble and learned Lord. I have added my name to that of my noble friend Lady Thornton to Amendment 128, which was introduced by my noble friend Lady Wheeler. This regards the organisations to be consulted—other noble Lords have already referred to this—and concerns the provisions of Clause 41 for consultation on Parts 1, 2 and 3 of the Bill. As noble Lords have said, at the moment, it is entirely up to the Secretary of State who is consulted, other than the clarification the Government have brought in relation to the devolved Administrations.

The context of this amendment is the extensive power given to Ministers under the Bill. We have debated this before, but it is worth reminding the Committee that the Delegated Powers Committee in its report on the Bill was highly critical of Ministers for failing to provide sufficient justification for parts of the Bill adopting a skeletal approach. As the committee said, the Bill gives Ministers wide powers to almost completely rewrite the existing regulatory regime for medicines and medical devices.

It is also worth reminding the Committee that the Constitution Committee described the Bill as

“a skeleton bill containing extensive delegated powers, covering a range of significant policy matters, with few constraints on the extent of the regulatory changes that could be made using the powers.”

It went on to say:

“The Government has not provided the exceptional justification required for this skeleton approach.”


The case for a sunset clause is readily apparent, but in its absence, the way in which consultations are done assumes more importance than normal. It is very surprising that the duty to consult is open-ended and simply leaves it to Ministers to decide who to consult. The Minister may say that he does not like lists of organisations to be consulted, but legislation is littered with lists of organisations because it is important to reflect the range of bodies that ought to be consulted. Discretion is always given to Ministers to add to those lists of organisations.

I hope that the Minister will be prepared to take this back because in the end, certainly in the absence of a sunset clause, we have to beef up the provisions on consultation.

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[Lord Mackay of Clashfern (Con) [V]]

My Lords, I warmly support the noble Lord, Lord Patel, in both these amendments. First, in relation to safety, the idea that the Secretary of State “may” disclose information in relation to concerns about patient safety strikes me as extraordinary. If I knew that something was dangerous and that somebody was just about to take it, I think I might be in very grave difficulty if I did not warn the person. The idea that the Secretary of State can have information that suggests a danger to people, and yet is allowed to keep it to himself in the exercise of his discretion, strikes me as extraordinary. It may require some explanation from the Minister as to why that should be. There is a tendency to provide for discretion rather than compulsion. We have seen a bit of that already this afternoon. In the area of safety, discretion should certainly give way to compulsion where it is a matter of risk to a person who is involved.

Amendment 114 concerns confidentiality. Patient confidentiality is one of the most important aspects of the law on medical treatment. It requires to be taken into account very carefully because people have a great concern about the confidentiality of their medical situation—some people more than others because it depends on the origin of the difficulties of the medical history. The general principle of confidentiality in relation to patients is, in my opinion, extremely important and I cannot understand why this little provision has been included that interferes, in my mind, with a very important principle, without much explanation. I support both these amendments.

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[Lord Mackay of Clashfern (Con) [V]]

My Lords, the Bill will confer a power to amend or supplement the law relating to human medicines, veterinary medicines and medical devices. I respectfully submit that a power to create a system to protect the public in relation to all three, but particularly two of them, is well within the scope of the Bill.

When I first read the report of my noble friend Lady Cumberlege, I was extremely upset by what it disclosed. When the noble Lord, Lord Hunt, followed me last time, he said that doing so was a privilege. I want to say that following him is a tremendous privilege because he knows much more about the internal structures of the health service and its related services than I do.

I was privileged to represent the Medical and Dental Defence Union of Scotland for a good number of years before I joined the public service. The work was concerned primarily with mistakes of one kind or another that doctors or dentists had been involved in, but the need for safety was absolutely clear in most of the cases I was involved in. The first time I ever came to the House of Lords was on the instruction of the Medical and Dental Defence Union of Scotland, but of course, that was long ago. The case concerned the safety of a patient.

The message that cries out from the report of the committee chaired by my noble friend Lady Cumberlege is that people are suffering considerable harm as a result of treatments given in the health service, but they have no one to turn to. There is no direct public voice for patients to come to and discuss the matter. It is essential to have someone to whom patients can bring their concerns, which may not always be complaints. It may start as something much less than a complaint—a concern that becomes a complaint if not attended to in any way.

It is essential that somebody with authority and complete independence of the health service be put in place now who is able to listen to what any patient may want to say in connection with the treatment he or she has received. There is a huge deficiency, as has been exposed clearly by the examples given in the report. Therefore, there is an urgent need for Her Majesty’s Government to deal with that immediately. It is all very well to say that it is not this or that, but the truth is that this is urgent, because people are suffering and have suffered from the absence of anybody to whom they can turn in situations such as those described in the report. The Government would be heavily at fault if treatments and difficulties of this kind emerged in the future without them having done anything about it.

The setting up of a patient safety commissioner seems to require in the first instance the appointment of a completely independent person who would be a voice for patients, with a knowledge of the service but independent of it. He or she could bring a patient’s question or trouble to the attention of the part of the service that was intimately concerned with it and do something about it. The report makes it clear that the full powers that a patient safety commissioner should have is a matter for detailed work by a taskforce, but in the meantime statutory authority should be given to an independent person to listen to those suffering in some way from a difficulty in relation to the health service so that it can be brought to people who understand the nature of the subject. The independent person could bring it to the appropriate authority. It is a serious matter that should be dealt with straightaway.

I am very impressed by the example of the Children’s Commissioner, which has been referred to. In the recent discussion about whether to keep schools open, the Children’s Commissioner could not be said to be an organ of the Government, of the trade unions, or particularly of children; she stood independently in a relationship that considered all three parties. That gave her tremendous authority in a very difficult situation, which remains difficult. She was able as an independent person authoritatively to say that children should come back to school. Of course, it was necessary to take effective steps to protect them, but I believe that she was influential in bringing that about. In Scotland also, that has been an important area in delivering people from the stringency of the lockdowns.

So that is a very good illustration of what an independent person can do. I strongly hope that the Government will put forward an amendment to deal with this matter in the simplest possible terms at present, but with the possibility of enlargement as time goes on. Indeed, I suggested some time ago to the Department of Health that it would be useful for it to consider an amendment that would give effect to the report—but I gather that nothing has happened in that direction so far. So we might have to think about amendments to try to deal with some of those matters, as well as the present one. But I strongly support the essence of the present amendment, and I strongly support it happening now.

[The Deputy Chairman of Committees (Lord Russell of Liverpool) (CB)]

Before I call the next speaker, could I request that the noble Lord, Lord Patel, mutes himself?

Medicines and Medical Devices Bill

Lord Mackay of Clashfern Excerpts

Committee stage & Committee: 7th sitting (Hansard) & Committee: 7th sitting (Hansard): House of Lords
Thursday 19th November 2020 Grand Committee

[Lord Mackay of Clashfern (Con) [V]]

Yes, I am here. My internet was turned off on the basis that I was on an aeroplane—which I have not been since March. That shows that some things are not absolutely reliable. Anyway, the noble Lord, Lord Patel, has dealt with the subject, and I do not need to trouble noble Lords any further.

[The Deputy Chairman of Committees (Lord Brougham and Vaux) (Con)]

I now call the noble Baroness, Lady Wheeler. No? I gather that the noble Lord, Lord Patel, wants to speak. I call Lord Patel.

Medicines and Medical Devices Bill

Lord Mackay of Clashfern Excerpts

Report stage & Report stage (Hansard): House of Lords & Report: 1st sitting & Report: 1st sitting: House of Lords
Tuesday 12th January 2021 Lords Chamber

Finally, in several briefings received on this matter it has been stressed that it will be important to ensure that the office of the commissioner, and any other associated committees or boards, reflects the diversity of our population and a range of patient experiences involving mental health and learning difficulties, as well as the physical health problems so sadly outlined in the report by the noble Baroness, Lady Cumberlege. I hope that we will also ensure that we embrace all chronological ages of our society that are served by our healthcare services. Can the Minister inform us whether these important issues of representation will be carefully considered?

[Lord Mackay of Clashfern (Con) [V]]

My Lords, I would like to join in the praise that has been very well entitled from the many people who have spoken today, and at other times, in thanking the noble Baroness, Lady Cumberlege, and her team for the excellent report, which lies at the beginning of this development. I thank my noble friend Lord Bethell and his team for the way they have taken this forward, because I am conscious—I have tried to think about it quite a bit —of how difficult this has been. I feel that, apart from some questions that have been raised—which I do not seek to mention again as it would be useless repetition—the scheme that is involved in these amendments is very good indeed. I shall say one thing about it in a few minutes.

It is quite clear to me that safety in the NHS and in other services is an extremely important matter. When you see the amount of money that the Health Foundation pays out in respect of claims against the health service, it is fairly plain that it is a very serious problem, in fact, and one which has been found to be extremely difficult to reduce substantially. The money that goes out for these claims is a very substantial proportion of the total amount spent on the health service, so this is certainly a very important area, and it is important that it should be attended to in this way as soon as possible.

When I read the report originally, I felt that it revealed a very urgent and important problem in the health service, and that it was vital that patients should have a voice when damage emerged from a particular source, particularly where that source was in some general use. There can be no question but that this is a difficult problem and that it will take all the skill and command of the Government to produce a satisfactory and workable answer.

The report emphasises the need for principles to guide the commissioner and the wisdom of seeking the help of the public to enunciate them. I am very pleased that the Government have taken this on and that the Scottish Government have also indicated their hand to tackle this problem. Although health is devolved, it is important that, if it is at all possible, the answer to this question is agreed across the whole of the United Kingdom.

The title of the report is First Do No Harm. However, the report indicates harm having been done in a number of cases. Many treatments start with an incision and, sadly, some patients pass away on the operating table. In none of these cases do any of the practitioners involved intend to do harm. Surely this shows the calibre of the person required to take on this essential role. To enunciate the principles involved in patient care I consider to be an extremely important labour and a task demanding a person of tremendous responsibility.

I strongly support these amendments, subject to the questions that have been raised, and I am happy that they have been put forward so fully at this stage by the Government.

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[The Deputy Speaker (Lord McNicol of West Kilbride) (Lab)]

After the next speaker, the noble and learned Lord, Lord Mackay of Clashfern, I will call the noble Lord, Lord Kakkar.

[Lord Mackay of Clashfern (Con) [V]]

My Lords, I strongly support the amendments dealing with consolidation. I regard it as very important that the legislation that controls medicines, medical devices and veterinary medicines is consolidated in a way that makes it possible for an interested person easily to achieve knowledge of the regulations. After all, when you think of how important medicine is—we have just had a considerable debate about its safety—it is important to make sure that those who administer and operate the system know the rules. If you do not know what the rules are, the chances are that you will be misled into thinking that you know when you do not know at all. Therefore, it is important to make sure that we do everything we can to lay before those who practise these arts the true rule that has been set down, and it should be possible for them to reach it without too much research into a number of statutory instruments.

We just need to think for a moment about the current virus regulations. I have had occasion to look at them from time to time, and it is quite difficult to follow what is required at a particular moment in England, Scotland or other parts of the United Kingdom. If that is the position in relation to the virus, it is obvious that the general position in relation to these sciences as a whole will be even more difficult. Therefore, I regard it as vital—indeed, as a fundamental duty of government—to ensure that the regulations on these important matters are clear and the rules accessible.

I am not very keen on the sunset clause because, if it operated without consolidation, we would be in a pretty difficult position. Therefore, I regard it as vital to require consolidation.

I am aware of the difficulty of consolidation. For a short time, I was the chairman of the committee on consolidation and, when it sat, it was extremely difficult to get a quorum because people did not find the exercise interesting. But unfortunately, although it might not be very interesting or novel, in the sense that you are not doing anything very new, it is absolutely vital to allow the system to work properly. So I regard it as important that that is put into the statute as an obligation. If we are allowing the Government to legislate in these important areas by statutory instrument —the criticism has been levelled that they are doing so too much—that should be replaced in a reasonable time. Three years is probably quite reasonable, but I am very willing to hear whatever is said about that. I regard it as very important that this is an obligation on the Government as a condition of getting away with this method of legislating quickly in this area.

[Lord Kakkar (CB) [V]]

My Lords, it is a pleasure to speak in support of Amendments 29, 36 and 63 in the name of my noble friend Lord Patel, to which I have added my name, and broadly for the principles of the other amendments in this group. This is a critical area of public policy, as we have heard in this debate and in the excellent debates on these questions in Grand Committee. We have also heard that the regulations—the legislation attending medicines, medical devices and veterinary medicines, and their regulation in our country —have appeared on the statute book as a result of facilitations through the European Communities Act 1972. These represent in many ways a haphazard patchwork of regulation, created over time, with good intention, but obviously with the need to be consolidated and brought to a clear and precise place, as we heard from the noble and learned Lord, Lord Mackay of Clashfern, in such a way that any party interested in this vital area, which impacts on the lives of every citizen, can do so with simplicity, understanding obligations, understanding their rights and protections and being able to act confidently with regard to the rule of law.

The current regulations represent a challenge, and as a result of our departure from the European Union, there remains much contemporary regulation, agreed at the European level, with specific reference to clinical trials and medical devices, that has yet to be incorporated into domestic legislation, once again representing an important challenge with regard to the framework within which we are to proceed.

The Government rightly have stated that patient safety is at the forefront of their thinking when it comes to regulations regarding medicines and medical devices. To bring clarity will improve safety and will also achieve the Government’s other stated objective of ensuring that our country can continue to lead globally in the life sciences. We have seen the benefits of that leadership during the Covid pandemic, in terms of innovation, the application at scale and pace of that innovation for the benefit of our citizens, and the sharing of that knowledge globally.

Therefore, it is difficult to understand why Her Majesty’s Government would reject the opportunity to commit to consolidating legislation so that simplified, clear, effective and intuitive regulatory regimes exist in our country and can deliver the objectives that we all agree upon. In Grand Committee, we heard from the noble Lord, Lord Lansley, an interesting proposition that the Law Commission might be approached to support the task of consolidating legislation in this area of public policy. We have heard from the noble and learned Lord, Lord Mackay of Clashfern, that when he chaired a committee of consolidation there was little interest in dealing with some of the more demanding and exacting elements with the fastidious nature that is required to create effective consolidated primary legislation. Has the Minister had an opportunity to explore whether the Law Commission might be approached on the basis of the Law Commissions Act 1965, to determine whether it would be in a position to propose and engage with the consolidation of legislation regarding medicines, medical devices and veterinary medicines, as part of its forthcoming 14th programme under the obligations and opportunities afforded by the Law Commissions Act?