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?