Medicines and Medical Devices Bill

Lord Patel Excerpts

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

[Lord Patel (CB) [V]]

My Lords, I shall be extremely brief. It was a pleasure to support the noble Baroness, Lady Cumberlege, and I congratulate her on achieving a remarkable feat of getting patient safety in statute for the first time in the United Kingdom. Her tenacity was such that she was never going to give up. I also congratulate the Minister. He obviously listened and understood all the arguments that were made. He has produced the establishment of an independent patient safety commissioner. Having been concerned with patient safety for many years, it is good to know that for the first time it is in statute. The noble Baroness made a few important points that were well argued as to why words may be misinterpreted. I hope that the Minister has listened and will respond positively. Again, I congratulate her—it was a pleasure to support her.

--- Later in debate ---

[Baroness Thornton (Lab)]

My Lords, in moving Amendment 2 I will speak also to Amendments 27 and 40 in my name. I also support the amendments in the names of the noble Lords, Lord Patel and Lord Kakkar, and of the noble and learned Lord, Lord Mackay.

This amendment would provide a sunset provision for Part 1, requiring the Government to return with primary legislation. It is linked to the sunset amendments for Parts 2 and 3 and the amendments in the name of the Lord, Lord Patel, requiring consolidated legislation. We discussed all these issues in Committee. Through discussion, the noble Lord, Lord Patel, the noble Baroness, Lady Jolly, and others have joined together to put this together as a suite of amendments, which makes sense.

At Second Reading, the noble Lord, Lord Blencathra, said:

“Thus it grieves me to say that the structure of the Bill is absolutely atrocious and an affront to parliamentary democracy. Of course, it is not unique; it is just one more Bill stuffed full of Henry VIII clauses but devoid of substantive content. It is the barest skeleton, all to be filled in with negative secondary legislation.


I am speaking in my capacity as chair of the Delegated Powers Committee. We considered the key clauses—Clauses 1, 8 and 12—and concluded that they contain inappropriate delegations of power. We say that


‘the Government have failed to provide sufficient justification for … the Bill adopting a “skeleton bill” approach, with Ministers given very wide powers to almost completely re-write … regulatory regimes’.”—[Official Report, 2/9/20; col. 415.]


Here we are some distance away from that remark. Indeed, the question we must ask is: have we succeeded? Is the Bill less atrocious now than at the beginning when the DPC was so scathing?

All of us, in particular the Minister, the noble Baroness, Lady Penn, and the Bill team, have listened and improved the Bill. The Government have worked hard to meet some if not all of the Constitution Committee’s and the Delegated Powers Committee’s recommendations.

We believe that this suite of amendments, in a way, builds on those improvements that have already been made to the Bill. They propose a very simple objective that was articulated from the very beginning. It is neither democratic nor safe to run medicines, devices and veterinary medicines through regulation alone in the long run. Our regulatory framework needs to be in primary legislation. This must be achieved in a timely fashion, hence these amendments. Sooner or later—and there is agreement on this—there will need to be consolidation in primary legislation. We would prefer it to be sooner. We think that some agreement is necessary on this.

While I recognise the need to get this legislation on the statute book, the Minister must know about the disquiet that some of this has caused and the need to address the issues of accountability in regulation. The truth is that while we are very pleased to now have affirmative regulation, it is very rare for that to be rejected once it reaches Parliament, however unsatisfactory it might be. In fact, we have learned a great deal about regulation over this year of Covid regs.

The amendments in my name and those of the noble Lord, Lord Patel, and the noble Baroness, Lady Jolly, would amend Parts 1, 9 and 14, which concern the three objectives of the regulation of medicine, medical devices and veterinary devices, with a three-year sunset provision. In Committee, I proposed that there should be consolidation of regulatory legislation within a two-year period, so I hope the Minister might recognise that we have been quite generous here because we have now extended that to three years.

Other noble Lords who are much better qualified than I will discuss the merits of the group. I look forward to hearing their discussion. In the meantime, I beg to move.

[Lord Patel (CB) [V]]

My Lords, I support the amendments in the name of the noble Baroness, Lady Thornton. As she said, they should be read in conjunction with my Amendments 26, 39 and 63 on the need for consolidating legislation, which I will come to in a minute.

As has previously been debated, the Bill confers an extensive range of delegated powers relating to medicines, veterinary medicines and medical devices. Previously, the power to create relevant secondary legislation in the UK was derived from the European Communities Act 1972. Those delegated powers were simply to allow the implementation of laws in the UK that have already been consulted on, debated and scrutinised at EU level and by our own EU committees in the Lords.

The powers in the Bill are such that areas of policy that previously would have been subject to greater scrutiny at EU level may now be amended without similar levels of scrutiny in the United Kingdom. They do not, as such, represent an equivalent conferral of power to the legislature seen under the previous regulatory arrangements.