I am extremely pleased to be back at the Dispatch Box to speak to this Bill. It is a changed Bill since we last looked at it but one that still has the patient at its heart. I am pleased that it comes back to us with the same spirit of consensus and collaboration that it left us with.
Since we had the Bill’s Third Reading, the pandemic’s evolution and the importance of the regulation of clinical trials, the roll-out and regulatory approval of a vaccine,
and the ability of healthcare professionals to get medicines into patients has bought into sharp focus precisely how essential this Bill is. The Government made a number of amendments to the Bill through the other place in response to Committees of the House, the report of the independent medicines and medical devices review, led by Baroness Cumberlege, and, importantly, as a result of genuine, cross-party discussions on how to make this Bill better.
I am glad to say that the Bill still—and for those who know me, this is my passion—puts patients first: patients who will have the opportunity to trial new treatments; patients whose safety is paramount; patients who need to see quick and effective action from regulators in the event of an emergency. The Bill that left us on Report had a new change to it, anticipating Baroness Cumberlege’s report. The medical device information system, which will transform post-market surveillance of medical devices and improve the ability to track down patients and prevent harm, followed talks across this House and in the other place. I reiterate my thanks in particular to the hon. Members for Washington and Sunderland West (Mrs Hodgson) and for Central Ayrshire (Dr Whitford) for their contributions to that effort.
We said on Report that we awaited the conclusions of the Cumberlege review and that we would take steps when the review was published. I can tell the House now that we have, and Lords amendment 1 establishes a Patient Safety Commissioner—a champion for patients in relation to medicines and medical devices. I pay tribute to all those who have spoken here and in the other place of the impact of harm on patients and on women—those who have not been listened to whose stories are difficult and heart-wrenching. Much was said during the Bill’s passage in the other place about the whole system change to enshrine the voice of patients at the heart of the process and our commitment to it. The Patient Safety Commissioner will act within and outside the system. They will be an advocate for patients and ensure that the patient voice is primary. The commissioner will be able to seek information, make reports without fear or favour and expect responses, and, more importantly, get change.
Lords amendments 1, 41, 47, 54 and 56 together provide for both the appointment of a Patient Safety Commissioner and regulations to support this appointment. I congratulate Baroness Cumberlege and her team, and thank her and others who contributed to getting this into the Bill so quickly after her report.
Lords amendment 31 provides for a small but important change that was also recommended in that review: a power to put the devices expert advisory committee on to a legislative footing.
I am very conscious of the passion and commitment shown by the hon. Member for St Helens South and Whiston (Ms Rimmer) when we were last discussing the Bill. She has shown admirable determination. I am pleased to draw her attention to Lords amendment 8, which the Government were happy to support in the other place. That important amendment provides for provisions about the origin and treatment to be made in relation to the regulation of human medicines.
We have had two reports, one from the Delegated Powers and Regulatory Reform Committee and one from the House of Lords Constitution Committee.
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When we last stood opposite each other, the hon. Member for Nottingham North (Alex Norris) challenged me on how to make it clear that patient safety was the absolute priority. I thank him and his team, and those who work in the other place, for their constructive dialogue on these issues. We all want to see patients receiving effective, safe medicines and medical devices, and we all want to ensure that the UK remains at the forefront of pharmaceutical innovation. Amendments 4, 5, 6, 7, 15, 16, 17, 18, 19, 26, 27, 28 and 29 all change the nature of the regulatory powers in clauses 1, 8 and 12. They introduce an objective to safeguard public health, putting it at the heart of regulations. They remove the word “attractiveness” from the Bill and set out what I hope is as agreeable here as it was in the other place—a list of the types of activity we would hope the UK would be a favourable place to conduct. Importantly, they apply a safety lock. Regulations that affect the safety of a medicine or a medical device can be made only if the benefits outweigh the risks.
Hon. Members here were very clear that we should go further to demonstrate that patient safety was absolutely paramount. These changes do that, but they also assist in turning a Bill that was called a skeleton Bill into a true framework Bill that makes it clear how delegated powers will be used and how, in making regulatory changes, safeguarding public health remains key. These changes better reflect the discussions in this House and the other place, and answer the criticisms of the DPRR and the Constitution Committee.
We have also made changes to criminal offences—another area of earlier concern. Amendments 9, 10, 20, 21 and 55 clarify the maximum penalty that may be created by regulations. Both the DPRR and the Constitution Committee recommended increased parliamentary scrutiny, and the shadow Minister’s colleagues also pressed for public involvement.
Amendments 44, 45 and 46 all provide for Parliament to have multiple opportunities to inform, and be informed by, the Government’s plans for regulatory changes. First, consultations have become public consultations under clause 44. Secondly, the appropriate authority is obliged to produce an assessment of how the regulatory proposal meets the overarching framework considerations at the time of going out for consultation. As Members are aware, the Government prepare a response to the consultation, and how the consultation responses are considered will be made public in that way. The amendments introduce a reporting requirement that means a separate report back to Parliament every two years summarising how regulations made under clauses 1, 8, 12 and 18 have been operating during that time. It must include any concerns raised, what has been done as a consequence, and any plans for further changes to regulations. This gives the flexibility for Parliament to be interested in—and if individual Members or Committees wish it, to submit responses to—any individual consultation, without requiring it to.
Last time we discussed this Bill, the hon. Member for Nottingham North asked whether we could accept a sunset clause as a way of settling his colleagues’ concerns as to how we might use the powers contained in the Bill. I hope that he can agree that how these powers can be used has materially changed as a result of the Bill’s going through the other place. Another option that was
put forward in the other place, as well as a sunset clause, was a requirement to bring forward and publish draft legislation. Unfortunately, we cannot accept these changes. Three years is simply not long enough to have a fully settled regime in a steady state to make reassessment practical, and amendments 2, 12, 13, 23, 24 and 40 would definitely introduce a cliff edge for new legislation. That is not the best way to go about legislation in general, but in this Bill, where essential changes could be needed to protect patients, there are better and more effective alternatives. Lords amendments 3, 14, 25, 30 and 48 to 50 also introduce the use of the super-affirmative procedure for regulatory changes that introduce significant new policy or changes to policy. Quite aside from how difficult it would be to assess what “significant” means, it is very much using a sledgehammer to crack a nut—as we are often guilty of doing in this place. In both cases, I have heard the arguments for these amendments. People are concerned about the lack of detail in the new likely changes to the existing regulatory regimes, in particular for medical devices, and therefore Parliament wants greater visibility of what happens next. We have stressed the critical importance of consultation and have made changes there, and we have provided the reporting, as I have outlined.
Amendment (b) in lieu, in the name of my right hon. Friend the Secretary of State, proposes an alternative that goes further. This would require a report to be prepared within five years of Royal Assent that looked at the operation of the legislation. It would oblige the Secretary of State to take into account a report of any parliamentary Committee. That could mean, for example, a Select Committee choosing a report on the basis of a post-legislative scrutiny memorandum, and that report would need to address a series of considerations, such as whether the legislation needs restructuring or consolidating, whether certain parts of the legislation should be an Act of Parliament, and whether any of the powers in the Bill need amending or repealing. That provides the time needed to get the regulatory system into a steady state. It allows for consideration of how the system works on the ground and of all the factors that the hon. Member for Nottingham North and others have fairly raised in arguing in support of their amendments. I hope that he will support this solution.
I do not intend to spend very long on Lords amendments 11, 22 and 32 to 39, not because they are not important, but because they have been arrived at with significant consensus. We introduced these important powers to allow for information to be shared with relevant persons, such as regulators and regulatory networks outside of the UK, in order to give effect to international arrangements. These amendments provide safeguards on data shared by the Medicines and Healthcare Products Regulatory Agency and the Veterinary Medicines Directorate. They define patient information. They provide a definition of relevant persons with whom information can be shared. Government amendment (a) to Lords amendment 11 would remove the reference to pharmaco-vigilance from the requirement to share information in the public interest, as, of course, pharmacovigilance is in the public interest and therefore covered.
Madam Deputy Speaker, I do not intend to spend any time at all—you may be glad to hear—on Lords amendments 51 to 53, which make consequential commencement changes.
To finish, the Bill has gone through with a great deal of well-informed, well-intentioned debate and changes. I am pleased that the constructive discussions that we had before it left us have continued. The other place has brought something back to us that I hope we can agree delivers for UK patients and the UK life sciences industry, which is vital and enables us to build a stand-alone regulatory system for the UK for the future and one that has patients absolutely at its heart.