Medicines and Medical Devices Bill — House of Lords, 2021-01-12
Topic: Health
James Bethell (Conservative, Centre-right): My Lords, one of the key qualities of this place is bringing to bear years of expertise in refining legislation. From those involved in life sciences to ex-Health Ministers, we have between us cumulative decades of experience. In moving this amendment, it may be convenient if I speak also to Amendments 6, 8, 9, 11, 29, 30 to 33, 42 to 45 and 47 I am very grateful to all noble Lords who spoke at Second Reading, who have written, who have met with me and who spoke in Grand Committee on the fundamental points that we are discussing now through Amendment 4: how we ensure that we have the powers needed to make regulatory changes to the bodies of law that govern medicines and medical devices; how we ensure that the changes are swift and safe, and support the continued availability of medicines and devices; how we ensure that essential changes are practicable in a fast-paced environment; and how we provide confidence in the checks and balances built into the framework in which these powers can be exercised The amendments that I have tabled are the result of detailed talks. I pay tribute in particular to my noble friend Lord Lansley, the noble and learned Lord, Lord Woolf, and the noble Baroness, Lady Thornton. Their amendments in Grand Committee can be seen as the seeds from which my amendments have grown. I say "my amendments" but I view them as a collective effort—an evolution from our discussions in Grand Committee and refined through cross-party conversation. I will come to and address the noble Baroness’s amendments to my amendments, where I hope I can provide further assurances As I have said before, this Bill is a framework Bill. It is so because we must have powers that allow us to work with the comprehensive and established regulatory regimes that already exist. We must also have the means to respond effectively, swiftly and appropriately to questions asked. My noble friend Lord Blencathra and his committee asked us very politely to look again at our drafting, and noble Lords suggested that the Bill needed to move from a skeleton Bill to a true framework Bill Amendments 4, 6, 8, 9 and 11 make a number of important changes to the regulation-making powers in Clause 1. They provide for the overarching objective sought by my noble friend Lord Lansley and the noble and learned Lord, Lord Woolf. When exercising the power to make regulations, they are to be made in pursuit of the objective of safeguarding public health. That provides all the benefits that my noble friend set out in Committee—an objective test. I do not propose to dwell long on this, as my noble friend explained it so eloquently when he proposed his own amendment then However, the noble Baroness, Lady Thornton, has put forward Amendment 5, which would alter the wording of that overarching objective. This would amend the objective from safeguarding "public health" to safe- guarding "the health and safety of the public" This was, as she knows, the original language of the government amendment in Grand Committee. I expect that the noble Baroness is querying rather than pressing us on this drafting. I say to her that, in the spirit of collegiate drafting, we have adopted the language proposed by my noble friend Lord Lansley. He made a good argument in Committee; we have listened. It was repeated during our conversations outside Committee, and we saw this amendment as a product of the whole House rather than simply the Government. I hope that that answers her questions here Turning back to the government amendments, they update the considerations that must be given regard to in pursuit of that objective. Noble Lords did not find the clarification of "attractiveness of the UK" clear enough. A number of alternatives were proposed, setting out the sorts of activities that noble Lords thought were good things to promote. My amendment does away with "attractiveness" and supplies a consolidated list of the sorts of activities that we hope the UK will be seen as a favourable place to undertake. This is absolutely in line with the Government’s intention to support the life sciences sector that we have now and to encourage innovation and interest in the UK as a good place to do business in future Among others, my noble friend Lady Cumberlege, the noble Lords, Lord Patel and Lord Hunt of Kings Heath, and the noble Baroness, Lady Thornton, made salient points about the importance of safety. While there has never been any intention that making the UK attractive to the life sciences sector should make patients less safe, we have provided for a clear and unambiguous lock on patient safety—that is, as part of the decision-making process behind regulatory changes, if proposed changes have an impact on the safety of human medicines, the appropriate authority may make those changes only if the benefits outweigh the risks This is very clear. There may, as I said earlier during the Bill’s passage, be instances where we do need to make changes that deregulate to ensure the supply of medicines. We have made changes to address the rollout of a vaccination programme; that is absolutely the right thing to do. It requires an assessment of the risks by the experts and requires the benefit—a benefit that the noble Lords who spoke to me at length on this agreed was present—to outweigh the risks. Equally, there is regulatory change that may have no impact at all on safety In Amendments 12, 34 and 48, the noble Baroness, Lady Thornton, presses me on the criteria for making this assessment of risks and benefits and on whether the Government will publish that assessment. On the latter point, I can assure her that the amendments made in Committee entirely provide for this. We have already committed to publishing our initial assessment of proposals when we go out to public consultation. That will be the first exposure of our thinking on all aspects, not just risks and benefits. It will be open for persons who respond to that consultation to disagree with us. On the basis of that consultation, we will publish an Explanatory Memorandum when we lay the regulations. There will be ample opportunity to check our homework On the criteria, it will not be news to the noble Baroness when I talk of the challenge of specifying a single set of criteria that could apply for the assessment of the risks and benefits of all changes, when regulations may make vastly different changes to the existing regimes. I know that we spoke about these issues with other noble Lords during the discussions preceding Report. I simply do not think that this is necessary or helpful. When the Secretary of State makes amending or supplementary regulatory changes, the Minister will take advice, including from the host of experts inside the MHRA and the VMD, whose day-to-day responsibility it is to protect safety. We have all heard from the excellent Dr June Raine on the importance of safety. It makes sense to take a sensible approach to assessment, particularly in the light of the fact that we will set it out in the ways I have spoken to I am very pleased that we have arrived at a formulation that works. It is practicable and good legislation at the same time. Amendments 29 to 33 repeat this set of changes in relation to the regulation-making powers at Clause 9 for veterinary medicines—with an important distinction. The difference relates to how the overarching objective is formulated. This reflects the material differences and choices made for the regulation of veterinary medicines, such as reserving certain medicines for use in humans to avoid further antimicrobial resistance. It is right that we have an objective but that that objective works in this context. It is also right that the same lock on safety is applied Amendments 42 to 45 and 47 would apply the same framework to the regulation-making power in Clause 14 in relation to medical devices. When making amending and supplementary changes to the regulation of devices, it provides a separate but similar list of activities that we would wish to be seen as favourable, including the addition of carrying out research on medical devices. In the light of our debate in Committee and the debate we have ahead of us on the importance of medical technologies, this inclusion is absolutely right I do not propose to take significant time speaking to Amendments 73 and 94. They both make minor changes, but for an intent with which I do not think any noble Lord would disagree. In the interests of clarity, Amendment 73 would require a consultation on regulations under Clauses 1, 9 or 14 to include a summary of the assessment of the person making the regulations of all matters mentioned in these clauses. Amendment 94 serves to clarify the commencement of the definition of "human medicines provision" at Clause 5.