(2 days, 1 hour ago)
Lords ChamberI just reinforce to the noble Lord that it would be completely wrong to pre-empt the decisions of Parliament—I am sure he is fully aware of that. I just want to give reassurance that, across all these issues, evidence would be considered in the usual way in considering the substances to be used should the Bill pass. I think I have been exceptionally clear on this, and we need to move forward.
Given the size of the group, I reaffirm that it would be impossible to address each amendment specifically, but the broad thematic workability concern is that the use of unclear and ambiguous language could result in unworkable duties and increased risk of legal challenge.
I turn to amendments tabled in relation to the regulation of approved substances and clinical trials. Many of these amendments are policy choices and are therefore a matter for the sponsor and for Parliament. However, noble Lords may wish to note that many of these amendments also introduce new concepts that would require significant work to ensure the policy intent is clearly understood and that they are coherent for the rest of the Bill. I draw noble Lords’ attention to a number of amendments where the Government have major workability concerns.
Amendments 701 and 713, tabled by the noble Baronesses, Lady Grey-Thompson and Lady Hollins, relate to clinical trials for approved substances. First, these amendments could delay implementation of the Bill until a clinical trial or evidence-gathering study is completed, which could make implementation within the four-year timeframe difficult. Noble Lords may wish to be aware that these amendments could create workability concerns relating to the ethical and regulatory challenges for clinical trial processes for approved substances.
Does the Minister think it is ethical and right to administer drugs that have not been cleared through a normal process and to expedite their use? Surely we have to wait until the drugs have been properly tested.
I do not think it would be appropriate to comment on that level of detail at this point.
Apologies; I thank the noble Baroness for her clarification on that point. I was mid-sentence, so forgive me if I repeat myself. Limiting the number of manufacturers based on prior prescriptions is operationally impractical and could risk supply shortages.
I turn to Amendment 713A from the noble Baroness, Lady Hollins. This amendment appears to seek to introduce a parallel approvals regime, but it does not specify how that should relate to the Secretary of State’s separate power.
I just want to ask the Minister about her response to the noble Baroness, Lady Lawlor. She was, I think, saying to the Committee that limiting the places at which you can get the lethal drugs that will be required for death would inhibit the process. I say to her that there are situations in which the supply of medication is limited in exactly that way. Some years ago, I had toxoplasmosis, and the only place the drug could be administered then was Scotland. So it is possible; such systems exist now. I do not quite understand why drugs to treat toxoplasmosis have to be controlled, but the suggestion is that drugs that will kill people do not.
I would be happy to write to the noble Baronesses with clarification on that point; I thank them for their interventions.
As I was saying, Amendment 713A appears to introduce a parallel approvals regime, but it does not specify how that should relate to the Secretary of State’s separate power under Clause 27 to specify the list of approved substances. This could lead to operational uncertainty. Although the amendment could be delivered, establishing a dedicated regulatory pathway would likely require adjustments to the MHRA’s remit and internal processes.
I turn finally to Amendments 887A and 888A from the noble Lord, Lord Empey, which would amend Clause 57 by removing the reference to Northern Ireland. This would mean that regulations made under Clause 37 would not extend to or apply in Northern Ireland. As medicines regulations are UK-wide, should this amendment be accepted, it might create legislative divergence across the UK. This does not mean that assisted dying would be legalised in Northern Ireland.
As noble Lords will be aware, many of these amendments have not had technical drafting support from officials. If your Lordships support these amendments, the Government will need to revisit the drafting of amendments and the Bill as a whole to ensure that they are workable and coherent, both internally and with the wider statute book.