Baroness Blake of Leeds (Lab)

I hope that noble Lords can listen to what I have to say. The clinical trial processes for approved substances are, of course, an essential part as we move forward. Amendment 703, also tabled by the noble Baroness, Lady Grey-Thompson, would not be workable in its current form. It would require a clinical trial process that would delay implementation. The effect of the amendment is unpredictable as it is unclear whether the intention of proposed new paragraph (d) is to regulate the substances themselves, the approval process or the body responsible for oversight. Amendments 704, 705, 698, 708 and 710 were tabled by the noble Baroness, Lady Finlay. Amendments 704 and 705 seek to amend the powers under Clause 37. These amendments would limit Clause 37(4), so that regulations may apply only to substances that have received approval in the Human Medicines Regulations 2012—the HMRs. Those regulations provide for licensing, which is a marketing authorisation of medicinal products and not approval. This is a different legal concept. Additionally, if the amendment is read as requiring licensing under the HMRs specifically for assisted dying, this would be operationally complex to design and implement. Amendment 698 would require any regulations made under Clause 37 to be consistent with the existing rules for medicine overseen by the MHRA and for controlled drugs overseen by the Home Office. We believe that this requirement, in practice, is unworkable. The substances that may be approved under Clause 27 will not necessarily be medicines licensed for this indication or controlled drugs. If a substance falls outside those regimes, it would be impossible to make regulations that are genuinely consistent with them. This amendment may therefore place requirements on the Secretary of State that cannot be met. Amendment 708 would require that, for the Secretary of State to make provision by regulation to allow for the use of devices to enable assisted dying, such devices must have Medicines and Healthcare products Regulatory Agency approval. This approach does not align with how much the regulatory system for medical devices currently operates. Although the MHRA is responsible for regulating the UK medical devices market and requires such devices to be registered with the agency, it does not approve or license medical devices individually. Medical devices are placed on the market following conformity assessment under the UK Medical Devices Regulations 2002, usually carried out by independent approved bodies.