My Lords, Amendments 137 and 138 in this group are in my name. They have partly been answered by government Amendment 133, and I shall speak about all three. My amendments are probing amendments, which would prevent regulation exercise in respect of Clauses 6 and 15 in relation to the disapplication of certain provisions in the medicines and medical devices regulations where there is a serious risk to public health. The reasons for this are the same as those set out earlier on the amendment tabled by the noble Baroness, Lady Thornton, and the noble Lord, Lord Hunt of Kings Heath.
The Government do not require the negative procedure to intervene swiftly in emergency scenarios, as the affirmative procedure is available, and safeguards parliamentary scrutiny. That is what the amendment is about. The Government have tried to respond to it, to some extent, through their Amendment 133, which removes subsections (3) to (9) of Clause 42 and inserts
instead many new subsections, including a table detailing which specific provisions will be subject to the negative procedure, the “made affirmative” procedure and the draft affirmative procedure.
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This accomplishes, in my view, mainly what the Minister set out in his letter, saving the negative procedure for the setting of fees and “supplementary” regulation relating to the new civil sanctions regime for medical devices. It also provides that the “made affirmative” procedure will be used for the disapplication of provisions under Clause 6 in cases of emergency. However, the wording of the table regarding Clause 6 is very specific and states that the “made affirmative” procedure will be used only where the relevant regulations
“contain a declaration that the person making them considers that they need to be made urgently to protect the public from an imminent risk of serious harm to health”.
Clause 6 itself already sets out that regulations made under it may be made where there is
“a risk of serious harm to health”.
The issue is that it is not clear how risk is being interpreted, and the judgment of what constitutes an urgent and
“imminent risk of serious harm to health”
is being left entirely to the person drafting the regulations.
Further, the amendment is not accompanied by amendments to Clause 6, which itself provides that regulations disapplying certain provisions of medicine and medical devices regulations can be subject to conditions to be set out in protocols. In my view, this circumvents parliamentary scrutiny. Overall, the amendment seems at least to address concerns relating to legislative procedure. However, none of the amendments includes a sunset clause, so they do not address the overarching concern that this skeleton Bill circumvents parliamentary scrutiny and adds to the complexity of existing regulations.