My Lords, I thank the noble Baroness, Lady Thornton, for her amendment, which would require the Secretary of State to act in accordance with the guidance on the use of civil sanctions—I am sorry, I am on the wrong amendment.
Amendment 145, in the name of the noble Lord, Lord Sharkey, seeks to amend the commencement clause, Clause 44, so that all provisions would come into force on the day the Bill receives Royal Assent. I am confident that the amendment is not necessary. Clause 44(1) provides that the clauses needed to make emergency amending regulations will come into force the day the Bill receives Royal Assent.
Under Clause 44(2), a significant number of clauses come into force after the customary two-month commencement period. Chapters 3 and 4 of Part 3 come into force on a day the Secretary of State appoints which is specified in regulations. This combination of commencement provisions is for a good reason. Patients, stakeholders and Parliament must know what the law is before the law is made. The two-month commencement period allows the Government to continue to engage with industry and the relevant stakeholders properly before provisions come into force.
Importantly, Clause 44 provides for the necessary powers and provisions to come into force on Royal Assent should it be necessary, within that two-month period, to make regulations urgently in order to protect the public from an imminent risk of serious harm to health.
I understand that there may be concern about Clause 44(3), which allows the Secretary of State to determine when Chapters 3 and 4 of Part 3 come into force, but I assure the noble Lord that, again, this is for a good reason. Chapter 3 of Part 3 is concerned with enforcement and included in that is the introduction of a civil sanctions regime. Civil sanctions will act as a flexible, proportionate enforcement mechanism, enhancing the MHRA’s ability to incentivise compliance. The new civil sanctions regime requires supplementary regulations to be made under paragraph 9 of Schedule 1 before it can be fully operational. It is important that
the MHRA engages with industry and stakeholders on these regulations and the accompanying guidance. Indeed, the Bill requires a consultation to be carried out before they are made. If these provisions came into force on the day the Bill achieved Royal Assent, we would have no time to make the necessary regulations. Our time to consult in advance on those regulations and the guidance would be severely condensed.
It is absolutely right that we consider the views of stakeholders and the public before making the supplementary regulations and bringing the new civil sanctions regime into force. I assure noble Lords that the Government are committed to bringing the enforcement and data and disclosure chapters into force as soon as is appropriate in order to enhance the safety of the medical devices regime. I hope the noble Lord, Lord Sharkey, understands the reasoning behind the clause and feels able to withdraw his amendment.