Medicines and Medical Devices Bill – in a Public Bill Committee am 9:25 am ar 10 Mehefin 2020.
With this it will be convenient to discuss the following:
Government amendments 3 and 4.
Clause stand part.
Government amendments 5 to 7.
Amendments 2 to 7 relate to the clauses about defences available for offences under clause 23 and regulation 60A to be inserted into the Medical Devices Regulations 2002 by schedule 2.
Clause 23 will provide that it is an offence to fail to comply with a compliance, suspension, safety or information notice. Schedule 2 makes it an offence to fail to comply with certain provisions of the Medical Devices Regulations 2002. Further, the Bill provides that a defence of due diligence will be available with respect to each of those offences. That means that a person charged with an offence under either clause 23 or regulation 60A will be able to argue that they have not committed an offence because they took reasonable steps to avoid doing so.
The provisions that make those defences available are in clause 24 and schedule 2. It is those provisions that we seek to amend. Amendments 2 to 4 are to clause 24 and amendments 5 to 7 are to schedule 2.
I do not have an awful lot to say. I am comfortable with the amendments, and I know that the hon. Member for Central Ayrshire is, too, as she put her name to them. I always find it reassuring when there are Government amendments during Committee, as it means they are still reading the Bill, which is a good thing. So, yes, we are content.
On that basis I commend the amendment to the Committee.
Amendments made: 3, in clause 24, page 13, line 32, after ‘hearing’ insert ‘of the proceedings’.
See the explanatory statement for Amendment 2.
Amendment 4, in clause 24, page 14, line 2, at the end insert ‘, and
(b) the reference in subsection (3) to “the hearing of the proceedings” is to be read as a reference to “the trial diet”.’—(Jo Churchill.)
See the explanatory statement for Amendment 2.