Medicines and Medical Devices Bill — House of Commons, 2020-06-23
Topic: Health
Johanna Peta Churchill (Conservative, Centre-right): I thank the hon. Gentleman for his contribution. These are unusual times, so it was my pleasure to work with the hon. Member for Central Ayrshire (Dr Whitford) to do what we could to ensure that the Bill proceeded with a degree of consensus, as it was to work with her on access to off-licence drugs some years ago Our consideration of the Bill has been led by good sense and common ground, and by general understanding and consensus about its purpose. I am grateful to everyone who contributed along the way. I think the themes we heard today and in Committee—the paramount importance of patients; the need to ensure that we carefully consider and scrutinise legislation and that it is made after consultation; and the use of data to underpin better regulation and improve safety—were the right ones for us to consider. Although it is not necessarily part of regulatory scrutiny, I am grateful to the hon. Member for St Helens South and Whiston for raising the important issue of the UK’s continued promotion of human rights and ethics I am grateful to the Clerks for their help; these are unusual circumstances, but I have felt no less supported and, working towards ensuring that we can make progress in the other place, we will continue to use imagination. The Bill is a framework for where we want to go. It will allow us to ensure that the regulation that governs critical areas that matter for us all and are likely to affect us all indirectly is up to date and supports the thriving life sciences sector and patients. To that end, I commend the Bill to the House Question put and agreed to. New clause 1 accordingly read a Second time, and added to the Bill. Clause 14 Fees, information, offences Amendment made: 1, page 8, line 35, leave out "efficacy" and insert "performance, including the clinical effectiveness,".—(Jo Churchill.) This amendment clarifies the matters relating to medical devices the recording of information about which may be the subject of provision in regulations under Clause 12(1). Clause 35 Offence relating to information Amendments made: 2, page 18, line 36, at end insert— "(2) A person to whom information is disclosed under regulations under section (Information systems) commits an offence if the person uses or discloses that information in contravention of those regulations." This amendment and Amendment 3 provide that a person who discloses information in breach of regulations made under the new clause inserted by NC1 commits a criminal offence. Amendment 3, page 18, line 37, after "subsection (1)" insert "or (2)".—(Jo Churchill.) See the explanatory statement for Amendment 2. Clause 38 Power to make consequential etc provision Amendment made: 4, page 21, line 41, leave out "and 12(1)" and insert ", 12(1) and (Information systems)(1)".—(Jo Churchill.) This amendment enables regulations made under the new clause inserted by NC1 to make consequential and other provision. Clause 40 Consultation Amendments made: 5, page 22, line 11, leave out "sections 1(1), 8(1) or 12(1), or paragraph 9 of Schedule 1" and insert "a provision of Part 1, 2 or 3". This amendment and Amendment 6 have the effect that the Secretary of State is required to consult before making regulations under the new clause inserted by NC1. Amendment 6, page 22, line 29, after "section 12(1)" insert "or (Information systems)(1),".—(Jo Churchill.) See the explanatory statement for Amendment 5. Clause 41 Procedure Amendments made: 7, page 22, line 32, leave out "section 1(1), 8(1) or 12(1), or paragraph 9 of Schedule 1," and insert "a provision of Part 1, 2 or 3" This amendment has the effect that regulations made under the new clause inserted by NC1 are to be made by statutory instrument. Amendment 8, page 22, line 42, leave out "section 1(1), 8(1) or 12(1)" and insert "a provision of Part 1, 2 or 3" This amendment and Amendments 9 to 17 enable regulations under powers in the Bill which are subject to negative procedure to be combined in a single statutory instrument with regulations under powers which are subject to affirmative procedure, or with regulations under powers in other legislation which are subject to negative procedure. Amendment 9, page 23, line 12, leave out "to which subsection (9) applies" See the explanatory statement for Amendment 8. Amendment 10, page 23, line 13, at end insert "if the only regulations under a provision of Part 1, 2 or 3 that it contains are regulations to which subsection (9) applies" See the explanatory statement for Amendment 8. Amendment 11, page 23, line 14, leave out "to which subsection (9) applies" See the explanatory statement for Amendment 8. Amendment 12, page 23, line 16, at end insert "if the only regulations under section 1(1) or 8(1) that they contain are regulations to which subsection (9) applies" See the explanatory statement for Amendment 8. Amendment 13, page 23, line 18, leave out "to which subsection (9) applies" See the explanatory statement for Amendment 8. Amendment 14, page 23, line 23, at end insert— ", if the only regulations under a provision of Part 1, 2 or 3 that it contains are regulations to which subsection (9) applies" See the explanatory statement for Amendment 8. Amendment 15, page 23, line 24, after "to" insert "— (a) " See the explanatory statement for Amendment 8. Amendment 16, page 23, line 36, at end insert ", and (b) regulations under paragraph 9 of Schedule 1" See the explanatory statement for Amendment 8. Amendment 17, page 23, line 37, leave out subsection (10).—(Jo Churchill.) See the explanatory statement for Amendment 8. Clause 43 Commencement Amendment made: 18, page 24, line 15, at end insert ", and (d) section (Information systems)".—(Jo Churchill.) This amendment provides for the new clause inserted by NC1 to come into force two months after the Bill is passed. Bill read the Third time and passed.