Medicines and Medical Devices Bill

Baroness Winterton of Doncaster Excerpts

Report stage & 3rd reading & 3rd reading: House of Commons & Report stage: House of Commons
Tuesday 23rd June 2020 Commons Chamber

It is also essential that we remove unnecessary bureaucracy for the lowest-risk clinical trials to encourage rapid introduction of new medicines while still maintaining safety. That is crucial for the wellbeing of our patients in all of the United Kingdom of Great Britain and Northern Ireland. This is a marvellous opportunity. Our research and development needs to keep us as world-leading innovators, and yet the foundation of all of this must be the safety of the patient—that is paramount. I know that that is the Minister’s intention, and it would certainly be mine. It is my belief that we can achieve this and still share communication and projects with EU countries. I am supportive of this Bill—I want the Minister to know that—and hopeful for our future in this field. We can have safety, security and co-operation without mindless red tape, and I hope that that is exactly what this Bill will do. I welcome it as the Minister prepares to reply.

[Madam Deputy Speaker (Dame Rosie Winterton)]

I call Tim Farron. [Interruption.]

[Tim Farron (Westmorland and Lonsdale) (LD)]

Jim, you could have carried on a bit longer, couldn’t you? It is an honour to follow the hon. Member for Strangford (Jim Shannon).

When it comes to the regulation of the introduction of new, innovative medicines, treatments and technologies, I am bound to say that cancer will be at the forefront of many of our minds. It is an area that deeply concerns every single one of us, and it could be severely impacted if we do not get the negotiations right. The NHS long-term plan, which is full of very good and wise things, recognised the significant problem that we have in the United Kingdom with our cancer survival rates. Our survival rates, and it has been the case under many Governments of different colours, are among the worst in Europe. We have the second lowest survival rate for lung cancers and below average survival rates for nine of the 10 major cancers. The terrifying statistic for us personally is that one in every two of us is likely to get cancer at some point in our lives. That means we will, all of us, almost certainly be touched by cancer in some way in our families at some point during our lives, if we have not been already.

The need to step up our efforts to fight this horrific disease is amplified by the current context. We have seen a 60% drop in cancer referrals and a 20% fall in the numbers of those starting treatment during the covid crisis—for obvious reasons, and some of them justifiable reasons. Clearly, there are people who are at risk of their immunity being suppressed during the virus or who could gain the infection via surgery during the pandemic, so we understand why clinicians make such decisions.

--- Later in debate ---

[Jo Churchill]

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.

[Madam Deputy Speaker (Dame Rosie Winterton)]

I will now suspend the House for three minutes.