(4 years, 6 months ago)
Commons ChamberI am most grateful to hon. Friends and hon. Members for their contributions. This is not a stop-gap Bill to get us through the transition; it is a proportionate approach to regulating an industry that moves quickly, with regulators that want to take effective action but are renowned for working with the industry in the best interests of patients. It is about setting a new direction and making clear what the UK wants after the end of the transition period.
Let me turn to the points that hon. Members made. I reiterate to the hon. Member for Nottingham North the commitment to consult when the Cumberlege report is published. We are keen to take account of its recommendations and ensure we are taking the necessary steps to protect patients, as patient safety is paramount to the future of medicines and medical devices regulation. We have of course had routine engagement with the review team, as would be expected, to ensure it is adequately supported and resourced to conduct its review.
I believe that the situation for pharmacies is quite the contrary to what the shadow Minister outlined. For hub-and-spoke dispensing, we intend to give smaller community pharmacies the same opportunity that large pharmacy businesses already enjoy. We will support them, and remove the legal barrier that allows such an arrangement only when the spoke pharmacy and the central dispensing hub are part of the same retail pharmacy business. That would level the playing field for smaller community pharmacies, rather than put them under threat. As I outlined in Committee, particularly during covid, all 11,600 of our community pharmacies have gone above and beyond. They have kept their doors open and have been there every single day for our constituents. I thank them once again. We have committed to consulting before making regulations, and that applies to any changes to rules on pharmacy registration. It means that no changes can be made without first undertaking proper consultation.
I understand the passion of the hon. Member for St Helens South and Whiston (Ms Rimmer) on the subject she raised. As the hon. Member for Strangford (Jim Shannon) alluded to, we are talking about a thoroughly abhorrent process. As I indicated, the Foreign and Commonwealth Office regularly raises concerns with China, including on the extensive use of the death penalty, and on the treatment of religious and ethnic minorities, which sit at the heart of this. I look forward to having a conversation with her after she has had that meeting, in order to understand what was discussed and to continue the conversation further.
I thank the hon. Member for Strangford for his kind words and for highlighting that we have a unique ecosystem here; we have brilliant academics, such as those he mentioned from Queen’s and others from right across the UK. We have a world-leading life science industry, employing some 240,000 people, and they are working to bring the best products to patients. We want to ensure that in and around clinical trials we have a regulatory system that maintains and enhances the UK as a site for global co-operation in research and allows us flexibility to achieve what is best for patients.
On clinical trials, the Government value the strong, collaborative partnerships we have across Europe in the areas of science, research and innovation, and we want to continue to support those opportunities. We are committed to ensuring that the UK maintains its position as a global science superpower and continues to collaborate with Europe on scientific research. The Prime Minister has made it clear that the UK sits ready to consider a relationship in line with non-EU member states’ participation in Horizon Europe, provided that that represents value for money and is in the UK’s interest.
The Bill, as drafted, does not breach the Northern Ireland protocol and the powers in the Bill are capable of being exercised compatibly with the protocol. We will ensure that that is the case. We are clear that the protocol provides that where a GB authority currently approves goods for sale, it will continue to be able to do so, in order to have that free-flowing movement.
To the hon. Member for Westmorland and Lonsdale (Tim Farron), who never misses an opportunity to remind me that he would like more services close to his constituents, I say: I hear you, again. Following Health oral questions this morning, I can say that I know we both share that commitment to drive patient access to radiotherapy and treatments together. Many hon. Members know that that is dear to my heart, having had cancer on more than one occasion. I came here to try to get more cancer nurse specialists and to make sure that on their journey those who have metastatic cancer, which is rarely spoken about in this place, are treated as people who still have full lives to live. Living with and beyond cancer is something we should embrace. The next round of negotiations with the EU will start shortly and we will continue to explore with the EU what future relationship arrangements can look like.
In conclusion, I would like to thank everyone for their efforts in getting us to this place.
I was not in the Chamber earlier, but just before the Minister comes to a conclusion, I wish to thank her for her comments about the engagement she has had with my hon. Friend the Member for Central Ayrshire (Dr Whitford), who has not been able to participate in person in the process of this Bill. I know, however, that my hon. Friend has been grateful for the engagement on a cross-party basis, for the comments the Minister made about the amendments tabled by the Scottish National party in Committee, for the commitments the Government made in response to them and for their engagement with the Scottish Government. I just want to place on the record our thanks for all that and my sympathy with the amendment tabled by the hon. Member for St Helens South and Whiston (Ms Rimmer). A number of my constituents, like those of several other Members, have raised concerns about these issues of forced organ harvesting, and I hope some of that can be considered as well.
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.