To ask Her Majesty's Government what plans they have to follow the approach of the government of the United States' Food and Drug Administration in adapting regulatory requirements by putting clinical evidence into the post-market approval phase and improving the introduction of medical innovation devices.

To ask Her Majesty's Government what plans they have to follow the approach of the government of the United States' Food and Drug Administration in adapting regulatory requirements by putting clinical evidence into the post-market approval phase and improving the introduction of medical innovation devices.

To ask Her Majesty's Government why the definition of a health institution as defined in the Guidance on the regulation of In Vitro Diagnostic medical devices in Great Britain, published in January, differs from that in the MHRA guidance on the health institution exemption (HIE) – IVDR and MDR (Northern...

To ask Her Majesty's Government why the definition of a health institution as defined in the Guidance on the regulation of In Vitro Diagnostic medical devices in Great Britain, published in January, differs from that in the MHRA guidance on the health institution exemption (HIE) – IVDR and MDR (Northern...

To ask Her Majesty's Government what plans they have to introduce a separate budgeting and adoption process for medical devices designated as innovative products.

To ask Her Majesty's Government what plans they have to introduce a separate budgeting and adoption process for medical devices designated as innovative products.

To ask Her Majesty's Government how many of the medical device innovations sent from the HealthTec Connect portal in its first 12 months to (1) NHS, and (2) Government, agencies, have since been adopted by NHS Supply Chain.

To ask Her Majesty's Government how many of the medical device innovations sent from the HealthTec Connect portal in its first 12 months to (1) NHS, and (2) Government, agencies, have since been adopted by NHS Supply Chain.

To ask Her Majesty's Government what plans they have (1) to put in place a framework agreement specifically for the adoption of medical devices innovation, and (2) to ensure that each procurement framework agreement has a section specifically for innovation adoption to speed up the use of innovative medical devices for...

To ask Her Majesty's Government what plans they have (1) to put in place a framework agreement specifically for the adoption of medical devices innovation, and (2) to ensure that each procurement framework agreement has a section specifically for innovation adoption to speed up the use of innovative medical devices for...

To ask Her Majesty's Government what assessment they have made of the research by Mark Ashworth et al 'Spatio-temporal associations of air pollutant concentrations, GP respiratory consultations and respiratory inhaler prescriptions: a 5-year study of primary care in the borough of Lambeth, South London', published in Environmental Health on 7...

To ask Her Majesty's Government what assessment they have made of the research by Mark Ashworth et al 'Spatio-temporal associations of air pollutant concentrations, GP respiratory consultations and respiratory inhaler prescriptions: a 5-year study of primary care in the borough of Lambeth, South London', published in Environmental Health on 7...

To ask Her Majesty's Government how many COVID-19 test kits manufactured in China have been purchased for use in the UK; what those kits have cost; and what capacity there is in the UK for the production of such kits.

To ask Her Majesty's Government how many COVID-19 test kits manufactured in China have been purchased for use in the UK; what those kits have cost; and what capacity there is in the UK for the production of such kits.

To ask Her Majesty's Government what assessment they have made of the impact of intermittent self-catheterisation with single use catheters on the level of hospital admissions in England for urinary tract infections; and what steps they are taking to ensure that patients with urinary continence challenges have access to single use...

To ask Her Majesty's Government what assessment they have made of the impact of intermittent self-catheterisation with single use catheters on the level of hospital admissions in England for urinary tract infections; and what steps they are taking to ensure that patients with urinary continence challenges have access to single use...

To ask Her Majesty's Government what proportion of (1) syringes, (2) vials, and (3) other medical equipment required for a national COVID-19 vaccination programme they have (a) purchased, and (b) ordered.

To ask Her Majesty's Government what proportion of (1) syringes, (2) vials, and (3) other medical equipment required for a national COVID-19 vaccination programme they have (a) purchased, and (b) ordered.

To ask Her Majesty's Government what assessment they have made of the level of tariff that would be introduced by the UK Global Tariff regime in the event of a no-deal Brexit on adhesive removal sprays for use with incontinence sheaths and stoma products; what assessment they have made of the...

To ask Her Majesty's Government what assessment they have made of the level of tariff that would be introduced by the UK Global Tariff regime in the event of a no-deal Brexit on adhesive removal sprays for use with incontinence sheaths and stoma products; what assessment they have made of the...

My Lords, the UK is at the forefront of efforts to drive global collaboration on the development of new vaccines and has committed to procuring a Covid-19 vaccine for the UK, the Crown dependencies and the overseas territories. We are collaborating with international partners on vaccine development, manufacturing scale-up and future distribution. The NHS has allocated and assigned more than 28,000 items of critical care equipment across the UK and Crown dependencies and the remainder is available for allocation across England according to NHS regions, based on future need.

My Lords, the UK is at the forefront of efforts to drive global collaboration on the development of new vaccines and has committed to procuring a Covid-19 vaccine for the UK, the Crown dependencies and the overseas territories. We are collaborating with international partners on vaccine development, manufacturing scale-up and future distribution. The NHS has allocated and assigned more than 28,000 items of critical care equipment across the UK and Crown dependencies and the remainder is available for allocation across England according to NHS regions, based on future need.

The UK has pledged more than £1 billion in aid to counter health, humanitarian and economic risks, including £829 million on the development and delivery of vaccines. I thank all those involved in the COVAX Facility, a multinational mechanism administered by Gavi which pools funding. The COVAX

scheme is an emphatically impactful scheme. Britain has taken a leadership role in it, and I thank all those involved in its development.

The UK has pledged more than £1 billion in aid to counter health, humanitarian and economic risks, including £829 million on the development and delivery of vaccines. I thank all those involved in the COVAX Facility, a multinational mechanism administered by Gavi which pools funding. The COVAX

scheme is an emphatically impactful scheme. Britain has taken a leadership role in it, and I thank all those involved in its development.

The noble Lord raises an important point about those with blood cancer. In fact, many who are in the “extremely vulnerable” group have conditions that may or may not be affected by the vaccine. We are working extremely hard to accommodate their particular needs. The JCVI has an extremely thoughtful prioritisation process. I would be happy to meet the group the noble Lord describes.

The noble Lord raises an important point about those with blood cancer. In fact, many who are in the “extremely vulnerable” group have conditions that may or may not be affected by the vaccine. We are working extremely hard to accommodate their particular needs. The JCVI has an extremely thoughtful prioritisation process. I would be happy to meet the group the noble Lord describes.

I entirely endorse the sentiment the noble Lord expresses. I offer my profound thanks to the devolved authorities for the immense spirit of collaboration which has characterised the response to the pandemic. Often, it would seem from the headlines that the nations are at odds with each other; that is not my experience. The Christmas negotiations he cites are a very good example of that, and I hope the vaccination arrangements will be the finest moment.

I entirely endorse the sentiment the noble Lord expresses. I offer my profound thanks to the devolved authorities for the immense spirit of collaboration which has characterised the response to the pandemic. Often, it would seem from the headlines that the nations are at odds with each other; that is not my experience. The Christmas negotiations he cites are a very good example of that, and I hope the vaccination arrangements will be the finest moment.

My Lords, the noble Lord is entirely right that deprivation and ethnicity are key considerations in the morbidity of Covid; we are all acutely aware of them. The JCVI has looked extremely closely at a variety of different models for prioritising vaccination. Prioritisation based largely on age gives the most accurate and thoughtful prioritisation of the vaccine and is also simple to understand and deliver. That is why it has gone down that route.

My Lords, the noble Lord is entirely right that deprivation and ethnicity are key considerations in the morbidity of Covid; we are all acutely aware of them. The JCVI has looked extremely closely at a variety of different models for prioritising vaccination. Prioritisation based largely on age gives the most accurate and thoughtful prioritisation of the vaccine and is also simple to understand and deliver. That is why it has gone down that route.

My Lords, we have extremely detailed and energetic plans to deal with misinformation, which is based on confusion, and disinformation, which is based on malice. It would not be right for me to go through those plans in detail at the Dispatch Box, but I reassure my noble friend that they are in place and are being characterised by a degree of consideration for those who have concerns about the vaccine. It is a grave undertaking to have an injection such as that. People naturally have searching questions they would like to ask, and we are trying to meet those questions with a degree of thoughtfulness and to answer them in the spirit in which they are asked.

My Lords, we have extremely detailed and energetic plans to deal with misinformation, which is based on confusion, and disinformation, which is based on malice. It would not be right for me to go through those plans in detail at the Dispatch Box, but I reassure my noble friend that they are in place and are being characterised by a degree of consideration for those who have concerns about the vaccine. It is a grave undertaking to have an injection such as that. People naturally have searching questions they would like to ask, and we are trying to meet those questions with a degree of thoughtfulness and to answer them in the spirit in which they are asked.

I thank the noble Lord for the opportunity to make this crystal clear: the MHRA is an independent regulator, its work on vaccine approval has no political interference whatever and there is no pressure on either time or outcome. I pay tribute to those at the MHRA, who are extremely dedicated to the cause. We are going to approach the entire process with a spirit of transparency for exactly the reasons the noble Lord identified. Public trust is essential, and the only way we can gain the public’s trust is by being open and honest about how we go about these approvals. That is the way we will pursue the process.

I thank the noble Lord for the opportunity to make this crystal clear: the MHRA is an independent regulator, its work on vaccine approval has no political interference whatever and there is no pressure on either time or outcome. I pay tribute to those at the MHRA, who are extremely dedicated to the cause. We are going to approach the entire process with a spirit of transparency for exactly the reasons the noble Lord identified. Public trust is essential, and the only way we can gain the public’s trust is by being open and honest about how we go about these approvals. That is the way we will pursue the process.

My Lords, our forthcoming chairmanship of the G7, at the beginning of next year, is giving us a good opportunity to engage with our

partners, including the United States, on issues such as the vaccine. We are grateful to Gavi, which is doing a terrific job at buying the vaccine; it is being characterised by what I would term commercial savviness. The spending review implications for ODA have yet to be published fully, but I reassure the noble Lord that funding the global response to the pandemic and the equitable distribution of vaccines, in particular, remains a massive commitment for the Government.

My Lords, our forthcoming chairmanship of the G7, at the beginning of next year, is giving us a good opportunity to engage with our

partners, including the United States, on issues such as the vaccine. We are grateful to Gavi, which is doing a terrific job at buying the vaccine; it is being characterised by what I would term commercial savviness. The spending review implications for ODA have yet to be published fully, but I reassure the noble Lord that funding the global response to the pandemic and the equitable distribution of vaccines, in particular, remains a massive commitment for the Government.

My Lords, the question of vaccine intellectual property is a delicate one because, as was mentioned earlier, we rely on the private sector for a lot of funding and research, and for supplying the research. So, we are respectful of intellectual property as a principle. None the less, we are also grateful to vaccine manufacturers that have taken an open-source approach to vaccine intellectual property and have made local manufacturing available, so that there can be an extremely wide distribution of vaccines, including to those in the developing world who would otherwise struggle.

My Lords, the question of vaccine intellectual property is a delicate one because, as was mentioned earlier, we rely on the private sector for a lot of funding and research, and for supplying the research. So, we are respectful of intellectual property as a principle. None the less, we are also grateful to vaccine manufacturers that have taken an open-source approach to vaccine intellectual property and have made local manufacturing available, so that there can be an extremely wide distribution of vaccines, including to those in the developing world who would otherwise struggle.