Medical Devices (Northern Ireland Protocol) Regulations 2021
Lord Bhatia Excerpts(3 years, 5 months ago)
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Lord Bhatia (Non-Afl) [V]
My Lords, the changes that the EU MDR introduces will affect medical device economic operators in Northern Ireland, estimated to be about 300, and any prospective UK notified bodies. This instrument does not implement the EU MDR itself, but updates the statute book to allow us to implement the EU MDR effectively and addresses areas of national decision to align with policy that applies in the rest of the UK. Specifically, these areas of national decision allow for the continued practice of allowing the reprocessing of single-use devices, if reprocessors adhere to the requirements of an original manufacturer. The instrument will also give the MHRA powers to serve enforcement notices for breaches of the EU MDR.
The instrument will correct current legislation where required, introduce relevant enforcement provisions and outline the fees structure for Northern Ireland. It will introduce provisions in areas of flexibility allowed for under the EU MDR, to allow Northern Ireland to continue to align with Great Britain policy, where possible.
In addition to the 2002 regulations, the instrument also makes amendments to the following retained EU law: namely the Blood Safety and Quality Regulations 2005, to include a reference to the EU MDR alongside the reference to the 2002 regulations; and the human tissue regulations 2007, to include a reference to the EU MDR in order to maintain the scope of the regulations.
I believe that this instrument will protect the safety of medical devices that will be used in the UK and Northern Ireland.
Health Security (EU Exit) Regulations 2021
Lord Bhatia Excerpts(3 years, 5 months ago)
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Lord Bhatia (Non-Afl) [V]
My Lords, I largely agree with what the noble Lord, Lord Lansley, said just now.
These regulations, which support and are aligned to the common framework, revoke and restate with modifications retained EU law on health security. The regulations ensure that EU law continues to function effectively following the end of the transition period, and provide a legislative regime for epidemiological surveillance and response to serious cross-border health threats, whether at risk of extending beyond the UK to an EU member state or as may otherwise necessitate a co-ordinated response within the UK to ensure a high level of human health protection. Will the current variant now coming to the UK be dealt with by these regulations?
The Deputy Chairman of Committees (Lord Faulkner of Worcester) (Lab)
The noble Baroness, Lady Gardner of Parkes, has withdrawn, so I call the noble Baroness, Lady Brinton.
Health Protection (Coronavirus, Restrictions) (Steps and Other Provisions) (England) (Amendment) Regulations 2021
Lord Bhatia Excerpts(3 years, 6 months ago)
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Lord Bhatia (Non-Afl) [V]
My Lords, this SI has been prepared by the Department of Health and Social Care. The instrument revokes and replaces the health protection regulations 2020 and contains the legislative framework that will implement steps 1 to 3 of the Government’s road map out of lockdown in England. This instrument enables a number of public measures to be taken to reduce the public health risks posed by the spread in England of severe acute respiratory syndrome coronavirus 2, which causes the disease Covid-19. The SI also amends a number of other coronavirus regulations.
This SI is made under the emergency procedure set out in Section 45R of the Public Health (Control of Disease) Act 1984. Furthermore, this instrument is made without a draft having been laid and approved by a resolution of each House of Parliament. It is the opinion of the Secretary of State that, by reason of urgency, it is necessary to make this instrument without a draft being laid and approved, so that public health measures can be taken in response to the serious and imminent threat to public health posed by the incidence and spread of severe acute respiratory syndrome coronavirus 2.
This instrument was laid and published and came into force on 29 March 2021, and the measures will expire at the end of 30 June 2021. This instrument will cease to have effect at the end of the period of 28 days, beginning on the day it was made, unless during that period it is approved by a resolution of each House of Parliament. The Secretary of State must review the need for the restrictions imposed by this instrument at least every 35 days, with the first review taking place by 12 April 2021.
I support this SI as put forward by the Minister.
The Deputy Chairman of Committees (Baroness McIntosh of Hudnall) (Lab)
My Lords, the noble Baroness, Lady Gardner of Parkes, has withdrawn, so I call the noble Baroness, Lady Brinton.
Care Homes: Insurance Indemnity
Lord Bhatia Excerpts(3 years, 7 months ago)
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Lord Bethell (Con)
My Lords, the financial stability of the care home sector is, as the noble Baroness rightly pointed out, something that we monitor extremely closely. There will, of course, always been new entrants and new departures from such a rich and varied sector. That is not something to be regretted; it brings innovation and new opportunities to the sector. She is right that the potential increase in insurance payments is something that we need to factor in to the finance. That is why we have brought in the designated settlement support scheme and increased the support from local authorities for social care.
Lord Bhatia (Non-Afl) [V]
My Lords, are there any estimates of how many care homes have gone under because of financial difficulties? How many have been closed down?
Lord Bethell (Con)
My Lords, I do not have the precise number at my fingertips, but I can reassure the noble Lord that the proportion that has gone under in the last year is not dramatically higher than in previous years. We monitor the situation extremely closely. I am aware of the concerns of noble Lords about the financial position of the social care industry and we are taking very careful measures to ensure that we are on top of the financial monitoring situation.
Covid-19: One Year Report
Lord Bhatia Excerpts(3 years, 8 months ago)
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Lord Bhatia (Non-Afl) [V]
My Lords, after hearing all the previous speeches, I do not wish to repeat them. My question for the Minister is: who is to be held responsible for all the deaths caused by the Government’s inability to plan properly? Will there be any compensation for the grieving families who have suffered so much because of the Government’s inability to deal with the issue properly?
Health Protection (Coronavirus, International Travel) (England) (Amendment) (No. 7) Regulations 2021
Lord Bhatia Excerpts(3 years, 9 months ago)
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Lord Bhatia (Non-Afl) [V]
My Lords, this SI has been prepared by the DHSC. It amends the Health Protection (Coronavirus, International Travel) (England) Regulations in order to introduce a new system. First, it addresses quarantine for travellers who have been in one of the designated registered countries that pose a high risk to the UK of the importation of a variant of concern in the 10 days prior to arrival in England. Secondly, it will make mandatory testing for all travellers who have been outside the common travel area in the 10 days prior to travelling to England. These measures are designed to reduce the public health risk caused by the spread from international travellers of a severe respiratory syndrome, coronavirus, which causes the disease Covid-19, particularly with respect to the possibility of a variant of concern being imported to the UK. The regulations came into force on 15 February 2021. This instrument applies in England and Wales.
That is the correct way to deal with the variants that have emerged from South Africa and other countries. We all must appreciate the speed with which the Government have enacted these regulations.
Covid-19: Over-75s
Lord Bhatia Excerpts(3 years, 10 months ago)
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Lord Bethell (Con)
The noble Lord explains the situation of those who have been in care homes and separated from their loved ones extremely well. We all feel extremely heartbroken by the stories of people who have been separated from their loved ones, but we need to put the saving of life as the first priority. Visits have been allowed outdoors, behind screens and in safe environments. I appreciate that that is not the same as an intimate face-to-face meeting but, where we can, we have put in place guidelines to ensure that people are protected. A review of the guidelines will happen on 22 February, and that seems the right moment to review these procedures.
Lord Bhatia (Non-Afl) [V]
My Lords, can the Minister confirm that those over 75 years of age must receive the vaccine first?
Lord Bethell (Con)
My Lords, the priority list from the JCVI indicates that all residents in care homes, older adults and those over 80 will be first. But, with the current state of the rollout, all those over 65 should have been offered a vaccine, and I encourage them all to step up and respond to the letter when they receive it.
Social Care Funding (EAC Report)
Lord Bhatia Excerpts(3 years, 10 months ago)
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Lord Bhatia (Non-Afl) [V]
My Lords, being the 28th speaker in the debate, I fear that all that needs to be said has been said. I do not wish to repeat points that already have been made. Therefore, I limit my contribution to, first, thanking the noble Lord, Lord Forsyth, and his committee for this excellent report. It will bring tears to the eyes of those who read it, particularly carers, those who need support and the general public. I say well done to the noble Lord, Lord Forsyth, and the committee. I plead to the Committee to support this report and bring the greatest possible pressure on the Government to commit £8 billion immediately.
Nutrition (Amendment etc.) (EU Exit) Regulations 2020
Lord Bhatia Excerpts(4 years ago)
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Lord Bhatia (Non-Afl) [V]
My Lords, this instrument was prepared by the Department of Health and Social Care and laid before Parliament. Its purpose is to reflect the Northern Ireland protocol by amending and revoking the nutritional regulations 2019 and to remedy deficiencies in retained European Union legislation on nutrition.
The NIP was designed as a practical solution to avoid a hard border on the island of Ireland, while ensuring that the UK, including Northern Ireland, could leave the EU as a whole. It necessarily included a number of special provisions which apply in Northern Ireland only for as long as the protocol is in force.
Nutrition law is a devolved competence; however, this policy area has been designated by the UK Government for consideration for a common approach. The justifications for a common approach are twofold. First, as these laws originally relate to the cohesion of the EU single market, it is appropriate that similar consideration is given to the UK’s internal market. Secondly, the statutory instrument will ensure a swift, smooth and orderly EU exit that minimises disruption for business and consumers, which is why I support it. Nutrition is an important part of our daily life. In this pandemic era, there are many families unable to have nutritious food, so the health of the family suffers, causing long-term harm, particularly to the children.
Health Protection (Coronavirus, Restrictions) (No. 2) (England) (Amendment) (No. 5) Regulations 2020
Lord Bhatia Excerpts(4 years, 2 months ago)
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Lord Bhatia (Non-Afl) [V]
My Lords, this regulation enables the Health Minister to make regulations preventing dangers to public health from conveyances arriving anywhere and preventing the spread of infection or contamination. It also provides powerful regulations to give effect to international agreements or arrangements—for example, the World Health Organization’s recommendations.
These are necessary powers for the pandemic, restricting travellers arriving from outside. The virus has now spread virtually all over the world. People arriving from outside the UK must conform to the regulations that have been made to protect the population. We must expect that people arriving from countries with a high level of coronavirus should be subjected to isolation for two weeks if there is any sign of a fever or cough when they arrive. It is the responsibility of the Government to protect their citizens.