Asked by: Lord Black of Brentwood (Conservative - Life peer)
Question to the Department for Environment, Food and Rural Affairs:
To ask His Majesty's Government, further to the Written Answer by Lord Benyon on 13 July (HL9238), what is the makeup of the Veterinary Medicines Directorate’s internal scientific review committee; what process and criteria the scientific review committee follows to develop its assessment report; and what documents are provided to the scientific review committee by Veterinary Medicines Directorate assessors.
Answered by Lord Benyon - Minister of State (Foreign, Commonwealth and Development Office)
The scientific review committee for pharmaceutical products is chaired by the Head of Pharmaceuticals. Membership includes all pharmaceutical assessors (quality, safety and efficacy), representatives from Regulatory Affairs, Pharmacovigilance, and other government bodies including the UK Health Security Agency, Health and Safety Executive, Food Standards Agency, Environment Agency, and the Department of Agriculture, Environment and Rural Affairs of Northern Ireland. Other agencies may also be invited on an ad hoc basis.
The documents for the formal review meeting include the assessment report, list of questions to be addressed by the applicant and an executive summary which highlights the main issues and the benefit-risk conclusion.
The scientific review committee provides a formal peer -review forum, where each application is summarised, and key issues raised and discussed. The operation of the committee is described in internal operating procedures. Formal minutes are produced. The committee output is to endorse the list of questions for the applicant, decide whether these are likely to be resolvable, agree the benefit-risk conclusion and decide whether or not further scientific advice from the Veterinary Products Committee should be sought.
Similar scientific committee and processes are in place for non-pharmaceutical products (immunological and biological products).
Asked by: Lord Black of Brentwood (Conservative - Life peer)
Question to the Department for Environment, Food and Rural Affairs:
To ask His Majesty's Government, further to the remarks by Lord Benyon on 13 July (HL Deb col 1885), whether they intend to include cats at the outset of any proposed pet abduction offence.
Answered by Lord Benyon - Minister of State (Foreign, Commonwealth and Development Office)
We have listened carefully to views expressed on pet abduction during the passage of the Animal Welfare (Kept Animals) Bill and we will take this feedback into consideration when delivering this measure.
Asked by: Lord Black of Brentwood (Conservative - Life peer)
Question to the Department for Environment, Food and Rural Affairs:
To ask His Majesty's Government, further to the Written Answer by Lord Benyon on 13 July (HL9237), what is the process for members of the Veterinary Products Committee to question the Veterinary Medicines Directorate’s assessors following receipt of the assessment report; what criteria the Veterinary Medicines Directorate uses to determine whether any potential increased risks to (1) animal health, (2) public health, or (3) the environment, can be suitability mitigated; and what criteria the Veterinary Medicines Directorate uses to assess the potential benefits of allowing over-the-counter sale, especially when the non-prescription category is already established.
Answered by Lord Benyon - Minister of State (Foreign, Commonwealth and Development Office)
If a product is referred to the Veterinary Products Committee (VPC) for advice, the VPC will be provided with a briefing document. Relevant scientific assessors will attend the VPC meeting and respond to questions by VPC members as directed by the VPC Chair.
Legislation and published guidance set out the information (including data, scientific studies and risk assessments) that applicants must provide for a new marketing authorisation or change to an existing marketing authorisation. Each part of the dossier is supplemented by a critical overall summary prepared by an appropriate scientific expert commissioned by the applicant. The VMD assess the data package against the same guidance. Every year a sample of VMD assessment reports is reviewed by the VPC to score the VMD’s assessment of the application against criteria in the areas of: quality, efficacy and target species safety, safety to the user and consumers, environmental safety and overall benefit risk.
If a non-prescription category is already established, another product will normally be allowed to have the same distribution category provided it contains the same active substance, is the same pharmaceutical presentation, and for the same species. Should information become available at any stage post-authorisation that potentially impacts the benefit-risk balance, the VMD can review the marketing authorisation(s) and require changes and/or suspend a product (or group of products) to protect animal health, public health and the environment.
Asked by: Lord Black of Brentwood (Conservative - Life peer)
Question to the Department of Health and Social Care:
To ask His Majesty's Government what assessment they have made of by the scientific accuracy of the Health and Safety Executive's guidance on blood borne virus transmission.
Answered by Lord Markham - Parliamentary Under-Secretary (Department of Health and Social Care)
The Health and Safety Executive (HSE) is Britain’s national regulator for workplace health and safety. It prevents work-related death, injury and ill health. No assessment has been made, however the HSE guidance on bloodborne virus transmission references current UK Health Security Agency (UKHSA) scientific evidence on risk of transmission of blood-borne viruses.
UKHSA provides advice on management of exposure to blood-borne viruses in occupational settings through its local, regional and national health protection function and through specialist advice from its national team. UKHSA also hosts the UK Advisory Panel for Healthcare Workers living with Bloodborne Viruses which provides advice about the transmission and management of bloodborne viruses among healthcare workers
Asked by: Lord Black of Brentwood (Conservative - Life peer)
Question to the Department for Environment, Food and Rural Affairs:
To ask His Majesty's Government what criteria the Veterinary Products Committee uses to recommend whether an application to vary the marketing authorisation of a prescription-only veterinary medicine to allow over-the-counter sale be granted.
Answered by Lord Benyon - Minister of State (Foreign, Commonwealth and Development Office)
The VPC review VMD’s assessment and conclusion (they may question the assessors if necessary) and provide an opinion as to whether they agree (or not) with the VMD’s conclusion to grant (or not) the lower distribution category.
The VMD consider the VPC’s advice and make a final decision as to whether an application to vary the marketing authorisation of a prescription-only veterinary medicine to allow over-the-counter sale is granted.
The criteria for the VMD’s decision are that:
Asked by: Lord Black of Brentwood (Conservative - Life peer)
Question to the Department for Environment, Food and Rural Affairs:
To ask His Majesty's Government what documents are provided by the Veterinary Medicines Directorate to the Veterinary Products Committee to enable them to assess whether an application to vary the marketing authorisation of a prescription-only veterinary medicine to allow over-the-counter sale can be granted.
Answered by Lord Benyon - Minister of State (Foreign, Commonwealth and Development Office)
The VMD provides the VPC with the assessment report (as peer-reviewed and agreed by the internal scientific review committee). The assessment report includes a benefit-risk assessment and conclusion as to whether the VMD consider that the variation to lower the distribution category should be granted.
Asked by: Lord Black of Brentwood (Conservative - Life peer)
Question to the Department for Environment, Food and Rural Affairs:
To ask His Majesty's Government what process the Veterinary Medicines Directorate uses to determine whether to grant an application to vary the marketing authorisation of a prescription-only veterinary medicine to allow over-the-counter sale.
Answered by Lord Benyon - Minister of State (Foreign, Commonwealth and Development Office)
Veterinary medicine approvals are assessed against statutory criteria for safety, quality and efficacy, as set down in the Veterinary Medicines Regulation. We assess the risks of providing products over-the-counter against the benefits and this is taken to the VPC for independent consideration.
Asked by: Lord Black of Brentwood (Conservative - Life peer)
Question to the Department of Health and Social Care:
To ask His Majesty's Government further to the Written Statement by Lord Markham on 8 June (HLWS826), what assessment they have made of the incidence of HIV in (1) women, and (2) heterosexual men, between 2019 and 2021; and what steps they are taking to improve this.
Answered by Lord Markham - Parliamentary Under-Secretary (Department of Health and Social Care)
The UK Health Security Agency is currently developing a methodology to estimate incidence among heterosexual men and women based on the methodology currently used to produce estimates of incidence for gay, bisexual and other men who have sex with men. As estimates of incidence are not available for heterosexual men and women, new diagnoses first made in the United Kingdom are used as a proxy and interpreted in context of levels of HIV testing amongst those populations.
Between 2019 and 2021, there was a slight increase in HIV diagnoses and late HIV diagnoses among heterosexuals, whilst HIV testing coverage remained substantially lower in 2021 than in 2019. In addition, the estimated number of undiagnosed people among heterosexual men and women did not decline over the same period. These figures suggest that there was no fall in incidence in this population.
The HIV Action Plan published in 2020 aims to reduce new HIV infections by 80% between 2019 and 2025 and details a range of actions committed to in order to help achieve this ambition.
Asked by: Lord Black of Brentwood (Conservative - Life peer)
Question to the Department of Health and Social Care:
To ask His Majesty's Government what assessment they have made of the effectiveness of opt-out HIV testing in emergency departments in areas of London with high HIV prevalence.
Answered by Lord Markham - Parliamentary Under-Secretary (Department of Health and Social Care)
NHS England has committed £20 million in 2022 to 2025 to fund the expansion of HIV opt-out testing in emergency departments (EDs) in areas with extremely high HIV prevalence. The NHS England London region took a decision to include all EDs in the project, which included some of which were in high HIV prevalence areas.
Provisional data from NHS England indicates that this HIV opt-out testing initiative has helped find more than 550 cases of undiagnosed or untreated HIV in the first year of the programme. We are currently considering the results of the first year of HIV opt-out testing and the programme’s contribution to finding cases of undiagnosed or untreated HIV and preventing further HIV transmissions, alongside data on progress towards our ambitions to end new HIV transmissions, AIDS and HIV-related deaths within England by 2030.
Asked by: Lord Black of Brentwood (Conservative - Life peer)
Question to the Home Office:
To ask His Majesty's Government what steps they are taking to enable the National Symphony Orchestra of Ukraine to tour the UK this autumn, particularly in regard to the granting of visas.
Answered by Lord Murray of Blidworth
UK Visas and Immigration can confirm that the Visa application centre (VAC) is open in Kyiv along with 242 other global VACs. Visa applications for those intending to visit or work in the UK are currently being processed within 15 days, or should a decision be required quicker, there are priority services available in a number of locations.