Asked by: Lord Strathcarron (Conservative - Excepted Hereditary)
Question to the Department of Health and Social Care:
To ask His Majesty's Government what assessment they have made of reports that draft NHS guidance stated that "Not everyone who experiences menopause is a woman."
Answered by Lord Markham - Parliamentary Under-Secretary (Department of Health and Social Care)
NHS England is reviewing its internal policy on menopause, which applies to National Health Service staff. A draft was briefly published in error by NHS England on 13 March 2024. NHS England plans to publish the updated staff policy in the next few weeks. No specific assessment was made by the Government of the draft guidance prior to this.
We have been clear that biological sex matters, and it is important to use language that recognises the separate health and biological needs of men and women. It is also important that health information is provided in language that is inclusive of everyone that needs to hear it, so everyone who can be affected by certain conditions can get the help they need.
Asked by: Lord Strathcarron (Conservative - Excepted Hereditary)
Question to the Department of Health and Social Care:
To ask His Majesty's Government, further to the answer by Lord Evans of Rainow on 11 January (HL Deb col 98), what assessment they have made of whether it is appropriate to describe COVID-19 vaccinations as “very safe” given that the Medicines and Healthcare products Regulatory Agency's Blue Guide, says that "advertising which states or implies that a product is 'safe' is unacceptable"; and whether they intend to publish the evidence base that supports the claim that the COVID-19 vaccinations are “very safe.”
Answered by Lord Markham - Parliamentary Under-Secretary (Department of Health and Social Care)
All vaccines used in the United Kingdom must be authorised by the UK’s independent medicines’ regulator, the Medicines and Healthcare products Regulatory Agency (MHRA). Each COVID-19 vaccine is only authorised once it has met robust standards of effectiveness, safety, and quality. As with all vaccines and medicines, the safety of COVID-19 vaccines is continuously monitored, and the advice from the MHRA remains that the benefits of vaccination in preventing COVID-19 and serious complications associated with COVID-19 outweigh any currently known side effects in the majority of patients. Information on the characteristics of each vaccine is published by the MHRA on the GOV.UK website. The MHRA’s Blue Guide relates to the advertising and promotion of medicinal products, and in general, debates in Parliament about vaccination are considered to be outside its scope.
Asked by: Lord Strathcarron (Conservative - Excepted Hereditary)
Question to the Department of Health and Social Care:
To ask His Majesty's Government, further to the Written Answer by Lord Markham on 27 April (HL7380), whether they considered whether materials disseminated by public bodies in support of a public health campaign to increase routine vaccination uptake were seen to "promote the prescription, supply, sale or use" of specific medicine or medicines, either intentionally or unintentionally; if so, whether this material fell within the definition under regulation 7 of the Human Medicines Regulations 2012; and if not, which legal provision provided an exemption from regulation 7 for public health campaign advertisements.
Answered by Lord Markham - Parliamentary Under-Secretary (Department of Health and Social Care)
It is the view of the Medicines and Healthcare products Regulatory Agency (MHRA) that materials disseminated by Government bodies in support of a public health campaign are not caught by the definition of an advertisement for a medicine as given in regulation 7. This is because these materials were not ‘designed to promote the prescription, supply, sale or use’ of a specific medicine or medicines. Instead, these materials were disseminated to promote public health by encouraging people to seek appropriate medical intervention, in this case uptake of vaccination against COVID-19.
The MHRA is obliged to consider any complaints made to it about the advertising of medicines. While carrying out its statutory duties, the MHRA will assess each case on its own merits and in light of the available evidence.
Asked by: Lord Strathcarron (Conservative - Excepted Hereditary)
Question to the Department of Health and Social Care:
To ask His Majesty's Government, further to the Written Answer by Lord Markham on 11 April (HL6877), in which legislation it states that advertisements which form part of Government campaigns to encourage routine vaccination uptake “sit outside of the scope of United Kingdom advertising regulations”, and how that is consistent with (1) regulation 280 of the Human Medicines Regulations 2012, and (2) the definition of the promotion of a medicinal product in the MHRA’s Blue Guide as any thing or any activity "designed to promote the prescription, supply, sale or consumption of medicinal products".
Answered by Lord Markham - Parliamentary Under-Secretary (Department of Health and Social Care)
The Medicines and Healthcare products Regulatory Agency (MHRA) is responsible, on behalf of Health Ministers, for administering the legislation on advertising medicines as set out in Part 14 of the Human Medicines Regulations 2012, as amended. The relevant definition of an advertisement for a medicine is given in regulation 7. It is the view of the MHRA that materials disseminated by Government bodies in support of a public health campaign are not caught by this definition as they are not ‘designed to promote the prescription, supply, sale or use’ of a specific medicine or medicines. Their purpose is rather to promote public health by encouraging people to seek appropriate medical intervention, in this case uptake of vaccination against COVID-19. On the basis of this view, that Government campaigns are outside the definition outlined in regulation 7, regulation 280 does not apply.
Asked by: Lord Strathcarron (Conservative - Excepted Hereditary)
Question to the Department of Health and Social Care:
To ask His Majesty's Government, further to the Written Answer by Lord Markham on 21 March (HL5868), what steps they will take to uphold the provisions of Chapter 4 of the Medicines and Healthcare products Regulatory Agency’s Blue Guide, which sets out the general rules for advertising medicines to both healthcare workers and the public, and states there is a requirement not to exaggerate the benefits of medicines; and whether the reference in Chapter 4 to section 6.6 “for more information on safety claims” implies that the rules around the use of the word “safe” are applicable to advertising aimed at the general public.
Answered by Lord Markham - Parliamentary Under-Secretary (Department of Health and Social Care)
The Department is committed to following the Medicines and Healthcare products Regulatory Agency (MHRA) Blue book and Advertising Standards Agency guidelines. Careful consideration is given to what guidance is applicable to the campaigns that are run. Government campaigns to encourage routine vaccination uptake are considered as public health interventions and therefore sit outside the scope of United Kingdom advertising regulations, which are interpreted in the MHRA Blue Guide. Whether or not specific guidance applies, all campaign messaging is subject to rigorous clinical and policy approvals, to ensure information is communicated accurately.
Asked by: Lord Strathcarron (Conservative - Excepted Hereditary)
Question to the Department of Health and Social Care:
To ask His Majesty's Government, further to the Written Answer by Lord Markham on 8 February (HL5061), when data for April 2022 and beyond will be validated for release; and on what grounds this information is commercially sensitive.
Answered by Lord Markham - Parliamentary Under-Secretary (Department of Health and Social Care)
The data relating to the number of lateral flow device (LFD) tests purchased between 1 April 2022 and 31 March 2023 will be available in late 2023 on completion of the National Audit Office audit on financial year 2022/23. The timescales of the audit are currently being discussed and agreed.
The UK Health Security Agency consider that releasing the information on the total costs of LFD tests would not be in the public interest as it could prejudice future commercial relations with suppliers if this information were to be disclosed in the public domain.
Asked by: Lord Strathcarron (Conservative - Excepted Hereditary)
Question to the Department of Health and Social Care:
To ask His Majesty's Government, further to the Written Answer by Lord Markham on 8 February (HL4994), whether they are aware that the Medicine and Healthcare products Regulatory Agency’s Blue Guide, published in November 2020, defines advertisements as “any activity which is intended to encourage prescription or supply by healthcare professionals and use of medicines by the general public”; and therefore why the word “safe” has been used by the NHS to promote COVID-19 vaccines over the past two years, such as in a tweet from the NHS on 9 December 2022.
Answered by Lord Markham - Parliamentary Under-Secretary (Department of Health and Social Care)
Chapter 6 of the Medicines and Healthcare products Regulatory Agency’s Blue Guide, in which the statement in question is made around the use of the word ‘safe’ in relation to advertising medicines, is about advertising to healthcare professionals, not the general public. The chapter is introduced as guidance on advertising of medicinal products, both prescription only and over-the-counter medicines, targeting healthcare professionals who are “persons qualified to prescribe or supply” medicines as defined in the regulations. Since National Health Service communications on COVID-19 vaccines such as the tweet in question are intended to raise awareness and to answer common questions among the general public rather than promoting any individual product, they lie beyond the scope of this guidance.
Asked by: Lord Strathcarron (Conservative - Excepted Hereditary)
Question to the Department of Health and Social Care:
To ask His Majesty's Government, further to the Written Answer by Lord Markham on 6 February 2023 (HL4993), what plans they have to launch an evidence-led investigation into why more people are dying unexpectedly than normal.
Answered by Lord Markham - Parliamentary Under-Secretary (Department of Health and Social Care)
The Office for Health Improvement and Disparities is already working closely with the Office for National Statistics to understand excess deaths. Deaths involving acute respiratory infections (including influenza and pneumonia) are likely to explain many of the excess deaths in the four week period to 27 January 2023. There were 3,389 more deaths involving acute respiratory infections than expected. Deaths involving all cardiovascular diseases were 12% higher than expected during the four week period to 27 January 2023, while deaths involving heart failure were 21% higher than expected. The Government is taking a range of actions to address excess deaths, including preparing for the challenge of variants of COVID-19 and respiratory infections, with an integrated COVID-19 booster and flu vaccination programme. We will be announcing details of our action on cardiovascular diseases in the forthcoming Major Conditions Strategy.
Asked by: Lord Strathcarron (Conservative - Excepted Hereditary)
Question to the Department of Health and Social Care:
To ask His Majesty's Government why, in advertisements distributed as part of NHS public health campaigns, the word "safe" has been used to promote the COVID-19 vaccines, given that the Medicines and Healthcare products Regulatory Agency's Blue Guide, published in November 2020, says that "advertising which states or implies that a product is 'safe' is unacceptable".
Answered by Lord Markham - Parliamentary Under-Secretary (Department of Health and Social Care)
The Winter Vaccinations campaign ‘Boost Your Immunity This Winter’ ran over two years (2021/22 and 2022/23). The campaign prompted those eligible to get a COVID-19 booster to ‘Get Vaccinated. Get Boosted. Get Protected’. The Department is unable to locate any paid advertising – delivered as part of this multi-year campaign – using the word ‘safe’ to encourage uptake of COVID-19 vaccines. Our aim is that all paid advertising follows Medicines and Healthcare products Regulatory Agency and Advertising Standards Authority guidance.
Asked by: Lord Strathcarron (Conservative - Excepted Hereditary)
Question to the Department of Health and Social Care:
To ask His Majesty's Government what assessment they have made of the analysis in chapter 10 of the Technical report on the COVID-19 pandemic in the UK, published on 1 December 2022, that non-COVID excess deaths are being caused by, among other factors, patients not receiving statins or blood pressure medicines during the pandemic.
Answered by Lord Markham - Parliamentary Under-Secretary (Department of Health and Social Care)
We have made no specific assessment; however, it is likely that a combination of factors has contributed to non-COVID-19 excess deaths, including high flu prevalence and health conditions such as heart disease and diabetes. Different organisations are producing diverse estimates based on differing methodologies.