Found: Letter from Lord Markham, Parliamentary Under Secretary of State (Minister for the Lords), Department

Question to the Department of Health and Social Care:

To ask His Majesty's Government, further to the Written Answer by Lord Markham on 5 April (HL3640), when they intend to publish feedback to the licensing of non-surgical cosmetic procedures consultation, which ran from 2 September to 28 October 2023.

Answered by Baroness Merron - Parliamentary Under-Secretary (Department of Health and Social Care)

The Government is currently considering the work done to date on introducing regulatory oversight of the non-surgical cosmetics sector in England, and will set out its views at the earliest opportunity.

Question to the Department of Health and Social Care:

To ask His Majesty's Government, further to the Written Answer by Lord Markham on 26 March (HL3163), in each year since 2014, how many prescriptions for vortioxetine were issued; what was the annual cost to the National Health Service of those prescriptions; how many Yellow Card reports of sexual dysfunction and persistent sexual dysfunction the MHRA received for vortioxetine; and what consideration has NHS England given to adding sexual dysfunction as a side effect on the patient information leaflets for vortioxetine.

Answered by Baroness Merron - Parliamentary Under-Secretary (Department of Health and Social Care)

The following table shows the number of items issued for vortioxetine and the net ingredient cost (NIC) from 2014 to 2023, and from January to May of 2024:

Source: data provided by the NHS Business Services Authority, based on information within the Prescription Cost Analysis published statistics, using British National Formulary chemical substance vortioxetine.

Note: items have been dispensed, but not necessarily prescribed, in England.

"Persistent sexual dysfunction" does not represent a specific medical condition, so this term is not a category available for a structured search of the Medicines and Healthcare products Regulatory Agency’s (MHRA) Adverse Drug Reaction database. The structured data field search terms are drawn from the regulatory drugs dictionary, the medical dictionary (MedDRA), or from terms adopted in clinical coding guidance such as The Diagnostic and Statistical Manual of Mental Disorders Fifth Edition, or the International Classification of Diseases 11th Revision. A search of the database would therefore rely on manual assessment of individual cases.

The MHRA has received a total of 29 Yellow Card reports of sexual dysfunction related reactions, suspected to be associated with vortioxetine, between 1 January 2014 and 21 July 2024. This includes reactions grouped under MedDRA Higher Level Terms, which are more specific than sexual dysfunction and persistent sexual dysfunction. The following table shows the number of spontaneous suspected Yellow Card reports of sexual dysfunction related reactions suspected to be associated with vortioxetine in the United Kingdom, received by the MHRA each year from 2014 to 2024:

Source: data provided by the MHRA.

The inclusion of a particular report on the MHRA’s system does not necessarily mean that the adverse reactions reported have been caused by the suspect drug. Additionally, the number of reports received should not be used as a basis for determining the incidence of a reaction, as neither the total number of reactions occurring, nor the number of patients using the drug, is known.

Sexual dysfunction was assessed as part of the clinical studies to support the authorisation of vortioxetine. The clinical studies indicated that doses between 5 milligrams and 15 milligrams did not show a difference from placebo in relation to the risk of sexual dysfunction. However, the 20 milligram dose was associated with an increase in sexual dysfunction. This information was included in the Summary of Product Characteristics (SmPC) for healthcare professionals for all strengths of vortioxetine since authorisation in 2021. The SmPC and patient information leaflet were subsequently updated in April 2024 to list sexual dysfunction as a possible side effect for all strengths, following reports of sexual dysfunction associated with doses below 20 milligrams.

Question to the Cabinet Office:

To ask the Minister for the Cabinet Office, how many Ministers attended the Great Futures conference in Riyadh, Saudi Arabia, on 14 and 15 May 2024.

Answered by Alex Burghart - Shadow Secretary of State for Northern Ireland

5 UK Ministers attended the conference.

The GREAT FUTURES launch event in Riyadh on 14-15 May 2024 is the flagship moment that kickstarts a year-long programme bringing to life the sheer scale of opportunities for UK businesses in Saudi Arabia linked to Vision 2030. The purpose is to forge partnerships across a number of sectors by gathering together some of the UK's most creative and innovative companies with their Saudi counterparts.

The Deputy Prime Minister led a strong Ministerial delegation comprising Kemi Badenoch, Secretary of State for Business and Trade; Lucy Frazer, the Culture Secretary; Lord Johnson, Minister for Investment; Lord Markham, Minister of Health; and Sir Steve Smith the PM’s Special Representative for Higher Education. The delegation of more than 450 UK companies made this the largest trade delegation the UK has sent anywhere for a decade.

Some 50+ agreements and MOUs were signed during the two days. The Deputy Prime Minister and Saudi Minister of Commerce convened a Pillar 1 meeting of the UK-Saudi Strategic Partnership where they agreed the ambition of increasing bilateral trade from £17bn to £30 billion by 2030.

Question to the Department of Health and Social Care:

To ask His Majesty's Government, further to the Written Answer by Lord Markham on 15 May (HL4224), how they reconcile the answer with that given by the Parliamentary Under Secretary of State for Health and Social Care on 23 November 2023 (HC527), which precluded the ability of a medical practitioner to form a "good faith" opinion through a telemedicine consultation alone that the patient's gestation was below 10 weeks, and therefore to dispense early medical abortion pills for use by the patient at home.

Answered by Lord Markham

The response of 23 November 2023 does not preclude the ability of a medical practitioner to form a good faith opinion, through a telemedicine consultation alone, that the patient's gestation was below 10 weeks. This opinion can be formed either during a teleconsultation, or an in-person appointment.

Pregnancy duration can be assessed from the first day of the last menstrual period (LMP). Advice from the Royal College of Obstetricians and Gynaecologists is clear that most women can determine the duration of their pregnancy with reasonable accuracy by LMP alone.

However, if there is any uncertainty about the gestation of the pregnancy, the medical practitioner would ask the woman to attend an in-person appointment to enable them to form an opinion that the pregnancy will not have exceeded 10 weeks at the time the first abortion pill is taken. If she does not attend in-person when requested, the terminating practitioner would not be able to form an opinion in good faith that the pregnancy is below 10 weeks gestation, and therefore would not be able to prescribe abortion pills for home use.

Question to the Department of Health and Social Care:

To ask His Majesty's Government, further to the Written Answer by Lord Markham on 9 May (HL4286), whether they have issued guidance to telemedicine providers about complying with the prohibition of termination of pregnancy at gestations over 10 weeks outside a National Health Service facility or an approved place; and if not, why.

Answered by Lord Markham

No specific guidance has been issued, however, all abortion providers are aware that termination of pregnancy in England and Wales can only be provided within the legal framework laid down in the Abortion Act 1967.

The legal framework for home use of early medical abortion pills is set out in the Department’s guidance, Abortion: procedures for the approval of independent sector places for termination of pregnancy (abortion) in England. This guidance applies to independent sector abortion clinics and states that the Abortion Act 1967 allows women having an abortion during the first 10 weeks of pregnancy, specifically up to nine weeks and six days gestation, to take one or both medicines for an early medical abortion at home. It also highlights that women having an early medical abortion at home should be given information on the implications, health and otherwise, of taking the abortion medicine beyond the legal limit of nine weeks and six days gestation.

In addition, the National Institute for Health and Care Excellence’s guideline on abortion care, to which all abortion providers are expected to have due regard, highlights that women who are having a medical abortion and will be taking the first pill, mifepristone, up to and including nine weeks six days gestation, can be offered the option of expulsion at home.

Found: While the government has yet to respond to the committee’s report, the then Health Minister, Lord Markham

Found: forthcoming meeting in May 2024 may contravene Article 55 of those Regulations Answering Member : Lord

Found: the Minister for Investment, Lord Johnson, and the Parliamentary Under Secretary of State for Health, Lord

Found: Ministers The Rt Hon Victoria Atkins MP The Rt Hon Andrew Stephenson CBE The Rt Hon Andrea Lead som MP Lord

Found: The Rt Hon Victoria Atkins MP The Rt Hon Andrew Stephenson CBE The Rt Hon Andrea Leadsom MP Lord

Found: Atkins MP The Rt Hon Andrew Stephenson MP CBE The Rt Hon Andrea Leadsom MP Maria Caulfield MP Lord

Found: Atkins MP The Rt Hon Andrew Stephenson MP CBE The Rt Hon Andrea Leadsom MP Maria Caulfield MP Lord

Found: the Minister for Investment, Lord Johnson, and the Parliamentary Under Secretary of State for Health, Lord