Found: first Patient Safety Commissioner to champion the patient voice in relation to the safety of medicines

Found: Marie Morris declared the following interest: Chair of the All-Party Parliamentary Group on Access to Medicines

Found: nirms-transitional-labelling-financial-assistance-scheme#:~:text=The %20scheme%20will%20provide%20retrospective,close%20on%2015%20March%202024 )Medicines

Question to the Department of Health and Social Care:

To ask the Secretary of State for Health and Social Care, on what date work on digitally linking Medicines and Healthcare products Regulatory Authority Yellow Card information to NHS clinical records (a) began and (b) is expected to be completed.

Answered by Andrew Stephenson - Minister of State (Department of Health and Social Care)

The Medicines and Healthcare products Regulatory Agency (MHRA) has been working with the National Health Service to explore approaches to facilitate digital linkage of Yellow Card information to clinical records, and to potentially enable faster access to information, where considered necessary for an assessment. Any such approach would be subject to strict information governance controls and prior consultation with stakeholder groups.

In 2020, the MHRA began delivery of a substantially enhanced Yellow Card platform under the SafetyConnect programme, aligned to the recommendations in Baroness Cumberlege’s Independent Medicines and Medical Devices Safety Review. The new infrastructure is designed with the intent of enabling connectivity to other systems, to facilitate the exchange of information. During that time the MHRA has engaged with the NHS around the evolving technical options for robust and secure connectivity and enhanced user journeys. The first step in these enhancements is use of the common NHS login capability within Yellow Card, which is expected to go live in 2024.

Deeper connectivity between systems will be subject to internal and external stakeholder engagement and substantial information governance controls, with elements completed over a phased and multi-year work plan.

Found: companies entering the Colombian market and will help the country access essential products such as medicines

Found: Update on the government’s response to the Independent Medicines and Medical Devices Safety Review .

Found: Update on the government’s response to the Independent Medicines and Medical Devices Safety Review .

Found: The Medicines and Healthcare products Regulatory Agency (MHRA) is responsible for regulating all medicines

Found: The Medicines and Healthcare products Regulatory Agency (MHRA) is responsible for regulating all medicines

Found: The Medicines and Healthcare products Regulatory Agency (MHRA) is responsible for regulating all medicines

Found: ), the Medicines and Healthcare products Regulatory Agency (MHRA) is responsible for regulating all medicines

Found: The Medicines and Healthcare products Regulatory Agency (MHRA) is responsible for regulating all medicines

Found: editors The Medicines and Healthcare products Regulatory Agency (MHRA) is responsible for regulating all medicines

Found: diagnostics Continuing to strengthen our vigilance role, as specified in Baroness Cumberlege’s Independent Medicines

Found: enhance and improve the health of millions of people every day through the effective regulation of medicines

Found: The Medicines and Healthcare products Regulator y Agency (MHRA) is responsible for regulating all medicines

Found: and Social Care that acts to protect a nd promote public health and patient safety, by ensuring that medicines

Found: Medicines and Healthcare produc ts Regulatory Agency - GOV.UK (w ww.gov.uk) Yellow Card | Making medicines

Found: progressed, changes must be made to the Human Medicines Regulations 2012 using the powers in the Medicines

Found: report also aligns with recommendations made in the ‘First do no harm’ report of the Independent Medicines

Found: Update on the government’s response to the Independent Medicines and Medical Devices Safety Review .

Found: to take forward the work in relation to specialist services, a recommendation from the Independent Medicines

Question

To ask the Scottish Government how many children have been affected as a consequence of their mothers being prescribed sodium valproate during pregnancy.

Answered by Minto, Jenni - Minister for Public Health and Women's Health

We do not know the numbers of children affected because the information has not been collected historically.

In response to the Independent Medicines and Medical Devices Safety Review (IMMDSR), the Scottish Government commissioned Public Health Scotland (PHS) to establish a medicines in pregnancy surveillance asset. This resource will support monitoring and reporting to progress improvements in the safe use of valproate and other teratogenic medicines in Scotland. Its first output is due to be published by PHS in April 2024 and will include prescribing data and trends for valproate and other anti-seizure medicines.

Question

To ask the Scottish Government what arrangements are in place to compensate any children that have been affected as a consequence of their mothers being given sodium valproate during pregnancy, and when it expects compensation payments to commence.

Answered by Minto, Jenni - Minister for Public Health and Women's Health

The Scottish Government will await the view and any decisions by the UK Government in relation to redress for anyone who was affected by exposure to valproate.

As set out in our letter to MSPs, this is because the recommendations on redress the UK Government is considering may involve a new agency and schemes that would be funded via a levy on manufacturers of medicines and medical devices and the Scottish Government has only limited powers under the devolution arrangements to impose levies.

We will of course update the Parliament about any important developments.