UK Covid-19 Inquiry Module 4 report: Scottish Government response

Recommendation 4 – Proportionate access to linked healthcare records for use in the assessment of safety signals

Chair’s recommendation:

The UK Government and devolved administrations should work together, with their respective health delivery services, to facilitate and coordinate regulatory bodies’ access to healthcare records in order to make the post-authorisation safety monitoring of new vaccines and therapeutics more efficient.

In particular, the Medicines and Healthcare products Regulatory Agency should be granted specific and proportionate access to comprehensive and comparable data from across the four nations of the UK, including linked primary and secondary healthcare data records. This should include data on vaccines and therapeutics administration. This improved linkage must be accompanied by strong safeguards for patient confidentiality, which the Information Commissioner’s Office should work with the four governments to ensure.

Scottish Government response:

The Scottish Government accepts this recommendation in principle.

The Scottish Government notes that this recommendation will require the leadership of the Department of Health and Social Care (DHSC) and the Medicines and Healthcare products Regulatory Agency (MHRA), as medicines regulation and safety is a reserved matter and responsibility rests with the UK Government. However, the Scottish Government is supportive and accepts the broad principle of the recommendation. Proportionate and timely access to linked healthcare data across the UK would significantly accelerate the identification and assessment of safety signals for vaccines and therapeutics and substantially strengthen vigilance capabilities.

There is a clear need for the MHRA to access linked data from primary care, secondary care and other care settings, such as homecare services, in a timely manner, alongside administration data, to better understand safety issues and strengthen post-authorisation surveillance particularly learning from the challenges experienced during Covid-19.

A strong and comprehensive safety surveillance system also underpins the MHRA’s approach to innovation, supporting research, enabling clinical trial recruitment and supporting risk-proportionate regulation. This facilitates access for patients to safe and effective innovative products in a timelier fashion.

Yellow Card (YC) reporting is a UK wide mechanism to gather safety data, and normalising reporting is a key aim for the Scottish Government and supports the recommendation. CIREG members highlighted the need for clear public information on medicine and vaccine safety, including how the Yellow Card scheme enables members of the public and healthcare professionals to report suspected side effects and supports ongoing safety monitoring.

Scotland's development of the NHS Scotland MyCare App provides a valuable opportunity to incorporate direct links to YC reporting and explore possible solutions to link YC data to other datasets. CIREG members highlighted the importance of establishing accessibility and improving public awareness and uptake of the MyCare App as key prerequisites for achieving the intended benefits of direct YC reporting functionality. Raising awareness of the YC scheme itself is a continual activity for the Scottish Government and relevant stakeholders, including healthcare professionals, parents and children and young people. Further considerations also include how the YC can be integrated into Scottish prescribing systems that builds on work already underway in England.

The Scottish Government is committed to working with the UK and other Devolved Governments, respective health services and relevant partners to improve access to linked healthcare data across the UK for post-authorisation safety monitoring, while maintaining strong safeguards for patient confidentiality. In doing this it will be important to ensure that any UK-wide framework is practical for all four nations.

The Scottish Government already has excellent linked medicine data in primary care, in-patient secondary care and home care in Scotland through our work to establish a Medicines in Acute and Chronic Care in Scotland (MACCs) data asset which provides near-universal coverage. We will engage with the MHRA on taking its work on population-scale safety surveillance forward.

CIREG members stressed the importance of being open and clear about how data is collected, protected, shared and used, to help build public trust and confidence.

Meeting this recommendation will require an agreed framework for sharing, linking and using health data across the UK, which is supported by strong safeguards for patient privacy and confidentiality. It may also require:

• Sustained investment in secure systems
• Data quality
• Analytical capability
• The specialist workforce needed to manage and use linked data effectively

Actions and implementation timescales

Delivery of this recommendation will require a four-nation, cross-system collaborative approach. It is a long-term programme of work that requires assessment of data availability, data quality and structure, technical infrastructure, and governance arrangements across respective delivery organisations and emerging platforms.

Scottish Government officials have met with MHRA officials and agreement has been reached across the four nations that NHS England the MHRA will co-lead discussions focused on resolving specific issues and agree decisions that enable the work to move forward. It is expected that these talks will continue throughout 2026.

Accountable Officer:

The Director General for Health and Social Care, working with policy officials from the Chief Medical Officer and Chief Operating Officer Directorates and PHS, will be accountable for the implementation of the Scottish elements of this recommendation.