High-cost drug patient data to support the National Congenital Anomaly and Rare Disease Registration Service (NCARDRS)

To identify patients who have received specific high-cost drugs for the treatment of a rare disease, NHS England and Improvement are working with NCARDRS to improve the commissioning decisions for these and future high-cost drugs. In order to support this decision making the Trust is required to share the details (including NHS number and date of birth) of any patients receiving high-cost drugs for the treatment of rare diseases to NCARDRS.

NCARDRS has permission to process confidential patient information (without prior patient consent) afforded through Regulation 5 of The Health Service (Control of Patient Information) Regulations 2002. Specific permission has been granted to Public Health England through the Health Research Authority’s Confidentiality Advisory Group (CAG) process for Regulation 5 (Ref: CAG10-02(d)/2015) access to confidential patient information without consent through Section 60 of the Health and Social Care Act 2001 as re-enacted by Section 251 of the NHS Act 2006.

National data opt outs do not apply to the national disease registration, and NCARDRS has implemented a policy of supporting opt out requests from patients. This is publicised through the NCARDRS website and patient information leaflet, as well as through representatives. If you would like to request copies of the leaflet, please email NDRSengagement@nhs.net or you can find more information, and access the leaflet, from the National Disease Registration Service webpage