The Medicines and Healthcare products Regulatory Agency ( MHRA ) and Genomics England will pilot a brand-new genetic research resource, called a ‘biobank,’ to gain a better understanding of how a patient’s genetic makeup can impact the safety of their medicines.
In this joint venture, the MHRA will operate the Yellow Card biobank, which will house genetic data and patient samples. It will work alongside the Yellow Card reporting site for suspected side effects and adverse incidents related to medicines and medical devices.
The aim is to support the vision of personalized medicine by utilizing the genetic information in the biobank to determine if specific genetic traits are responsible for medication side effects. This will in turn enable doctors to target prescriptions using rapid screening tests, so patients across the UK will receive the safest medication for them, based on their genetic makeup.
Adverse Drug Reactions (ADRs), or side effects, continue to be a significant burden on the NHS and account for one in 16 hospital admissions. Understanding the underlying mechanism of an adverse reaction would support the development of pharmacogenetic testing strategies, such as the screening tests enabled through the information provided by the Yellow Card biobank. These strategies would in turn provide the opportunity to prevent rather than react to adverse drug reactions.
The biobank pilot will officially begin on 1 June 2023 with participant recruitment commencing later this year, on 1 September. The sequencing of participants’ genetic material will begin in Spring 2024, with initial research findings from the pilot due to be published in 2025. Genomics England will be supporting the MHRA with sequencing and storage of genetic material through use of their well-established and secure infrastructure.
