MHRA and Genomics England to launch pioneering resource to better understand how genetic makeup influences the safety of medicines
The Medicines and Healthcare products Regulatory Agency (MHRA) has today announced it will be the first drug safety regulator in the world to pilot its own genetic ‘biobank’, launching 1 June 2023
A brand-new genetic research resource, known as a ‘biobank’, will be piloted by the Medicines and Healthcare products Regulatory Agency (MHRA) in a joint venture with Genomics England to better understand how a patient’s genetic makeup can impact the safety of their medicines.
The Yellow Card biobank, which will contain genetic data and patient samples, will operate alongside the MHRA’s Yellow Card reporting site for suspected side effects and adverse incidents involving medicines and medical devices. It forms part of a long-term vision for more personalised medicine approaches, as scientists will use the repository of genetic information in the biobank to determine whether a side effect from a medicine was caused by a specific genetic trait. 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.
The pilot phase will start with a medicine called allopurinol and related rare, severe skin reactions; including Stevens-Johnson Syndrome (SJS) and Toxic Epidermal Necrolysis (TEN). Other topics of focus for the pilot phase will be confirmed in due course.
Patients who get involved will be visited at home by a nurse, who will then take a blood sample to be added to the biobank and sequenced. Participants’ data will be de-identified and added to a secure research environment led and managed by Genomics England.
More information on how to participate will be made available in due course. Those interested in getting involved should visit the Yellow Card biobank page. Individuals who have previously submitted a Yellow Card report relating to the pilot topics may also be asked if they would like to participate. In instances where a healthcare professional has reported on behalf of a patient, they may be asked to help contact the affected patient to see if they wish to be involved.
Dr June Raine DBE, MHRA Chief Executive, said:
We are excited by the upcoming launch of the Yellow Card biobank, which demonstrates that we are at the absolute forefront of innovation in the field of drug safety monitoring.
Almost a third of adverse reactions to medicines could be prevented with the introduction of genetic testing.
The biobank will help us move towards our goal of personalised medicine - which, when achieved, means patients across the UK will receive the safest medicine for them, based on their genetic makeup.
This has the potential to transform our safety monitoring activities – enabling us to meet a real need by using high-quality patient data to reduce side effects of medicines.
Professor Matt Brown, Chief Scientific Officer for Genomics England, said:
We are thrilled to embark on this transformative partnership with the MHRA, as we delve into the genomics of severe adverse drug reactions.
Many of these reactions are influenced by underlying genetic risk factors, substantially heightening an individual’s vulnerability.
By joining forces with the MHRA, we are poised to gain greater understanding of these genetic influences – discoveries that will be vital if we are to move to harness the power of genomics to proactively protect patients from these harms.
Together, we hope that this is the first step towards redefining the future of drug safety.
Steve Barclay, Health and Social Care Secretary, said:
Adverse drug reactions place a huge strain on the NHS, costing the health service over £2 billion a year – so it’s vital that we tackle this issue to help us cut waiting lists and get patients the tailored care they need.
Developing a better understanding of our DNA can transform outcomes for patients, through improved treatments and sped-up diagnosis for conditions such as cancer and rare diseases.
We’re backing research programmes with £175 million, like this biobank, which will harness the UK’s genomic capabilities to help patients receive safe, effective medicines.
Further information
- Pharmacogenetics is a field of research that looks at how a person’s genes affect the safety of their medicines, with the goal of helping healthcare professionals to choose a prescription and dose that is tailored to each patient.
- National Genomic Research Library is a secure research environment of de-identified genomic and health data managed by Genomics England.
- The Canadian Pharmacogenomics Network for Drug Safety is a Canada-wide active surveillance network which searches for patients with Adverse Drug Reactions (ADRs) and coordinates data collection and research.
- Colorado Center for Personalized Medicine Biobank in the US is based in the University of Colorado conducts research to facilitate personalised medicine.
Notes to editors
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The Medicines and Healthcare products Regulatory Agency (MHRA) is responsible for regulating all medicines and medical devices in the UK by ensuring they work and are acceptably safe. All our work is underpinned by robust and fact-based judgements to ensure that the benefits justify any risks.
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The MHRA is an executive agency of the Department of Health and Social Care.
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Genomics England is a company established and wholly owned by the Department for Health and Social Care, which is responsible for delivering genomic medicine in partnership with the NHS.
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This project forms part of the Government’s Life Sciences Vision.
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For media enquiries, please contact the newscentre@mhra.gov.uk.