A 12-gene blood test could prevent one in three serious drug reactions, but the UK has no system to deliver it. Pharmacogenomics—matching drugs to patients’ DNA—is already used in the US and parts of Europe, yet the NHS has no clear regulatory pathway to adopt it. This matters because adverse drug reactions cause 6.5% of all hospital admissions (15% in elderly patients with multiple conditions), costing the NHS in England £2.2 billion each year. Meanwhile, 90% of drugs work in only 30–50% of patients. A recent Lancet study showed that a 12-gene prescribing panel cut adverse reactions by 30%. The proposed Centre for Excellence in Regulatory Science and Innovation in Pharmacogenomics will work with the MHRA, NICE, the NHS, and industry to remove the regulatory, educational, and economic barriers blocking adoption. If successful, the UK could become a global leader in genomic prescribing, reducing hospital admissions, improving drug efficacy, and lowering NHS costs—without requiring new drugs, just better targeting of existing ones.
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Pharmacogenomics is the study of how variation in the human genome affects the efficacy and safety of medicines. For efficacy, 90% of drugs only work in 30-50% of patients. Considering safety, adverse drug reactions (AD Rs) account for 6.5% of all hospital admissions, rising to about 15% in the elderly with multimorbidity, at a cost to the NHS in England of £2.2 billion/year. Our recent study published in the Lancet (PMID: 36739136) showed that using a 12-gene panel to guide prescribing reduced ADRs by 30%. There is an increasing drive towards clinical implementation of pharmacogenomics. However, most implementation programmes are in the US. In the EU, implementation is progressing in the Netherlands, and recently in Spain. The UK must catch up to receive the many benefits of pharmacogenomics, including enhancing growth in the UK economy, increasing innovation by mainstreaming genomic medicine, moving us towards a preventive approach, upskilling our workforce and increasing productivity. However, there are many barriers and challenges, which hamper the uptake and diffusion of pharmacogenomic innovation into the NHS. The UK has a complex regulatory ecosystem for pharmacogenomics. In the discovery phase, we liaised with the MHRA, NICE, the NHS, industry (pharmaceutical, genomics, digital health) and academia to map the most important modifiable issues which currently hamper innovation and uptake. In our proposed Centre for Excellence in Regulatory Science and Innovation in Pharmacogenomics (CERSI-PGx), we have identified key areas to focus on over the next year: guidance, pharmacogenomic testing, education and training, and health economics. Working collaboratively with the regulators and other important stakeholders, our aim will be to foster proportionate regulatory decision making across pharmacogenomic development and implementation pathways. The four CERSI-PGx work-packages will be supported by a fifth cross-cutting work-package which will focus on patient and public involvement. We have brought together a diverse and skilled team of experts spanning various sectors. We will work across all four nations, collaboratively between academia, healthcare and industry, to achieve our aim to catalyse innovative strategies for incorporating pharmacogenomics into the regulatory pathways in the UK. Our ultimate goal is to position the UK at the forefront of pioneering pharmacogenomic advancements, encompassing both current and emerging medications. This transformative endeavour will yield substantial benefits across the regulatory landscape, the NHS, industry, patients, and the broader UK economy.
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