What were we trying to do?
Pharmacogenomics is the study of how our genes influence our response to medicines. Differences in our genes can make medicines work well, have very little effect, or even cause serious side effects.

 

Funding from the UK Regulatory Science and Innovation Networks (RS&IN) has supported the creation of a Centre for Excellence in Regulatory Science and Innovation in Pharmacogenomics. This centre is helping to bring together information about pharmacogenomics in the UK to develop sensible and practical guidelines for using pharmacogenomics in our healthcare system. The aim is for pharmacogenomics to be used more widely, introducing genetic tests to help prescribe the most suitable medicines, to improve care for patients and save the NHS money.

 

 

Why was this important?
It is thought that 90% of medicines only work for between 30 and 50% of people and that this is because of differences in our genetic make-up. Serious side effects from medicine - also called adverse drug reactions (ADRs) - cause 6.5% of all hospital admissions, and this number is even higher for older people with multiple illnesses. This is thought to cost the NHS around £2.2 billion per year. 

 

Previous work showed that using a 12-gene panel test to help decide which medicines to prescribe can reduce ADRs by 30%. However, despite this, the UK has not been as advanced as some other countries in bringing pharmacogenomics into everyday prescribing. The UK has complex rules around pharmacogenomics that make introducing it difficult. Regulations need to be made simpler and clearer to allow the UK to catch up – and lead the way – when it comes to using pharmacogenomics as part of prescribing decisions. 

 

 

How did we do it?
In the early stages of the study, the Medicines and Healthcare products Regulatory Agency (MHRA), the National Institute for Health and Care Excellence (NICE), the NHS, healthcare organisations and academia all came together to agree the most important reasons why pharmacogenomics hasn’t yet been widely introduced into everyday care in the UK. 

 

This allowed the four most important areas to be identified and formed the focus of the the Centre for Excellence in Regulatory Science and Innovation in Pharmacogenomics. The areas of focus have been supported by wide-ranging patient and public involvement (PPI) to make sure that results are relevant and meaningful for patients.

 

The main areas of focus – called Work Packages (WPs) – were:

• WP1: Create and develop pharmacogenetic guidelines 
• WP2: Develop pharmacogenetic tests and interpretation systems
• WP3: Education and training for the healthcare workforce
• WP4: Health economics of pharmacogenomics.
• WP5: An additional Patient and Public Involvement (PPI) work package that worked across WP1-4. 

 

The ARC-GM was involved in WP5 - Patient and Public Involvement - which was split into two overlapping programmes of work: 

1. A Patient and Public Involvement and Engagement (PPIE) Board was set up to provide guidance to each of the four main WPs. The Board involved members representing the UK’s ethnic and socioeconomic diversity.
2. A programme of qualitative research (interviews) identified the preferences of patients and members of the public about the regulation of pharmacogenomics. The interviews asked opinions on two main areas: drug patient information leaflets, and the regulation of pharmacogenomic tests. 

 

 

Findings

Findings for WP5 are expected in 2026.

 

 

Who did we work with?
The study was led by Prof Sir Munir Pirmohamed (NHS Chair of Pharmacogenetics) and David Weatherall (Chair of Medicine, University of Liverpool) and involved representatives from a range of UK-based organisations and universities, including:

• The University of Manchester
• The University of Liverpool
• Bangor University (Wales)
• Queen Mary University London
• British Pharmacological Society
• Office of Health Economics
• JS Obrien Business Solutions
• Alderley Lighthouse Labs Ltd

 

 

Funding information
The Centre for Excellence in Regulatory Science and Innovation in Pharmacogenomics project was funded via Innovate UK – the UK’s innovation agency, in partnership with the Medicines and Healthcare products Regulatory Agency (MHRA), Office for Life Sciences, and the Medical Research Council, as one of seven Centres of Excellence for Regulatory Science and Innovation (CERSIs).

 

 

More information

 

 

Programme Manager
Gill Rizzello
gill.rizzello@manchester.ac.uk