Festival of Genomics – Speaker Event: Pharma and the Growing Need for Patient Genetic Diversity
Part 2 – Registering Medicines in the UK – An Issue of Health Inequality
REGISTERING MEDICINES IN THE UK – AN ISSUE OF HEALTH INEQUALITY [PART 2]
So with that, I just want to now quickly go through the clinical trial process that pharmaceutical companies generally follow when they want to register a drug. The first thing they do, they have a molecule from the discovery phase which they think has the potential to meet an unmet clinical need. From there, they test it in animals, to see whether it is safe and if it is, it enter this clinical trial process which has 3 phases; as you can see.
So, in this country, for a pharmaceutical company to run their trial which has NHS patients enrolled onto it, it has to receive ethical approval from the Health Research Authority. Assuming the molecule has made its way from Phase 1 to the end of Phase 3, and has shown to be efficacious and safe, then the Pharma company can apply for market authorisation from a regulator. So if they go through a European route, it’ll be the European Medicines Agency, otherwise they can apply directly to the UK, to the MHRA, the Medical and Health Products Regulatory Agency. Assuming they grant a license, the pharma company is in a position to market their product for appropriate use in patients in the general public.
So in the UK, certainly for our major cities, they’re cosmopolitan, as we all know. If you look at the UK as a whole, 14% of the population comprises of different ethnic minorities. If you compare that general population to the population that makes up the phase 3 drug registration clinical trial, emphasising that this is not just any old RCT (Randomised Clinical Trial), this phase 3 trial is run registering a drug. It is very different between the general population and the patient composition. The first difference is that ethnic minorities are generally under-represented, to the point that there’s no statistical power to demonstrate efficacy or safety of that product in somebody from an ethnic minority. The second point is that; although these phase 3 drug registration clinical trials tend to be predominantly Caucasian/white, the clinical characteristics are quite narrow. So that is also an issue.