We all need medicines. They are part of the scientific revolution that helped our life expectancy skyrocket to unprecedented levels – the anticipated life expectancy in 50 years is over 100! But how do medicines arise? They don’t just appear; they go through an arduous 12-year journey to be in a position where they can help people like you. If you’re interested in what this journey looks like then read on!
Development
Most medicines start off life in a university laboratory. A disease is researched by scientists and funded by a grant provided by a research body or a pharmaceutical institution. The pathways of a disease are put under a microscope and every observable process is investigated and deduced. When there is enough information about the disease’s pathways, researchers search for a molecule or compound that can intercept the pathways and halt the disease. These molecules may come from plants or they could be generated by computer programs.
Testing
It is obviously highly important that the molecules are safe for humans and actually have an effect, so they go through a series of trials. Preclinical testing uses computerized models to test if it effectively disrupts the pathway before testing it on whole cells and even animals in some cases. About 50% of medicines make it through this stage and onto clinical testing.
Before clinical testing occurs, a clinical trial application needs to be reviewed by a board of experts. If it passes the review then they will start trialing on humans. At first they will tryit on healthy humans, and if no adverse effects are seen then they will conduct a trial on a group of those suffering from the disease that the medicine is meant to cure. This whole process costs about £1.15bn.
Logistics
After the tests have been successful, the tiny proportion of drugs that make it through the licensing process can now be sold. But medicines pose delivery difficulties due to their often delicate nature. They need to be shipped from the industrial production facility to pharmacies throughout the world and often need to be refrigerated the whole time. They are typically shipped by air to pharmacies that keep them in special conditions. Medical refrigeration and environmental control are typically handled by pharmacy fridges like those from FFD Ltd, which need to be able to control the temperature to the degree.
Marketing
It’s strange to think of medicine needing marketing, but its end goal is to drive profits. They need to obtain marketing authorizations from national regulation agencies like the MHRA in the UK and the FDA in the USA. They supply information about preclinical and clinical results as well as pharmacology and labeling intentions. If a license is granted they are able to market the process, but if they want to go through special institutions like the NHS in the UK, they will need approval from yet another board. For the NHS its NICE – which bases decisions on cost and efficacy to see if the cost-benefit it offers can be afforded by the NHS.
That’s the journey that your medicines embark upon to end up at your door, be it through a pharmacy or the NHS.