Medicine development starts in laboratory
A medicine travels a long way from the laboratory to the pharmacy shelf. The development of a medicine takes at least 10–12 years.
The development starts from understanding the origination mechanism of diseases and realising how the respective clinical course or symptoms can be impacted. This marks the beginning of a demanding process to develop a novel medicine.
Among as many as 10 000 molecules, a few tens or one hundred candidates are selected to be further studied in the so-called preclinical trials.
During the preclinical phase, researchers determine whether the chosen molecule is safe enough to be administered to humans. The preclinical phase involves computer modelling, cell and organ testing outside the living organism.
This phase is followed by animal testing. No novel medicine would have a marketing authorisation without indispensable animal tests.
The industry's major objective is to reduce animal testing, using other methods instead, as well as to avoid causing pain to the test animals.
The web service Animal Testing Perspectives was launched already in 2013 by the European pharmaceutical industry, EFPIA (European Federation of Pharmaceutical Industries and Associations). The site is an open discussion forum focusing on the use of animals in European biomedicine.
Only after having sufficient amount of information on the safety of the medicine can the project proceed to the clinical trials .
Patents protect medicine inventions
It costs a billion euro to bring one medicine from its molecule stage to the market.
When a molecule appears to be promising, a patent application is made. The patent protects medicine inventions and encourages the companies to develop novel medicine. The patents protecting a novel medicine remain in force for the maximum of 20 years. Part of the protection period is taken up by the development stages preceding the medicine’s entry into the market. Once the protection period expires, it is possible to start the development of so-called generic medicines.
In addition to the research and development costs, the expenses incurred for unsuccessful projects must also be covered during the patent period. Patent protection guarantees the return on the investment made in research. In the western world, the inventor has an exclusive right to the product for a determined period of time after which others can copy or further refine the invention.