Bringing a new Pharmaceutical to Market

Bringing a New Pharmaceutical to the Market Name Class Professor Bringing a New Pharmaceutical to the Market As the world market is experiencing various changes in different sectors, stiff competition in the pharmaceutical industry is becoming the order of the day, with different companies trying to outdo others in the quest to dominate the market (Tidd & Bessant, 2013). Scientists spend a lot of time doing research on how to find causes, cure, or vaccines to various diseases. It takes a lot of time, procedures, and experiments to come up with drugs that are allowed into the market. Once a drug passes through all the required steps it is approved and can be introduced into the market. However, there has been the discussion of whether pharmaceutical companies should have patents on their drugs citing the fact that such companies incur huge costs to research and develop the drugs. In this view, this paper seeks to analyze what it takes to bring a new medication to the market, besides focusing on the issue of patents on drugs. What It Takes To Introduce New Medication into the Market As at 2015, new medication can take up to 12 years and can cost up to $350 million from the start, in the lab, to the end product when it is approved (Lipsky, 2015). The drug approval process takes place in phases. The first phase is the pre-clinical phase, which takes three to four years. It includes testing drugs on animals or living tissue in a laboratory. A formula is then developed, which is submitted to the next phase. The next stage occurs at Food and Drug Administration’s (FDA) office. At the FDA, the drug is tested on humans. According to Lipsky (2015), some people volunteer to be tested on, where the side effects are monitored. The dosage and the dosage frequency are also tested on this stage. If there are any severe side-effects or contradictions, they are mitigated in this stage. Once approved, the drug goes on for clinical tests. First, they involve a few healthy subjects to see how well the drug is administered. It then moves on to a few patients who are closely monitored in hospitals, and if all goes well, it finally moves on to a large number of between 1000-3000 patients. At this stage, a drug company is involved so as to produce enough drugs to the patients. After this stage, the results and a drug approval application are presented to the FDA. The review process may take up to two and a half years before approval. About 10% of drugs may fail at this stage (Tidd & Bessant, 2013). However, if the drug is approved, it can be marketed to the doctors and members of the public. Patents for Pharmaceutical Companies Pharmaceutical companies should have patents on their drugs; this is because it takes almost twelve years and a lot of money to come up with a drug. Frakt (2015) observed that drug companies discard many potentially good ideas because they are unpatentable. Patents, therefore, are important because they allow the company to sell their product without competition for a period of time so that they can get back some of the money they invest...