International issues and regulation
The global pharmaceutical industry makes over $800 billion in profit a year. This presents issues, not only about where this profit comes from, but where this is then reinvested. Several problems arise about how how much money is put into research and development, and the populations in which this money should be invested. The presentation below explains some of the big gaps that exist between the areas in which research is conducted.
the issue of evergreening
Patents are a sensitive issue as they are a prime way that pharmaceutical
companies are able to make money. Having a patent on a drug means that the pharmaceutical company that owns the patent can have 10 years producing the drug exclusively, and can charge whatever price they like. Once the patent runs out, anyone is allowed access to the formula to reproduce, and is considered to be 'generic'. As you might expect, 'Big Pharma' doesn't like this, and tries to find ways to extend the life of their patents and maximise their profits. Evergreening is an international issue and happens in countries all over the world. It describes the phenomenom of very slightly altering a drug's formula, so that it doesn't change the efficacy or action of a drug, but can be filed under a separate patent. This allows the company to maximise their profits on a drug. You may have heard of a common term for this sort of mimicking drugs- the 'me too' drugs. To the left you can find a button link to a paper published by the BMJ that explains the concept of Evergreening and the problems it presents. The practice of prescribing generic drugs versus named drugs is particularly a problem in general practice, with at least 17% of primary care prescriptions coming from branded drugs. The issue of prescribing generic vs branded is fast becoming a focused target in primary care today, with some practices requiring a set proportion of doctors' prescribing to be generic drugs. But how do companies create these new drugs without altering their function? One answer lies with the simple chemistry of isomers/enantiomers. These are the different rotations of the atoms within the chemical structure, so that the rotation and asymmetry of the atoms alters slightly the way the drug is metabolised by the body. This means that it can be considered to have a new action, and merit a new patent. which allows an additional 10 years of exclusivity. |
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As for the other topics on this site, we have collated all the info you need into a document you can download and keep.
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