To answer this question, let’s consider how a new medicine enters the market. It all starts in clinical laboratories, where scientists get a new formula for the drug, which turns out to be more effective than existing analogs. After that, the company-inventor receives a patent for a new drug, conducts laboratory tests, clinical studies, and only after that, it can be admitted to the market.
In order for a new medication to reach the markets, it is necessary to meet all the medical standards that are specified as mandatory. Different countries have various standards. In many cases, these differences are quite significant.
That is why the cost of modern medications is so high. After the invention of the drug, the company receives a patent, thanks to which only this very company has a legal right to produce a new drug. The term of the patent depends on the country in which it was received.
As soon as the patent ends, the generics immediately appear. Any company can make a generic drug. To do this, it is enough to master the technology of the drug production process and to prove the similarity of the main active ingredient of the drug.
Pros of generics’ production
But the benefits for the production of generics are obvious. It is not necessary to invent a new drug – there is a ready-made chemical formula. Clinical studies are not necessary. The consumer is familiar with the product, which means that neither large-scale advertising campaigns nor marketing research are required.
Often, consumers mix concepts such as fake, copy and generic, considering them to be synonymous. But let’s clarify these concepts. Generic is a drug whose active formula is completely identical to the original drug. A copy is a medical product that is produced in violation of patent protection: either during the period when the patent is still valid, or the drug is identical in name.
And in a fake medication, the active substance of the drug is replaced by a cheaper one, or even with chalk or soda. It is clear they cannot be called drugs.
The world leader in generic production is India. This country is rich in pharmacological companies that specialize exclusively in the production of generics, and the products of the entire therapeutic group. Some of these companies have been on the market for over 50 years supplying European and the USA markets with generic drugs.
It may seem that the generic is a product of the poor quality who cannot afford to buy expensive drugs. However, this is not quite true.
The share of generic sales in the pharmacological markets:
- the USA – 10-15%;
- Japan – 25-30%;
- Germany – 35%;
- France – 50%;
- England – 55%;
- Italy – 60%;
- Canada – 64 %.