What is a generic medicine (is it safe and equivalent to the original product)?

A medicine is called a generic when it can replace an existing brand medicine (specialty or original product). The generic medicine contains the same active ingredients in the same amounts as the original.
Before a generic medicine can be marketed, clinical research must have shown that the generic is equivalent to the original. This means that the generic medicine must work equally fast, good and safe as the original. These studies are independently assessed by the authorities (Medicines Evaluation Board, MEB). If the generic medicine meets the strict legislations (also applying to the original), MEB will sustain an authorisation for marketing the product and the medicine is added to the Registry of Medicines. After obtaining a marketing authorisation a generic medicine can only be marketed when the patent of the original product expired.

A patent offers the innovator/investors a temporary monopoly for selling new medicines. Within this period the fundamental research expenses can be earned back and profits can be made. If a patent expires, the invention or knowledge is no longer protected. Everyone is then allowed to use this knowledge, hence stimulating innovation.

Mylan uses this knowledge to develop new generic medicines, which are consequently being sold against lower prices. Since Mylan bases its development on the patent free fundamental research done by the innovator, these investments do not have to be earned back. Thus the final prices are lower, without making concessions to quality and efficacy.

Is it important to have generic medicines?

Generic medicines stimulate innovation and allow government expenses on healthcare to be controlled. Medicines amount to 8-15% of the total healthcare expenses. The western countries suffer from rapidly increasing expenses on their healthcare, while people in underdeveloped countries are often not even able to receive or buy lifesaving medicines. Ultimately the consumer pays the account by elevated premium of the healthcare insurance company or by not receiving medicines for diseases which can be treated. Generic medicines lower healthcare expenses leading to a broadly accessible healthcare system in which medicines are available to anyone for diseases which can be treated.