Original Drug is an international term used for new drugs which
- have been proven in lengthy studies and clinical trials to have beneficial effects on a disease,
- are based on a patented molecule, and
- have no similar product before it.
In many countries around the world, original drugs are afforded protection by powerful laws, patents and data protection rights for a specific period of time, during which no other pharmaceutical companies are allowed to manufacture a product similar to the original product. This allows original drug manufacturers to cover their R&D investments and generate funding for new research.
After expiration of the legal protection period for an original drug, other pharmaceutical companies are allowed to place on the market products which are similar to the original drug. These similar products are called “Generic Drugs.” Generic drug manufacturers must follow a number of rules for placing their generic drugs on the market:
- A generic drug must contain the same active substance in the same quantity as the original drug.
- It must have the same formulation and the same pharmaceutical form.
- Its bioequivalence to the original drug must be demonstrated.
- Generic drugs with proven bioequivalence can be placed on the market based on the proven efficacy and safety profile of the original drug, without having to incur hundreds of millions of dollars in research expenses. Therefore, generic drugs have a far lower cost.
The pharmaceutical sector needs both original drugs and generic drugs to advance the quality of life of humans. Original drugs provide humans with novel, effective and safer treatments while generics offer a more affordable alternative. This relay race should be able to work in a robust cycle to improve the quality of life.
Original and Generic Drug Policies
Because Turkey had in the past omitted to fully perform her obligations under international conventions for protecting research-based pharmaceutical industry to which Turkey is a party, a situation has resulted where original drugs and copy drugs can be freely sold in the domestic market. However, in line with the accession process of Turkey into the EU, progress is being made on eliminating the shortcomings in “intellectual property rights” practices, such as patents and data protection, which are essential to support a robust cycle of original drugs and generic drugs.