- All > Public Health, Innovation, Intellectual Property and Trade > Intellectual Property (IP) and Trade
- Keywords > bioequivalence
- Keywords > data exclusivity - clinical and pre-clinical trial
- Keywords > innovation and access
- Keywords > intellectual property laws
- Keywords > medicines regulatory systems
- Keywords > patent and exclusivity status
- Keywords > Trade Related Aspects of the Intellectual Property Rights (TRIPS)
- Keywords > TRIPS flexibilities
- Keywords > TRIPS-plus provisions
(2006; 4 pages)
The pharmaceutical market is highly regulated. Two sets of laws and regulations play a crucial role in this market. These are
- the intellectual property laws and
- the laws and regulations about drug registration.
These two sets of laws have different objectives, and are administered by different government agencies. Intellectual property rights, notably patents (on which this briefing note will focus, since they have the most profound implications on access to medicines) are meant to reward innovation by providing inventors with temporary monopoly rights. Patents, however, confer negative rights: a patent on a certain pharmaceutical product means that the patent holder can prevent others from producing or selling that product. But it does not give the patent holder the right to actually sell that medicine. In order to be allowed to sell a medicine, it has to be registered by the national Drug Regulatory Authority.
The drug regulatory system, or registration system, seeks to ensure that only medicines of assured safety, quality and efficacy are available on the national market. This is important, since consumers do not normally have sufficient information and knowledge about a pharmaceutical product to make their own assessment about its quality, safety and efficacy. In addition, medicines that are ineffective or of poor quality can be dangerous, both for the patient and for public health...