Data exclusivity and other “trips-plus” measures

The pharmaceutical market is highly regulated. Two sets of laws and regulations play a crucial role in this market. These are (i) the intellectual property laws and (ii) the laws and regulations on 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, as 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, selling or importing 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.