The concept of pharmaceutical data exclusivity protection comes from the West. The Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) establishes the basic rules for pharmaceutical data exclusivity protection. People's Republic of China's domestic law is consistent with the TRIPS agreement. In the drug registration approval process of the People's Republic of China's Dru...

The development and diffusion of antibiotics contributed to large improvements in human health and living standards. The antibiotic revolution also spawned the modern pharmaceutical industry. This paper reviews the development of the early antibiotics, and the roles of intellectual property rights (in particular, patents) in their development and diffusion. Though today the pharmaceutical secto...

The pharmaceutical industry has in recent years come under attack from an ethical point of view concerning its patents and the non-accessibility of life-saving drugs for many of the poor in both less developed countries and in the United States. The industry has replied with economic and legal justifications for its actions. The result has been a communication gap between the industry on the on...

The impact of intellectual property protection in the pharmaceutical sector on developing countries has been a central issue in the fierce debate during the past 10 years in a number of international fora, particularly the World Trade Organization (WTO) and WHO. The debate centres on whether the intellectual property system is: (1) providing sufficient incentives for research and development in...

There is often a gap between promises made politically and the will to implement these promises meaningfully. One example is Canada's Access to Medicines Regime (CAMR). CAMR was enacted following a WTO decision that changed global intellectual property rules, allowing countries to issue compulsory licences for the production and export of domestically patented medicines to countries without pha...