The paper describes the legal and regulatory mechanism in the United States pursuant to which generic versions of patented medicines may be approved for marketing by the Food and Drug Administration (FDA). The paper makes two basic points: (1) the system works reasonably well for the United...

In the decade since the Doha Declaration was adopted, significant progress has been made in addressing problems associated with innovation and access to medicines, including through expanded financial support for procurement and distribution of treatments and vaccines and the establishment of...

China's prospective membership in the World Trade Organization is one of the most significant developments relating to international institutions to take place in the past several decades. It comes in the midst of the broad transformation of post-World War II command economies to market...

This contribution reviews an important study — "Promoting Access to Medical Technologies and Innovation: Intersections between public health, intellectual property and trade" (the "Trilateral Study") jointly prepared by the Secretariats of the World Health Organization, World Intellectual...

This report identifies and analyses trends in the local production of medicines in developing countries and related technology transfer. The objective is to assist the World Health Organization (WHO) in its support for Member States in implementing the global strategy and plan of action on...

The WHO Global Strategy and Plan of Action mandated the Director General to support transfer of technology and local production of medicines in developing countries. This paper briefly lays out the conditions for local production in Africa and describes the on-going work program of the WHO...

Integration may be viewed as an evolutionary outgrowth of heightened social and economic interdependence brought about by advances in technology. As persons, goods, capital, services and ideas cross artificial national frontiers at increased rates of speed, the wisdom of imposing disparate...

In 1970, the countries of the Andean Common Market (the Andean Pact or ANCOM), adopted uniform foreign investment regulations. The Andean Foreign Investment Code, as Decision 24 of the Andean Commission is called, regulates both the treatment of foreign capital entering or within ANCOM, and...

This paper was prepared by the author for the Max Planck Encyclopedia of Public International Law. It was initially published in the online edition in 2009, and in 2012 appeared in the hard copy bound volumes. The paper describes the various forms of intellectual property, the international...