Pharma confronts the 21st century: Generic competition, compulsory licensing, and drug access and safety challenges from abroad

The worldwide pharmaceutical market is undergoing very profound adjustments across this century. Multinational drug firms that have dominated the production of Western pharmaceuticals for the past three decades now face formidable new challenges. Their R&D has not been well sustained with breakthrough entities, and scores of branded drugs have been losing patent protection; these drugs were considered “blockbusters” in that their sales tallied in the billions each. Without patents, the rise of the generic drug industry chiefly based outside the Northern Hemisphere represents a major shift in revenues and easy profits. Moreover, the upgrading in technological capability and manufacturing might of various firms from Israel, India, China, Brazil, South Africa, and elsewhere allows these nations to better address the mounting unmet pharmaceutical needs across the developing world that the U.S. and European firms have historically neglected. Further specific challenges in trade policy (namely, compulsory licensing, national price setting, etc.) are directed at multinational Pharma firms, which, along with actions to address access and drug safety may delimit Western multinationals' previous power to shape the marketplace.