Biopharmaceutical innovation has had a profound health and economic impact globally. Developed countries have traditionally been the source of most innovations as well as the destination for the resulting economic and health benefits. The rapid pace of discovery in the biotechnological sciences has created substantial difficulties for the Federal food and Drug Administration (FDA), European Union and all major regulators, which ensures the safety and efficacy of biopharmaceutical products. The speed of biotechnological discovery necessarily requires rapid product approval by regulators, as...