Balancing the need for innovative drugs while providing lower cost alternatives to consumers: Hatch-Waxman reviewed

There is a long continuum of differing positions amongst academia, the private sector, and the public sector in determining the appropriate balance between providing incentives to both innovator drug companies and generic drug manufacturers, while at the same time also protecting legitimate patent rights. Juxtaposed to these issues is the fact that the cost of biomedical research is enormous and it continues to grow as the government seeks to provide for the health and welfare of a public that not only seeks therapeutic medicine and medical care when sick, but also wants prophylactic and diagnostic products. Furthermore, personalized medicine, resulting from the advances in functional genomics and new and increased use of lifestyle drugs providing therapies ranging from male pattern baldness to erectile dysfunction, is indicative of the ever-increasing expectations for a greater range of products. The debate then is not only how to make such products available but also how to make them affordable. With more than 500 drug patents scheduled to expire between 2004 and 2009 (with 26 of these drugs accounting for more than 38 billion dollars in sales annually), the stakes are high, for not only the generic and brand name manufacturers, but also for the consumer.