BIOPHARMING: UNIQUE CHALLENGES AND POLICY PROPOSALS

Abstract

Biopharming is the genetic engineering of plants to produce novel pharmaceuticals and useful industrial compounds. It has the potential to provide revolutionary benefits, but it also raises a host of daunting challenges. Part II provides background information on the technology of biopharming, including the types of products, host plants, and harvesting procedures involved. Part III describes the dramatic benefits of large-scale, flexible, and inexpensive production of life-saving pharmaceuticals and useful industrial compounds. Part IV explains the grave risks associated with the escape of biopharm material outside its intended scope, and the potential environmental, health, and economic damage that may result. Part V describes the U.S. federal regulatory regime's current efforts at controlling the dangers of biopharming, but notes its inadequacy with respect to post-market oversight. Part VI examines the legal liability system as an auxiliary mechanism for post-market oversight, but acknowledges that litigation has its own shortcomings. And finally, Part VII explores policy proposals for the creation of a comprehensive solution to minimize the risks of biopharming so that its benefits can be fully realized.