Author: Lea M. Gulotta
Abstract
The pharmaceutical industry, one of the largest industries in the world, is rapidly becoming globalized. Clinical trials, which are required for drugs to be approved for human use, are increasingly performed outside of the pharmaceutical company’s home country in an attempt to save money. This is mainly due to drug development’s steep costs, and the high risks involved in an industry where only 12 percent of products that begin development ever make it to market. In order to help offset these risks and encourage innovation, many countries offer clinical trial data certain protections through patents, market exclusivity, or trade secret protection. However, regulations and clinical data protection often do not align between the originator country and the location of the clinical trial. This leads to confusion and undermines the goals of providing clinical data protection. Additionally, providing too much protection to test data can negatively affect consumers, who will not be able to access cheaper generic versions of drugs. While it is commonly accepted that clinical data protection must be standardized on a global level, it is less clear what level and type of protection is appropriate. This Note proposes a hybrid system of clinical data protection that offers one year of data exclusivity, followed by a four-year period of cost sharing, during which generic competitors must pay a fee to rely on the originator company’s data. Such a scheme would properly balance the need to encourage pharmaceutical companies to undertake the risky business of innovating with the need to provide easy access to affordable medications.