Legal Issues

Over the last few years, there have been a number of high-profile legal actions related to a class of drugs known as COX-2 inhibitors. These cases - involving some of the largest companies in the industry - have received a great deal of media coverage and, due to the complexity of the cases, may go on for many years. In addition to the legal cases, the FDA also has investigated these issues, and in each case the companies involved have worked with the FDA to protect and inform the public as fully as possible.
 
As in many industries, there have been legal cases regarding accounting procedures and other financial misdealings. All of these legal issues have an impact on the reputation and public perception of the companies in question and of the industry as a whole, but they are the exception and not the rule. The healthcare industry, by and large, is considered to be well run, a valuable contributor to the economy, and (most importantly) an ally of the public in the fight to improve healthcare and the lives of people worldwide.

Other lawsuits becoming more prevalent in the industry deal with the issue of patent infringement. It is a complicated issue involving intellectual property, the globalization of the industry, the rise of generics, and access and availability for poor or developing nations. The healthcare industry invests a great deal of money into R&D as we have seen. It is only natural that they wish to protect and get a return on their investment. Changes to the FDA regulations in the past two decades have made it easier for generics to be brought to market and, as the time between the approval of a generic and the end of the primary drug’s patent gets shorter, patent battles become more common.
 
Some drugs that are in high demand across the developing world are often products that are still under patent but which aren’t necessarily the most cost effective for their companies to produce in large quantities. This has led many of the nations most in need of these medical supplies to relax their restrictions on the development of “copies.” In that case, the driving force behind the infringement isn’t profits as much as it is saving lives, and it involves not only the patent laws of the originating company but of the global marketplace as a whole. It’s not an issue that is going away anytime soon and it’s not something where the solution -- if found -- will be easily implemented. But in the larger scheme of things, it is being managed as effectively as possible so that it doesn’t prevent other, equally important progress to be made on other products