Bioshield II Proposal Would Hurt Seniors, Uninsured in the Name of Homeland Security

Bonus for Big Pharma Disguised as Bioterrorism Defense

Sep. 20, 2005

By Jeffrey Light
www.patientsnotpatents.org

In 2004, President Bush signed into law the Project Bioshield Act, now referred to as Project Bioshield I. The law was intended to act as a straightforward government procurement program, allowing the government to enter into contracts to purchase drugs and vaccines in a similar manner to how it purchases bombs and missiles. Congress earmarked $5.6 billion over ten years for this program, expecting drug companies to quickly research new drugs and take the cash. So far, few firms have accepted the government’s offer.

Apparently, the $5.6 billion prize was too little for the band-name drug companies, and few have taken the bait. Pfizer spokesman Jack Cox bluntly admits that Bioshield I “isn’t enough to spur the development of new drugs to counter bioterrorism attacks.” Their sights are now set on new legislation that would yield more than a measly few billion dollars. The brand name drug companies are seeking to extend their patents far into the future, effectively prohibiting lower-cost generic drugs from coming to market. If Big Pharma has its way, the costs of the patent extensions will fall disproportionately to the elderly and the infirm, who consume more prescription drugs at a higher rate than the general population, as well as individuals without health insurance. The bills being promoted, the euphemistically titled S.3, “Protecting America in the War on Terror Act” and S.975 “Project Bioshield II Act” are outstanding examples of corporate welfare at its worst.

Both bills would allow Big Pharma to receive unlimited patent extensions on any drug which could be considered a countermeasure to a biological threat. Strikingly, the definition of “countermeasure” in both bills is so broad that virtually any drug, even existing ones, would qualify. Countermeasures would include drugs that treat side effects of antibiotics, vaccines, and other bioterrorism-related medicines. Accordingly, drugs that treat headache or nausea would qualify with minimal testing performed by the manufacturer, because they treat extremely common side effects of such medicines.

Patents normally last for 20 years from the date on which the application is filed. In the case of pharmaceuticals, however, patents can extend for several additional years. The extra time is intended to offset the lengthy FDA approval process that must be completed before the product can be marketed. Currently, this extra time is capped at five years for patents on new compounds, as opposed to new indication for existing compounds, or slight chemical variations of the original compound.

The Bioshield II Act would eliminate this five-year cap, as well as allow drug companies to extend the term of their patents based on a new indication for an existing drug, as long as the new indication qualifies as a countermeasure. As a result, brand manufacturers would be able to keep generic drugs off the market potentially for decades. The benefits to society would be miniscule, as the National Institutes of Health, Centers for Disease Control and Prevention, and the Department of Defense have already determined which drugs would be effective countermeasures for bioterrorism threats.

A particularly galling part of the Bioshield II Act is the “wild card” provision. This part of the legislation would allow brand name drug companies to gain two extra years of protection for ANY of their products, including ones wholly unrelated to bioterrorism, simply by having any other product they make approved as a countermeasure. For example, Pfizer would get a wild card if it could show that its over-the-counter drug Emetrol, which has already been approved to treat nausea, would alleviate nausea caused by an anthrax treatment like the antibiotic Cipro. The wild card would then be worth $14.3 billion if applied to Pfizer’s best-selling drug Lipitor. Pfizer’s next two wildcards could be applied to Zoloft and Neurontin, raking in $6.1 and $5.3 billion, respectively. Proponents of the related bill, S.3, have asserted that the controversial wild card provision has been dropped from their version of the bill. Although S.3 removes the language explicitly stating that the two year extension may be applied to any product, it falls short of including specific restrictions on the ways in which the extension may be used, such as extending protection only for bioterrorism-related countermeasures. As a result, it’s hard to predict which way a court would interpret the provision, should the bill become law.

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