The hotly debated Trans-Pacific Partnership (TPP) patent protection could cost lives as big pharma uses the duration extensions to keep affordable medicine priced out of reach of most Americans. In short, the TPP’s benefits to patent holders could result in shocking detriments to humanity.
Remember smallpox and polio? Public health efforts focused on saving lives, not making profits, were responsible for the virtual elimination of these killer diseases. No more premature deaths and no more debilitating after effects, such as paralysis. All because the discoverers of the treatments cared more about people than profits and worked to save lives.
Sadly, “profit” these days is seen only on balance sheets. There is profit in keeping people healthy, active participants in society and the market, too. This type of profit could even be factored into a balance sheet as an asset. It’s just not done, though because the short-term payoff isn’t there.
Case in point: Ebola, arguably a dangerous disease despite its fairly limited spread thus far. However, governments are still concerned about its possible future reach. The best treatment for the disease, a drug called ZMap, was created by academicians and entrepreneurs with a lot of government funding. One would think that big pharma would have jumped at the chance to cure a disease, but no, it didn’t.
At the same time ZMap was being developed, big pharma ignored Ebola. The rationale was that the disease hadn’t killed that many people and the most affected patient populations couldn’t afford the treatments anyway.
Enter the TPP and its patent protection. The current level of patent protection lasts for 20 years. Under the TPP’s provision, big pharma can freely engage in a process called “evergreening.” This process would allow companies to change one small, inactive ingredient in their drugs and re-patent them with a full 20-year coverage. Goodbye generics.
It becomes virtually impossible for more affordable version of medications to find their way onto the market. The TPP further provides data exclusivity protections of at least five years of exclusivity for new drugs and an additional three years for new uses of existing drugs. This means that the patent holder does not have to share results of clinical trials with anyone, not generics producers, not even the FDA at least for the purposes of determining a generic version’s safety. Generics firms must either pay to replicate the hugely expensive clinical trials or wait the number of years specified until the data exclusivity expires.
Welcome to drug monopolies that care more about the financial bottom line than the people who rely on their products to get well and, in some cases, to survive. If I ran Pfizer or GlaxoSmithKline and was beholden to my shareholders for maximizing bottom line profits, I’d have my research teams find a way to reformulate Viagra as it came close to losing its patent protection. I’d have them substitute the hypromellose (HPMC) excipient (coating agent) with a hydroxypropyl cellulose (HPC) or hydroxyethyl cellulose (HEC) excipient and re-patent that cash cow.
As a human being thinking of other medications, such as those that treat cancer, I find the financial-bottom-line-based logic repulsive. Yet, if the TPP passes, “evergreening” and other obnoxious forms of profit mongering at the expense of human lives will become the norm.
There are other parts to the TPP’s intellectual property chapter that could have potentially damaging impacts on health care in the U.S. They are topics for other posts.