Generally, trade agreements are not something I scrutinize and typically have little to do with the medical field. Recently, I was surprised to learn that the Trans-Pacific Partnership (TPP) has language in its intellectual property chapter that could impact the lives of millions (A Kapczynski. NEJM 2015; 373: 201-3). The background for this story is that pharmaceutical companies want to have patent protection for their medications for as long as possible. This has a substantial impact on pricing. “For example, patents increase the annual cost of antiretroviral therapy from around $100 per person to $10,000 per person.”
Some countries, like India, have undermined patent protections. “India allows patents on new drugs but not on new uses of old drugs or new forms of known drugs that do not increase therapeutic efficacy.” Other countries have been following India’s lead. Even in the U.S., there are efforts to decrease data exclusivity, which prevents regulatory agencies like the FDA from registering a generic version of a drug.
“President Barack Obama’s fiscal year 2016 budget proposes rolling back the data exclusivity period for biologic drugs in the United States to 7 years from 12 years, yielding a projected savings of more than $4 billion over the next decade. In the TPP negotiations, however, the United States is proposing a 12-year term of exclusivity.”
Other potential concerns include both the elimination of a provision to use “competitive market-derived prices” and the potential for promoting foreign companies to sue TPP countries for millions of dollars in damages due to loss of profits.
Currently there are escalating drug prices, both with innovative new medications and well-established treatments. Even lifesaving cures are being rationed in the United States. While the TPP has not been finalized, there are provisions that could limit the United States from regulating “critical aspects of health policy for years to come.”
Related blog posts:
- This Is A Stick Up — Your Money or Your Life” | gutsandgrowth
- Cornering the Generic Markup | gutsandgrowth
- Why U.S. Consumers Pay More For Medications | gutsandgrowth