THE BLOG

Escalating Drug Prices Likely from Secret "Fast Track" Trade Bill

06/11/2015 03:59 pm ET | Updated Jun 10, 2016

Congress could vote this week on a "Fast-Track" trade bill that would dump a double whammy on the many Americans whose health and finances are already hit hard by the high price of prescription drugs. Wikileaks and the NY Times today published a draft chapter on drugs, negotiated entirely in secret as part of the Trans-Pacific Partnership (TPP). If it approves proposed "Fast Track" rules, Congress would surrender its ability to amend this chapter, and whatever remaining secret text that the secret negotiations produced.

The leaked trade chapter, entitled Transparency and Procedural Fairness for Pharmaceutical Products and Medical Devices, was presented in December, 2014, to the 12 nations negotiating the Trans-Pacific Partnership (TPP). It could derail present programs that offer access to affordable prescription drugs in the U.S. and abroad, including Medicare and Medicaid, and stymie future progress.

How to create and produce affordable medicines, and assure wide access to the resulting products, is a critical, life-and-death concern for both the public and the drug industry. A new treatment for Hepatitis C can transform lives, but the price tag of $80,000 a year will condemn too many to go without it. Existing U.S. laws that rely on competition from copycat generic drugs to achieve affordability will be less effective in the case of new drugs classified as biologics, which are far harder and in some cases impossible to copy. The TPP text reveals threats to existing and proposed systems that cover and finance access to medicines in the U.S., Australia, New Zealand, and elsewhere, and will increasingly have to address emerging new products, including policies on:

• Direct-to-consumer advertising
• Rules on the extent and timing of drug industry participation in government decisions about the selection and pricing of covered prescription drugs
• The treatment of medical devices
• The grounds for a drug company to initiate a trade charge against a country's drug coverage and pricing systems

These threats and ambiguities are the inevitable result of misguided efforts to determine critical health, economic and social policy issues through the secret process of trade negotiations, dominated by commercial interests, while explicitly excluding and silencing other experts, consumer advocates, public officials, and the public at large from the debate. The few non-industry participants on trade advisory committees are prohibited from revealing or publicly discussing the contents of privileged negotiating text. Such a process cannot succeed in a democratic system.

Open public debate reveals and helps to determine where agreement is possible, and which issues will remain contentious. It is the only basis for providing reliable assurance to our trading partners that the negotiations reflect what the U.S. will actually stick to.

Congress must vote No on Fast Track/Trade Promotion Authority.