ObamaTrade Details Unveiled, Officials Warn "It’s Worse Than We Thought"

November 6th, 2015

Awake Goy

The sprawling deal would affect a variety of issues, including tariffs, labor rights, and international investment. But the deal’s most controversial provisions are the ones limiting competition in the pharmaceutical industry. According to Doctors Without Borders, “The TPP will still go down in history as the worst trade agreement for access to medicines in developing countries.”

Though the final text of the agreement won’t be available for at least another month, here’s what we know so far.

The TPP will drive up costs for some of the most expensive drugs on the market in the poorest countries

One of the biggest sticking points in the negotiations had to do with data protection for biologic drugs.

Biologics are treatments made from biological sources, including vaccines, anti-toxins, proteins, and monoclonal antibodies for everything from Ebola to cancer. As the Brookings Institution explains, biologics are much more structurally complex than regular “small-molecule drugs” and are therefore more difficult and expensive to make, costing on average 22 times more than nonbiologic drugs.

Because of the high prices of these drugs, companies are very interested in developing “biosimilars” – cheaper copies of the original drugs, similar to generic versions of pharmaceuticals. The reason these biosimilars are so cheap is that manufacturers can usually just rely on data from clinical trials submitted by the maker of the original biologic. But, of course, the maker of the original drug doesn’t want everyone using its data and making cheap knockoffs.

So in the United States, there are really protective rules around this: Any maker of a biologic gets 12 years of data exclusivity. The FDA can’t approve a similar drug that relies on the original data during this time. (Theoretically, other companies could conduct their own trials to create a biosimilar, but because this is so expensive, it defeats the point.) By contrast, in other countries, there are looser rules – or no rules – around such data exclusivity. Japan offers eight years, for instance. Brunei offers zero.

As part of the TPP, the United States (and the pharmaceutical lobby) had been pushing to get every country to agree on 12 years of data protection for biologics. The final agreement falls somewhere in between, with a period of data exclusivity from at least five to eight years, according to the New York Times.