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TPP Negotiators Reached Agreement With Sticky Compromise On Biologics Drugs
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TPP Negotiators Reached Agreement With Sticky Compromise On Biologics Drugs

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TPP Negotiators Reached Agreement With Sticky Compromise On Biologics Drugs

TPP Negotiators Reached Agreement With Sticky Compromise On Biologics Drugs
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A big sticking point in the negotiations over the Trans-Pacific Partnership involved biologics medicines and vaccines created from living organisms. The dispute centered on patent protection: how many years drug companies should have before facing competition from generics. The negotiators ended up with a complicated compromise that gives drug makers five to eight years of protection. But nobody is really happy with the outcome.

ROBERT SIEGEL, HOST:

On Monday, the United States and 11 other countries reached an agreement to boost trade throughout the Pacific basin. It's called the Trans-Pacific Partnership, and it still has to be approved by the legislatures of the countries involved. One of the most controversial parts of the agreement involved the sale of biologics, the class of medicines derived from living organisms. As NPR's Jim Zarroli reports, the compromise reached by the countries has left many unsatisfied.

JIM ZARROLI, BYLINE: U.S. officials say the dispute over biologics was so intense this weekend that it nearly caused several countries to walk away from the table. The reason has everything to do with money. Judith Rios of Doctors Without Borders says biologics is a fast-growing and very lucrative segment of the drug industry.

JUDITH RIOS: Pharmaceutical companies consider it to be the future. It's basically going to be one of the most important markets for the pharmaceutical industry not only in the United States but, of course, globally.

ZARROLI: The pharmaceutical industry has developed biologics to treat rheumatoid arthritis, Crohn's disease and psoriasis, and others are in the pipeline. But the drug industry has long complained that competitors can can essentially copy and sell their own version of biologics can biosimilars, and in 2010, the industry convinced Congress to pass a law protecting the data used to develop biologics for 12 years. Joseph Damond is vice president of the Biotechnology Industry Organization.

JOSEPH DAMOND: What that means is that a copycat company can't just piggyback on that data and say, well, our product's like theirs, so we don't have to do any clinical trials.

ZARROLI: Damond says that will give pharmaceutical companies more incentive to develop biologics. But public health advocates say the law sharply curtails competition in the drug business. Again, Judith Rios.

RIOS: Nobody can manufacture. Nobody can sell. Nobody can import, export. It's a complete barrier to competition. Basically, you cannot enter this country's market for that period of time.

ZARROLI: And Rios says that will hurt developing countries that desperately need access to inexpensive drugs. Rios notes that drugs are already protected by patent law for 20 years almost everywhere in the world, so drug makers already have plenty of protection from copycats. But Joseph Damond argues that Biologics aren't like regular drugs, so they're more vulnerable to being imitated.

DAMOND: They're not identical to the original product because these products are synthesized by living cells. If you have a different cell line, it's going to be slightly different. And because they're not identical, it allows a biosimilar company to claim that they're not violating the patent.

ZARROLI: As the Trans-Pacific Partnership talks got underway, U.S. officials had hoped to persuade other countries to extend the same 12 years of data protection that Congress had given U.S. drugmakers. But the idea proved deeply unpopular, and the U.S. was forced to accept a complicated compromise that protects data for at least five years and potentially eight.

Critics say the deal will cause drug prices to stay higher than they otherwise would have been. But drug industry officials say they're disappointed with the compromise too, and they're holding out the possibility of opposing the deal outright. The opposition from both sides will make it harder for Congress to pass the trade pact next year. Jim Zarroli, NPR News, New York.

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