[Ip-health] NYT on TPP & meds IP
pmaybarduk at citizen.org
Tue Oct 6 08:12:50 PDT 2015
What Changes Lie Ahead From the Trans-Pacific Partnership Pact
By KEITH BRADSHER and ANDREW POLLACKOCT. 5, 2015
One of the final sticking points to making a deal was agreeing on a standard for temporarily protecting the drugs made using biotechnology from competition. In the end, negotiators agreed to a five-year minimum period of market exclusivity in each country, plus options for additional years, before these drugs could face competition from cheaper imitations known as biosimilars.
"The agreement recognizes that we can travel on different roads but end up at the same outcome," said Andrew Robb, Australia's minister for trade and investment. Michael Froman, the United States trade representative, described it as "at least five years of data protection plus other government measures that can achieve a comparable outcome."
The pharmaceutical and biotechnology industries had pushed for 12 years, the same period granted in the 2010 Affordable Care Act. The 12-year standard will remain in effect for the American market, but the pharmaceutical industry wanted that for all of the countries in the pact.
"We are disappointed that the ministers failed to secure 12 years of data protection for biologic medicines, which represent the next wave of innovation in our industry," John Castellani, president of the Pharmaceutical Research and Manufacturers of America, said in a statement Monday. "This term was not a random number, but the result of a long debate in Congress, which determined that this period of time captured the appropriate balance that stimulated research but gave access to biosimilars in a timely manner."
Critics of the pharmaceutical industry, while welcoming the shortening of the exclusivity period, said that the trade agreement as a whole would still impede access to affordable medicines, particularly for the less-developed countries in the pact.
"They've been able to eliminate a number of harmful rules from the agreement, and that will save many lives," said Peter Maybarduk, director of the access-to-medicines program at the public-interest group Public Citizen. "The agreement could have been much worse."
Still, Mr. Maybarduk said the agreement as a whole imposed new patent and market exclusivity rules on countries that now do not have them.
"For us, any T.P.P. is making things worse," he said. "The industry will have many more tools with which to defend its monopoly business model."
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