An Asia-Pacific trade deal first proposed by President Obama in 2009 was agreed today, eliminating a number of trade barriers between the US and 11 countries across Asia, Oceania and the Americas.*
But the issue of intellectual property (IP) for biologic medicines kept negotiations at a deadlock until early Monday morning, with the committee agreeing on a minimum of five years of data protection for such products.
“This is the first trade agreement in history to ensure a minimum period of protection to biologics,” US Trade Representative Michael Froman said in a press conference.
The US had been campaigning for 12 years of data protection to ensure there would be incentive for innovation, while Australia and New Zealand had campaigned for five years, to allow greater patient access to cheaper, copycat biosimilars.
“What we’re doing in TPP is recognising that we’re all trying to achieve that effective market protection and delivering a comparable outcome through various mechanisms, including at least five years of data protection plus other government measures,” Froman said.
Despite saying inspections, clinical trials and regulatory measures could add years to bringing such products to market, US industry groups have already expressed their discontent with the agreement.
Data protection
The controversial point is the length of data protection for the results of clinical trials of biopharmaceuticals. Without access to data from originator biologics, biosimilar makers cannot file their own applications with regulators, and repeating the trials is considered unethical under Helsinki rules.
Data protection agreements can prevent rival drugs from launching, even if the patent and marketing exclusivity of the reference product have expired.
“We are disappointed that the Ministers failed to secure 12 years of data protection for biologic medicines,” said John Castellani, President of Pharmaceutical Research and Manufacturers of America (PhRMA).
“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.”
The Biotechnology Industry Organization (BIO) too was campaigning for 12 years of data exclusivity, and expressed its disappointment yesterday to reports suggesting the decision wasn’t going that way.
The agreement will be officially signed in 90 days time.
*The 12 countries involved in the deal are Australia, Brunei Darussalam, Canada, Chile, Japan, Malaysia, Mexico, New Zealand, Peru, Singapore, USA and Vietnam