Long periods of market exclusivity are no longer needed with technology that allows for faster, safer drug development, Jonathan Kimball, vice president for trade and international affairs at the Association for Accessible Medicines, argued in an opinion piece published in STAT. Association for Accessible Medicines is the trade group that represents generic drugmakers.
House Democrats are currently trying to remove a provision in the U.S.-Canada-Mexico trade agreement that gives drug companies 10 years of guaranteed market protection.
Brand-name drug companies argue that 10 years of market exclusivity promotes innovation and is needed because of the time and cost of drug development. Pharmaceutical Research and Manufacturers of America, the trade group representing brand-name drugmakers, says it takes an average of more than 12 years and $2.6 billion to develop a new drug, but Mr. Kimball argued that estimate is outdated.
A recent study from Oregon Health and Science University in Portland published in JAMA Internal Medicine suggests it takes an average time of 7.3 years and $648 million to develop a new drug. However, Mr. Kimball also noted that estimating the cost of drug development is exceptionally difficult and no study is completely accurate.
PhRMA regularly promotes the fact that drug development is fundamentally changing, which undercuts its argument for how long and expensive drug development is, according to Mr. Kimball.
Technology such as artificial intellegenceand biomarkers have significantly reduced the amount of time and money it takes to develop new drugs. Yet, PhRMA has not changed its narrative that the time and money justify the 10 year market exclusivity rule, Mr. Kimball argues.
Mr. Kimball said reducing the market exclusivity time would bring down drug prices because generic and biosimilar competitors could be introduced to the market sooner.
"Going into an election year, with enormous political pressure from voters on the president and members of Congress to rein in high drug prices, the industry has a right to be worried that blind support for innovation over pragmatic policy may be ending," Mr. Kimball wrote.
Read the full column here.