Tahir Amin, DipLP, cofounder and director of intellectual property of Initiative for Medicines, Access, and Knowledge (I-MAK), explains how a recent trade deal could take a toll on biosimilars.
How might the new trade deal among the United States, Mexico, and Canada impact biosimilar availability?
Certainly for Mexico and Canada, one of the particular clauses that has been inserted in the agreement is the requirement of data exclusivity or clinical trial data, and Mexico only used to have 5 years and now they have required a minimum of 10 years. So in at least in Mexico they’re going to have a delay before seeing biosimilars, and in Canada it used to be 7 years and they’re going to have to increase it to a minimum of 10 years.
What’s also important is the United States has 12 years already, so it’s already in that minimum period of 10 years, but there’s a lot of conversation, various bills that are in the pipeline in the United Sates to try and reduce that 12 years to 7 years, which is what President Obama tried to do in the outset.
Any chance of rolling back to 7 years that is going to be less given that this trade agreement has been signed, and I think this is one of the strategic moves that a branded pharmaceutical company always does is ty to get these trade agreements locked in to increase their monopoly power or their exclusivity periods and that essentially then becomes harder to change domestic law in the United States.
So, while the immediate impact will probably be in Mexico and Canada because they’re increasing the number of years of marked exclusivity, it also impacts the United States, because it makes it much harder to take these changes in the United States, and there are other provisions in the agreement which enable pharmaceutical companies to get easier patented rights on new uses of existing medicines; that is only going to increase the number of patents on existing drugs and we think that’s a fundamental problem, too.