This week, the Colorado Department of Health Care Policy and Financing issued a request for proposals, called an Invitation to Negotiate, to operate a state wholesale drug importation program as permitted under federal law and the administrative final rule issued by HHS last year, referred to as the Section 804 rule. Colorado’s proposal request is chock full of details, with many regulatory and legal issues addressed, quite ably predicting pushback from drug companies who virulently oppose importation. Notably, it addresses the Canadian government’s valid concerns about new drug importation channels from the United States aggravating Canadian drug shortages.
Last year, just before the Section 804 rule went into effect, the Canadian government issued an interim order mandating that Canadian wholesale pharmacies not export drugs that could create or exacerbate domestic drug shortages. Certain drugs will require proper supply reporting before approved for export. The pharmaceutical industry’s flawed and, in some cases, false arguments against importation invoking drug safety issues are not working to stop the momentum on Section 804 state programs. In the industry’s public relations and lobbying efforts against the program, they often highlight Canada’s understandable and protective response. That won’t work either.
Colorado’s RFP is clear in its obligation to not cause drug shortages in Canada. A full quote from the proposal is in order here:
“This ITN takes into account the recent Canadian Interim Order that aims to prevent or exacerbate drug shortages in Canada. This order in no way halts the U.S. importation program from moving forward. That said, Colorado has always intended to take any Canadian drug shortages into account when identifying drugs for importation and have expressed this sentiment to the Canadian government through their Colorado-based consulate. We will ensure that all supply chain partners abide by this Order…”
In the coming year, Colorado and vendors that it hires will create lists of eligible drugs for wholesale import, ensuring only substantial savings for the State and its residents—not aggravation of Canadian drug shortages.
Colorado now joins Florida as the second state to announce requests for proposals on wholesale drug importation programs. Four others — Maine, New Hampshire, New Mexico, and Vermont — have passed laws to permit wholesale drug importation from Canada. These programs have yet to be approved through the HHS.
I’m glad to see Colorado’s diplomatic and practical approach in ensuring that Canada’s concerns about shortages are addressed. It provides a blueprint for other states to follow on this front.