But Marc-André Gagnon, a pharmaceutical policy researcher at Carleton University in Ontario, Canada, and Master of Advanced Studies in Economics, said he doesn’t buy into all the negativity.
“There’s a bit of a fear-mongering campaign in Canada that this type of proposal will be a catastrophe, people will die, the pharmacy shelves will be empty,” said Gagnon. “So it’s all about drug shortages in Canada.”
The proposed program would allow states, pharmacies, and drug distributors to develop pilot programs to import drugs from other countries, primarily Canada.
Gagnon said while implementing the proposal could create turbulence, technically it wouldn’t be a problem in terms of adapting the supply lines.
“The timeline for implementing the proposal is so long,” said Gagnon. “I mean nothing would be done before 18 months. So there will be plenty of time to adapt the supply lines and make this possible without creating a massive amount of drug shortages.”
Drug lobby groups are against the proposal, but Gagnon says when the effective demand for a product increases in a country and there are months to prepare, investment and manufacturing can be increased and the economy and employment can improve.
“The thing is you know as an economist … if you increase the effective demand for some products in a country and you go ‘Well this will be happening in a few months.’ … let’s invest in mass manufacturing facilities and hire more people, that creates employment.”
“What creates a lot of turbulence in the supply line is when you have mergers and acquisitions especially in the generic sector that create a massive amount of drug shortages,” said Gagnon. “But nobody is saying we need to stop mergers and acquisition in the pharmaceutical sector.
“But when it comes to a political proposal to make sure that patients will have better access to the drugs they need, all of a sudden potential shortages become a huge issue.”
One of the obstacles of the plan to import drugs is the U.S. Food and Drug Administration’s (FDA) Drug Supply Chain Security Act (DSCSA) that was enacted in 2013. It is a track and trace system to stop harmful and counterfeit drugs from circulating in the United States and would require pilot programs to show how they will comply with the system.
“We’ve been keenly focused on ensuring the importation approaches we’ve outlined pose no additional risk to the public’s health and safety,” said Acting FDA Commissioner, Ned Sharpless in a statement announcing the importation plan.
The Pharmaceutical Research and Manufacturers of America released a statement condemning the proposal saying, “There is no way to guarantee the safety of drugs that come into the country from outside the United States’ gold-standard supply chain. Drugs coming through Canada could have originated from anywhere in the world and may not have undergone stringent review by the FDA.”
Gagnon said one aspect of the proposal that could be beneficial is if online pharmacies have to become certified importers in order to ensure every drug was trackable and traceable.
“We have a proposal on the table and now both Democrats and Republicans will have to follow through with this,” said Gagnon. “Because it will look very bad for anyone to oppose this type of proposal that gets a lot of popular support.
Gagnon said his main concern is if the proposal goes through and drug companies give approval, they might create artificial shortages in Canada that force the Canadian government to stop exports to the United States.
“If Canada is doing the right thing in terms of the drug price regulations,” said Gagnon. “Then if you want to solve the issues in the U.S. maybe go forward with the same type of regulation for drug prices.”