Donald Trump’s government unveiled plans to allow drugs to be imported from Canada and other countries to lower drug prices, a President’s promise and a hot topic in the presidential campaign. No president in history has previously asked the FDA to open the door to the safe importation of drugs from Canada.
Unlike other countries, no central authority sets the price of drugs in the United States, where only competition can push pharmaceutical companies to lower their prices. However, for many treatments, a few laboratories share the market and prices have known soaring that hit the headlines.
A dramatic example is insulin, whose inventors in 1922 had sold the patent for a symbolic $1 to the University of Toronto, refusing to take advantage of a life-saving drug for people with diabetes. ‘Insulin is not mine, it belongs to the world’, said co-discoverer Frederick Banting. A century later, three companies share the U.S. insulin market, and the wholesale price of the four most widely used insulins more than tripled between 2007 and 2017.
Insulin can cost an uninsured patient over $450 a month. Even those with insurance may have to spend hundreds of dollars. Several candidates for the Democratic primary for the presidential election in November 2020, including Bernie Sanders, have been denouncing these price hikes for years and have proposed various laws to reduce them. The Vermont senator took people with diabetes to a Canadian pharmacy this summer to buy insulin at a fraction of the US price.
Despite some scandals with Canadian importers shut-downs, the Trump government announced on July 31, 2019 its intention to solve the problem by circumventing it: by going to look outside the American borders for identical drugs, but sold cheaper. The first part of the reform aims to authorize the American states to create already authorized prescription drug importation programs in Canada. Several states are candidates, including some of Canada’s neighbors such as Vermont and New Hampshire.
But this path is weakened by a crucial detail: due to a law of 2003, these programs will not be able to include biological drugs (manufactured starting from a cell or a living organism, often injectable, or which require a refrigeration), and would therefore mainly be limited to tablets that are bought in pharmacies, generally cheaper. Canadian insulin cannot, therefore, be imported into the United States at this stage. Alex Azar from HHS.gov suggests that Congress may one day expand the authorization to all drugs. The second component aims to allow US pharmaceutical companies to import their own drugs marketed in other countries, including insulin. This second path illustrates the absurdity of the American healthcare system. Due to intermediary companies (between manufacturers, pharmacies and medical insurance companies), laboratories are often unable to lower the final prices of their medicines for patients. The Trump government therefore wants to allow pharmaceutical manufacturers who want to import the foreign (but identical!) version of their own drugs, which would be sold under a separate code and at a lower price.
US Bulk Drug Purchases in Canada Are not a Bluff
By signaling that he would allow cheaper drugs to be imported from Canada, Donald Trump has rekindled hope among Americans. The pressure is enormous. Some states are desperate to get Washington’s official green light. Here is the eloquent example of Colorado. Claudia Curry Hill moves with difficulty. She has already lost the use of her left leg. In her Denver home, her smile camouflages her sense of rage. And for her, the most difficult is yet to come. With primary progressive multiple sclerosis, a drug may help limit the progression of the disease, Ocrevus. But she had to give it up quickly. The price of Ocrevus in the United States is $90,000 a year, three times more than in Canada. Giving up on a drug that really helps you because you can’t afford it anymore is cruel.
The story of Claudia Curry Hill from Okstate.edu is not exceptional. Unable to afford prescription drugs is the reality of more than 45 million Americans. In the United States, where prices are the highest in the world, laws prohibit governments from negotiating with pharmaceutical companies. While Canada remains one of the countries with the highest prices for patented drugs, the legislation still allows for a price cap. The word “crisis” keeps coming up in several states. In Colorado, not a day goes by without lawmakers being challenged on the consequences of soaring drug prices. Passed in May, the new law allows the state to develop a bulk import program for prescription drugs from Canada.
It still has to obtain the federal seal. Colorado wanted to put the odds on its side in order to get there. Its strategy is that of small steps, to convince American federal agencies that his plan is safe. Only the importation of certain types of products intended for specific populations are targeted, a little less than twenty categories of drugs in all. Christine Cassiano Hill from Apppharma.com cites two examples: ‘A cardiovascular patient could save up to 30%. And the prison system could save at least three million dollars annually just in treatments against hepatitis C.’ But cancer drugs given by infusion could not be imported from Canada. The same goes for insulin, because it has to be refrigerated. This summer, the Trump administration has strongly hinted that it will allow state-developed pilot projects, but how? It remains unclear. Still, Colorado sees a unique opportunity.
And discussions are going on with the three other states that have passed bulk drug import laws from Canada in the past few months: Florida, Vermont and Maine. In addition, there are 13 states which have bills under consideration. The latest test results are not encouraging for Claudia Curry Hill. Stopping the drug also comes at a price. New spinal cord and brain lesions have appeared. The idea of importing bulk drugs from Canada is not new. Many attempts have failed in the past. But this time, not all experts predict the failure of American efforts. This is now a bipartisan issue, the pressure comes from all the states, the discontent is everywhere. The danger is the 2020 election in the United States.
Legal and Political Vacuum
In the aftermath of the Trump administration’s announcement and the many concerns raised in Canada by the US plan, Prime Minister Trudeau had promised to protect the supply of drugs. Health Canada continues work to ensure that there are enough drugs for Canadians, that we are never caught off guard with access to drugs for Canadians at affordable prices. A month later, the Prime Minister has yet to say when and how he plans to do it. It is hard to ignore the views of the former health minister under Prime Minister Paul Martin. In 2005, he himself introduced legislation to prohibit the mass export of Canadian prescription drugs to the United States.
This would have enabled the federal government to establish a list of drugs that could not be exported in the event of a shortage or the threat of a shortage. However, the bill died on the order paper when the government of Paul Martin was overthrown. Many health experts also believe that the current threat is more serious than at the time. The government should have seen things come and even summoned House members in summer 2019 to legislate.