Caution urged over drug price guidelines
CLINICAL TRIALS
OTTAWA • Pharmaceutical companies and patient groups fear new price-setting guidelines could cut the number of clinical trials taking place in Canada and leave life-saving treatments out of reach.
New final guidelines were expected Thursday from the Patented Medicine Prices Review Board, an arm'slength and quasi- judicial agency that sets the maximum price drug companies can charge for new therapies, but they were delayed until next week.
The new rules are set to come into force in January and will apply to new drugs that are still covered by a patent.
Draft versions of those guidelines have been out since last November and would take a number of steps that could reduce prices. Currently, the board uses a list of comparison countries and sets a maximum Canadian price based on how much the drug costs in foreign markets.
The new guidelines propose using a different group of countries, all similar to Canada, removing two highcost jurisdictions, Switzerland and the U.S.
Pamela Fralick, president of Innovative Medicines Canada, an industry lobby group, said driving prices down like this will mean companies will avoid the Canadian market.
“If implemented as currently drafted, innovative new medicines will not launch in Canada, depriving patients of potentially lifechanging new treatments,” she said in a statement.
Fralick said the industry has been concerned about the rules since they were first revealed and firms are already choosing not to bring their drugs to market here. She pointed out that of 54 drugs approved by the U.S. in 2019, only 15 have been submitted to Health Canada for the same approval.
She said at the very least the new rules should be delayed until the pandemic is over, so pharmaceutical companies don't have to split their focus.
John Adams, chair of the Best Medicines Coalition, a patient group that takes funding from the industry, said the government's move to bring down prices is a good one. He supports the change in comparison countries, but other measures the government is taking are a risk to patients.
The new guidelines also propose a pharmo-economic value be applied to drugs, essentially a measure of how much of an improvement the drug offers over existing therapies. The board could also use the size of the Canadian market to help determine a maximum price.
Adams said the government is attempting several reforms at once and it should be taking it one step at a time. He said some or all of the reforms might reduce prices, but they might also limit access and by applying all the reforms at the same time, it will be impossible to tell which are working.
“The concern is that patients will be hurt as collateral damage, as the government seems to be trying to do too many things at the same time.”
He said he worries about the early signs that drug companies will walk away from Canada because the prices will be set too low.
“I won't say it's a big red flashing light. I will say it's an amber flashing light.”
Trikafta, made by U. S. company Vertex Pharmaceuticals, is a breakthrough treatment for cystic fibrosis. But Vertex has yet to submit the treatment to Health Canada for approval, which means it is not available to patients living here. In the U.S., it costs more than $300,000 per patient per year.
Health Minister Patty Hajdu was asked about the drug in question period last week and said the government has contacted the company to encourage it to bring the drug to Canada.
“We have reached out to the corporation to ask it to apply. We have assured it that we will expedite the review of Trikafta.”
Hajdu has defended the changes the government is set to implement, arguing they will save Canadians billions of dollars.
The changes have received support from Canadians worried about the rising cost of drugs, with more than 2,000 people signing a petition submitted in the House of Commons calling on the government to move ahead with the new rules.
Nigel Rawson, an affiliate scholar with the Canadian Health Policy Institute, said the pricing policy sends the wrong signal to companies thinking about where to launch new drugs. “Why would you perform research and development here for a drug that you were thinking, well, I'm not going to get to a price that is sustainable.”
Rawson said these changes could mean Canada moves down the list of countries where companies launch new medications.
The new regulations have already been the subject of two court challenges. In one case in Toronto, the industry successfully argued the government didn't have the right to demand information on rebates that drug companies give to large buyers.
In a pending Quebec case, several drug firms are arguing setting prices should be under provincial jurisdiction.
Adams said he worries the entire process will get stuck in courts and the losers will be the patients waiting for the treatment.
“Five years from now, we will be waiting for a decision from the Supreme Court of Canada on these questions.”