Shortening the regulatory timeline will benefit patients and the economy
Less than 20 per cent of new medicines launched globally are available to Canadians served by public drug plans. istock.com
Despite ongoing challenges that have been made worse by the pandemic, Canadians have many reasons to be proud of our health systems. Our hospitals are among the best in the world. Our doctors, nurses, surgeons and specialists are dedicated professionals who consistently deliver the highest standards of care. Our universities produce ground-breaking research that supports and improves lives every day.
But our system is far from perfect. Many Canadians would be shocked to know that potentially life-saving new medicines are not always available or accessible to the patients who need them most. In fact, less than 20 per cent of new medicines launched globally are available to Canadians served by public drug plans. Of those that are available, Canadians are waiting at least twice as long as patients in countries like the United States, Germany and Japan.
“Not only are many new medicines unavailable to Canadians, but, when they are launched in Canada, it takes more than two years on average before Canadians are able to access them through public drug plans. Canadian patients expect and deserve better.”
“When you boil it down, we have an availability and an accessibility problem in Canada, and it is hurting patients,” said Pamela Fralick, president of Innovative Medicines Canada (IMC), the organization that represents the country’s innovative pharmaceutical industry. “Not only are many new medicines unavailable to Canadians, but, when they are launched in Canada, it takes more than two years on average before Canadians are able to access them through public drug plans. Canadian patients expect and deserve better.”
The challenges are due to several factors. These include the duplicative regulatory and approvals processes drug manufacturers go through at the federal and provincial levels, which contribute to delays in the time it takes new medications to reach patients. Of particular concern is the role of the Patented Medicine Prices Review Board (PMPRB), which exists to ensure that the prices of patented medicines are not excessive. Speaking on behalf of the industry, Ms. Fralick believes that the PMPRB’s overriding focus on price control, with inadequate attention paid to the value of innovative new medicines to patients, their families and friends, as well as to the broader Canadian economy, is a major part of the problem.
“The complex, often unpredictable nature of our regulatory regime, coupled with the PMPRB’s approach of driving prices down at any cost, can be a deterrent to drug companies launching new medicines in Canada,” said Ms. Fralick. “It also deters them from conducting clinical trials and investing here.
“If a company is going to conduct clinical trials in Canada, it wants to know that once the trial has finished, participating patients will have access to that medicine via drug plans. But if a manufacturer doesn’t believe it can get a fair price for its medicine, not only will they be reluctant to conduct clinical trials in Canada, but they may simply focus on making it available elsewhere,” Ms. Fralick adds.
For drug manufacturers, these are critical business decisions. A new drug can take up to $2.6-billion and more than a decade to develop and then deliver to patients. And that assumes that it passes clinical trials. Of the 5,000 to 10,000 compounds that are screened for their potential, only five ultimately make it to the clinical trials phase.
The impact on patients and on the economy is also significant. Earlier this year, a Conference Board of Canada report looked at five different cancers and found that, if Canadians living with these cancers had been able to access innovative new treatments, not only would they have lived longer lives, but there would have been a $5.9-billion in potential economic value to the Canadian economy over the last decade.
While IMC believes the existing system is not serving the best interests of Canadian patients, the COVID-19 pandemic showed us what is possible when all parties work together in the interest of patients.
“During the pandemic, new policies were put in place to expedite vaccine approvals, without compromising patient safety. No corners were cut, but we did cut time to access, and Health Canada is doing a good job of creating more permanent policies for some of those steps,” said Ms. Fralick. “We need to apply those lessons learned and work together to reduce the time it takes for new drugs to reach Canadian patients.
“The urgency of the situation opened up opportunities for communication, collaboration and partnerships between our industry, academia, governments and patients,” said Ms. Fralick. “There’s a better understanding that things can be done to balance the equation. It’s not going to happen overnight, but we’ve seen that there is a better way.”
By the numbers
#1 Lung cancer is the most commonly diagnosed cancer in Canada
25% Percentage of all cancer deaths caused by lung cancer
1 in 5 Number of Canadians who will develop lung cancer on their lifetime
22% Lung cancer survival rate compared to 64% for all other cancers combined
To view this report on The Globe's website, visit globeandmail.com
To view the full report as it appeared in The Globe's print edition: Medical Innovation