According to one study, Canadian patients are on average more than 450 days longer than Americans and Europeans, waiting for new drugs that can improve their health and save lives.
The· Research, Of the 218 drugs approved in both Canada and the United States between 2012/13 and 2018/19, an average of 469 days ago in the United States, the Fraser Institute at think tanks announced on May 13. Approval has been given. When compared to Europe during the same period, 205 approved drugs were approved by Europe on average 468 days earlier than Canada.
One of the reasons for the delay is the efficiency of the approval process. Bacchus Barua, Deputy Director of Health Policy Research at Fraser Institute.
“Innovative new drugs can have a significant impact on the health and well-being of people suffering from illness. Unfortunately, Canadians are already considered safe and effective by European Union and US regulators. These benefits are often denied for months, if not years, waiting for the government to approve the drug. ” Bacchus He said in a statement released last Thursday.
Another reason, the study says, is the difference in when the drug was submitted for regulatory approval in the first place.
Investigations into why manufacturers choose to postpone the submission of new drugs to Canada include shrinking markets, weak intellectual property protection, federal drug price regulation, and insurer-implemented reimbursement policies. , And reasons such as “user fees and costs associated with creating submissions for a particular institution.”
One way to improve the situation is to consider replacing Health Canada’s mandatory approval process with an agreement to approve the approval of a new drug by an equivalent international organization such as the United States. Food and Drug Administration (FDA) or European Union European Medicines Agency (EMA) helps to remove duplicate processes.
“Under such an approach, FDA or EMA approval may be considered sufficient for market access in Canada,” the author writes. “If Canada had such agreements with Europe and the United States (accepting approvals from either agency as equivalent), patients would have 223 new drug therapies (224 samples) before a median of 383 (average 742) days. Should have been available. “
Despite such agreement, Canadian patients are to many approved drugs currently not available in Canada that have not been approved by Health Canada or submitted by pharmaceutical companies for marketing approval at all. The author added that they are likely to receive access to.
In addition, this approach can issue safety warnings and maintain Health Canada’s ability to withdraw drugs from the market as needed.
“FDA and EMA approvals may be found to be sufficient to enter the market, but the approval is FDA and EMA approvals and a label indicating that Health Canada did not approve the particular drug. It may also be subject to requirements, “the study states. Is called.
“This gives Canadians and their healthcare providers the opportunity to determine for themselves whether they feel that Health Canada’s approval process provides additional safety or protection from the risks associated with new drugs. “