May 02, 2012
Canada has announced a regulatory change which will speed patient access to new over-the-counter (OTC) medicines and save taxpayers money.
The government is getting rid of Schedule F of Health Canada’s Food and Drug Regulations, to which prescription drugs are currently required to be formally added through a regulatory amendment. Another amendment is required to remove a drug from Schedule F, a process which can take 14-20 months to complete, long after Health Canada has determined that it is safe to move a prescription drug to OTC status.
Eliminating Schedule F will cut red tape without compromising safety, says Health Canada, pointing out that drug safety will continue to be confirmed through a rigorous process of scientific review before a drug can be approved for sale and before a drug can be sold OTC.
Health Minister Leona Aglukkag says the change is being made through Canada’s Economic Plan 2012 as a result of issues raised during the Red Tape Reduction Commission. “Companies and consumers will no longer be required to wait for months before a prescription drug can become OTC. With this move, customers will soon benefit from quicker access to safe non-prescription drugs,” she said.
Moreover, taxpayers will no longer have to cover the costs of outdated regulatory processes, the Minister noted. “Health Canada will replace the current inefficient process with a faster and transparent posting of each new prescription drug on our website,” she said.
Major companies in the sector have supported the move. “Providing consumers with more OTC healthcare alternatives is a great way to promote the importance of self-care within our system and contribute to the viability of our health care system,” said Bruno Mader, general manager at Merck Consumer Care.
“We applaud all measures that will make our health care system more efficient without compromising the safety of consumers,” he added.
McNeil Consumer Healthcare also said it welcomed the government’s recognition of the importance of self-care to Canadians, and the fact that rigorous scientific review will continue to be required prior to the approval of all prescription to non-prescription medicine switches.
“We support this rigorous process and are pleased that it will continue as an important step in ensuring the availability and safety of self-care products,” said Gerry Wright, the company’s senior director of regulatory and medical affairs.
– A new report forecasts that the global OTC market will grow at an average annual rate of 4.6% during 2011-2015, rising from a value of $104 billion in 2010 to $124.8 billion by 2015. While the US and western Europe jointly account for nearly 50% of the market at present, and Japan for 11%, emerging regions are set to drive future growth as OTCs gain popularity worldwide, says the study, from GBI Research.