Toronto, October 17, 2016 – Greater regulatory convergence is needed to ensure a consistent supply of safe, effective and high-quality generic medicines in Canada, according to a new study prepared by Deloitte LLP and commissioned by the Canada Generic Pharmaceutical Association (CGPA).
The study released today documents the challenges faced by the generic pharmaceutical industry with the current regulatory environment as well as the impact of these challenges on patients and payers, and seeks to identify solutions. The study calls on CGPA and its members to work more closely with Health Canada and Canada’s provinces and territories to implement solutions that will realize the benefits of the globalization of supply chains while maintaining the highest levels of patient safety and product quality.
“Canada represents less than two percent of the global generic pharmaceutical market yet the barriers and costs to market entry are high,” said Jim Keon, President of CGPA. “Over the past ten years, prices of generic prescription medicines in Canada have been significantly reduced. As prices continue to fall, we need to work with regulators to ensure that new, cost-saving generic drugs continue to be introduced into the Canadian market.”
Improved regulatory convergence between Health Canada and regulatory bodies, such as the United States Food and Drug Administration (FDA) and the European Medicines Agency (EMA), can help generic pharmaceutical manufacturers leverage the global supply chain. This ultimately helps patients, governments and payers as well by increasing the number of medicines entering the Canadian market, providing timelier access, and reducing costs. It will also increase the ability to divert product from one market to another to minimize the potential for drug shortages.
The report also notes that some Canadian provinces continue to require additional data and/or clinical trials even after the drug has been reviewed and authorized for sale by Health Canada, which increases the cost of introducing a generic drug to market, delaying patient access and savings to taxpayers.
Copies of Ensuring a Consistent Supply of Safe, Effective and High Quality Generic Medicines for Canadians are available at www.canadiangenerics.ca.