February 11, 2011 – Depending on your perspective and whom you ask, health Canada is either too slow to approve new drugs to the market or it perilously quick. Many patient groups and the pharmaceutical industry would prefer speedy drug approvals so that patients have earlier access. Other patient groups and drug experts, however, want Health Canada to err on the side of caution and public safety, even if it means slowing down the approval process.
Over the course of three information gathering sessions billed as Technical Discussions on Regulatory Modernization, Health Canada brought together regulators, pharmaceutical representatives, patient and citizen groups, including CARP, scientists, and academics to state their interests, opinions, and concerns on the approval of drugs.
The Technical Discussions were intended to solicit feedback and information on modernizing the federal framework for drugs and medical devices and to find a safe, middle ground between accelerated drug approval and public safety.
Background on Regulatory Modernization
In 2007, Health Canada held workshops to discuss changes to Canada’s regulatory system for drugs. These sessions consisted of interactions between Health Canada’s regulatory staff, industry, health care professionals, patient and consumer groups, provincial/territorial representatives, academic professionals, and other agencies. During these sessions, interested parties had the opportunity to discuss potential changes and hear the points of view of other groups.
The input received during these sessions was used to develop a legislative proposal that was introduced in the House of Commons in April 2008. This proposal, Bill C-51, An Act to amend the Food and Drugs Act, contained many new provisions that were based on several years of research and consultation with stakeholders.
This bill expired when an election was called in October 2008. However, the federal government is proceeding with legislative modernization. The input received during the latest round of technical discussions will be used by Health Canada to update the regulations governing drugs and medical devices, from pre-market authorization to post-market vigilance.
Speed or Safety?
So which way will health Canada lean, now that the information from stakeholders is gathered? That’s a difficult question to answer and not even Health Canada has the answer just yet.
The drug industry, bolstered by a number of patient groups, intently argues that drug regulations should not stand in the way of public access to life saving medicines. Further, they argue, Canada needs to look to Europe and the US in modernizing regulations, as increased harmonization across jurisdictions will not only speed up the approval of new drugs, but may also prove to be a valuable method of obtaining safety information from trials and tests done elsewhere.
Public safety advocates, however, argue that there is little reason to rush drugs to market, especially since some estimates suggest that less than 1% of new drugs released are major therapeutic innovations. Under the circumstances, public safety should be prioritized by modernized regulations.
Safety advocates are especially concerned that Health Canada will shift from a precautionary approach to drug approvals to a risk management approach. Such a shift, they argue, would mean that after initial pre-market tests, drugs would be presumed safe until proven otherwise.