Progressive drug licensing: an opportunity to achieve transparency and accountability?

摘要

Health Canada's Progressive Licensing Framework, as described in this issue by Neil Yeates, suggests that the present drug regulation system needs improvement. The most substantive change in the new framework is that Health Canada will take a more active role after a drug reaches the market. In addition, Health Canada's decision-making will become more evidence-based, accountable, efficient and transparent, and there will be an increased focus on patients and drug safety. All are important and highly laudable goals; however, one of the less explicit expectations of the framework is that new drugs will reach the market more quickly. Unfortunately, little information is provided about how drug approvals would be granted more rapidly, and I fervently disagree with any attempt to change the process with faster drug approval as an objective. Although earlier release of new drugs would be welcomed by the pharmaceutical industry, Mr. Yeates also implied that this will not compromise safety, because a new and enhanced postmarket surveillance system will identify problems quickly and effectively. This is speculative and is not supported by evidence or by Health Canada's track record.