Health Canada Deficient in Ensuring the Safety of Prescription Medications

Approved...but safe?The recent report from the Auditor General just reinforces the knowledge that Health Canada is seriously deficient in its ability to ensure the safety of prescription medications.

The problems start even before drugs are marketed. Although Health Canada has developed criteria to decide which clinical trials it should monitor it doesn’t collect the data to know what trials fit those criteria. It should be monitoring about 80 trials per year but barely does half that number because it doesn’t have the resources.

When Health Canada declines to approve a new drug it doesn’t bother to let Canadian patients and their doctors know about that decision. If the drug is similar to products already on the market then how safe are the ones already being used? Many drugs are used for unapproved indications. If the application was to get formal approval for use for that indication and the evidence showed that the drug was ineffective or unsafe then doctors may continue to prescribe and patients take the drug without knowing that crucial information.

In the face of these and other criticisms from the Auditor General, Health Canada has agreed with all of the findings in the report and promised to make the appropriate changes. If only it were so. None of these problems are new and Health Canada has been told about them many times before including by its own Science Advisory Board back in 2000 and by the House of Commons Standing Committee on Health in 2004. Each time Health Canada promises to reform its house and each time nothing substantial happens.

What’s going on here? It’s not as if Health Canada doesn’t have models for reform. While other regulatory agencies have serious problems some have taken steps that Health Canada seems to be deliberately avoiding. The European Medicines Agency has given out information about drugs that it refuses to approve since 2005. The United States Food and Drug Administration releases redacted versions of the reports that its reviewers generate about drug applications. Health Canada regards this information as commercially confidential and will only give it out if the relevant company agrees.

The Auditor General found that Health Canada systematically does not meet its own benchmarks for completing safety assessments. For example, five medium priority assessments took more than two years to complete and one took more than three years. On other safety issues Health Canada has explicitly declined to develop timelines lamely claiming that “development of quantitative service standards for post-market surveillance activities or compliance and enforcement activities is difficult given the unpredictability and volatility of the activities involved.” There is no such reticence about having timelines for how long drugs should be in the review process – 300 working days for drugs with a standard approval and 180 days for those with a priority approval.

Up until now these time frames have been aspirational but with the passage of the User Fees Act failure to meet these deadlines will have serious financial implications for Health Canada if service standards (completion of reviews of new drug applications within the targeted time) are not met. If the actual performance in a given fiscal year is more than 110% of the target for a particular fee category (different types of approval applications are subject to different fees), penalties apply for the amount in excess. Fees are then to be reduced for the next reporting year by a percentage equivalent to the performance not achieved, up to a maximum of 50%; so if approvals are 20% overtime fees will drop by 20%. Faced with the prospect of penalties it is possible that Health Canada might follow the pattern set by the FDA and rush to approve new drugs that are approaching the deadline in order to avoid incurring a financial loss in the next year. The American experience is that if the deadline is imminent the FDA does a less thorough job of reviewing drugs in order to avoid crossing the deadline and potentially jeopardizing its revenue from drug companies.

It might be reasonable to speed drugs to market, despite concerns about safety, if these drugs represented major therapeutic advances. But even a generous reading of the evidence about new drugs comes to the conclusion that only about 1 in 10 offer any significant benefit compared to older medications. The benefit of most new drugs is mainly to the coffers of the companies that make them.

Rushing new drugs to market already seems dangerous. Once the drugs that Health Canada approves through its priority review process are available, over the course of about 17 years almost half of them will be the subject of a new safety warning or have to be withdrawn entirely because of safety issues.

The mentality within Health Canada seems to be driven by the federal government’s (both the previous Liberal and current Conservative) philosophy of Smart Regulation best summed up in one of its documents as regulating “in a way that enhances the climate for investment and trust in the markets” and “accelerate reforms in key areas to promote health and sustainability, to contribute to innovation and economic growth, and to reduce the administrative burden on business.” Business 1, drug safety and consumers 0.

About the Contributor

Joel Lexchin saves lives in an emergency department in Toronto and tries to teach health policy at York University.