We all want to be sure that when we take medications, they have been manufactured under what are commonly known as Good Manufacturing Practices (GMP). The primary responsibility for ensuring that this is the case falls to Health Canada. To do this, Health Canada has long had a system for the inspection of drug manufacturing facilities; one that was co-developed with the cooperation of the pharmaceutical industry. As of fiscal 2023-24, drug company fees accounted for 73 per cent of the $43 million that was spent on inspecting drug manufacturing plants.

There haven’t been any serious manufacturing problems recently, but they have occurred in the relatively recent past. The U.S. Food and Drug Administration (FDA) inspects foreign plants, including those in Canada, that make drugs for the American market. According to the Toronto Star, FDA inspections found serious manufacturing violations in 40 Canadian plants between 2008 and 2014.

Apotex, the largest Canadian-based pharmaceutical company, was the subject of numerous FDA inspections. At its Brantford plant in 2013, the FDA found unacceptable levels of contamination. Apotex started, and then shelved, an internal review into the problem but, in September 2014, made multiple batches of drug products using the same equipment cleaning methods that had earlier failed the cleaning validation.

Like other aspects of drug operations, plant inspections have been compromised by a lack of resources. In a 2006 report from the Auditor General, program managers at Health Canada reported that they did not believe that the agency was allocating sufficient resources for the inspection of manufacturing facilities.

These were problems from a decade or longer ago. Are there similar problems today? The short answer is that we don’t really know. The last publicly available report about the results of Health Canada’s inspection program covered the period 2006 to 2011.

The document broke down the findings into gross categories, such as the number of inspections performed, the percentage of inspections where various problems were found, and the most common problems. There was no information about any specific inspection; no comment about what actions, if any, were taken to correct the problems; and nothing about the individual products involved.

Those inspection reports seem to have been replaced by a combination of Health Canada’s Inspection Tracker and Drug & Health Product Inspections websites that post information about  individual manufacturing inspection reports. But, once again, the information disclosed is extremely limited.

For example, in the Inspection Tracker, under the column headed “Status of the Issue”, there are vague statements, such as “Continuing to review evidence submitted”. If a “non-compliant” rating is issued, there is nothing to indicate what measures the company needed to undertake to become compliant. If we want to know the primary reason for action, all we are told is that it was the result of “General GMP observations”.

The Drug & Health Product Inspections gives the dates of the start and end of the inspections and what, if any, deficiencies were found but, again, it doesn’t give any information about what corrective measures were taken or how serious the deficiencies were.

There are three risk levels that are documented during inspections: critical ones that involve fraud, misrepresentation or falsification of processes, products or data; major ones that mean that a drug may not consistently meet its marketing authorization; and other ones that are a departure from good manufacturing practices. How many risks fall into each of these categories is not disclosed on the Inspection Tracker website.

This practice of only releasing minimal information is not new. Back in 2014, GlaxoSmithKline had quality control problems at its flu vaccine manufacturing plant in Ste. Foy, Quebec. A few years earlier, Health Canada had inspected the plant, but it refused to release a copy of that inspection report to the Toronto Star. According to the agency, there were no “critical risks” but there were problems with contamination levels.

Health Canada says that the frequency of its inspections to assess GMP compliance is based on the inherent risk posed by the nature of the activities performed, and products being handled.

More frequent inspections may occur when risks have been identified. Health Canada is supposed to conduct inspections every two to four years, but there is no documentation about whether that standard is being met or what “more frequent” means.

The risk-based approach to inspections was implemented in 2016. Health Canada does not tell the public how it calculates risk but, in response to an Access to Information request that I filed, it says that, unlike the Canadian Food Inspection Agency, it does not use an algorithm to calculate risk.

For almost 40 years, I worked as an emergency department doctor and prescribed drugs multiple times each time I was on shift. I’m also old enough that I need a number of prescription drugs.

I like to believe that the people that I prescribed to were not harmed by a possibly inadequate Health Canada inspection regime and that I’m going to be OK when I take the drugs that have been prescribed for me.

The first step in making the public feel comfortable that drugs are being made under safe conditions is for Health Canada to explain how it calculates risk when it comes to drug plant inspections. Second, is to make sure that the information that gets released about inspections truly lets the public know what’s going on. And finally, we need to know how quickly any serious problems that are identified are being corrected.