Health Canada rubbishes Cassels comments through IPT
Last week, University of Victoria health regulation researcher Alan Cassels launched a scathing review of Canada’s medicine supply chain, questioning the validity of Health Canada’s current screening process.
In his article – published in the Canadian Medical Association Journal (CMAJ) – he also claimed the authority does not release enough public information about plant inspections, and suggested it is covering up its failures.
Now, in a reply through in-PharmaTechnologist.com, the regulator said Cassels is missing several “important facts” and that he must “better understand Health Canada's approach of assessing compliance with Canadian good manufacturing practice (GMP) standards.”
It said: “Any foreign site that makes a drug product sold in Canada has to meet Canadian standards of good manufacturing practice. Health Canada verifies that these standards are being met in a number of ways, including its own inspection of foreign sites and information provided from mutually recognised inspections conducted by other countries.”
The authority also contradicted Cassels’ claims that three-quarters of medical imports come from countries which do not have any manufacturing standards agreements with Canada. It said that in reality almost 80 per cent of drug products imported into Canada come from countries with a mutual recognition agreements for inspections, or from the US where standards are already on a par with its own.
Furthermore the health body said although inspectors may not always travel to supplier’s production plants, compliance with Canadian standards may be “ascertained” through inspection reports from another recognised regulatory authority.
“The source of the inspection information is from a recognized regulatory authority or trusted regulator and the same standards used in a domestic inspection are used to evaluate the paper documents,” the regulator told us.
“A paper assessment of a foreign site is considered equivalent to and is in place of Health Canada physically conducting an inspection of the facility (…) If the GMP evidence provided to Health Canada for a foreign site is deemed unacceptable, the importation of drug products from that site is not authorised.”
“Why is everything so secret?”
It seems however that Health Canada agrees – in part – with one thing Cassels questions; “Why is everything so secret?"
In his article, titled ‘Most of our prescription drugs are manufactured overseas — but are they safe?’, Cassels said the regulator does not reveal what it inspects, what it finds, what remedies it will make or what effect “its few inspections” have.
Although the authority did say some of the information is already available, it told us it recognises the need to share more about its activities.
“Health Canada is taking steps to share more information with Canadians about how we regulate drugs and medical devices and protect them from unsafe products,” it said.
“This builds on information already available, including a list of establishment licences that allows the public to confirm whether a company has a valid licence, where the sites are located, any regulatory activity that has been authorised, the date of the last inspection, and whether there are applicable terms and conditions on an establishment licence.”
