Health Canada is not protecting health of Canadians
While U.S. Food and Drug Administration banned tainted drugs, Health Canada merely asked drug company Apotex to pull them off the shelf.
Health Minister Rona Ambrose admitted that her department let potentially dangerous medicines be sold to Canadians.
By: Amir Attaran Published on Sat Sep 27 2014
Health Canada is not looking out for you. This month in the House of Commons, Health Minister Rona Ambrose admitted that her department let potentially dangerous medicines be sold to Canadians. Those drugs were made by a Canadian company, Apotex, which according to the Toronto Star, “altered and in some cases destroyed test data that showed their products were tainted or potentially unsafe.”
For that deceit, America’s Food and Drug Administration banned many Apotex products from entering that country. But closer to home, Health Canada only asked — and never demanded — that Apotex pull those drugs off the shelf.
Shamefully, Apotex refused, and Ambrose let the company carry on selling its dodgy drugs to Canadians. She could have persuaded Apotex to co-operate by suspending its licenses to do business, but never did. Only after a serious drubbing in the Toronto Star and in Question Period did Ambrose, Health Canada and Apotex flip-flop and reach an agreement to stop distributing some of the company’s drugs. Journalists, politicians and others basically forced them to behave ethically, where it was not their impulse.
So now might be a good time for Canadians to ask the following question: should we reduce, or nearly abolish, Health Canada’s drug regulatory functions? Could we be safer by trusting in the decisions of larger, better-funded, foreign drug regulators instead of little lame Health Canada?
These questions are not as strange as they seem. The 28 countries of the European Union, many of them quite small, long ago decided that it is expensive, inefficient and sometimes dangerously ineffective for each country to have its own drug regulator. Nowadays, most of them have delegated large parts of their drug regulatory functions to an EU-wide organization, the European Medicines Agency.
This makes sense: by pooling scientific brains and money, the EMA can make better, safer drug regulatory decisions for all Europeans, compared to the alternative of each European country acting alone. The advantages are so compelling that Africa, Asia and South America are now taking their first steps toward regionally harmonizing their drug and medical device regulations.
But not Canada. Here, the Harper government’s asphyxiating control of government scientists and almost childish pride in Canadian sovereignty mean that Health Canada minimally co-operates with America’s FDA just next door. This is dumb: the FDA is more transparent, better resourced and scientifically better equipped than Health Canada will ever be. By standing alone and not tag-teaming with the FDA, the government is taking ignorant risks with Canadians’ lives.
Consider the case of Ranbaxy, a pharmaceutical company from India. Last year, the FDA successfully prosecuted Ranbaxy for manufacturing adulterated drugs and misleading it with false, fictitious and fraudulent drug testing data — crimes for which Ranbaxy paid $500 million (U.S.) in criminal and civil penalties. Fortune Magazine, among other sources, alleges that this fraud was not isolated, but that Ranbaxy managers were aware of data falsification affecting “more than 200 products in more than 40 countries.” No wonder the FDA, after failed inspections, banned several Ranbaxy factories from accessing the United States market.
But not in Canada. Even though former Ranbaxy executives say they are “confident there were problems” with drugs sold here, after the criminal conviction Health Canada refused to ban Ranbaxy’s factories, and instead negotiated with the company to voluntarily pull a few of its medicines off the market for testing; Health Canada won’t say which ones. Worse, Health Canada routinely lets drug importers like Ranbaxy choose who inspects their foreign factories. Private consultants hired by companies, and not arm’s length government inspectors, often do so.
That is the deplorable state of drug regulation in Canada today: rather than enforce the law with vigour as the FDA does, Health Canada negotiates with companies like Ranbaxy that have committed terrible crimes and lets them cherry-pick their inspectors. Ranbaxy medicines banned as unsafe in the United States are on the shelves of Canadian hospitals and pharmacies today.
Our country can to a limited extent fix these problems from within. Bill C-17, now before Parliament, would modestly improve drug safety in Canada if it becomes law. However, our bigger problem is not legal but cultural, namely the indolent, lapdog attitude of ministers like Ambrose and the public servants at Health Canada, who seem to lack any understanding of how governments should regulate. As we learned by the carnage of Lac-Mégantic and the deaths from the listeriosis outbreak, regulation does not mean bargaining or pleading with the industry that you are regulating. It means ordering them, with a big stick in hand.
This is something that Health Canada could learn by riding the coattails of the more aggressive FDA or EMA. And it is why, rather than count on reform from within, we should in part abolish Health Canada and harmonize our drug regulation with those foreign agencies that are more competent than our own government.
Amir Attaran is a Professor in the Faculty of Law and Faculty of Medicine and the Institute of Population Health at the University of Ottawa.