Public health shouldn’t be a secondary consideration for regulator
September 13th, 2013 - 3:33pm
It is pretty easy to view drug companies as Dr. Jekyll and Mr. Hyde type entities. For those who are relieved of symptoms or illness by proprietary drugs, they do good and important work. For those who struggle with side effects, receive little or no relief, have adverse reactions - or worse, they can be seen to play fast and loose with people’s health. This is why it is important to have regulatory bodies that act as a buffer to ensure, among other things, that prospective drugs are safe for human use.
This just scratches the surface of the nature of these gatekeepers in the relationship between drug companies and consumers. In Canada the job is performed by Health Canada while their American counterpart is the Food and Drug Administration (FDA).
A common complaint leveled at Health Canada is that they take too long to approve drugs that have been given the green light by the FDA, but how often do you hear about them taking too long to pull prescription items from the market based on the work of the FDA?
That is exactly what is happening with some of the drugs produced by the Indian pharmaceutical company Ranbaxy. They have been under investigation by the FDA for the past 5 years for selling drugs that have gone through false testing procedures, are full of impurities, deteriorate too quickly, repeating lies and false statements, as well as trying to fool inspectors. Three months ago Ranbaxy admitted that allegations of fraud leveled against them were true. It cost them a half billion dollars in fines as well as access to the United States for 30 of the company’s products, but it is business as usual in Canada.
Canadians are left to wonder if Health Canada is merely slow to act or if there is more to consider? Given the way the current government has brought about the deterioration of environmental regulations and safeguards to clear the way for resource projects, it isn’t difficult to question their commitment to an individual’s health when it runs up against the interests of a multi-national drug company.
As fantastic as that may sound, the Harper government has proven that the public interest will take a firm back-seat to market interests as long as they remain in power. That may explain why Health Canada officials have stated that while falsification of data is a serious offense under Canadian law, they have found no basis in terms of health and safety to prohibit the import of Ranbaxy drugs.
Is the process of ensuring the safety of drugs produced offshore beyond the capacity of Health Canada? Experts suggest the problems arise from the need to cut corners coupled with the fact that many drugs are produced far from our shores making it difficult to inspect production facilities. Whatever the reasons, it is disturbing to think that Health Canada’s interests may not flow from an over-arching goal to ensure the well-being of Canadians or that their primary interest may well be the well-being of drug companies.