Finally Canada passed a Drug Safety Law, called Vanessa’s Law, following sustained criticism that prescription drug safety was lacking. The Canadian Drug Safety Law gives the Health Minister authority over the national regulatory agency and practices involving the pharmaceutical industry.
Under Vanessa’s Law, the Health Minister of Canada will have the power to recall any drugs that are considered unsafe. Drug makers will be compelled to upgrade their product labeling, clinical trial information will be posted in a public registry, and regulators must disclose decisions about their approvals.
The passage of Vanessa’s Law came after a period of complaints about Canada’s drug industry transparency and the fact that Health Canada failed to oversee properly drug clinical trials. Vanessa’s Law ensures that Canadians will be better informed about their prescribed medications and the Canadian government will be empowered to recall unsafe products. That means that Canadians will be will be better protected as a result of these changes.
However, not everyone is content with the new Canadian Drug Safety Law. The pharmaceutical industry is concerned regarding the law’s provisions requesting the release of confidential business information. On the other side, there are critics of the new law who consider that the Drug Safety Law does not go far enough and it still leaves a number of gaps in drug regulation. The critics also notice that there are portions of the law that make use of the word “may”. Such language indicates when the Canadian health minister might take action but not make it a requirement for the minister to take action. That means that the necessary steps are left to the discretion of the Canadian health minister.
It is also unclear who can request disclosure of confidential business information about a certain drug. As the law stipulates it is understood that the information can only be released to someone whose job is to protect public safety, someone whom the minister seeks advice, or to a government employee. However, it is not clear that this will also apply to researchers who are formulating clinical guidelines, and to those looking for information for court cases. The law may place restrictions on some groups who may have legitimate motives to request such information in order to formulate patient safety guidelines.
Another potential issue is that the new Canadian Drug Safety Law does not contain any provision to release additional clinical trial information to the drugs already existing on the market. That means that even in case that post-market studies are required, it is possible that Canadians will not have access to that information. And, because the drug makers are allowed to design and run post-market trials, this can lead to bias.
Health Canada tried to respond to this criticism, by saying that drug makers will be required to make public the information about their clinical trials and the drug regulation authority will be able to make regulations prescribing the availability of the clinical trial information.
The spokesman of the Health Canada has also explained that the use of the word “may” does not mean the Health Minister can exercise the power arbitrarily but it bound by a duty of care to protect Canadians from the risks related to medical devices and drugs. The Health Minister has to exercise these powers fairly and reasonably, based on evidence.
Related to the concerns about releasing confidential business information, the spokesman of Health Canada specify that this is not information in the public domain, but failed to explain why the disclosure would not undermine the competitive position or economic interest of the owner of this information.
The new Drug Safety Law in Canada is a welcomed improvement of the drug public safety in the country, but as we can see the law is not perfect. The best way to understand drug safety is by consulting a former FDA official. If you have any questions regarding drug safety, you can solicit a no obligation, free of charge consultation from a drug safety expert. Their services reunites a specialized and exclusive group of clinicians and scientists, all of who are former FDA officials, scientists or reviewers; the most qualified and experienced individuals from the pharmaceutical industry and academia.
