Good morning. My name is Diana Dowthwaite. I am the director general of the inspectorate part of the Health Products and Food Branch of Health Canada.
I would like to start by providing a brief overview of the role and mandate of the inspectorate. The inspectorate's role is to deliver a national compliance and enforcement program under the Food and Drugs Act, for all products under the Health Products and Food Branch mandate, with the exception of products regulated as foods. This includes pharmaceuticals, veterinary drugs, biologics, natural health products, and medical devices. We deliver these services across the country, with inspectors in B.C., Manitoba, Ontario, Quebec, and Atlantic Canada.
We have four key core functions that help us verify that health products on the Canadian market are legally authorized for sale and are safe. First is our proactive role in compliance promotion with our various inspection programs, under which companies intending to conduct an activity such as manufacturing, importation, packaging, labelling, wholesaling, testing, and distribution of drugs in Canada are required to pass an inspection before they are licensed to operate. Companies are inspected on a regular cycle that can vary from two to four years, depending on their activities. These inspections are linked to our licensing requirements.
Second is our reactive role through compliance, verification, and investigation, whereby we actively look at mitigating risk, based on information from sources such as complaints from consumers, industry, or other regulatory authorities. This is where the majority of our work takes place with respect to counterfeit health products.
Third is our laboratory capacity with our two ISO-certified labs in Ontario and Quebec, which provide lab analysis, a necessary part of compliance investigations. This is especially relevant in counterfeit investigations.
Last is our establishment licensing program whereby we issue a drug or a medical device establishment licence for the licensing activities l have just mentioned.
To help in carrying out our mandate and to help reduce the potential for counterfeit health products to enter the supply chain, we work with other enforcement and regulatory organizations, such as the RCMP and CBSA and also provincial colleges of pharmacy. We also work with our international partners through MOUs and treaties and other international forums to increase our capacity for detection and identification of counterfeit health products.
Counterfeit products pose a health and safety risk because they may contain the incorrect dose, the wrong ingredients, dangerous additives, or no active ingredients at all, which could result in potentially serious health risks to patients.
These products represent an emerging trend in the supply chain of developing countries and, yes, even in Canada. In the summer of 2005, the RCMP laid charges against two separate pharmacies for selling counterfeit pharmaceuticals at the retail pharmacy level. In both of these cases, as counterfeiting is a criminal activity, the inspectorate worked with the RCMP and the relevant college of pharmacy to provide investigative and laboratory expertise as well as advice pertaining to the Food and Drugs Act.
Incidents regarding counterfeit health products are very complex, often involving numerous domestic and international regulatory agencies and policing bodies. In Canada, the sale of a counterfeit health product is a violation of the Food and Drugs Act, as the products fall within the scope of unapproved products. The sale of these products may also violate other acts, such as the Copyright Act and the Criminal Code, and therefore the investigation of these can be referred to other regulatory authorities.
It is clearly impossible, as you've heard my colleagues say, for any one entity to combat counterfeiting alone. It requires a multi-partner, multinational approach.
The inspectorate is currently developing an anti-counterfeiting strategy to help reduce the opportunities for counterfeit health products to enter the Canadian supply chain; to increase our capacity for detection and identification; to increase our awareness of the associated risks; and to reduce the incentives that facilitate the counterfeiting of health products.
As is the case with the RCMP, we have many challenges ahead of us. For example, our current regulatory oversight mechanisms are outdated. The act is over 50 years old, and there are no prohibitions in the Food and Drugs Act or regulations that pertain to counterfeiting directly.
As well, within the act the penalties are more health-risk-oriented and less penalty-oriented and may not provide a sufficient disincentive to fraudulent activities such as counterfeiting of health products. Prosecutions, as we can all appreciate, are very resource-intensive, and we are not well equipped at this point to identify fraud; this is where the RCMP provides its assistance. We are working to modernize our regulatory framework to more effectively address these types of violations.
We are currently not experienced and equipped in investigating intent. Our traditional approach is focused on mitigating risk to health where it is the regulated parties' responsibility to take appropriate action to comply with legislative and regulatory requirements. Within the paradigm of counterfeiting that we are seeing today, those responsible not only have deceitful intentions, but complete disregard for the regulatory system.
We are now operating within an environment of rapidly expanding global trade, where we see complex drug supply chains, increased sales via the Internet of cheaper and possibly counterfeited health products, and a higher volume of imports of health products, and their deceptive characteristics make it difficult to assess the validity of these products.
The established regulatory oversight mechanisms alone are insufficient to appropriately address the threats posed by such products. Protecting the health and safety of Canadians is a responsibility that is shared by the federal, provincial, and territorial governments, as well as health care professionals, industry, and consumers. Our anti-counterfeiting strategy will work to mitigate the health and safety risk posed to Canadians by counterfeit health products. It will focus on new legislative authorities, an education plan for consumers, and most importantly, building stronger partnerships with regulatory authorities and with industry.