Good afternoon, Mr. Chairman and committee members. My name is Diana Dowthwaite. I am director general of the inspectorate with the health products and food branch of Health Canada.
One of the ways in which Health Canada fulfills its mandate is by playing the role of regulator. This is a stewardship role that involves both protecting Canadians and facilitating the provision of products vital to the health and well-being of citizens. The department regulates and approves the use of thousands of such products, including pesticides, consumer goods, and toxic substances. We deliver a range of programs and services in environmental health and protection and have responsibilities in the areas of substance abuse, tobacco policy, workplace health and safety, and safe use of consumer products. Each of these areas is regulated by a regulatory framework or by a combination of regulatory frameworks, all designed to protect the health and safety of Canadians by facilitating access to quality products.
However, I'm here to speak to the connection of IPR and one specific set of products only, namely, health products, which fall under the mandate of the Health Products and Food Branch. I am going to start by providing a brief overview of the role and the mandate of the inspectorate, the group that I work in.
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 the Atlantic provinces.
We have four 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. Our various inspection programs require companies intending to conduct activities such as manufacturing, importation, packaging, labelling, wholesaling, testing, and distribution of drugs in Canada 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, and these inspections are linked to licensing requirements.
Second is the reactive role we play with compliance verification and investigation. We actively look at mitigating risks, based on information from sources such as complaints from consumers, industry, or other regulatory authorities. It is in this area that the majority of our work takes place with counterfeit health products.
Third is our laboratory capacity. Our two ISO-certified labs in Ontario and Quebec provide lab analysis, which is a necessary part of compliance investigations and is especially relevant in counterfeit investigations.
Last is our fourth core activity, which is our establishment licensing program. In this program we issue a drug or a medical device establishment licence for the licensing activities I've 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 CBSA, the RCMP, and the 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 an 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 are 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 inspector worked with the RCMP and the relevant college of pharmacy to provide investigative and laboratory expertise and advice pertaining to the Food and Drugs Act.
Incidences regarding counterfeit health products are very complex, often involving numerous domestic and international regulatory agencies and policing bodies. In Canada, the sale of counterfeit health products is a violation of the Food and Drugs Act and regulations, as these 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 as such can be referred to other regulatory authorities.
It is clearly impossible for any one entity to combat counterfeiting alone; a multi-partner, multinational approach is essential.
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.
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 related more to health risk and are less oriented toward punishment, so they may not provide a sufficient disincentive to fraudulent activities such as counterfeiting. Prosecutions, as we're all aware, are very resource-intensive, and we are not well equipped at this point to identify fraud; it is in this area that the RCMP helps us with their expertise. We are working to modernize our regulatory framework to more effectively address these types of violations.
We are currently not experienced or equipped in investigating intent. Our traditional approach is focused on mitigating risks to health, so that it is a regulated party's responsibility to take appropriate action to comply with legislative and regulatory requirements. Within this new paradigm of counterfeiting, those responsible not only have deceitful intentions but also complete disregard for the regulatory system.
We are now operating within an environment of rapidly changing, expanding global trade. We see complex drug supply chains, increased sales via the Internet of cheaper and possibly counterfeited health products, and a higher volume of imported health products. 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 shared between federal and provincial and territorial authorities, health care professionals, industry, and consumers. Our anti-counterfeiting strategy will work to mitigate the health and safety risks posed to Canadians by these 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.
Thank you.