Thank you, Rob.
I'm on to slide 5 now. I'll just back up for a second to say that Canada's patent system rewards the extensive investment that's needed to develop new, innovative products, including medicines, by giving patent holders exclusive rights to sell the results of their research for a number of years. In Canada, it's 20 years. When the patent expires, of course, others are free to sell the product, as when we see generic drug manufacturers selling copies of formerly patented medicines.
The access to medicines regime is an exception to our patent system. It allows the Canadian government to authorize someone other than the patent holder, whose property the patent is, to manufacture a patented drug or a medical service for export to a list of particularly needy countries. In recognition of the tremendous investment that's needed to develop these products, and because we want to continue to encourage companies to develop innovative new products, and medicines in particular, Canada's access to medicines regime, CAMR, was designed in a specific way to clearly define its limits, essentially.
While the process for applying for a special authorization under CAMR is actually pretty straightforward—and if the committee is interested, I could share the forms that are required, because when you see them they're actually quite straightforward—CAMR does contain some important disclosure provisions, which were designed first of all to promote transparency and prevent abuse, including the diversion of products back to Canada or to other markets where they might not actually be needed for humanitarian reasons, and, as I said, to ensure that the drugs manufactured are actually used for humanitarian and public health reasons and not for commercial purposes. Also, it's to allow the government or the Federal Court to cancel a licence if, for example, it's abused, is not used in good faith, or is used for commercial reasons. It's important to know that the regime relies on patent holders and not the government to police the use of products licensed under CAMR.
What Bill C-393 proposes to do is remove some of the important anti-diversion and transparency measures that make the regime enforceable. For example, it reduces the information that an applicant must disclose before it gets government approval—basic things such as the requirement to identify the patents involved, the name of the patent holder, the quantity shipped, where it's being shipped to; it would make the authorizations unlimited in duration and quantity; it would remove requirements to notify the patent holder when the medicine is being shipped, how much is being shipped, where it's being shipped to, and who will be handling it in transit as well; it proposes to remove requirements that licensed products have special markings, colouring, and labelling, to make them distinguishable from the patented versions available in Canada. It would significantly also narrow the ability of the government to terminate an authorization, and it eliminates the ability of a patent holder to challenge the shipment of goods, if they're for commercial purposes, in court.
What this means is that anyone could apply to the government for a licence to sell unlimited quantities of products outside Canada, and the government would be required to issue a licence on the basis of not a lot of information and without a mechanism at the back end to make sure that products are actually being shipped for commercial reasons, or to the country they're intended for.
Research and development-focused pharmaceutical companies have global reach, they have global perspective, they have flexibility about where they invest their R and D dollars, and they naturally favour jurisdictions that provide strong and predictable IP regimes. We're concerned that reducing the safeguards provided in CAMR will result in pharmaceutical companies' hesitating to invest in Canada for lack of certainty about the protection of their investments. If they believe the patented products they sell in Canada could also be sold in an unlimited way to other countries, including perhaps being diverted to relatively well-off countries like the ones I mentioned earlier, such as Mexico or Poland or Hungary, they might hesitate to invest the time, money, and resources to bring new and innovative products to Canada.
Another key concern with Bill C-393 is that it introduces a double standard: it would no longer require—it makes optional—that drugs manufactured and exported under the regime pass the Canadian health and safety review at Health Canada.
Many of these developing countries do not have the infrastructure in place to make sure that drugs they are purchasing are safe and effective. The Health Canada review process under CAMR makes sure that they receive the same level of protection as is provided to Canadians.
I'll just turn for a moment to Brigitte, who can expand a little on that point.
We're really now just getting to the end of slide 5, and on to slide 6 in a second.