Editor: Bill C-393 has been lauded by Access to Medicines advocates, but nobody has given a simple statement about what it actually changes. We wrote this article to address that issue.
Bill C-393 passed in Canada’s House of Commons on March 9, and now awaits the Senate vote. The bill makes significant reforms to Canada’s Access to Medicines Regime, or CAMR. CAMR allows the Canadian government to issue compulsory licenses on domestic brand-name medicines so that cheaper generics can be exported to developing countries. Unfortunately, the current application process is embedded with bureaucratic complications, and CAMR has been left with the reputation of being virtually “unusable.” Indeed, many of the key current requirements of CAMR are more restrictive than the expressed guidelines of the WTO and TRIPS.
Bill C-393, called the “one-license solution” by its advocates, eliminates many of these extra restrictions.
Generic pharmaceuticals who wish to use CAMR can now apply directly to the government for a compulsory license — they will no longer be forced to first engage in negotiations with private companies for voluntary licenses every time they want to export. Generic pharmaceuticals will also no longer be required to preemptively identify and then wait for a confirmation from the one specific importing country before the manufacturing can even begin. Generic pharmaceuticals will also be able name an “expected quantity” of medicine flexible to future changes according to need, rather than having to identify an exact “maximum quantity” of medicine before manufacturing. Generics will also be able to export to more than one country once granted the compulsory license, rather than go through the entire application process again with every new country, as current CAMR rules dictate. The licenses will no longer be limited to a lifespan of 2 years as it is now, but “limited to the purpose for which it was authorized,” which again, allow for more flexibility. Additionally, compulsory licenses can now be granted for any “drug” as defined under the Food and Drugs Act, rather than the limited list of products set out by the original CAMR.
Essentially, the bill strips the current CAMR restrictions down to only what is delineated in WTO and TRIPS, and the entire CAMR application procedure down to a simple compulsory license. Advocates of the bill hope these simplifications will result in CAMR being more efficient and more widely used, providing more access to medicines to more people in developing nations. Supporters of the bill also point out that the revisions will increase competition over medicine pricing in developing countries as the flexibility in quantity and distribution will allow generic pharmaceuticals to take advantage of economies of scale.
At present, in its current form, CAMR has been used only once in its six years of existence: Canada’s largest generic pharmaceutical company, Apotex, shipped a single shipment of HIV/AIDS medicine to Rwanda enough for 21,000 people. The process took over two years, and the Apotex president, Jack Kay, was quoted saying the company would be “reluctant to go through this process again if changes are not made to streamline CAMR.”