The World Trade Organization (the “WTO”) obliges WTO countries, such as Canada, to help developing countries acquire affordable generic medicines in order to combat diseases epidemic diseases. Canada has recently made some changes to its Access to Medicines Regime (“CAMR”).
Under CAMR introduced in 2004, the Canadian government can issue compulsory licenses for the production of generic versions of patented drugs and medical devices, for export to developing countries that do not have their own drug production facilities and cannot afford to purchase patented medicines.
Unfortunately since the CAMR’s inception it has been used only in relation to a single AIDS drug shipment and this lack of use has been blamed on the difficult procedural requirements placed on both the developing countries and generic manufactures.
Changes to the legislation have been proposed which aim to streamline the CAMR. With the current regime, approvals are required for each shipment and a generic pharmaceutical manufacturer currently has to file a licence application for every drug, for every amount of drug produced, and for every country that it wants to export to.
A “one-licence solution” is proposed. This would enable generic manufacturers to obtain a single open-ended compulsory licence that authorizes the export of any pharmaceutical product patented in Canada to any eligible country. This means that generic manufacturers would not need to carry out separate negotiations with the drug patent-holders for each order and country.
Other amendments are proposed in order to simplify the process and to meet the needs of developing countries, including the following:
- Generic manufacturers would no be required to certify that it sought a voluntary licence without success and the notice requirements to the patentee will be simplified;
- A clear definition for “pharmaceutical product” and “patented product” will be included to avoid any misinterpretation or potential litigation by a patentee.
- NGOs will be able to purchase the drugs directly;
- Health Canada approval routes for generic manufacturers will be modified.
- The additional requirements for non-WTO developing countries to become eligible to import Canadian-made generics will be eliminated.
Generic manufacturers will still be responsible for paying applicable royalty rates to the patentees following receipt of the licence and will still be required to establish a web site with details of CAMR exports in order to preclude re-exportation of the product.
Comment - The Canadian pharmaceutical industry is obviously concerned that intellectual property rights on patented drugs will be seriously curtailed with a greater risk of diversion of generic medication to other markets. In addition as the licence will be perpetual it is said not to be WTO- and TRIPS-compliant.