on 17 July, Rwanda
informed the WTO that it intends to import 260,000 packs of TriAvir — a
fixed-dose combination product of Zidovudine, Lamivudine and Nevirapine —
over two years. The drug is to be made in Canada by Apotex, Inc and is
called ApoTriavir by the manufacturer.
Canada’s notification completes the circle. Both notifications were required for the medicine to be exported to Rwanda under an important agreement among WTO members reached on 30 August 2003, which eased the way for countries with public health problems to import cheaper generics made under compulsory licensing elsewhere when they are unable to manufacture the medicines themselves.
The 2003 decision is often called the “paragraph 6 system” because it implements paragraph 6 of the 2001 Doha Declaration on the Trade-Related Aspects of Intellectual Property Rights (TRIPS) Agreement and Public Health.
Canada’s notification comes under paragraph 2(c) of the 30 August 2003 General Council decision, which requires exporting countries to supply relevant information on the compulsory licence to the TRIPS Council, the WTO body comprising all members that is responsible for administering the intellectual property agreement.
The notification informs WTO members that Canada has authorized the medicine to be produced and exported to Rwanda, including, as required, the following:
the conditions attached to the compulsory licence
the details of the medicines to be exported under compulsory licence
the website address where the company licensed to make the generic drug is to posts information on the quantities and the distinguishing features of the product manufactured under the system — this has to be published before shipment
This and future notifications of this kind can be found on a dedicated page for notifications on exports
• compulsory licence: when a government allows someone else to
produce the patented product or process without the consent of the
• generic: copies of a patented drug, or of a drug whose patent has expired (sometimes also related to trademarks)
• notification: a transparency obligation requiring member governments to report trade measures to the relevant WTO body if the measures might have an effect on other members
• TRIPS: trade-related aspects of intellectual property rights, one of the WTO’s agreements
• waiver: a dispensation granted to a WTO member or members, freeing it or them from the obligation to apply certain provisions of WTO agreements
See also: TRIPS and Health fact sheet
More jargon-busting: glossary
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