CANADIAN WTO NOTIFICATION CLEARS PATH FOR RWANDA TO IMPORT GENERIC HIV/AIDS DRUG

Rwanda is on the verge of becoming the first country to use WTO procedures designed to allow poor nations to import cut-price medicines that they are unable to manufacture, after Canada last week formally notified the global trade body that it had authorised the production of generic copies of a patented HIV/AIDS drug for export to the African state.

The notification (IP/N/10/CAN/1), submitted on 4 October, noted that Canadian patent authorities had issued a compulsory licence to Apotex, a Toronto-based generics manufacturer, to legally make 15.6 million tablets of 'Apo-TriAvir', a combination of three patented medicines, for export to Rwanda over the next two years (see BRIDGES Weekly, 26 September 2007). It also provided an address for Apotex's new website describing the product, as required by the WTO.

In July, Rwanda had notified the WTO that it intended to import 260,000 packs of Apo-TriAvir from Canada (see BRIDGES Weekly, 25 July 2007).

This set in motion a process set out in the so-called '30 August Decision', which established procedures for poor countries with limited pharmaceutical manufacturing capacity to import generics produced under compulsory licence elsewhere. Agreed to by WTO Members on that day in 2003, the decision established terms for waiving the requirement for generic drugs thus produced to be "predominantly" for a country's domestic market. Although WTO intellectual property rules allow governments to suspend drug patents without patent-holders' consent in circumstances such as public health crises, the domestic-use requirement had left only limited quantities of medicines eligible for export to countries unable to make them.

Health activists complained that the administrative requirements set out in the 30 August Decision waiver were so onerous that countries would have difficulty using it at all, let alone rapidly to address emergencies.

Nearly four years passed before Rwanda became the first country to try to use the procedure - and as a least-developed country, it did not have to prove that its domestic drug making capacity was insufficient to meet its needs.

Nevertheless, with Canada's notification and Apotex's creation of a website describing the generic tablets' composition, shape and distinguishing markings intended to prevent them from being confused with brand-name products - in addition to a pledge to provide the drug at cost - the 30 August Decision's requirements appear to have been fulfilled. Apo-TriAvir "can now be made and exported to Rwanda," said a press release issued by the WTO last week.

This does not mean that drug shipments are about to start. That is not likely until December or January, according to Elie Betito, Apotex's director for public affairs. "We're still in the final phases of developing the active ingredients" in cooperation with the Clinton Foundation, he said, with production set to commence "in the next month and a half."

Even then, Betito added, Apotex would still have to defeat potential competitors to win a Rwandan government tender for the purchase of the combination drug, expected in November or December.

Rwandan domestic law requires it to issue tenders whenever buying drugs, explained Anita Asiimwe, director of the Rwandan health ministry's Treatment and Research AIDS Centre. "Apotex can bid," she told Bridges, but it "is not guaranteed to win." Other bidders, she suggested, could conceivably come from India or other countries where the components of Apo-TriAvir are not eligible for patent protection, since they would not need compulsory licences to produce generic versions of the drug.

So why didn't Kigali simply import generics from India in the first place? Rwanda wanted to ensure that "a quality generic manufacturer was in a position to compete with other manufacturers" bidding for the tender, Asiimwe said. The Rwandan government would then award the tender based on price and quality as defined by the World Health Organization (WHO).

Apo-TriAvir made by Apotex has received 'pre-qualification' status from the WHO, indicating that it meets certain quality, safety, and efficacy standards. So has an identical triple-drug combination produced by Hetero Drugs Limited, an Indian company, according to information on the WHO website.

Last month, Richard Elliott, executive director of the Canadian HIV/AIDS Legal Network, welcomed the compulsory licence for Apotex, but reiterated a call for simplifying Canada's three-year old legal regime for exporting affordable drugs under the 30 August Decision. If Canada is serious about wanting to facilitate the provision of medicines to developing countries, he said, it should transform the barely-used regime into a 'one-licence solution' that would authorise a company to produce the same drug for export to any country that submits notifications to the WTO.

Apotex's Betito made a similar argument, noting that if another country sought to import Apo-TriAvir, the company would have to repeat the entire process, right down to seeking voluntary licences from the brand-name manufacturers that hold the patents on the components of the drug.

Apotex's website for Apo-TriAvir is at http://www.apotex.com/apotriavir/default.asp.

ICTSD reporting.