RWANDA SHOULD RECEIVE CUT-PRICE HIV/AIDS DRUGS IN SEPTEMBER, FIVE YEARS AFTER 30 AUGUST DECISION

In July 2007, Rwanda became the first country to announce its intention to use WTO procedures to import a cheap generic version of a patented HIV/AIDS medicine from Canada. Nearly ten months have passed since then, but not a single tablet of the lifesaving drug has yet been delivered to the African country.

The delay appears to be the combined result of complexities in the WTO rules, the Canadian implementing legislation, and Rwandan government practice.

In any event, the wait may soon be over.

A significant barrier to imports of the drug from Canada fell last week when the Rwandan government awarded a tender to Apotex, a Toronto-based generics manufacturer, to supply it with 'Apo-TriAvir', a combination of three patented HIV/AIDS medicines.

Apotex now expects to complete production of the drug and start exports by September or October, said Elie Betito, the company's director of public and government affairs. This timeline was confirmed by Anita Asiimwe, the director in charge of HIV/AIDS in the Rwandan health ministry, who said that the first shipment was expected on 30 September.

Betito explained that the additional months were necessary because Apotex had to wait until it was sure that it had won the competitive tender before starting production. The generics maker had procured active ingredients and determined a price for the treatment last fall, which will shorten the production process.

Although Apotex had initially expected the tender process to take place in late 2007 or early this year, it did not receive the Rwandan government's verdict until 7 May. "We don't really know why it took four or five more months than it should have," Betito said.

Asiimwe said that she could not speak to the delay, since procurement fell outside her jurisdiction. However, she assured Bridges that it did not cause any patients to go without treatment, since Rwanda had adequate stockpiles of the drug from other suppliers.

If Apo-TriAvir shipments do start by September, it would be well over a year after Rwanda notified the WTO in July 2007 that it planned to import 260,000 packs of Apotex's drug from Canada (see BRIDGES Weekly, 25 July 2007).

That notification triggered processes set out in the so-called '30 August Decision', a 2003 accord by WTO Members establishing procedures for poor countries with limited pharmaceutical manufacturing capacity to import generics produced elsewhere under compulsory licence. The decision established terms for waiving the requirement for generic drugs produced without patent-holders' consent to be "predominantly" for a country's domestic market.

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.

As per those requirements, Canada in October 2007 notified the WTO TRIPS Council of its intention to export the drug to Rwanda, providing information about the licences Apotex had received from the patent-holders and the Canadian patent office for the components of the triple drug cocktail, as well as about a website created by Apotex outlining the quantity of medicine and the distinguishing characteristics aimed at ensuring that generics are not illegally diverted into other markets (see BRIDGES Weekly, 10 October 2007).

Following this, it became possible for Rwanda to issue a competitive tender for the purchase of the drug, as required by domestic law whenever the government buys medicines. Other bids for the tender could have come from companies in India or other developing countries where the components of Apo-TriAvir are not eligible for patent protection, since they would not need licences (whether compulsory or voluntary) to produce generics.

In an interview with Bridges last year, the Rwandan health ministry's Asiimwe explained that Kigali went through the 30 August Decision procedure -- even though it could have directly imported generics from elsewhere -- because it wanted to bring Apotex in as "a quality generic manufacturer" to compete with the other bidders for the tender. This week, she stressed that Apotex's bid had the best price, too.

Apotex's 7 May press release announcing that it had won the Rwandan government tender said that it would provide Apo-TriAvir at cost, at a rate of 19.5 cents (US) per tablet. The three brand name components would cost $6 per dose if bought individually, the statement claimed.

With the path seemingly clear for Apo-TriAvir exports to Rwanda under the 30 August Decision, Apotex's Betito expressed hope that other countries would follow Rwanda's example. However, he repeated his company's call for the Canadian government to simplify its law for exporting drugs via the WTO procedure. Under the Canadian Access to Medicines Regime, he said, if another country tried to import the same drug, Apotex would have to repeat the entire process, right down to hiring lawyers to seek voluntary licences from the brand-name manufacturers that hold the patents on the components of the drug.

Richard Elliott, executive director of the Canadian HIV/AIDS Legal Network, welcomed the announcement that the Rwandan government had chosen to import Apo-TriAvir, but also reiterated that it was necessary to remove "unnecessary hurdles" from the Canadian legislation. "What we need is a straightforward system that is user-friendly for both developing countries and for generic manufacturers in Canada."

"Instead of requiring separate negotiations and a separate licence for each country and each order of medicines," he advocated 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.

Despite calls for reform from the generic pharmaceutical industry and public health campaign groups, Canada's industry ministry in December 2007 ruled out any changes to the access to medicines regime.

ICTSD reporting.