Mr. Eric Nyiligira, acting director general for the national drug distributor CAMERWA, said he received word from Apotex Inc. Thursday that the shipment would be leaving Canada that day or the next.
“The shipment should be here (in Kigali) by Tuesday,” Nyiligira told RNA.
The first shipment in September 2008 included about 6.8 million tablets, according to Apotex documents. This second shipment will consist of about 8.8 million pills. Apo-TriAvir combines three different HIV/AIDS medications into a single dosage.
HIV/AIDS patients in Rwanda have universal access to ARVs through the roughly 400 ARV sites located across the country. By the end of September, there will be roughly 74,000 people taking ARVs. Last year’s shipment of Apo-TriAvir was said to have been enough to treat about 20,000 patients over a year.
However, CAMERWA distributes the medication to all of its ARV sites based on the expiry date, said Nyiligira. That means more than 20,000 Rwandans could be taking Apo-TriAvir at any given time.
The last shipment?
Apotex, the Canadian generic drug manufacturer, produced and exported the drugs under the provisions of Canada’s Access to Medicines Regime (CAMR). The legislation waives patent rules in certain circumstances, allowing generic drug manufacturers to produce low-cost medication for the treatment HIV, tuberculosis and malaria in developing countries, particularly in Africa.
This month’s shipment is the last under the Rwanda and Apotex’s current contract – which expires this month.
However, it could be the last shipment to any country. Apotex previously indicated it would likely cease the production of Apo-TriAvir using CAMR because the legislation proved too “cumbersome”, according to the company and campaigners.
Under the current legislation, the drug manufacturer holds separate negotiations with the patent holders and the purchasing countries, which must be repeated with each new order.
Campaign groups such as the Canadian HIV/AIDS Legal Network and MSF argue that CAMR leads to an excessive amount of paperwork and legal bills, and prefer the process to be streamlined.
Nyiligira from CAMERWA said an Apotex official informed him Thursday the company would not be able to produce another batch of Apo-TriAvir unless the Canadian government amends the CAMR legislation.
However, Nyiligira said Apotex’s decision would not affect Rwanda too seriously.
“It’s not a big problem, we will find some other drugs,” Nyiligira said. “We have been buying drugs for about the last seven years, so we used to buy these drugs from other suppliers.”
While Nyiligira would not speculuate who may fill the void left by Apotex, one possibility is Duovir-N, the medication that Apo-TriAvir replaced.
Like Apo-TriAvir, Duovir combines three HIV/AIDS different medications in one tablet.
Apotex facing U.S ban
In late August, the U.S. Food and Drug Administration (FDA) issued an import alert for two of Apotex’s Canadian plants, which means drugs produced at those sites could be stopped at the border.
According to an earlier warning letter, an inspection at one of the plants last December “revealed significant deviations from U.S. current good manufacturing practice regulations.”
Apotex officials could not be reached by RNA for comment regarding whether the two affected plants were used to produce Apo-TriAvir.
However a statement released by the company appeared to indicate the two factories in question only produced drugs destined for the United States.
“This alert relates to observations made following routine audits for products destined to the US only,” the statement read.
Despite this, New Zealand imposed a ban on Apotex medication this week, according the newspaper reports from that country.
Nyiligira said he was not aware of the FDA alert, and it was not brought up during his conversation with an Apotex official on Thursday.
“They didn’t mention anything about that.”
However, Nyiligira said he would look into the issue to determine whether the drugs destined for Rwanda were manufactured at the two plants affected by the FDA alert.
“If an audit found that some standards were not met, that is the cause of some worry,” he said.
RNA also reported last month that some patients at ARV sites in Kigali had skipped their doses – a worrying situation blamed on the unusually bitter taste of the Apo-TriAvir tablets. A study is ongoing to determine the next course of action.