AIDS drugs could be heading for Rwanda as soon as November under a Canadian program that allows generic-drug companies to send copies of brand-name medicines to poor countries.
GlaxoSmithKline Inc. said yesterday it had given consent to Apotex Inc. to manufacture an antiretroviral medication for the treatment of HIV/AIDS patients in Rwanda. Consent, through Canada's Access to Medicines Regime, was needed as GSK has patent rights for two of the three molecules in the medication.
"We have made a commitment, we have the drug and if we can get the green light, we will move quickly on it," said Elie Betito, director of public and government affairs for Apotex Inc.
Though Canada's Access to Medicines Regime was created three years ago to help supply inexpensive drugs to developing nations facing public health threats such as HIV/AIDS, not one pill has been exported. Critics say it is due to legislative flaws and an inordinately cumbersome process.
Whatever the case, yesterday's development is good news for Rwanda, a country where 250,000 people are infected with HIV.
If the agreement goes through, 15 to 16 million tablets of Apotex's triple combination AIDS medicine will be sent. Mr. Betito said that's enough to treat 21,000 Rwandans for one year or 200,000 for one month. It would be sold on a no-profit basis: It costs roughly 40 cents a tablet to make, he said.
Mr. Betito cautioned that there are still outstanding issues, among them the need to reach an agreement with one group of patentees associated with the medicine nevirapine, which also appears in the triple combination therapy.
"The bottom line is that the patentees have not lifted all of the barriers to shipment," Mr. Betito said. "Apotex cannot ship tomorrow."
Yesterday, Joanne Csete, executive director of Canadian HIV/AIDS Legal Network, said the process is a reminder of how "enormously complicated" the law still is.
"It took three years and it's practically a miracle it has gotten to this point."