Low-cost medicine for developing world lost in red tape

From the Ottawa Citizen:
This week, Senator Yoine Goldstein will rise in the upper chamber and ask his fellow senators to fix Canada’s Access to Medicines Regime.

Passed in 2004, CAMR was hailed as a world-leading initiative that would help millions in developing countries get life-saving medicine to treat HIV, tuberculosis, malaria and other diseases. CAMR was supposed to make it easier for Canadian companies to produce cheap, generic medicine for export.

But five years after CAMR became law, just one shipment of medication has been exported.

The Harper government and brand-name pharmaceutical companies say the law is fine just the way it is, but legal experts and access-to-medicine campaigners say CAMR created a process so laden with red tape and time-wasting regulatory steps that it was doomed from the start. ...more

Canadian to ship AIDS drugs to Rwanda for first, perhaps last time

From the Vancouver Sun:
Seven million pills will leave Toronto Wednesday bound for Rwanda, the first and perhaps the last shipment of generic, low-cost drugs to treat HIV-AIDS produced under Canada's Access to Medicine Regime (CAMR).

This is the first time any manufacturer in any country has used such a licensing framework to get essential medicine to people in the developing world.

But Apotex, the drug manufacturer that produced the pills, says the Canadian legislation - and the World Trade Organization regulations it's based on - has created such a complicated, costly system, the company won't be doing it again unless the regulations are changed.

"It took us more than four years just to get to this point," says Elie Betito, director of public affairs for Apotex, the generic-drug manufacturer supplying the pills. "It's a huge process, with huge costs involved.

"We will not be doing this again."

The process began when humanitarian organization Medecins Sans Frontieres asked Apotex to produce a generic version of several costly, brand-name antiretroviral medications - treatments easily accessible to patients in the developed world and proven to prolong the life of most AIDS patients for years. ...more

First batch of AIDS meds leaves for Africa

From the Winnipeg Sun:
The first batch of Canadian-made AIDS drugs will leave for Africa this week, four years after the federal government established a program to get cheaper medications into the hands of patients in poor countries.

The shipment from generic drug giant Apotex Inc., will likely start its journey to Rwanda on Wednesday.

Apotex says it plans to send another batch of medication to Africa next year, but says the company won’t participate in the program any more until the government fixes laws that have left the initiative bogged down in red tape.

Canada’s Access to Medicines Regime was passed in 2004 with much fanfare and heralded internationally as an opportunity for Canada to be a major player in the global fight against disease in poor countries.

The government promised access to first-world therapies at reduced prices by getting brand-name pharmaceutical firms to negotiate with generic drug makers and allow the generics to manufacture cheaper AIDS drugs. ...more

Canadian AIDS meds may soon head to Rwanda

From CBC News:
Four years after it was passed unanimously by Parliament, a bill drafted to allow low-cost Canadian-made AIDS drugs to be exported to developing countries may finally be on the verge of producing results.

Generic drug maker Apotex Inc. announced Wednesday that it has been awarded a contract by the government of Rwanda to sell its three-in-one AIDS pill Apo Triavir to the African country. Securing that contract was the final legal hurdle that Apotex had to manoeuvre in the onerous process of making Canada's Access to Medicines Regime work.

"We're almost there," Elie Betito, the company's director of public and government affairs, said in an interview.

"By October sometime we're hoping that the product will be on a plane on delivery to Rwanda."

He noted, though, that nothing will be final until that actually happens. The companies that hold the patents on the drugs in the Apotex combined medication can still withdraw permission for the sale to take place "even on the day we are shipping." ...more

Life-saving meds wrapped in red tape

From the McGill (Que.) Daily:
Six months after Industry Canada finished its review of legislation that allows Canadian drug manufacturers to produce and export generic medicines, a report of the findings has yet to be completed.

The legislation, known as the Canada Access to Medicines Regime (CAMR), was passed in 2004 to facilitate access to affordable essential medicines in developing countries. But the legislation is widely recognized as flawed – so far, not a single pill has left the country. ...more

Canadian companies agree to share generic AIDS drugs with Rwanda

From the Globe and Mail:
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. ...more