Apotex, the first generic drugmaker to use the Canadian Access to Medicines Regime (CAMR) to manufacture and ship cheap life-saving drugs for Africa, has described the process as “unworkable.”

The firm has been awarded the first ever tender under the CAMR, to supply the Rwandan government with the fixed-dose combination HIV/AIDS drug Apo Triavir (zidovudine/lamivudine/nevirapine), under an agreement established back in 2003 by the World Trade Organization (WTO). However, the firm says that following the CAMR process has taken over three years and it would be unwilling to go through it again unless the process is greatly simplified.

"If other critical medicines are to go to Africa in a reasonable timeframe, the federal government must change the CAMR legislation. Apotex decided to do this because it was the right thing to do for the people dying from AIDS in Africa,” said Apotex’ president, Jack Kay
.
The Regime was unanimously approved by Canada’s federal parliament in May 2004 - at that time it was titled the Jean Chretien Pledge to Africa Act, named for the Liberal Prime Minister of the day. But it was not until last year that the first request was received from a country for medicines under the process.

As it now stands, the process is voluntary and controlled by the originator drugs’ patent holders – in the case of Apo Triavir, these are GlaxoSmithKline, Shire and Boehringer Ingelheim. The process of obtaining a license to produce a drug has to be restarted every time a new country makes a request, and there is no assurance that the patent holders will not attempt to delay the process and the supply of these vital medicines to developing countries in the future, says Apotex. “In the end, GSK and Shire did not oppose the application [for Apo Triavir], but chose not to grant a voluntary licence, requiring Apotex to navigate the complexities of the CAMR. Boehringer Ingelheim was also not prepared to freely grant a licence,” the firm adds.

The Canadian Generic Medicines Association (CGPA) has also repeatedly told the government that the CAMR was proving unworkable in practice and says none of its member-companies are willing to use the process as it now stands. Last year, the group’s president, Jim Keon, told the House of Commons that: it had become clear early in the process “that the government intended to include too many concessions to brand-name drug makers and that it would be virtually impossible for Canadian generic pharmaceutical manufactures to use the scheme.”

The Canadian HIV/AIDS Legal Network also believes that the law is “riddled with unnecessary hurdles” as it now stands. “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, we need a simple one-licence solution,” said the Network’s executive director, Richard Elliott.

However, following a mandatory review conducted two years after the programme was launched, the government concluded last December that it was “of the view that the case for making legislative or regulatory changes to CAMR has not yet been made out.”

- Apotex is producing Apo Triavir at cost, priced at US$19.5 cents per tablet. The three separate brand products would cost around $6.00 per dose if bought individually, says the firm, which plans to start shipping the drug in October.

_

Apotex, the first generic drugmaker to use the Canadian Access to Medicines Regime (CAMR) to manufacture and ship cheap life-saving drugs for Africa, has described the process as “unworkable.”

The firm has been awarded the first ever tender under the CAMR, to supply the Rwandan government with the fixed-dose combination HIV/AIDS drug Apo Triavir (zidovudine/lamivudine/nevirapine), under an agreement established back in 2003 by the World Trade Organization (WTO). However, the firm says that following the CAMR process has taken over three years and it would be unwilling to go through it again unless the process is greatly simplified.

"If other critical medicines are to go to Africa in a reasonable timeframe, the federal government must change the CAMR legislation. Apotex decided to do this because it was the right thing to do for the people dying from AIDS in Africa,” said Apotex’ president, Jack Kay
.
The Regime was unanimously approved by Canada’s federal parliament in May 2004 - at that time it was titled the Jean Chretien Pledge to Africa Act, named for the Liberal Prime Minister of the day. But it was not until last year that the first request was received from a country for medicines under the process.

As it now stands, the process is voluntary and controlled by the originator drugs’ patent holders – in the case of Apo Triavir, these are GlaxoSmithKline, Shire and Boehringer Ingelheim. The process of obtaining a license to produce a drug has to be restarted every time a new country makes a request, and there is no assurance that the patent holders will not attempt to delay the process and the supply of these vital medicines to developing countries in the future, says Apotex. “In the end, GSK and Shire did not oppose the application [for Apo Triavir], but chose not to grant a voluntary licence, requiring Apotex to navigate the complexities of the CAMR. Boehringer Ingelheim was also not prepared to freely grant a licence,” the firm adds.

The Canadian Generic Medicines Association (CGPA) has also repeatedly told the government that the CAMR was proving unworkable in practice and says none of its member-companies are willing to use the process as it now stands. Last year, the group’s president, Jim Keon, told the House of Commons that: it had become clear early in the process “that the government intended to include too many concessions to brand-name drug makers and that it would be virtually impossible for Canadian generic pharmaceutical manufactures to use the scheme.”

The Canadian HIV/AIDS Legal Network also believes that the law is “riddled with unnecessary hurdles” as it now stands. “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, we need a simple one-licence solution,” said the Network’s executive director, Richard Elliott.

However, following a mandatory review conducted two years after the programme was launched, the government concluded last December that it was “of the view that the case for making legislative or regulatory changes to CAMR has not yet been made out.”

- Apotex is producing Apo Triavir at cost, priced at US$19.5 cents per tablet. The three separate brand products would cost around $6.00 per dose if bought individually, says the firm, which plans to start shipping the drug in Octobe