Canada still has a long way to go in fulfilling its promise of legislation designed to ease the export of lower-priced generic drugs to developing countries, says one Toronto lawyer who''s part of a team trying to get generic AIDs medication to Ghananians.
During the International AIDS Conference held earlier this month in Toronto, Federal Health Minister Tony Clement announced that the government is planning a review of Canada's Access to Medicines Regime. But is that just more promises and no action?
"In some ways I would like to say that I would be excited about this review. At the same time, people have talked about the problems in this system for two or three years now," says Toronto lawyer Tim Gilbert, of Gilbert's LLP.
"It was a noble gesture, but very short on results," Gilbert says of the legislation, formerly known as bill C9, originally designed to facilitate access to generic drugs for diseases such as HIV/AIDS and malaria in developing countries.
As a result, Gilbert and a team of students travelled to Ghana last year as part of the Access to Drugs Initiative (ADI), a partnership between the University of Toronto and Gilbert's.
"The goal of our group was to go down there and take matters into our own hands and just go right to the source, go to where there is a need for lower-priced generics and find out if we can actually break through the barriers ourselves and process the first application," says Gilbert.
The team's aim is to bring high-quality, affordable medicines to developing countries. Accord-ing to ADI, the initiative is currently in collaboration with the Clinton Foundation, Médecins Sans Frontières, Ghanaian pharmaceutical company Phyto-Riker, and Stephen Lewis, UN special envoy for HIV/AIDS in Africa.
Melanie DeWit was one of the law students who traveled to Ghana with the ADI on two occasions, and has since graduated from U of T's law school.
"We realized, based on our first trip, that they were a little ways away from viable domestic production and that we should focus on getting them equipped to legally import low-cost drugs, generic alternatives," she says. "To do that, we needed to draft amendments to their Patent Act," changes that are pending at the moment, she added.
Gilbert notes that there were three components of the group's work in Ghana. First of all, they signed a memorandum of understanding with the Ghanaian government, which committed the University of Toronto to work with the government to reform its patent laws to allow for compulsory licensing.
The team also looked at the issue of domestic manufacturing.
"One of the commitments that we gave to the minister for health was that we would work with them on a strategic assessment of their own capacity, in Ghana," says Gilbert.
The third component was that they were also interested in enhancement of training and distribution systems.
Gilbert says this has resulted in the first compulsory licences being issued in Ghana. He adds that this is a significant feat, but it was not achieved through the former bill C-9. The medications that reached the country through the compulsory licence were imported from India via the Netherlands, according to DeWit.
While the team was working in Ghana, Canadian pharmaceutical company Apotex was working on the first Canadian application for approval of a generic triple-dose HIV medication, says Gilbert. They would then be looking to Médecins Sans Frontières for distribution, he adds.
"We talked about the time as to whether they were going to work through the compulsory licensing regime and it looked to be quite a complicated system," he says. "We've offered assistance to Apotex, and they have accepted that assistance, in terms of leveraging our experience in Ghana into possibly obtaining a compulsory license."
Looking ahead, he adds that while Ghana is only one country, one of the ideas of the joint initiative would be to use regional trade agreements to import into one country and allow distribution through one compulsory licence to other countries.
"What we're doing now is trying to work with Ghana to implement the Doha declaration on a more regional level, to take advantage of an extra exception that would allow a developing country to import a generic drug and then to re-export it to another developing country that might not be equipped to do it themselves," says DeWit.
"It does appear that that may be possible, and we want to investigate, we really want to test it, we want to run through that," says Gilbert.
The group is also looking to play an advisory role to government, Gilbert says. "It isn't this huge win for a generic company to sell drugs into Africa. It is a very difficult enterprise, and we should do everything possible to make it easier, not put up roadblocks to it."
Gilbert says the group hopes to return to Ghana again this year with a team of students, but added that this would depend on funding.
During the International AIDS Conference held earlier this month in Toronto, Federal Health Minister Tony Clement announced that the government is planning a review of Canada's Access to Medicines Regime. But is that just more promises and no action?"In some ways I would like to say that I would be excited about this review. At the same time, people have talked about the problems in this system for two or three years now," says Toronto lawyer Tim Gilbert, of Gilbert's LLP.
"It was a noble gesture, but very short on results," Gilbert says of the legislation, formerly known as bill C9, originally designed to facilitate access to generic drugs for diseases such as HIV/AIDS and malaria in developing countries.
As a result, Gilbert and a team of students travelled to Ghana last year as part of the Access to Drugs Initiative (ADI), a partnership between the University of Toronto and Gilbert's.
"The goal of our group was to go down there and take matters into our own hands and just go right to the source, go to where there is a need for lower-priced generics and find out if we can actually break through the barriers ourselves and process the first application," says Gilbert.
The team's aim is to bring high-quality, affordable medicines to developing countries. Accord-ing to ADI, the initiative is currently in collaboration with the Clinton Foundation, Médecins Sans Frontières, Ghanaian pharmaceutical company Phyto-Riker, and Stephen Lewis, UN special envoy for HIV/AIDS in Africa.
Melanie DeWit was one of the law students who traveled to Ghana with the ADI on two occasions, and has since graduated from U of T's law school.
"We realized, based on our first trip, that they were a little ways away from viable domestic production and that we should focus on getting them equipped to legally import low-cost drugs, generic alternatives," she says. "To do that, we needed to draft amendments to their Patent Act," changes that are pending at the moment, she added.
Gilbert notes that there were three components of the group's work in Ghana. First of all, they signed a memorandum of understanding with the Ghanaian government, which committed the University of Toronto to work with the government to reform its patent laws to allow for compulsory licensing.
The team also looked at the issue of domestic manufacturing.
"One of the commitments that we gave to the minister for health was that we would work with them on a strategic assessment of their own capacity, in Ghana," says Gilbert.
The third component was that they were also interested in enhancement of training and distribution systems.
Gilbert says this has resulted in the first compulsory licences being issued in Ghana. He adds that this is a significant feat, but it was not achieved through the former bill C-9. The medications that reached the country through the compulsory licence were imported from India via the Netherlands, according to DeWit.
While the team was working in Ghana, Canadian pharmaceutical company Apotex was working on the first Canadian application for approval of a generic triple-dose HIV medication, says Gilbert. They would then be looking to Médecins Sans Frontières for distribution, he adds.
"We talked about the time as to whether they were going to work through the compulsory licensing regime and it looked to be quite a complicated system," he says. "We've offered assistance to Apotex, and they have accepted that assistance, in terms of leveraging our experience in Ghana into possibly obtaining a compulsory license."
Looking ahead, he adds that while Ghana is only one country, one of the ideas of the joint initiative would be to use regional trade agreements to import into one country and allow distribution through one compulsory licence to other countries.
"What we're doing now is trying to work with Ghana to implement the Doha declaration on a more regional level, to take advantage of an extra exception that would allow a developing country to import a generic drug and then to re-export it to another developing country that might not be equipped to do it themselves," says DeWit.
"It does appear that that may be possible, and we want to investigate, we really want to test it, we want to run through that," says Gilbert.
The group is also looking to play an advisory role to government, Gilbert says. "It isn't this huge win for a generic company to sell drugs into Africa. It is a very difficult enterprise, and we should do everything possible to make it easier, not put up roadblocks to it."
Gilbert says the group hopes to return to Ghana again this year with a team of students, but added that this would depend on funding.
