Canada's plan to sell generic drugs to developing countries is threatened
http://www.100md.com
《英国医生杂志》
The Canadian HIV/AIDS Legal Network has posted an urgent action alert on its website asking Canadians to write to Prime Minister Paul Martin by 22 March demanding amendments to a bill before parliament concerning the sale of generic drugs to developing countries (www.aidslaw.ca). The network maintains that the bill as it stands will prevent manufacturers of generic drugs from selling them to poor countries to fight diseases such as AIDS, malaria, and tuberculosis.
"Unless amended, Bill C-9 will not lead to cheaper medicines for people most in need," the website says.
Bill C-9 was first introduced in November 2003 as Bill C-56 (BMJ News extra 2003;327:832) and was reinstated in February 2004. Its purpose is to implement the 30 August 2003 decision by the World Trade Organization (WTO) to enable countries lacking sufficient drug manufacturing capacity to "make effective use of compulsory licensing" to obtain cheaper pharmaceutical products to deal with public health problems such as HIV and AIDS, tuberculosis, and malaria (BMJ 2003;327:517).
The legal network contends that Bill C-9 is flawed, in that it
Allows brand name companies to block competition from manufacturers of generic drugs,
Limits drugs for export to a list that does not include many needed by developing countries, and
Excludes some countries facing public health problems with limited resources, high poverty rates and low levels of access to medicines, because they do not belong to the World Trade Organization.
Bill C-9 now contains a "right of refusal" that allows holders of drug patents to take over a contract after it has been negotiated between the manufacturer of a generic drug and a purchasing country. The network objects to this clause.
It also objects to a change being proposed by Canada抯 Research-based Pharmaceutical Companies (www.canadapharma.org). The group of companies is proposing what they call an alternative to the "right of refusal" that would require any manufacturer of generic drugs to notify the patent holder when it begins negotiations with the developing country.
This, says the network, amounts to the same right of refusal already there in the bill and in fact would invite repeated competitive bidding by the patent holder, which would have the effect of completely preventing manufacturers of generic drugs from entering the market.
"The only 'right of refusal' required by TRIPS is that the holder of the Canadian patent is given a right to refuse to issue a voluntary licence if it does not feel the commercial terms proposed are reasonable," says the legal network. "It is then up to the Commissioner of Patents to determine whether to issue a compulsory licence and the royalty rate appropriate in the circumstances."
WTO抯 agreement does not require that a patent holder be given the right to take over contracts that have been negotiated by a manufacturer of generic drugs, nor does it require the patent holder to be given notice of generic manufacturer抯 negotiations with developing countries, says the network.
The network proposes that the patent holder be notified after a Canadian company has negotiated its contract and then be given 30 days to decide whether it will grant a voluntary licence at the statutorily determined rate of 2%. If the patent holder refuses to grant a voluntary licence within 30 days, the Commissioner of Patients could grant a compulsory licence and fix the royalty rate as appropriate under the circumstances, with a cap of 4%.(Quebec David Spurgeon)
"Unless amended, Bill C-9 will not lead to cheaper medicines for people most in need," the website says.
Bill C-9 was first introduced in November 2003 as Bill C-56 (BMJ News extra 2003;327:832) and was reinstated in February 2004. Its purpose is to implement the 30 August 2003 decision by the World Trade Organization (WTO) to enable countries lacking sufficient drug manufacturing capacity to "make effective use of compulsory licensing" to obtain cheaper pharmaceutical products to deal with public health problems such as HIV and AIDS, tuberculosis, and malaria (BMJ 2003;327:517).
The legal network contends that Bill C-9 is flawed, in that it
Allows brand name companies to block competition from manufacturers of generic drugs,
Limits drugs for export to a list that does not include many needed by developing countries, and
Excludes some countries facing public health problems with limited resources, high poverty rates and low levels of access to medicines, because they do not belong to the World Trade Organization.
Bill C-9 now contains a "right of refusal" that allows holders of drug patents to take over a contract after it has been negotiated between the manufacturer of a generic drug and a purchasing country. The network objects to this clause.
It also objects to a change being proposed by Canada抯 Research-based Pharmaceutical Companies (www.canadapharma.org). The group of companies is proposing what they call an alternative to the "right of refusal" that would require any manufacturer of generic drugs to notify the patent holder when it begins negotiations with the developing country.
This, says the network, amounts to the same right of refusal already there in the bill and in fact would invite repeated competitive bidding by the patent holder, which would have the effect of completely preventing manufacturers of generic drugs from entering the market.
"The only 'right of refusal' required by TRIPS is that the holder of the Canadian patent is given a right to refuse to issue a voluntary licence if it does not feel the commercial terms proposed are reasonable," says the legal network. "It is then up to the Commissioner of Patents to determine whether to issue a compulsory licence and the royalty rate appropriate in the circumstances."
WTO抯 agreement does not require that a patent holder be given the right to take over contracts that have been negotiated by a manufacturer of generic drugs, nor does it require the patent holder to be given notice of generic manufacturer抯 negotiations with developing countries, says the network.
The network proposes that the patent holder be notified after a Canadian company has negotiated its contract and then be given 30 days to decide whether it will grant a voluntary licence at the statutorily determined rate of 2%. If the patent holder refuses to grant a voluntary licence within 30 days, the Commissioner of Patients could grant a compulsory licence and fix the royalty rate as appropriate under the circumstances, with a cap of 4%.(Quebec David Spurgeon)