[Ip-health] BMJ: Canada's plan to sell generic drugs to developing countries is threatened

[Richard Elliott]

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[ Picked text/plain from multipart/alternative ]

British Medical Journal, 27 March 2004

BMJ  2004;328:728 (27 March), doi:10.1136/bmj.328.7442.728-d tio
http://bmj.bmjjournals.com/cgi/reprint_abr/328/7442/728-d


News roundup



Canada's plan to sell generic drugs to developing countries is threatened

Quebec David Spurgeon

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=92s 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 [the WTO=92s agreement on
trade related aspects of intellectual property rights] 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=92s 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=92s 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%.






Other related articles in BMJ:

NewsWorld Trade Organization finally agrees cheap drugs deal.
Fiona Fleck
BMJ 2003 327: 517.
<http://bmj.bmjjournals.com/cgi/content/full/328/7442//cgi/content/full/327=
/7414/517>[Full
text]

News extraCanada decides to lead the way in exempting AIDS drugs from
patent laws.
David Spurgeon
BMJ 2003 327: 832-0.
<http://bmj.bmjjournals.com/cgi/content/full/328/7442//cgi/content/full/327=
/7419/832-e>[Full
text]


Richard Elliott
Director, Legal Research & Policy / Directeur, politiques et recherche
juridique
Canadian HIV/AIDS Legal Network / R=E9seau juridique canadien VIH/sida
890 Yonge Street, Suite 700, Toronto, Canada M4W 3P4
Tel : +1 (416) 595-1666                 Fax +1 (416) 595-0094
E-mail: relliott@aidslaw.ca     Web: www.aidslaw.ca

The Canadian HIV/AIDS Legal Network is a partner organisation of the
AIDS Law Project of South Africa, and a non-governmental organization in
Special Consultative Status with the Economic and Social Council of the
United Nations. //
Le R=E9seau juridique canadien VIH/sida est un organisme partenaire  du AID=
S
Law Project
de l'Afrique du Sud et ONG dot=E9 de statut consultatif sp=E9cial aupr=E8s =
du
Conseil =E9conomique
et social des Nations Unies.
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