[Ip-health] Canada's Access to Meds Regime Flops

[Sarah Rimmington]

http://www.theglobeandmail.com/news/politics/canadas-aids-assistance-flops/=
article1225236/
Canada's AIDS assistance flops
The consensus among AIDS activists is that program is so cumbersome that
no developing country will use it again to apply for assistance

by Michael Valpy
 From Tuesday's Globe and Mail Last updated on Tuesday, Jul. 21, 2009
08:33AM EDT

Ottawa's Cheshire cat grin to the global AIDS pandemic will vanish in
September when the last, small shipment of drugs produced under Canada's
Access to Medicines Regime leaves the country for Rwanda.

Virtually no one outside the federal government expects there will be
more =96 a gloomy backdrop to the indictments of the world's wealthiest
nations at this week's international AIDS conference in Cape Town, South
Africa, for a chain of broken promises on helping poorer countries to
obtain life-saving treatment.

In the five years that the Canadian legislation, CAMR =96 initially dubbed
the Jean Chr=E9tien Pledge to Africa Act =96 has been in place, only one
allotment of low-cost medicine has been arranged: for 21,000 Rwandans
for one year. The first shipment went last year; the last lot will go at
the summer's end.

The consensus among AIDS activists and generic drug manufacturers is
that CAMR is so overwhelmingly flawed and cumbersome that no developing
country will use it again to apply for assistance, and no generic
pharmaceutical company will use it to manufacture anti-retroviral drugs.

=93We're still where we were five or six years ago, and the system needs
to get fixed,=94 said Elie Betito, director of public and government
affairs for Apotex Inc. in Toronto, which made the Rwandan
anti-retroviral product at cost after long and expensive legal
negotiations with three pharmaceutical companies holding patents on
components of the medication.

=93But I don't think this government wants to change [CAMR], because it's
not their legislation,=94 he added. It was introduced by a Liberal
government, although passed unanimously by Parliament.

Apotex, one of the world's largest generic drug manufacturers, has said
its one and only experience working under CAMR was so bad that it won't
seek a new licensing agreement using the legislation, although it's
ready to produce a desperately needed pediatric formulation that it says
would both meet high Canadian standards and be globally cost competitive.

The CAMR legislation was designed to allow generic pharmaceutical
companies to produce and export affordable drugs that are under patent
to developing countries facing public health emergencies.

But it requires countries on an approved list to go through a mountain
of red tape to apply for assistance and tender for manufacturers, and
generic manufacturers to negotiate new licensing agreements with patent
holders on each contract and with each country.

Thus, if Apotex was to have won a contract from Rwanda for another year
of supplying drugs to the same 21,000 patients, it would have had to go
through the same negotiations as before with the patent holders.

=93You're looking at 65-page contracts,=94 Mr. Betito said.

Tony Clement, while national health minister in 2006, told the
international AIDS conference, held that year in Toronto, that the
legislation was flawed. But since becoming Minister of Industry =96 with
responsibility for the legislation =96 in 2008, he has not given any
intention of amending it.

A government review concluded in 2007 that it would be premature to
change the legislation. The patent-holding pharmaceutical manufacturers
have said there's nothing wrong with the legislation as it stands, and
have lobbied strenuously against changes.

A Senate bill being shepherded by Manitoba Liberal Senator Sharon
Carstairs and a House of Commons private member's bill introduced by
Manitoba New Democrat Judy Wasylycia-Leis would require only a single
licence.

Apotex would prefer the government take over the whole process and
simply hand compulsory licences to generic manufacturers.

Laura Esmail, a University of Toronto doctoral candidate in pharmacy
whose academic research is on CAMR and affordable AIDS drugs, said the
one-licence proposal would allow Canadian companies, such as Apotex, to
develop affordable global drugs using economies of scale.

She also said developing countries find themselves pressured by
international corporations and other governments not to apply for drugs
under legislation such as CAMR, and they need wealthy countries like
Canada to make it easier for them to do so.

--
Sarah Rimmington
Attorney
Essential Action, Access to Medicines Project
Washington, DC
Tel: +1 (202) 387-8030
Cell: +1 (202) 422-2687
www.essentialaction.org/access/