[Ip-health] Globe and Mail: Canada's generic drug law is all talk, no action

[Sheila.SHETTLE@geneva.msf.org]

Canada's generic drug law is all talk, no action
By RACHEL KIDDELL-MONROE
14 August 2006

The International AIDS Conference that began in Toronto yesterday comes two
years after Canada took the bold step of becoming the first Group of Eight
country to allow generic pharmaceutical companies to export life-saving
medicines to developing countries that don't have the capacity to
manufacture drugs themselves.

The Jean Chr=E9tien Pledge to Africa was passed in accordance with the rule=
s
of the World Trade Organization's August 30th Decision in 2004 and hailed
by the government as a "model to the world."

M=E9decins sans fronti=E8res (Doctors Without Borders) was among the first =
to
try to use the international decision by placing an order for
antiretroviral drugs -- medication urgently needed by AIDS patients in our
field projects -- as soon as the law was passed. But, two years on, not a
single pill has left Canada. Not one patient has received medication thanks
to this legislation. With AIDS claiming 8,000 lives each day, such results
are unacceptable.

Admittedly, the blame cannot be laid solely at the Canadian government's
door. The WTO decision itself is unworkable, hugely complex, and involves
jumping through a series of bureaucratic hoops. Any country's
implementation of it will also be flawed.

The WTO rules are the source of major delays. Instead of simply faxing an
order to a drug company and paying the bill, obtaining medicine under the
August 30th Decision means pushing for a government to agree to import
under these circumstances, and identifying a drug company willing, and
able, to produce the drugs. It means waiting for obligatory prior
negotiations between the generic firm and the patent holder to have
concluded. These talks may last for months, and it is impossible to
determine with certainty when they have reached an end.

Worse, by making this a case-by-case, drug-by-drug and country-by-country
mechanism, the WTO decision kills any incentive a company that manufactures
generics might have had to participate in the process. Drug needs must be
determined with precision before an order is made -- if more patients are
identified and more doses are needed later, the entire process must be
restarted from the beginning. If fewer doses are used, they cannot be
shared with other countries in need.

This ignores the practical realities of a medical program and the basics of
economics: A company will not get involved without the pull of a viable
market for their products.

But the Canadian government chose to add to the bureaucratic complexities
mapped out by the WTO. Canada requires that drugs for export under the Jean
Chr=E9tien Pledge to Africa be included in the legislation's list of
acceptable products. The process of adding a drug to that list takes
months, and Canada's original list did not contain even the most widely
sought fixed-dose combination antiretrovirals that include several drugs in
one pill.

The Canadian law also requires that the generic drug be approved by Health
Canada. In the drug order by M=E9decins sans fronti=E8res, this took seven
months. Since potential importing countries often require drugs to be
approved by the World Health Organization's international approval process,
the double-approval requirement wastes time.

Canada further reinforces the case-by-case nature of the mechanism by
imposing limits on how long a drug can be exported, and by requiring that
purchasers spell out a maximum quantity of medicines to be bought.

The process of ordering generic drugs under the WTO's August 30th Decision
is too slow -- and has yet to benefit a single patient. Countries cannot
afford to engage in endlessly bureaucratic systems to get the treatments
people need.

By January of 2005, nearly all the generic-medicine-producing countries had
implemented a patent protection in their laws. With international patent
protection enforced on a country-by-country basis, the doors to generic
production and export are closing fast. Unless a fast, simple and automatic
mechanism to export life-saving drugs where they are needed is found,
millions will have no option but to wait out 20-year patent terms before
they can have access to essential medicines.

The situation can be changed: Canada must address the flaws in its
legislation. It must use its experience as the basis to act at the WTO to
remedy the rules governing the delivery of generic medicines to those 3.5
million people in desperate need of medicines.

Rachel Kiddell-Monroe is the Canadian head of M=E9decins sans Fronti=E8res
Campaign for Access to Essential Medicines.


+++++++++++++++++++++
at Toronto AIDS Conference:  +1.416.455.7916
+++++++++++++++++++++
Sheila Shettle
Communications Officer
M=E9decins Sans Fronti=E8res
Campaign for Access to Essential Medicines
Rue de Lausanne 78
1211 Geneva
Switzerland
+ 41.22.849.8403
sheila.shettle@geneva.msf.org
www.accessmed-msf.org