[Ip-health] Toronto Star: Clement vows to get cheap drugs flowing

[Sheila.SHETTLE@geneva.msf.org]

The Toronto Star

                          August 14, 2006 Monday

Clement vows to get cheap drugs flowing

ISABEL TEOTONIO, Toronto Star

The federal health minister wants Canada to keep its promise of supplying
cheap AIDS drugs to Africa and is seeking advice on changing legislation
that is hindering the flow of life-saving medication.

"If we can put a man on the moon, we can solve this issue," said Tony
Clement of Canada's Access to Medicines Regime, which, ironically, was
designed to boost the Canadian production of generic drugs for poor
countries.

The problem, say critics, is that Canada based its law on an already
complicated framework designed by the World Trade Organization, and muddled
it further when implementing it into national law.

To date, not a single pill has been exported and not a single patient has
benefited from the Canadian law, which was passed two years ago.

"Obviously the legislation isn't working," said Clement, while attending an
international nurses forum in Toronto on the weekend.

In the days leading up to last night's opening in Toronto of AIDS 2006, the
16th international conference on AIDS - the theme of which is "Time to
Deliver" - activists have been extremely critical of Canada's record.

Clement said he has sought advice from organizations such as Doctors
Without Borders and the Canadian HIV/AIDS Legal Network, as well as Stephen
Lewis, the UN's special envoy for AIDS in Africa, on how to make the law
work.

"We have failed lamentably," said Lewis. "It's almost unbelievable that two
governments - one Liberal and one Conservative - can't get a single pill to
Africa."

Lewis said Clement pressed him "fairly hard" for advice on Saturday on how
to get the drugs flowing. The answer, said Lewis, is to issue compulsory
licences to generic pharmaceutical companies that would allow them to make
drugs without the patent holder's permission.

Currently, legislation stipulates the drug's patent holder and the generic
company planning to reproduce the drug must negotiate at least 30 days
before asking for a compulsory licence. But there is no time limit on how
long talks can last.

"What's wrong with these governments?" asked Lewis. "In truth, the minister
of health and minister of industry have all the power in the world to issue
a compulsory licence and get the generic drugs that Canada promised to
Africa at prices that Africans can afford and will save, ultimately,
millions of lives."

One of the companies currently caught in the legislation is Apotex Inc.,
which has developed the generic Apo-triAvir, but is locked in negotiations
with the patent holder, GlaxoSmithKline.

"This is not rocket science - a government has great power," said Lewis,
adding that Clement seemed genuinely interested in doing what he could. But
then again, said Lewis, he had a similar conversation with the minister
three months ago and nothing came of it.

Richard Elliott, deputy director of the Canadian HIV/AIDS Legal Network,
said he and Doctors Without Borders met three of Clement's advisers last
Thursday.

During the hour-long meeting, both organizations tried to hammer home the
point that Canada needs to introduce a more direct and streamlined
mechanism.

"There are a number of problems with the (WTO) framework and the Canadian
legislation," said Elliott. "But at its core, it's got the process
backward."

Melinda Gates, in Toronto for AIDS 2006 with her husband to represent the
Bill and Melinda Gates Foundation, said yesterday getting drug companies to
lower their prices so more drugs can make it out to impoverished African
nations isn't really an issue any more.

"The issue now is how do we retain enough personnel in these countries to
help administer and deliver the drugs on an ongoing basis," she told
reporters. "And that cost is still very high."

At a press briefing yesterday, Clement said Canada is doubling its
investment in its national fight against AIDS from the current $42.2
million to $84.4 million by 2008. However, this is not new money - the
original announcement was made in December 2005.

Internationally, Canada has committed $800 million in the present and as
for the future, he hinted an announcement could be forthcoming.

The fight to get a better system to deliver generic HIV drugs dates back to
Aug. 30, 2003, when negotiations among WTO members resulted in a landmark
decision that allowed generic versions of patented drugs to be copied under
compulsory licence and exported to developing nations.

According to the decision, a generic producer must negotiate a tentative
contract with a developing country to supply a certain product in a certain
quantity at a certain price. Based on that agreement, the country must send
a notification to the WTO declaring its intention to import drugs and the
generic company must negotiate with the patent holder for a voluntary
licence. If those talks fail, then the generic producer must apply for two
compulsory licences - one in its home country and one in the country where
the drugs are destined if they're protected under patent there.

"Each of these steps is time-consuming and holds no guarantee of success,"
reads a report by Doctors Without Borders that will be presented at the
conference.

In September 2003, Canada announced it would implement the WTO's decision
and in May 2004 it passed the Jean Chretien Pledge to Africa act, which has
since been renamed Canada's Access to Medicines Regime. But it topped its
legislation with additional requirements that made it even tougher for
generic producers to get drugs out.

For instance, since negotiations over voluntary licensing between generic
companies and patent holders must last at least 30 days, it is tough to
discern when talks are simply stalled or have broken down. Also, the law is
limited to a list of specific medicines in specific formulations. Even if a
generic company makes it through all those hurdles and a compulsory licence
is granted, it is valid for only two years. After that, the entire process
starts again.

At the bare minimum, said Elliott, Canada needs to get rid of the extra
requirements it added. But that, he warns, would be "sort of like tinkering
around the edges" and not addressing the real problem which is the original
Aug. 30, 2003 decision by the WTO to allow copies of patented drugs.

It's clearly not working, he said, since no one has taken advantage of it.
Not one country has notified the WTO that it plans to import cheaper drugs.

It's an indication the barriers to accessing the life-saving drugs are
simply too high, said Elliott.

He said he proposed to Clement's advisers that legislation be enacted that
would automatically grant a compulsory licence to a generic manufacturer.

With that in hand, the company could negotiate contracts with various
countries and pay royalties to the patent holder based on whatever deals
were reached.

LOAD-DATE: August 14, 2006

+++++++++++++++++++++
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