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Colleagues:
The article below gives us no indication of what the serious flaw is
in the Act passed by Canada to support the availability of generic
medicines in poor countries. Does anyone have more information in this
regard?
The article speaks to many issues of technology transfer, incentives for
local producers to export, and the political machinations of Canada. It
however does not report on other activities that might have severely
hampered the implementation of the Act.
Your views?
Regards
Joco Carapinha
South Africa
carapinhaj@therapy.wits.ac.za
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http://www.canada.com/health/story.html?id=d94f614a-db3c-4b5e-88a5-e5639
b98f2b9
Chretien's plan to deliver cheap medicines for Africa stuck in
uncertainty
Dennis Bueckert
Canadian Press
Tuesday, May 03, 2005
[Copied as fair use. BS]
OTTAWA (CP) - Almost a year after Canada won global praise for passing
legislation to provide cheap drugs for poor countries, the law hasn't
resulted in a single pill being exported.
Government officials say the Jean Chretien Pledge to Africa Act has been
stalled by technicalities. Critics say it is fatally flawed and will
never have any real impact.
"We're still in a waiting game," said Tony Parmar of Doctors Without
Borders, which had hoped the bill would be a lifeline for countries
devastated by AIDS, malaria and other treatable diseases.
"The conclusion we can draw is that one year later, not a single drug
has been exported.
"We're hopeful we can do that in the future but there's no guarantees at
this point. To be honest, there hasn't been a whole lot of interest for
the generic drug makers to use this legislation."
The bill, introduced during the dying days of the Chretien
administration, won praise from champions of international development
such as Bono of the rock band U2 and South Africa President Thabo Mbeki.
It took advantage of a new (at the time) World Trade Organization policy
permitting generic drug firms to produce cheap versions of patented
drugs, provided the products were sold only in poor countries.
Canada was the first country to take advantage of the policy, and
generic firms initially were strong backers, but stepped back in dismay
when they saw the actual provisions of the bill.
"There are many, many restrictions on it (the legislation) that are
actually not necessary according to the World Trade Organization," says
Jim Keon, president of the Canadian Generic Pharmaceutical Association.
He suggests the legislation was strongly influenced by brand-name
pharmaceutical manufacturers worried about giving an advantage to their
arch rivals.
The bill allows generic drug firms to charge the cost of manufacturing
plus 15 per cent. If they charge more than 25 per cent of what the drug
sells for in Canada they are open to challenge by the patent-holder.
Doug Clark, a senior official at Industry Canada, said the bill perhaps
mistakenly assumed drug makers will seek to export drugs for
humanitarian reasons.
"There is room there to make some money but it definitely does not
accommodate lucrative transactions."
The problem, he conceded, is that generic drug makers are not charities.
"That's the unspoken issue with this bill that no one has really talked
about. The incentives are simply not significant because the money is
not there. There was really no discussion of that at any point."
Any serious attempt to explore the bill's potential has been impossible
because its regulations - the detailed rules on what is and isn't
allowed - have not yet been published.
Clark says the regulations have been delayed because a Senate committee
studying the bill discovered a serious flaw which had been missed in the
Commons. A new bill had to be drawn up to fix the flaw, and it is expected to get
consideration this week and to be passed soon, unless of course the
government falls.
"There is no excuse for this kind of delay," says Stephen Lewis, UN
Special Envoy for HIV/Aids in Africa. "I think that the delay on issuing the regulations is just absolutely absurd, and frankly intolerable. But the far more important point is,
will the bill become a reality?
"If in fact there's been no significant initiative for drug production
and export thus far under the bill, then I think the bill is in danger
of becoming a non-entity because it will be lost in the politics of
Canada."
While the bill has crawled through Parliament at a snail's pace, the
international drug market has changed. Tim Gilbert, a Toronto lawyer who does work for both generic and brand-name manufacturers, recently visited Ghana to assess needs, and
found that most AIDS drugs are already available. The drugs are being supplied by companies in India, China and Brazil at prices that Canadian firms can't match. What the Ghanaians really want, says Gilbert, are the latest, most sophisticated drugs, and also the technology to make the drugs themselves.
Canadian firms are reluctant to transfer technology because they'd be planting the seeds for future competition.
"Is the social conscience alive and well in Canada?" asks Gilbert. "Yes it is, but it's got to make sense economically too."
Doctors Without Borders has approached Toronto-based Apotex about
producing a new triple-combination AIDS therapy that definitely is
wanted in Africa, but it's a drug not available now even in Canada.
That raises the question of how a generic manufacturer could obtain
approval, since the current Health Canada process requires proof that a
generic product is equivalent to the original brand-name product.
Since the triple-combination drug isn't available even from brand-name
manufacturers, how could a generic drug firm prove equivalence? Apotex
spokesman Elie Batito said discussions are still at an early stage.
Keon of the generic pharmaceutical association says discussions continue
"but there are no products waiting to be shipped." He says Ottawa should
provide research funding to develop the products needed.
Liberal Senator Jim Munson, who once served as Chretien's press
spokesman, hopes the bill bearing his former boss's name will yet prove
its worth.
"It's a shame that it's taken this long to go through this political
labyrinth to get it to this point. Let's get on with it. Tens of
thousands of people are dying and it's a shame that it's taken this long
to get this far."