[e-drug] Cipro and emergency

["Ellen 't Hoen" <ethoen@hotmail.com>]

E-drug: Cipro and emergency
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[All articles below copied as fair use. HH]

Here are a few editorials on cipro and government use of a Bayer
patent. Most journalist writing about this issue seem to believe that
a national emergency is an essential condition for government use
of a patent without the consent of the patent holder. This is NOT
true.

Note that the grounds for issuing a compulsory license are not
prescribed in the TRIPS agreement. The procedural requirements are
different in the case of a national emergency or other circumstances
of extreme urgency or in the case of public non-commercial use. In
these situations it is not required to first obtain authorization from
the patent holder (a voluntary license) first. All of this can be found
in article 31(b) of the TRIPS Agreement:

- 31(b) such use may only be permitted if, prior to such use, the
proposed user has made efforts to obtain authorization from the
right holder on reasonable commercial terms and conditions and
that such efforts have not been successful within a reasonable
period of time. This requirement may be waived by a Member in the
case of a national emergency or other circumstances of extreme
urgency or in cases of public non-commercial use. In situations of
national emergency or other circumstances of extreme urgency, the
right holder shall, nevertheless, be notified as soon as reasonably
practicable. In the case of public non-commercial use, where the
government or contractor, without making a patent search, knows
or has demonstrable grounds to know that a valid patent is or will
be used by or for the government, the right holder shall be informed
promptly; - 

Ellen 't Hoen
MSF ellen.t.hoen@paris.msf.org


THE SKEPTIC: Govt Patent Call On Cipro Is Bad Medicine
By Robb M. Stewart

10/22/2001
Dow Jones International News

LONDON -(Dow Jones)- NBC anchor Tom Brokaw may have put his
trust in Cipro, but the Canadian government isn't taking its
chances. 

Canada has unapologetically ignored Bayer's patent on the
antibiotic favored in the treatment of anthrax and placed an order
for Cipro with a non-licensed manufacturer.

And now there are signals the U.S. too may step on Bayer's toes:
Senate Minority Leader Trent Lott has predicted the Senate will
soon debate whether to strip Bayer's patent, while the Wall Street
Journal reports Sen. Charles Schumer has telephoned the U.S.
subsidiary of one of India's largest ciprofloxacin makers to ask if it
would be able to quickly ship the drug.

All governments have the power to override patents in the event of
a national emergency - though Canada hasn't taken that step here -
but it would be hard to argue the current situation constitutes such
an emergency, even in the U.S.

By overriding the patent on Cipro, the Canadian and other
governments not only set an unwelcome precedent for the pharma
industry, they also deepen the trench between "us" and "them."

So far just three people have been diagnosed with the more-deadly
pulmonary version of anthrax and six others with an anthrax illness,
all in the U.S. As horrible, and unusual, as any case of anthrax is,
the numbers pale in comparison with the number of cases of AIDS
in South Africa alone.

Canada and the U.S. were on the other side of the trench when the
South Africans wanted to override the agreement on Trade-Related
Aspects of Intellectual Property Rights, or Trips, to gain access to
lower-priced AIDS treatments.

While governments' preparing for worst-case bioterrorism scenarios
is understandable in the current circumstances, it must be
remembered that anthrax isn't contagious and there's a risk the
unrestrained use of antibiotics will spur resistance to treatments,
not to mention fuel public anxiety.

To date, Bayer has been able to meet all Cipro orders and is
ramping up production to meet the increased demand.

As for equity investors watching this play out, it's too early to say
whether Canada's move will be echoed in the U.S. and elsewhere,
or indeed repeated with other drugs.

The pharma industry is unlikely to sit still. A great portion of its
value is wrapped up in patents. It fiercely protects them and argues
they are essential for innovation.

Without the security of a patent, why risk millions of dollars and
years developing a product which can then be easily copied?

In Bayer's case, sales of Cipro account for roughly 9% of the
company's 2002 operating profit penciled in by Dresdner Kleinwort
Wasserstein, without calculating for the increase in production. The
increase, say other analysts, should add a further EUR1 or so to
their fair value estimates for Bayer's stock price.

Given the recent woe facing Bayer - slumping chemical markets;
pulling its big-selling cholesterol drug Baycol when its use was
linked to a rare but potentially lethal side effect - the threat to its
patent on Cipro will do nothing for a share price which has been
recovering from lows in recent weeks.

There remain reasons to be wary of the stock, but Canada's
hypocritical stance on drug patents shouldn't have to be one of
them.

By Robb M. Stewart, Dow Jones Newswires; 44-20-7842-9294;
robb.stewart@dowjones.com

---

EDITORIALS
Save patent, risk lives?

10/22/2001
The San Francisco Chronicle

SUPPOSE there was a magic-bullet drug that could knock out a
looming fatal disease. Would it make sense to let pharmaceutical
firms crank out millions of extra pills, or stick with the one licensed
manufacturer to rev up the supply line? This is the choice facing
Washington with the patented Cipro, an antibiotic that can quell
anthrax.

True enough, Cipro can be overhyped. It's not for everyone. It
shouldn't be used in advance of a confirmed exposure. It mustn't
be stockpiled by nervous types. It's not cheap -- about $10 per day
-- and requires a steady dosage to work. But the wave of anthrax
exposures, from mail carriers to U.S. senators, suggests extra
caution and preparation are in order. The anthrax-laced letters are
only a handful for now, but who can predict the future? A reliable
supply of Cipro makes sense.

Washington should be devising an insurance policy against disaster,
but instead we're getting foot-dragging. The reason is clear. Cipro
is a drug licensed by Bayer, which has refused to allow rivals to sell
generic knockoffs. Bayer promises to step up production threefold,
but it wants to keep control, saying any change in the rules would
undercut the rewards of developing new drugs.

The Bush administration says it has pushed Bayer for extra Cipro
supplies, but has refused to override patent laws, which it could
arguably do.

That's a shortsighted, even dangerous, approach. Canada, with no
cases of anthrax, has authorized a generic drug maker to make a
Cipro copy. It's a responsible move that should quell public anxiety
and prepare for trouble.

Washington's hesitancy has other sources. If drug licensing laws
are suspended for Cipro, what about big-ticket AIDS drugs?
Countries such as Brazil, South Africa and India are challenging
American drugmakers, either in court or by open defiance, to permit
cheaper copycat drugs. Allowing Cipro generics may embolden
these challenges and prompt other groups to protest high drug
prices.

But Washington has bigger worries. It must calm a climate of fear,
worsened partly by muddled official reactions, including the
House's hasty adjournment after an anthrax scare. Capitol Hill
became a ghost town, a specter that sends a message of weakness
and fright.

Our leaders need to set an example of tough-mindedness out of
Washington. That means staying on the job and standing up to the
powerful drug industry.


 
California; Metro Desk
Commentary Stop the Rx Profiteers
ROBERT KUTTNER
Robert Kuttner is co-editor of the American Prospect

10/19/2001
Los Angeles Times

Depending on what terrorists do next, the United States could be
on the verge of a public health catastrophe.

The administration is moving--belatedly--to develop stocks of
antibiotics to treat anthrax. The government also is looking to
procure 300 million doses of smallpox vaccine to inoculate a new
generation.

Bayer, the maker of the anthrax antibiotic Cipro, resisted
government efforts to mandate patent licensing, which would
enable other labs to manufacture an emergency supply. The generic
version of Cipro is easily produced for a tiny fraction of the $350
for a month's dosage that Bayer charges. Producers in India sell
that much generic ciprofloxacin for about $10.

Another antibiotic, doxycycline, is just as effective as Cipro to treat
anthrax. A month's treatment of doxycycline retails for about $20.

But until this crisis, Cipro was the only drug approved by the Food
and Drug Administration explicitly to treat anthrax exposure caused
by inhalation of spores.

Meanwhile, the trade association of brand-name drug makers, the
Pharmaceutical Research and Manufacturers of America, or PhRMA,
has convened a task force of chief executives from the industry to
address the extra production needs. This sounds good, but PhRMA
explicitly excludes makers of generic drugs.

There is a name for this behavior: war profiteering.

We should hardly be surprised. This is the same industry that
mightily resisted supplying inexpensive AIDS drugs to Africa until it
was shamed by world public opinion and outfoxed by makers of
generic equivalents in India and Brazil. The Third World basically
dared American and European drug makers to take them to court,
and PhRMA blinked first.

What is good enough for a public health emergency also is sound
policy for everyday emergencies. Millions of people are denied
medicine they need because they have to choose between paying
to fill expensive prescriptions and eating. We need federal controls
on drug prices and more production of generic drugs financed by
public funds.

The other part of this story has to do with public health. For 20
years, public health has been a stepchild of federal policy, while
both parties have supported prodigious increases in the budget for
the National Institutes of Health.

What magic does NIH possess? The drug industry loves it because
the NIH finances the basic research on which the industry relies to
make its customized products and exorbitant profits. Every time a
particular disease comes into vogue as a public cause, the drug
industry jumps on the bandwagon and gets another hike in NIH
funding.

It makes sense for the public to fund basic research. But then
taxpayers should not have to pay twice via high prices at the
drugstore.

Neither is it sound policy to favor research that helps the drug
industry while short-changing public health and epidemiological
efforts that could safeguard more people at lower cost.

Let's rein in drug company profits and rebuild our public health
system so that all Americans can get the drugs and vaccines that
we need at the lowest possible cost.


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