[Ip-health] Sherrod Brown letter to Bush regarding HR 4131,

[James Love]

* the legislation would establish a "compulsory licensing" process
for medicines needed in the event of a public emergency. . . The
generic companies would pay licensing fees for
the use of the brand-name drug company=92s patent.

* As it stands, the U.S. government lacks a reliable mechanism for
increasing the supply of emergency medicines. While the federal
government can wield "eminent domain" authority to override patent
protections , in doing so the government waives its immunity to
lawsuits.  This can lead to excessive costs and force the federal
government to fight drawn-out court battles.  During the anthrax
scare, Health and Human Services Secretary Thompson cited these
concerns when he decided not to use eminent domain authority to
secure adequate supplies of the drug Cipro.

* H.R. 4131 creates a legal framework for expedited access to
emergency medicines, avoiding the uncertainty surrounding use of
eminent domain authority while ensuring that patent holders receive
compensation rewarding them for their medical innovations.


-----------------
November 7, 2005

The Hon. George W. Bush
President of the United States
The White House
1600 Pennsylvania Avenue, NW
Washington, DC 20500-0005

Dear Mr. President:

I am writing to urge your support for The Public Health Emergency
Medicines
Act (H.R. 4131).  This legislation would enable your Administration to
proactively address a major obstacle in flu pandemic preparedness:
insufficient production of the antivirals and antibiotics needed to
protect
the American public.   If Congress and the White House do not address
this
issue now, we are potentially forsaking millions of American lives.
It is
that serious.

Two drugs, Tamiflu and Relenza, can reduce the severity and duration of
seasonal flu. For bird flu, the drugs may improve prospects of
survival, if
administered early.  The main constraint hindering the United States
from
stockpiling sufficient supplies of these medicines is production
capacity.
At current manufacturing capacity, it could take a decade to produce
enough
of these medicines to meet the minimum global need.  Our nation cannot
afford to wait another day, much less a decade, to build up our
stockpile of
antiviral medicines.

We must also seriously consider stockpiling antibiotics to treat
secondary
conditions associated with bird flu.   Allowing the drug industry to
dictate
the timeframe for stockpiling needed medicines would be a potentially
deadly
mistake.

I appreciate your efforts to minimize the likelihood of a flu
pandemic and
prepare the nation should such a pandemic occur.  Responding to the
possibility of a global flu pandemic is a daunting task and a critical
imperative; the nation cannot afford the delays and missteps that will
invariably occur if preparedness efforts are politicized.  Congress
and the
White House must work quickly and on a bipartisan basis to get the
job done.

In that context, I hope you will consider the merits of H.R. 4131 in a
dispassionate manner.  Because this legislation gives the Executive
Branch
expedited authority to temporarily =91break=94 a patent if that is the
only way
to secure sufficient supplies of an emergency medicine, the brand-
name drug
industry is likely to oppose the bill.  Nevertheless, your office
needs this
legal tool to eliminate the risk of deadly shortages in emergency
medicines.

Drawing from intellectual property laws already in place for nuclear
technologies and other American products, the legislation would
establish a
"compulsory licensing" process for medicines needed in the event of a
public
health emergency.  If the stockpile of a medicine needed in a national
emergency is insufficient to protect American lives, the President could
authorize generic drugmakers to supplement the supply available from the
brand-name manufacturer.  The generic companies would pay licensing
fees for
the use of the brand-name drug company=92s patent.

As it stands, the U.S. government lacks a reliable mechanism for
increasing
the supply of emergency medicines. While the federal government can
wield
=93eminent domain=94 authority to override patent protections, in doing
so the
government waives its immunity to lawsuits.  This can lead to excessive
costs and force the federal government to fight drawn-out court battles.
During the anthrax scare, Health and Human Services Secretary
Thompson cited
these concerns when he decided not to use eminent domain authority to
secure
adequate supplies of the drug Cipro.

H.R. 4131 creates a legal framework for expedited access to emergency
medicines, avoiding the uncertainty surrounding use of eminent domain
authority while ensuring that patent holders receive compensation
rewarding
them for their medical innovations.

If the drug industry ignores the gravity of this situation and
opposes H.R.
4131, drugmakers will likely invoke the same argument they rely on
whenever
the status quo is at risk:  They will claim that H.R. 4131 will have a
chilling effect on research and development.  In the case of medicines
needed in a public health emergency, that concern is wholly
misplaced.  It
is difficult to have a chilling effect on research and development
that is
already sorely neglected.  The reason Congress is considering financial
incentives to spur the development of emergency medicines is that
there is
insufficient private investment in this type of medicine.

Ideally, the federal government would not have to break drug company
patents
to secure needed medicines.  But we do not live in an ideal world.
The few
existing medicines that may help prevent or treat bird flu are in
desperately short supply.  Under extreme public pressure, Roche
Laboratories
has agreed to consider licensing the right to produce Tamiflu to generic
manufacturers.   Our nation doesn=92t have the luxury of time.  It is
irresponsible for the federal government to defer to the drug
industry when
we need adequate stockpiles now.

We can=92t afford the delay, we can=92t afford the uncertainty, and we can=
=92t
afford the risk.  H.R. 4131 would allow you to act independently of
the drug
industry to save American lives.  It=92s an authority you need now.

Thank you for your consideration, Mr. President.  I hope you will
issue a
Statement of Administration Policy on H.R. 4131 to help expedite
Congressional approval.

Sincerely,


SHERROD BROWN
Member of Congress