[Ip-health] CPTech comments on H.R.3235, the ''Public Health Emergency Medicines
Act.''
James Love
love@cptech.org
Wed, 07 Nov 2001 12:32:23 -0500
Date: November 7, 2001
Re: CPTech comments on H.R.3235, the ''Public Health
Emergency Medicines Act.''
1. The United States needs to have every possible tool to ensure that
it protects Americans from biological or chemical attacks or other
possible health care emergencies.
2. The recent dispute over the CIPRO patent illustrates a weakness in
the US legal system. While the US government had the right to override
the patent under 28 USC 1498, there was a reluctance by the Bush
Administration to act, because of uncertainty over the compensation that
would be paid. For example, an October 19, 2001 Reuters article by Lisa
Richwine reported that Secretary Thompson said "lawyers advised him
that the United States would have to pay damages if it ordered generic
Cipro, which could make the move expensive." And on October 28, 2001,
the New York Times published a letter from Bush Administration official
Berard A. Schwetz, the Acting Principal Deputy Commissioner of the FDA,
where he defended the decision to not override the Bayer patent on Cipro
on the grounds that "if the government overrode the patent, Bayer could
bill the Treasury for lost revenues." Neither Thompson nor Schwetz
were articulate about there concerns regarding compensation under 28 USC
1498, and probably overstated the problems, given the case law on
similar disputes. However, it appears as though they were uncomfortable
with a process that would make the amount of the compensation an
uncertain proposition, to be decided later by a Judge, and at least
possibility of budget busting awards.
3. As a consequence of concerns about uncontrolled or unpredictable
costs, public health officials will act conservatively and expose the
public to higher risks. Bureaucrats will cut corners with the public
health. HR 3235 solves this problem by giving the Secretary the
authority to determine the reasonable compensation, administratively.
4. HR 3235 is needed to introduce more predictability and certainty in
the compensation process, so that public health officials can act fast
and confidently, to address a crisis as it happens.
5. HR 3235 is a limited power for public health emergencies only.
6. The provision for exports of medicines public health emergencies is
quite important. For example, this would be needed if a highly
contagious disease put the lives of Americans at risk, and there was
inadequate supply of medicine to anther country, due to patent
barriers. Or in cases where for humanitarian reasons the US wanted to
rush medicines to aid in a foreign public health emergency, including an
act of terrorism or biological warfare. It is unthinkable that we would
fail to do so in cases where our actions could help. The provisions of
this section of the bill require that the legitimate rights of the
patent owner be protected in the country were the medicines are used, to
conform to US obligations under Article 30 of the WTO/TRIPS accord.
7. All regulations for the bill must be consistent with the WTO TRIPS
accord, ensuring that the US follows international law.
H.R.3235
(introduced 11/6/2001)
Latest Major Action: 11/6/2001 Referred to House committee
Title: To amend title 35, United States Code, to provide for compulsory
licensing of certain patented inventions relating to health care
emergencies.
107TH CONGRESS
1ST SESSION H. R.3235
IN THE HOUSE OF REPRESENTATIVES
A BILL
To amend title 35, United States Code, to provide for compulsory
licensing of certain patented inventions relating to health care
emergencies.
Be it enacted by the Senate and House of representatives of the United
States of America in Congress assembled,
SECTION 1. SHORT TITLE. This Act may be cited as the ''Public Health
Emergency Medicines Act''.
SEC. 2. COMPULSORY LICENSING OF PATENTED INVENTIONS.
(a) IN GENERAL.-Chapter 14 of title 35, United States Code, is amended
by adding at the end the following:
''§ 158. Compulsory licensing
''(a) COMPULSORY LICENSING OF PATENTED INVENTIONS IN PUBLIC HEALTH
EMERGENCY.-In the case of any invention relating to health care the
Secretary of Health and Human Services shall have the right to authorize
use of the subject matter of the patent without authorization of the
patent holder or any licensees of the patent holder if the Secretary
makes the determination that the invention is needed to address a public
health emergency.
''(b) COMPENSATION FOR USE OF A PATENT.-In exercising the right under
subsection (a) to authorize other use of the subject matter of a patent,
the right holder shall be paid reasonable remuneration for the use of
the patent. In determining the reasonableness of remuneration for the
use of a patent, the Secretary of Health and Human Services may
consider-
''(1) evidence of the risks and costs associated with the invention
claimed in the patent and the commercial development of products that
use the invention;
''(2) evidence of the efficacy and innovative nature and importance to
the public health of the invention or products using the invention;
''(3) the degree to which the invention benefited from publicly funded
research;
''(4) the need for adequate incentives for the creation and
commercialization of new inventions;
''(5) the interests of the public as patients and payers for health care
services;
''(6) the public health benefits of expanded access to the invention;
''(7) the benefits of making the invention available to working families
and retired persons;
''(8) the need to correct anti-competitive practices; or
''(9) other public interest considerations.
''(c) EXPORT OF HEALTH CARE PRODUCTS IN PUBLIC HEALTH EMERGENCIES.-The
Secretary may authorize the use of a patent, without authorization of
the patent holder or any licensees of the patent holder, to export
medicines or other health care products that are needed to address
global public health emergencies, when the legitimate rights of the
patent holder are protected in the export market.
''(d) CONSISTENCY WITH TRIPS.-The Secretary of Health and Human
Services may adopt regulations to implement the purposes of this
section, consistent with the Agreement on Trade-Related Aspects of
Intellectual Property Rights referred to in section 101(d)(15) of the
Uruguay Round Agreements Act.
''(e) DEFINITION.-In this section, the term 'health care product' means
any drug or device (as those terms are defined in section 201 of the
Federal Food, Drug, and Cosmetic Act), any biological product (as
defined in section 351 of the Public Health Service Act), or any
technology or process to the extent the technology or process is applied
to health or health care.''.
(b) CONFORMING AMENDMENT.-The table of sections for chapter 14 of title
35, United States Code, is amended by adding at the end the following
new item:
''158. Compulsory licensing.''.
--
James Love
Consumer Project on Technology
P.O. Box 19367, Washington, DC 20036
http://www.cptech.org, mailto:love@cptech.org
voice: 1.202.387.8030 fax 1.202.234.5176 mobile 1.202.361.3040