[Pharm-policy] Debate on Amendment to limit USTR to TRIPS with regard to health care inventions

[James Love]

Yesterday the US House of Representatives passed H.R. 4690, a bill for
Commerce, Justice, State, the Judiciary, and Related Agencies
Appropriations.  Congressman Sherrod Brown (D-OH) offered an amendment
that would have prevented any of those agencies from seeking WTO/TRIPS
plus policies in cases involving health care inventions.  (In order to
overcome a proceedural objection, the amendment was narrowed to address
only the Special 301 process).  The Congress rejected the amendment by a
voice vote.  Here was the debate, from the Congressional Record:

   Jamie

Beginning page H5151

 PERSONAL EXPLANATION (House of
Representatives - June 26, 2000)


AMENDMENT NO. 53 OFFERED BY MR. BROWN OF OHIO

Mr. BROWN of Ohio. Mr. Chairman, I offer an amendment. 

The CHAIRMAN. The Clerk will designate the amendment. 

The text of the amendment is as follows: 

Amendment No. 53 offered by Mr. Brown of Ohio: 
At the end of the bill, insert after the last section (page 107,
after line 21) the following new title: 

TITLE VIII--ADDITIONAL GENERAL PROVISIONS


Sec. 801. None of the funds made available in this Act may be
used to seek the revocation or revision of the laws or
regulations of another country that relate to intellectual
property rights with respect to pharmaceuticals or other medical
technologies and comply with the Agreement on Trade Related
Aspects of Intellectual Property Rights referred to in section
101(d)(15) of the Uruguay Round Agreements Act. 

The CHAIRMAN. Pursuant to the order of the House of Friday, June
23, 2000, the gentleman from Ohio (Mr. Brown) and a Member
opposed each will control 5 minutes. 

The Chair recognizes the gentleman from Ohio (Mr. Brown). 

MODIFICATION TO AMENDMENT NO. 53 OFFERED BY MR. BROWN OF OHIO

Mr. BROWN of Ohio. Mr. Chairman, I ask unanimous consent to
modify my amendment such that it explicitly applies only when the
United States Trade Representative is engaged in a Special 301
process established under the 1974 Trade Act and that it applies
only to developing countries. 

The CHAIRMAN. The Clerk will report the modification. 

The Clerk read as follows: 

Modification to amendment No. 53 offered by Mr. Brown of Ohio: 

In lieu of the matter proposed to be: 

Sec. 801. None of the funds made available in this Act may be
used by the United States Trade Representative to seek the
revocation or revision of the laws or regulations of a developing
country under the Special 301 process established under the Trade
Act of 1974 as amended that relate to intellectual property
rights with respect to pharmaceuticals or other medical
technologies and comply with the Agreement on Trade Related
Aspects of Intellectual Property Rights referred to in section
101(d)(15) of the Uruguay Round Agreements Act. 

The CHAIRMAN. Is there objection to the modification offered by
the gentleman from Ohio (Mr. Brown)? 

Mr. CRANE. Mr. Chairman, reserving the right to object, I yield
to the gentleman from Ohio (Mr. Brown) for an explanation of his
modification. 

Mr. BROWN of Ohio. Mr. Chairman, malaria killed 1.1 million
people last year; 2.2 million people, mostly children, died of
diarrheal infections; 2.3 million died of AIDS; 1.5 million of
tuberculosis. Mr. Chairman, we know how to treat each of these
diseases. We could have saved the lives of many of these people. 

Countries around the world are attempting to expand access to
desperately needed prescription drugs by pursuing competitive
strategies explicitly permitted under international trade
agreements. The USTR, on behalf of the global prescription drug
industry, has made a practice of pressuring these nations to
forsake legitimate strategies that can achieve lower prices;
strategies like parallel importing and compulsory licensing. 

Mr. CRANE. Mr. Chairman, I withdraw my reservation and object. 

The CHAIRMAN. Objection is heard. The gentleman from Ohio (Mr.
Brown) is recognized for 5 minutes. 

Mr. BROWN of Ohio. Mr. Chairman, I yield myself such time as I
may consume. 

Both of these practices, parallel importing and compulsory
licensing, are explicitly permitted under a world trade agreement
commonly referred to as TRIPS. The WTO TRIPS accord sets global
norms for patents, for trademarks, for copyrights, and for other
types of intellectual property. 

It is a tough set of requirements. For example, it requires all
WTO member countries, including the United States, to adopt
20-year patents on medicines, even though under our patent law
our patent length was 17 years. 

The WTO TRIPS agreement requires many poor countries to adopts
rules that actually raise the price of their medicines. The USTR,
on behalf of the prescription drug industry, is pushing countries
to abandon fully sanctioned actions, like parallel importing and
compulsory licensing. 

It is difficult to believe the U.S. is participating in efforts
to prevent developing countries from fighting back when drug
companies ignore the dire consequences of their actions and abuse
their monopoly power, for example, when they impose higher prices
in developing countries than in industrialized nations, as in the
case with AIDS drug Fluconazole. 

                                       [Page: H5152]  GPO's PDF

                                             [TIME: 2130]

U.S. trade officials have pressured South Africa, Thailand,
Indonesia, the Philippines, India, Pakistan, Costa Rica, the
Dominican Republic, and many other poor nations, threatening
sanctions unless they forsake rights they have under the TRIPS
agreement. 

In many of these countries, the average income is less than $1 a
day. 

In December last year, President Clinton told the WTO it was time
to change U.S. trade policy, to consider the issue of access to
medicines. 

In May, the President issued an executive order prohibiting the
USTR from pressuring sub-Saharan African nations into giving up
legitimate competitive strategies aimed at expanding access to
HIV/AIDS drugs. 

In justifying his decision to reign in the USTR, the President
asserted `it is in the interest of the United States to take all
reasonable steps to prevent further spread of infectious disease,
particularly HIV/AIDS. The TRIPS agreement recognizes the
importance of promoting effective and adequate protection of
intellectual property rights and the right of countries to adopt
measures necessary to protect public health.' 

Our amendment is grounded in that same logic. 

The United States should enforce the TRIPS agreement to ensure
the proper protection of property rights to be sure, but it
should not undercut the balance TRIPS strikes between protecting
intellectual property and promoting the public health. 

The President's executive order applies only to AIDS drugs and
only to sub-Sahara Africa. Our amendment says the United States
should not interfere in legitimate efforts to expand access to
essential medicines in developing countries in health crises. 

This amendment does not undercut in any way intellectual property
protections. It permits the U.S. to insist on tough provisions of
the WTO TRIPS agreement, but it prevents the U.S. Government from
seeking to impose so-called `TRIPS Plus' protections on countries 
when these more onerous protections would have a negative impact
on access to medicine. 

Not only is this policy appropriate from a public health point of
view, it is also consistent with the WTO TRIPS agreement itself.
Article I of the TRIPS agreement says `Members may, but shall not
be obliged to, implement in their law more extensive protection
than is required by this Agreement.' The key phrase is `not
obliged to.' 

The United States should honor, in fact we should applaud,
policies in other countries that place the health and well-being
of people ahead of the profit goals of the prescription drug
industry. 

Hindering efforts to combat debilitating and fatal diseases on
behalf of the global prescription drug industry is an
unjustifiable and counterproductive use of our Nation's power and
influence. This amendment, Mr. Chairman, helps us to put a stop
to it. 

Mr. Chairman, I yield back the balance of my time. 

Mr. ROGERS. Mr. Chairman, I yield myself such time as I may
consume, and I rise in opposition to the amendment. 

Mr. Chairman, this amendment does not belong on this bill. It is
a subject for the Committee on Ways and Means. It is within their
jurisdiction. And they are objecting. In addition, the
administration is strongly opposing the amendment. It will bog
down this bill. 

So, for all of the foregoing reasons, Mr. Chairman, I am in
opposition. 

Mr. Chairman, I yield 2 minutes to the gentleman from Illinois
(Mr. Crane) the chairman of the Subcommittee on Trade of the
Committee on Ways and Means. 

Mr. CRANE. Mr. Chairman, I thank the gentleman for yielding me
the time. 

Mr. Chairman, I rise in opposition to the Brown amendment. The
Brown amendment compromises USTR's ability to protect U.S.
intellectual property rights around the world for U.S.
pharmaceutical companies and medical device manufacturers. 

Section 315 of the Uruguay Round Agreements Act clearly states
that it is U.S. policy to seek enactment and implementation of
foreign intellectual property laws that strengthen and supplement
TRIPS. The Brown amendment directly contradicts this provision,
conflicting with U.S. law. 

The pharmaceutical and medic al technologies industry depend on
consistent and fair trade rules, including those that protect
intellectual property rights. Without such practices, companies
and those who invest in them will be discouraged from providing
the necessary capital to pursue the development of new medicines. 

A consistent theme in U.S. trade policy is encouraging an
environment based on rule of law around the world that U.S. firms
need to be able to compete. The Brown amendment sends countries
conflicting messages that we would like them to provide the
highest degree of intellectual property protection in every
category except pharmaceuticals and medical technology. 

Ironically, the Brown amendment, which is intended to help poor
countries, will actually hurt them by reducing their ability to
attract foreign investment. Developing countries need the
transfer of technology and know-how for their economic growth and
stronger, not weaker, intellectual protection is the way to get
it. 

In short, the Brown amendment is the wrong solution to increasing
the access of developing countries to pharmaceuticals and medical
technologies. Instead of stripping U.S. firms of their legal
rights, we should seek to encourage partnerships between U.S.
pharmaceutical firms and developing countries. 

For example, several U.S. firms are already involved in pilot
programs to increase access to AIDS drugs in African countries.
Encouraging growing economies, as we are doing in the recently
enacted African Growth and Opportunity Act, also enables
developing countries to have the resources to purchase drugs
without discouraging further innovation. 

I urge my colleagues to oppose the Brown amendment. 

Mr. ROGERS. Mr. Chairman, I yield 1 minute to the gentleman from
New Jersey (Mr. Frelinghuysen), a hardworking member of our
committee. 

(Mr. FRELINGHUYSEN asked and was given permission to revise and
extend his remarks.) 

Mr. FRELINGHUYSEN. Mr. Chairman, I thank the gentleman for
yielding me the time. 

Mr. Chairman, I rise in opposition to this amendment. 

Mr. Chairman, we have a system of patents for a reason, to
protect intellectual property rights of the people who create new
inventions and products, as well as protect the efficacy of the
actual product. And the efficacy of drug products and medicines
are important. It is all about safeguarding patients, patients
around the world. 

Our U.S. Trade Representative, Charlene Barshefsky, has been
pursuing the enforcement of U.S. patent laws in virtually every
international market and she has done so effectively. As the U.S.
representative for the fair treatment of U.S. products anywhere
and everywhere in the world, this is her charge. 

This amendment basically tells that representative to stop doing
her job. That is not only wrong, it is dangerous. 

I know that the intent of the gentleman is to help those
suffering from horrendous diseases, such as AIDS and other
diseases in Africa and other places, by guaranteeing access to
prescription medicine at the cheapest cost. But, with all due
respect to the gentleman, this is not the way to achieve his goal
and he will not likely achieve his goal. 

                                       [Page: H5153]  GPO's PDF

Mr. ROGERS. Mr. Chairman, I yield the balance of the time to the
gentleman from California (Mr. Berman) the ranking member on the
Subcommittee on Courts and Intellectual Property of the Committee
on the Judiciary. 

Mr. BERMAN. Mr. Chairman, I thank the gentleman for yielding me
the time. 

Mr. Chairman, I have some concerns about this amendment. A year
ago, on the Commerce-State-Justice appropriations bill, we
debated the Sanders amendment dealing very specifically with
Asian and African countries applying specifically to
pharmaceuticals. 

The amendment now that we have before us seems to me to apply far
beyond pharmaceuticals to any medical technology. It could cover
laser equipment used in cosmetic surgery, prohibit the executive
branch from encouraging nations to provide TRIPS Plus protection
to patents which cover such laser technologies. 

It also seems like the Sanders amendment last year was designed
to make pharmaceuticals more affordable. It specifically was
approaching trade representative activities which enforced patent
laws that would make drugs more expensive. This does not have
that kind of limitation. 

The Brown amendment would prohibit the executive branch from
seeking to appeal a TRIPS compliant law covering IPR and
pharmaceuticals that is intended to discriminate against U.S.
pharmaceuticals. 

So a Western European law that has nothing to do with getting
drugs to Africa, which has nothing to do with dealing with the
crisis in Africa, but which is designed to discriminate against
U.S.-made pharmaceuticals or medical technologies, the USTR would
be prohibited from focusing on it if it did not violate TRIPS. 

I think that it may overreach in that regard, and that is why I
have some concerns about this amendment. 

The CHAIRMAN. All time has expired. 

The question is on the amendment offered by the gentleman from
Ohio (Mr. Brown). 

The amendment was rejected. 

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James Love, Director           | http://www.cptech.org
Consumer Project on Technology | mailto:love@cptech.org 
P.O. Box 19367                 | voice: 1.202.387.8030
Washington, DC 20036           | fax:   1.202.234.5176
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