February 16, 2005
109th Congress, 1st Session
Issue: Vol. 151, No. 17 — Daily Edition
[Pages S1498-S1499]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]
THE DOHA DECLARATION AND THE TRADE PROMOTION AUTHORITY ACT OF 2002
Mr. KENNEDY. Mr. President, the Trade Promotion Authority Act of 2002
gives the President and the U.S. Trade Representative the power to
negotiate bilateral and multilateral trade agreements that must be
given expedited consideration by Congress. The Doha Declaration was
adopted by the World Trade Organization at the Fourth Ministerial
Conference at Doha, Qatar, on November 14, 2001, and addresses the need
for access to medicines for all and how to reconcile that need with
intellectual property protections.
When the Trade Act came to the floor of the Senate, Senator Feinstein
and I offered an amendment to the section on the negotiating objectives
of the United States in trade negotiations. Our amendment made it a
principal objective of the United States to respect the Doha
Declaration in all trade negotiations. Regrettably, in several trade
agreements since then, administration has refused to fulfill this
obligation.
The basic issue was the interpretation of the so-called TRIPS
agreement on intellectual property protections such as patents and
copyright. The Doha Declaration specifically states that the TRIPS
agreement “does not and should not prevent members from taking
measures to protect public health.” It recognized the need to
interpret and implement TRIPS in a way that supports a nation’s “right
to protect public health and, in particular, to promote access to
medicines for all.”
The Doha Declaration went on to specify that “[e]ach member country
has the right to grant compulsory licenses and the freedom to determine
the grounds upon which such licenses are granted.” It stated that each
member nation is “free to establish its own regime” on whether a sale
of a patented product by the patent owner or licensee exhausts the
patent, so that it cannot be asserted against subsequent purchasers or
users of the product.
The Doha Declaration recognized a basic principle–poor people in the
developing nations often cannot afford many patented drugs, even though
the drugs are their only hope for surviving AIDS and other serious and
life-threatening diseases.
The Doha Declaration is clearly intended to prevent patents from
blocking access to life-saving drugs. Developing nations obviously do
not have the capacity to manufacture drugs themselves, and they must be
free to purchase these drugs from another country.
Our amendment to the Trade Promotion Authority Act reinforces the
Doha Declaration. The Bush administration should be using it to
negotiate trade agreements that allow urgently needed access to
medicines. Instead, the administration has used trade agreements to
promote the interests of the pharmaceutical industry at the expense of
access to drugs in developing nations.
Again and again, the administration has defied the Doha Declaration
and imposed unjustified restrictions on the availability of patented
drugs. They’ve done it on trade agreements with Australia, with Jordan,
with Morocco, with Singapore, and other nations. In these agreements,
the Bush administration has undermined the very core of the Doha
Declaration. They’re trying to do it now in the Central American Free
Trade Agreement.
They block the approval and use of generic version of drugs. They
prevent new treatments for HIV/AIDS from getting to the people of the
developing world.
It’s an outrageous policy. The administration has made it U.S. policy
to block affordable, life-saving drugs for AIDS for the people of
Central America, because they feel it’s more important to protect the
profits of brand name drug companies..
The administration is defying the statutory requirement of the Doha
Declaration, that our objective in these agreements must be to
guarantee access to essential drugs for the sick and the poor in the
developing nations of the world.
They use countless legal tactics to cause delays in the approval of
generic drugs in developing countries, even
[[Page S1499]]
when patents are invalid or are not infringed at all by the generic
drug. In essence, the administration has set up a bottleneck to prevent
approval of generic drugs in many countries of the developing world.
That’s completely at odds with the Doha Declaration.
U.S. law allows a generic drug company to use a patented drug to
develop a generic version of the drug before the patent has expired. It
takes time to develop a drug, test it, and have it reviewed by the FDA.
The theory of the law is that a generic drug company should be able
to complete this approval process before the patent expires, so that
developing countries can get generic versions of drugs as quickly as
possible.
That process is permitted by TRIPS, which means it is permitted by
the trade agreements the administration has negotiated. It is not
required by those agreements, however, and the administration has not
tried to include it. In fact, they give brand name drug companies the
opportunity to block that process in each of these developing
countries. It’s another example of the administration cynically
protecting the interests of the brand name drug companies in violation
of the law.
The administration claims that its tactics are consistent with
another objective of the Trade Act, which is to seek standards for
intellectual property protection and enforcement in other countries.
That’s true, but it’s in the same provision in the act as the Doha
Declaration.
The administration has a good track record in protecting the brand
name drug industry, but it has never gotten even one provision that
respects the Doha Declaration. Selectively interpreting laws to apply
one provision and ignore another is unacceptable.
It’s no secret that the brand name drug companies want better patents
and longer exclusivities in the United States. But it’s wrong for the
administration to side with them in trade agreements that defy the Doha
Declaration.
The administration has systematically blocked Congress from changing
intellectual property protections except in ways that benefit brand
name drug companies. It gets even worse. When brand name drug companies
successfully lobby for protections under the laws of our trading
partners that are greater than those under U.S. law, the industry then
argues that the United States should “harmonize” its intellectual
property protections with those of our trading partners. That’s a slap
in the face to Congress and the American people. They should not be
forced by the Bush administration to endure even higher drug prices
than they do today.
The question is: What should be done to put real teeth in Doha
Declaration in trade negotiations?
First, the administration should follow U.S. law and respect the
declaration in future negotiations, such as those about to begin with
the nations of the Andes. It should immediately stop seeking
intellectual property protections that prevent access to medicines for
all and should start to seek those that promote greater access to
medicines for all.
Second, the negotiators for countries of the developed and developing
world should stop every time the U.S. Trade Representative asks for an
intellectual property provision, especially one directed specifically
at drug patents or drug data exclusivity, and ask how that provision
affects access to needed drugs.
The U.S. Trade Representative should not be surprised if negotiators
from developing nations refuse to accept restrictive provisions that
violate the Doha Declaration. They should challenge our Trade
Representative to obey the rule of law.
And here in Congress, we have to do a better job of insisting that
our trade agreements comply with the letter and the spirit of the Doha
Declaration. It’s the law of the land, and it’s a matter of life and
death for hundreds of millions of people in other lands. The tactics we
are so shamefully using against them can only breed greater resentment
and greater hatred of the United States. And we can’t afford to let
that happen at this critical time in our role in the world.
I ask unanimous consent that a brief description of provisions in
trade agreements that violate the Doha Declaration be printed in the
Record as a technical appendix.
There being no objection, the material was ordered to be printed in
the Record, as follows:
Technical Appendix to Statement of Senator Edward M. Kennedy on the
Doha Declaration and the Trade Promotion Authority Act of 2002
Compulsory Licensing and Parallel Trade
The Administration has successfully imposed restrictions on
the right to compulsory license medicines in the trade
agreements with Australia, Jordan, and Singapore. The
Administration has obtained provisions that can block
parallel imports in trade agreements with both developed and
developing nations, such as Australia, Morocco, and
Singapore. For the Doha Declaration to work, both developed
and developing countries must be able to issue compulsory
licenses and then engage in parallel importation of the drug
from the developed country that can manufacture the drug to
the developing country whose people need the drug, yet these
agreements undermine both compulsory licensing and parallel
importation.
Data Exclusivities
The Administration has also pursued data exclusivities to
protect brand name drugs in trade agreements with Australia,
Bahrain, Chile, Jordan, Morocco, and Singapore, and now seeks
them in the Central American Free Trade Agreement. To receive
authorization to market a drug, many countries, like the
United States, require the drug manufacturer to present data
to show that the drug is safe and effective for its intended
use. The clinical trials to produce these data can be quite
expensive, and protecting these data for a period of years–
meaning that the data may not be used to approve another,
similar product–can create an incentive for and protect the
investment in producing them.
In the developing world, however, data exclusivities
prohibit a country from approving even a compulsory licensed
version of a patented drug. The trade agreements that require
exclusivities provide no mechanism to allow for distribution
of compulsory licensed products notwithstanding the
exclusivities. The exclusivities therefore will block
compulsory licensed versions of the new treatments for HIV/
AIDS and other serious diseases from getting to the people of
the developing world, at least until the data exclusivities
have expired.
Linkage between Patents and Drug Approval
Most recently, the Administration has also negotiated for
provisions in trade agreements with the countries of Central
America that link approval of generic drug products to the
status of patents on the pioneer drug product. In other
words, approval of generic drugs is blocked if there are
patents and the government approval agency has not
ascertained whether the generic product infringes a brand
name drug patent.
In the United States, approval of a generic drug is blocked
because of a patent only if the brand name company sues to
defend the patent. The obligation is not on the Food and Drug
Administration, which has repeatedly stated that it has no
capacity to assess or evaluate patents. The Administration’s
trade agreements place the responsibility to defend brand
name drug patents on the FDA’s of the developing nations,
which we can only assume are more overburdened than our own
FDA and similarly lack the expertise to assess and evaluate
patents. The inevitable result will be delays in the approval
of generic drugs in developing countries caused by patents
that are invalid or that are not infringed by the generic
drug.
The Bolar Amendment
In the United States, the Bolar Amendment allows a generic
drug company to use a patented invention to develop a generic
version of a drug before the patent has expired because it
takes time to develop and test a drug and have it reviewed by
the FDA and a generic drug company should be able to complete
this process before the patent has expired.
Without a Bolar provision, a drug patent is arbitrarily
extended because of the time needed for drug formulation and
approval. The Bolar Amendment in a developing country will
improve timely access to medicines for the sick and poor. The
Administration has not sought to mandate the Bolar provision
in trade agreements, however.