E-drug: GATT and the Gap: How to Save Lives
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by John S. James
[kindly forwarded by Richard Laing]
This year's World AIDS Conference (Geneva, June 28 - July
3, 1998) chose the theme "Bridging the Gap"--the gap between
the lifesaving treatment advances for about 10% of people
with AIDS or HIV in rich countries, and the other 90% in
developing countries who have no access to modern HIV care.
Despite the work of many organizers, it was clear at the
conference and afterwards that the world as a whole is doing
very little about this lack of medical care (see "'Bridge the
Gap?' Or, 'Cut the Crap!'," Project Inform Perspective #25,
September 1998, available at
http://www.projinf.org/pub/25/gap.html). Before the speeches
of World AIDS Day, on December 1, again recount this grim
reality, we want to suggest a new target for AIDS activism--
the rules of international trade--where the work of a small
number of people might save many lives.
Until recently, pharmaceutical patents and other
intellectual property restrictions on life-saving and other
medications were widely recognized among major industrialized
countries, but the system did not care very much if poor
countries quietly manufactured patented medicines like AZT
without permission when necessary. The patent holders' losses
were negligible, since otherwise there would have been almost
no sales anyway, as the people and governments who needed the
medicines could not afford them and would only have been
forced to do without. And these low-cost products took little
if any market share in rich countries, since few people pay
for expensive drugs out of pocket, and the government health
plans, pharmacies, distributors, private insurance, and
managed-care companies which do pay cannot use illegally
imported medications. (In over 10 years of publishing AIDS
Treatment News, we never heard of any U.S. resident obtaining
AZT or any other antiretroviral which was manufactured
without authorization of the patent holder.)
But today the system has changed. Not only are there major
international efforts to stamp out all pharmaceutical
"piracy" anywhere, regardless of the circumstances and the
human cost, but these efforts go far beyond unauthorized drug
manufacture to impose other restrictions as well. The U.S. in
particular has taken the lead in trying to force even the
poorest countries throughout the world to sacrifice their
public health and the welfare of their people, whenever
necessary to preserve the interests (even only symbolic
interests) of multinational corporations. U.S. government and
industry even try, with mixed success, to force other
countries to obey rules that the U.S. does not follow
domestically.
These changes resulted mainly from GATT, the Global
Agreement on Tariffs and Trade, which was signed by over 120
countries several years ago. GATT, intended to improve the
world economy by rationalizing trade and other economic
rules, requires all countries to change their laws when
necessary to meet a whole list of conditions, all of which
are mandatory. GATT created the World Trade Organization
(WTO), headquartered in Geneva, to resolve enforcement
disputes--and basically established a regime such that any
country in the world which chooses to run its own affairs
differently can face ruinous economic warfare by WTO members.
GATT is not all bad. It was supposed to create trillions of
dollars of additional wealth in the world (and may have done
so, before the current world economic crisis). Many
developing countries have better rights under GATT than then
could get if forced to rely on bilateral negotiations with
much more powerful nations. GATT can often be used to
support, as well as to oppose, measures which advance human
health in poor countries.
Intellectual-Property Abuses
The problem is that the system is not evenhanded. As with
most such efforts, the rules are distorted to favor the
interests of the rich and powerful--multinational
corporations, big investors, and large industrialized
countries. The poorest nations and peoples are the biggest
losers.
The result is a growth of what might be called 21st century
tribute. In traditional tribute, vassal states had to pay
extortion money to their conquerors. Today, tribute payment
is usually made not through lumps of gold, but through
submission to biased rules which poison the future of the
weak to unjustly enrich the strong.
Probably the worst single feature of GATT was the decision
to include pharmaceutical patents--effectively locking in a
system which cuts off most of the world's population from
almost all access to new medicines, until 20 years later when
the patents expire. No one can fully tabulate the human
costs, because of the overall complexity; for example, high
pharmaceutical prices are not the only major barrier to
better medical care. Perhaps the most pernicious consequence
of the GATT/WTO system is that many creative advances in
medical care for poor countries cannot move at all, because
they might cross the rights of too many parties, some of
which will require prohibitive royalty payments, or
prohibitive costs for legal research and negotiation.
It is likely that the GATT/WTO inclusion of pharmaceuticals
will kill many millions of people, as companies increasingly
price their proprietary medicines for rich countries and tiny
elites exclusively, with most forms of relief now legally
prohibited throughout the world.
What Can Be Done?
It may be impossible to change the GATT treaty itself,
because so many countries willingly or unwilling signed on.
But still it would be surprisingly feasible for an activist
movement to save lives.
The reason is that GATT is not only a fixed, static body of
rules, but is constantly being litigated and otherwise
applied in thousands of specific cases. In this ongoing
activity under the trade rules, the U.S. (the "world's only
remaining superpower") has consistently been an extremist in
trying to force unworkable conditions on other countries--
resulting in ongoing disputes with countries representing
most of the people of the world. ??
The reason for the U.S. extremism in this area is that
Congress, the White House, the U.S. Trade Representative, and
others usually hear from only from one side--multinational
corporations, their industry associations, and other
organizations which have been paid or pressured to echo their
line. Usually no one even addresses any other side--
effectively turning the U.S. government into a tool of
corporate interests. When abuses occur--for example, when a
major pharmaceutical company got Senator Jesse Helms to
obstruct an unrelated treaty, in order to punish South Africa
for passing a domestic law which could be interpreted to give
the public health and welfare of South Africans priority over
the intellectual property interests of multinationals--or
when policy makers abroad are given misleading information,
such as copies of a U.S. law but with a key section omitted--
the U.S. public seldom hears anything about it.
Access to health care when life and death are at stake
could become a world-class moral issue, like the
international campaign against apartheid. But meanwhile, even
a far smaller movement could restrain some of the worst
excesses, by exposing abuses and forcing debate on the
merits.
The current problems of intellectual property and treatment
access may have resulted partly from oversight. A few years
ago this writer attended an AIDS meeting where another
participant happened to be an intellectual-property
professional. I asked about the effect of GATT on treatment
access in poor countries. He seemed startled to hear about
that possibility, and said that it had never occurred to him
before. Apparently the effect on treatment access was not a
significant part of the discussions leading up to GATT--which
we have heard was originally intended to not include
pharmaceutical patents.
This issue is winnable because the powerful pharmaceutical
industry need not be the enemy. Industry gains nothing, and
only loses, from condemning most of the world's people to
lack of access to modern treatment even when they need it to
save their lives. Surely the human race, and the companies as
well, can do better than that. The problem is that
corporations tend to act on autopilot, with mid-level
managers habitually seeking short-term gain, oblivious to
long-term consequences, including effects on the company's
reputation. Much can be gained without pressuring companies
to go against their interests--only to stop and think about
what they are doing and what their interests are.
For More Information
In our experience, the hardest part of engaging this issue
was knowing where to begin. The following can help others get
started.
* The leading U.S. organization on international
intellectual property and consumer protection is the Consumer
Project on Technology, an organization created by Ralph
Nader; see their Web pages on intellectual property and
health care (http://www.cptech.org/ip/health), which have
collections of background papers on international and other
issues (including U.S. pricing of pharmaceuticals). CPT has
additional information, and was able to supply us with
documents on South Africa and the dispute between President
William Clinton and President Nelson Mandela about
pharmaceuticals and intellectual property, during Clinton's
visit to that country in 1998. (Much of this information came
from Freedom of Information Act requests to the office of the
U.S. Trade Representative.)
* Health Action International (HAI) is "a non-profit,
global network of health, development, consumer and other
public interest groups in more than 70 countries working for
a more rational use of medicinal drugs"; see
http://www.haiweb.org.
* The treatment access forum, an electronic mailing list on
AIDS treatment access for the developing world was started by
organizers of the World AIDS Conference in Geneva. For more
information, including an archive of previous postings, see
http://www.hivnet.ch:8000/treatment-access/tdm.??
* Some law firms which advise clients on international
intellectual property have Web sites anyone can use, with
background articles and news bulletins in this field. Of
course these are written from a corporate viewpoint, but they
are professionally authoritative. For example, see the Ladas
& Parry site, http://www.ladas.com.
* The U.S. Trade Representative Web site is
http://www.ustr.gov. The U.S. Trade Representative is a
member of Clinton's Cabinet.
* You can find other Web pages by using the search engine
of your choice (for example, www.metacrawler.com). Some of
the following search terms may be helpful; and often the Web
pages they return will have other terms for additional
searches reflecting your interests. The same list may also
help reporters, librarians, and others with access to
searchable archives of news stories.
Some search terms for learning more about pharmaceutical
intellectual property and world trade issues:
WTO (or World Trade Organization)
GATT (or Global Agreement of Tariffs and Trade)
TRIPS (or Trade Related Aspects of Intellectual
Property Rights, which is a section of GATT)
U.S. Trade Representative (see explanation above)
Special 301 (A provision in U.S. law which requires the
U.S. Trade Representative to create an annual watch list of
countries for possible retaliation for not adequately
protecting U.S. intellectual property rights; this year about
40 countries are on the list.)
PhRMA (or Pharmaceutical Research and Manufacturers
of America, representing about 100 U.S. pharmaceutical
corporations--a major opponent of liberalization of
pharmaceutical intellectual-property restrictions; see
http://www.phrma.com)
Data exclusivity (forbidding the use of data submitted
to regulatory authorities--even if publicly available--for
approval of other companies' drugs)
Compulsory licensing (the practice of governments requiring
patent holders to license their rights in an emergency. The
U.S. has pressured countries to end compulsory licensing,
making it more difficult for doctors to obtain medications
for their citizens.)
Turmeric; Neem; and other medicinal plants (on the issue
of multinational companies patenting plants which have been
used in traditional medicine for centuries; fortunately, such
U.S. patents are now being overturned by courts, which are
recognizing the prior traditional uses, although the U.S.
Patent and Trademark Office did not.??)
Parallel importing (whether a country can import
authorized patented drugs, originally sold by the patent
holder at discount to distributors in large markets who have
more negotiating power than many small countries, then resold
without the patent holder's permission. Parallel importing is
related to the doctrine of "exhaustion of rights" of the
patent holder by the first sale, which is neither supported
nor opposed by GATT ??).
Bolar provision (a provision in U.S. law which allows the
use of patented drugs (purchased on the open market) for
medical research, without the approval of the patent holder.
Generic drug companies can then prepare bioequivalent
products near the end of a patent term, so that they will
have low-cost generics ready to go as soon as the patent
expires. Some U.S./multinational pharmaceutical companies
want to stop other countries from using this strategy to
reduce drug costs.)
Trade dress (color and appearance of pills or other
medicine. By trademarking the appearance, companies can
create disincentives to the substitution of generics, because
of the risk that public confusion could cause dangerous
medication errors)
Medicines and Related Substances Control Amendment
(South African law strongly opposed by PhRMA)
Nkosazana Zuma (South African health minister, advocate
of wider use of generic drugs and other public-health
reforms)
Other search terms: Intellectual property;
Pharmaceutical; Names of specific countries; 1998; etc.
--
John S. James
AIDS Treatment News
phone 415-861-2432; fax 415-255-4659
jjames@aidsnews.org
id
Richard Laing Associate Professor Department of International Health
Boston University School of Public Health 715 Albany St Boston MA
02118-2526 Tel 617 414-1444 Fax 617 638-4476
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