[Ip-health] US Action Plan for Thailand comes straight from Pharma

[B.Baker@neu.edu]

US Action Plan for Thailand comes straight from Pharma

May 9, 2007

After placing Thailand on its 2007 301 priority watch list for an alleged
"lack of transparency and due process" in issuing compulsory licenses and
"its weakening respect for patents," the USTR has shown its true colors in
its reported May 8 "Action Plan" for Thailand.  Because the U.S. cannot
back up its claim that Thailand violated the international TRIPS agreement
or Thai law and because it cannot even explain how Thailand's repeated
negotiations with drug companies and publication of a 100-page rationale
for its compulsory licenses violated any known norms of transparency and
due process, the USTR has turned to its true agenda - acting as a bullyboy
for Big Pharma in imposing even stronger patent and data-related monopolies
on Thailand.  In a truly ironic twist, the USTR has failed to publicly
disclose its Action Plan in advance of its meeting with the Commerce
Ministry on May 14, showing how strongly it values the alleged principle of
"transparency."

The US previously sought similar "action" terms in its free trade agreement
negotiations with Thailand.  At that time, in February of 2006, AIDS
activists and others protested vigorously against the USTR's pro-Pharma
agenda and temporarily halted trade negotiations in Chang Mai.  Now,
fifteen months later, the US has dressed up its FTA demands and repackaged
them as an "Action Plan," where Thai acquiescence is allegedly necessary to
remove Thailand from the priority watch list and from the escalating threat
of US trade sanctions.

A close look at the alleged details of the Action Plan shows how the USTR
is carrying water for Big Pharma.

First, the USTR seeks patent term extensions for regulatory delays in
issuing patents or in registering medicines.  Although patent terms already
run for a long 20 years, more is better for drug companies like Abbott and
Merck that would like to have the right to charge monopoly prices and
exclude generic competitors for an even longer period of time.

Second, the USTR is seeking a five-year period of "data exclusivity",
during which the Thai Food and Drug Administration would be prevented from
relying upon data previously filed by the innovator in order to validate
the safety and efficacy of equivalent generic products.  Instead, as the
USTR and Pharma are fond of saying, the generic companies would be "free"
to conduct costly, time-consuming, and ultimately unethical clinical trials
to prove through other means what is already provable - namely that a
generic that proves its therapeutic equivalence is just as safe and
efficacious as an already marketed product.  Not satisfied with just five
years of data exclusivity, the USTR/Pharma team is demanding that Thailand
to add on another three years any time a drug company submits new clinical
data to register a new formulation or a new use of an existing product.
Data exclusivity is especially important to Pharma because sometimes drug
companies do not even bother to file patent application on unproven medical
innovations in smaller and poorer countries.  They would rather wait until
the product is fully developed and marketable to have another monopoly
system beside patents to exclude generic competition.  That other system is
data exclusivity.

Related to data exclusivity is the third restriction provision,
patent/registration linkage, which turns the Thai Food and Drug
Administration into a patent enforcement agency by requiring it to prevent
registration of a follow-on generic product if a prior registrant claims
that its patent(s) would be violated.  Although the FDA is in no position
to confirm the merits of the drug company's patent claims, it assumes the
burden of protecting patents even though the patent holder already has full
means to protect its patent claims via infringement proceedings.

Fourth, the USTR wants to limit the grounds upon which compulsory licenses
can be granted to national emergencies, competition cases, and public,
non-commercial use.  This restriction is ironic in the current environment
where both Abbott and the US are retaliating against Thailand for having
actually issued one of the US-preferred licenses - those for public,
non-commercial use.  Clearly, Thailand and other countries can and should
issue licenses on these three grounds, but they should also be free to
issue compulsory licenses on other grounds as confirmed both by the TRIPS
Agreement and by the Doha Declaration on the TRIPS Agreement and Public
Health.  They should also be free to make clear that their compulsory
licenses override the monopoly bars posed by data exclusivity and
patent/registration linkage provisions described above.

Fifth, the USTR is seeking to expand the required subject matter of patents
by requiring that Thailand grant licenses on "plants and animals," on
"diagnostic, surgical and medical procedures," and on "new uses of existing
products."  In addition to now requiring that Thailand give up patent
subject exclusions that are permissible under TRIPS, the USTR is pursuing
Pharma's agenda of being able to evergreen patents by claiming successful
new uses of existing medicines.

Sixth, the USTR is seeking to prevent the use of pre-grant opposition
procedures that help forestall the granting of weak or frivolous patents by
allowing other interested parties to provide relevant information to the
Thai patent office.  These procedures are currently being used to good
effect in India both by generic companies and civil society activists.

The USTR, acting as the handmaiden for Big Pharma, is seeking to restrict
Thailand's right to use TRIPS- and Doha-compliant flexibilities for
accessing more affordable medicines to sustain its comprehensive,
public-sector supported health care program.  Simultaneously, the USTR is
seeking to punish Thailand for using one of the few flexibilities, public
non-commercial use licenses, that the USTR would theoretically leave on the
table.

Make no mistake - Abbott, Merck, Pfizer and the other big drug companies
don't want an even playing field, they want monopolies so that they can
sell high-price drugs to rich people in poor countries even if the non-rich
must go without.  Rather than stand up for the human right of access to
medicines, the USTR has once again chosen the side of the hugely
profitable, transnational pharmaceutical industry.

To counteract this pressure, Thailand, its Commerce Ministry, and its
people must stand firm against the US's hypocrisy and coercion. They must
also continue to be supported by other developing countries and activists
and by opinion leaders such as former President Clinton who just yesterday
defended Thailand's right to issue compulsory licenses.

Professor Brook K. Baker, Health GAP
Northeastern U. School of Law
Program on Human Rights and the Global Economy
400 Huntington Ave.
Boston, MA 02115
617-373-3217 (office)
617-259-0760 (cell)