Healthy Skepticism Library item: 8910
Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.
Publication type: news
Baker BK.
Abbott Withdraws Seven Medicines in Thailand
E-Drug 2007 Mar 14
http://www.essentialdrugs.org/edrug/archive/200703/msg00054.php
Full text:
A New Low in the Pharma Drug Wars – Abbott Withdraws Seven Medicines in Thailand
How low will drug companies go to protect their intellectual property
empire? We knew they would sue South Africa, the epicenter of the global
AIDS pandemic, to prevent comparison shopping for cheaper versions of brand
name drugs (parallel-importation case 1998-2001). We knew that they would
sue Indian the pharmacy of the poor, to try to ease legal standards to make
getting pharmaceutical patents for minor variations of existing medicines
even easier (Novartis v. India, 2006-2007). And now we know that they will
go even lower and withdraw pending registration applications for essential
life-saving medicines and boycott sales of all new medicines in Thailand
because Thai leaders dared to issue a lawful compulsory license on a
crucial, but over-priced AIDS medicine, Kaletra [ritonavir/lopinavir] (Abbott, March 13, 2007).
Abbott’s abrupt decision to withdraw seven pending registration
applications, including one for a new heat-stable form of Kaletra, and its
threat to make Thailand a no-drug zone for all new Abbott medicines is a
truly appalling example of corporate hubris. (The six other drugs are the
painkiller Brufen [ibuprofen]; an antibiotic, Abbotic [clarithromycin]; a blood clot drug, Clivarine [reviparine]; the arthritis drug Humira [adalimumab]; the high-blood pressure drug Tarka [trandalapril/verapamil]; and the Kidney disease drug, Zemplar [paricalcitol].) After touting itself to the be the engine of new life-saving discoveries, Abbott is now willing to withhold medicines altogether in order to extract even greater intellectual property concessions from developing countries.
Abbott falsely claims that Thailand has “broken patents and ignored the
patent system” when it issued its compulsory license. To the contrary,
Thailand has used a completely lawful flexibility under the WTO TRIPS
Agreement to issue compulsory licenses permitting non-commercial use of
essential medicines within its public health system. Abbott continues its
unfettered, high mark-up sales to rich Thai consumers and to medical
tourists who can afford higher price medicines in the private health care
delivery system. Moreover, Abbott is scheduled to receive royalties on
sales made to the public sector.
Article 31 of the TRIPS Agreement permits Thailand to issue a public,
non-commercial use license without prior negotiations, but Thailand had in
fact engaged in protracted but fruitless price negotiations with Abbott.
Instead of negotiating, however, Abbott has unilaterally offered to sell
Thailand Kaletra at its fixed middle-income tiered company price,
$2200/patient/year, a price that is 440% higher than the cost price Abbott
offers to African countries and more than five times as much as what will
be charged by generic producers once there are sufficient economies of
scale and competitive generic markets.
In order to provide alterative, life-saving anti-retroviral therapy to the
steady stream of patients who develop drug-resistence or suffer undue
adverse side effects from first-line therapies, Thailand determined that it
would have to find a cheaper source of supply. Thus, it issued a
compulsory license on Kaletra, as it had on another AIDS medicines,
efavirenz, and on a cardiovascular medicine, Plavix [clopidogrel].
Some industry pundits and Pharma allies in Congress wonder whether Thailand
is planning a wholesale assault on the patent system by granting compulsory
licenses for everything from erectile dysfunction drugs to patented facial
creams. Addressing these concerns, Thailand has publicly announced strict
criteria that will guide its compulsory licensing policy and has
established a Subcommittee to implement the Government Use of Patents. The
published criteria would limit compulsory licenses to drugs and medical
supplies that are listed on the National Essential Drug List or that are
necessary to solve important public health problems, to address emergencies
or matters of extreme urgency, to prevent and control the outbreak of
epidemics or pandemics, or to save lives. Accordingly to an additional
criterion, Thailand will seek government use licenses only when the price
of the particular medicine is too high to be affordable.
Applying these criteria, Thailand estimates that it will only consider
licenses for fewer than 15% of medicines – hardly a wholesale assault on
the patent system.
It would be bad enough if Abbott’s product withdrawals affected its
innovator products only, especially if there are not therapeutic
equivalents available. But, there is the additional risk that by
withdrawing the registration packets Abbott will succeed in preventing or
delaying the registration of generic equivalents by making it harder for
Thai drug regulators to confirm the safety and efficacy of the equivalent.
Because drug regulatory agencies often rely upon or refer to originator
data to grant marketing approval for follow-on products, this option is now
moot. Hopefully, Thai regulator will be able to rely on the original
Kaletra registration packet or on published data to support registration of
new generic heat-stable versions of Kaletra, but this option is by no means
certain.
This new tactic by Abbott in Pharma’s war for profits exceeds all previous
tactics. It directly violates the universal human right of access to
essential medicines. It directly violates both the letter and the spirit
of the Doha Declaration. It directly violates any conceivable norm of
corporate responsibility. It is in fact the equivalent of a tactical
nuclear device dropped into the middle of 580,000 people living with
HIV in Thailand. How low is too low – Abbott has let us see the
Pharma abyss.
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)
B.Baker@neu.edu
[Generic names added to text by moderator.BS]
