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Why boycott Abbott ? |
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Professor Brook K. Baker, Health GAP
Northeastern U. School of Law
Program on Human Rights and the Global Economy |
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1. What kind of effects it can causes to the health public in Thailand and
in the world?
Abbott's decision to withdraw seven registration packets on new medicines
in retaliation for Thailand's issuance of a lawful government-use license
creates unprecedented risks for global health.
Firstly, Abbott has withdrawn registration of a Meltrex (heat-stable) form
of Kaletra (marketed as Aluvia), which is one of the most important
second-line anti-retroviral medicines in the world. This medicine is the
only one that directly combines ritonovir, a so-called booster, with a
protease inhibitor in a single tablet, thereby easing patient compliance
and supply chain management. Because the old, still available form of Kaletra is not heat-stable, it requires a cold-supply chain and
refrigeration in tropical countries like Thailand. Of course, such
conditions are nearly impossible to provide even in urban centers in
Thailand, let alone in rural regions. Accordingly, AIDS patients who
develop drug resistance or who suffer adverse effects from first-line
therapies will have little practical access to an essential life-saving
medicine.
Secondly, Abbott has raised retaliatory, patent-protection tactics to a new
level, sending a powerful message to developing countries everywhere that
they should not use lawful flexibilities for accessing more affordable,
generic versions of patented medicines even if national and international
law permits them to do so. Thailand's compulsory licenses, issued to
permit government non-commercial use of efavirenz, another AIDS medicine,
Plavix, a heart-disease medicine, and Kaletra, were completely lawful under
the Thai Patent Act and under the WTO TRIPS Agreement. Pursuant to Article
31 of the TRIPS Agreement and pursuant to the Doha Declaration on the TRIPS
Agreement and Public Health, signed by all WTO members, including the U.S.,
in November of 2001, governments are free to choose the grounds upon which
to issue compulsory licenses. When they do so to provide government,
non-commercial use and to address an emergency or matter of extreme
urgency, they are permitted by Article 31 to grant the license without any
prior notification or negotiations with the patent holder. Paradoxically,
U.S. law contains these same no-negotiation provisions, 28 U.S.C. sec.
1498(a) and U.S. Executive Order 12899, sec. 6, both of which relieve the
U.S. government and its contractors of any obligation to negotiate with a
patent holder before making public use of any patented product. It is
ironic that the U.S. and its pharmaceutical industry chide other countries
for doing exactly what is permissible under U.S. law. An even greater
irony in this case is that the Thai government had sought price
negotiations with Abbott unsuccessfully for nearly two years before issuing
the compulsory license. Instead of negotiating, in August of 2006, Abbott offered a unilateral price of $2200 per year to middle-income developing
countries like Thailand, 440% higher than the $500 per year price offered
to African and lower-income countries.
Although the U.S. and other developed countries promised developing
countries that they had flexibilities to address their public health needs,
they both tolerate and encourage their multinational drug companies to
threaten and institute lawsuits against developing countries like Thailand
that boldly use completely lawful flexibilities. This new and
hyer-aggressive tactic by Abbott means that developing countries risk being
stuck with monopoly-based prices and unilateral price discount decisions by
Big Pharma as their only means for accessing newer medicines. This is turn
means that poor people would have to wait decades (20 years for the patent
to expire and additional years for the generic alternative to be developed)
before they have access to the newest life-saving medicines.
2. Are these Abbott medicines important for the public health is possible
to change them for other medicines?
I've discussed the importance of Aluvia above, and emphasized that there is
no two-drug combination equivalent that could be substituted. Likewise,
the other medicines being withheld might also be important, though
information gathering on their alternatives in not yet complete. The other
withheld drugs include a pain medicine (Brufen), an antibiotic (Abbotic), a
blood clot medicine (Clivarine), an arthritis medicine (Huira), a
high-blood pressure medicine (Tarka), and a kidney disease medicine
(Zemplar). Of course, Abbott has also threatened to withhold any future
discoveries from the Thai market as well.
3. What kind of measures you think that the Thai government should study
after this decision?
Frankly, I think the Thai government should consider the possibility of
bringing a competition case against Abbott under Section 25(3) of its
Competition Act for unlawfully "restricting ... distribution, deliveries,
or importation without justifiable reasons." As a dominant company in the
market for boosted protease inhibitors and as the patent-holder for a
significantly improved, heat-stable version, Abbott has abused it economic
power. Simultaneously, it is violating Thai people human rights of access
to essential medicines.
In addition, I think the Thai government should continue to pursue its
policy of selectively choosing medicines for which compulsory licenses
should be granted and should further refuse to back down to Abbott's
blackmail. Although Abbott may offer price discounts, it should not get
off the hook so easily. Thailand should insist that Abbott grant voluntary
licenses to qualified generic producers who can then compete to produce and
sell Kaletra at prices matching or lower than Abbott's.
4. What kind of effects it can cause for the countries that are studying
the government use of patents on essential drugs, as Thailand have done?
I've discussed this issue above. In sum, some countries that are exploring
the issuance of government use licenses are likely to be intimidated by the
prospect of product withdrawals and the possibilities of protracted
lawsuits. Thus, they will neglect to amend their laws to permit maximize
use of TRIPS-compliant flexibilities for accessing medicines, and/or they
will hesitate to use the flexibilities that they have.
However, other countries, including Brazil, could also take heart from the
Thai example. On three separate occasions, the Brazilian government
threatened to issue compulsory licenses only to back down and settle for
price discounts. In each instance, including with Abbott, Brazil settled
for a price that was higher than what its own manufacturers would charge.
For example, in the case of Abbott, Brazil is paying $.63 pill for Kaletra
whereas Brazilian manufacturers were reported to be capable of producing
Kaletra for $.42 pill. Instead of settling for price discounts, developing
countries should cooperate to create patent pools and other mechanisms for
creating a robust and competitive generic market for fulfilling global
demand for essential medicines.
Do you think that this Abbott decision is going to be "an example" for
other industries?
I don't think that this will be an example for other industries, but I fear
it will be an example for other drug companies. We already know that
Novartis has just sued India to making patenting of minor variations of
existing drug easier. We know that Pfizer has recently sued the government
of Philippines to prevent early working (registration) of patented drugs
and that it has sued distributors in Kenya to prevent parallel importation.
We know that this same drug industry was previously willing to sue the South Africa government from 1998-2001 to prevent parallel importation of
cheaper medicines and that it seek to put developing countries on the U.S.
Special 301 Watch List every year if they don't acquiesce to Pharma's
market hegemony. Lastly, we know that this is the industry that convinced
to U.S. to begin a WTO trade complaint against Brazil in 2001, only to
withdraw it in response to worldwide condemnation. The multinational drug
industry has decided to mount a new offensive in its war for market
domination, for every higher intellectual property protections, and for
non-use of existing flexibilities for accessing cheaper medicines. To win
this new Pharma War, developing countries, AIDS and human rights activists,
and medical providers around the world are going to have to condemn
Abbott's product withdrawals. In the long run, they are also going to have
to create a different system for ensuring access to medicines innovations. |
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