[Ip-health] Re: [aidsdrugs] Abbott Abusive Registration Practices

Tue Mar 13 19:03:32 2007

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This is something that the World Health Assembly should address in
May.  Jamie

On Mar 13, 2007, at 3:11 PM, B.Baker@neu.edu wrote:

> Standing Up To Abbott's Decision to Withhold Registration and
> Marketing of
> Life-Saving Medicines - A New Variant of Pharmaceutical Apartheid
> Brook K. Baker, Health GAP
> March 13, 2007
>
> Abbott is now doing what drug companies have long threatened to do
> when
> developing countries use lawful flexibilities to access more
> affordable
> generic medicines - it is threatening to take its marbles and go home.
> Unfortunately, however, Abbott is not playing marbles, it is playing a
> deadly game of Pharmaceutical Apartheid, where drug companies withhold
> access to affordable life-saving medicines in a perverse effort to
> preserve
> intellectual property rights at all costs.
>
> Abbott is upset because Thailand has lawfully issued a compulsory
> license
> on an important antiretroviral medicine, Kaletra.  According to
> Abbott (and
> its think-tank apologists and Wall Street Journal defenders), Thailand
> issued this license without prior negotiations for a price discount
> or for
> a voluntary license.  However, contrary to Abbott's claim, both
> international law (the WTO TRIPS Agreement, Article 31) and the
> Thailand
> Patent Act permit Thailand to issue compulsory licenses for
> governmental,
> noncommercial use without prior negotiation.  Moreover, contrary to
> Abbott's claim, Thailand, like many other developing countries, had
> long
> engaged in fruitless negotiations with Big Pharma for deeper price
> discounts, but  Abbott used its monopoly power to unilaterally
> determine
> the price points for its tiered-pricing "access" program.
>
> Because Thailand has not caved into to threats and entreaties from
> Abbott,
> the USTR, certain members of Congress, and the international business
> press, Abbott has now raised the stakes further by withdrawing
> registration
> applications for the new heat stable form of Kaletra, an important
> AIDS
> medicine, and for six other medicines that it had submitted for
> marketing
> approval.  (The meltrex, heat stable form of Kaletra is especially
> important in warm country climates like Thailand were maintaining a
> cold-supply chain and ensuring that poor patients have access to
> refrigerators to store their medicines is virtually impossible.)
>
> This withdrawal is profoundly cynical and immoral.  A company which
> has
> been subsidized through NIH and university research for most of its
> discoveries, which gets huge taxes breaks for its research and
> development
> expenditures, and which earns monopoly profits on all its sales in
> rich
> country markets that collectively comprise 90% of global
> pharmaceutical
> sales, now determines that it will withhold marketing of life-saving
> medicines when a country seeks to exercise its lawful, TRIPS-compliant
> rights to access more affordable generic medicines.
>
> This withdrawal will make it much more difficult for Thailand to grant
> marketing approval for generic versions of Kaletra and other Abbott
> medicines because the Thai drug regulatory authority will not
> simply be
> able to compare the generic version against the innovator version to
> confirm that they are therapeutically equivalent.  In the worst case
> scenario, generic companies will now have to repeat costly, time-
> consuming,
> and ultimately unethical clinical trials to prove something that is
> already
> crystal clear - equivalent generic medicines are safe and efficacious.
> Even if Thailand decides to forego reliance on new clinical trials,
> it may
> instead have to amend its law so that it can rely on WHO pre-
> qualification
> and/or the fact of registration by a stringent regulatory authority
> elsewhere.  (Note:  The U.S. is trying to block Thailand's future
> right to
> legislate such reliance in its free trade agreement negotiation
> where it
> seeks five-years of data exclusivity.)
>
> However, even though Abbott will not necessarily by able to completely
> block registration of follow-on generics by its market withdrawals,
> its
> withdrawals will have devastating effects for those medicines for
> which
> there is no generic alternative at present.
>
> Thus, to prove its point, and to maintain its market and intellectual
> property hegemony, Abbott is willing to make Thailand and its
> patients a
> "no drug zone."  The predictable, inevitable consequence of this
> cynical
> power play will be the deaths of innocent patients.
>
> Drug companies like Abbott have all kinds of lame excuses for their
> murderous policies.  Novartis defends its patent law lawsuit in India
> because it wants to maintain its right to sell Glivec to middle-income
> patients, even though India represents only 1.3% of the global
> pharmaceutical market and even though 99% of Indians are not middle
> class.
> Pfizer wants to maintain its patent monopolies in the Philippines
> by filing
> frivolous lawsuits against government officials and generic
> companies who
> seeks to permit lawful early registration of generic medicines.
> And now
> Abbott, pulls a new "troop-surge" weapon from its arsenal - wholesale
> market withdrawals.
>
> Once again activists and thought leaders need to rally to the
> support of
> Thailand's lawful effort to access more affordable medicines and to
> condemn
> this latest variant of pharmaceutical apartheid.  One hopes
> fervently that
> Thailand will stand firm, that it will find alternative ways to grant
> marketing approval/registration of generic versions of Pharma
> products, and
> that even more developing countries will stand up and fight for the
> human
> right of access to essential medicines.
>
>
> 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)
>
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Knowledge Ecology International
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"If everyone thinks the same: No one thinks." Bill Walton"