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Saturday, February 16, 2008
Carl Horowitz :: Townhall.com Columnist
Breaking Our Patents Abroad: How Not to Promote Affordable Drugs
by Carl Horowitz
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The South African government has been of a like mind. About a decade ago, it passed a law to override existing patents in order to "determine that the rights with regard to any medicine under a patent granted in this Republic shall not extend to acts in respect of such medicine." The new law also allowed the government to license domestic companies to produce generic drugs at far lower prices, following payment of a fee to affected companies. Several dozen pharmaceutical firms doing business in that country challenged the law in court, but sustained so much public-relations damage that they dropped the suit.

Undoing the problem is easier said than done. Legalized patent infringement is woven into the World Trade Organization-administered Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) of 1994 and its more onerous successor, the Doha Declaration of 2001. The latter document explicitly authorizes governments, under cover of national emergency, to issue compulsory licenses without securing the permission of patent holders, so as "to promote access to medicines for all." Apparently, "free trade" doesn't refer to the freedom of U.S. pharmaceutical corporations to operate profitably in Third World countries.

Not surprisingly, the United Nations, hardly a reliable defender of American sovereignty, also has pulled this stunt. In the spring of 2000, following weeks of discussions with U.N. officials, several U.S. companies agreed to sell their products at prices well below even already-discounted levels. "It's the first time the companies are collectively willing to discuss a truly significant decline in prices," said Peter Piot, director of the U.N.'s AIDS program. "It is something many of us have long hoped for."

The Interfaith Center on Corporate Responsibility applauds such strong-arm practices. In November 2006, the center released an update of its "Benchmarking AIDS" study, lamenting the lack of progress by drug companies in providing "access" to essential medicines. The report did find room to congratulate the Thai government for issuing compulsory licenses for producing generic Kaletra. Yet such actions have consequences. Early in 2007, Abbott Laboratories pulled Kaletra and six other drugs out of Thailand. True to form, Christian Brothers Investment Services, an ICCR affiliate, condemned Abbott's decision rather than the action precipitating it. The ICCR, the Access to Medicines Project, Doctors without Borders, and other defenders of Third World regimes want patent protection to take a back seat to social justice.

In our own country, a drug company's main worry may be revocation. And it's already happened. On January 23 of this year, the U.S. Patent & Trademark Office revoked four key patents held by Gilead Sciences on its HIV/AIDS retrovirus drug, tenofovir disoproxil fumarate (TDF). The left-leaning Public Patent Foundation had challenged the validity of the patents, claiming that TDF's chemical properties had been known before Gilead had filed its applications.

One can't lose sight of the fact that millions of lives are at stake. But legalized extortion is a bad long-run strategy, as it harms the most vulnerable of people in nations with widespread poverty. University of Chicago legal scholar Richard Epstein explains:

Decisions like those in Brazil and Thailand cripple incentives to invest in new drugs, particularly for AIDS, for which sick people worldwide will pay the price tomorrow. What drug company will invest in new and useful products when the ensuing harsh policy will damage its global brand? Better to stand aside and let someone else take the heat. But who will step forward?

Patent infringement to some extent is an inevitable by-product of global economic integration. But its legalization, in the name of high moral principle, is nothing short of alarming. It's another example of what Czech President Vaclav Klaus calls the "denationalization of nation-states." Our nation's drug companies surely are paying the bills. One is less certain if God is collecting.

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About The Author

Carl F. Horowitz is director of the Organized Labor Accountability Project of the National Legal and Policy Center, a Townhall.com Gold Partner organization dedicated to promoting ethics in American public life.
 
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The cost of developing new drugs
would be greatly reduced if there weren't hundreds or thousands of taxes imposed on every step of the development process.

Lovely lilly - 30 years in the FDA
--
Then your husband, at least, has no excuse for illusions about the purposes (and the history) of FDA standards for the establishment of efficacy in specific indications, or the costs that are associated with meeting the OND's requirements for satisfying said standards.

Your own ignorance is understandable, though your reference to a 1910 Sears catalog is a remarkable demonstration of the abysmal *DEPTHS* of that ignorance. The marketing of prescription drugs had moved along from that level while my mom was writing V-mail to my dad "somewhere in the Pacific."

Clinical assessment of safety, tolerability, and efficacy continues in areas *outside* FDA-approved indications even when a pharmaceuticals marketer is not pursuing approval for sNDA applications (i.e., permission to market in those presently "off-label" therapeutic areas).

As long as a drug is approved for any indication, it can be used in ethical Phase IV studies as the clinical investigators desire, and these investigators need not be funded by the pharma companies while undertaking these structured trials.

There is ample reason, however, for the patent-holders (and NDA applicants) to undertake such trials of efficacy even without regulatory requrement, and that's the need to establish the utility, cost-benefit and risk-benefit characteristics of their products.

To the satisfaction of prescribers and patients alike. The criminal statutes regarding the crime of fraudulent advertising, if enforced (and not "safe harbored" by the FDA's regulatory approvals) suffice as protection.

This is the free market at work, rather than the structured (and profoundly unsatisfactory) political regulatory environment on which you blindly dote.

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