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Saturday, February 16, 2008
Breaking Our Patents Abroad: How Not to Promote Affordable Drugs
By Carl Horowitz
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"To serve God's law, one must break man's law."

There's nothing new about this principle. Men throughout the ages have fought, killed and died for it. And latter-day political progressives are hardly exempt from its pull. Heavily animated by religious conviction, various Left-leaning activist organizations have come to believe that fighting poverty and disease in developing nations requires taking extralegal emergency steps. One of those steps is presenting commercial makers of life-saving drugs, especially for HIV/AIDS, with an ultimatum: Lower your prices or watch your patents become meaningless.

In this country, such a practice would be illegal. But other countries don't have to play by our rules. And that's the way these activists like it.

The Interfaith Center on Corporate Responsibility (ICCR), a New York-based nonprofit umbrella group of 275 investor organizations controlling a combined $110 billion in assets, is a prime organizer behind a worldwide movement to redefine corporate governance. At the 16th Global AIDS Conference in Toronto in August 2006, the ICCR and various affiliates distributed a new study, "Benchmarking AIDS: Evaluating Pharmaceutical Company Responses to Public Health Crisis in Emerging Markets." The report evaluated the record of 15 global drug manufacturers according to putative industry best practices, one of which is "increased licensing and technology transfer to generic drug companies." The authors praised five companies -- Abbott Laboratories (U.S.), Gilead Sciences (U.S.), GlaxoSmithKline (U.K.), Roche (Switzerland) and Novartis (Switzerland) -- for making progress on several fronts following "consultation" with shareholders, communities and non-governmental organizations. "(T)hese actions begin to bring industry practice in line with the needs of long-term investors and public health," said Cathy Rowan, corporate responsibility consultant to the Maryknoll Sisters and co-chair of ICCR's Access to Health Care Working Group.

These religious progressives, adept at playing hardball with top management, profess good intentions. But good intentions, whether or not grounded in Christian theology, don't necessarily make for sound economics. And in this case, they mask a deep animus toward profit maximization and a key means of its protection: the patent.

A patent, like a copyright, is a government grant of monopoly for a certain period of time. It secures for its holder an exclusive right to enjoy revenues from an original discovery. Though the U.S. Constitution (Article I, Section 8, Clause 8) authorizes the federal government's awarding of patents, a number of free-market economists find this anathema. Stephan Kinsella, Timothy Lee and other libertarian critics argue that requiring a patent for drugs, software or other products creates barriers to market entry among potentially more efficient competitors. This in turn raises consumer prices.

On the surface, it's a valid objection. The problem is that it exists in a legal and political vacuum. Without patent protection, especially in today's lawsuit-prone environment, few individuals and firms would have the incentive to create economically viable products. This is especially true in the highly competitive pharmaceutical industry, with its exorbitant and time-consuming front-end investment requirements and constant Food and Drug Administration oversight.

It takes on average around a dozen years, not to mention hundreds of millions of dollars worth of research, testing and marketing, to commercially launch an innovative drug. It's unlikely, for example, that the anti-blood clotting agents Persantin and Plavix would have reached pharmacy shelves had their respective manufacturers, Boehringer Ingelheim and Bristol-Myers Squibb, anticipated widespread competition from unauthorized generic (i.e., non-branded) copies. Patents uphold property rights. A drug company shouldn't be obligated to share with competitors the rewards of its discoveries any more than a homeowner should be obligated to share his dwelling with squatters.

Once awarded, a patent is no guarantee of profit during its typically 20-year life, which starts at the date of filing rather than of commercial availability. And revenues may decline, as Merck found out after its patent for cholesterol-reducer Zocor expired on June 30, 2006. Pharmaceutical firms have begun to establish generic subsidiaries -- e.g., Greenstone (Pfizer) and Sandoz (Novartis) -- precisely to avoid this outcome.

But the libertarians are right about this much: The power to grant a patent is by definition the power to deny, withdraw or undermine it. Possessed of this power, national governments exercise veto power over a firm's ability to set prices. This has major implications for American enterprise, which happens to be responsible for about 80 percent of the world's key drug and biotechnology patents. If a foreign government decides to undercut prices for U.S.-patented brand-name drugs by allowing or mandating the sale of generic versions, there is little a given company can do about it.

The recent browbeating by Brazil of Abbott Laboratories is instructive. In July 2005, that country's Ministry of Health announced a six-year agreement with Abbott in which the Chicago-area company would lower the price of its HIV/AIDS retrovirus drug Kaletra. The pact also included a technology-transfer procedure to enable the government-run Farmanguinhos Laboratories to begin producing the drug in 2009 and a provision to provide Brazilian patients greater access to Meltrex, a heat-stable form of Kaletra. The Brazilian government had declared Kaletra a drug "of national interest," and had given Abbott a 10-day ultimatum to charge a lower price or watch its profits evaporate in the face of a compulsory generic license. Initially, Abbott termed the ultimatum illegal -- which it certainly was by U.S. standards -- and warned that developing unproven, alternative medication posed "significant consequences for patients." Yet soon after, the company announced it would be open to an "agreeable solution."

Brazil, if nothing else, is an equal-opportunity abuser of rule of law. In May 2006, its government announced an "agreement" with the San Francisco-based Gilead Sciences to reduce its price of the anti-HIV retrovirus drug Viread by about 50 percent. A year later, it issued a license to produce a generic version of Merck's anti-HIV drug Efavirenz after giving the firm a week to "negotiate" a lower price. Continued...

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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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Subject: 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
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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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