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Oversight in U.S. is effective.

We in the United States are fortunate. We have a well-established Food and Drug Administration with a rigorous medication patent approval process. Along with intellectual property rights written into law and judicial due process, the U.S. system seems to serve most involved--patients included--quite well most of the time.

Granted, such processes and protections are most often costly and time consuming. And it can be argued that up-front cost hurdles likely discourage some innovation in new medication discovery. Without a patent-protected market that rewards risk with reward, why would private or public enterprises risk researching and studying new medication discovery?

Consider some alternatives. From long-term consulting engagements in India, Venezuela, West Africa, Canada, the Caribbean and Europe, this writer has had first-person experience with patent and intellectual property protection systems that govern medication approval and distribution outside our borders. In some of these countries the real question is how does the medical care system assure medication ingredient and product integrity? The answer is that it all too often cannot and does not.

Consider India. To be sure, some India-based pharmaceutical manufacturers operate to the best world standards. They willfully comply with U.S. Good Manufacturing Practices and submit to FDA inspections. Ranbaxy and Dr. Reddy's come to mind; there are others. Yet in India there are medication manufacturing enterprises that operate quite differently.

For instance, before Pfizer introduced Viagra in India, there were more than 100 branded sildenafil medications manufactured and marketed in the country. For an in-country manufacturer and/or marketer, the patent approval process in India provides for a patent on a manufacturing process. That means, for example, that using machine screws with hexagonal rather than round heads allows a business enterprise to patent a specific manufacturing process. The brand name assigned to the product made can be anything the enterprise chooses. But a brand is a brand and, when prescribed, it cannot be substituted without physician approval.

To game the system further, a manufacturer/marketer holding a medication brand patent is free to enlist physician interest in the brand via an ownership stake in the company. When a brand is marketed, physicians with a financial interest in the company prescribe the brand, which then compels pharmacists to acquire and dispense it.

Another India-based pharmaceutical manufacturer with whom this writer is familiar manufactures and markets anti-carcinogenic medications for in-country use. This manufacturer also exports to other countries with weak or nonexistent intellectual property protections. Russia, China and Brazil are very large markets for this company. These anti-carcinogenic pharmaceuticals are unregulated copies of branded medications made by major global brand pharma and generic companies. Their products have been FDA-approved and are in distribution in the U.S., Europe and other countries with robust regulatory mechanisms.

During a private, one-hour meeting, the Indian Minister of Industry and Commerce in New Delhi acknowledged that there is much left to be done to assure medication product integrity in his country. Venezuela presents a similar but different situation. Most medications in distribution in Venezuela are sourced from other nations. Particularly with generics, which represent a very large part of the total market, many come from Cuba and Mexico. Community pharmacists in Venezuela are frequently presented with patient and physician comments that medications known to be effective seem not to be working. Without regulatory oversight, legal recourse or supply chain tracking back to the original manufacturer--which there is not--there is little that can be done to assure product integrity.

Ghana, in West Africa, presented a similar medication integrity and patient protection dilemma. In a personal meeting, the Minister of Health in Accra, the capital of Ghana, acknowledged the limits of governmental and regulatory control over medication in distribution in the country.

There may be no perfect system. But there are countries with systems that work far more effectively than others. For patients and chain community pharmacists alike, we in the U.S. are far more fortunate than many others.

Robert Coopman is president of Robert Coopman Consultants, which is based in San Antonio. He can be contacted at
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Comment:Oversight in U.S. is effective.(BRANDED DRUG REPORT)
Author:Coopman, Robert
Publication:Chain Drug Review
Geographic Code:1USA
Date:Jan 7, 2013
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