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Passion For Reason
Generics war: Who won, who lost

By Raul Pangalangan
Philippine Daily Inquirer
First Posted 02:21:00 05/02/2008

Filed Under: Medicines, Pharmaceuticals, Legislation

MANILA, Philippines—The score card is mixed. The senate was able to block the House-approved "generics-only" clause, but that shouldn't detract from the several pointed measures to bring down the exorbitant cost of medicines.

The cost of medicines in the Philippines is second highest in Asia next to Japan. The World Health Organization has documented that medicines are sold in the Philippines at 4 to 18 times higher than international comparator prices. I have earlier written a piece showing that over-the-counter pills sold in Thailand and in India at P2 to P4 are sold in Manila at P20 to P40 each.

Comparing the approved bill to the standards elaborated at a University of the Philippines (UP) forum on "Improving Accessibility to Cheaper Medicines," what we have is a significant victory. In October 2007, the UP Center for Integrative and Development Studies invited Alberto Roxas, dean of the UP College of Medicine, Representatives Joseph Emilio Abaya, Ferjenel Biron and Satur Ocampo to speak. Almost all of the objectives in the House version apparently have been carried through in the bill finally approved by the bicameral conference committee. Based on newspaper reports on the contents of the bill, Congress has taken on the pharmaceutical monopolies.

First, the drug companies have effectively extended their patents—and their monopoly control over medicines—by delaying experimentation until after the patents expire. That makes for a good two to three years' de facto extension of their exclusive rights. The bill adopts the "early working doctrine" (or the Bolar provision, in the well-researched presentation by Abaya), which will end this practice by allowing generic drug companies to begin experimentation in advance, so that their substitute products will hit the ground running, so to speak, upon patent expiry.

Second, the drug companies have yet another way to extend their patents through what is called "evergreening." When an existing patent is about to expire, they apply for a fresh patent on the same drug but for new uses, thereby opening the door to the seemingly endless extension of their monopoly rights. The bill now prohibits the practice of evergreening.

Third, the bill allows "parallel importation." A pharmaceutical behemoth can sell exactly the same drug in India and in the Philippines but at different prices. An asthma inhaler is sold in India at P85 and at P410 in Manila. Yet the patent holder of, say, Ventolin in the Philippines has effectively insisted that their Philippine patent allows them the exclusive right to sell it in Manila unless they are unable to meet the needs of the domestic market. They have used intellectual property laws to curtail the normal operation of the law of supply and demand. With parallel importation, we will be able to buy our asthma inhalers from India, resell them in Manila, and let the market decide whether they want to buy the same inhalers at P85 or at P410.

Fourth, until now, the main anxiety about generics is the influx of counterfeit or fake medicines. The bill addresses that legitimate concern by strengthening the Bureau of Food and Drugs, so that both the medical practitioners and the consuming public can be assured that generics are an effective and viable alternative to branded drugs.

Fifth, the bill also targets drug stores, the frontline retail outlets, because they can effectively "direct" the unknowing consumers away from generics by simply not keeping enough inventories of these drugs and keeping their branded stocks steadily replenished.

Finally, the bill, as I understand it, puts in place price-control mechanisms to monitor and check prices, in an industry in which prices are fixed less on the basis of the cost of production and more on the basis of what the market will bear.

On the other hand, the final bill does away with the House-approved generics-only clause. After two decades, the old Generics Bill has failed to achieve the desired result. It triumphed before the courts of law as a legitimate measure to advance the right to health. It was defeated however in the democracy of the open market. The Old Generics Bill required the doctors to write in their prescriptions both the branded and the generic name of the drugs they prescribe.

But experience has shown that patients have instinctively preferred the branded product, in the mistaken belief that they are superior to the generics drugs. Thus, the House boldly insisted that the doctors write only the generic name.

The doctors banded together to resist this clause, saying it intruded into their professional judgment, and indeed that it delegated to the drugstores' in-house pharmacists the power to substitute their judgment for that of the doctors. They claim that they prescribe drugs with specific uses and potencies that are rarely contained in generics.

I am in no position to contest the doctors, but what I see here is the limit of what law can do to achieve socially desirable goals when the patients themselves do not share the legislated preference for generics. It is only proper that our legislators are politically and ideologically ahead of their constituents, but to push too far ahead will lead precisely to the bizarre situation of the generics-only clause. Here we were trying to protect a public that didn't want our protection, and who would prefer to pay more for illusory benefits. We have fought a battle in the halls of Congress and won significant victories, but the real war will have to be won in the hearts of the Filipino consumer, who has yet to learn who his real friends are.



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