21 JANUARY 2008
P C I J I N V E S T I G A T I O N — WILL PUBLIC HEALTH TRUMP PATENTS IN CONGRESS?
PHAP says that the IP Code has sufficient safeguards against double patenting and evergreening, which, the association says, do not have a significant impact on access to medicines. After all, it argues, only one percent of the drugs in WHO’s List of Essential Drugs are patented, with the rest already outside the patent system.
But Bureau of Food and Drug (BFAD) Deputy Director Joshua Ramos counters, “What if the one percent with patents are the ‘miracle drugs’ needed by large numbers of people? Also, those that are already off-patent as new molecules — the 99 percent they claim — may again be patented for new use without the provision preventing patentability based on ‘new use.’”
PHAP’s arguments actually go to the heart of the pharmaceutical industry’s justification for strengthening the regime of intellectual property protection, which is that it provides an incentive to develop innovative drugs and allows it to recoup investments on research and development (R&D).
Yet a report by the U.S. National Institute for Health Care Management (NIHCM) makes this assumption of innovation among pharmaceutical companies suspect. From 1989 to 2000, says the NIHCM, only 35 percent of the approved 1,035 new drug applications in the U.S. Food and Drug Administration (FDA), were products with new active ingredients. The rest had active ingredients already available in an approved product. Over half (54 percent) were in fact incrementally modified drugs or new versions of available medicines. Eleven percent out of the supposedly new drugs, meanwhile, contained the same active ingredient as identical marketed products.
PHAP’s list of objections, however, includes the House bill’s provision on parallel importation. Citing the lack of an adequate infrastructure and effective monitoring systems to monitor parallel imports and prevent entry of counterfeit drugs into the country, PHAP says that substandard medicines and counterfeit drugs could proliferate through uncontrolled parallel importation.
BFAD’s Ramos also says there is “no real threat” as the agency, together with law enforcement agencies, can easily detect counterfeit drugs. Besides, medicines that will be subject of parallel importation will have to be registered with BFAD. The agency is also tasked to conduct the necessary post-market surveillance.
“The counterfeit medicines issue is not a real issue,” remarks Elpidio Peria. An associate of the Third World Network that is among the various nongovernmental organizations supporting the Senate bill, Peria explains that most, if not a large majority, of the pharmaceutical products that will be brought in through parallel imports are the same products produced by the same pharmaceutical firms already operating in the country.
“It is a fact,” he adds, “that these same companies imported from their mother units or manufacturing bases and made money out of the price differentials between the Philippines and the countries from where these products were sourced.”
But a healthcare professional who was once part of the Department of Health (DOH) says that while the parallel importation provision in the House bill is “relevant,” it is nevertheless “too simplistic.” He says there are no protocols to ensure checks and balance; neither are there provisions to ensure that imported drugs would come from firms complying with current good manufacturing practice and from legitimate wholesalers and consolidators. He also notes the lack of punitive clauses for those who would import or manufacture substandard generic drugs.
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