[Ip-health] Philippines: Pfizer vs Phil International Trading Corp on NORVASC

[Stephanie Weinberg]

 Saturday, March 25, 2006

 Manila Times
 EDITORIAL

 Affordable drugs


 THE issue for most Filipinos in the legal tussle between Pfizer and the
 Philippine International Trading Corp. (PITC) is not intellectual
property
 rights but the high cost of prescription drugs.

 On March 1 Pfizer sued the PITC and the Bureau of Food and Drugs (BFAD)
 for patent infringement.

 The PITC had brought in from Pakistan a handful of pills known as
 amlopidine besylate, marketed locally under the brand name Norvasc.

 The PITC's purpose was to have it tested and registered by the BFAD in
 preparation for the day in 2007 when Pfizer's patent for it expires.
 Norvasc is a maintenance drug for hypertension that many people use.
Its
 continued availability at affordable prices is therefore important.

 Norvasc is not cheap. The price of the 5 mg pill is P44.75; the 10 mg
 tablet costs P74.57 each. In India the same medicine (under a different
 brand name) retails in pesos for P5.98 and P8.95, respectively.

 We do not find it unreasonable for the PITC to prepare for the time
when
 it could ask local manufacturers-including Pfizer-to produce a generic
 version that could be sold more cheaply.

 This process takes at least 18 months. If the PITC waited for patent
 expiry on June 13, 2007, before acting, Pfizer would have that much
more
 time to keep on selling the off-patent Norvasc.

 According to the PICT, the annual sales of Norvasc in 2005 were P1.185
 billion, "growing at 34.5 percent." Pfizer, therefore, stood to "lose"
 over P2 billion in 18 months-or, put another way, consumers of the drug
 would have saved a good part of that amount.

 The pricing policies of pharmaceutical companies are a deep secret. No
one
 has been able to explain why there's such a wide difference between the
 price of Norvasc in the Indian and Philippine markets.

 In an exchange in the pages of Science between Dr. W. Ross Tracey of
 Pfizer's Department of Cardiovascular and Metabolic Diseases and Dr.
Jerry
 Avorn of Harvard Medical School, Dr. Tracey stressed that Pfizer's
 principal aim in pricing its drugs was to recover within 20 years (the
 effective period of a patent), the costs of R&D and the US Food and
Drug
 Administration's requirement of a lengthy testing and review procedure.

 Dr. Avorn, short of accusing the pharmaceutical industry of predatory
 pricing, said that despite "the record profits of the last decade,
[they]
 have not been transformed into the expected returns in new drug
products."

 Most of the income, he said, was spent on advertising and marketing and
on
 the development of "me too" drugs rather than on new or improved ones.

 Developing countries like the Philippines that are unable to undertake
 their own R&D and testing procedures have to resort to schemes such as
 parallel importation (bringing in lower-priced drugs from other
 countries), targeted consumer subsidies, or making generic versions of
 off-patent medicines to put the price of essential drugs within reach.

 The PITC, it must be said, is covering not only the intellectual
property
 issue but also the trade issue. Both the World Trade Organization (WTO)
 and the World Health Organization (WHO) recognize the "primacy of
national
 interest in public health."

 Only 30 percent of Filipinos, according to the WHO, can afford
 prescription drugs. Secretary Roberto Pagdanganan, the president of the
 PITC, said that drug companies like Pfizer should "review their present
 pricing structures so that medicines, such as Norvasc, can be made
 available at lower than current prices."

 In matters of health, profit is not all. We suggest that Pfizer
withdraw
 its civil case and allow BFAD registration under the Bolar provision
that
 permits "early-working exception."

 In this way Pfizer, a longtime partner of the country, can keep its
 enviable reputation intact.



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