Cheaper Medicines Law

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REY CHRISTIAN S.

REYNO, RPH
MS PHARM I

Small drug firms cry foul vs multinational company


Written by Tribune Wires Thursday, 10 July 2014 00:00

Small pharmaceutical firms have accused multi-national drug companies of blocking the implementation of Republic Act
9502 or the Universally Accessible Cheaper and Quality Medicine Act of 2008 by filing cases against them under the
guise of “violating the patent protection law.”
Three firms — Ferma Drug, Ellebasy Medicale Trading, and Mark Erickson Enterprises — complained that they were
recently raided by police and National Bureau of Investigation agents on a warrant and seizure order obtained by
Canada-based company Merk & Dome from a Makati court for alleged violation of infringement on patent right and
selling “illegal drugs.
The firms denied the charges, saying that their drugs are generic and all registered with the Food and Drugs
Administration (FDA).
“How could the FDA issue a certification to us if the drugs we are selling are illegal? They are actually cheaper than what
multi-national companies sell,” Mack Macalanggan, the group’s spokesman, said.
“In a newspaper report, Merck claimed that the drugs seized by authorities were worth P15 million when these only
amounted to P2 million. It is because they based the cost of the drugs on their selling prices, which are seven times
higher than small drug firms,” Macalanggan said.
Last year, Merck also filed an infringement on patent right case against Sahar International Trading and Suhitas Inc.
pharmaceuticals for selling an anti-inflammatory drug called etoricoxib.
Merck claimed the drug under its patent.
In a statement, the firms, however, clarified that etoricoxib is not the drug name patented by Merck because “it is
markedly and substantially different
from the chemical structure of the generic drug under the brand.”
They said under Section 7-M of RA 9502, “generic drugs refer to drugs that have the same active pharmaceutical
ingredient as the innovator drugs and are not covered by patent protection law.”
“These drugs are labeled by their international non-proprietary or generic name and may or may not have brand
names,” Sahar and Suhitas said.
They added that there is no preliminary injunction or restraining order issued by any court enjoining them from
marketing or distributing etoricoxib, contrary to a public notice circulated by Merck.
“The power and authority to issue preliminary injunction or restraining order resides only in the Supreme Court. We will
exert all efforts to bring into light the provisions embodied in R.A. 9502, in support of the people’s constitutional right to
avail themselves of cheaper and quality medicines,” they said.
They stressed that under the RA 9502 or the generic law, drug outlets are allowed to carry a variety of medicine brands,
including those sourced through parallel importation, to give choices to consumers
Court dismisses patent case vs 2 drug firms
April 23, 2015 10:07 pm
The Makati Regional Trial Court has dismissed a patent infringement case filed by a multi-national company against two
pharmaceutical firms—Sahar and Suhitas.
At the same time, it ordered Merck Canada to return all documents and items that belong to Sahar within 10 days
which were confiscated based on a Search and Seizure Order implemented on October 11, 2013
Sahar spokesman Mack Macalanggan welcomed the decision, saying on Thursday that “it was a victory for Republic Act
(RA) 9502 or the Universally Accessible Cheaper and Quality Medicines Act of 2008.
The court dismissed the case against the two firms on the ground of “forum shopping” after Merck, through its law firm
Sapalo Velez Bundang & Bulilan, filed another case similar in nature before the Intellectual Property Office (IPO), a quasi-
judicial body.
The IPO initially dismissed the patent infringement case for pain reliever drugs Xibra and Torico imported and
distributed by Sahar and Suhitas, but later reversed its decision.
In its order, the court stated, “The plaintiff in this case filed a patent infringement and damages with application for
preliminary injunction and temporary restraining order before the Intellectual Property Office with Case No. 10-2014-
00017.”
“The same patent, Philippine Patent No. 1-1997-57253 issued on November 8, 2005 is the subject of a complaint filed
before the IPO office. Therefore, this court can conclude that the same or similar action or claim has been filed or is
pending, which shall be caused for dismissal of the case without prejudice.”
Macalanggan, in a statement onThursday, said the ruling underscored efforts being undertaken by small pharmaceutical
firms to distribute and sell quality but affordable drugs to Filipinos as part of their constitutional right to health.
“Congress has realigned some legal measures in providing such right to citizens by crafting RA 9502, but there are many
challenges that come our way such as the patent issue. The accessibility of cheap but quality drugs is our first and
foremost concern, especially for the poor citizens who cannot afford expensive medicines,” he added.
AREEJ MAGDI M. RUSDI
MS PHARM I
Dumaguing: Is your food safe to eat?
Friday, July 17, 2015
By
DR. VICTOR DUMAGUING
TO YOUR HEALTH

FIRST, news of fake rice. Even before that, the horrifying stories of fatal outcome of drinking milk tea or
the couple found dead inside their car after allegedly partaking a meal from a fast-food outlet.
Whether these unfortunate incidents are accidental, by virtue of contamination, or have criminal elements
in them, the fact remains that more than ever, the public is forewarned to be more careful with what they
put into their mouths.
The durian and mangosteen candies that have been suspected to cause signs and symptoms to
hundreds of folks, mostly of school age in Surigao and Agusan Provinces have brought more attention,
awareness of the danger of consuming goodies which might be laced or contaminated with harmful, toxic
and even deadly substances.
Early on, there were sporadic cases of food poisoning among meetings and small groups who ate
previously-prepared foods and the reaction of the general populace was not as dramatic as it is now.
So much so that the good people of the FDA has come out in media to disseminate basic information
about food preparation, handling, storage and eventual distribution.
The Food and Drug Administration was established in June 1963 with the purpose of safeguarding the
interest of the Filipinos as to their food and medicines requirements. Later, it was changed to BFAD or the
Bureau of Food and Drug Administration and it was only lately, when the name reverted to its original.
Just recently, Mr. Timothy Moises Mendoza, FDA Regulatory Officer was on TV citing among other things
government efforts to stem the tide of these food mishaps, noting RA 9711 which mandated that one of
the functions of the FDA is to check the quality of food, drugs, cosmetics and devices used for medial and
clinical purposes.
The gentleman was quick though to emphasize that their agency does not include jurisdiction over meat
products which is the domain of the NMIS.
However, Mr. Mendoza was quick to stress that imported products are still under their care, citing the
case of imported ice cream which was recalled early enough, because it contained the bacteria Listeria
monocytogenes.
The more salient points brought out in the discussion is for consumers to be careful with canned goods
and check for labeling, lot number, manufacturing date and expiration date. Mr. Mendoza strictly stressed
that the words “consume before" and "best before" may be vague and can be construed by the person
that a few days after the designated date, the product "might" still be good for consumption.
Knowing the mentality of Filipinos about saving dropped food because "wala pang five minutes", surely
this warning arise a lot of weight. Thus, these goodies, whether canned or processed food, would better
carry the “expiration date" beyond which, these should go to the garbage bin.
Speaking of canned goods, the public is instructed to carefully inspect canned goods, noting for dents,
bulges. Apparently, canned goods have “linings” which make them easier to pry open, thus a drop
can/may disrupt these linings allowing contaminants like microbes to colonize. Also rust in the rim of cans,
and of course, the more obvious dirty labels of the canned products.

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