[DRUGS AND MEDICINE UNDER RA 9502]
Case Citation: G.R. No. 149907
Date: April 16, 2009
Petitioners: ROMA DRUG and ROMEO RODRIGUEZ, as Proprietor of ROMA DRUG
Respondents: THE REGIONAL TRIAL COURT OF GUAGUA, PAMPANGA, THE PROVINCIAL PROSECUTOR
OF PAMPANGA, BUREAU OF FOOD & DRUGS (BFAD) and GLAXO SMITHKLINE
Antecedent ● August 14, 2000: A team composed of NBI Operatives and inspectors of BFAD conducted a
Facts: raid on petitioner Roma Drug, a duly registered proprietorship of Romeo Rodriguez,
operating as a drug store in Pampanga.
● The raid was conducted pursuant to a search warrant issued by the RTC. The raiding team
seized several imported medicines, including Augmentin (375mg.) tablets, Orbenin (500mg.)
capsules, Amoxil (250mg.) capsules and Ampiclox (500mg.)
● It appears that Roma Drug is one of six drug stores which were raided on or around the
same time upon the request of SmithKline Beecham Research Limited (SmithKline), a duly
registered corporation which is the local distributor of pharmaceutical products manufactured
by its parent London-based corporation.
○ SmithKline has since merged with Glaxo Wellcome Phil. Inc to form Glaxo
SmithKline. The seized medicines, which were manufactured by SmithKline, were
imported directly from abroad and not purchased through the local SmithKline, the
authorized Philippine distributor of these products.
● NBI subsequently filed a complaint against Rodriguez for violation of Section 4 (in relation
to Sections 3 and 5) of Republic Act No. 8203, also known as the Special Law on
Counterfeit Drugs (SLCD), with the Office of the Provincial Prosecutor in San Fernando,
Pampanga.
○ (The section prohibits the sale of counterfeit drugs, which under Section 3(b)(3),
includes "an unregistered imported drug product." The term "unregistered"
signifies the lack of registration with the Bureau of Patent, Trademark and
Technology. Transfer of a trademark, trade name or other identification mark of a
drug in the name of a natural or juridical person, the process of which is governed
under Part III of the Intellectual Property Code.)
● In this case, there is no doubt that the subject seized drugs are identical in content with their
Philippine-registered counterparts. Their classification as "counterfeit" is based solely on the
fact that they were imported from abroad and not purchased from the Philippine-registered
owner of the patent or trademark of the drugs.
● During PI, Rodriguez questioned the constitutionality of the SLCD, but the prosecutor skirted
the challenge. The Assistant Provincial Prosecutor issued a Resolution recommending that
Rodriguez be charged with violation of Section 4(a) of the SLCD.
● Hence, this petition for Prohibition to desist respondent from further proceedings and that
Sections 3(b)(3), 4 and 5 of the SLCD be declared unconstitutional.
Petitioner’s Rodriguez asserts that the challenged provisions contravene three provisions of the Constitution.
Contention: The first is the equal protection clause of the Bill of Rights. The two other provisions are Section
11, Article XIII, which mandates that the State make "essential goods, health and other social
services available to all the people at affordable cost;" and Section 15, Article II, which states
that it is the policy of the State "to protect and promote the right to health of the people and
instill health consciousness among them."
Respondent’s ● Glaxo Smithkline asserts the rule that the SLCD is presumed constitutional, arguing that
Contention: both Section 15, Article II and Section 11, Article XIII "are not self-executing provisions, the
disregard of which can give rise to a cause of action in the courts."
● It adds that Section 11, Article XIII in particular cannot work "to the oppression and
unlawfulness of the property rights of the legitimate manufacturers, importers or distributors,
who take pains in having imported drug products registered before the BFAD."
● Glaxo Smithkline further claims that the SLCD does not in fact conflict with the
aforementioned constitutional provisions and in fact are in accord with constitutional
precepts in favor of the people’s right to health.
Issue: Whether or not Sections 3(b)(3), 4, and 5 of the SLCD are unconstitutional.
SC Ruling: The constitutional aspect of this case raises interesting questions. However, these questions have
been mooted by the passage of RA 9502, also known as the "Universally Accessible Cheaper and
Quality Medicines Act of 2008."
● Section 7 of Rep. Act No. 9502 amends Section 72 of the Intellectual Property Code in that
the later law unequivocally grants third persons the right to import drugs or medicines whose
patents were registered in the Philippines by the owner of the product. (see provision below)
● The unqualified right of private third parties such as petitioner to import or possess
"unregistered imported drugs" in the Philippines is further confirmed by the "Implementing
Rules to Republic Act No. 9502" promulgated on 4 November 2008.
● It may be that Rep. Act No. 9502 did not expressly repeal any provision of the SLCD.
However, it is clear that the SLCO’s classification of "unregistered imported drugs" as
"counterfeit drugs," and of corresponding criminal penalties therefore are irreconcilably in the
imposition conflict with Rep. Act No. 9502 since the latter indubitably grants private third
persons the unqualified right to import or otherwise use such drugs.
○ Where a statute of later date, such as Rep. Act No. 9502, clearly reveals an
intention on the part of the legislature to abrogate a prior act on the subject that
intention must be given effect.
○ When a subsequent enactment covering a field of operation coterminous with a prior
statute cannot by any reasonable construction be given effect while the prior law
remains in operative existence because of irreconcilable conflict between the two
acts, the latest legislative expression prevails and the prior law yields to the extent of
the conflict.
● Therefore, the prosecution of the petitioner is no longer warranted and the quested writ of
prohibition should accordingly be issued.
Other notes: What if the Court decided on the validity of the provisions?
● It would have placed doubt on the validity of the provisions.
● As written, the law makes a criminal of any person who imports an unregistered drug
regardless of the purpose, even if the medicine can spell life or death for someone in the
Philippines.
● It does not accommodate the situation where the drug is out of stock in the Philippines,
beyond the reach of a patient who urgently depends on it. It does not allow husbands, wives,
children, siblings, parents to import the drug in behalf of their loved ones too physically ill to
travel and avail of the meager personal use exemption allotted by the law.
● It discriminates, at the expense of health, against poor Filipinos without means to travel
abroad to purchase less expensive medicines in favor of their wealthier brethren able to do
so. Less urgently perhaps, but still within the range of constitutionally protected behavior, it
deprives Filipinos to choose a less expensive regime for their health care by denying them a
plausible and safe means of purchasing medicines at a cheaper cost.
● It equates the importers of such drugs, many of whom motivated to do so out of altruism or
basic human love, with the malevolents who would alter or counterfeit pharmaceutical drugs
for reasons of profit at the expense of public safety.
● For a law that is intended to help save lives, the SLCD has revealed itself as a
heartless, soulless legislative piece.
"Sec. 72. Limitations of Patent Rights. – The owner of a patent has no right to prevent third parties from performing,
without his authorization, the acts referred to in Section 71 hereof in the following circumstances:
"72.1. Using a patented product which has been put on the market in the Philippines by the owner of the product , or with
his express consent, insofar as such use is performed after that product has been so put on the said market: Provided,
That, with regard to drugs and medicines, the limitation on patent rights shall apply after a drug or medicine has
been introduced in the Philippines or anywhere else in the world by the patent owner , or by any party authorized
to use the invention: Provided,
further, That the right to import the drugs and medicines contemplated in this section shall be available to any
government agency or any private third party;
"72.2. Where the act is done privately and on a non-commercial scale or for a non-commercial purpose: Provided, That it
does not significantly prejudice the economic interests of the owner of the patent;
"72.3. Where the act consists of making or using exclusively for experimental use of the invention for scientific purposes
or educational purposes and such other activities directly related to such scientific or educational experimental use;
"72.4. In the case of drugs and medicines, where the act includes testing, using, making or selling the invention including
any data related thereto, solely for purposes reasonably related to the development and submission of information and
issuance of approvals by government regulatory agencies required under any law of the Philippines or of another country
that regulates the manufacture, construction, use or sale of any product: Provided, That, in order to protect the data
submitted by the original patent holder from unfair commercial use provided in Article 39.3 of the Agreement on Trade-
Related Aspects of Intellectual Property Rights (TRIPS Agreement), the Intellectual Property Office, in consultation with
the appropriate government agencies, shall issue the appropriate rules and regulations necessary therein not later than
one hundred twenty (120) days after the enactment of this law;
"72.5. Where the act consists of the preparation for individual cases, in a pharmacy or by a medical professional, of a
medicine in accordance with a medical shall apply after a drug or medicine has been introduced in the Philippines or
anywhere else in the world by the patent owner, or by any party authorized to use the invention: Provided, further, That
the right to import the drugs and medicines contemplated in this section shall be available to any government agency or
any private third party; xxx