In a landmark decision, the Supreme Court addressed the legality of importing medicines not directly purchased from the Philippine-registered owner of the drug’s patent or trademark. The Court ruled that prosecuting individuals for importing such drugs, even if unregistered locally, is unwarranted. This decision effectively prioritizes public access to affordable medicines over strict trademark enforcement, reflecting a significant shift in the interpretation of laws governing drug importation in the Philippines.

Counterfeit Concerns or Affordable Care: Did the Law go too Far?

The case originated from a raid on Roma Drug, owned by Romeo Rodriguez, where authorities seized imported medicines, including versions of popular drugs like Augmentin and Amoxil. These drugs were manufactured by SmithKline, but imported independently, bypassing the local SmithKline distributor. Rodriguez faced charges under the Special Law on Counterfeit Drugs (SLCD), which classified “unregistered imported drug products” as counterfeit. This raised a constitutional challenge, questioning whether the SLCD unduly restricted access to affordable medicines, conflicting with the State’s duty to ensure public health.

During preliminary investigations, the Provincial Prosecutor recommended charging Rodriguez, prompting the Petition for Prohibition, asserting the SLCD provisions contravened the Constitution’s equal protection clause, as well as provisions mandating affordable healthcare and the right to health. A temporary restraining order was issued, halting the trial against Rodriguez. The central question was whether the SLCD’s strict prohibition on importing unregistered drugs was a valid measure to combat counterfeiting, or an unconstitutional barrier to accessing essential and affordable medicines. The case put into sharp focus the tension between protecting intellectual property rights and ensuring public access to essential healthcare.

The Court considered the potential conflict between intellectual property rights and the constitutional right to health. Glaxo Smithkline argued that the SLCD was constitutional, asserting that constitutional provisions on health were not self-executing. The Office of the Solicitor General framed the issue as a matter of policy, beyond judicial interference. However, the landscape shifted significantly with the enactment of Republic Act No. 9502, the “Universally Accessible Cheaper and Quality Medicines Act of 2008”.

Section 7 of Rep. Act No. 9502 amended the Intellectual Property Code, explicitly granting third parties the right to import drugs, even if their patents were registered in the Philippines:

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.

The implementing rules of Rep. Act No. 9502 further cemented this right. These rules explicitly allowed any private third party to import medicines already introduced in the Philippines or elsewhere in the world. This effectively overturned the SLCD’s classification of “unregistered imported drugs” as “counterfeit drugs,” rendering prosecutions under the SLCD untenable. Thus the SLCD conflicted irreconcilably with Rep. Act No. 9502, mandating the later law to prevail.

The Court emphasized that when a later statute clearly intends to abrogate a prior act, that intention must be upheld. The new law, Rep. Act No. 9502, nullified the reason behind the SLCD’s import restrictions, rendering them meaningless and nonfunctional. Furthermore, the Supreme Court reflected on the broader implications had they been forced to rule directly on the SLCD’s constitutionality, suggesting the restrictions were potentially invalid. The law, as written, criminalized importing unregistered drugs, regardless of the purpose or potential benefit, disproportionately affecting those unable to afford expensive medicines.

The original law did not consider scenarios where the drug was unavailable locally. The Court highlighted that the law punished those acting out of altruism as harshly as those counterfeiting for profit. With the passage of Rep. Act No. 9502, the state adopted a more reasonable, compassionate approach towards the importation of medicines necessary to fulfill the people’s constitutional right to health. This was a major turning point in access to medicine.

FAQs

What was the central legal question in this case?	The primary issue was whether classifying unregistered imported drugs as “counterfeit” under the Special Law on Counterfeit Drugs (SLCD) was constitutional, especially considering the right to health and access to affordable medicines.
What did the Special Law on Counterfeit Drugs (SLCD) prohibit?	The SLCD prohibited the sale and distribution of counterfeit drugs, which included unregistered imported drug products. It treated such drugs as inherently dangerous and subject to criminal penalties.
What changed with the passage of Republic Act No. 9502?	Republic Act No. 9502, also known as the “Universally Accessible Cheaper and Quality Medicines Act of 2008”, amended the Intellectual Property Code to allow the importation of drugs and medicines by any government agency or private third party, even if patented.
How did Republic Act No. 9502 affect the SLCD?	Rep. Act No. 9502 effectively rendered the SLCD’s provisions on unregistered imported drugs unenforceable, as it explicitly permitted their importation. The SLCD’s restrictions now conflicted with the new law’s goal of making medicines more accessible.
What was the Court’s ruling in this case?	The Supreme Court ruled that prosecuting Romeo Rodriguez for violating the SLCD was no longer warranted due to the passage of Rep. Act No. 9502. A writ of prohibition was issued, stopping further prosecution.
Did the Court rule on the constitutionality of the SLCD?	The Court did not make a direct ruling on the SLCD’s constitutionality, as the passage of Rep. Act No. 9502 made the issue moot. However, they strongly indicated that the SLCD provisions were of doubtful validity.
Who was Romeo Rodriguez, and what was his role in the case?	Romeo Rodriguez was the proprietor of Roma Drug, a drug store raided for selling imported medicines not purchased from the local SmithKline distributor. He was the petitioner who challenged the legality of his prosecution.
What is the practical effect of this ruling for consumers?	The ruling supports access to potentially more affordable medicines by allowing importation from sources other than the patent holder’s authorized distributor, thus promoting competition and potentially lower drug prices.

This case reflects a vital shift in the legal landscape, prioritizing public health and access to affordable medicines over strict enforcement of intellectual property rights. The decision reinforces the state’s commitment to making essential goods and health services accessible to all citizens. It demonstrates how legislation and judicial interpretation can evolve to better serve the public interest and promote a more equitable healthcare system.

For inquiries regarding the application of this ruling to specific circumstances, please contact ASG Law through contact or via email at frontdesk@asglawpartners.com.

Disclaimer: This analysis is provided for informational purposes only and does not constitute legal advice. For specific legal guidance tailored to your situation, please consult with a qualified attorney.
Source: Roma Drug and Romeo Rodriguez vs. The Regional Trial Court of Guagua, Pampanga, G.R. No. 149907, April 16, 2009