Cheaper medicine over quality medicine?
01-12-2011
Ignacio S. Sapalo
The Universally Accessible Cheaper and Quality Medicines Act of 2008 has succeeded in bringing down the cost of essential drugs and those to treat chronic diseases in The Philippines.
The coming into force on July 4, 2008 of Republic Act No. 9502, known as the Universally Accessible Cheaper and Quality Medicines Act of 2008, has succeeded in bringing down the cost of essential drugs and those to treat chronic diseases.
On the other hand, because of the desire of the courts to help the poor gain access to cheaper medicine, it also resulted in incorrect jurisprudence. The decision of the Supreme Court in the case of Roma Drug v GlaxoSmithKline which was promulgated on April 16, 2009 neglected to consider the more important objective of the law to ensure that the quality of medicine is not compromised.
Roma Drug imported Augmentin, Orbenin, Amoxil and Ampiclox, which it sold without obtaining prior registration from the Bureau of Food and Drugs (BFAD), now the Food and Drug Administration (FDA). The BFAD registrations of these drugs were made by GlaxoSmithKline.
A case was filed against Roma Drug for violation of the Special Law on Counterfeit Drugs (SLCD), Republic Act No. 8203, subsequent to a raid conducted on August 14, 2000 by the National Bureau of Investigation and the BFAD.
The SLCD prohibits the sale, offering for sale, importation or possession of counterfeit drugs. Under the statute, an imported product is considered to be counterfeit if it is not registered with the BFAD and the brand is not registered with the Intellectual Property Office (IPO). Roma Drug challenged the constitutionality of these provisions of the SLCD.
The Supreme Court, disposing of the constitutional questions, declared them as having, in fact, been mooted by the passage of Republic Act No. 9502.
This law amended the Intellectual Property Code, Republic Act 8293. It provided for international exhaustion of patents for medicine and allowed their parallel importation by third parties.
The court stated that Republic Act No. 9502 clearly reveals an intention of the legislature to
abrogate the SLCD because of irreconcilable inconsistencies between the two. It ruled that Republic Act No. 9502 nullifies the reason or purpose of the SLCD so the latter loses all meaning and function.
Thus, the Supreme Court considered the prosecution of Roma Drug to be no longer warranted.
“THE HEALTH OF THE PEOPLE WILL BE PUT AT RISK IF WE ADOPT THE RULE THAT NO FDA REGISTRATION IS REQUIRED PRIOR TO THE SALE OF PARALLEL IMPORTS OF MEDICINE.”
This decision created a furore in the pharmaceutical industry. It challenges a fundamental and internationally accepted notion, recognised by Republic Act 9502, that the primary objective of the state shall be to protect the health of the people, and shall provide access to not only affordable but also quality medicine. It is universally the rule that before any medicine is sold to the public, it should be tested and evaluated by the government, through the FDA, to ensure that it is safe, effective and stable.
This is the rationale of the SLCD, the FDA Act of 2009, Republic Act No. 9711 and the Consumer Act, Republic Act No. 7394. A perusal of Republic Act No. 9502 will disclose that it is neither in conflict nor inconsistent with these statutes. It does not provide, either expressly or by implication, that parallel imports of medicines are exempt from FDA registration before they can be sold to the public.
By allowing the parallel importation of medicine by third parties, Republic Act 9502 exempted the importer from any liability for infringement of patent: no more, no less. Likewise, use of the same brand for the imported drug will also excuse the importer from any liability for infringement of trademarks, provided the original brand has not been tampered with or modified.
The health of the people will be put at risk if we adopt the rule that no FDA registration is required prior to the sale of parallel imports of medicine. To prevent this situation, the validity of the SLCD, the FDA Act of 2009 and the Consumer Act mandating such registration must be put beyond any shadow of doubt. It is imperative that the legal doctrine promulgated in Roma Drug v. GlaxoSmithKline be abandoned.
Ignacio S. Sapalo is the managing partner at Sapalo Velez Bundang & Bulilan. He can be contacted at: info@sapalovelez.com