Amid proliferation of fake over-the-counter drugs

AMID the proliferation lately of fake over-the-counter (OTC) medicines, Camarines Sur legislators led by Rep. LRay Villafuerte on Tuesday said they want the 19th Congress to toughen up the Food and Drug Administration (FDA) on pharmacovigilance, so it can crack down hard on manufacturers and dealers of counterfeit or substandard drugs for common ailments like fever, colds or coughs that are even sold online.

They propose that the FDA establish a pharmacovigilance unit within its Center for Drug Regulation and Research (CDRR), under a measure that Villafuerte and his peers had introduced with the goal of imposing heavier penalties, including life imprisonment, against the largescale sale, manufacture, distribution, and/or possession of counterfeit pharmaceutical goods.

To strengthen our country’s system of pharmacovigilance or the detection and assessment of the efficacy of medicines, Villafuerte and his fellow authors likewise mandate the FDA in House Bill (HB) No. 3984 to develop a consumer advocacy and education program, in partnership with private organizations and relevant government agencies, on the dangers of using bogus or substandard pharmaceutical items.

These Camarines Sur solons made the pitch as the FDA has been issuing advisories warning the public to exercise care when buying OTC medicines , following its discovery of counterfeit versions of assorted commonly used drugs.

In an earlier advisory, FDA Director-General Samuel Zacate said his office had found counterfeit versions of OTC medicines Kremil S, Alaxan FR, Biogesic, Medicol Advance, Bioflu and Tuseran Forte in the local market.

The FDA, in a follow-up warning this August, said that on top of these OTC drugs, it has also found other counterfeit medicines locally, including Solmux and Diatabs capsules.

Counterfeit medicine is defined as a product “with the correct ingredients but not in the amounts as provided, wrong ingredients, without active ingredients, with insufficient quantity of active ingredient, which results in the reduction of the drug’s safety, efficacy, quality, strength, or purity.”

The FDA said counterfeit products “pose potential danger or injury to consumers.”

The former CamSur governor said that the FDA had asked help from the local government units (LGU) and law enforcement agencies to ensure the counterfeit products are taken out of the market.

The FDA had cautioned the public on the potential health risks associated with the use of counterfeit medicines, and warned all drug outlets and other establishments not to sell or dispense counterfeit drugs, as the importation or sale of such products are in violation of Republic Act (RA) No. 9711, or the FDA Act of 2009, and RA 8203, or the Special Law on Counterfeit Drugs of 1996.

Once enacted into law, HB 3894 will complement Republic Act (RA) No. 11223, or the Universal Health Care (UHC) Act, which carries out a comprehensive outpatient drug benefit program and ensures that Filipinos have a wider and easier access to quality medicines and health care, Villafuerte said.

Villafuerte explained that in HB 3984, the FDA is tasked to coordinate with the Department of Health (DOH) and other stakeholders in strengthening the existing National Policy and Program on Pharmacovigilance by pursuing initiatives aimed at strengthening the capability of the government and other stakeholders to effectively check counterfeit pharmaceutical products, prevent their proliferation, and prosecute offenders.

Within 120 days from the effectivity of this Act, “the FDA shall establish a pharmacovigilance unit within its CDRR with appropriate staffing of officers and personnel and experts and be regularly allocated with appropriate budget,” Villafuerte said in HB 3984, which he had introduced with fellow CamSur Reps. Miguel Luis Villafuerte and Tsuyoshi Anthony Horibata plus Bicol Saro Rep. Brian Raymund Yamsuan.

On the FDA’s website, pharmacovigilance is defined as “the science and activities relating to the detection, assessment, understanding, and prevention of adverse effects or any other medicine/vaccine related problem.”

The FDA states that before it approves a medicine or vaccine, the safety and efficacy of these medicines are first “clinically proven through rigorous research with the aid of people who volunteer to take part in clinical trials … Pharmacovigilance plays an important role in making sure that the medicines and vaccines we use are continuously providing benefits rather than the risk of having side effects.”

“The FDA must step its game on pharmacovigilance as the proliferation of bogus medicines are becoming more complex and compounded,” Villafuerte, who is president of the National Unity Party (NUP), said.

“Being an archipelago, the Philippines is vulnerable to the illegal entry of smuggled goods including medicines,” Villafuerte said. “Additionally, cases of counterfeit pharmaceutical products entering and moving through countries worldwide are increasing with the growing sale of such contraband via the Internet.”

To better address the real and increasing threat that counterfeit pharmaceutical goods present to Filipinos, Villafuerte said that alongside beefing up the powers of the FDA to check fake goods and run after their producers, distributors and sellers, HB 3894 aims to:

· Strengthen the prohibitions against counterfeit pharmaceutical products;

· Declare the manufacture, importation, distribution, sale, offering for sale, donation, trafficking, brokering, exportation, or possession of counterfeit pharmaceutical products as acts of “economic sabotage;” and

· Provide stricter penalties for violations of this Act.

“Our medicines must conform to national and international standards of quality, efficacy, and safety. If they don’t, then these drugs may potentially harm and even create additional health risks for our people,” Villafuerte said.

HB 3984 provides that, in a routine or regular inspection of a factory or warehouse of pharmaceutical products, once the FDA’s Food and Drug Regulation Officers (FDROs) suspect certain stocks as counterfeit ones, it is empowered to conduct an inventory, segregate and seal the suspected stocks, and collect samples for examination as to these drugs’ genuineness and authenticity.

In case the FDROs come across information about the presence of counterfeit medicines in the possession of any person or establishment, the bill empowers them, too, to undertake a verification process, following the existing system and procedure in the conduct of case build-up, investigation or other appropriate interventions adopted by the FDA.

The bill authorizes the FDROs to seize the counterfeit pharmaceutical products found in establishments and take them into custody; and then proceed with the filing of criminal complaints and/or administrative complaints against the offenders.

If the counterfeit pharmaceutical products are located in private residences, the bill authorizes the FDROs to secure valid search warrants from competent courts, and, after obtaining such writs, seize such counterfeit pharmaceutical products, take them into custody, and then proceed with the filing of criminal complaints and/or administrative complaints against the guilty parties.

After filing the applicable court proceedings against firms or persons caught in possession of counterfeit drugs in their establishments or homes, respectively, the FDA is directed by HB 3984 to file the appropriate action against the registered pharmacists with the Professional Regulations Commission (PRC) for the imposition of the suitable penalties, as provided under Republic Act (RA) No. 10918 or the Philippine Pharmacy Act.

HB 3984 authorizes the FDA director general to call on the assistance of any Department, Office, Agency, Organization or Body for the effective implementation of the provisions of this Act.

RA 8203, or the Special Law on Counterfeit Drugs of 1996, defines counterfeit medicines, declares prohibited acts, identifies liable parties, and imposes administrative sanctions and penalties involved.

Villafuerte explained that HB 3984 is needed to fight the proliferation of counterfeit drugs because RA 8203’s implementation has been enfeebled by several cases on counterfeit drugs in which the Supreme Court (SC) had issued rulings favoring the accused.

In one case, the SC stated that RA 9502, or the Universally Accessible Cheaper and Quality Medicines Act of 2008, nullified the purpose of RA 8203, he said, “so the latter has lost all its meaning and function.”

He said that several laws written by the Congress, including RA 9502, or the FDA Act of 2009, and RA 10918, or the Philippine Pharmacy Law, have inconsistent definitions of “drugs,” hence affecting certain provisions of RA 8203.

HB 3984 defines counterfeit pharmaceutical products as those that either have no active ingredients, have active ingredients but not the correct amounts as claimed, or have wrong ingredients—thereby affecting the safety, efficacy, quality, strength and/or purity of these types of drugs.

Products that are deliberately and fraudulently misrepresented with respect to their respective identities, compositions and/or sources are also classified as counterfeit drugs, under the bill.

Any offense is considered “economic sabotage” under the bill when the amount of the counterfeit product or products involved is P1 million or higher, as valued by the FDA.

Although possession of counterfeit products is considered a crime under the bill, any person shall be exempted from liability if he or she can:

· Present official receipts (ORs), sales invoices or other legally acceptable documents proving that the drugs had been purchased from a drugstore, hospital pharmacy or dispensary, or from any other person or place duly licensed to sell and/or dispense pharmaceutical products; or

· Present certificates and other documents proving the importation or exportation of the counterfeit pharmaceutical products found in his or possession, as required by existing laws, including those documents covering the commercial transactions involving counterfeit pharmaceutical products.

For acts of economic sabotage, the penalties are life imprisonment and a fine ranging from P5 million to P10 million.

Below cases involving economic sabotage, the administrative penalties under HB 3984 include fines of P100,000 to P5 million and the suspension or revocation of the license to do business; while the criminal punishment include prison terms ranging from 6 months to 15 years.

Life imprisonment and a fine of P500,000 to P5 million is the penalty , under the bill, in cases where the counterfeit medicine is proven to be the proximate cause of death of a victim who unknowingly purchased and took this drug.

AUTHOR PROFILE

Ryan Ponce Pacpaco