Thursday, June 04, 2009

Counterfeit Drugs 3: The SCLD, RA 8203

There was a legal opinion column the other day by Atty. Jose C. Sison entitled “Heartless piece of legislation”. The author talked about the “Special Law on Counterfeit Drugs” (SLCD, RA 8203, approved on September 1996), in relation to the new “Cheaper medicines law” (RA 9502, approved June 2009).

The case is about a drugstore in the country which was raided by NBI and BFAD forces upon a search warrant issued by a local court, upon the request of GSK, a UK-based pharmaceutical company, because the said drugstore was selling some imported GSK products without the latter’s permission and suspected of being counterfeit drugs. Read the full article here,

RA 8203 or SLCD defined Counterfeit drug/medicine as:

“medicinal products with the correct ingredients but not in the amounts as provided hereunder, wrong ingredients, without active ingredients, with sufficient quantity of active ingredient, which results in the reduction of the drug’s safety, efficacy, quality, strength or purity. It is a drug which is deliberately and fraudulently mislabeled with respect to identity and/or source or with fake packaging, and can apply to both branded and generic products. It shall also refer to:

1) the drug itself or the container or labeling thereof or any part of such drug, container or labeling bearing without authorization the trademark, trade name or other identification mark or imprint or any likeness to that which is owned or registered in the Bureau of Patent, Trademark and Technology Transfer (BPTTT) in the name of another natural or juridical person;

2) a drug product refilled in containers by unauthorized persons if the legitimate labels or marks are used;

3) an unregistered imported drug product, except drugs brought in the country for personal use as confirmed and justified by accompanying medical records;

4) a drug which contains no amount of or a different active ingredient or less than eighty percent (80%) of the active ingredient it purports to possess as distinguished from an adulterated drug including reduction or loss or efficacy due to expiration.”

This is a comprehensive definition of counterfeit drug. Though I am not a lawyer, I will take a stab on this issue since it involves intellectual property rights (IPR), a subject which I have some familiarity with.

The author wrote,
“The imported drugs are identical in content with their Philippine-registered counterparts and not in any way adulterated or mislabeled. But Rody was accused of violating Section 4 (a) of R.A. 8203 also known as the Special Law on Counterfeit Drugs (SLCD) which classifies the said medicines as “counterfeit” because they are imported drug products not registered in the name of a natural or juridical person with the Bureau of Patent, Trademark and Technology Transfer of a trademark, trade name or other identification mark of a drug pursuant to Section 72 Part III of the Intellectual Property Code. Can Rody be prosecuted under said Act?

No. With the passage in 2008 of Republic Act 9502, also known as the “Universally Accessible Cheaper and Quality Medicines Act”, particularly Section 7 thereof, third parties like Rody have been granted unqualified right to import or possess “unregistered imported drugs”. It may be that R.A. 9502 did not expressly repeal any provision of the SLCD. However it is clear that the SLCD’s classification of “unregistered imported drugs” as “counterfeit drugs” and of the corresponding criminal penalties therefore are irreconcilably in conflict with R.A. 9502 since the latter indubitably grants private third persons the unqualified right to import or otherwise use such drugs.”

I do not know the other circumstances for the issuance of a search warrant by a local court. It is possible that the imported medicine was indeed made by GSK in other countries (India, China, Pakistan, etc.) that contained the correct active ingredients at the correct amount with the correct labeling. If this is so, then Atty. Sison is correct that the parallel importation provision of RA 9502 has decriminalized that practice and hence, Mr. Rody is not guilty.

However, if the imported product was made by GSQ or GSP or any other pharmaceutical company and copied the labels and trademark of GSK, produced a drug with the wrong ingredients, or correct ingredients but at a lower amount as specified, then RA 9502 cannot rescue Mr. Rody because that medicine is indeed a counterfeit. He may not know it because it was only sold to him by some importers who themselves do not know also that the drug was a counterfeit, they simply brought the medicine to the country for the simple reason that it is “cheap”.

How did GSK and BFAD know that the medicine is a fake? Maybe some patients who took the medicine bought from that drugstore suffered some allergies or other adverse effects, complained to GSK or DOH or BFAD, the latter bought the same medicine for testing and found that it is indeed a fake.

Atty. Sison then argued why SLCD is a “heartless piece of legislation”.

“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 law.”

Yes, an unregistered and counterfeit drug can indeed spell life or death for a patient in the Philippines or anywhere else. As reported in the most recent report published by International Policy Network (IPN) and co-sponsored by MG Thinkers, “Keeping it real: combating the spread of fake drugs in developing countries”, this is how fake drugs kill:

“As fake drugs usually contain insufficient bioavailable active ingredient, a patient who believes he is addressing his disease is in fact going untreated. The disease thus progresses, often leading to death, especially in children and the elderly. We estimate that approximately 700,000 deaths from malaria and tuberculosis are attributable to fake drugs.”

Since around 25 percent of all drug supply in developing countries are considered fake, a data coming from the WHO itself, this alarming situation should be fought. The SLCD, therefore, is a practical and humane piece of legislation that should be fully implemented if the country is serious in fighting the spread of fake and substandard drugs.

In the case of patients who took the counterfeit medicine and developed adverse and new disease, who will shoulder for their additional treatment, Mr. Rody and his drugstore? the physician, the importer, GSK, DOH or BFAD?

The issue of counterfeit drugs will be a continuing problem, a problem that was supposed to have been remedied by the SLCD , but contradicted and given new leeway by the parallel importation provision of the new cheaper medicines law.

A continuing and joint vigilance by BFAD and pharmaceutical companies here in the country, domestic or multinational, will help fight the spread of counterfeit drugs. We ordinary patients and citizens are helpless and ignorant in finding out whether the medicine that we take is real or simply made out of insufficient active ingredient, if not simply flour.

And to the basic question: how to bring down medicine prices?
My favorite candidates: One, abolish or drastically cut all those various taxes and fees on medicines. And two, invite all those big innovator companies from the US, Europe, Japan, India, etc., and let them compete here with their more powerful, good quality and safe medicines.

See also:
Counterfeit Drugs 1: On the Growing Fake Drugs Worldwide, December 21, 2007
Counterfeit Drugs 2: IPN Report on Fake Drugs in Poor Countries, May 29, 2009

1 comment:

Anonymous said...

with all due respect to the High Court, I beg to differ with their decision.Obviously, they havent been victimized by unregistered imported drugs. The decision talked about "registration" with the DTI-BTTTP;however BFAD also registered ALL drugs, whether imported or locally manufactured.The subject products in the case which were parallel imported are NOT registered with the BFAD.The SLCD only considers as counterfeit drugs that are not registered with BTTP and did not consider registration with BFAD.