Generic drugs are cheap, but are they safe?

We, concerned members of the Philippine Society of Experimental and Clinical Pharmacologists, a scientific community of pharmacologists mainly from the academe, are concerned over a proposed measure in the House of Representatives that is pushing for a "generics only, branded not included" provision in the proposed Cheaper Medicines Act.

The proposed measure in the Lower House – authored by Reps. Ferjenel Biron (himself an owner of a drug manufacturing and importing company) and Janette Garin – is pending deliberation by a bicameral conference committee this week. But both denied in a recent media forum the so-called "midnight insertion" which was finally admitted by the Department of Health in recent hearings at the House of Representatives.

At the Senate, the cheaper medicines bill authored by Sen. Mar Roxas, is not being questioned by the doctors since it involves only regulating the prices of drugs available in the market.

We, as doctors and patients occasionally, favor cheap medicines that generics drugs can offer. But we are equally concerned about ensuring the safety of the drugs we prescribe our patients and ourselves.

We do not oppose generics drugs per se but the questionable provision of "generics only, branded not included" in the Lower House version of the measure.

For the record, we support the full implementation of the Generics Law of 1988. We do not need more laws. What we need is strict enforcement of the existing laws.

But, we strongly and unequivocally oppose the questionable insertion of the "generics only, branded not included" provision in the proposed Cheaper Medicines Act because it virtually removes from the doctors the authority and capability to prescribe only the tried and tested quality medicines to their patients and leaves this crucial matter to the "discretion" of the sales clerks of the drugstores, who know nothing about the products they are selling.

Worse, this questionable insertion opens the floodgates to dumping and importation of substandard and unsafe medicines and encourages the operation of fly-by-night, opportunist generics drugs companies and drugstores.

Already, the government, through the Philippine International Trading Corp. (PITC) imports generics drugs from India and China, re-prices and sells them in Botika Ng Bayan which it oversees.

The private sector has also been importing generics drugs from the same countries and selling them locally at higher than Botika ng Bayan rates after obtaining clearance from BFAD.

These disturbing developments are creating problems that we might not be able to rectify over the short term and the long haul. Today, we already see entrepreneurs who hardly have any background in pharmacology and medicine venturing into this critical side of medical care. It is scary to even imagine big-time fruit traders or importers of used car and truck parts venturing into generic medicine or drugs distribution because of a huge, live captive market where they could literally make a "killing."

Generics and cheaper medicines are ideal medical care options that we want to succeed. We all would like these initiatives, whether carried by force of law or by scrupulous and well-intended programs of the private and government sectors, to prosper and deliver its much-ballyhooed benefits to the majority of our people, especially the poor.

But like the rest of the medical professionals in the country, we must prepare for such programs to make them successful. Let us prepare the government agencies tasked with handling and regulating these enterprises to be better equipped, manned and primed to the fullest.

Sadly and admittedly, there is a lot to be desired. The BFAD needs all the help it can get from government. It lacks the resources – money, facilities and equipment and manpower to perform its mandate to the fullest – to analyze and test the efficiency, potency and safety of generics drugs.

We therefore ask this crucial question: Who protects our patients and the millions of hapless Filipinos against the proliferation of fake, substandard drugs if even the government, through the Bureau of Food and Drug, lacks the resources and therefore the capability to determine the safety, bioequivalence and chemical analysis of food and drugs being sold in the market.

We urge government to provide total support and assistance to the BFAD in terms of resources – money and facilities and manpower, especially highly-skilled pharmacologists and bio-chemists, to be able to efficiently and effectively meet the demand and challenges of the Generics Law of 1988 and the proposed Cheaper Medicines Act.

Failing this, no amount of rhetoric and grandstanding can alleviate the pain and suffering that fake, substandard and ineffective medicine or drugs can inflict on the Filipino people. – DR. SONIA BONGALA, President, Philippine Society of Experimental and Clinical Pharmacologists