May 05 2008
Revisiting The Cheaper Medicines Bill Issue
It’s been almost 4 months since my last update on the still highly debated issue of Quality Affordable Medicines Bill or more popularly known as Cheaper Medicines Bill (see my other post too). And it seems a lot of people (and doctors too) are still confused over the provisions of this bill. But I think what everybody wants (including the doctors) is that something should be done with the high cost of medicines in this country.
According to Newsbreak, Congress has already passed the law (see the full article here).
It is expected that this law will result into increased competition, by allowing parallel importation of drugs from another country selling it at a lower price, without necessitating permission from the patent holder, and allowing local companies to start developing generic versions of the more expensive innovator brands earlier. It will also require drugstores to carry competing products, not only few products from selected large pharmaceutical companies. Price monitoring and control mechanisms are all set to be new responsibilities of DOH secretary.
I am glad that the provision requiring doctors to write ONLY the generic names has been removed. I still stand by my belief that requiring doctors to do so impinges on their right to preference. Prescriptions are already written with the generic and brand names and there’s absolutely no need to limit doctors to writing only the generic names as the patient still has the CHOICE whether to avail of the cheaper generics or the branded ones when they’re at the local drugstore already. At this point, I’ve to say, though, that I know of several cases in which the drugstore (which I will not mention the name anymore) refused to dispense the generic version of the drug, simply because the patient (the acquiring customer) is a senior citizen using his senior citizen card, and that the prescription, included a brand name of a specific drug. I find this rather ironic, for there were already several instances that drugstores do dispense prescription drugs even without the prescription. Selective implementation? It bewilders me, both as a citizen and as a doctor, why some drugstores intermittently tend to be unnecessarily strict when it comes to senior citizens buying their medications and using their senior citizen priviliges.
As I’ve said in my previous posts, people have to realize that it’s not actually the doctor’s prescription that is hindering them from availing cheaper medicines, but rather it’s the drugstore where they acquire their medicines. There were also instances when patients have difficulty looking for specific brands of medications (of which they’re already used to) because drugstores in the immediate vicinity only carry few brands of that particular medication. This is the part in which I agree that drugstores should be required to carry many brands in their stores, so that patients will not have a hard time looking for their maintenance medications.
But I’m more worried about parallel importation and the possibility that there will be no strict regulation of the quality of medicines manufactured. Since even private sector will be allowed to import drugs from other countries into the Philippines (as long as they follow BFAD guidelines, which remains to be elaborated), this will result into flooding of the drug market and thus, increasing competition, which is good. The problem, however, is if quality control will be stringent. BFAD should be responsible in analyzing which medications are good and which are fakes or not good. As what Dr. Marcelo Imasa, industrial pharmacist and medical practitioner, affiliated with one of the many generics pharmaceutical companies in the country, said in his talk last Tuesday on bioequivalence studies, there are still few bioequivalence studies of generics products conducted. Also, it is important that, if a pharmaceutical company producing a new drug (or a generic version of an innovator drug), it should undergo bioequivalence studies only in accredited research centers, such as those in University of the Philippines, University of Santo Tomas, and De La Salle University. Bioequivalence studies are important because it measures whether a specific drug is a pharmaceutical equivalent (same active ingredient, same dosage form, route of administration, identical strength or concentration) of the innovator drug. Meaning, it can be switched with the innovator drug (switchability) and will give the same expected results or better. Otherwise, it may be a pharmaceutical alternative (same therapeutic moiety, different salts, esters or complexes of moiety, different dosage form or strength). In simpler terms, the bioequivalence study determines if Drug B 5 mg can give the same effect as Drug A 5 mg. A drug is a pharmaceutical alternative if for example, Drug B 10 mg will only give the same effect as if using Drug A 5 mg. Bioequivalence studies measures liberation (release of drug from the dosage administration form and variable release mechanisms employed) and absorption (rate and extent of the drug entry into the systemic circulation of the user quantified by bioavailability) of the drug.
Dr. Imasa’s talk on bioequivalence was enlightening and interesting and I sort of wished that all the congressmen and senators were there to have listened to it, before wasting months of debate uninformed and misinformed of the important information needed to be able to make this law work at best and for everybody’s good (Dr. Imasa, if I recall it right, did admit to the fact that, of all doctors-researchers involved in these bioequivalence studies, none were invited to deliberate with the congressmen and senators regarding this bill, which, in my opinion, all the more show that our lawmakers might have been uninformed and/or misinformed during the deliberation of this law and this we ought to keep in mind as we observe, hopefully, its progress).
However, since it’s already been passed to law (if the article is accurate), then I guess what we should work on next is to be able to follow through with proper and strict implementation of the law, with careful attention to details that might need revision or removal.
Addendum:
- See Inquirer’s article on the newly ratified Cheaper Medicines Bill.





