Wednesday, May 06, 2009

Parallel importation and BFAD

The Congressional Oversight Committee on RA 9502 (cheaper medicines law) held a public hearing yesterday to monitor the implementation of the law. Sen. Mar Roxas was reported to nearly blow his top when some BFAD and DOH officials could not answer him why some medicines are still "expensive".

Among the issues tackled was why parallel imported medicines (from India, Pakistan, etc.) take 6 months to reach the Philippines. Even the state-owned Philippine International Trading Corp. (PITC), in charge of parallel importation, admitted they do not have the capacity for such a big task, they need "third party importation" (private importers) which takes 6 months for the drugs to be delivered here.

My guess why it takes parallel imported medicines half-year to reach the country is that BFAD is putting some strict monitoring of those imported drugs. Remember that those cheap drugs are mostly manufactured in India -- where WHO says is the origin of about half of all counterfeit medicines in the world.

If some patients here will die, or at least develop new diseases and allergies because of those parallel imported medicines that are counterfeit or sub-standard, no one is exactly accountable. Not the importers, not the foreign manufacturers, not the foreign wholesalers, not the local retailers, not the physicians, not the legislators, not DOH or BFAD. That is why I noted earlier that parallel importation scheme is lousy and can be dangerous to patients.

To prevent this possibility, I think BFAD is trying to be strict in giving permits to those parallel imported drugs. Because if one patient will die and it is heavily publicized, BFAD will be put in a hot seat situation, will be subjected to endless congressional investigations.

Unlike if the manufacturer, importer and distributor is one and the same company, say GSK or Roche or Pfizer or Novartis or whatever multinational pharma, if one patient will die as a result of using their medicine, and it is proven that their medicine was defective, they are clearly accountable, they'll go to prison. BFAD will be out of the blame game there.

If my conjecture is correct or valid, then BFAD should say so and those legislators should listen.

One compromise there is that whoever is the importer of those parallel imported drugs, will have the SOLE responsibility and accountability, should something bad happens to the patients who took the drugs they brought in. BFAD will be safe. If it's the PITC that brought in any defective drugs, then they will be accountable.

I have heard of a few local cases where some patients tried to "save" on medicine prices, they bought those cheap medicines from India or Pakistan because the products by multinational pharma was expensive. After several treatment, the patient vomitted and developed new diseases. Could be counterfeit or sub-standard drugs. They ended up paying more in the hospital as their diseases have worsened or increased.

During the MeTA national forum last January, a WB-Philippines staff showed -- complete with pictures -- how some local government units (LGUs) that they inspected were dispensing expired, nearly expired, mis-stored and mis-handled medicines to the public. The medicine warehouses of those LGUs, cockroach, rats and garbage mixed in the same warehouse! Some warehouse personnel cannot tell how many drugs are on stock, and from those stocks, how many are expired, how many are still useful, etc.

Some medicines need storage of below 30 Celsius (or at lower temperature) all the time. But some warehouses don't even have thermometers, don't have air-con. For some warehouses with thermometers and air-con, when weekend or holiday comes, they turn off the air-con, room temperature can shoot up to 34 or 35 C, which can render those medicines ineffective immediately. But the LGUs were still dispensing those drugs. That is why during the open forum, I spoke up and said that it was possible that those LGUs and their health personnel may have killed some patients by dispensing expired or ineffective medicines.

Is this situation still under BFAD's nose? I guess not, should be under the DOH and LGUs' noses and responsibility.

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